topiramate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
2706 97240-79-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • topiramate
  • beta-D-fructopyranose sulfamate
  • epitoma
  • epitomax
  • topamac
  • topamax
  • topimax
  • topomax
  • topina
The precise mechanisms by which topiramate exerts its anticonvulsant and migraine prophylaxis effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and migraine prophylaxis. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
  • Molecular weight: 339.36
  • Formula: C12H21NO8S
  • CLOGP: 0.04
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 1
  • TPSA: 115.54
  • ALOGS: -1.70
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 9.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.65 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.27 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.72 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 34.80 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.562 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 5.728 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 22.029 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.350 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 70.340 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 77.330 % High 1
herg hERG pIC50 4.012 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.324 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 4.009 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 77.250 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,ITK,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,SIK2,TEK 22
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.396 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 7.047 High 1
mh-clint Mouse hepatocyte intrinsic clearance 14.825 High 1
mppb Mouse plasma protein binding (% unbound) 62.450 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 15.776 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 71.530 % High 1
rat-kpuu-brain Rat brain Kpuu 0.074 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.358 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 87.350 % High 1
rppb Rat plasma protein binding (% unbound) 60.490 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 814.704 uM High 1

Approvals:

DateAgencyCompanyOrphan
July 1, 2007 PMDA
Dec. 24, 1996 FDA JANSSEN PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Angle closure glaucoma 1194.01 9.96 376 191477 2399 90434195
Seizure 987.74 9.96 1406 190447 151223 90285371
Drug ineffective for unapproved indication 593.87 9.96 719 191134 65925 90370669
Epilepsy 575.62 9.96 787 191066 81419 90355175
Multiple-drug resistance 510.35 9.96 273 191580 7503 90429091
Taste disorder 431.96 9.96 590 191263 60956 90375638
Myopia 430.82 9.96 160 191693 1772 90434822
Blepharospasm 423.57 9.96 554 191299 54891 90381703
Product substitution issue 420.59 9.96 330 191523 17678 90418916
Renal tubular acidosis 420.20 9.96 165 191688 2150 90434444
Completed suicide 414.18 9.96 935 190918 144123 90292471
Choroidal effusion 411.82 9.96 124 191729 665 90435929
Migraine 368.20 9.96 1059 190794 189333 90247261
Product quality issue 327.37 9.96 596 191257 78729 90357865
Nail disorder 322.57 9.96 503 191350 58564 90378030
Paraesthesia 316.86 9.96 1206 190647 249120 90187474
Visual perseveration 308.15 9.96 62 191791 13 90436581
Gastrooesophageal reflux disease 304.10 9.96 907 190946 165430 90271164
Depression 300.02 9.96 1346 190507 299255 90137339
Product use in unapproved indication 283.59 9.96 1434 190419 334802 90101792
Status epilepticus 282.16 9.96 268 191585 18606 90417988
Back injury 268.57 9.96 407 191446 46215 90390379
Onychomadesis 268.45 9.96 404 191449 45594 90391000
Intentional self-injury 265.31 9.96 319 191534 29015 90407579
Memory impairment 261.74 9.96 965 190888 196279 90240315
Anaemia 259.91 9.96 219 191634 352583 90084011
Product label confusion 247.95 9.96 273 191580 22577 90414017
Suicidal ideation 244.95 9.96 506 191347 73349 90363245
Pyrexia 238.17 9.96 668 191185 659817 89776777
Medication overuse headache 234.39 9.96 96 191757 1405 90435189
Off label use 204.27 9.96 3368 188485 1098884 89337710
Finger deformity 202.09 9.96 296 191557 32601 90403993
Adverse reaction 199.65 9.96 279 191574 29433 90407161
Febrile neutropenia 198.07 9.96 46 191807 158303 90278291
Nephrolithiasis 188.93 9.96 358 191495 48727 90387867
Abortion spontaneous 179.98 9.96 371 191482 53685 90382909
Acute kidney injury 177.21 9.96 252 191601 320135 90116459
Neck pain 176.52 9.96 587 191266 113376 90323218
Acute myopia 172.13 9.96 45 191808 127 90436467
Infection 170.15 9.96 317 191536 361777 90074817
Wound infection 170.12 9.96 554 191299 105848 90330746
Malignant neoplasm progression 167.97 9.96 16 191837 106854 90329740
Generalised tonic-clonic seizure 164.37 9.96 278 191575 34625 90401969
Breast cancer stage III 164.28 9.96 471 191382 83976 90352618
Pruritus 163.29 9.96 593 191260 540932 89895662
Intentional overdose 162.29 9.96 502 191351 93332 90343262
Petit mal epilepsy 161.32 9.96 111 191742 4847 90431747
Drug ineffective 160.40 9.96 3943 187910 1380355 89056239
Overdose 159.20 9.96 709 191144 157000 90279594
Neutropenia 156.63 9.96 147 191706 224757 90211837
Peripheral venous disease 155.50 9.96 460 191393 83461 90353133
Disease progression 152.85 9.96 70 191783 156545 90280049
Onychomycosis 150.57 9.96 278 191575 37098 90399496
Somnolence 146.40 9.96 848 191005 208236 90228358
Choroidal detachment 144.74 9.96 44 191809 245 90436349
Irritability 139.59 9.96 262 191591 35400 90401194
Metabolic acidosis 139.26 9.96 341 191512 55335 90381259
Hypoaesthesia 138.31 9.96 1137 190716 313073 90123521
Sleep disorder due to general medical condition, insomnia type 136.11 9.96 51 191802 128643 90307951
Myoclonic epilepsy 135.31 9.96 67 191786 1560 90435034
Acidosis hyperchloraemic 134.88 9.96 56 191797 850 90435744
Thrombocytopenia 133.30 9.96 147 191706 208578 90228016
Drug intolerance 133.25 9.96 1491 190362 446100 89990494
Exposure during pregnancy 129.20 9.96 906 190947 237504 90199090
Hyperammonaemic encephalopathy 126.41 9.96 76 191777 2623 90433971
Disturbance in attention 123.68 9.96 294 191559 46815 90389779
Coeliac disease 121.03 9.96 282 191571 44328 90392266
Bursitis 118.92 9.96 573 191280 131081 90305513
Myokymia 118.68 9.96 23 191830 0 90436594
Dyspnoea 117.44 9.96 1246 190607 879709 89556885
Aggression 117.17 9.96 206 191647 26462 90410132
Psychotic disorder 116.75 9.96 225 191628 31005 90405589
Cognitive disorder 114.18 9.96 365 191488 69042 90367552
Pleural effusion 114.11 9.96 47 191806 111944 90324650
Atrial fibrillation 113.82 9.96 71 191782 133540 90303054
Joint swelling 112.47 9.96 616 191237 502684 89933910
Cough 111.76 9.96 403 191450 368559 90068035
Cardiac failure 111.49 9.96 46 191807 109450 90327144
Haemoglobin decreased 111.40 9.96 107 191746 161849 90274745
Pancytopenia 109.42 9.96 59 191794 120204 90316390
Flat anterior chamber of eye 107.19 9.96 25 191828 35 90436559
Drug resistance 106.11 9.96 213 191640 30236 90406358
Rheumatoid factor positive 99.89 9.96 130 191723 171520 90265074
Infusion site reaction 99.56 9.96 159 191694 18880 90417714
Live birth 98.14 9.96 379 191474 78728 90357866
Erythema 97.09 9.96 213 191640 229033 90207561
Facet joint syndrome 96.74 9.96 439 191414 97950 90338644
Obesity 96.57 9.96 461 191392 105046 90331548
Sepsis 95.85 9.96 145 191708 179669 90256925
Serotonin syndrome 94.69 9.96 232 191621 37655 90398939
Headache 93.86 9.96 2439 189414 860307 89576287
Ciliary body disorder 93.83 9.96 20 191833 12 90436582
Toxicity to various agents 93.00 9.96 975 190878 286871 90149723
Liver function test increased 92.09 9.96 390 191463 84465 90352129
Diarrhoea 90.10 9.96 1423 190430 937767 89498827
Myelosuppression 89.84 9.96 6 191847 53585 90383009
Arthritis 88.14 9.96 136 191717 167179 90269415
Partial seizures 88.01 9.96 92 191761 7168 90429426
Arthralgia 87.83 9.96 1142 190711 777380 89659214
Neovascularisation 87.13 9.96 50 191803 1580 90435014
Weight increased 85.48 9.96 1300 190553 416627 90019967
Focal dyscognitive seizures 85.27 9.96 63 191790 3081 90433513
Blood creatinine increased 84.81 9.96 55 191798 101331 90335263
Interstitial lung disease 82.95 9.96 29 191824 76376 90360218
Death 82.72 9.96 596 191257 455955 89980639
Paradoxical drug reaction 82.63 9.96 80 191773 5686 90430908
Hyponatraemia 80.96 9.96 98 191755 133440 90303154
Fatigue 80.67 9.96 1846 190007 1152177 89284417
Abnormal behaviour 79.70 9.96 159 191694 22469 90414125
Lip dry 78.94 9.96 422 191431 100533 90336061
Anorexia nervosa 78.74 9.96 28 191825 271 90436323
Hepatitis 78.22 9.96 327 191526 70412 90366182
Renal impairment 78.05 9.96 65 191788 105356 90331238
Tremor 77.09 9.96 572 191281 152601 90283993
Mucosal inflammation 75.58 9.96 15 191838 57610 90378984
Oedema 74.61 9.96 199 191654 200096 90236498
Pneumonia 74.10 9.96 930 190923 637129 89799465
Intraocular pressure increased 73.94 9.96 83 191770 7010 90429584
Product use issue 72.81 9.96 1040 190813 328879 90107715
Sinusitis 71.66 9.96 429 191424 342659 90093935
Gastrointestinal haemorrhage 71.43 9.96 52 191801 90196 90346398
Renal failure 71.40 9.96 104 191749 130903 90305691
Swollen tongue 71.36 9.96 237 191616 45719 90390875
Mitochondrial DNA mutation 70.52 9.96 29 191824 429 90436165
Hyperammonaemia 69.61 9.96 77 191776 6398 90430196
Cardiac failure congestive 68.09 9.96 65 191788 98629 90337965
Oedema peripheral 67.71 9.96 298 191555 257617 90178977
Grip strength decreased 67.69 9.96 380 191473 92196 90344398
Dehydration 66.66 9.96 201 191652 194246 90242348
Hyperkalaemia 66.60 9.96 27 191826 64937 90371657
Septic shock 64.67 9.96 50 191803 84110 90352484
Infantile spasms 64.28 9.96 23 191830 227 90436367
Cerebral venous thrombosis 63.93 9.96 47 191806 2281 90434313
Propofol infusion syndrome 63.47 9.96 38 191815 1301 90435293
Blood pressure systolic increased 61.88 9.96 23 191830 58322 90378272
Aura 61.52 9.96 36 191817 1181 90435413
Maculopathy 60.84 9.96 47 191806 2459 90434135
Suicide attempt 59.50 9.96 316 191537 75083 90361511
Platelet count decreased 59.01 9.96 126 191727 136843 90299751
Coma blister 58.69 9.96 19 191834 134 90436460
Gait inability 58.55 9.96 519 191334 145937 90290657
Blindness 57.39 9.96 154 191699 26414 90410180
White blood cell count decreased 57.09 9.96 173 191680 166936 90269658
Hypomagnesaemia 56.79 9.96 5 191848 35583 90401011
Hypocitraturia 56.76 9.96 11 191842 0 90436594
Hypercholesterolaemia 56.70 9.96 387 191466 100505 90336089
Hepatic enzyme 56.50 9.96 63 191790 5281 90431313
Neoplasm progression 55.45 9.96 13 191840 44473 90392121
Bipolar disorder 55.39 9.96 81 191772 8904 90427690
Bradyphrenia 54.93 9.96 74 191779 7538 90429056
Multiple sclerosis 54.81 9.96 156 191697 27684 90408910
Intentional product use issue 54.50 9.96 700 191153 216192 90220402
Neuropathy peripheral 54.15 9.96 132 191721 136838 90299756
Hip arthroplasty 53.97 9.96 49 191804 76159 90360435
Photophobia 53.95 9.96 131 191722 21138 90415456
Multiple sclerosis relapse 53.37 9.96 236 191617 52069 90384525
Hypocholesterolaemia 53.24 9.96 67 191786 6382 90430212
Plasma cell myeloma 52.77 9.96 11 191842 40817 90395777
Drug withdrawal convulsions 52.18 9.96 35 191818 1465 90435129
Joint range of motion decreased 51.82 9.96 476 191377 135167 90301427
Night sweats 51.82 9.96 457 191396 128309 90308285
Hostility 51.66 9.96 41 191812 2232 90434362
Change in seizure presentation 51.08 9.96 25 191828 567 90436027
Injection site reaction 51.03 9.96 352 191501 91728 90344866
Visual field defect 50.70 9.96 69 191784 7097 90429497
Anhidrosis 50.64 9.96 18 191835 174 90436420
Aphasia 50.56 9.96 202 191651 42610 90393984
Rash 50.35 9.96 1292 190561 794808 89641786
Discomfort 50.17 9.96 357 191496 273978 90162616
Dry mouth 50.09 9.96 603 191250 183456 90253138
Tonic convulsion 49.79 9.96 36 191817 1702 90434892
Libido increased 49.68 9.96 36 191817 1708 90434886
Osteonecrosis of jaw 49.59 9.96 11 191842 39092 90397502
Neutrophil count decreased 49.47 9.96 47 191806 71485 90365109
Skin ulcer 49.43 9.96 22 191831 50053 90386541
Sluggishness 49.34 9.96 62 191791 5897 90430697
Corneal oedema 49.11 9.96 37 191816 1864 90434730
Alexia 48.98 9.96 10 191843 3 90436591
Sedation 48.88 9.96 217 191636 47954 90388640
Drug interaction 48.61 9.96 839 191014 275614 90160980
Haematochezia 48.57 9.96 47 191806 70866 90365728
Therapeutic response unexpected 48.45 9.96 128 191725 21752 90414842
Drug abuse 48.14 9.96 319 191534 82028 90354566
Withdrawal syndrome 48.09 9.96 130 191723 22394 90414200
Visual snow syndrome 47.96 9.96 13 191840 44 90436550
Muscular weakness 47.77 9.96 657 191196 206009 90230585
Self-induced vomiting 47.08 9.96 13 191840 48 90436546
Amenorrhoea 46.96 9.96 87 191766 11635 90424959
Type 2 diabetes mellitus 46.52 9.96 645 191208 202599 90233995
Heat stroke 46.38 9.96 27 191826 877 90435717
Knee arthroplasty 46.34 9.96 65 191788 83117 90353477
Therapeutic product effect incomplete 46.29 9.96 620 191233 193276 90243318
Atonic seizures 46.23 9.96 26 191827 790 90435804
Vision blurred 45.71 9.96 394 191459 109899 90326695
Abdominal discomfort 45.65 9.96 723 191130 476605 89959989
Macular degeneration 45.57 9.96 12 191841 37958 90398636
Ascites 45.54 9.96 22 191831 47718 90388876
Lactic acidosis 45.54 9.96 25 191828 50438 90386156
Bone marrow failure 45.28 9.96 7 191846 32214 90404380
CSF oligoclonal band present 44.86 9.96 21 191832 430 90436164
Migraine with aura 44.69 9.96 44 191809 3192 90433402
Diplopia 44.51 9.96 148 191705 28566 90408028
Abdominal distension 44.31 9.96 447 191406 130154 90306440
Rectal haemorrhage 43.80 9.96 67 191786 82677 90353917
Dizziness 43.30 9.96 1589 190264 587695 89848899
Crying 43.20 9.96 136 191717 25509 90411085
Dysphonia 42.88 9.96 254 191599 62830 90373764
Mood altered 42.85 9.96 105 191748 17039 90419555
Overlap syndrome 42.80 9.96 70 191783 8478 90428116
Lennox-Gastaut syndrome 42.55 9.96 18 191835 287 90436307
Hallucination, auditory 42.25 9.96 100 191753 15875 90420719
Blood prolactin increased 42.15 9.96 45 191808 3592 90433002
Salivary gland calculus 42.00 9.96 16 191837 191 90436403
Infusion related reaction 41.98 9.96 625 191228 416155 90020439
Fanconi syndrome 41.93 9.96 34 191819 1909 90434685
Hypoxia 41.92 9.96 55 191798 72344 90364250
Benign familial pemphigus 41.86 9.96 9 191844 6 90436588
Urinary tract infection 41.85 9.96 429 191424 305203 90131391
Melaena 41.76 9.96 11 191842 34786 90401808
Mood swings 41.73 9.96 117 191736 20585 90416009
Normal newborn 41.31 9.96 126 191727 23236 90413358
Alice in wonderland syndrome 41.10 9.96 11 191842 35 90436559
Cellulitis 41.05 9.96 82 191771 91255 90345339
Dyspnoea exertional 40.76 9.96 56 191797 72232 90364362
Mania 40.19 9.96 91 191762 14033 90422561
Suicidal behaviour 39.89 9.96 39 191814 2805 90433789
Myocardial infarction 39.66 9.96 105 191748 105867 90330727
Fat embolism syndrome 39.55 9.96 11 191842 42 90436552
Magnetic resonance imaging head abnormal 39.55 9.96 37 191816 2519 90434075
Back pain 39.51 9.96 455 191398 316720 90119874
Sleep disorder 38.86 9.96 612 191241 197418 90239176
Speech disorder 38.70 9.96 195 191658 45390 90391204
Constipation 38.62 9.96 393 191460 280002 90156592
