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

Stem definitionDrug idCAS RN
inhibitors of phosphodiesterase PDE5 with vasodilator action 2441 139755-83-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mysildecard
  • sildenafil
  • sildenafil citrate
  • revatio
A PHOSPHODIESTERASE TYPE-5 INHIBITOR; VASODILATOR AGENT and UROLOGICAL AGENT that is used in the treatment of ERECTILE DYSFUNCTION and PRIMARY PULMONARY HYPERTENSION.
  • Molecular weight: 474.58
  • Formula: C22H30N6O4S
  • CLOGP: 2.20
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 1
  • TPSA: 109.13
  • ALOGS: -3.01
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 7.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.52 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 38 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.36 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.731 High 0.83
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.321 High 0.83
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 50.466 10^-6 cm/s High 0.83
dh-clint Dog hepatocyte intrinsic clearance 11.272 uL/min/10^6 cells High 0.83
dppb Dog plasma protein binding (% unbound) 15.520 % High 0.83
fcs-ppb Fetal calf serum protein binding (% unbound) 23.190 % High 0.83
herg hERG pIC50 4.932 pIC50 High 0.83
hh-clint Human hepatocyte intrinsic clearance 14.289 uL/min/10^6 cells High 0.83
hlm-clint Human liver microsomal intrinsic clearance 199.526 uL/min/mg protein High 0.83
hppb Human plasma protein binding (% unbound) 10.450 % High 0.83
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,ITK,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PIK3CB,PIK3CD,PIK3CG,PRKDC,SIK2,STK33,TEK 26
kinase-selectivity-class AXL,BRAF,CDK9,MAPK7 4
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.236 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.793 High 0.83
mh-clint Mouse hepatocyte intrinsic clearance 70.795 High 0.83
mppb Mouse plasma protein binding (% unbound) 8.720 High 0.83
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 7.396 High 0.83
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 22.110 % High 0.83
rat-kpuu-brain Rat brain Kpuu 0.115 % High 1
rh-clint Rat hepatocyte intrinsic clearance 84.723 uL/min/10^6 cells High 0.83
rh-fuinc Rat hepatocyte fraction unbound in incubation 58.050 % High 0.83
rppb Rat plasma protein binding (% unbound) 8.960 % High 0.83
solubility-dd Solubility at pH 7.4 in DMSO 27.606 uM High 0.83

Approvals:

DateAgencyCompanyOrphan
March 27, 1998 FDA PFIZER IRELAND
Sept. 13, 1998 EMA UPJOHN EESV

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
Pulmonary arterial hypertension 3112.08 13.37 1257 138304 24930 90463956
Dyspnoea 2763.86 13.37 4876 134685 876079 89612807
Right ventricular failure 2195.98 13.37 897 138664 18308 90470578
Pulmonary hypertension 1996.70 13.37 1073 138488 41450 90447436
Fluid retention 1943.85 13.37 1372 138189 86719 90402167
Death 1905.61 13.37 2883 136678 453668 90035218
Pain in jaw 1787.38 13.37 1040 138521 46945 90441941
Hypervolaemia 1232.80 13.37 715 138846 32042 90456844
Dyspnoea exertional 1138.81 13.37 921 138640 71367 90417519
Headache 864.03 13.37 3097 136464 859649 89629237
Oxygen saturation decreased 803.37 13.37 907 138654 106576 90382310
Catheter site erythema 780.02 13.37 291 139270 4603 90484283
Flushing 720.34 13.37 781 138780 87710 90401176
Hospitalisation 681.92 13.37 911 138650 127189 90361697
Lung transplant 652.93 13.37 237 139324 3455 90485431
Nasal congestion 623.31 13.37 704 138857 82710 90406176
Drug ineffective 616.86 13.37 739 138822 1383559 89105327
Device related infection 608.52 13.37 419 139142 25367 90463519
Transfusion 598.16 13.37 359 139202 17129 90471757
Infusion related reaction 575.67 13.37 14 139547 416766 90072120
Cardiac failure 540.67 13.37 751 138810 108745 90380141
Catheter site pruritus 538.47 13.37 182 139379 2120 90486766
Hypoxia 537.39 13.37 609 138952 71790 90417096
Infusion site pain 521.42 13.37 344 139217 19394 90469492
Catheter site pain 508.68 13.37 222 139339 5357 90483529
Syncope 504.48 13.37 805 138756 131858 90357028
Catheter management 503.92 13.37 186 139375 2850 90486036
Pulmonary oedema 491.27 13.37 540 139021 61540 90427346
Hypotension 449.46 13.37 1307 138254 324090 90164796
Pulmonary arterial pressure increased 447.66 13.37 183 139378 3733 90485153
Alopecia 440.95 13.37 110 139451 494961 89993925
Glossodynia 439.71 13.37 12 139549 321767 90167119
Cough 433.19 13.37 1400 138161 367562 90121324
Respiratory failure 426.26 13.37 701 138860 117717 90371169
Chest pain 419.60 13.37 1261 138300 318384 90170502
Catheterisation cardiac 409.34 13.37 184 139377 4772 90484114
Catheter site discharge 408.74 13.37 150 139411 2259 90486627
Oedema peripheral 403.26 13.37 1084 138477 256831 90232055
Cardiac failure congestive 401.65 13.37 618 138943 98076 90390810
Contraindicated product administered 382.60 13.37 29 139532 320110 90168776
Palpitations 369.37 13.37 714 138847 136014 90352872
Oxygen consumption increased 362.00 13.37 165 139396 4424 90484462
Arthropathy 359.44 13.37 65 139496 366177 90122709
Catheter site infection 352.93 13.37 173 139388 5481 90483405
Treatment failure 350.86 13.37 32 139529 303896 90184990
Drug hypersensitivity 340.55 13.37 144 139417 463465 90025421
Rheumatoid arthritis 337.72 13.37 73 139488 362541 90126345
Pneumonia 334.57 13.37 1894 137667 636165 89852721
Stomatitis 325.06 13.37 26 139535 274672 90214214
Joint swelling 324.84 13.37 186 139375 503114 89985772
Scleroderma 324.72 13.37 169 139392 6092 90482794
Rash 320.11 13.37 457 139104 795643 89693243
Hepatic enzyme increased 315.52 13.37 83 139478 360653 90128233
Wound 305.52 13.37 50 139511 302930 90185956
Therapeutic product effect decreased 305.41 13.37 35 139526 277536 90211350
Infusion site erythema 303.46 13.37 214 139347 13456 90475430
Helicobacter infection 300.70 13.37 11 139550 226839 90262047
Folliculitis 298.08 13.37 3 139558 204350 90284536
Psoriatic arthropathy 292.90 13.37 14 139547 228321 90260565
Pericarditis 287.59 13.37 38 139523 270113 90218773
Impaired healing 283.22 13.37 20 139541 234179 90254707
Unevaluable event 282.29 13.37 384 139177 54464 90434422
Central venous catheterisation 280.75 13.37 119 139442 2667 90486219
Acute respiratory failure 278.35 13.37 337 139224 42581 90446305
Musculoskeletal stiffness 277.47 13.37 59 139502 296473 90192413
Diarrhoea 273.91 13.37 2417 137144 936773 89552113
Dizziness 273.09 13.37 1694 137867 587590 89901296
Blood cholesterol increased 266.01 13.37 13 139548 207999 90280887
Toxicity to various agents 265.81 13.37 59 139502 287787 90201099
Cardiac disorder 265.59 13.37 380 139181 56492 90432394
Epistaxis 264.19 13.37 472 139089 84653 90404233
Catheter site swelling 263.61 13.37 101 139460 1724 90487162
Type 2 diabetes mellitus 262.17 13.37 12 139549 203232 90285654
Catheter site haemorrhage 258.56 13.37 122 139439 3546 90485340
Hypersensitivity 251.73 13.37 199 139362 454478 90034408
Device leakage 251.48 13.37 169 139392 9822 90479064
Muscle injury 251.41 13.37 4 139557 176650 90312236
Irritable bowel syndrome 244.36 13.37 20 139541 207428 90281458
Oedema 242.73 13.37 769 138792 199526 90289360
Mobility decreased 242.66 13.37 46 139515 250688 90238198
Pericardial effusion 241.76 13.37 291 139270 36542 90452344
Urticaria 241.18 13.37 90 139471 312644 90176242
Device alarm issue 239.31 13.37 95 139466 1790 90487096
Neutropenia 238.48 13.37 32 139529 224872 90264014
Catheter placement 238.47 13.37 103 139458 2421 90486465
Systemic lupus erythematosus 230.11 13.37 136 139425 361760 90127126
Fibromyalgia 229.40 13.37 25 139536 206244 90282642
Disease progression 226.35 13.37 640 138921 155975 90332911
Infusion site infection 220.45 13.37 99 139462 2561 90486325
Discomfort 219.98 13.37 74 139487 274261 90214625
Blister 218.48 13.37 61 139500 254937 90233949
Drug intolerance 212.02 13.37 226 139335 447365 90041521
Cardiac operation 208.83 13.37 108 139453 3841 90485045
Hypertension 206.88 13.37 240 139321 457292 90031594
Therapy change 202.85 13.37 138 139423 8184 90480702
Device occlusion 198.39 13.37 142 139419 9140 90479746
Transplant evaluation 196.24 13.37 75 139486 1271 90487615
Chest discomfort 194.64 13.37 560 139001 137805 90351081
Pulmonary veno-occlusive disease 193.47 13.37 77 139484 1461 90487425
Dialysis 190.24 13.37 150 139411 11179 90477707
Febrile neutropenia 190.03 13.37 14 139547 158335 90330551
Psoriasis 189.63 13.37 9 139552 147745 90341141
Ascites 188.59 13.37 295 139266 47445 90441441
Product use in unapproved indication 187.45 13.37 146 139415 336090 90152796
Catheter site rash 184.60 13.37 63 139498 757 90488129
Maternal exposure during pregnancy 182.84 13.37 171 139390 359892 90128994
Complication associated with device 178.26 13.37 183 139378 19266 90469620
Injury 177.06 13.37 43 139518 197306 90291580
Off label use 175.99 13.37 989 138572 1101263 89387623
Concomitant disease aggravated 175.35 13.37 144 139417 11374 90477512
Joint range of motion decreased 174.93 13.37 8 139553 135635 90353251
Osteoarthritis 174.92 13.37 43 139518 195687 90293199
Sleep disorder due to general medical condition, insomnia type 174.91 13.37 5 139556 128689 90360197
Completed suicide 173.57 13.37 13 139548 145045 90343841
Confusional state 169.80 13.37 207 139354 385998 90102888
Bursitis 169.01 13.37 8 139553 131646 90357240
Liver injury 165.61 13.37 31 139530 170536 90318350
Pulmonary hypertensive crisis 161.77 13.37 50 139511 427 90488459
Malaise 161.37 13.37 1491 138070 584495 89904391