Oxygen saturation decreased 38.35 9.96 109 191744 107374 90329220
Blood gases abnormal 38.20 9.96 24 191829 897 90435697
Swollen joint count increased 38.06 9.96 115 191738 111091 90325503
Agitation 38.06 9.96 258 191595 66840 90369754
Slow speech 37.91 9.96 32 191821 1901 90434693
Blood pressure increased 37.84 9.96 253 191600 196964 90239630
Intellectual disability 37.67 9.96 27 191826 1259 90435335
Dyspepsia 37.61 9.96 609 191244 197551 90239043
Basal cell carcinoma 37.41 9.96 12 191841 33377 90403217
Gene mutation 37.20 9.96 33 191820 2097 90434497
Colitis 36.67 9.96 57 191796 69885 90366709
Bulimia nervosa 36.43 9.96 19 191834 495 90436099
Product physical issue 36.32 9.96 52 191801 5608 90430986
Hypervolaemia 36.30 9.96 12 191841 32745 90403849
Post-traumatic neck syndrome 36.25 9.96 35 191818 2479 90434115
Phonophobia 36.01 9.96 18 191835 428 90436166
Congenital anomaly 35.96 9.96 55 191798 6292 90430302
Fibromyalgia 35.88 9.96 625 191228 205644 90230950
Soft tissue injury 35.72 9.96 32 191821 2060 90434534
Malaise 35.66 9.96 956 190897 585030 89851564
Pneumonitis 35.54 9.96 25 191828 44145 90392449
Mental disorder 35.41 9.96 149 191704 32169 90404425
Somnambulism 35.33 9.96 54 191799 6174 90430420
Cytokine release syndrome 35.21 9.96 8 191845 27965 90408629
C-reactive protein increased 35.00 9.96 559 191294 180830 90255764
Liver disorder 34.99 9.96 135 191718 121134 90315460
Swelling face 34.96 9.96 293 191560 81059 90355535
Acute myocardial infarction 34.96 9.96 15 191838 34875 90401719
Hepatic cytolysis 34.84 9.96 11 191842 30905 90405689
Metastases to liver 34.77 9.96 9 191844 28798 90407796
Inflammation 34.69 9.96 551 191302 178041 90258553
Migraine without aura 34.69 9.96 21 191832 734 90435860
Arthropathy 34.57 9.96 556 191297 365686 90070908
Nasopharyngitis 34.56 9.96 630 191223 406474 90030120
Partial seizures with secondary generalisation 34.44 9.96 18 191835 471 90436123
Concussion 34.44 9.96 74 191779 11017 90425577
Angiofibroma 34.42 9.96 12 191841 109 90436485
Injury 34.33 9.96 598 191255 196751 90239843
Muscle spasms 34.22 9.96 735 191118 251148 90185446
Nephrocalcinosis 34.12 9.96 25 191828 1207 90435387
Enzyme inhibition 34.02 9.96 9 191844 27 90436567
Iris adhesions 33.79 9.96 17 191836 410 90436184
Ammonia increased 33.76 9.96 47 191806 4939 90431655
Apathy 33.52 9.96 73 191780 10967 90425627
Muscle twitching 33.38 9.96 120 191733 24082 90412512
Visual acuity reduced 33.08 9.96 117 191736 23293 90413301
Influenza 32.94 9.96 167 191686 139097 90297497
Metastases to bone 32.70 9.96 7 191846 25498 90411096
Blindness transient 32.53 9.96 44 191809 4499 90432095
Oligomenorrhoea 32.48 9.96 23 191830 1052 90435542
Major depression 32.37 9.96 68 191785 9967 90426627
Hypophosphataemic osteomalacia 32.33 9.96 14 191839 237 90436357
Necrotising colitis 32.28 9.96 25 191828 1313 90435281
Upper gastrointestinal haemorrhage 32.27 9.96 5 191848 22971 90413623
Sternal fracture 32.20 9.96 35 191818 2852 90433742
Foot deformity 31.86 9.96 48 191805 59603 90376991
Hepatotoxicity 31.84 9.96 30 191823 45812 90390782
Extrapyramidal disorder 31.75 9.96 91 191762 16212 90420382
Blood bicarbonate decreased 31.66 9.96 36 191817 3083 90433511
Sudden unexplained death in epilepsy 31.57 9.96 16 191837 392 90436202
Respiratory arrest 31.52 9.96 147 191706 33164 90403430
Pleocytosis 31.46 9.96 22 191831 986 90435608
Underdose 31.42 9.96 209 191644 53808 90382786
Hypotension 31.37 9.96 492 191361 324905 90111689
Coronary artery disease 31.30 9.96 16 191837 33607 90402987
Joint dislocation 31.17 9.96 29 191824 44553 90392041
Anger 31.13 9.96 81 191772 13639 90422955
Hypersensitivity 31.09 9.96 729 191124 453948 89982646
Cervix neoplasm 30.98 9.96 13 191840 203 90436391
Ciliary muscle spasm 30.96 9.96 6 191847 0 90436594
Herpes zoster 30.89 9.96 100 191753 94544 90342050
Diverticulitis 30.88 9.96 30 191823 45157 90391437
Hypercalcaemia 30.84 9.96 17 191836 34223 90402371
Peritonitis 30.82 9.96 3 191850 19702 90416892
Cytomegalovirus infection 30.82 9.96 9 191844 26593 90410001
Myoclonus 30.78 9.96 100 191753 19068 90417526
Epistaxis 30.61 9.96 86 191767 85039 90351555
Rash erythematous 30.51 9.96 57 191796 65047 90371547
Anxiety 30.42 9.96 865 190988 308907 90127687
Drug withdrawal syndrome 30.37 9.96 131 191722 28592 90408002
Congenital ureterocele 30.24 9.96 8 191845 24 90436570
Affective disorder 30.17 9.96 57 191796 7736 90428858
Anti-cyclic citrullinated peptide antibody 30.12 9.96 10 191843 27211 90409383
Productive cough 29.87 9.96 75 191778 76988 90359606
Leukopenia 29.78 9.96 111 191742 100599 90335995
Pneumocystis jirovecii pneumonia 29.69 9.96 5 191848 21611 90414983
Psoriatic arthropathy 29.64 9.96 662 191191 227673 90208921
Disseminated intravascular coagulation 29.55 9.96 5 191848 21533 90415061
Blood bilirubin increased 29.55 9.96 29 191824 43441 90393153
Mental impairment 29.39 9.96 90 191763 16630 90419964
Tearfulness 29.33 9.96 43 191810 4737 90431857
Brugada syndrome 29.28 9.96 16 191837 459 90436135
Creatinine renal clearance decreased 29.24 9.96 3 191850 18896 90417698
Anticonvulsant drug level decreased 29.16 9.96 24 191829 1376 90435218
Contusion 29.12 9.96 366 191487 250850 90185744
Alanine aminotransferase increased 29.08 9.96 140 191713 118198 90318396
Food allergy 28.83 9.96 9 191844 25469 90411125
Cholestasis 28.61 9.96 21 191832 36278 90400316
Pulmonary oedema 28.53 9.96 55 191798 62025 90374569
Thalamic infarction 28.16 9.96 16 191837 496 90436098
Hepatic function abnormal 28.01 9.96 34 191819 46254 90390340
Insomnia 27.88 9.96 913 190940 332561 90104033
Acute myeloid leukaemia 27.86 9.96 5 191848 20635 90415959
Full blood count decreased 27.83 9.96 14 191839 29675 90406919
Vertigo 27.68 9.96 247 191606 69564 90367030
Simple partial seizures 27.63 9.96 18 191835 717 90435877
Aspartate aminotransferase increased 27.56 9.96 118 191735 102819 90333775
Hallucination, tactile 27.55 9.96 15 191838 427 90436167
Bronchitis 27.45 9.96 200 191653 152727 90283867
Fluid retention 27.43 9.96 95 191758 87996 90348598
Cystitis 27.39 9.96 63 191790 66655 90369939
Status migrainosus 27.36 9.96 11 191842 153 90436441
Sciatica 27.27 9.96 116 191737 101266 90335328
Dysphemia 27.12 9.96 33 191820 3037 90433557
Electroencephalogram abnormal 26.82 9.96 38 191815 4058 90432536
Toxic epidermal necrolysis 26.72 9.96 18 191835 32510 90404084
Femur fracture 26.69 9.96 35 191818 46047 90390547
Pulmonary arterial hypertension 26.65 9.96 11 191842 26176 90410418
Anaphylactic shock 26.64 9.96 17 191836 31600 90404994
Respiratory tract infection 26.58 9.96 53 191800 59025 90377569
Retinogram abnormal 26.49 9.96 11 191842 167 90436427
Cytopenia 26.41 9.96 3 191850 17446 90419148
Blood lactate dehydrogenase increased 26.22 9.96 11 191842 25921 90410673
Blood pressure diastolic decreased 26.14 9.96 12 191841 26814 90409780
Kidney duplex 26.13 9.96 10 191843 121 90436473
Cardiac malposition 26.10 9.96 8 191845 46 90436548
Narrow anterior chamber angle 26.10 9.96 8 191845 46 90436548
COVID-19 26.07 9.96 230 191623 168613 90267981
Depressed mood 26.07 9.96 189 191664 50033 90386561
Paranoia 26.06 9.96 73 191780 12835 90423759
Borderline personality disorder 26.06 9.96 20 191833 1036 90435558
Pre-existing condition improved 26.01 9.96 59 191794 9110 90427484
Blood pressure measurement 25.93 9.96 14 191839 392 90436202
Vestibular migraine 25.89 9.96 12 191841 240 90436354
Bone pain 25.88 9.96 58 191795 61925 90374669
Hyposthenuria 25.80 9.96 5 191848 0 90436594
Eye pain 25.75 9.96 171 191682 43997 90392597
Respiratory alkalosis 25.61 9.96 34 191819 3414 90433180
Congenital hand malformation 25.52 9.96 13 191840 322 90436272
Iridocyclitis 25.52 9.96 35 191818 3626 90432968
Folliculitis 25.44 9.96 589 191264 203764 90232830
Cholecystitis chronic 25.43 9.96 61 191792 9765 90426829
Breast cancer 25.25 9.96 47 191806 53714 90382880
Eczema 25.03 9.96 46 191807 52824 90383770
Drug screen positive 24.82 9.96 35 191818 3722 90432872
Hypocalcaemia 24.72 9.96 32 191821 42336 90394258
Autism spectrum disorder 24.53 9.96 21 191832 1272 90435322
Nystagmus 24.51 9.96 50 191803 7177 90429417
Upper respiratory tract infection 24.41 9.96 165 191688 128153 90308441
Frontal lobe epilepsy 24.39 9.96 6 191847 12 90436582
Amino acid level increased 24.38 9.96 14 191839 443 90436151
Dysarthria 24.36 9.96 198 191655 54284 90382310
Myelodysplastic syndrome 24.35 9.96 7 191846 20896 90415698
Retinitis pigmentosa 24.31 9.96 10 191843 148 90436446
Pulmonary fibrosis 24.25 9.96 131 191722 107372 90329222
Chills 23.98 9.96 172 191681 131809 90304785
Pseudomyopia 23.95 9.96 8 191845 63 90436531
Pulmonary hypertension 23.91 9.96 33 191820 42490 90394104
Abdominal pain upper 23.87 9.96 895 190958 331779 90104815
Peripheral swelling 23.79 9.96 679 191174 412427 90024167
Hip fracture 23.74 9.96 21 191832 33056 90403538
Ejection fraction decreased 23.69 9.96 13 191840 26240 90410354
Seizure cluster 23.69 9.96 13 191840 376 90436218
Psychomotor retardation 23.68 9.96 39 191814 4750 90431844
Osteonecrosis 23.67 9.96 13 191840 26228 90410366
Persistent left superior vena cava 23.65 9.96 7 191846 35 90436559
Psychogenic seizure 23.46 9.96 25 191828 1991 90434603
Lung neoplasm malignant 23.43 9.96 11 191842 24262 90412332
Hyperthermia 23.43 9.96 61 191792 10274 90426320
Hypoalbuminaemia 23.40 9.96 3 191850 15894 90420700
Hypohidrosis 23.31 9.96 8 191845 69 90436525
Haematoma 23.29 9.96 29 191824 39019 90397575
Rales 23.27 9.96 3 191850 15824 90420770
Developmental delay 23.26 9.96 23 191830 1677 90434917
Heart rate decreased 23.22 9.96 49 191804 53456 90383138
Rhinorrhoea 23.17 9.96 102 191751 88214 90348380
Toxic skin eruption 23.17 9.96 3 191850 15771 90420823
Wheezing 23.14 9.96 664 191189 237416 90199178
Colitis ulcerative 23.09 9.96 59 191794 60207 90376387
Lichen planus 23.05 9.96 29 191824 2762 90433832
Galactorrhoea 23.04 9.96 38 191815 4634 90431960
Rheumatoid nodule 23.04 9.96 7 191846 20159 90416435
Pain 23.00 9.96 1807 190046 994534 89442060
Haemoptysis 22.91 9.96 22 191831 33298 90403296
Ataxia 22.82 9.96 87 191766 17955 90418639
Iris disorder 22.82 9.96 8 191845 74 90436520
Central nervous system lesion 22.67 9.96 65 191788 11581 90425013
Angiomyolipoma 22.66 9.96 11 191842 245 90436349
Chest pain 22.53 9.96 510 191343 319135 90117459
Angioedema 22.45 9.96 223 191630 64653 90371941
Eye movement disorder 22.36 9.96 44 191809 6154 90430440
Anoxia 22.14 9.96 11 191842 258 90436336
Bezoar 21.93 9.96 28 191825 2706 90433888
Blood pressure fluctuation 21.92 9.96 49 191804 52364 90384230
Blood pressure systolic abnormal 21.82 9.96 7 191846 19471 90417123
Apnoea 21.79 9.96 56 191797 9358 90427236
Bronchiectasis 21.74 9.96 10 191843 22320 90414274
Negativism 21.59 9.96 13 191840 450 90436144
Sensory processing disorder 21.56 9.96 6 191847 23 90436571
Anticonvulsant drug level above therapeutic 21.55 9.96 14 191839 555 90436039
Oropharyngeal pain 21.47 9.96 149 191704 115038 90321556
Biliary dyskinesia 21.45 9.96 27 191826 2572 90434022
Pseudomonas infection 21.42 9.96 3 191850 14862 90421732
Tardive dyskinesia 21.28 9.96 61 191792 10869 90425725
Granulomatous dermatitis 21.22 9.96 10 191843 208 90436386
Ulcer 21.14 9.96 23 191830 32859 90403735
Myalgia 21.10 9.96 253 191600 174872 90261722
Immunodeficiency 21.02 9.96 37 191816 43197 90393397
Blood cholesterol increased 21.01 9.96 583 191270 207429 90229165
Brain stem microhaemorrhage 20.97 9.96 6 191847 26 90436568
Granuloma annulare 20.86 9.96 16 191837 828 90435766
Tenosynovitis 20.85 9.96 3 191850 14564 90422030
Thrombotic microangiopathy 20.85 9.96 4 191849 15739 90420855
International normalised ratio increased 20.81 9.96 43 191810 47273 90389321
Burning mouth syndrome 20.81 9.96 14 191839 589 90436005
Drug-induced liver injury 20.80 9.96 287 191566 90031 90346563
Chronic obstructive pulmonary disease 20.78 9.96 83 191770 73746 90362848
Psychomotor hyperactivity 20.71 9.96 67 191786 12746 90423848
Macular detachment 20.67 9.96 8 191845 100 90436494
Panniculitis 20.64 9.96 3 191850 14455 90422139
Coma 20.64 9.96 240 191613 72392 90364202
Blindness day 20.64 9.96 4 191849 0 90436594
Broad autism phenotype 20.64 9.96 4 191849 0 90436594
Anomalous pulmonary venous connection 20.54 9.96 7 191846 59 90436535
Clostridium difficile infection 20.51 9.96 28 191825 36217 90400377
Amnesia 20.40 9.96 333 191520 108172 90328422
Therapeutic response changed 20.25 9.96 19 191834 1298 90435296
Posterior reversible encephalopathy syndrome 20.25 9.96 11 191842 22328 90414266
Hepatic enzyme increased 20.24 9.96 595 191258 360141 90076453
Device related infection 20.22 9.96 15 191838 25771 90410823
Breath sounds abnormal 20.19 9.96 4 191849 15382 90421212
Cerebellar microhaemorrhage 20.11 9.96 6 191847 31 90436563
Transfusion 20.11 9.96 6 191847 17482 90419112
Necrotising enterocolitis neonatal 20.07 9.96 10 191843 236 90436358
Enuresis 19.93 9.96 30 191823 3384 90433210
Nightmare 19.91 9.96 95 191758 21630 90414964
Lung disorder 19.90 9.96 436 191417 149447 90287147
Oral herpes 19.89 9.96 25 191828 33499 90403095
Bone density decreased 19.85 9.96 6 191847 17339 90419255
Body temperature decreased 19.80 9.96 13 191840 23803 90412791
Congenital megaureter 19.72 9.96 8 191845 114 90436480
Breast cancer metastatic 19.71 9.96 4 191849 15128 90421466
Red blood cell count decreased 19.65 9.96 43 191810 46308 90390286
Hyperbilirubinaemia 19.65 9.96 3 191850 13933 90422661
Chronic idiopathic pain syndrome 19.57 9.96 7 191846 69 90436525
Acquired haemophilia 19.55 9.96 17 191836 1052 90435542
Parasomnia 19.36 9.96 14 191839 662 90435932
Hypoglycaemia 19.36 9.96 79 191774 69769 90366825
Myocardial oedema 19.33 9.96 12 191841 439 90436155
Pericardial effusion 19.32 9.96 30 191823 36803 90399791
Speech disorder developmental 19.30 9.96 16 191837 927 90435667
Blood pressure diastolic abnormal 19.21 9.96 9 191844 19872 90416722
Screaming 19.17 9.96 31 191822 3719 90432875
Intentional product misuse 19.14 9.96 281 191572 89323 90347271
Panic attack 19.11 9.96 108 191745 26257 90410337
Localised infection 18.92 9.96 26 191827 33536 90403058
Lack of spontaneous speech 18.85 9.96 9 191844 193 90436401
Homicidal ideation 18.85 9.96 21 191832 1759 90434835
Transaminases increased 18.84 9.96 31 191822 37161 90399433
Incorrect product administration duration 18.82 9.96 86 191767 19236 90417358
Therapeutic product effective for unapproved indication 18.77 9.96 8 191845 130 90436464
Lymphangioleiomyomatosis 18.72 9.96 10 191843 274 90436320
Hyperglycaemia 18.69 9.96 51 191802 50919 90385675
Thyroxine free decreased 18.64 9.96 15 191838 833 90435761
Drug dependence 18.60 9.96 116 191737 29211 90407383
Ischaemic stroke 18.56 9.96 12 191841 22154 90414440
Disorientation 18.48 9.96 158 191695 43956 90392638
Ureterolithiasis 18.37 9.96 23 191830 2179 90434415
Numb chin syndrome 18.33 9.96 6 191847 44 90436550
Hyperacusis 18.29 9.96 26 191827 2785 90433809
Hyperinsulinaemia 18.23 9.96 8 191845 140 90436454
Regressive behaviour 18.20 9.96 9 191844 209 90436385
Communication disorder 18.08 9.96 28 191825 3238 90433356
Lymphomatoid papulosis 17.98 9.96 8 191845 145 90436449
Open angle glaucoma 17.90 9.96 10 191843 300 90436294
Feeling abnormal 17.82 9.96 472 191381 166763 90269831
Oral pain 17.75 9.96 26 191827 32657 90403937
Antipsychotic drug level decreased 17.73 9.96 11 191842 402 90436192
Blood urea increased 17.71 9.96 23 191830 30390 90406204
Transferrin saturation decreased 17.70 9.96 15 191838 896 90435698
Presyncope 17.57 9.96 25 191828 31780 90404814
Hypersomnia 17.50 9.96 91 191762 21440 90415154
Bacteraemia 17.45 9.96 13 191840 22287 90414307
Joint effusion 17.44 9.96 10 191843 19700 90416894
Application site discolouration 17.32 9.96 15 191838 923 90435671
Social (pragmatic) communication disorder 17.23 9.96 5 191848 23 90436571
Eosinophilia 17.22 9.96 21 191832 28512 90408082
Social problem 17.17 9.96 17 191836 1242 90435352
Asthma 17.16 9.96 386 191467 241774 90194820
C-reactive protein 16.99 9.96 25 191828 31342 90405252
Fungal infection 16.94 9.96 41 191812 42620 90393974
Hypotonia 16.92 9.96 58 191795 11368 90425226
Conjunctival oedema 16.90 9.96 15 191838 954 90435640
Dry skin 16.87 9.96 113 191740 87960 90348634
Pain in jaw 16.87 9.96 49 191804 47936 90388658
Decreased interest 16.77 9.96 32 191821 4375 90432219
Temperature regulation disorder 16.76 9.96 5 191848 14574 90422020
Product counterfeit 16.69 9.96 8 191845 173 90436421
Red blood cell sedimentation rate abnormal 16.62 9.96 16 191837 24188 90412406
Hyperuricosuria 16.61 9.96 4 191849 7 90436587
Jaundice 16.57 9.96 27 191826 32490 90404104
Convulsive threshold lowered 16.51 9.96 11 191842 455 90436139
Muscle spasticity 16.48 9.96 31 191822 35291 90401303
Treatment failure 16.45 9.96 794 191059 303134 90133460
Cluster headache 16.42 9.96 14 191839 843 90435751
Urine calcium/creatinine ratio increased 16.30 9.96 7 191846 116 90436478
Blood thyroid stimulating hormone normal 16.30 9.96 7 191846 116 90436478
Congenital diaphragmatic eventration 16.26 9.96 4 191849 8 90436586
Cleft lip 16.25 9.96 8 191845 184 90436410
Depressed level of consciousness 16.24 9.96 230 191623 72554 90364040
Calculus urinary 16.23 9.96 19 191834 1679 90434915
Post-traumatic stress disorder 16.20 9.96 41 191812 6787 90429807
Idiopathic intracranial hypertension 16.17 9.96 28 191825 3553 90433041
Musculoskeletal stiffness 16.16 9.96 491 191362 296041 90140553
Confusional state 16.16 9.96 985 190868 385220 90051374
Congenital mitral valve incompetence 16.13 9.96 5 191848 30 90436564
Delusion 16.10 9.96 65 191788 13775 90422819
Narcolepsy 16.09 9.96 18 191835 1514 90435080
Drug tolerance decreased 16.08 9.96 27 191826 32103 90404491
Inappropriate schedule of product administration 16.06 9.96 222 191631 149711 90286883
Metabolic myopathy 16.03 9.96 7 191846 121 90436473
Frequent bowel movements 16.02 9.96 64 191789 56871 90379723
Autoimmune disorder 15.97 9.96 96 191757 76648 90359946
Haemorrhage 15.94 9.96 84 191769 69285 90367309
Neonatal seizure 15.92 9.96 12 191841 605 90435989
Vascular malformation 15.89 9.96 13 191840 739 90435855
Benzodiazepine drug level increased 15.82 9.96 8 191845 195 90436399
Postictal paralysis 15.81 9.96 9 191844 280 90436314
Rash maculo-papular 15.74 9.96 40 191813 40893 90395701
Self-injurious ideation 15.73 9.96 26 191827 3177 90433417
Liver function test abnormal 15.71 9.96 55 191798 50790 90385804
Night blindness 15.71 9.96 11 191842 494 90436100
Ovarian germ cell cancer stage II 15.65 9.96 6 191847 73 90436521
Hypopyon 15.64 9.96 14 191839 900 90435694
Nodular rash 15.64 9.96 8 191845 200 90436394
Cataract 15.63 9.96 89 191764 72003 90364591
Product administration interrupted 15.61 9.96 60 191793 12432 90424162
Osteoporosis 15.57 9.96 130 191723 96401 90340193
Maternal exposure during pregnancy 15.56 9.96 921 190932 359142 90077452
Hydrocele 15.48 9.96 3 191850 0 90436594
Full blood count abnormal 15.48 9.96 34 191819 36563 90400031
Blood calcium decreased 15.44 9.96 25 191828 30157 90406437
Haemolytic anaemia 15.43 9.96 3 191850 11694 90424900
Metastases to lymph nodes 15.42 9.96 3 191850 11686 90424908
Blood test abnormal 15.40 9.96 13 191840 20939 90415655
Haematemesis 15.39 9.96 30 191823 33696 90402898
Accommodation disorder 15.22 9.96 10 191843 404 90436190
Depersonalisation/derealisation disorder 15.17 9.96 18 191835 1614 90434980
Haematuria 15.16 9.96 32 191821 34905 90401689
Gastroenteritis 15.15 9.96 24 191829 29205 90407389
Near drowning 15.12 9.96 5 191848 38 90436556
Pregnancy on oral contraceptive 15.10 9.96 15 191838 1100 90435494
Thyroid atrophy 15.06 9.96 9 191844 307 90436287
Psoriasis 15.04 9.96 221 191632 147533 90289061
Alopecia 15.04 9.96 876 190977 494195 89942399
Deep vein thrombosis postoperative 15.04 9.96 88 191765 70721 90365873
Psychomotor skills impaired 15.04 9.96 24 191829 2848 90433746
COVID-19 pneumonia 15.01 9.96 10 191843 18167 90418427
Complex regional pain syndrome 15.00 9.96 23 191830 2636 90433958
Blood bilirubin decreased 14.99 9.96 14 191839 951 90435643
Calcitonin secretion disorder 14.79 9.96 5 191848 41 90436553
Mydriasis 14.76 9.96 67 191786 14945 90421649
Cardio-respiratory arrest 14.68 9.96 201 191652 62939 90373655
Aspartate aminotransferase decreased 14.65 9.96 14 191839 979 90435615
Congenital anomaly in offspring 14.58 9.96 7 191846 152 90436442
Pulmonary mass 14.56 9.96 24 191829 28748 90407846
Angina pectoris 14.50 9.96 39 191814 39121 90397473
Swelling 14.49 9.96 732 191121 418326 90018268
Educational problem 14.47 9.96 11 191842 562 90436032
Chest discomfort 14.42 9.96 206 191647 138159 90298435
Impulsive behaviour 14.32 9.96 18 191835 1712 90434882
Symptom masked 14.32 9.96 14 191839 1007 90435587
Osteomyelitis 14.30 9.96 23 191830 27823 90408771
Hyperphosphaturia 14.29 9.96 5 191848 46 90436548
Anticonvulsant drug level increased 14.27 9.96 18 191835 1718 90434876
Inappropriate affect 14.27 9.96 14 191839 1011 90435583
Wrong patient received product 14.17 9.96 26 191827 3451 90433143
Renal fusion anomaly 14.04 9.96 4 191849 17 90436577
Hand deformity 13.95 9.96 500 191353 295862 90140732
Nasal polyps 13.92 9.96 3 191850 10877 90425717
Obsessive thoughts 13.89 9.96 11 191842 597 90435997
Intestinal perforation 13.85 9.96 6 191847 13875 90422719
Basilar migraine 13.83 9.96 5 191848 51 90436543
Aspergillus infection 13.81 9.96 3 191850 10820 90425774
Dysgeusia 13.76 9.96 171 191682 52389 90384205
Gambling disorder 13.65 9.96 15 191838 1237 90435357
Neutropenic sepsis 13.64 9.96 11 191842 18119 90418475
Cerebral infarction 13.63 9.96 22 191831 26574 90410020
Dystonia 13.61 9.96 71 191782 16748 90419846
Dermatillomania 13.60 9.96 8 191845 265 90436329
Temperature intolerance 13.60 9.96 56 191797 11974 90424620
Thinking abnormal 13.57 9.96 55 191798 11677 90424917
Blunted affect 13.49 9.96 8 191845 269 90436325
Snoring 13.46 9.96 32 191821 5094 90431500
Papilloedema 13.43 9.96 30 191823 4585 90432009
Red blood cell sedimentation rate increased 13.42 9.96 111 191742 82484 90354110
Plasmodium falciparum infection 13.41 9.96 5 191848 56 90436538
Acidosis 13.39 9.96 58 191795 12678 90423916
Vasculitis 13.38 9.96 17 191836 22676 90413918
Mastoiditis 13.23 9.96 17 191836 1653 90434941
Blood chloride increased 13.08 9.96 24 191829 3186 90433408
Autonomic nervous system imbalance 13.07 9.96 25 191828 3425 90433169
Paranasal cyst 13.06 9.96 12 191841 798 90435796
Musculoskeletal pain 13.06 9.96 464 191389 170787 90265807
Cushingoid 13.03 9.96 3 191850 10392 90426202
Spinal compression fracture 13.01 9.96 8 191845 15170 90421424
Nausea 13.00 9.96 2109 189744 1108207 89328387
Treatment noncompliance 12.99 9.96 167 191686 51560 90385034
Cardiac disorder 12.99 9.96 69 191784 56803 90379791
Self esteem decreased 12.99 9.96 12 191841 804 90435790
Haemorrhage intracranial 12.98 9.96 8 191845 15154 90421440
Impulse-control disorder 12.91 9.96 13 191840 969 90435625
Fine motor delay 12.90 9.96 7 191846 198 90436396
Enteritis 12.89 9.96 3 191850 10318 90426276
Magnetic resonance imaging abnormal 12.88 9.96 25 191828 3461 90433133
Pleural rub 12.88 9.96 5 191848 63 90436531
Therapeutic product ineffective for unapproved indication 12.88 9.96 8 191845 293 90436301
Dysmorphism 12.82 9.96 21 191832 2547 90434047
Rash pruritic 12.68 9.96 112 191741 82102 90354492
Foreign body in reproductive tract 12.66 9.96 14 191839 1163 90435431
Hallucination, visual 12.62 9.96 88 191765 23004 90413590
Drop attacks 12.62 9.96 11 191842 683 90435911
Illogical thinking 12.61 9.96 5 191848 67 90436527
Hypertension 12.59 9.96 817 191036 456715 89979879
Skin exfoliation 12.58 9.96 88 191765 67825 90368769
Deformity 12.57 9.96 5 191848 12165 90424429
Weight decreased 12.53 9.96 950 190903 378960 90057634
Skin lesion 12.53 9.96 39 191814 37326 90399268
Circadian rhythm sleep disorder 12.49 9.96 11 191842 692 90435902
Gamma-glutamyltransferase increased 12.45 9.96 40 191813 37912 90398682
Bacterial infection 12.39 9.96 19 191834 23425 90413169
Medical diet 12.38 9.96 4 191849 28 90436566
Gastrointestinal mucosal exfoliation 12.34 9.96 6 191847 134 90436460
Blastocystis infection 12.34 9.96 5 191848 71 90436523
Cerebral haemorrhage 12.32 9.96 35 191818 34487 90402107
Retinitis 12.29 9.96 41 191812 38417 90398177
Poor quality sleep 12.29 9.96 92 191761 24601 90411993
Severe myoclonic epilepsy of infancy 12.28 9.96 5 191848 72 90436522
Occipital neuralgia 12.27 9.96 11 191842 709 90435885
Prinzmetal angina 12.24 9.96 13 191840 1032 90435562
Hyperaldosteronism 12.20 9.96 8 191845 322 90436272
Delayed light adaptation 12.20 9.96 3 191850 6 90436588
Emotional distress 12.19 9.96 125 191728 36537 90400057
Product administered to patient of inappropriate age 12.17 9.96 29 191824 4624 90431970
Potassium wasting nephropathy 12.16 9.96 5 191848 74 90436520
Hyporesponsive to stimuli 12.10 9.96 16 191837 1601 90434993
Vaginal discharge 12.09 9.96 14 191839 19450 90417144
Blood glucose increased 12.09 9.96 136 191717 95110 90341484
Drug tolerance 12.08 9.96 72 191781 17844 90418750
Cardiomyopathy 12.06 9.96 15 191838 20191 90416403
Osteoarthritis 12.03 9.96 518 191335 195212 90241382
Polyneuropathy 11.92 9.96 14 191839 19327 90417267
High-pitched crying 11.92 9.96 4 191849 32 90436562
Chronic sinusitis 11.91 9.96 20 191833 23782 90412812
Intracranial hypotension 11.84 9.96 8 191845 339 90436255
Lung infiltration 11.84 9.96 9 191844 15273 90421321
Self-medication 11.79 9.96 23 191830 3197 90433397
Blood potassium increased 11.77 9.96 16 191837 20733 90415861
Atrioventricular septal defect 11.76 9.96 8 191845 343 90436251
Impaired gastric emptying 11.73 9.96 56 191797 12753 90423841
Slow response to stimuli 11.72 9.96 13 191840 1083 90435511
Housebound 11.71 9.96 7 191846 239 90436355
Keratoconus 11.71 9.96 4 191849 34 90436560
Failed induction of labour 11.70 9.96 9 191844 468 90436126
Secondary adrenocortical insufficiency 11.63 9.96 19 191834 2299 90434295
Hyperventilation 11.63 9.96 36 191817 6692 90429902
Hallucinations, mixed 11.59 9.96 33 191820 5856 90430738
Soliloquy 11.59 9.96 8 191845 351 90436243
Crystal urine present 11.54 9.96 15 191838 1475 90435119
Faeces discoloured 11.54 9.96 17 191836 21303 90415291
Carbon dioxide decreased 11.45 9.96 21 191832 2787 90433807
Subdural haematoma 11.43 9.96 11 191842 16634 90419960
Automatism 11.42 9.96 5 191848 87 90436507
Dissociative disorder 11.40 9.96 10 191843 626 90435968
Coagulopathy 11.26 9.96 20 191833 23269 90413325
Dropped head syndrome 11.23 9.96 7 191846 258 90436336
Stillbirth 11.21 9.96 38 191815 7405 90429189
Limb injury 11.20 9.96 32 191821 31476 90405118
Oral candidiasis 11.20 9.96 38 191815 35417 90401177
Skin disorder 11.15 9.96 40 191813 36666 90399928
Candida infection 11.10 9.96 36 191817 34021 90402573
Congenital foot malformation 11.04 9.96 7 191846 266 90436328
Epileptic encephalopathy 11.01 9.96 8 191845 381 90436213
Skin infection 10.94 9.96 13 191840 17851 90418743
Femoral neck fracture 10.91 9.96 4 191849 10229 90426365
Appendicitis 10.90 9.96 4 191849 10227 90426367
Sleep-related eating disorder 10.90 9.96 12 191841 992 90435602
Atelectasis 10.89 9.96 22 191831 24387 90412207
Abdominal pain 10.82 9.96 707 191146 395014 90041580
Poisoning 10.81 9.96 62 191791 15155 90421439
Suspiciousness 10.80 9.96 8 191845 393 90436201
Small for dates baby 10.79 9.96 29 191824 4978 90431616
Ophthalmic migraine 10.79 9.96 9 191844 526 90436068
Central obesity 10.78 9.96 14 191839 1376 90435218
Blood loss anaemia 10.75 9.96 4 191849 10136 90426458
Respiratory failure 10.75 9.96 181 191672 118237 90318357
Tooth disorder 10.74 9.96 32 191821 31058 90405536
Sedation complication 10.73 9.96 12 191841 16932 90419662
Tri-iodothyronine free abnormal 10.71 9.96 4 191849 45 90436549
Fear 10.70 9.96 66 191787 16556 90420038
Respiratory disorder neonatal 10.69 9.96 14 191839 1387 90435207
Multiple organ dysfunction syndrome 10.58 9.96 93 191760 68243 90368351
Glossodynia 10.56 9.96 565 191288 321214 90115380
Skin discolouration 10.55 9.96 53 191800 44262 90392332
Lymphoma 10.53 9.96 8 191845 13583 90423011
Altered visual depth perception 10.53 9.96 8 191845 408 90436186
Tenderness 10.53 9.96 26 191827 26842 90409752
Electrocardiogram PR prolongation 10.50 9.96 11 191842 859 90435735
Enterococcal infection 10.49 9.96 4 191849 9987 90426607
Delayed sleep phase 10.49 9.96 3 191850 13 90436581
Cerebral vasoconstriction 10.47 9.96 13 191840 1221 90435373
Pancreatitis acute 10.43 9.96 34 191819 32081 90404513
Osmotic demyelination syndrome 10.42 9.96 12 191841 1042 90435552
Bed rest 10.41 9.96 4 191849 49 90436545
Glycosuria 10.38 9.96 14 191839 1428 90435166
Mitral valve incompetence 10.31 9.96 20 191833 22504 90414090
Corneal pigmentation 10.31 9.96 3 191850 14 90436580
Aborted pregnancy 10.26 9.96 4 191849 51 90436543
Stress 10.24 9.96 235 191618 81160 90355434
Congenital hydronephrosis 10.20 9.96 8 191845 428 90436166
Lethargy 10.15 9.96 189 191664 62950 90373644
Decreased nasolabial fold 10.14 9.96 3 191850 15 90436579
Congenital floppy infant 10.14 9.96 3 191850 15 90436579
Bipolar II disorder 10.14 9.96 8 191845 432 90436162
Cardiogenic shock 10.13 9.96 23 191830 24445 90412149
Throat irritation 10.08 9.96 61 191792 48634 90387960
Arterial occlusive disease 10.07 9.96 7 191846 12439 90424155
Rubber sensitivity 10.07 9.96 20 191833 2817 90433777
Sarcoidosis 10.05 9.96 5 191848 10668 90425926
Breast cancer female 10.04 9.96 10 191843 14876 90421718
Antisocial behaviour 10.00 9.96 9 191844 583 90436011
Cerebral venous sinus thrombosis 9.98 9.96 18 191835 2358 90434236
Chorioretinal folds 9.98 9.96 3 191850 16 90436578

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Seizure 1147.76 13.47 947 40958 119614 42459816
Drug ineffective 590.64 13.47 1642 40263 628555 41950875
Sedation 514.54 13.47 339 41566 30136 42549294
Multiple-drug resistance 489.23 13.47 205 41700 7117 42572313
Nephrolithiasis 438.67 13.47 331 41574 36499 42542931
Status epilepticus 376.73 13.47 218 41687 15360 42564070
Angle closure glaucoma 298.56 13.47 88 41817 1034 42578396
Aggression 293.48 13.47 284 41621 43879 42535551
Nightmare 252.58 13.47 204 41701 24808 42554622
Heat stroke 239.32 13.47 74 41831 1034 42578396
Epilepsy 215.93 13.47 190 41715 25981 42553449
Generalised tonic-clonic seizure 210.64 13.47 188 41717 26191 42553239
Somnolence 204.21 13.47 437 41468 140668 42438762
Ataxia 200.90 13.47 149 41756 15976 42563454
Hyperammonaemia 174.12 13.47 104 41801 7762 42571668
Off label use 168.20 13.47 1135 40770 637200 41942230
Migraine 166.03 13.47 162 41743 25252 42554178