Vascular device infection 160.49 13.37 139 139422 11813 90477073
Haemoptysis 159.02 13.37 225 139336 33095 90455791
Catheter site irritation 158.71 13.37 53 139508 593 90488293
Heart rate increased 157.84 13.37 456 139105 112446 90376440
Ill-defined disorder 155.07 13.37 46 139515 184845 90304041
Dermatitis contact 152.75 13.37 143 139418 13452 90475434
Therapeutic product effect incomplete 152.46 13.37 54 139507 193842 90295044
Product dose omission issue 152.30 13.37 866 138695 290821 90198065
Lower respiratory tract infection 151.22 13.37 100 139461 250559 90238327
Dyspnoea at rest 147.55 13.37 92 139469 4699 90484187
Myalgia 147.49 13.37 597 138964 174528 90314358
Device dislocation 146.43 13.37 210 139351 31272 90457614
Presyncope 146.24 13.37 211 139350 31594 90457292
Pruritus 145.19 13.37 394 139167 541131 89947755
Productive cough 144.18 13.37 347 139214 76716 90412170
Exercise tolerance decreased 139.92 13.37 106 139455 7445 90481441
Feeling abnormal 139.16 13.37 568 138993 166667 90322219
Device infusion issue 138.46 13.37 72 139489 2590 90486296
Lip dry 136.91 13.37 4 139557 100951 90387935
Hypercholesterolaemia 136.81 13.37 4 139557 100888 90387998
Intentional product use issue 135.66 13.37 83 139478 216809 90272077
Blood pressure decreased 135.59 13.37 333 139228 74562 90414324
Hypoaesthesia 135.35 13.37 171 139390 314039 90174847
Right ventricular dysfunction 134.72 13.37 68 139493 2296 90486590
Infusion site swelling 133.07 13.37 124 139437 11596 90477290
N-terminal prohormone brain natriuretic peptide increased 131.23 13.37 72 139489 2890 90485996
Inflammation 130.07 13.37 56 139505 178536 90310350
Malignant neoplasm progression 129.50 13.37 9 139552 106861 90382025
C-reactive protein increased 127.22 13.37 60 139501 181329 90307557
Nausea 125.01 13.37 2399 137162 1107917 89380969
Cyanosis 123.25 13.37 151 139410 19304 90469582
Paracentesis 122.33 13.37 49 139512 946 90487940
Brain natriuretic peptide increased 121.79 13.37 89 139472 5916 90482970
Walking distance test abnormal 119.72 13.37 42 139519 551 90488335
Catheter site inflammation 117.21 13.37 47 139514 910 90487976
Arthralgia 116.73 13.37 712 138849 777810 89711076
Wound infection 115.49 13.37 14 139547 106388 90382498
Drug interaction 115.39 13.37 154 139407 276299 90212587
Cardiac pacemaker insertion 112.00 13.37 75 139486 4332 90484554
Catheter site related reaction 111.68 13.37 47 139514 1034 90487852
Atrial flutter 111.07 13.37 108 139453 10650 90478236
Heart transplant 110.81 13.37 40 139521 573 90488313
Night sweats 109.86 13.37 31 139530 128735 90360151
Influenza 109.56 13.37 465 139096 138799 90350087
Abdominal distension 108.16 13.37 443 139118 130158 90358728
Sleep disorder 107.75 13.37 88 139473 197942 90290944
Obesity 107.18 13.37 17 139544 105490 90383396
Depression 103.09 13.37 191 139370 300410 90188476
Pleural effusion 102.51 13.37 392 139169 111599 90377287
Delirium 99.10 13.37 20 139541 104339 90384547
Asthma 98.92 13.37 137 139424 242023 90246863
Condition aggravated 98.50 13.37 1372 138189 594173 89894713
Prescribed underdose 98.12 13.37 4 139557 75015 90413871
Drug-induced liver injury 97.74 13.37 12 139549 90306 90398580
Injection site pain 97.25 13.37 75 139486 173624 90315262
Disease complication 95.39 13.37 64 139497 3708 90485178
Device related sepsis 94.87 13.37 70 139491 4723 90484163
Red blood cell sedimentation rate increased 94.40 13.37 9 139552 82586 90406300
Infusion site discharge 93.79 13.37 54 139507 2381 90486505
Peripheral venous disease 93.69 13.37 10 139551 83911 90404975
Chronic obstructive pulmonary disease 93.49 13.37 288 139273 73541 90415345
White blood cell count decreased 92.48 13.37 73 139488 167036 90321850
Gastrointestinal haemorrhage 90.20 13.37 325 139236 89923 90398963
Paraesthesia 89.46 13.37 155 139406 250171 90238715
Gait inability 88.87 13.37 58 139503 146398 90342488
Cardiac ablation 88.37 13.37 46 139515 1658 90487228
Emergency care 85.59 13.37 44 139517 1545 90487341
Cor pulmonale 85.58 13.37 48 139513 2012 90486874
Respiratory distress 84.55 13.37 186 139375 38760 90450126
Atrial fibrillation 83.49 13.37 417 139144 133194 90355692
Chronic respiratory failure 82.81 13.37 52 139509 2689 90486197
Right ventricular dilatation 82.81 13.37 44 139517 1655 90487231
Injection site reaction 82.68 13.37 20 139541 92060 90396826
Oxygen therapy 81.75 13.37 54 139507 3048 90485838
Neutrophil count decreased 81.21 13.37 8 139553 71524 90417362
Respiration abnormal 80.45 13.37 79 139482 7884 90481002
Epilepsy 79.64 13.37 15 139546 82191 90406695
Catheter site vesicles 78.81 13.37 28 139533 382 90488504
Foot deformity 78.62 13.37 3 139558 59648 90429238
Infusion site haemorrhage 76.87 13.37 65 139496 5346 90483540
Intentional overdose 75.69 13.37 25 139536 93809 90395077
Mucosal inflammation 75.60 13.37 3 139558 57622 90431264
Right ventricular systolic pressure increased 75.58 13.37 30 139531 565 90488321
Electrocardiogram QT prolonged 75.13 13.37 11 139550 72445 90416441
Thrombosis in device 74.96 13.37 51 139510 3024 90485862
Sinusitis 74.66 13.37 274 139287 342814 90146072
Systemic scleroderma 74.21 13.37 40 139521 1549 90487337
Infusion site pruritus 73.78 13.37 70 139491 6695 90482191
Heart and lung transplant 73.71 13.37 20 139541 101 90488785
Product quality issue 73.67 13.37 16 139545 79309 90409577
Device malfunction 72.45 13.37 122 139439 20855 90468031
Infusion site induration 72.13 13.37 39 139522 1520 90487366
Abdominal cavity drainage 72.01 13.37 27 139534 433 90488453
Pain in extremity 71.60 13.37 1031 138530 449498 90039388
General physical health deterioration 71.25 13.37 293 139268 354822 90134064
Mechanical ventilation 71.16 13.37 38 139523 1444 90487442
Anaphylactic reaction 71.16 13.37 23 139538 87501 90401385
Atrial septal defect repair 71.10 13.37 23 139538 231 90488655
Leukopenia 71.07 13.37 33 139528 100677 90388209
Balloon atrial septostomy 70.76 13.37 18 139543 67 90488819
Myelosuppression 69.61 13.37 3 139558 53588 90435298
Internal haemorrhage 69.06 13.37 65 139496 6155 90482731
Blood potassium decreased 68.82 13.37 195 139366 47532 90441354
Cardiac arrest 68.76 13.37 332 139229 104603 90384283
Overdose 68.71 13.37 85 139476 157624 90331262
Cardioversion 68.25 13.37 36 139525 1334 90487552
Oxygen saturation abnormal 68.20 13.37 55 139506 4233 90484653
Terminal state 66.95 13.37 46 139515 2772 90486114
Cardiac failure acute 66.69 13.37 87 139474 11842 90477044
Drug abuse 66.31 13.37 22 139539 82325 90406561
Gout 66.31 13.37 104 139457 16755 90472131
Catheter site warmth 65.45 13.37 21 139540 205 90488681
Ventilation perfusion mismatch 65.40 13.37 27 139534 565 90488321
Liver transplant 65.13 13.37 42 139519 2275 90486611
Inappropriate schedule of product administration 65.12 13.37 81 139480 149852 90339034
Sepsis 65.02 13.37 487 139074 179327 90309559
Catheter removal 64.87 13.37 24 139537 370 90488516
Multiple sclerosis relapse 64.56 13.37 4 139557 52301 90436585
Congestive hepatopathy 63.90 13.37 46 139515 2987 90485899
Right ventricular hypertrophy 63.25 13.37 29 139532 788 90488098
Sciatica 63.07 13.37 39 139522 101343 90387543
Infusion site irritation 63.03 13.37 34 139527 1319 90487567
Suicide attempt 62.75 13.37 19 139542 75380 90413506
Medication error 62.48 13.37 26 139535 84626 90404260
Therapy cessation 61.93 13.37 158 139403 36203 90452683
Pulmonary arterial pressure abnormal 61.28 13.37 26 139535 584 90488302
Device connection issue 60.74 13.37 30 139531 966 90487920
Treatment noncompliance 60.18 13.37 196 139365 51531 90437355
Blood culture positive 60.17 13.37 55 139506 5017 90483869
Tracheostomy 60.06 13.37 27 139534 700 90488186
Transplant 59.27 13.37 30 139531 1019 90487867
Incorrect route of product administration 59.25 13.37 5 139556 50621 90438265
Autoimmune disorder 59.23 13.37 22 139539 76722 90412164
Catheterisation cardiac abnormal 59.21 13.37 21 139540 285 90488601
Concomitant disease progression 59.17 13.37 39 139522 2193 90486693
Suicidal ideation 59.00 13.37 20 139541 73835 90415051
Renal disorder 58.86 13.37 159 139402 37700 90451186
Stent placement 58.70 13.37 50 139511 4153 90484733
Contusion 58.40 13.37 195 139366 251021 90237865
Onychomadesis 58.37 13.37 3 139558 45995 90442891
Rhinovirus infection 58.09 13.37 58 139503 5905 90482981
Therapeutic response decreased 57.96 13.37 33 139528 89696 90399190
Infusion site warmth 57.60 13.37 38 139523 2140 90486746
Joint stiffness 57.55 13.37 24 139537 78018 90410868
Medical device change 57.54 13.37 21 139540 311 90488575
X-ray abnormal 57.52 13.37 3 139558 45421 90443465
Dizziness postural 56.91 13.37 70 139491 8983 90479903
Liver function test abnormal 56.78 13.37 190 139371 50655 90438231
Arthritis 56.70 13.37 107 139454 167208 90321678
Injection site bruising 56.47 13.37 7 139554 52300 90436586
Coeliac disease 56.32 13.37 3 139558 44607 90444279
Neoplasm progression 56.14 13.37 3 139558 44483 90444403
Pulmonary congestion 55.50 13.37 104 139457 19329 90469557
Pain 54.74 13.37 1145 138416 995196 89493690
Infection 54.68 13.37 330 139231 361764 90127122
Device breakage 54.36 13.37 86 139475 13958 90474928
Rehabilitation therapy 53.57 13.37 35 139526 1939 90486947
Neuropathy peripheral 53.43 13.37 80 139481 136890 90351996
Orthopnoea 53.24 13.37 59 139502 6776 90482110
Sedation 53.11 13.37 6 139555 48165 90440721
Blood pressure increased 53.09 13.37 143 139418 197074 90291812
Renal failure 52.66 13.37 364 139197 130643 90358243
Haemorrhage 52.50 13.37 229 139332 69140 90419746
Dry mouth 52.19 13.37 130 139431 183929 90304957