Myopia 164.98 13.47 58 41847 1233 42578197
Drug resistance 148.98 13.47 176 41729 34072 42545358
Petit mal epilepsy 144.57 13.47 71 41834 3579 42575851
Choroidal effusion 135.12 13.47 35 41870 243 42579187
Product use in unapproved indication 128.59 13.47 436 41469 184020 42395410
Hyperammonaemic encephalopathy 122.40 13.47 58 41847 2700 42576730
Febrile neutropenia 120.91 13.47 19 41886 185684 42393746
Cognitive disorder 120.39 13.47 158 41747 34014 42545416
Product substitution issue 120.14 13.47 95 41810 11195 42568235
Anaemia 120.14 13.47 63 41842 280215 42299215
Dyspnoea 111.04 13.47 165 41740 442456 42136974
Foetal exposure during pregnancy 108.95 13.47 179 41726 47132 42532298
Drug ineffective for unapproved indication 108.12 13.47 176 41729 45987 42533443
Head discomfort 103.15 13.47 64 41841 5113 42574317
Renal tubular acidosis 101.53 13.47 51 41854 2699 42576731
Partial seizures 100.75 13.47 66 41839 5793 42573637
Hypospadias 99.93 13.47 55 41850 3512 42575918
Anhidrosis 98.39 13.47 26 41879 197 42579233
Product use issue 95.44 13.47 224 41681 76527 42502903
Treatment failure 90.43 13.47 194 41711 62430 42517000
Death 90.30 13.47 207 41698 470978 42108452
Acute kidney injury 88.13 13.47 141 41764 367196 42212234
Completed suicide 87.44 13.47 250 41655 96215 42483215
Hyperhidrosis 87.37 13.47 240 41665 90272 42489158
Tonic convulsion 86.45 13.47 39 41866 1620 42577810
Myoclonic epilepsy 86.11 13.47 39 41866 1635 42577795
Acidosis hyperchloraemic 84.79 13.47 30 41875 650 42578780
Flat anterior chamber of eye 82.79 13.47 18 41887 50 42579380
Diarrhoea 81.55 13.47 211 41694 460638 42118792
Focal dyscognitive seizures 81.28 13.47 36 41869 1431 42577999
Sudden unexplained death in epilepsy 80.17 13.47 27 41878 502 42578928
Ammonia increased 78.94 13.47 52 41853 4607 42574823
Memory impairment 78.81 13.47 161 41744 50061 42529369
Myokymia 77.36 13.47 19 41886 103 42579327
Abnormal behaviour 76.17 13.47 111 41794 26340 42553090
Toxicity to various agents 75.71 13.47 433 41472 228703 42350727
Suicidal ideation 75.11 13.47 154 41751 48007 42531423
Pneumonia 74.86 13.47 193 41712 421956 42157474
Infantile spasms 74.82 13.47 22 41883 256 42579174
Psychotic disorder 73.36 13.47 115 41790 29093 42550337
Drug interaction 70.94 13.47 477 41428 266522 42312908
Malignant neoplasm progression 68.48 13.47 12 41893 108388 42471042
Product used for unknown indication 68.24 13.47 30 41875 1171 42578259
Developmental delay 67.64 13.47 41 41864 3141 42576289
Intentional self-injury 67.53 13.47 79 41826 15123 42564307
Hyperthermia 65.51 13.47 71 41834 12503 42566927
Disturbance in attention 64.72 13.47 110 41795 29756 42549674
Encephalopathy 64.25 13.47 132 41773 41201 42538229
Magnetic resonance imaging head abnormal 63.61 13.47 31 41874 1536 42577894
Speech disorder 61.45 13.47 106 41799 29015 42550415
Multiple drug therapy 60.29 13.47 27 41878 1102 42578328
Interstitial lung disease 58.52 13.47 5 41900 78457 42500973
Metabolic acidosis 57.64 13.47 145 41760 51713 42527717
Intellectual disability 57.55 13.47 31 41874 1896 42577534
Atrial fibrillation 57.34 13.47 33 41872 139560 42439870
Irritability 56.25 13.47 100 41805 28028 42551402
Myoclonus 54.12 13.47 75 41830 16990 42562440
Nystagmus 52.30 13.47 43 41862 5353 42574077
Behaviour disorder 51.81 13.47 48 41857 7006 42572424
Change in seizure presentation 51.09 13.47 17 41888 304 42579126
Intentional overdose 50.16 13.47 137 41768 51319 42528111
Organic brain syndrome 49.94 13.47 17 41888 327 42579103
Priapism 49.80 13.47 45 41860 6362 42573068
Dysmorphism 48.99 13.47 34 41871 3282 42576148
Maculopathy 48.91 13.47 23 41882 1052 42578378
Cardiac failure 48.75 13.47 22 41883 106834 42472596
Apathy 48.29 13.47 50 41855 8356 42571074
Intensive care unit acquired weakness 48.06 13.47 24 41881 1254 42578176
Phonophobia 47.78 13.47 16 41889 292 42579138
Failure to suspend medication 47.34 13.47 17 41888 385 42579045
Drug withdrawal convulsions 47.01 13.47 24 41881 1314 42578116
Cardiac failure congestive 46.94 13.47 13 41892 85589 42493841
Cleft lip 46.79 13.47 16 41889 312 42579118
Pyrexia 45.58 13.47 216 41689 393826 42185604
Pancytopenia 44.01 13.47 31 41874 117712 42461718
Ascites 43.99 13.47 3 41902 56675 42522755
Abdominal pain 43.79 13.47 75 41830 190396 42389034
Agitation 43.76 13.47 151 41754 64163 42515267
Therapy non-responder 43.26 13.47 133 41772 53226 42526204
Pleural effusion 42.79 13.47 21 41884 97145 42482285
Partial seizures with secondary generalisation 42.74 13.47 16 41889 409 42579021
Exposure during pregnancy 42.33 13.47 47 41858 8501 42570929
Disease progression 41.54 13.47 48 41857 143608 42435822
Hyperchloraemia 41.17 13.47 17 41888 567 42578863
Therapy partial responder 41.09 13.47 72 41833 19949 42559481
Delusion of replacement 40.18 13.47 13 41892 212 42579218
General physical health deterioration 40.11 13.47 54 41851 151192 42428238
Neck pain 39.91 13.47 90 41815 29924 42549506
Atonic seizures 39.44 13.47 15 41890 401 42579029
Sepsis 38.47 13.47 87 41818 199247 42380183
Arthralgia 38.47 13.47 91 41814 205147 42374283
Urge incontinence 38.06 13.47 16 41889 559 42578871
Tuberous sclerosis complex 38.05 13.47 10 41895 74 42579356
Fanconi syndrome 37.83 13.47 23 41882 1771 42577659
Platelet count decreased 37.23 13.47 49 41856 138532 42440898
Acute myopia 37.12 13.47 8 41897 21 42579409
Autonomic nervous system imbalance 37.02 13.47 28 41877 3088 42576342
Angular cheilitis 36.90 13.47 12 41893 199 42579231
Mood altered 36.86 13.47 49 41856 10669 42568761
COVID-19 36.58 13.47 36 41869 115912 42463518
Haemoglobin decreased 36.45 13.47 46 41859 132425 42447005
Patient dissatisfaction with treatment 36.42 13.47 10 41895 89 42579341
Nasal septum disorder 36.31 13.47 9 41896 51 42579379
Cough 35.79 13.47 76 41829 178027 42401403
Erectile dysfunction 35.72 13.47 77 41828 24836 42554594
Vision blurred 35.59 13.47 125 41780 53574 42525856
Lethargy 35.37 13.47 114 41791 46776 42532654
Affective disorder 35.23 13.47 36 41869 5924 42573506
Accidental death 35.08 13.47 27 41878 3056 42576374
Anticonvulsant drug level increased 34.48 13.47 21 41884 1622 42577808
Psychogenic seizure 34.08 13.47 14 41891 461 42578969
Hypothermia 33.84 13.47 51 41854 12464 42566966
Hallucination, visual 33.68 13.47 68 41837 20952 42558478
Bladder hypertrophy 33.52 13.47 16 41889 757 42578673
Congenital hand malformation 32.89 13.47 15 41890 639 42578791
Blood homocysteine increased 32.88 13.47 12 41893 285 42579145
Seizure cluster 32.61 13.47 12 41893 292 42579138
Drug level fluctuating 32.46 13.47 15 41890 659 42578771
Depressed mood 32.08 13.47 71 41834 23313 42556117
Atrial septal defect 31.64 13.47 39 41866 7880 42571550
Non-24-hour sleep-wake disorder 31.55 13.47 7 41898 22 42579408
Neuroleptic malignant syndrome 31.51 13.47 67 41838 21405 42558025
Hippocampal sclerosis 31.44 13.47 10 41895 154 42579276
Astrocytoma, low grade 31.07 13.47 9 41896 99 42579331
Hypoxia 30.84 13.47 15 41890 69771 42509659
Suicide attempt 30.28 13.47 107 41798 45993 42533437
Staring 30.10 13.47 19 41886 1564 42577866
Hallucination, auditory 29.91 13.47 53 41852 14811 42564619
Lower respiratory tract infection 29.72 13.47 3 41902 41203 42538227
Bradyphrenia 29.69 13.47 31 41874 5231 42574199
Small for dates baby 29.68 13.47 31 41874 5232 42574198
Hyperexplexia 29.67 13.47 7 41898 31 42579399
Rhinolithiasis 29.63 13.47 5 41900 0 42579430
Malaise 29.62 13.47 108 41797 212048 42367382
Haemoptysis 29.38 13.47 5 41900 46162 42533268
Tremor 29.22 13.47 179 41726 96750 42482680
Social avoidant behaviour 28.88 13.47 25 41880 3339 42576091
Hypotension 28.69 13.47 143 41762 257488 42321942
Ehlers-Danlos syndrome 28.49 13.47 7 41898 38 42579392
Blood creatinine increased 28.42 13.47 40 41865 109963 42469467
Psychomotor skills impaired 28.19 13.47 30 41875 5174 42574256
Neutropenia 28.18 13.47 101 41804 199330 42380100
Disorientation 27.92 13.47 89 41816 36300 42543130
Asthenia 27.87 13.47 162 41743 280631 42298799
Gastrointestinal haemorrhage 27.86 13.47 33 41872 97693 42481737
Microcephaly 27.82 13.47 15 41890 919 42578511
Bundle branch block right 27.79 13.47 37 41868 8069 42571361
Headache 27.70 13.47 358 41547 239011 42340419
Dysarthria 27.54 13.47 94 41811 39713 42539717
Teratogenicity 27.36 13.47 7 41898 46 42579384
Coagulation disorder neonatal 27.25 13.47 6 41899 18 42579412
Electroencephalogram abnormal 27.25 13.47 23 41882 2969 42576461
Acid-base balance disorder mixed 27.10 13.47 7 41898 48 42579382
Product administered to patient of inappropriate age 26.77 13.47 28 41877 4733 42574697
Hyperkalaemia 26.52 13.47 24 41881 80434 42498996
Pain in extremity 26.46 13.47 69 41836 150535 42428895
Vitamin D deficiency 26.38 13.47 36 41869 8037 42571393
Perseveration 26.19 13.47 8 41897 107 42579323
Oesophageal atresia 26.19 13.47 12 41893 517 42578913
Therapeutic response unexpected 26.09 13.47 43 41862 11338 42568092
Depression 25.98 13.47 193 41712 111170 42468260
Myocardial infarction 25.67 13.47 52 41853 123957 42455473
Anger 25.66 13.47 46 41859 12972 42566458
Epileptic encephalopathy 25.63 13.47 10 41895 287 42579143
Necrotising colitis 25.59 13.47 16 41889 1295 42578135
Septic shock 25.04 13.47 32 41873 91640 42487790
Paraesthesia 24.94 13.47 140 41765 73319 42506111
Photophobia 24.72 13.47 35 41870 8084 42571346
Urticaria 24.50 13.47 22 41883 74014 42505416
Cerebrovascular accident 24.44 13.47 36 41869 97124 42482306
Paranoia 24.43 13.47 47 41858 13979 42565451
Neonatal respiratory depression 24.42 13.47 11 41894 455 42578975
Chronic obstructive pulmonary disease 24.39 13.47 16 41889 63098 42516332
Haematuria traumatic 24.18 13.47 10 41895 335 42579095
Gait disturbance 24.09 13.47 172 41733 97828 42481602
Sluggishness 23.88 13.47 24 41881 3872 42575558
Optic atrophy 23.77 13.47 15 41890 1234 42578196
Insomnia 23.76 13.47 198 41707 118055 42461375
Muscle twitching 23.70 13.47 42 41863 11738 42567692
Retinogram abnormal 23.69 13.47 8 41897 150 42579280
Substance use 23.65 13.47 17 41888 1734 42577696
Chills 23.52 13.47 35 41870 94031 42485399
Neuropathy peripheral 23.48 13.47 40 41865 101813 42477617
Sleep-related eating disorder 23.45 13.47 10 41895 362 42579068
Renal colic 23.29 13.47 18 41887 2050 42577380
Vagal nerve stimulator implantation 23.17 13.47 7 41898 90 42579340
Benign cardiac neoplasm 23.12 13.47 6 41899 42 42579388
Trigeminal neuralgia 22.97 13.47 16 41889 1553 42577877
Craniofacial fracture 22.83 13.47 10 41895 387 42579043
Delusion 22.82 13.47 47 41858 14687 42564743
Rebound effect 22.75 13.47 32 41873 7347 42572083
Infusion related reaction 22.72 13.47 16 41889 60790 42518640
Toxic encephalopathy 22.71 13.47 31 41874 6922 42572508
Overdose 22.63 13.47 179 41726 105085 42474345
Neuromyopathy 22.54 13.47 14 41891 1120 42578310
Anaphylactic reaction 22.49 13.47 7 41898 42736 42536694
Dystonia 22.45 13.47 43 41862 12747 42566683
Cardiogenic shock 22.37 13.47 4 41901 35636 42543794
Depressed level of consciousness 22.35 13.47 100 41805 47870 42531560
Chest discomfort 22.15 13.47 18 41887 63598 42515832
Retinal disorder 22.08 13.47 14 41891 1161 42578269
Aorticopulmonary septal defect 22.02 13.47 5 41900 18 42579412
Muscle contracture 21.87 13.47 15 41890 1420 42578010
Wrong patient received product 21.83 13.47 22 41883 3561 42575869
Plagiocephaly 21.74 13.47 11 41894 591 42578839
Speech disorder developmental 21.71 13.47 18 41887 2267 42577163
Mental disorder 21.70 13.47 52 41853 17977 42561453
Pneumonitis 21.65 13.47 7 41898 41711 42537719
Ultrasound liver abnormal 21.64 13.47 7 41898 114 42579316
Bicuspid aortic valve 21.61 13.47 9 41896 307 42579123
Joint swelling 21.58 13.47 21 41884 68001 42511429
Plasma cell myeloma 21.37 13.47 10 41895 47568 42531862
Calculus urinary 21.35 13.47 16 41889 1741 42577689
Renal impairment 21.33 13.47 48 41857 110180 42469250
Eosinophilic pneumonia acute 21.25 13.47 12 41893 805 42578625
Oedema peripheral 21.21 13.47 66 41839 136010 42443420
Tooth discolouration 21.07 13.47 10 41895 467 42578963
Tic 21.05 13.47 18 41887 2365 42577065
Haematochezia 21.02 13.47 16 41889 58420 42521010
C-reactive protein increased 20.89 13.47 19 41886 63541 42515889
Weight increased 20.73 13.47 179 41726 107804 42471626
Hypohidrosis 20.66 13.47 8 41897 225 42579205
Prostate cancer 20.65 13.47 9 41896 44634 42534796
Drug intolerance 20.26 13.47 142 41763 80282 42499148
Hypermetropia 20.25 13.47 10 41895 510 42578920
Therapeutic product effect incomplete 20.12 13.47 129 41776 70810 42508620
Persecutory delusion 20.11 13.47 21 41884 3543 42575887
Cleft lip and palate 19.79 13.47 12 41893 920 42578510
Ischaemic gastritis 19.66 13.47 4 41901 7 42579423
Retinal vein occlusion 19.65 13.47 16 41889 1965 42577465
Chronic kidney disease 19.62 13.47 11 41894 47230 42532200
Hypersomnia 19.61 13.47 44 41861 14574 42564856
Dyskinesia 19.38 13.47 62 41843 25328 42554102
Cryptorchism 19.32 13.47 16 41889 2011 42577419
Hypotonia 19.28 13.47 34 41871 9465 42569965
Multiple sclerosis 19.18 13.47 30 41875 7568 42571862
White blood cell count decreased 19.06 13.47 51 41854 110345 42469085
Aura 19.05 13.47 9 41896 416 42579014
Pseudomyopia 19.01 13.47 6 41899 90 42579340
Pericardial effusion 19.01 13.47 3 41902 29272 42550158
Dissociation 19.01 13.47 21 41884 3777 42575653
Hypocitraturia 19.00 13.47 4 41901 9 42579421
Coronary artery disease 18.95 13.47 15 41890 53705 42525725
Slow speech 18.90 13.47 15 41890 1775 42577655
Gastrectomy 18.85 13.47 7 41898 175 42579255
Maternal drugs affecting foetus 18.82 13.47 21 41884 3818 42575612
Blood bilirubin increased 18.79 13.47 9 41896 42243 42537187
Hypercapnic coma 18.70 13.47 7 41898 179 42579251
Cerebral atrophy 18.68 13.47 24 41881 5055 42574375
Abdominal distension 18.61 13.47 26 41879 71709 42507721
Hyperglycaemia 18.58 13.47 11 41894 45848 42533582
Erythema 18.23 13.47 51 41854 108742 42470688
Psychomotor hyperactivity 18.21 13.47 36 41869 10922 42568508
Premature baby 18.10 13.47 57 41848 23096 42556334
Initial insomnia 17.99 13.47 21 41884 4009 42575421
Necrotising enterocolitis neonatal 17.94 13.47 8 41897 323 42579107
Tonic clonic movements 17.85 13.47 13 41892 1354 42578076
Stomatitis 17.82 13.47 14 41891 50315 42529115
Angiofibroma 17.78 13.47 3 41902 0 42579430
Pre-existing condition improved 17.70 13.47 18 41887 2945 42576485
Dyspnoea exertional 17.69 13.47 14 41891 50134 42529296
Abdominal pain upper 17.64 13.47 34 41871 82575 42496855
Renal failure 17.61 13.47 77 41828 143649 42435781
Madarosis 17.56 13.47 9 41896 497 42578933
Blood insulin abnormal 17.49 13.47 4 41901 15 42579415
Hyperthermia malignant 17.45 13.47 17 41888 2641 42576789
Hyponatraemia 17.42 13.47 47 41858 101415 42478015
Hypertension 17.36 13.47 95 41810 167109 42412321
Pyloric stenosis 17.30 13.47 11 41894 917 42578513
Somnambulism 17.29 13.47 19 41886 3396 42576034
Premature ejaculation 17.27 13.47 6 41899 123 42579307
Intestinal obstruction 17.15 13.47 3 41902 27155 42552275
Febrile infection-related epilepsy syndrome 16.94 13.47 5 41900 59 42579371
Body height below normal 16.91 13.47 7 41898 235 42579195
Low birth weight baby 16.90 13.47 33 41872 9922 42569508
Peripheral swelling 16.90 13.47 40 41865 90230 42489200
Mania 16.75 13.47 34 41871 10513 42568917
Cerebellar atrophy 16.71 13.47 10 41895 748 42578682
Concussion 16.69 13.47 17 41888 2785 42576645
Psychomotor retardation 16.51 13.47 21 41884 4378 42575052
Mental impairment 16.44 13.47 37 41868 12280 42567150
Thinking abnormal 16.34 13.47 27 41878 7134 42572296
Aspartate aminotransferase increased 16.27 13.47 32 41873 77131 42502299
Confusional state 16.25 13.47 243 41662 167354 42412076
Lung disorder 16.14 13.47 14 41891 47909 42531521
Melaena 16.12 13.47 9 41896 38737 42540693
Talipes 16.01 13.47 15 41890 2221 42577209
Myelosuppression 15.98 13.47 10 41895 40451 42538979
Suspiciousness 15.96 13.47 8 41897 421 42579009
Periventricular haemorrhage neonatal 15.94 13.47 4 41901 24 42579406
Mood swings 15.90 13.47 30 41875 8796 42570634
Salivary hypersecretion 15.89 13.47 34 41871 10909 42568521
Hypertelorism 15.85 13.47 9 41896 610 42578820
Adjustment disorder 15.81 13.47 12 41893 1330 42578100
Severe myoclonic epilepsy of infancy 15.80 13.47 4 41901 25 42579405
Ventricular fibrillation 15.73 13.47 5 41900 30118 42549312
Blood ketone body decreased 15.70 13.47 3 41902 3 42579427
Ganglioglioma 15.70 13.47 3 41902 3 42579427
Treatment noncompliance 15.68 13.47 76 41829 37596 42541834
Blood prolactin increased 15.66 13.47 15 41890 2283 42577147
Full blood count abnormal 15.53 13.47 5 41900 29871 42549559
Anterior chamber disorder 15.48 13.47 5 41900 81 42579349
Distractibility 15.40 13.47 8 41897 454 42578976
Clonic convulsion 15.39 13.47 10 41895 865 42578565
Body dysmorphic disorder 15.38 13.47 6 41899 172 42579258
Quadriparesis 15.37 13.47 15 41890 2335 42577095
Chordee 15.37 13.47 5 41900 83 42579347
Hallucination 15.34 13.47 103 41802 57404 42522026
Bacteraemia 15.31 13.47 3 41902 25037 42554393
Oxygen saturation decreased 15.27 13.47 25 41880 64662 42514768
Hyperglycinaemia 15.24 13.47 3 41902 4 42579426
Enuresis 15.16 13.47 16 41889 2732 42576698
Alanine aminotransferase increased 15.14 13.47 41 41864 88365 42491065
Essential tremor 15.10 13.47 10 41895 893 42578537
Obstructive airways disorder 15.07 13.47 3 41902 24756 42554674
Vascular malformation 15.00 13.47 5 41900 90 42579340
Mutism 14.90 13.47 12 41893 1450 42577980
Herpes zoster 14.82 13.47 10 41895 38867 42540563
Angioedema 14.81 13.47 12 41893 42465 42536965
Pulmonary embolism 14.70 13.47 64 41841 119548 42459882
Eosinophilia 14.64 13.47 7 41898 32892 42546538
Walking disability 14.63 13.47 11 41894 1203 42578227
Developmental hip dysplasia 14.61 13.47 7 41898 334 42579096
Anticonvulsant drug level decreased 14.54 13.47 11 41894 1214 42578216
Neutrophil count decreased 14.52 13.47 25 41880 63390 42516040
Transient epileptic amnesia 14.49 13.47 3 41902 6 42579424
Neonatal hypotension 14.48 13.47 6 41899 202 42579228
Bradykinesia 14.48 13.47 22 41883 5414 42574016
Hypomagnesaemia 14.40 13.47 5 41900 28483 42550947
Lactic acidosis 14.32 13.47 14 41891 45247 42534183
Choroidal detachment 14.23 13.47 8 41897 532 42578898
Lennox-Gastaut syndrome 14.19 13.47 5 41900 107 42579323
Postictal psychosis 14.13 13.47 6 41899 215 42579215
Ventricular tachycardia 14.07 13.47 6 41899 30154 42549276
Liver disorder 14.07 13.47 11 41894 39633 42539797
Diplopia 14.07 13.47 48 41857 20268 42559162
Gout 14.05 13.47 5 41900 28050 42551380
Withdrawal syndrome 14.05 13.47 39 41866 14736 42564694
Postictal state 14.00 13.47 10 41895 1010 42578420
Myalgia 13.99 13.47 48 41857 96032 42483398
Psychiatric symptom 13.99 13.47 19 41886 4222 42575208
Skeletal dysplasia 13.93 13.47 5 41900 113 42579317
Blood bicarbonate abnormal 13.89 13.47 5 41900 114 42579316
Inflammation 13.88 13.47 8 41897 33839 42545591
Self-destructive behaviour 13.80 13.47 7 41898 378 42579052
Nephrocalcinosis 13.69 13.47 9 41896 794 42578636
Suspected suicide 13.64 13.47 23 41882 6176 42573254
Fear 13.60 13.47 32 41873 10933 42568497
Peroneal nerve palsy 13.59 13.47 17 41888 3485 42575945
Drop attacks 13.56 13.47 8 41897 583 42578847

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Angle closure glaucoma 1365.79 10.86 422 195481 3077 110390319
Seizure 1132.61 10.86 1660 194243 219525 110173871
Multiple-drug resistance 691.14 10.86 376 195527 12859 110380537
Epilepsy 675.68 10.86 860 195043 99349 110294047
Choroidal effusion 580.83 10.86 160 195743 730 110392666
Myopia 569.79 10.86 196 195707 2075 110391321
Drug ineffective for unapproved indication 547.71 10.86 787 195116 102051 110291345
Drug ineffective 493.35 10.86 4465 191438 1516075 108877321
Completed suicide 453.93 10.86 1190 194713 241191 110152205
Blepharospasm 443.17 10.86 516 195387 54335 110339061
Taste disorder 438.79 10.86 560 195343 64827 110328569
Migraine 432.82 10.86 946 194957 170706 110222690
Renal tubular acidosis 430.93 10.86 196 195707 4519 110388877
Status epilepticus 404.33 10.86 380 195523 31191 110362205
Anaemia 399.73 10.86 237 195666 546849 109846547
Nephrolithiasis 387.08 10.86 530 195373 65682 110327714
Nail disorder 380.59 10.86 491 195412 57444 110335952
Product quality issue 370.37 10.86 563 195340 76736 110316660
Acute kidney injury 367.14 10.86 351 195552 635079 109758317
Febrile neutropenia 365.41 10.86 61 195842 316706 110076690
Product use in unapproved indication 364.03 10.86 1663 194240 445714 109947682
Memory impairment 349.45 10.86 948 194955 195996 110197400
Onychomadesis 318.90 10.86 399 195504 45264 110348132
Visual perseveration 313.65 10.86 62 195841 20 110393376
Intentional self-injury 307.16 10.86 355 195548 37074 110356322
Back injury 305.53 10.86 398 195505 47001 110346395
Gastrooesophageal reflux disease 304.05 10.86 851 195052 179125 110214271
Pyrexia 299.83 10.86 723 195180 897542 109495854
Product label confusion 290.47 10.86 273 195630 22404 110370992
Paraesthesia 289.67 10.86 1111 194792 275410 110117986
Drug intolerance 281.44 10.86 1443 194460 405069 109988327
Off label use 272.52 10.86 3938 191965 1496247 108897149
Aggression 272.01 10.86 423 195480 58787 110334609
Depression 270.89 10.86 1197 194706 316138 110077258
Wound infection 261.83 10.86 548 195355 95917 110297479
Neck pain 258.91 10.86 632 195271 122498 110270898
Finger deformity 251.85 10.86 302 195601 32790 110360606
Product substitution issue 243.84 10.86 250 195653 22811 110370585
Suicidal ideation 235.80 10.86 517 195386 93420 110299976
Malignant neoplasm progression 231.97 10.86 21 195882 174546 110218850
Heat stroke 227.36 10.86 96 195807 1839 110391557
Generalised tonic-clonic seizure 226.97 10.86 373 195530 54307 110339089
Sedation 226.60 10.86 427 195476 69256 110324140
Petit mal epilepsy 226.07 10.86 150 195753 7397 110385999
Adverse reaction 223.45 10.86 269 195634 29325 110364071
Breast cancer stage III 213.00 10.86 448 195455 78669 110314727
Hyperammonaemic encephalopathy 212.87 10.86 128 195775 5306 110388090
Neutropenia 210.22 10.86 212 195691 374408 110018988
Acidosis hyperchloraemic 207.65 10.86 85 195818 1501 110391895
Product use issue 207.64 10.86 1095 194808 310600 110082796
Medication overuse headache 205.43 10.86 84 195819 1479 110391917
Acute myopia 205.26 10.86 52 195851 158 110393238
Hyperammonaemia 200.65 10.86 178 195725 13554 110379842
Atrial fibrillation 193.74 10.86 82 195821 229560 110163836
Pancytopenia 193.28 10.86 65 195838 209548 110183848
Somnolence 192.68 10.86 1037 194866 296412 110096984
Disease progression 189.13 10.86 98 195805 243936 110149460
Onychomycosis 187.85 10.86 283 195620 38248 110355148
Intentional overdose 187.02 10.86 588 195315 131913 110261483
Peripheral venous disease 185.64 10.86 440 195463 83677 110309719
Dyspnoea 182.08 10.86 1182 194721 1105690 109287706
Sepsis 180.51 10.86 188 195715 327158 110066238
Myoclonic epilepsy 179.22 10.86 90 195813 2601 110390795
Cardiac failure 171.57 10.86 59 195844 187567 110205829
Hypoaesthesia 170.46 10.86 1045 194858 313178 110080218
Myokymia 169.28 10.86 42 195861 114 110393282
Interstitial lung disease 162.43 10.86 26 195877 139308 110254088
Bursitis 162.20 10.86 553 195350 129365 110264031
Death 161.82 10.86 663 195240 698206 109695190
Nightmare 161.13 10.86 265 195638 38598 110354798
Flat anterior chamber of eye 160.53 10.86 41 195862 130 110393266
Haemoglobin decreased 154.63 10.86 128 195775 248599 110144797
Pleural effusion 153.86 10.86 61 195842 177648 110215748
Cough 152.47 10.86 373 195530 461268 109932128
Thrombocytopenia 152.33 10.86 239 195664 348646 110044750
Ataxia 152.30 10.86 225 195678 29883 110363513
Coeliac disease 150.90 10.86 273 195630 42914 110350482
Disturbance in attention 147.45 10.86 334 195569 61661 110331735
Metabolic acidosis 144.76 10.86 447 195456 99297 110294099
Cognitive disorder 143.95 10.86 410 195493 87101 110306295
Weight increased 143.13 10.86 1249 194654 418395 109975001
Choroidal detachment 142.21 10.86 53 195850 719 110392677
Live birth 141.08 10.86 352 195551 69132 110324264
Overdose 139.26 10.86 797 195106 232997 110160399
Pneumonia 139.03 10.86 946 194957 875768 109517628
Headache 137.23 10.86 2259 193644 880118 109513278
Renal failure 135.48 10.86 121 195782 226453 110166943
Partial seizures 134.67 10.86 131 195772 11218 110382178
Pruritus 131.25 10.86 557 195346 581003 109812393
Toxicity to various agents 130.52 10.86 1363 194540 479192 109914204
Drug resistance 129.96 10.86 300 195603 56074 110337322
Mucosal inflammation 129.24 10.86 11 195892 96130 110297266
Renal impairment 128.65 10.86 88 195815 188357 110205039
Irritability 127.82 10.86 270 195633 47539 110345857
Liver function test increased 126.80 10.86 395 195508 88153 110305243
Psychotic disorder 126.27 10.86 279 195624 50658 110342738
Facet joint syndrome 124.24 10.86 416 195487 96412 110296984
Blood creatinine increased 124.06 10.86 86 195817 182803 110210593
Grip strength decreased 122.62 10.86 366 195537 79808 110313588
Type 2 diabetes mellitus 122.29 10.86 629 195274 176603 110216793
Erythema 119.43 10.86 208 195695 291239 110102157
Hyponatraemia 118.81 10.86 126 195777 217527 110175869
Maculopathy 117.79 10.86 71 195832 2956 110390440
Obesity 117.34 10.86 454 195449 112897 110280499
Infection 116.93 10.86 296 195607 361904 110031492
Hyperkalaemia 116.91 10.86 47 195856 135749 110257647
Myelosuppression 116.02 10.86 15 195888 94325 110299071
Platelet count decreased 114.35 10.86 144 195759 230299 110163097
Treatment failure 112.17 10.86 858 195045 276376 110117020
Diarrhoea 110.25 10.86 1392 194511 1138113 109255283
Septic shock 109.62 10.86 72 195831 157456 110235940
Cardiac failure congestive 109.23 10.86 66 195837 150934 110242462
Gastrointestinal haemorrhage 108.12 10.86 81 195822 165437 110227959
Ciliary body disorder 107.89 10.86 23 195880 21 110393375
Focal dyscognitive seizures 106.90 10.86 73 195830 3776 110389620
Hypercholesterolaemia 106.71 10.86 379 195524 90458 110302938
Gait inability 105.45 10.86 500 195403 135876 110257520
Folliculitis 101.41 10.86 574 195329 167079 110226317
Anhidrosis 101.36 10.86 35 195868 375 110393021
Lip dry 99.65 10.86 396 195507 99687 110293709
Infusion site reaction 99.48 10.86 139 195764 17543 110375853
Infantile spasms 99.08 10.86 34 195869 357 110393039
Ascites 98.21 10.86 22 195881 92786 110300610
Haematochezia 96.20 10.86 42 195861 115482 110277914
Myocardial infarction 95.32 10.86 120 195783 191963 110201433
Joint range of motion decreased 95.16 10.86 448 195455 121384 110272012
Oedema peripheral 94.56 10.86 284 195619 328376 110065020
Neovascularisation 92.49 10.86 50 195853 1687 110391709
Cytokine release syndrome 89.36 10.86 10 195893 70296 110323100
Fibromyalgia 87.95 10.86 561 195342 170348 110223048
Hypoxia 87.69 10.86 61 195842 129454 110263942
Tonic convulsion 87.04 10.86 59 195844 3015 110390381
Injury 85.81 10.86 573 195330 176692 110216704
Sudden unexplained death in epilepsy 84.12 10.86 37 195866 786 110392610
Dehydration 83.69 10.86 237 195666 279274 110114122
Neutrophil count decreased 83.17 10.86 56 195847 120885 110272511
Neuropathy peripheral 81.87 10.86 119 195784 179158 110214238
Abnormal behaviour 81.59 10.86 200 195703 38839 110354557
White blood cell count decreased 79.92 10.86 180 195723 229210 110164186
Psoriatic arthropathy 79.57 10.86 609 195294 196152 110197244
Anorexia nervosa 78.64 10.86 27 195876 284 110393112
Hypotension 78.08 10.86 575 195328 523274 109870122
Fanconi syndrome 77.61 10.86 58 195845 3461 110389935
Injection site reaction 76.60 10.86 337 195566 88733 110304663
Dyspepsia 76.07 10.86 589 195314 190376 110203020
Hypomagnesaemia 75.69 10.86 9 195894 60361 110333035
Night sweats 74.70 10.86 449 195454 133534 110259862
Mitochondrial DNA mutation 74.44 10.86 29 195874 447 110392949
Drug withdrawal convulsions 74.14 10.86 49 195854 2400 110390996
Paradoxical drug reaction 73.72 10.86 89 195814 9728 110383668
Sluggishness 72.78 10.86 78 195825 7489 110385907
Plasma cell myeloma 72.77 10.86 12 195891 62924 110330472
Change in seizure presentation 70.99 10.86 33 195870 801 110392595
Lactic acidosis 70.79 10.86 38 195865 92773 110300623
Magnetic resonance imaging head abnormal 70.77 10.86 55 195848 3480 110389916
Dry mouth 70.60 10.86 600 195303 199348 110194048
Arthritis 70.08 10.86 118 195785 167468 110225928
Sleep disorder due to general medical condition, insomnia type 69.89 10.86 51 195852 105592 110287804
COVID-19 69.58 10.86 213 195690 244847 110148549
Intentional product use issue 69.00 10.86 707 195196 247199 110146197
Neoplasm progression 68.97 10.86 15 195888 64580 110328816
Cytomegalovirus infection 68.55 10.86 8 195895 54436 110338960
Hepatic enzyme 67.73 10.86 63 195840 5100 110388296
Ammonia increased 67.25 10.86 78 195825 8172 110385224
Blood pressure increased 66.84 10.86 234 195669 258139 110135257
Blood pressure systolic increased 66.26 10.86 32 195871 82959 110310437
Hepatitis 65.87 10.86 325 195578 89729 110303667
Melaena 65.69 10.86 20 195883 68737 110324659
Seizure cluster 64.87 10.86 31 195872 802 110392594
Speech disorder 64.02 10.86 247 195656 61322 110332074
Partial seizures with secondary generalisation 63.96 10.86 31 195872 828 110392568
Hypocholesterolaemia 63.20 10.86 67 195836 6354 110387042
Maternal exposure during pregnancy 63.07 10.86 710 195193 254173 110139223
Coronary artery disease 63.04 10.86 24 195879 71666 110321730
Haemoptysis 62.55 10.86 24 195879 71330 110322066
Hepatic cytolysis 62.54 10.86 11 195892 55042 110338354
Pneumonitis 61.88 10.86 29 195874 76502 110316894
Blood cholesterol increased 61.84 10.86 548 195355 184237 110209159
Aura 61.65 10.86 33 195870 1091 110392305
Oxygen saturation decreased 61.61 10.86 115 195788 156867 110236529
Exposure during pregnancy 61.54 10.86 507 195396 166917 110226479
Sleep disorder 61.36 10.86 579 195324 198065 110195331
Serotonin syndrome 61.26 10.86 237 195666 58916 110334480
Alanine aminotransferase increased 60.96 10.86 148 195755 183625 110209771
Intellectual disability 60.89 10.86 40 195863 1939 110391457
Colitis 60.71 10.86 55 195848 102268 110291128
Swollen tongue 60.20 10.86 239 195664 60123 110333273
Bradyphrenia 59.82 10.86 88 195815 11640 110381756
Chills 58.96 10.86 159 195744 190421 110202975
Aspartate aminotransferase increased 58.59 10.86 122 195781 159814 110233582
Corneal oedema 58.44 10.86 47 195856 3126 110390270
Phonophobia 57.68 10.86 27 195876 666 110392730
Wound 57.53 10.86 652 195251 233785 110159611
Intraocular pressure increased 57.50 10.86 83 195820 10793 110382603
Cerebral venous thrombosis 57.30 10.86 47 195856 3215 110390181