Dependence on oxygen therapy 52.16 13.37 23 139538 569 90488317
Gastrointestinal disorder 51.32 13.37 212 139349 256475 90232411
Live birth 51.23 13.37 29 139532 79078 90409808
Aspiration pleural cavity 51.18 13.37 26 139535 890 90487996
Road traffic accident 50.11 13.37 55 139506 107571 90381315
Finger amputation 49.50 13.37 23 139538 645 90488241
Infusion site cellulitis 49.23 13.37 19 139542 331 90488555
Biopsy liver 49.05 13.37 20 139541 405 90488481
Osteoporosis 48.73 13.37 46 139515 96485 90392401
Acute right ventricular failure 48.05 13.37 17 139544 229 90488657
Wheezing 47.99 13.37 196 139365 237884 90251002
Abdominal discomfort 47.79 13.37 487 139074 476841 90012045
Injection site erythema 47.35 13.37 49 139512 98453 90390433
Seasonal allergy 46.79 13.37 107 139454 22876 90466010
Localised oedema 45.73 13.37 52 139509 6142 90482744
Onychomycosis 45.70 13.37 3 139558 37373 90451513
Pulmonary haemorrhage 45.67 13.37 59 139502 7954 90480932
Rales 45.57 13.37 85 139476 15742 90473144
Drug reaction with eosinophilia and systemic symptoms 45.48 13.37 6 139555 42752 90446134
Right ventricular enlargement 45.46 13.37 20 139541 492 90488394
Catheter site extravasation 45.36 13.37 19 139542 413 90488473
Premature delivery 45.20 13.37 147 139414 38615 90450271
Dehydration 44.65 13.37 477 139084 193970 90294916
Eczema 44.58 13.37 13 139548 52857 90436029
Infusion site abscess 44.49 13.37 18 139543 357 90488529
Fall 44.34 13.37 1012 138549 480798 90008088
Depressed level of consciousness 43.90 13.37 29 139532 72755 90416131
Therapy interrupted 43.87 13.37 173 139388 49935 90438951
Pulmonary vascular resistance abnormality 43.60 13.37 13 139548 97 90488789
Catheter site scab 43.17 13.37 16 139545 248 90488638
Prescribed overdose 43.17 13.37 52 139509 97573 90391313
Aspartate aminotransferase increased 43.14 13.37 289 139272 102648 90386238
Blood bilirubin increased 42.95 13.37 156 139405 43314 90445572
Device issue 42.89 13.37 121 139440 29416 90459470
Device physical property issue 42.87 13.37 35 139526 2741 90486145
Pulmonary fibrosis 42.69 13.37 62 139499 107441 90381445
Catheter site discolouration 42.27 13.37 13 139548 109 90488777
Taste disorder 42.15 13.37 21 139540 61525 90427361
Colitis ulcerative 42.13 13.37 20 139541 60246 90428640
Atrial tachycardia 42.06 13.37 49 139512 5941 90482945
Lung assist device therapy 41.96 13.37 13 139548 112 90488774
Right-to-left cardiac shunt 41.60 13.37 16 139545 276 90488610
Knee arthroplasty 41.57 13.37 40 139521 83142 90405744
Blood alkaline phosphatase increased 41.29 13.37 165 139396 47914 90440972
Hospice care 41.17 13.37 62 139499 9642 90479244
Coma 41.09 13.37 31 139530 72601 90416285
Retching 41.02 13.37 91 139470 19068 90469818
Catheter site nodule 40.80 13.37 11 139550 54 90488832
Pancytopenia 40.66 13.37 77 139484 120186 90368700
Viral infection 40.40 13.37 148 139413 41266 90447620
Paranasal sinus hypersecretion 40.22 13.37 42 139519 4509 90484377
Swelling 40.11 13.37 432 139129 418626 90070260
Injection site discharge 40.04 13.37 26 139535 1425 90487461
Sudden death 39.76 13.37 65 139496 10844 90478042
Skin exfoliation 39.71 13.37 28 139533 67885 90421001
Cardiomegaly 39.52 13.37 89 139472 18836 90470050
Anaemia 39.25 13.37 762 138799 352040 90136846
Hepatitis 39.00 13.37 31 139530 70708 90418178
Application site pruritus 38.98 13.37 40 139521 4207 90484679
Infusion site discolouration 38.90 13.37 23 139538 1066 90487820
Toxic epidermal necrolysis 38.65 13.37 3 139558 32525 90456361
Haemoglobin decreased 37.97 13.37 399 139162 161557 90327329
Vasodilatation 37.63 13.37 33 139528 2851 90486035
Application site irritation 37.38 13.37 28 139533 1933 90486953
Injection site swelling 37.24 13.37 23 139538 59816 90429070
Psychotic disorder 36.78 13.37 3 139558 31227 90457659
Deafness 36.46 13.37 96 139465 22418 90466468
Loss of consciousness 35.99 13.37 352 139209 139886 90349000
Generalised oedema 35.84 13.37 86 139475 18967 90469919
Vascular resistance pulmonary increased 35.70 13.37 10 139551 58 90488828
Blood pressure systolic increased 35.52 13.37 23 139538 58322 90430564
Echocardiogram abnormal 35.41 13.37 25 139536 1574 90487312
Heart sounds 35.31 13.37 22 139539 1122 90487764
Head injury 35.22 13.37 117 139444 31071 90457815
Endotracheal intubation 35.15 13.37 34 139527 3330 90485556
Left-to-right cardiac shunt 35.06 13.37 14 139547 268 90488618
Cardiac output decreased 35.03 13.37 21 139540 999 90487887
Patent ductus arteriosus repair 34.73 13.37 8 139553 17 90488869
Left ventricular failure 34.59 13.37 47 139514 6653 90482233
Pulmonary artery dilatation 34.51 13.37 15 139546 358 90488528
Disability 34.39 13.37 10 139551 40735 90448151
Cardiogenic shock 34.33 13.37 99 139462 24369 90464517
Pulmonary arterial pressure 34.29 13.37 9 139552 39 90488847
Adverse drug reaction 34.20 13.37 81 139480 116620 90372266
Vascular resistance pulmonary decreased 34.09 13.37 10 139551 70 90488816
Joint dislocation 34.03 13.37 13 139548 44569 90444317
Pulmonary artery aneurysm 33.97 13.37 10 139551 71 90488815
Dysentery 33.88 13.37 21 139540 1061 90487825
Sinus congestion 33.80 13.37 106 139455 27318 90461568
Thrombocytopenia 33.74 13.37 186 139375 208539 90280347
Prolonged expiration 33.41 13.37 22 139539 1235 90487651
Hip arthroplasty 33.26 13.37 41 139520 76167 90412719
Pulmonary arterial wedge pressure increased 33.15 13.37 15 139546 395 90488491
Bone marrow failure 33.15 13.37 5 139556 32216 90456670
Systemic-pulmonary artery shunt 33.02 13.37 8 139553 23 90488863
Rhinorrhoea 32.93 13.37 241 139320 88075 90400811
Gastrostomy 32.71 13.37 19 139542 852 90488034
Pulmonary thrombosis 32.60 13.37 56 139505 9726 90479160
Pulseless electrical activity 32.25 13.37 53 139508 8879 90480007
Pulmonary vein stenosis 32.19 13.37 10 139551 87 90488799
Blood culture negative 32.14 13.37 12 139549 190 90488696
Peripheral swelling 32.07 13.37 848 138713 412258 90076628
Ammonia increased 32.06 13.37 39 139522 4947 90483939
Haemoglobin increased 32.03 13.37 48 139513 7433 90481453
Carbon dioxide increased 31.85 13.37 25 139536 1850 90487036
Wrong technique in product usage process 31.77 13.37 38 139523 71533 90417353
Blood iron decreased 31.59 13.37 79 139482 17880 90471006
Drug dependence 31.47 13.37 4 139557 29323 90459563
Staphylococcus test positive 31.27 13.37 36 139525 4309 90484577
Pericardial drainage 31.27 13.37 13 139548 277 90488609
Hip fracture 31.25 13.37 117 139444 32960 90455926
Multiple epiphyseal dysplasia 31.22 13.37 10 139551 97 90488789
Jugular vein distension 31.19 13.37 20 139541 1073 90487813
Central venous catheter removal 31.10 13.37 15 139546 458 90488428
Cardiac flutter 31.01 13.37 37 139524 4601 90484285
Swollen tongue 30.99 13.37 16 139545 45940 90442946
Lymphocyte count decreased 30.71 13.37 8 139553 35042 90453844
Drug resistance 30.70 13.37 5 139556 30444 90458442
Nocturnal dyspnoea 30.70 13.37 22 139539 1418 90487468
Deep vein thrombosis 30.67 13.37 59 139502 91561 90397325
Coronary artery compression 30.35 13.37 7 139554 15 90488871
Skeletal dysplasia 30.35 13.37 10 139551 107 90488779
Muscular weakness 30.31 13.37 190 139371 206476 90282410
CREST syndrome 30.13 13.37 16 139545 601 90488285
Sleep study 30.04 13.37 7 139554 16 90488870
Bronchopulmonary dysplasia 29.96 13.37 16 139545 608 90488278
Head discomfort 29.94 13.37 73 139488 16260 90472626
Facial pain 29.80 13.37 64 139497 13118 90475768
Hernia repair 29.78 13.37 24 139537 1845 90487041
Accidental exposure to product 29.70 13.37 14 139547 42352 90446534
Laryngitis 29.57 13.37 21 139540 50732 90438154
Walking aid user 29.45 13.37 9 139552 35497 90453389
Blood creatine phosphokinase increased 29.37 13.37 8 139553 34015 90454871
Heart valve operation 29.25 13.37 11 139550 178 90488708
Immunodeficiency 29.23 13.37 15 139546 43219 90445667
Therapeutic embolisation 29.16 13.37 12 139549 249 90488637
Musculoskeletal pain 29.13 13.37 150 139411 171101 90317785
Choking sensation 28.95 13.37 33 139528 3909 90484977
Weight decreased 28.94 13.37 778 138783 379132 90109754
Increased ventricular preload 28.92 13.37 7 139554 20 90488866
Oral herpes 28.72 13.37 8 139553 33516 90455370
Loss of personal independence in daily activities 28.71 13.37 110 139451 135995 90352891
Nasal dryness 28.57 13.37 39 139522 5544 90483342
Intra-abdominal fluid collection 28.33 13.37 28 139533 2816 90486070
Lactic acidosis 27.96 13.37 22 139539 50441 90438445
Frequent bowel movements 27.73 13.37 28 139533 56907 90431979
Therapy non-responder 27.58 13.37 327 139234 136377 90352509
Infusion site oedema 27.40 13.37 19 139542 1162 90487724
Anti factor VIII antibody test 27.39 13.37 5 139556 0 90488886
Respiratory syncytial virus infection 27.36 13.37 54 139507 10426 90478460
Oropharyngeal pain 27.09 13.37 284 139277 114903 90373983
Diabetic ketoacidosis 27.01 13.37 3 139558 24404 90464482
Ventricular septal defect repair 27.00 13.37 6 139555 10 90488876
Generalised tonic-clonic seizure 26.94 13.37 10 139551 34893 90453993
Hypocalcaemia 26.76 13.37 16 139545 42352 90446534
Dialysis related complication 26.53 13.37 9 139552 106 90488780
Exercise test abnormal 26.46 13.37 9 139552 107 90488779
Back injury 26.24 13.37 20 139541 46602 90442284
Blood pressure abnormal 26.14 13.37 78 139483 19567 90469319
Food allergy 26.11 13.37 4 139557 25474 90463412
Application site odour 26.02 13.37 7 139554 34 90488852
Emotional distress 25.88 13.37 12 139549 36650 90452236
Supraventricular tachycardia 25.78 13.37 69 139492 16267 90472619
Throat irritation 25.62 13.37 145 139416 48550 90440336