Blood lactate dehydrogenase increased 57.12 10.86 6 195897 44328 110349068
Hyperthermia 56.70 10.86 120 195783 21152 110372244
Normal newborn 56.61 10.86 122 195781 21774 110371622
Therapeutic product effect incomplete 56.54 10.86 626 195277 223179 110170217
Mood altered 56.30 10.86 120 195783 21255 110372141
Depressed mood 56.07 10.86 235 195668 60574 110332822
Photophobia 55.96 10.86 134 195769 25637 110367759
Mental disorder 55.48 10.86 173 195730 38618 110354778
Dyspnoea exertional 54.82 10.86 62 195841 103998 110289398
Pneumocystis jirovecii pneumonia 54.51 10.86 6 195897 42729 110350667
Irritable bowel syndrome 54.43 10.86 486 195417 163729 110229667
Coma blister 54.25 10.86 19 195884 213 110393183
Blood bilirubin increased 53.83 10.86 34 195869 75938 110317458
Concussion 53.77 10.86 83 195820 11455 110381941
Oedema 53.74 10.86 191 195712 209785 110183611
Myoclonus 52.69 10.86 153 195750 32845 110360551
Atonic seizures 52.63 10.86 30 195873 1124 110392272
Lennox-Gastaut syndrome 52.39 10.86 20 195883 291 110393105
Apathy 52.13 10.86 99 195804 16140 110377256
Visual field defect 51.99 10.86 76 195827 9996 110383400
Suicide attempt 51.70 10.86 337 195566 103057 110290339
Head discomfort 51.59 10.86 108 195795 18892 110374504
Osteonecrosis of jaw 51.57 10.86 11 195892 48006 110345390
Prostate cancer 51.44 10.86 4 195899 37637 110355759
Propofol infusion syndrome 51.22 10.86 40 195863 2549 110390847
Haematuria 51.20 10.86 43 195860 82962 110310434
Myelodysplastic syndrome 51.17 10.86 4 195899 37480 110355916
Rheumatic fever 50.99 10.86 382 195521 122197 110271199
Upper gastrointestinal haemorrhage 50.79 10.86 13 195890 50083 110343313
Nystagmus 50.78 10.86 81 195822 11496 110381900
Overlap syndrome 50.64 10.86 71 195832 8988 110384408
Chronic obstructive pulmonary disease 50.27 10.86 72 195831 109086 110284310
Psychogenic seizure 50.00 10.86 38 195865 2326 110391070
Bone marrow failure 49.81 10.86 20 195883 57828 110335568
Hostility 49.79 10.86 40 195863 2656 110390740
Acute myeloid leukaemia 49.51 10.86 5 195898 38105 110355291
Visual snow syndrome 49.38 10.86 13 195890 48 110393348
Constipation 49.37 10.86 401 195502 357385 110036011
Slow speech 48.99 10.86 44 195859 3404 110389992
Pulmonary oedema 48.77 10.86 64 195839 100595 110292801
Acute myocardial infarction 48.55 10.86 46 195857 83731 110309665
Respiratory failure 48.00 10.86 207 195696 215125 110178271
Hypervolaemia 47.96 10.86 14 195889 49446 110343950
Libido increased 47.59 10.86 38 195865 2501 110390895
Osteoarthritis 47.58 10.86 514 195389 182109 110211287
CSF oligoclonal band present 47.53 10.86 21 195882 451 110392945
Skin ulcer 47.17 10.86 27 195876 63618 110329778
Angiofibroma 47.10 10.86 15 195888 122 110393274
Multiple sclerosis 46.80 10.86 125 195778 25573 110367823
Arthralgia 46.67 10.86 1039 194864 778593 109614803
Vision blurred 46.49 10.86 389 195514 128633 110264763
Tremor 46.30 10.86 555 195348 201677 110191719
Multiple organ dysfunction syndrome 45.85 10.86 128 195775 151582 110241814
Cholestasis 45.54 10.86 29 195874 64489 110328907
Cellulitis 45.42 10.86 97 195806 125919 110267477
Systemic lupus erythematosus 45.35 10.86 667 195236 253671 110139725
Dysphonia 45.25 10.86 259 195644 75670 110317726
Hepatic function abnormal 45.11 10.86 55 195848 89240 110304156
Rectal haemorrhage 45.09 10.86 90 195813 119743 110273653
Malaise 45.00 10.86 879 195024 670940 109722456
Withdrawal syndrome 44.92 10.86 140 195763 31240 110362156
Blood prolactin increased 44.91 10.86 48 195855 4594 110388802
Retinogram abnormal 44.85 10.86 19 195884 367 110393029
Insomnia 44.79 10.86 892 195011 359698 110033698
Myalgia 44.69 10.86 222 195681 222159 110171237
Hypoglycaemia 43.86 10.86 87 195816 116017 110277379
Wheezing 43.82 10.86 665 195238 254565 110138831
Therapeutic response unexpected 43.45 10.86 116 195787 23727 110369669
Epistaxis 43.22 10.86 105 195798 130267 110263129
Pseudomyopia 43.17 10.86 15 195888 164 110393232
Bacteraemia 42.97 10.86 11 195892 42379 110351017
Post-traumatic neck syndrome 42.69 10.86 36 195867 2559 110390837
Product used for unknown indication 42.50 10.86 32 195871 1931 110391465
Amenorrhoea 42.45 10.86 66 195837 9165 110384231
Affective disorder 41.75 10.86 73 195830 11168 110382228
Electroencephalogram abnormal 41.59 10.86 53 195850 6120 110387276
Drug interaction 41.50 10.86 1170 194733 499013 109894383
Cerebral infarction 41.36 10.86 20 195883 51818 110341578
Muscular weakness 41.35 10.86 644 195259 247824 110145572
Agitation 41.35 10.86 342 195561 112709 110280687
Hyperglycaemia 41.32 10.86 54 195849 85036 110308360
Inflammation 41.07 10.86 523 195380 192715 110200681
Anaphylactic shock 40.95 10.86 20 195883 51526 110341870
Benign familial pemphigus 40.87 10.86 9 195894 11 110393385
Iris adhesions 40.85 10.86 21 195882 638 110392758
Mania 40.79 10.86 104 195799 20692 110372704
Rheumatoid factor positive 40.58 10.86 110 195793 131530 110261866
Peritonitis 40.53 10.86 5 195898 32602 110360794
Muscle twitching 40.52 10.86 131 195772 29804 110363592
Self-induced vomiting 40.41 10.86 12 195891 75 110393321
Metastases to liver 40.35 10.86 7 195896 35379 110358017
Herpes zoster 40.26 10.86 82 195821 108297 110285099
Cardiogenic shock 40.16 10.86 26 195877 57312 110336084
Thrombotic microangiopathy 40.11 10.86 3 195900 29146 110364250
Liver disorder 40.10 10.86 124 195779 142119 110251277
Pericardial effusion 40.00 10.86 26 195877 57191 110336205
Oligomenorrhoea 39.82 10.86 23 195880 884 110392512
Fatigue 39.06 10.86 1759 194144 1214199 109179197
Pemphigus 38.75 10.86 564 195339 214006 110179390
Liver injury 38.56 10.86 422 195481 149991 110243405
Respiratory tract infection 38.46 10.86 42 195861 71575 110321821
Soft tissue injury 38.32 10.86 32 195871 2244 110391152
International normalised ratio increased 38.24 10.86 59 195844 86713 110306683
Influenza 38.02 10.86 162 195741 168939 110224457
Nephrocalcinosis 38.01 10.86 29 195874 1785 110391611
Bronchiectasis 37.91 10.86 9 195894 36484 110356912
Full blood count decreased 37.38 10.86 6 195897 32093 110361303
Productive cough 37.16 10.86 93 195810 114212 110279184
Diplopia 37.15 10.86 160 195743 41734 110351662
Eosinophilia 36.99 10.86 29 195874 57907 110335489
Alexia 36.95 10.86 9 195894 22 110393374
Swelling face 36.87 10.86 285 195618 92036 110301360
Pericarditis 36.87 10.86 569 195334 218545 110174851
Hypocitraturia 36.69 10.86 8 195895 9 110393387
Underdose 36.06 10.86 214 195689 63340 110330056
Visual acuity reduced 35.87 10.86 132 195771 32041 110361355
Anticonvulsant drug level increased 35.82 10.86 34 195869 2824 110390572
Blood pressure fluctuation 35.81 10.86 48 195855 74776 110318620
Alice in wonderland syndrome 35.55 10.86 10 195893 50 110393346
Anti-cyclic citrullinated peptide antibody positive 35.53 10.86 485 195418 181499 110211897
Crying 35.46 10.86 113 195790 25515 110367881
Bipolar disorder 35.43 10.86 60 195843 8947 110384449
Ejection fraction decreased 35.42 10.86 14 195889 40866 110352530
Suicidal behaviour 35.32 10.86 37 195866 3460 110389936
Jaundice 34.94 10.86 32 195871 59204 110334192
Muscle spasms 34.83 10.86 689 195214 277468 110115928
Pulmonary hypertension 34.81 10.86 28 195875 55192 110338204
Right ventricular failure 34.79 10.86 3 195900 25951 110367445
Bulimia nervosa 34.70 10.86 15 195888 305 110393091
Cervix neoplasm 34.64 10.86 13 195890 180 110393216
Multiple sclerosis relapse 34.40 10.86 178 195725 50062 110343334
Haemophagocytic lymphohistiocytosis 34.37 10.86 7 195896 31552 110361844
Aspergillus infection 34.23 10.86 3 195900 25613 110367783
Metastases to bone 34.08 10.86 7 195896 31365 110362031
Paranoia 34.06 10.86 102 195801 22272 110371124
Transfusion 34.00 10.86 3 195900 25469 110367927
Chest pain 33.91 10.86 466 195437 375909 110017487
Appendicitis 33.87 10.86 5 195898 28459 110364937
Basal cell carcinoma 33.84 10.86 19 195884 45251 110348145
Sinusitis 33.76 10.86 349 195554 296339 110097057
Blood gases abnormal 33.61 10.86 24 195879 1334 110392062
Hallucination, auditory 33.48 10.86 113 195790 26284 110367112
Bacterial infection 33.45 10.86 20 195883 46016 110347380
Autonomic nervous system imbalance 33.36 10.86 46 195857 5734 110387662
Sternal fracture 33.34 10.86 35 195868 3281 110390115
Thrombosis 33.34 10.86 91 195812 108571 110284825
Heart rate decreased 33.02 10.86 60 195843 82696 110310700
Inappropriate schedule of product administration 32.99 10.86 218 195685 203419 110189977
Social avoidant behaviour 32.91 10.86 44 195859 5325 110388071
Pseudomonas infection 32.90 10.86 5 195898 27848 110365548
Migraine without aura 32.82 10.86 18 195885 625 110392771
Cerebrovascular accident 32.52 10.86 188 195715 181096 110212300
Muscle injury 32.47 10.86 387 195516 140420 110252976
Aphasia 32.41 10.86 197 195706 58800 110334596
Urinary tract infection 32.33 10.86 396 195507 325886 110067510
Anger 32.17 10.86 90 195813 18917 110374479
Cytopenia 32.14 10.86 7 195896 30109 110363287
Ciliary muscle spasm 32.03 10.86 6 195897 0 110393396
Eczema 32.01 10.86 49 195854 72244 110321152
Developmental delay 31.98 10.86 24 195879 1441 110391955
Salivary gland calculus 31.89 10.86 14 195889 296 110393100
Angina pectoris 31.85 10.86 38 195865 62257 110331139
Galactorrhoea 31.74 10.86 38 195865 4117 110389279
Failure to suspend medication 31.62 10.86 16 195887 470 110392926
Leukopenia 31.36 10.86 146 195757 148645 110244751
Full blood count abnormal 31.07 10.86 32 195871 56020 110337376
Clostridium difficile infection 30.94 10.86 28 195875 52101 110341295
Blood urea increased 30.89 10.86 31 195872 54926 110338470
Red blood cell count decreased 30.83 10.86 43 195860 65880 110327516
Toxic epidermal necrolysis 30.75 10.86 33 195870 56694 110336702
Respiratory alkalosis 30.74 10.86 44 195859 5677 110387719
Chronic kidney disease 30.72 10.86 55 195848 76236 110317160
Confusional state 30.58 10.86 1065 194838 467615 109925781
Tuberous sclerosis complex 30.51 10.86 11 195892 135 110393261
Lung neoplasm malignant 30.30 10.86 11 195892 33831 110359565
Diverticulitis 30.30 10.86 30 195873 53492 110339904
Chest discomfort 30.28 10.86 182 195721 173666 110219730
Rales 30.25 10.86 4 195899 24735 110368661
Fat embolism syndrome 30.15 10.86 11 195892 140 110393256
COVID-19 pneumonia 30.14 10.86 14 195889 37129 110356267
Delusion of replacement 30.14 10.86 13 195890 263 110393133
Mood swings 30.13 10.86 99 195804 22713 110370683
Respiratory disorder neonatal 29.94 10.86 9 195894 59 110393337
Priapism 29.93 10.86 44 195859 5817 110387579
Ischaemic stroke 29.88 10.86 18 195885 41245 110352151
Hyperchloraemia 29.87 10.86 22 195881 1284 110392112
Somnambulism 29.74 10.86 46 195857 6359 110387037
Mental impairment 29.68 10.86 98 195805 22541 110370855
Localised infection 29.50 10.86 20 195883 43028 110350368
Dysarthria 29.44 10.86 252 195651 83869 110309527
Blood pressure decreased 29.23 10.86 105 195798 114986 110278410
Sleep-related eating disorder 29.20 10.86 19 195884 906 110392490
Colitis ulcerative 29.19 10.86 58 195845 77305 110316091
Abdominal pain 29.13 10.86 689 195214 512300 109881096
Joint swelling 29.13 10.86 581 195322 442264 109951132
Thyroxine free decreased 28.91 10.86 21 195882 1199 110392197
Glossodynia 28.83 10.86 553 195350 221451 110171945
Back pain 28.72 10.86 473 195430 370523 110022873
Posterior reversible encephalopathy syndrome 28.68 10.86 12 195891 33849 110359547
Haemorrhage 28.67 10.86 95 195808 106597 110286799
Ventricular fibrillation 28.57 10.86 19 195884 41294 110352102
Pulmonary arterial hypertension 28.47 10.86 11 195892 32557 110360839
Migraine with aura 28.44 10.86 33 195870 3459 110389937
C-reactive protein increased 28.36 10.86 543 195360 217376 110176020
Wrong patient received product 28.32 10.86 46 195857 6628 110386768
Angiomyolipoma 28.21 10.86 13 195890 309 110393087
Psychomotor retardation 28.16 10.86 50 195853 7742 110385654
Hepatotoxicity 28.04 10.86 43 195860 63357 110330039
Transaminases increased 28.03 10.86 43 195860 63347 110330049
Astrocytoma, low grade 28.02 10.86 10 195893 119 110393277
Tubulointerstitial nephritis 27.88 10.86 33 195870 54251 110339145
Abdominal pain upper 27.65 10.86 812 195091 348299 110045097
Behaviour disorder 27.56 10.86 56 195847 9591 110383805
Blood uric acid increased 27.51 10.86 3 195900 21526 110371870
Skin necrosis 27.49 10.86 3 195900 21509 110371887
Hypocalcaemia 27.34 10.86 46 195857 65320 110328076
Hypophosphataemic osteomalacia 27.31 10.86 14 195889 423 110392973
Haematemesis 27.20 10.86 39 195864 59069 110334327
Cholecystitis chronic 26.97 10.86 55 195848 9445 110383951
Speech disorder developmental 26.88 10.86 18 195885 901 110392495
Rhinolithiasis 26.69 10.86 5 195898 0 110393396
Hyposthenuria 26.69 10.86 5 195898 0 110393396
Haematoma 26.50 10.86 39 195864 58437 110334959
Retinal deposits 26.48 10.86 10 195893 141 110393255
Arteriosclerosis coronary artery 26.48 10.86 6 195897 25112 110368284
Orthostatic hypotension 26.46 10.86 48 195855 66201 110327195
Gout 26.41 10.86 16 195887 36550 110356846
Dystonia 26.39 10.86 103 195800 25702 110367694
Enzyme inhibition 26.35 10.86 10 195893 143 110393253
Ventricular tachycardia 26.11 10.86 30 195873 49979 110343417
Retinitis pigmentosa 26.04 10.86 10 195893 148 110393248
Anticonvulsant drug level decreased 25.99 10.86 25 195878 2111 110391285
Presyncope 25.88 10.86 29 195874 48858 110344538
Neutropenic sepsis 25.87 10.86 11 195892 30735 110362661
Ulcer 25.78 10.86 23 195880 43093 110350303
Skin exfoliation 25.71 10.86 75 195828 87576 110305820
Transplant rejection 25.63 10.86 6 195897 24561 110368835
Pancreatitis acute 25.60 10.86 42 195861 60232 110333164
Creatinine renal clearance decreased 25.58 10.86 4 195899 21811 110371585
Dry skin 25.53 10.86 101 195802 107552 110285844
Blood pressure diastolic decreased 25.50 10.86 16 195887 35869 110357527
Iridocyclitis 25.33 10.86 39 195864 5369 110388027
Amnesia 25.31 10.86 292 195611 105116 110288280
Cerebral haemorrhage 25.12 10.86 48 195855 64920 110328476
Blindness 25.02 10.86 129 195774 36230 110357166
Hypohidrosis 24.99 10.86 12 195891 314 110393082
Disorientation 24.88 10.86 212 195691 70459 110322937
Dizziness 24.85 10.86 1492 194411 696701 109696695
Vagal nerve stimulator implantation 24.78 10.86 11 195892 239 110393157
Blood pressure measurement 24.77 10.86 14 195889 516 110392880
Extrapyramidal disorder 24.64 10.86 109 195794 28758 110364638
Toxic skin eruption 24.54 10.86 9 195894 27506 110365890
Macular detachment 24.53 10.86 11 195892 245 110393151
Pleocytosis 24.50 10.86 22 195881 1702 110391694
Abdominal distension 24.41 10.86 441 195462 174662 110218734
Depressed level of consciousness 24.32 10.86 305 195598 111973 110281423
Blood pressure systolic abnormal 24.15 10.86 7 195896 24843 110368553
Gene mutation 23.99 10.86 30 195873 3399 110389997
Gamma-glutamyltransferase increased 23.97 10.86 45 195858 61264 110332132
Vascular malformation 23.95 10.86 16 195887 798 110392598
Intensive care unit acquired weakness 23.90 10.86 25 195878 2334 110391062
Non-24-hour sleep-wake disorder 23.82 10.86 7 195896 42 110393354
Blood homocysteine increased 23.66 10.86 13 195890 453 110392943
Disseminated intravascular coagulation 23.54 10.86 23 195880 41263 110352133
Drug-induced liver injury 23.43 10.86 320 195583 119747 110273649
Hypermetropia 23.38 10.86 13 195890 464 110392932
Pneumothorax 23.38 10.86 17 195886 35268 110358128
Respiratory arrest 23.29 10.86 180 195723 58119 110335277
Hypercalcaemia 23.29 10.86 29 195874 46628 110346768
Breath sounds abnormal 23.19 10.86 8 195895 25396 110368000
Bladder cancer 23.17 10.86 4 195899 20288 110373108
Acute respiratory failure 23.11 10.86 63 195840 75197 110318199
Dysphemia 23.10 10.86 32 195871 4005 110389391
Faeces discoloured 22.96 10.86 16 195887 33932 110359464
Hippocampal sclerosis 22.88 10.86 10 195893 209 110393187
Delusion 22.84 10.86 93 195810 23662 110369734
Major depression 22.82 10.86 55 195848 10566 110382830
Osteonecrosis 22.69 10.86 16 195887 33725 110359671
Fluid retention 22.67 10.86 88 195815 94219 110299177
Osteomyelitis 22.52 10.86 19 195884 36581 110356815
Duodenal ulcer perforation 22.51 10.86 441 195462 177259 110216137
Renal tubular necrosis 22.48 10.86 13 195890 30462 110362934
Asthenia 22.38 10.86 995 194908 688004 109705392
Subdural haematoma 22.34 10.86 19 195884 36435 110356961
Lymphangioleiomyomatosis 22.21 10.86 10 195893 225 110393171
Hyperexplexia 22.19 10.86 7 195896 55 110393341
Pulmonary mass 22.18 10.86 20 195883 37281 110356115
Mobility decreased 22.12 10.86 564 195339 236858 110156538
Blood pressure diastolic abnormal 22.10 10.86 9 195894 25806 110367590
Retinal disorder 22.04 10.86 24 195879 2346 110391050
Anxiety 21.71 10.86 781 195122 344297 110049099
Brain stem microhaemorrhage 21.67 10.86 6 195897 28 110393368
Biliary dyskinesia 21.62 10.86 24 195879 2397 110390999
Vasculitis 21.61 10.86 19 195884 35854 110357542
Musculoskeletal pain 21.46 10.86 449 195454 182574 110210822
Device related infection 21.41 10.86 23 195880 39496 110353900
Blood glucose increased 21.37 10.86 142 195761 132354 110261042
Blindness day 21.35 10.86 4 195899 0 110393396
Cystitis 21.25 10.86 54 195849 65982 110327414
Screaming 21.20 10.86 34 195869 4847 110388549
Cardiac disorder 21.14 10.86 67 195836 76213 110317183
Encephalopathy 21.04 10.86 228 195675 80827 110312569
Hypersomnia 21.03 10.86 102 195801 27959 110365437
Skin lesion 20.98 10.86 37 195866 51594 110341802
Granuloma annulare 20.91 10.86 15 195888 840 110392556
Self-destructive behaviour 20.91 10.86 15 195888 840 110392556
Lymphoma 20.90 10.86 5 195898 20166 110373230
Hallucination, tactile 20.77 10.86 16 195887 999 110392397
Haematuria traumatic 20.54 10.86 11 195892 364 110393032
Simple partial seizures 20.48 10.86 16 195887 1020 110392376
Abortion spontaneous 20.46 10.86 117 195786 34165 110359231
Cluster headache 20.38 10.86 17 195886 1190 110392206
Drug withdrawal syndrome 20.23 10.86 126 195777 37928 110355468
Frontal lobe epilepsy 20.14 10.86 6 195897 38 110393358
Tearfulness 20.04 10.86 42 195861 7353 110386043
Suspiciousness 20.02 10.86 14 195889 753 110392643
Blindness transient 19.98 10.86 37 195866 5919 110387477
Blood test abnormal 19.92 10.86 13 195890 28541 110364855
Femur fracture 19.82 10.86 30 195873 44439 110348957
Staring 19.75 10.86 25 195878 2867 110390529
Cerebellar microhaemorrhage 19.75 10.86 6 195897 41 110393355
Intentional product misuse 19.69 10.86 338 195565 132566 110260830
Pneumonia bacterial 19.66 10.86 11 195892 26250 110367146
Eye pain 19.64 10.86 154 195749 49945 110343451
Benign cardiac neoplasm 19.62 10.86 6 195897 42 110393354
Frequent bowel movements 19.57 10.86 63 195840 71327 110322069
Incorrect product administration duration 19.51 10.86 80 195823 20418 110372978
Borderline personality disorder 19.48 10.86 16 195887 1096 110392300
Foot deformity 19.47 10.86 35 195868 48445 110344951
Blood calcium decreased 19.27 10.86 21 195882 35824 110357572
Rheumatoid nodule 19.21 10.86 6 195897 20290 110373106
Hyperphosphataemia 19.21 10.86 3 195900 16378 110377018
Cataract 19.21 10.86 74 195829 79411 110313985
Hypoalbuminaemia 19.14 10.86 14 195889 28960 110364436
Cholangitis 19.14 10.86 3 195900 16332 110377064
Haemorrhage intracranial 19.14 10.86 14 195889 28955 110364441
Burning mouth syndrome 19.11 10.86 13 195890 668 110392728
Pallor 19.09 10.86 45 195858 56422 110336974
Communication disorder 19.08 10.86 33 195870 5006 110388390
Embolism 19.07 10.86 3 195900 16286 110377110
Numb chin syndrome 19.04 10.86 6 195897 47 110393349
Inappropriate affect 19.02 10.86 19 195884 1680 110391716
Pulmonary alveolar haemorrhage 19.00 10.86 6 195897 20144 110373252
Bronchitis 18.99 10.86 182 195721 156850 110236546
Renal colic 18.91 10.86 26 195877 3232 110390164
Therapeutic product effective for unapproved indication 18.86 10.86 8 195895 155 110393241
Anoxia 18.81 10.86 11 195892 433 110392963
Panic attack 18.76 10.86 101 195802 28839 110364557
Hypotonia 18.74 10.86 66 195837 15679 110377717
Cardiomyopathy 18.74 10.86 19 195884 33506 110359890
Synovitis 18.65 10.86 626 195277 273466 110119930
Rash erythematous 18.63 10.86 78 195825 81754 110311642
Gastric ulcer 18.60 10.86 26 195877 39801 110353595
Drug abuse 18.50 10.86 428 195475 176983 110216413
Hip arthroplasty 18.46 10.86 45 195858 55768 110337628
Oral herpes 18.46 10.86 22 195881 36058 110357338
Diffuse large B-cell lymphoma 18.45 10.86 3 195900 15895 110377501
Intestinal perforation 18.43 10.86 7 195896 20937 110372459
Eye movement disorder 18.41 10.86 48 195855 9680 110383716
Haemolytic anaemia 18.40 10.86 7 195896 20913 110372483
Organic brain syndrome 18.39 10.86 12 195891 575 110392821
Pemphigoid 18.35 10.86 6 195897 19701 110373695
Squamous cell carcinoma 18.32 10.86 5 195898 18458 110374938
Narrow anterior chamber angle 18.18 10.86 8 195895 170 110393226
Vestibular migraine 18.14 10.86 8 195895 171 110393225
Rhinorrhoea 18.12 10.86 107 195796 102559 110290837
Helicobacter infection 18.12 10.86 436 195467 181441 110211955
Acid-base balance disorder mixed 18.08 10.86 7 195896 106 110393290
Calculus urinary 18.06 10.86 25 195878 3127 110390269
Lichen planus 17.99 10.86 26 195877 3384 110390012
Panniculitis 17.95 10.86 3 195900 15579 110377817
Oral pain 17.94 10.86 24 195879 37420 110355976
Idiopathic intracranial hypertension 17.82 10.86 28 195875 3924 110389472
Anticonvulsant drug level above therapeutic 17.73 10.86 16 195887 1246 110392150
Patient dissatisfaction with treatment 17.63 10.86 10 195893 371 110393025
Negativism 17.62 10.86 14 195889 915 110392481
Staphylococcal bacteraemia 17.56 10.86 4 195899 16684 110376712
Contraindicated product administered 17.40 10.86 569 195334 247698 110145698
Blood thyroid stimulating hormone normal 17.40 10.86 7 195896 118 110393278
Hip fracture 17.38 10.86 22 195881 35129 110358267
Hyperinsulinaemia 17.37 10.86 9 195894 278 110393118
Rash maculo-papular 17.37 10.86 70 195833 74152 110319244
Adverse event 17.32 10.86 280 195623 108529 110284867
Bezoar 17.28 10.86 28 195875 4026 110389370
Hepatic failure 17.26 10.86 63 195840 68676 110324720
Premature ejaculation 17.23 10.86 6 195897 66 110393330
Near drowning 17.23 10.86 6 195897 66 110393330
Accommodation disorder 17.23 10.86 12 195891 641 110392755
Asthma 17.16 10.86 326 195577 249965 110143431
Purpura 17.16 10.86 11 195892 24377 110369019
Lung disorder 17.15 10.86 429 195474 179618 110213778
Pathogen resistance 17.14 10.86 5 195898 17667 110375729
Metastases to lymph nodes 17.08 10.86 3 195900 15029 110378367
Microcephaly 17.07 10.86 8 195895 198 110393198
Bronchospasm 17.06 10.86 17 195886 30222 110363174
Dysmorphism 17.05 10.86 12 195891 652 110392744
Hepatitis acute 16.97 10.86 6 195897 18760 110374636
Hamartoma 16.97 10.86 4 195899 8 110393388
Psychomotor hyperactivity 16.88 10.86 76 195827 20201 110373195
Anticonvulsant drug level below therapeutic 16.85 10.86 15 195888 1147 110392249
Acute coronary syndrome 16.85 10.86 10 195893 23102 110370294
Thyroid atrophy 16.80 10.86 9 195894 298 110393098
Hallucination, visual 16.79 10.86 124 195779 39481 110353915
Thalamic infarction 16.78 10.86 16 195887 1336 110392060
Tendonitis 16.72 10.86 13 195890 26070 110367326
Epileptic encephalopathy 16.71 10.86 12 195891 673 110392723
Blunted affect 16.71 10.86 11 195892 535 110392861
Conjunctival oedema 16.69 10.86 17 195886 1539 110391857
Educational problem 16.67 10.86 11 195892 537 110392859
Therapeutic product effect decreased 16.62 10.86 558 195345 243758 110149638
Iris disorder 16.56 10.86 8 195895 212 110393184
Gastroenteritis 16.51 10.86 27 195876 38773 110354623
Metabolic myopathy 16.49 10.86 7 195896 136 110393260
Sciatica 16.47 10.86 96 195807 92303 110301093
Squamous cell carcinoma of skin 16.44 10.86 5 195898 17198 110376198
Regressive behaviour 16.39 10.86 8 195895 217 110393179
Diabetic ketoacidosis 16.33 10.86 31 195872 42027 110351369
Arteriosclerosis 16.32 10.86 12 195891 24755 110368641
Oropharyngeal pain 16.26 10.86 157 195746 135119 110258277
Blood potassium increased 16.25 10.86 21 195882 33228 110360168
Tachycardia 16.22 10.86 293 195610 226352 110167044
Illogical thinking 16.19 10.86 6 195897 80 110393316
Ehlers-Danlos syndrome 16.17 10.86 9 195894 322 110393074
Urge incontinence 16.17 10.86 16 195887 1399 110391997
Myasthenia gravis 16.12 10.86 9 195894 21502 110371894
Cervical dysplasia 16.10 10.86 22 195881 2718 110390678
Syncope 16.06 10.86 257 195646 202279 110191117
Knee arthroplasty 16.00 10.86 60 195843 64888 110328508
Red blood cell sedimentation rate abnormal 15.99 10.86 12 195891 24497 110368899
Acute respiratory distress syndrome 15.98 10.86 45 195858 53153 110340243
Proteinuria 15.97 10.86 29 195874 39989 110353407
Urine calcium/creatinine ratio increased 15.94 10.86 7 195896 148 110393248
Blood calcium increased 15.92 10.86 6 195897 18034 110375362
Blood insulin abnormal 15.88 10.86 5 195898 39 110393357
Feeling abnormal 15.88 10.86 426 195477 180285 110213111
Chorioretinal folds 15.77 10.86 5 195898 40 110393356
Calcitonin secretion disorder 15.67 10.86 5 195898 41 110393355
Benzodiazepine drug level increased 15.66 10.86 8 195895 240 110393156
Pulmonary fibrosis 15.65 10.86 111 195792 101931 110291465
Ureterolithiasis 15.59 10.86 28 195875 4374 110389022
Symptom masked 15.59 10.86 18 195885 1877 110391519
Parasomnia 15.44 10.86 12 195891 759 110392637
Accidental death 15.42 10.86 30 195873 4979 110388417
Generalised oedema 15.41 10.86 19 195884 30685 110362711
Heart rate irregular 15.39 10.86 23 195880 34251 110359145
Pulmonary haemorrhage 15.34 10.86 5 195898 16451 110376945
Joint effusion 15.30 10.86 9 195894 20896 110372500
Anterior chamber disorder 15.28 10.86 7 195896 164 110393232
Renal injury 15.27 10.86 7 195896 18706 110374690
Rash 15.18 10.86 1250 194653 819714 109573682
Thinking abnormal 15.14 10.86 60 195843 15080 110378316
Depersonalisation/derealisation disorder 15.13 10.86 19 195884 2162 110391234
Fear 15.07 10.86 81 195822 23112 110370284
Transferrin saturation decreased 15 10.86 15 195888 1328 110392068
Foreign body in reproductive tract 14.98 10.86 13 195890 961 110392435
Ultrasound liver abnormal 14.98 10.86 7 195896 172 110393224
Toxic encephalopathy 14.97 10.86 60 195843 15154 110378242
Lethargy 14.97 10.86 241 195662 93335 110300061
Cardiac murmur 14.89 10.86 13 195890 24615 110368781
Lung infiltration 14.89 10.86 13 195890 24615 110368781
Candida infection 14.88 10.86 40 195863 47969 110345427
Duodenal ulcer 14.86 10.86 8 195895 19506 110373890
Hyperventilation 14.78 10.86 42 195861 8905 110384491
Status migrainosus 14.76 10.86 6 195897 104 110393292
Coma 14.75 10.86 292 195611 117577 110275819
Splenomegaly 14.73 10.86 13 195890 24485 110368911
Skin disorder 14.67 10.86 34 195869 42879 110350517
Neuroleptic malignant syndrome 14.64 10.86 107 195796 33952 110359444
Brugada syndrome 14.63 10.86 16 195887 1572 110391824
Rash macular 14.60 10.86 29 195874 38657 110354739
Psychomotor skills impaired 14.58 10.86 36 195867 7022 110386374
Hypertensive crisis 14.57 10.86 13 195890 24359 110369037
Lens dislocation 14.55 10.86 7 195896 184 110393212
Product administered to patient of inappropriate age 14.54 10.86 39 195864 7997 110385399
Activated partial thromboplastin time prolonged 14.53 10.86 11 195892 22357 110371039
Atrioventricular septal defect 14.50 10.86 6 195897 109 110393287
Aplastic anaemia 14.49 10.86 13 195890 24295 110369101
Optic atrophy 14.45 10.86 20 195883 2501 110390895
Enuresis 14.44 10.86 26 195877 4070 110389326
Lymphopenia 14.40 10.86 31 195872 40139 110353257
Enteritis 14.38 10.86 8 195895 19148 110374248
Hepatocellular injury 14.37 10.86 44 195859 50598 110342798
SARS-CoV-2 test positive 14.34 10.86 6 195897 16929 110376467
Upper respiratory tract infection 14.31 10.86 156 195747 131172 110262224
Blood loss anaemia 14.31 10.86 7 195896 18018 110375378
Bone pain 14.27 10.86 63 195840 65070 110328326
Hypogammaglobulinaemia 14.20 10.86 9 195894 20067 110373329
Pain in jaw 14.14 10.86 45 195858 51132 110342264
Klebsiella infection 14.11 10.86 9 195894 20000 110373396
Perseveration 14.04 10.86 9 195894 418 110392978
Food allergy 14.03 10.86 9 195894 19939 110373457
Dissociative disorder 14.02 10.86 14 195889 1237 110392159
Systemic inflammatory response syndrome 13.98 10.86 3 195900 13040 110380356
Staphylococcal infection 13.94 10.86 70 195833 69874 110323522
Transient epileptic amnesia 13.94 10.86 3 195900 3 110393393
Failed induction of labour 13.91 10.86 8 195895 305 110393091
Escherichia infection 13.89 10.86 13 195890 23803 110369593
Therapeutic product ineffective for unapproved indication 13.88 10.86 8 195895 306 110393090
Open angle glaucoma 13.88 10.86 10 195893 564 110392832
Haematocrit decreased 13.86 10.86 65 195838 66052 110327344
Paranasal cyst 13.77 10.86 12 195891 892 110392504
Temperature intolerance 13.72 10.86 55 195848 13895 110379501
Pulmonary congestion 13.69 10.86 21 195882 30945 110362451
Basilar migraine 13.68 10.86 5 195898 64 110393332
Angina unstable 13.63 10.86 6 195897 16426 110376970
Rubber sensitivity 13.59 10.86 19 195884 2399 110390997
Incoherent 13.58 10.86 39 195864 8319 110385077
Pleural rub 13.54 10.86 5 195898 66 110393330
Impulse-control disorder 13.48 10.86 18 195885 2176 110391220
Lower gastrointestinal haemorrhage 13.47 10.86 8 195895 18478 110374918
Decreased interest 13.44 10.86 28 195875 4880 110388516
Hyperacusis 13.43 10.86 21 195882 2931 110390465
Automatism 13.40 10.86 7 195896 220 110393176
Urticaria 13.39 10.86 692 195211 318165 110075231
Nodular rash 13.38 10.86 8 195895 328 110393068
Lymphocyte count decreased 13.38 10.86 54 195849 57189 110336207
Night blindness 13.35 10.86 10 195893 599 110392797
Oral candidiasis 13.34 10.86 38 195865 44722 110348674
Self-injurious ideation 13.34 10.86 26 195877 4320 110389076
Dermatillomania 13.32 10.86 8 195895 331 110393065
Chronic idiopathic pain syndrome 13.26 10.86 7 195896 225 110393171
Femoral neck fracture 13.25 10.86 3 195900 12564 110380832
Enterococcal infection 13.25 10.86 10 195893 20356 110373040
Intestinal obstruction 13.22 10.86 49 195854 53178 110340218
Foetal exposure during pregnancy 13.16 10.86 36 195867 7469 110385927
Respiratory symptom 13.14 10.86 5 195898 14940 110378456
Substance use 13.07 10.86 19 195884 2487 110390909
Erectile dysfunction 12.88 10.86 66 195837 18490 110374906
Anti-cyclic citrullinated peptide antibody 12.74 10.86 10 195893 19954 110373442
Delayed light adaptation 12.73 10.86 3 195900 6 110393390
Enterocolitis 12.72 10.86 9 195894 18940 110374456
Limb injury 12.72 10.86 30 195873 37606 110355790