Hyponatraemia 25.62 13.37 112 139449 133426 90355460
Pneumothorax 25.41 13.37 76 139485 19091 90469795
Chronic right ventricular failure 25.38 13.37 7 139554 38 90488848
Product supply issue 25.35 13.37 27 139534 2965 90485921
Cardiac failure chronic 25.28 13.37 37 139524 5609 90483277
Cytokine release syndrome 25.25 13.37 6 139555 27967 90460919
Respiratory tract haemorrhage 25.19 13.37 13 139548 460 90488426
Bone disorder 25.19 13.37 3 139558 23117 90465769
Pulmonary pain 25.09 13.37 35 139526 5079 90483807
Multiple sclerosis 25.08 13.37 6 139555 27834 90461052
Hypoacusis 25.06 13.37 97 139464 27753 90461133
Sopor 24.95 13.37 4 139557 24640 90464246
Lower limb fracture 24.91 13.37 59 139502 84954 90403932
Hyperglycaemia 24.90 13.37 25 139536 50945 90437941
Lymphopenia 24.85 13.37 3 139558 22878 90466008
Cellulitis 24.79 13.37 232 139329 91105 90397781
Abortion spontaneous 24.75 13.37 28 139533 54028 90434858
Hepatic steatosis 24.71 13.37 13 139548 36932 90451954
Bacteraemia 24.60 13.37 83 139478 22217 90466669
Pulmonary arterial pressure decreased 24.58 13.37 8 139553 82 90488804
Injection site pruritus 24.52 13.37 28 139533 53806 90435080
Macular degeneration 24.47 13.37 14 139547 37956 90450930
Tracheostomy tube removal 24.46 13.37 5 139556 4 90488882
Right atrial dilatation 24.45 13.37 15 139546 744 90488142
Dry eye 24.41 13.37 32 139529 57899 90430987
Gastritis hypertrophic 24.38 13.37 7 139554 45 90488841
Drug titration error 24.33 13.37 18 139543 1219 90487667
Exposure during pregnancy 24.33 13.37 242 139319 238168 90250718
Diagnostic procedure 24.31 13.37 9 139552 139 90488747
Intra-abdominal haemorrhage 24.30 13.37 25 139536 2637 90486249
Bronchitis 24.23 13.37 350 139211 152577 90336309
Infusion site discomfort 24.14 13.37 21 139540 1795 90487091
Disease recurrence 24.09 13.37 14 139547 37639 90451247
Right atrial pressure increased 24.02 13.37 9 139552 144 90488742
Metastases to bone 23.97 13.37 5 139556 25500 90463386
Infusion site rash 23.91 13.37 24 139537 2459 90486427
Suspected counterfeit product 23.89 13.37 13 139548 513 90488373
Alanine aminotransferase increased 23.84 13.37 283 139278 118055 90370831
Pulmonary vasculitis 23.76 13.37 10 139551 220 90488666
Dizziness exertional 23.76 13.37 13 139548 519 90488367
Plasma cell myeloma 23.65 13.37 17 139544 40811 90448075
Oesophageal motility disorder 23.62 13.37 14 139547 652 90488234
Purulent discharge 23.60 13.37 35 139526 5370 90483516
Vascular device occlusion 23.56 13.37 12 139549 413 90488473
Infusion site inflammation 23.53 13.37 13 139548 529 90488357
Brachydactyly 23.51 13.37 10 139551 226 90488660
Brain natriuretic peptide abnormal 23.48 13.37 12 139549 416 90488470
Pulmonary valve replacement 23.46 13.37 5 139556 6 90488880
Stevens-Johnson syndrome 23.38 13.37 8 139553 29368 90459518
Ear tube insertion 23.37 13.37 8 139553 97 90488789
Injection site infection 23.30 13.37 23 139538 2309 90486577
Aphasia 23.30 13.37 19 139542 42793 90446093
Clostridium difficile infection 23.24 13.37 114 139447 36131 90452755
Diet noncompliance 23.17 13.37 12 139549 428 90488458
Oxygen consumption 23.15 13.37 8 139553 100 90488786
Suture related complication 22.99 13.37 11 139550 330 90488556
Tracheostomy malfunction 22.94 13.37 7 139554 57 90488829
Catheter site hypersensitivity 22.94 13.37 8 139553 103 90488783
Decreased appetite 22.93 13.37 750 138811 375790 90113096
Life support 22.92 13.37 10 139551 241 90488645
Arrhythmia 22.90 13.37 127 139434 42205 90446681
Catheter site cellulitis 22.87 13.37 11 139550 334 90488552
Arteriovenous malformation 22.75 13.37 19 139542 1536 90487350
Catheter site bruise 22.62 13.37 13 139548 571 90488315
Iron deficiency anaemia 22.60 13.37 84 139477 23578 90465308
Catheter culture positive 22.50 13.37 9 139552 173 90488713
Hypoglycaemia 22.50 13.37 46 139515 69802 90419084
Skin lesion 22.38 13.37 15 139546 37350 90451536
Device programming error 22.25 13.37 10 139551 259 90488627
Orthostatic hypotension 22.22 13.37 19 139542 41808 90447078
Catheter site dryness 22.16 13.37 6 139555 30 90488856
Basal cell carcinoma 21.96 13.37 12 139549 33377 90455509
Cardiac index decreased 21.94 13.37 7 139554 67 90488819
Cor pulmonale chronic 21.94 13.37 10 139551 268 90488618
Skin operation 21.84 13.37 6 139555 32 90488854
Posterior reversible encephalopathy syndrome 21.80 13.37 4 139557 22335 90466551
Portopulmonary hypertension 21.76 13.37 8 139553 121 90488765
Colitis 21.74 13.37 47 139514 69895 90418991
Rash erythematous 21.73 13.37 42 139519 65062 90423824
Acute myeloid leukaemia 21.71 13.37 3 139558 20637 90468249
Aggression 21.69 13.37 7 139554 26661 90462225
Angioedema 21.52 13.37 42 139519 64834 90424052
Mouth ulceration 21.43 13.37 18 139543 39956 90448930
Cognitive disorder 21.28 13.37 47 139514 69360 90419526
Choking 21.23 13.37 53 139508 11980 90476906
Muscle spasms 21.22 13.37 267 139294 251616 90237270
Immunoglobulin G4 related disease 21.18 13.37 8 139553 131 90488755
Localised infection 21.12 13.37 105 139456 33457 90455429
Dysarthria 21.06 13.37 32 139529 54450 90434436
Cardiopulmonary failure 21.05 13.37 29 139532 4159 90484727
Gastrointestinal tube insertion 20.91 13.37 17 139544 1323 90487563
Amnesia 20.81 13.37 91 139470 108414 90380472
Nodular regenerative hyperplasia 20.74 13.37 13 139548 670 90488216
Cardiospasm 20.63 13.37 26 139535 3420 90485466
Intentional product misuse 20.50 13.37 70 139491 89534 90399352
Coordination abnormal 20.46 13.37 4 139557 21352 90467534
Hypomagnesaemia 20.37 13.37 15 139546 35573 90453313
Application site erythema 20.30 13.37 32 139529 5176 90483710
Investigation 20.29 13.37 18 139543 1579 90487307
Ear discomfort 20.22 13.37 47 139514 10153 90478733
Vomiting 20.21 13.37 1441 138120 786852 89702034
Drug eruption 20.17 13.37 15 139546 35392 90453494
Protein-losing gastroenteropathy 20.08 13.37 10 139551 328 90488558
Anticoagulation drug level below therapeutic 19.93 13.37 13 139548 718 90488168
Eye irritation 19.87 13.37 14 139547 33964 90454922
Sudden visual loss 19.87 13.37 6 139555 47 90488839
Large intestinal polypectomy 19.86 13.37 10 139551 336 90488550
Device use error 19.82 13.37 38 139523 7183 90481703
Body temperature decreased 19.82 13.37 6 139555 23810 90465076
Cardiac failure high output 19.79 13.37 11 139550 453 90488433
Drug level increased 19.73 13.37 9 139552 27753 90461133
Staphylococcal infection 19.69 13.37 135 139426 48304 90440582
Cavopulmonary anastomosis 19.68 13.37 4 139557 3 90488883
Angioplasty 19.47 13.37 17 139544 1460 90487426
Mineral supplementation 19.47 13.37 13 139548 747 90488139
Biopsy 19.46 13.37 11 139550 468 90488418
Dilatation ventricular 19.36 13.37 21 139540 2355 90486531
Retinopathy of prematurity 19.12 13.37 10 139551 364 90488522
Tricuspid valve incompetence 19.10 13.37 63 139498 16668 90472218
Post procedural haemorrhage 19.07 13.37 42 139519 8756 90480130
Catheter site induration 19.04 13.37 6 139555 55 90488831
Dyskinesia 18.92 13.37 17 139544 36517 90452369
Rheumatoid nodule 18.86 13.37 4 139557 20162 90468724
Hypothyroidism 18.86 13.37 33 139528 53094 90435792
Heart valve replacement 18.81 13.37 13 139548 791 90488095
Decreased activity 18.78 13.37 40 139521 8152 90480734
Infusion site cyst 18.67 13.37 4 139557 5 90488881
Hot flush 18.67 13.37 156 139405 59332 90429554
Chronic hepatic failure 18.66 13.37 12 139549 647 90488239
Product label confusion 18.58 13.37 6 139555 22844 90466042
Sleep disorder due to a general medical condition 18.56 13.37 25 139536 44713 90444173
Polyarthritis 18.53 13.37 3 139558 18347 90470539
Galectin-3 increased 18.47 13.37 5 139556 25 90488861
Gastric antral vascular ectasia 18.45 13.37 13 139548 816 90488070
Subdural haematoma 18.40 13.37 62 139499 16583 90472303
N-terminal prohormone brain natriuretic peptide abnormal 18.31 13.37 6 139555 63 90488823
Balance disorder 18.27 13.37 82 139479 96998 90391888
Chemotherapy 18.22 13.37 18 139543 1809 90487077
Critical illness 18.22 13.37 9 139552 290 90488596
Hepatocellular injury 18.20 13.37 11 139550 28947 90459939
Oesophagogastric fundoplasty 18.19 13.37 7 139554 121 90488765
Faeces discoloured 18.17 13.37 73 139488 21247 90467639
Withdrawal syndrome 18.16 13.37 6 139555 22518 90466368
Sensory loss 18.15 13.37 3 139558 18072 90470814
Pulmonary artery therapeutic procedure 18.15 13.37 5 139556 27 90488859
Obstructive shock 18.14 13.37 6 139555 65 90488821
Chronic sinusitis 18.07 13.37 7 139554 23795 90465091
Metastases to liver 18.03 13.37 11 139550 28796 90460090
Vaginal discharge 17.92 13.37 4 139557 19460 90469426
Coronary arterial stent insertion 17.92 13.37 22 139539 2818 90486068
Urinary retention 17.88 13.37 19 139542 37725 90451161
Myelodysplastic syndrome 17.88 13.37 5 139556 20898 90467988
No adverse event 17.75 13.37 50 139511 67932 90420954
Sinus disorder 17.74 13.37 102 139459 34345 90454541
Eosinophilia 17.71 13.37 11 139550 28522 90460364
Metabolic acidosis 17.65 13.37 37 139524 55639 90433247
Mood swings 17.62 13.37 5 139556 20697 90468189
Injection site mass 17.61 13.37 6 139555 22084 90466802
Polyuria 17.48 13.37 44 139517 9996 90478890
Biopsy lymph gland 17.43 13.37 5 139556 32 90488854
Catheter site urticaria 17.43 13.37 5 139556 32 90488854
Gait disturbance 17.43 13.37 289 139272 260207 90228679
Biopsy lung 17.43 13.37 8 139553 218 90488668
Metastases to central nervous system 17.42 13.37 3 139558 17539 90471347
Palmoplantar keratoderma 17.20 13.37 24 139537 3483 90485403
Altered state of consciousness 17.15 13.37 14 139547 31518 90457368