Subcutaneous drug absorption impaired 12.70 10.86 36 195867 7623 110385773
Therapeutic response changed 12.69 10.86 15 195888 1603 110391793
Muscle spasticity 12.64 10.86 28 195875 35887 110357509
Small for dates baby 12.61 10.86 10 195893 652 110392744
Essential tremor 12.59 10.86 16 195887 1842 110391554
Blood sodium decreased 12.59 10.86 31 195872 38288 110355108
Red blood cell sedimentation rate increased 12.59 10.86 84 195819 78218 110315178
Endocarditis 12.57 10.86 4 195899 13367 110380029
Diabetes mellitus 12.52 10.86 114 195789 99267 110294129
Aspartate aminotransferase decreased 12.48 10.86 14 195889 1414 110391982
Emphysema 12.47 10.86 10 195893 19746 110373650
Fungal infection 12.47 10.86 47 195856 50759 110342637
Blood bilirubin decreased 12.41 10.86 14 195889 1423 110391973
Illiteracy 12.41 10.86 4 195899 34 110393362
Granulocytopenia 12.40 10.86 50 195853 12665 110380731
Hypopyon 12.39 10.86 14 195889 1426 110391970
Asterixis 12.37 10.86 21 195882 3137 110390259
Nasal polyps 12.32 10.86 4 195899 13196 110380200
Skin infection 12.31 10.86 13 195890 22496 110370900
Cortical dysplasia 12.30 10.86 4 195899 35 110393361
Vascular device infection 12.24 10.86 7 195896 16505 110376891
Hereditary optic atrophy 12.23 10.86 5 195898 88 110393308
Neutrophil count increased 12.21 10.86 27 195876 34625 110358771
Gingival hypertrophy 12.21 10.86 25 195878 4306 110389090
Dermatitis 12.19 10.86 19 195884 27818 110365578
Pre-existing condition improved 12.14 10.86 32 195871 6494 110386902
Aortic stenosis 12.11 10.86 4 195899 13055 110380341
Ischaemic gastritis 12.11 10.86 4 195899 37 110393359
Postictal psychosis 12.10 10.86 7 195896 270 110393126
Arterial occlusive disease 12.07 10.86 6 195897 15302 110378094
Occipital neuralgia 12.07 10.86 10 195893 694 110392702
Apnoea 12.02 10.86 52 195851 13587 110379809
Renal disorder 12.00 10.86 46 195857 49433 110343963
Cardiac failure acute 11.98 10.86 15 195888 24063 110369333
Unevaluable event 11.96 10.86 59 195844 59168 110334228
Progressive multifocal leukoencephalopathy 11.95 10.86 16 195887 24940 110368456
Hand deformity 11.94 10.86 487 195416 218019 110175377
Post-traumatic stress disorder 11.93 10.86 32 195871 6564 110386832
Therapy partial responder 11.92 10.86 109 195794 36952 110356444
Heart rate increased 11.91 10.86 181 195722 143653 110249743
Electroencephalogram 11.87 10.86 3 195900 9 110393387
Craniofacial fracture 11.83 10.86 11 195892 890 110392506
Product physical issue 11.82 10.86 27 195876 5009 110388387
Vertigo 11.82 10.86 218 195685 86652 110306744
White blood cell count increased 11.81 10.86 112 195791 96730 110296666
Abscess 11.79 10.86 19 195884 27450 110365946
Intestinal ischaemia 11.79 10.86 7 195896 16172 110377224
Febrile infection-related epilepsy syndrome 11.78 10.86 5 195898 97 110393299
Breast cancer stage II 11.77 10.86 86 195817 27289 110366107
Clostridium difficile colitis 11.75 10.86 39 195864 43739 110349657
Cardiomegaly 11.73 10.86 21 195882 29109 110364287
Psoriasis 11.65 10.86 176 195727 139817 110253579
Impulsive behaviour 11.63 10.86 21 195882 3294 110390102
Second primary malignancy 11.59 10.86 9 195894 18059 110375337
Vascular headache 11.57 10.86 4 195899 43 110393353
Hyperbilirubinaemia 11.56 10.86 23 195880 30648 110362748
Left ventricular failure 11.46 10.86 3 195900 11386 110382010
Muscle contracture 11.44 10.86 19 195884 2789 110390607
Sarcoidosis 11.41 10.86 4 195899 12575 110380821
Condition aggravated 11.38 10.86 1477 194426 733359 109660037
Drug dependence 11.31 10.86 137 195766 49883 110343513
Body temperature decreased 11.28 10.86 31 195872 36904 110356492
Hospice care 11.26 10.86 4 195899 12469 110380927
Angular cheilitis 11.22 10.86 12 195891 1149 110392247
Suspected suicide 11.21 10.86 55 195848 15144 110378252
Gingival pain 11.20 10.86 7 195896 15729 110377667
Brain natriuretic peptide increased 11.19 10.86 3 195900 11206 110382190
Atrial flutter 11.17 10.86 16 195887 24246 110369150
Diastolic dysfunction 11.16 10.86 4 195899 12400 110380996
Complication of device removal 11.10 10.86 25 195878 4595 110388801
Mastoiditis 11.09 10.86 18 195885 2593 110390803
Endometriosis 11.03 10.86 24 195879 4310 110389086
Laryngeal stenosis 11.03 10.86 13 195890 1385 110392011
Postictal paralysis 11.02 10.86 9 195894 612 110392784
Physical assault 11.00 10.86 14 195889 1614 110391782
Paronychia 11.00 10.86 3 195900 11078 110382318
Glycosuria 10.99 10.86 18 195885 2612 110390784
Hyperthyroidism 10.98 10.86 22 195881 29239 110364157
Aborted pregnancy 10.96 10.86 4 195899 51 110393345
Mitral valve incompetence 10.92 10.86 27 195876 33302 110360094
Binge eating 10.90 10.86 9 195894 621 110392775
Rash pruritic 10.88 10.86 116 195787 97953 110295443
Hypophagia 10.87 10.86 52 195851 52574 110340822

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A08AA51 ALIMENTARY TRACT AND METABOLISM
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
Centrally acting antiobesity products
ATC N03AX11 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000927 Anticonvulsants
MeSH PA D007004 Hypoglycemic Agents
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000185506 Cytochrome P450 3A4 Inducers
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:38633 sodium channel blocker

Related Drugs by ATC class:

A08AA Centrally acting antiobesity products 15 drugs
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N03AX Other antiepileptics 18 drugs
beclamidebrivaracetamcannabidiolcarisbamatecenobamatefelbamatefenfluramineganaxolonelacosamidelamotriginelevetiracetamperampanel show all 18 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Lennox-Gastaut syndrome indication 230418006
Tonic-clonic epilepsy indication 352818000 DOID:7725
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Migraine Prevention indication
Alcoholism off-label use 7200002
Essential tremor off-label use 609558009 DOID:4990
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Reduced visual acuity contraindication 13164000
Mood swings contraindication 18963009
Secondary angle-closure glaucoma contraindication 21571006
Depressive disorder contraindication 35489007
Metabolic acidosis contraindication 59455009
Diarrhea contraindication 62315008
Fatigue contraindication 84229001
Kidney disease contraindication 90708001 DOID:557
Paresthesia contraindication 91019004
Kidney stone contraindication 95570007
Diminished sweating contraindication 111980002
Disease of liver contraindication 235856003 DOID:409
Drowsy contraindication 271782001
Pregnancy, function contraindication 289908002
Fever contraindication 386661006
Impaired cognition contraindication 386806002
Memory impairment contraindication 386807006
Dizziness contraindication 404640003
Concentration Difficulty contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.6 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
EQ 11.25MG BASE;69MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 11.25MG BASE;69MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 15MG BASE;92MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 15MG BASE;92MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 3.75MG BASE;23MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 3.75MG BASE;23MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 7.5MG BASE;46MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 7.5MG BASE;46MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 11.25MG BASE;69MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 15MG BASE;92MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 3.75MG BASE;23MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 7.5MG BASE;46MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
100MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
150MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
200MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
25MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
50MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11433046 Aug. 21, 2040 INDICATED AS ADJUNCTIVE THERAPY FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11433046 Aug. 21, 2040 INDICATED AS INITIAL MONOTHERAPY FOR THE TREATMENT OF PARTIAL-ONSET OR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11433046 Aug. 21, 2040 INDICATED FOR THE PREVENTIVE TREATMENT OF MIGRAINE IN PATIENTS 12 YEARS AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11911362 Aug. 21, 2040 INDICATED AS ADJUNCTIVE THERAPY FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11911362 Aug. 21, 2040 INDICATED AS INITIAL MONOTHERAPY FOR THE TREATMENT OF PARTIAL-ONSET OR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11911362 Aug. 21, 2040 INDICATED FOR THE PREVENTIVE TREATMENT OF MIGRAINE IN PATIENTS 12 YEARS AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 12290503 Aug. 21, 2040 INDICATED AS ADJUNCTIVE THERAPY FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 12290503 Aug. 21, 2040 INDICATED AS INITIAL MONOTHERAPY FOR THE TREATMENT OF PARTIAL-ONSET OR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 12290503 Aug. 21, 2040 INDICATED FOR THE PREVENTIVE TREATMENT OF MIGRAINE IN PATIENTS 12 YEARS AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG/ML TOPIRAMATE ALKEM LABS LTD A217795 Oct. 31, 2024 RX SOLUTION ORAL Jan. 5, 2026 PATENT CHALLENGE
50MG TOPIRAMATE RUBICON RESEARCH A216683 May 27, 2025 RX CAPSULE ORAL Feb. 1, 2026 COMPETITIVE GENERIC THERAPY
EQ 11.25MG BASE;69MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2027 INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY
EQ 15MG BASE;92MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2027 INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY
EQ 3.75MG BASE;23MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2027 INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY
EQ 7.5MG BASE;46MG QSYMIA VIVUS LLC N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2027 INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Carbonic anhydrase 4 Enzyme INHIBITOR Ki 5.31 CHEMBL CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE MODULATOR WOMBAT-PK CHEMBL
Carbonic anhydrase 2 Enzyme INHIBITOR Ki 8.30 CHEMBL CHEMBL
Glutamate receptor ionotropic kainate Ion channel ANTAGONIST CHEMBL CHEMBL
Glutamate receptor ionotropic AMPA Ion channel ANTAGONIST CHEMBL CHEMBL
Sodium channel protein type 1 subunit alpha Ion channel BLOCKER DRUGBANK CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER WOMBAT-PK CHEMBL
Carbonic anhydrase 7 Enzyme Ki 9.06 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 7.35 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 5.84 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 7.33 CHEMBL
Carbonic anhydrase V Enzyme Ki 7.60 CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Carbonic anhydrase 1 Enzyme Ki 6.60 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 7.24 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 8.42 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Kd 7.60 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 7.52 CHEMBL
Carbonic anhydrase Enzyme Ki 6.76 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 7.33 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 7.27 CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel IC50 4.01 CHEMBL
Carbonic anhydrase 2 Enzyme IC50 5.85 CHEMBL
Carbonic anhydrase Enzyme Ki 6.92 CHEMBL
Carbonic anhydrase Enzyme Ki 4.63 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 7.11 CHEMBL
Carbonic anhydrase Enzyme Ki 6.96 CHEMBL
Carbonic anhydrase Enzyme Ki 8 CHEMBL
Probable transmembrane carbonic anhydrase (Carbonate dehydratase) (Carbonic dehydratase); Transmembrane carbonic anhydrase Enzyme Ki 5.52 CHEMBL
Carbonic anhydrase Enzyme Ki 6.96 CHEMBL
Alpha carbonic anhydrase Enzyme Ki 7.54 CHEMBL
Carbonic anhydrase Enzyme Ki 6.44 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.43 CHEMBL
Astrosclerin-3 Enzyme Ki 7.42 CHEMBL
Beta-carbonic anhydrase 1 Enzyme Ki 6.21 CHEMBL
Delta carbonic anhydrase Enzyme Ki 6.41 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.32 CHEMBL
Carbonic anhydrase, alpha family Enzyme Ki 6.11 CHEMBL
Carbonate dehydratase Enzyme Ki 8.18 CHEMBL

External reference:

IDSource
4021026 VUID
N0000148493 NUI
D00537 KEGG_DRUG
4021026 VANDF
C0076829 UMLSCUI
CHEBI:63631 CHEBI
TOR PDB_CHEM_ID
CHEMBL220492 ChEMBL_ID
DB00273 DRUGBANK_ID
D000077236 MESH_DESCRIPTOR_UI
5284627 PUBCHEM_CID
6849 IUPHAR_LIGAND_ID
6099 INN_ID
0H73WJJ391 UNII
220343 RXNORM
162273 MMSL
5601 MMSL
6438 MMSL
d04115 MMSL
005453 NDDF
108400009 SNOMEDCT_US
386844006 SNOMEDCT_US
0H73WJJ391 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1072 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1073 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1074 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1075 CAPSULE, EXTENDED RELEASE 150 mg ORAL NDA 30 sections
Phentermine and topiramate HUMAN PRESCRIPTION DRUG LABEL 2 0480-2299 CAPSULE, EXTENDED RELEASE 69 mg ORAL ANDA 29 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2356 CAPSULE, EXTENDED RELEASE 25 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2357 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2358 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2359 CAPSULE, EXTENDED RELEASE 200 mg ORAL ANDA 27 sections
Phentermine and topiramate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3295 CAPSULE, EXTENDED RELEASE 92 mg ORAL ANDA 29 sections
Phentermine and topiramate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3296 CAPSULE, EXTENDED RELEASE 46 mg ORAL ANDA 29 sections
Phentermine and topiramate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3297 CAPSULE, EXTENDED RELEASE 23 mg ORAL ANDA 29 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8138 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8139 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8140 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8593 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8594 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8595 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA authorized generic 30 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1072 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA authorized generic 30 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1073 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA authorized generic 30 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1074 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA authorized generic 30 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1075 CAPSULE, EXTENDED RELEASE 150 mg ORAL NDA authorized generic 30 sections
topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6928 TABLET, FILM COATED 25 mg ORAL ANDA 27 sections
topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6929 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10370-365 CAPSULE, EXTENDED RELEASE 25 mg ORAL ANDA 26 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10370-366 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 26 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10370-367 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 26 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10370-368 CAPSULE, EXTENDED RELEASE 200 mg ORAL ANDA 17 sections