Status epilepticus 17.13 13.37 4 139557 18870 90470016
Cardiorenal syndrome 17.13 13.37 14 139547 1098 90487788
Product storage error 17.02 13.37 5 139556 20236 90468650
Optic ischaemic neuropathy 16.99 13.37 17 139544 1735 90487151
Hyperlipidaemia 16.97 13.37 7 139554 22909 90465977
Acute kidney injury 16.96 13.37 370 139191 320017 90168869
Haemodynamic test abnormal 16.92 13.37 5 139556 36 90488850
Hepatomegaly 16.87 13.37 52 139509 13274 90475612
Metapneumovirus infection 16.87 13.37 15 139546 1320 90487566
Painful respiration 16.85 13.37 22 139539 2996 90485890
Procedural pain 16.71 13.37 16 139545 33344 90455542
Memory impairment 16.64 13.37 209 139352 197035 90291851
Sinus bradycardia 16.62 13.37 3 139558 16949 90471937
Neurodevelopmental disorder 16.57 13.37 8 139553 245 90488641
Infusion site vesicles 16.52 13.37 11 139550 629 90488257
Infusion site injury 16.37 13.37 6 139555 90 90488796
Cardiac procedure complication 16.31 13.37 7 139554 162 90488724
Pneumonia bacterial 16.28 13.37 50 139511 12740 90476146
Chest tube insertion 16.25 13.37 5 139556 42 90488844
Cyst 16.08 13.37 3 139558 16558 90472328
Pneumonitis 16.08 13.37 27 139534 44143 90444743
Flatulence 16.06 13.37 114 139447 41253 90447633
Ataxia 16.03 13.37 4 139557 18038 90470848
Liver disorder 16.01 13.37 115 139446 121154 90367732
Gastric disorder 16.00 13.37 97 139464 33287 90455599
Haemodynamic instability 15.99 13.37 47 139514 11692 90477194
Bedridden 15.94 13.37 48 139513 12100 90476786
Inferior vena cava dilatation 15.85 13.37 6 139555 99 90488787
Impaired work ability 15.84 13.37 5 139556 19321 90469565
Tenderness 15.81 13.37 11 139550 26857 90462029
Cardiac cirrhosis 15.66 13.37 7 139554 179 90488707
Spinal osteoarthritis 15.62 13.37 5 139556 19143 90469743
Fistula repair 15.57 13.37 5 139556 49 90488837
Pulmonary capillary haemangiomatosis 15.57 13.37 5 139556 49 90488837
Cytomegalovirus infection 15.51 13.37 11 139550 26591 90462295
Intracardiac pressure increased 15.48 13.37 5 139556 50 90488836
Product administration error 15.46 13.37 81 139480 26342 90462544
Drug tolerance decreased 15.42 13.37 16 139545 32114 90456772
Walking disability 15.42 13.37 15 139546 1480 90487406
Tubulointerstitial nephritis 15.41 13.37 10 139551 25333 90463553
Hypercalcaemia 15.39 13.37 18 139543 34222 90454664
Drug withdrawal syndrome 15.32 13.37 13 139548 28710 90460176
Biopsy kidney 15.28 13.37 7 139554 190 90488696
Wrong dose 15.23 13.37 17 139544 1967 90486919
Bone density decreased 15.12 13.37 4 139557 17341 90471545
Low cardiac output syndrome 15.09 13.37 9 139552 424 90488462
Acne 15.08 13.37 13 139548 28494 90460392
Pruritus genital 15.07 13.37 26 139535 4532 90484354
Intervertebral disc degeneration 15.02 13.37 4 139557 17270 90471616
Heart valve incompetence 15.01 13.37 22 139539 3340 90485546
Back pain 14.97 13.37 614 138947 316561 90172325
Implantable defibrillator insertion 14.96 13.37 10 139551 576 90488310
Unevaluable investigation 14.81 13.37 5 139556 58 90488828
Hallucination 14.77 13.37 52 139509 65907 90422979
Aortic valve replacement 14.73 13.37 12 139549 937 90487949
Pulmonary arteriovenous fistula 14.61 13.37 4 139557 21 90488865
Ventricular enlargement 14.58 13.37 5 139556 61 90488825
Pulmonary alveolar haemorrhage 14.58 13.37 30 139531 5968 90482918
Carotid artery occlusion 14.58 13.37 31 139530 6311 90482575
Telangiectasia 14.49 13.37 14 139547 1369 90487517
Aneurysm repair 14.46 13.37 4 139557 22 90488864
Varices oesophageal 14.43 13.37 23 139538 3756 90485130
Proteinuria 14.43 13.37 9 139552 23282 90465604
Skin fissures 14.40 13.37 7 139554 20802 90468084
Catheter site erosion 14.36 13.37 5 139556 64 90488822
Carbon dioxide abnormal 14.36 13.37 7 139554 219 90488667
Jejunostomy 14.36 13.37 3 139558 3 90488883
Pancreatitis acute 14.31 13.37 17 139544 32098 90456788
Tension headache 14.24 13.37 34 139527 7475 90481411
Catheter site mass 14.16 13.37 4 139557 24 90488862
Sleep terror 14.15 13.37 25 139536 4439 90484447
Sickle cell anaemia 14.13 13.37 10 139551 632 90488254
Cholecystectomy 14.08 13.37 45 139516 11710 90477176
Injection site rash 14.08 13.37 10 139551 24163 90464723
Premature baby 14.08 13.37 76 139485 25001 90463885
Spinal fracture 13.94 13.37 69 139492 21947 90466939
Body temperature increased 13.93 13.37 30 139531 44680 90444206
Middle ear effusion 13.91 13.37 19 139542 2702 90486184
Clubbing 13.90 13.37 9 139552 491 90488395
Arterial aneurysm repair 13.90 13.37 3 139558 4 90488882
Infusion site ulcer 13.89 13.37 4 139557 26 90488860
Upper respiratory tract infection 13.85 13.37 276 139285 128042 90360844
Osteonecrosis 13.84 13.37 12 139549 26229 90462657
Lung operation 13.77 13.37 8 139553 359 90488527
Gastrooesophageal reflux disease 13.75 13.37 177 139384 166160 90322726
Polypectomy 13.67 13.37 12 139549 1038 90487848
Bendopnoea 13.64 13.37 5 139556 75 90488811
Sudden cardiac death 13.61 13.37 17 139544 2215 90486671
Tendonitis 13.60 13.37 8 139553 21364 90467522
Device difficult to use 13.56 13.37 5 139556 17520 90471366
Administration site infection 13.51 13.37 4 139557 29 90488857
Hypercapnia 13.50 13.37 31 139530 6646 90482240
Intentional medical device removal by patient 13.48 13.37 6 139555 152 90488734
Deafness unilateral 13.45 13.37 21 139540 3370 90485516
Respiratory tract infection viral 13.45 13.37 20 139541 3076 90485810
Mitral valve repair 13.40 13.37 7 139554 254 90488632

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
Pulmonary arterial hypertension 927.64 11.28 451 93012 9736 42518136
Pulmonary hypertension 735.69 11.28 521 92942 23048 42504824
Right ventricular failure 708.22 11.28 368 93095 9187 42518685
Fluid retention 647.17 11.28 544 92919 31075 42496797
Dyspnoea 514.02 11.28 2120 91343 440501 42087371
Headache 498.50 11.28 1396 92067 237973 42289899
Pain in jaw 451.07 11.28 320 93143 14182 42513690
Optic ischaemic neuropathy 429.16 11.28 178 93285 2597 42525275
Death 370.68 11.28 2017 91446 469168 42058704
Cyanopsia 326.55 11.28 80 93383 148 42527724
Hypervolaemia 295.08 11.28 306 93157 22819 42505053
Flushing 292.78 11.28 383 93080 36645 42491227
Erection increased 258.35 11.28 79 93384 432 42527440
Neutropenia 256.93 11.28 61 93402 199370 42328502
Febrile neutropenia 253.04 11.28 50 93413 185653 42342219
Lung transplant 230.31 11.28 110 93353 2276 42525596
Nasal congestion 217.59 11.28 295 93168 29206 42498666
Oxygen saturation decreased 181.44 11.28 423 93040 64264 42463608
Malignant neoplasm progression 176.13 11.28 17 93446 108383 42419489
Priapism 171.14 11.28 129 93334 6278 42521594
Catheter management 165.68 11.28 68 93395 964 42526908
Dyspnoea exertional 163.17 11.28 348 93115 49800 42478072
Catheterisation cardiac 160.70 11.28 91 93372 2703 42525169
Infusion site pain 153.89 11.28 113 93350 5282 42522590
Erectile dysfunction 138.46 11.28 218 93245 24695 42503177
Syncope 133.50 11.28 500 92963 98906 42428966
Catheter site erythema 133.37 11.28 69 93394 1704 42526168
Thrombocytopenia 132.63 11.28 133 93330 190146 42337726
Visual field defect 122.18 11.28 95 93368 4843 42523029
Transfusion 121.44 11.28 132 93331 10382 42517490
Oxygen consumption increased 120.31 11.28 63 93400 1596 42526276
Blindness unilateral 119.07 11.28 97 93366 5291 42522581
Pulmonary arterial pressure increased 119.00 11.28 61 93402 1477 42526395
Off label use 118.03 11.28 869 92594 637466 41890406
Suspected counterfeit product 115.30 11.28 39 93424 308 42527564
Hospitalisation 113.52 11.28 390 93073 73940 42453932
Oedema 109.30 11.28 305 93158 51696 42476176
Visual impairment 109.09 11.28 271 93192 42842 42485030
Cardiac operation 106.76 11.28 78 93385 3617 42524255
Leukopenia 104.08 11.28 19 93444 74727 42453145
Dizziness 103.76 11.28 915 92548 248339 42279533
Drug ineffective 103.42 11.28 1945 91518 628252 41899620
Cardiac failure 102.48 11.28 485 92978 106371 42421501
Vision blurred 102.26 11.28 304 93159 53395 42474477
Retinal vein occlusion 101.89 11.28 60 93403 1921 42525951
Catheter placement 98.68 11.28 46 93417 899 42526973
Prescription drug used without a prescription 98.42 11.28 66 93397 2664 42525208
Acute kidney injury 97.75 11.28 444 93019 366893 42160979
Catheter site pruritus 96.63 11.28 34 93429 306 42527566
Hypoxia 94.46 11.28 352 93111 69434 42458438
Product use in unapproved indication 88.30 11.28 169 93294 184287 42343585
Mucosal inflammation 82.16 11.28 7 93456 49367 42478505
Substance use disorder 79.69 11.28 77 93386 5268 42522604
Pulmonary hypertensive crisis 79.58 11.28 26 93437 182 42527690
Pancytopenia 78.92 11.28 85 93378 117658 42410214
High risk sexual behaviour 78.55 11.28 22 93441 83 42527789
Oedema peripheral 76.64 11.28 536 92927 135540 42392332
Pyrexia 75.63 11.28 530 92933 393512 42134360
Infusion site erythema 75.43 11.28 63 93400 3559 42524313
Chest pain 75.33 11.28 544 92919 138986 42388886
Hyponatraemia 75.21 11.28 67 93396 101395 42426477
Retinal artery occlusion 73.79 11.28 51 93412 2164 42525708
Chromatopsia 73.78 11.28 27 93436 275 42527597
Complication associated with device 72.18 11.28 81 93382 6600 42521272
Anaemia 67.92 11.28 350 93113 279928 42247944
Catheter site discharge 67.55 11.28 34 93429 791 42527081
Device related infection 67.39 11.28 142 93321 20137 42507735
Device alarm issue 65.95 11.28 33 93430 758 42527114
Peyronie's disease 64.95 11.28 17 93446 46 42527826
Cytokine release syndrome 64.90 11.28 10 93453 44517 42483355
Penile abscess 64.65 11.28 21 93442 144 42527728
Myelosuppression 63.98 11.28 7 93456 40454 42487418
Heart transplant 63.60 11.28 35 93428 982 42526890
Counterfeit product administered 63.46 11.28 24 93439 270 42527602
General physical health deterioration 62.03 11.28 151 93312 151095 42376777
Thrombosis corpora cavernosa 61.50 11.28 12 93451 0 42527872
Central venous catheterisation 61.02 11.28 41 93422 1660 42526212
Catheter site pain 60.89 11.28 41 93422 1666 42526206
Cardiac failure congestive 60.35 11.28 357 93106 85245 42442627
Ventilation perfusion mismatch 60.02 11.28 20 93443 150 42527722
Peripheral swelling 59.54 11.28 370 93093 89900 42437972
Maculopathy 59.10 11.28 34 93429 1041 42526831
Pulmonary veno-occlusive disease 57.64 11.28 28 93435 602 42527270
White blood cell count decreased 56.48 11.28 97 93366 110299 42417573
Neutrophil count decreased 55.83 11.28 35 93428 63380 42464492
Palpitations 55.70 11.28 240 93223 50557 42477315
Pulmonary oedema 55.61 11.28 248 93215 53024 42474848
Catheter site irritation 53.71 11.28 17 93446 106 42527766
Infusion site haemorrhage 53.69 11.28 34 93429 1243 42526629
Transplant evaluation 53.20 11.28 25 93438 498 42527374
Pain in extremity 53.08 11.28 534 92929 150070 42377802
Infusion site infection 52.90 11.28 26 93437 574 42527298
Self-medication 52.40 11.28 49 93414 3217 42524655
Dyschromatopsia 52.04 11.28 25 93438 524 42527348
Deafness 52.03 11.28 99 93364 13041 42514831
Agranulocytosis 51.87 11.28 4 93459 30608 42497264
Catheter site infection 50.90 11.28 47 93416 3036 42524836
Cardiac disorder 50.47 11.28 227 93236 48705 42479167
Catheter site rash 50.06 11.28 19 93444 216 42527656
Device dislocation 49.83 11.28 73 93390 7758 42520114
Transient global amnesia 49.45 11.28 22 93441 384 42527488
Bone marrow failure 49.22 11.28 7 93456 33086 42494786
Device occlusion 48.41 11.28 75 93388 8375 42519497
Liver transplant 48.31 11.28 43 93420 2648 42525224
C-reactive protein increased 48.26 11.28 41 93422 63519 42464353
Cytomegalovirus infection 47.66 11.28 7 93456 32299 42495573
Electrocardiogram QT prolonged 47.22 11.28 23 93440 47922 42479950
Myalgia 46.94 11.28 366 93097 95714 42432158
Pre-existing condition improved 46.67 11.28 44 93419 2919 42524953
Blindness 46.50 11.28 114 93349 17864 42510008
Infusion related reaction 46.44 11.28 39 93424 60767 42467105
Rash maculo-papular 45.28 11.28 13 93450 37490 42490382
Drug resistance 44.96 11.28 10 93453 34238 42493634
Colitis 44.87 11.28 23 93440 46549 42481323
Deafness unilateral 44.42 11.28 37 93426 2082 42525790
Heart and lung transplant 43.15 11.28 13 93450 67 42527805
Septic shock 42.93 11.28 85 93378 91587 42436285
Treatment failure 42.17 11.28 45 93418 62579 42465293
Hypotension 41.81 11.28 795 92668 256836 42271036
Product counterfeit 41.23 11.28 15 93448 150 42527722
Loss of visual contrast sensitivity 41.00 11.28 8 93455 0 42527872
Product contamination 40.61 11.28 26 93437 969 42526903
Visual brightness 39.98 11.28 10 93453 21 42527851
Concomitant disease aggravated 39.91 11.28 60 93403 6526 42521346
Cyanosis 39.61 11.28 96 93367 14935 42512937
Condition aggravated 39.40 11.28 796 92667 259958 42267914
Blindness transient 39.38 11.28 39 93424 2750 42525122
Stomatitis 38.78 11.28 32 93431 50297 42477575
Eosinophilia 38.64 11.28 12 93451 32887 42494985
Inappropriate schedule of product administration 38.31 11.28 97 93366 95805 42432067
Toxicity to various agents 38.26 11.28 320 93143 228816 42299056
Pneumonitis 38.16 11.28 22 93441 41696 42486176
Vascular resistance pulmonary increased 37.96 11.28 10 93453 28 42527844
Malaise 37.66 11.28 664 92799 211492 42316380
Penile curvature 37.55 11.28 13 93450 111 42527761
Infusion site swelling 37.44 11.28 41 93422 3251 42524621
Renal impairment 37.07 11.28 121 93342 110107 42417765
Feeling abnormal 36.98 11.28 271 93192 69515 42458357
Ventricular assist device insertion 36.96 11.28 9 93454 16 42527856
Substance abuser 36.84 11.28 16 93447 263 42527609
Right ventricular dysfunction 36.81 11.28 28 93435 1381 42526491
Biopsy liver 36.78 11.28 16 93447 264 42527608
Pruritus 36.52 11.28 253 93210 188518 42339354
Therapy change 36.51 11.28 45 93418 4050 42523822
Dermatitis contact 36.21 11.28 47 93416 4456 42523416
Spontaneous penile erection 36.14 11.28 16 93447 276 42527596
Biopsy lung 36.10 11.28 13 93450 126 42527746
Drug reaction with eosinophilia and systemic symptoms 35.97 11.28 24 93439 42051 42485821
Pulmonary vein stenosis 35.85 11.28 10 93453 37 42527835
Walking distance test abnormal 35.84 11.28 14 93449 173 42527699
Catheter site swelling 35.71 11.28 20 93443 581 42527291
Multiple organ dysfunction syndrome 35.12 11.28 103 93360 96932 42430940
Neoplasm progression 35.11 11.28 10 93453 28990 42498882
Catheter site haemorrhage 34.81 11.28 35 93428 2513 42525359
Tumour lysis syndrome 34.76 11.28 4 93459 22227 42505645
Photophobia 34.43 11.28 63 93400 8056 42519816
N-terminal prohormone brain natriuretic peptide increased 34.16 11.28 40 93423 3413 42524459
Paracentesis 34.02 11.28 18 93445 466 42527406
Retinal vascular disorder 33.76 11.28 14 93449 204 42527668
Hepatic function abnormal 33.67 11.28 38 93425 51529 42476343
Platelet count decreased 33.52 11.28 173 93290 138408 42389464
Lactic acidosis 33.38 11.28 30 93433 45231 42482641
Scleroderma 33.09 11.28 29 93434 1749 42526123
Retinal vascular occlusion 33.09 11.28 14 93449 215 42527657
Hepatic cytolysis 32.98 11.28 9 93454 26835 42501037
Tracheostomy 32.50 11.28 23 93440 1014 42526858
Lymphocyte count 32.46 11.28 14 93449 226 42527646
Visual acuity reduced 32.11 11.28 98 93365 17452 42510420
Sepsis 32.09 11.28 281 93182 199053 42328819
Metabolic acidosis 31.95 11.28 40 93423 51818 42476054
Abdominal discomfort 31.56 11.28 277 93186 74978 42452894
Rheumatoid arthritis 31.46 11.28 28 93435 42412 42485460
Spinal cord infarction 31.21 11.28 19 93444 647 42527225
Oxygen therapy 31.17 11.28 25 93438 1333 42526539
Sedation 30.96 11.28 14 93449 30461 42497411
Pulmonary embolism 30.83 11.28 146 93317 119466 42408406
Foetal exposure during pregnancy 30.74 11.28 35 93428 47276 42480596
Acute respiratory failure 30.62 11.28 167 93296 38691 42489181
Catheterisation cardiac abnormal 30.61 11.28 10 93453 70 42527802
Vascular device infection 30.58 11.28 51 93412 6059 42521813
Painful erection 30.32 11.28 15 93448 336 42527536
Confusional state 30.29 11.28 229 93234 167368 42360504
Macrophages increased 30.24 11.28 12 93451 155 42527717
Epistaxis 30.14 11.28 250 93213 66576 42461296
Interstitial lung disease 30.08 11.28 81 93382 78381 42449491
Viral infection 30.05 11.28 113 93350 22370 42505502
Pneumocystis jirovecii pneumonia 29.90 11.28 9 93454 25172 42502700
Hepatotoxicity 29.88 11.28 9 93454 25158 42502714
Retinal toxicity 29.86 11.28 17 93446 510 42527362
Delirium 29.83 11.28 43 93420 52476 42475396
Lymphocyte count abnormal 29.80 11.28 30 93433 2157 42525715
Exercise tolerance decreased 29.52 11.28 50 93413 6016 42521856
Product use issue 29.38 11.28 277 93186 76474 42451398
Somnolence 29.35 11.28 185 93278 140920 42386952
Brain natriuretic peptide increased 29.30 11.28 53 93410 6717 42521155
Therapeutic response unexpected 29.25 11.28 72 93391 11309 42516563
Disseminated intravascular coagulation 29.19 11.28 9 93454 24785 42503087
Medical device change 28.91 11.28 11 93452 126 42527746
Mechanical ventilation 28.79 11.28 30 93433 2247 42525625
Infusion site discharge 28.79 11.28 15 93448 376 42527496
Hyperkalaemia 28.68 11.28 86 93377 80372 42447500
Infusion site irritation 28.61 11.28 15 93448 381 42527491
Colour blindness 28.57 11.28 15 93448 382 42527490
Penile vein thrombosis 28.55 11.28 7 93456 13 42527859
Ruptured cerebral aneurysm 28.38 11.28 12 93451 184 42527688
Acute myeloid leukaemia 28.22 11.28 7 93456 22249 42505623
Optic disc disorder 28.18 11.28 9 93454 58 42527814
Catheter site inflammation 28.12 11.28 13 93450 249 42527623
Fracture of penis 27.84 11.28 14 93449 325 42527547
Neuropathy peripheral 27.63 11.28 122 93341 101731 42426141
Toxic epidermal necrolysis 27.63 11.28 12 93451 26738 42501134
Infusion site inflammation 27.55 11.28 9 93454 63 42527809
Catheter removal 27.42 11.28 12 93451 201 42527671
Infusion site scar 27.29 11.28 7 93456 17 42527855
Thunderclap headache 27.12 11.28 11 93452 151 42527721
Bronchopulmonary aspergillosis 26.90 11.28 5 93458 19424 42508448
Device connection issue 26.84 11.28 16 93447 524 42527348
Chorioretinopathy 26.57 11.28 24 93439 1507 42526365
Infusion site warmth 26.54 11.28 12 93451 218 42527654
Hypothyroidism 26.50 11.28 19 93444 32065 42495807
Bronchiectasis 26.36 11.28 4 93459 18015 42509857
Anorgasmia 26.24 11.28 21 93442 1116 42526756
Aspiration pleural cavity 26.02 11.28 19 93444 880 42526992
Cardiac index increased 25.74 11.28 7 93456 23 42527849
Diplacusis 25.62 11.28 5 93458 0 42527872
Hypoglossal nerve paralysis 25.62 11.28 5 93458 0 42527872
Ejaculation disorder 25.57 11.28 20 93443 1028 42526844
Atrial septal defect repair 25.57 11.28 10 93453 124 42527748
Onychomycosis 25.46 11.28 31 93432 2755 42525117
Loss of consciousness 25.42 11.28 312 93151 92042 42435830
Polyneuropathy 25.42 11.28 5 93458 18656 42509216
Cor pulmonale 25.11 11.28 18 93445 810 42527062
Genital swelling 24.96 11.28 12 93451 252 42527620
Patent ductus arteriosus repair 24.89 11.28 6 93457 10 42527862
Pulmonary capillary haemangiomatosis 24.87 11.28 7 93456 27 42527845
Ejaculation failure 24.86 11.28 18 93445 823 42527049
Product quality issue 24.84 11.28 91 93372 17791 42510081
Hallucination 24.67 11.28 56 93407 57451 42470421
Haemophagocytic lymphohistiocytosis 24.57 11.28 5 93458 18217 42509655
Dehydration 24.54 11.28 196 93267 141571 42386301
Cough 24.35 11.28 536 92927 177567 42350305
Cardioversion 24.20 11.28 19 93444 982 42526890
Carbon dioxide increased 24.18 11.28 21 93442 1251 42526621
Hypoacusis 24.17 11.28 93 93370 18609 42509263
Osteonecrosis of jaw 24.14 11.28 6 93457 19043 42508829
COVID-19 24.12 11.28 152 93311 115796 42412076
Chest discomfort 24.05 11.28 229 93234 63387 42464485
Penis disorder 23.96 11.28 22 93441 1411 42526461
Expired product administered 23.91 11.28 37 93426 4126 42523746
Neurotoxicity 23.82 11.28 11 93452 23640 42504232
Hypocalcaemia 23.47 11.28 19 93444 30154 42497718
Plasma cell myeloma 23.24 11.28 43 93420 47535 42480337
Balloon atrial septostomy 22.99 11.28 6 93457 16 42527856
Drug eruption 22.82 11.28 11 93452 23064 42504808
Infusion site vesicles 22.72 11.28 10 93453 170 42527702
Therapy non-responder 22.67 11.28 197 93266 53162 42474710
Sudden death 22.57 11.28 84 93379 16545 42511327
Rash 22.54 11.28 450 93013 276504 42251368
Device infusion issue 22.51 11.28 19 93444 1089 42526783
Optic atrophy 22.50 11.28 20 93443 1229 42526643
Macular oedema 22.32 11.28 33 93430 3536 42524336
Thrombotic microangiopathy 22.28 11.28 3 93460 14779 42513093
Hypophosphataemia 22.27 11.28 9 93454 20936 42506936
Blood testosterone decreased 22.01 11.28 39 93424 4863 42523009
Dialysis 21.99 11.28 67 93396 11919 42515953
Abdominal pain 21.97 11.28 290 93173 190181 42337691
Therapy cessation 21.93 11.28 96 93367 20354 42507518
Acute right ventricular failure 21.71 11.28 9 93454 131 42527741
Weight increased 21.70 11.28 345 93118 107638 42420234
Unevaluable event 21.62 11.28 139 93324 34149 42493723
Blood culture negative 21.18 11.28 7 93456 51 42527821
Vasculitis 21.08 11.28 7 93456 18387 42509485
Pulmonary congestion 20.97 11.28 79 93384 15651 42512221
Congestive hepatopathy 20.95 11.28 26 93437 2356 42525516
Myelodysplastic syndrome 20.79 11.28 12 93451 22733 42505139
Sudden hearing loss 20.75 11.28 18 93445 1071 42526801
Urticaria 20.49 11.28 88 93375 73948 42453924
Completed suicide 20.29 11.28 126 93337 96339 42431533
Loss of personal independence in daily activities 20.18 11.28 50 93413 49766 42478106
Hyperbilirubinaemia 20.16 11.28 10 93453 20625 42507247
Metastases to bone 20.10 11.28 4 93459 14805 42513067
Aspergillus infection 20.04 11.28 5 93458 15832 42512040
Penile swelling 19.97 11.28 17 93446 986 42526886
Transplant rejection 19.91 11.28 3 93460 13585 42514287
Micrococcus test positive 19.83 11.28 5 93458 11 42527861
Circulatory collapse 19.58 11.28 103 93360 23533 42504339
Colour blindness acquired 19.58 11.28 8 93455 112 42527760
Hyperglycaemia 19.39 11.28 45 93418 45814 42482058
Road traffic accident 19.25 11.28 88 93375 19005 42508867
Carotid artery dissection 19.16 11.28 9 93454 179 42527693
Product administration interrupted 19.15 11.28 37 93426 4929 42522943
Male orgasmic disorder 19.08 11.28 8 93455 120 42527752
Candida infection 18.91 11.28 12 93451 21598 42506274
Lymphopenia 18.84 11.28 12 93451 21551 42506321
Dizziness exertional 18.79 11.28 10 93453 262 42527610
Spontaneous intrahepatic portosystemic venous shunt 18.73 11.28 5 93458 15 42527857
Myoclonus 18.69 11.28 7 93456 17058 42510814
Implant site extravasation 18.65 11.28 12 93451 451 42527421
Sudden cardiac death 18.64 11.28 32 93431 3892 42523980
Blood ethanol increased 18.49 11.28 12 93451 458 42527414
Deafness neurosensory 18.39 11.28 31 93432 3715 42524157
Stent placement 18.35 11.28 38 93425 5322 42522550
Vasodilatation 18.29 11.28 18 93445 1259 42526613
Intentional product misuse 18.29 11.28 212 93251 61688 42466184
Blood pressure decreased 18.24 11.28 202 93261 58130 42469742
Presyncope 18.16 11.28 97 93366 22290 42505582
Cardiac ablation 18.14 11.28 18 93445 1272 42526600
Macular degeneration 18.10 11.28 25 93438 2516 42525356
Therapeutic procedure 18.03 11.28 10 93453 285 42527587
Suture insertion 18.01 11.28 6 93457 45 42527827
Retinitis pigmentosa 17.82 11.28 5 93458 19 42527853
Vitreous detachment 17.77 11.28 16 93447 1000 42526872
Sinus congestion 17.77 11.28 44 93419 6936 42520936
Photopsia 17.74 11.28 24 93439 2368 42525504
Physical product label issue 17.74 11.28 4 93459 4 42527868
Retinal disorder 17.65 11.28 17 93446 1158 42526714
Lymphocyte count decreased 17.60 11.28 21 93442 27788 42500084
Retinal haemorrhage 17.56 11.28 39 93424 5731 42522141
Pneumonia aspiration 17.50 11.28 54 93409 50024 42477848
Lymphadenopathy 17.34 11.28 29 93434 33336 42494536
Appendicitis 17.29 11.28 12 93451 20601 42507271
Hypercalcaemia 17.27 11.28 9 93454 18049 42509823
Myocardial infarction 17.18 11.28 374 93089 123635 42404237
Atrial flutter 17.01 11.28 79 93384 17172 42510700
Infusion site cellulitis 16.95 11.28 8 93455 161 42527711
Hepatitis 16.87 11.28 21 93442 27279 42500593
Anaphylactic shock 16.85 11.28 16 93447 23501 42504371
Transaminases increased 16.71 11.28 29 93434 32856 42495016
Nephropathy toxic 16.69 11.28 8 93455 16830 42511042
Tricuspid valve incompetence 16.67 11.28 58 93405 11055 42516817
Hallucination, visual 16.65 11.28 13 93450 21007 42506865
Oxygen saturation abnormal 16.52 11.28 21 93442 1950 42525922
Painful ejaculation 16.51 11.28 8 93455 171 42527701
Eczema 16.47 11.28 31 93432 34055 42493817
Anaphylactic reaction 16.47 11.28 44 93419 42699 42485173
Cor pulmonale chronic 16.46 11.28 7 93456 109 42527763
Hypophagia 16.39 11.28 21 93442 26935 42500937
Right-to-left cardiac shunt 16.34 11.28 8 93455 175 42527697
Ocular vascular disorder 16.18 11.28 8 93455 179 42527693
Pulmonary vascular resistance abnormality 16.15 11.28 6 93457 64 42527808
Toxic skin eruption 16.14 11.28 5 93458 13725 42514147
Cardiac pacemaker insertion 16.10 11.28 27 93436 3221 42524651
Catheter site extravasation 16.02 11.28 8 93455 183 42527689
Palmar-plantar erythrodysaesthesia syndrome 15.96 11.28 13 93450 20569 42507303
Papilloedema 15.87 11.28 27 93436 3259 42524613
Therapy interrupted 15.79 11.28 93 93370 22157 42505715
Thoracic cavity drainage 15.78 11.28 8 93455 189 42527683
Clostridium difficile colitis 15.77 11.28 14 93449 21238 42506634
Incorrect route of product administration 15.77 11.28 18 93445 24287 42503585
Blood phosphorus increased 15.76 11.28 4 93459 12521 42515351
Heart valve operation 15.75 11.28 6 93457 69 42527803
Swelling face 15.74 11.28 109 93354 27445 42500427
Essential hypertension 15.68 11.28 29 93434 3739 42524133
Tinnitus 15.67 11.28 113 93350 28825 42499047
Device maintenance issue 15.67 11.28 6 93457 70 42527802
Psoriatic arthropathy 15.65 11.28 19 93444 24948 42502924
Diuretic therapy 15.56 11.28 5 93458 33 42527839
Tracheitis 15.55 11.28 15 93448 1024 42526848
Hypomagnesaemia 15.52 11.28 24 93439 28464 42499408
Chronic respiratory failure 15.48 11.28 19 93444 1703 42526169
Deep vein thrombosis 15.43 11.28 102 93361 76855 42451017
Thrombosis in device 15.40 11.28 26 93437 3120 42524752
Viral labyrinthitis 15.37 11.28 3 93460 0 42527872
Orchidopexy 15.37 11.28 3 93460 0 42527872
Drug interaction 15.35 11.28 457 93006 266542 42261330
Obstructive airways disorder 15.35 11.28 19 93444 24740 42503132
Swelling 15.34 11.28 186 93277 54699 42473173
Inflammation 15.31 11.28 32 93431 33815 42494057
Phlebotomy 15.30 11.28 6 93457 75 42527797
Viral upper respiratory tract infection 15.26 11.28 26 93437 3143 42524729
Infusion site discomfort 15.17 11.28 10 93453 392 42527480
Hernia repair 15.14 11.28 17 93446 1386 42526486
Heart rate increased 15.12 11.28 181 93282 53074 42474798
Muscle rigidity 14.89 11.28 4 93459 12055 42515817
Right ventricular dilatation 14.89 11.28 13 93450 780 42527092
Respiratory failure 14.85 11.28 377 93086 127755 42400117
Epstein-Barr virus antibody positive 14.80 11.28 9 93454 306 42527566
Blood creatinine increased 14.76 11.28 162 93301 109841 42418031
Catheter site scab 14.74 11.28 4 93459 13 42527859
Chloropsia 14.74 11.28 4 93459 13 42527859
Infusion site rash 14.74 11.28 12 93451 654 42527218
Transplant 14.71 11.28 14 93449 940 42526932
Vertebral artery stenosis 14.65 11.28 7 93456 145 42527727
Adrenal insufficiency 14.61 11.28 12 93451 18912 42508960
Hypoalbuminaemia 14.61 11.28 8 93455 15602 42512270
Pericardial effusion 14.54 11.28 112 93351 29163 42498709
Enteritis 14.52 11.28 3 93460 10813 42517059
Nasal abscess 14.51 11.28 4 93459 14 42527858
Blood uric acid increased 14.50 11.28 8 93455 15539 42512333
Metastases to liver 14.38 11.28 9 93454 16317 42511555
Pulmonary arterial pressure decreased 14.30 11.28 4 93459 15 42527857
Infusion site reaction 14.29 11.28 16 93447 1300 42526572
Device physical property issue 14.27 11.28 17 93446 1477 42526395
Dysphagia 14.27 11.28 97 93366 72622 42455250
Vitamin B6 deficiency 14.24 11.28 9 93454 328 42527544
Performance enhancing product use 14.22 11.28 7 93456 155 42527717
Peritonitis 14.16 11.28 12 93451 18621 42509251
Encephalopathy 14.14 11.28 45 93418 41288 42486584
Systemic scleroderma 14.05 11.28 11 93452 566 42527306
Schizophrenia 14.01 11.28 3 93460 10547 42517325
Endarterectomy 13.98 11.28 7 93456 161 42527711
Progressive multifocal leukoencephalopathy 13.92 11.28 4 93459 11532 42516340
Conjunctival hyperaemia 13.92 11.28 25 93438 3151 42524721
Food interaction 13.89 11.28 14 93449 1008 42526864
Cardiac failure acute 13.86 11.28 63 93400 13570 42514302
Chest tube insertion 13.85 11.28 6 93457 98 42527774
Seasonal allergy 13.83 11.28 44 93419 8011 42519861
Akathisia 13.82 11.28 3 93460 10448 42517424
Pemphigoid 13.79 11.28 4 93459 11463 42516409
Dizziness postural 13.77 11.28 43 93420 7752 42520120
Cardiac output increased 13.74 11.28 5 93458 50 42527822
Constipation 13.69 11.28 262 93201 162029 42365843
Blood cholesterol increased 13.67 11.28 103 93360 26638 42501234
Organic erectile dysfunction 13.64 11.28 8 93455 254 42527618
Internal haemorrhage 13.62 11.28 34 93429 5387 42522485
Full blood count decreased 13.58 11.28 15 93448 20545 42507327
Oesophageal variceal ligation 13.58 11.28 6 93457 103 42527769
Catheter site discolouration 13.57 11.28 5 93458 52 42527820
Chronic obstructive pulmonary disease 13.57 11.28 204 93259 62910 42464962
Basal cell carcinoma 13.52 11.28 18 93445 22715 42505157
Myocarditis 13.43 11.28 13 93450 18925 42508947
Hypokalaemia 13.42 11.28 97 93366 71624 42456248
Bronchopulmonary dysplasia 13.40 11.28 12 93451 745 42527127
Mineral supplementation 13.37 11.28 6 93457 107 42527765
Product taste abnormal 13.35 11.28 15 93448 1224 42526648
Rhinovirus infection 13.34 11.28 38 93425 6510 42521362
Respiratory depression 13.33 11.28 13 93450 18855 42509017
Fasciectomy 13.30 11.28 3 93460 3 42527869
Coital bleeding 13.30 11.28 3 93460 3 42527869
Blood lactate dehydrogenase increased 13.25 11.28 23 93440 26058 42501814
Disease complication 13.24 11.28 24 93439 3046 42524826
Loss of libido 13.24 11.28 24 93439 3046 42524826
Emergency care 13.24 11.28 10 93453 488 42527384
Choroidal effusion 13.21 11.28 8 93455 270 42527602
Respiratory syncytial virus infection 13.14 11.28 40 93423 7112 42520760
Dialysis related complication 13.03 11.28 7 93456 187 42527685
Alopecia 12.97 11.28 28 93435 29248 42498624
Executive dysfunction 12.94 11.28 8 93455 280 42527592
Catheter site mass 12.91 11.28 4 93459 23 42527849
Sensation of blood flow 12.84 11.28 3 93460 4 42527868
Exercise test abnormal 12.84 11.28 3 93460 4 42527868
Asthma 12.79 11.28 82 93381 62232 42465640
Retinal infarction 12.75 11.28 6 93457 120 42527752
Glare 12.75 11.28 6 93457 120 42527752
Leukocytosis 12.68 11.28 29 93434 29679 42498193
Neonatal hypotension 12.57 11.28 7 93456 201 42527671
Face injury 12.52 11.28 16 93447 1494 42526378
Infusion site induration 12.50 11.28 9 93454 408 42527464
Colitis ulcerative 12.48 11.28 24 93439 26151 42501721
Corneal abrasion 12.48 11.28 8 93455 299 42527573
Neutropenic sepsis 12.45 11.28 10 93453 15936 42511936
Prostatic disorder 12.45 11.28 26 93437 3663 42524209
Catheter site dermatitis 12.44 11.28 3 93460 5 42527867
Cholangitis 12.44 11.28 4 93459 10723 42517149
Hyperthermia 12.43 11.28 6 93457 12568 42515304
Therapeutic product effect delayed 12.39 11.28 16 93447 1509 42526363
Mobility decreased 12.39 11.28 38 93425 35268 42492604
Activated partial thromboplastin time prolonged 12.39 11.28 10 93453 15893 42511979
Fungal infection 12.37 11.28 15 93448 19707 42508165
Lung disorder 12.36 11.28 160 93303 47763 42480109
Retinal vein thrombosis 12.36 11.28 9 93454 415 42527457
Dyskinesia 12.35 11.28 23 93440 25367 42502505
Wheezing 12.34 11.28 70 93393 54711 42473161
Right atrial pressure increased 12.27 11.28 6 93457 131 42527741
Deafness transitory 12.17 11.28 5 93458 71 42527801
Second primary malignancy 12.16 11.28 3 93460 9572 42518300
Ischaemic stroke 12.15 11.28 87 93376 22146 42505726
Substance use 12.13 11.28 17 93446 1734 42526138
Pulmonary artery dilatation 12.13 11.28 8 93455 314 42527558
Vascular operation 12.12 11.28 4 93459 29 42527843
Micrococcus infection 12.09 11.28 3 93460 6 42527866
Pathogen resistance 12.04 11.28 5 93458 11445 42516427
Hyperinsulinaemic hypoglycaemia 12.02 11.28 6 93457 137 42527735
Retinal deposits 12.01 11.28 4 93459 30 42527842
Catheter site vesicles 12.01 11.28 4 93459 30 42527842
Decreased appetite 12.00 11.28 327 93136 192810 42335062
Escherichia infection 11.95 11.28 5 93458 11391 42516481
Gastrointestinal surgery 11.93 11.28 5 93458 75 42527797
Angioplasty 11.87 11.28 13 93450 1031 42526841
Glomerular filtration rate abnormal 11.85 11.28 14 93449 1206 42526666
Orgasm abnormal 11.83 11.28 6 93457 142 42527730
Cholestasis 11.81 11.28 35 93428 32844 42495028
Libido decreased 11.80 11.28 31 93432 5067 42522805
Stevens-Johnson syndrome 11.78 11.28 19 93444 22159 42505713
Cerebral artery embolism 11.78 11.28 13 93450 1040 42526832
Tubulointerstitial nephritis 11.76 11.28 33 93430 31515 42496357
Pulmonary arterial pressure abnormal 11.73 11.28 8 93455 332 42527540
Haematospermia 11.73 11.28 8 93455 332 42527540
Blood pressure fluctuation 11.70 11.28 26 93437 26882 42500990
Reversible cerebral vasoconstriction syndrome 11.68 11.28 11 93452 729 42527143
Oesophagogastroduodenoscopy 11.67 11.28 4 93459 33 42527839
Drug level increased 11.66 11.28 25 93438 26175 42501697
Blood pressure abnormal 11.54 11.28 48 93415 9950 42517922
Ileus 11.54 11.28 15 93448 19124 42508748
Drug-induced liver injury 11.52 11.28 44 93419 38229 42489643
Depressed level of consciousness 11.52 11.28 60 93403 47910 42479962
Blood calcium decreased 11.44 11.28 5 93458 11103 42516769
Respiratory symptom 11.44 11.28 5 93458 11101 42516771
Echocardiogram abnormal 11.39 11.28 14 93449 1256 42526616
Haematuria 11.38 11.28 77 93386 57722 42470150
Injection site pain 11.38 11.28 77 93386 57721 42470151
Melaena 11.37 11.28 45 93418 38701 42489171
Pneumonia fungal 11.36 11.28 3 93460 9143 42518729
Musculoskeletal stiffness 11.36 11.28 77 93386 57688 42470184
Neck pain 11.31 11.28 108 93355 29906 42497966
Body temperature decreased 11.30 11.28 9 93454 14404 42513468

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
Pulmonary arterial hypertension 3411.26 11.82 1495 197498 31073 110359233
Dyspnoea 2704.65 11.82 6049 192944 1100823 109289483
Right ventricular failure 2539.23 11.82 1136 197857 24818 110365488
Pulmonary hypertension 2314.89 11.82 1365 197628 53855 110336451
Fluid retention 2271.35 11.82 1647 197346 92660 110297646
Pain in jaw 1932.37 11.82 1183 197810 49994 110340312
Death 1833.09 11.82 3938 195055 694931 109695375
Hypervolaemia 1324.32 11.82 922 198071 48538 110341768
Headache 1070.80 11.82 3748 195245 878629 109511677
Dyspnoea exertional 1028.20 11.82 1095 197898 102965 110287341
Flushing 778.24 11.82 951 198042 103785 110286521
Catheter site erythema 770.73 11.82 319 198674 5709 110384597
Oxygen saturation decreased 767.28 11.82 1163 197830 155819 110234487
Lung transplant 703.92 11.82 288 198705 4998 110385308
Nasal congestion 653.03 11.82 844 198149 97438 110292868
Transfusion 635.60 11.82 455 198538 25017 110365289
Device related infection 572.31 11.82 513 198480 39006 110351300
Catheter management 561.28 11.82 222 198771 3513 110386793
Catheter site pruritus 560.00 11.82 195 198798 2111 110388195
Syncope 539.83 11.82 1152 197841 201384 110188922
Catheterisation cardiac 529.70 11.82 247 198746 5944 110384362
Infusion related reaction 522.05 11.82 44 198949 381118 110009188
Hypoxia 494.32 11.82 858 198135 128657 110261649
Infusion site pain 483.13 11.82 332 198661 17087 110373219
Hospitalisation 482.51 11.82 896 198097 141597 110248709
Cardiac failure 479.13 11.82 1049 197944 186577 110203729
Pulmonary arterial pressure increased 465.01 11.82 213 198780 4914 110385392
Catheter site pain 456.85 11.82 226 198767 6220 110384086
Pulmonary oedema 437.65 11.82 707 198286 99952 110290354
Chest pain 429.31 11.82 1570 197423 374805 110015501
Neutropenia 428.76 11.82 78 198915 374542 110015764
Oedema peripheral 409.07 11.82 1411 197582 327249 110063057
Catheter site discharge 405.87 11.82 165 198828 2814 110387492
Cardiac failure congestive 390.84 11.82 849 198144 150151 110240155
Oxygen consumption increased 390.12 11.82 195 198798 5490 110384816
Febrile neutropenia 389.40 11.82 54 198939 316713 110073593
Hypotension 359.27 11.82 1875 197118 521974 109868332
Alopecia 352.40 11.82 109 198884 364644 110025662
Catheter site infection 348.69 11.82 203 198790 7797 110382509
Stomatitis 329.94 11.82 47 198946 270195 110120111
Glossodynia 326.04 11.82 18 198975 221986 110168320
Palpitations 325.32 11.82 816 198177 158396 110231910
Cough 316.83 11.82 1653 197340 459988 109930318
Oedema 315.75 11.82 962 198031 209014 110181292
Catheter placement 313.94 11.82 142 198851 3178 110387128
Treatment failure 308.05 11.82 62 198931 277172 110113134
Off label use 307.08 11.82 1525 197468 1498660 108891646
Rheumatoid arthritis 307.02 11.82 80 198913 299533 110090773
Dizziness 303.14 11.82 2221 196772 695972 109694334
Contraindicated product administered 301.16 11.82 44 198949 248223 110142083
Central venous catheterisation 300.20 11.82 144 198849 3698 110386608
Cardiac disorder 289.16 11.82 504 198489 75776 110314530
Respiratory failure 285.77 11.82 945 198048 214387 110175919
Drug hypersensitivity 285.13 11.82 239 198754 453851 109936455
Scleroderma 284.59 11.82 164 198829 6177 110384129
Optic ischaemic neuropathy 283.84 11.82 142 198851 4005 110386301
Duodenal ulcer perforation 275.34 11.82 10 198983 177690 110212616
Unevaluable event 273.88 11.82 428 198565 58799 110331507
Folliculitis 272.39 11.82 6 198987 167647 110222659
Pericarditis 267.69 11.82 38 198955 219076 110171230
Device alarm issue 264.68 11.82 115 198878 2331 110387975
Arthropathy 263.50 11.82 94 198899 287428 110102878
Infusion site erythema 263.03 11.82 198 198795 11761 110378545
Psoriatic arthropathy 257.83 11.82 27 198966 196734 110193572
Hepatic enzyme increased 255.58 11.82 129 198864 320763 110069543
Helicobacter infection 254.43 11.82 19 198974 181858 110208448
Catheter site swelling 250.62 11.82 109 198884 2215 110388091
Malignant neoplasm progression 242.03 11.82 19 198974 174548 110215758
Acute respiratory failure 241.87 11.82 463 198530 74797 110315509
Product use in unapproved indication 241.87 11.82 269 198724 447108 109943198
Joint swelling 236.43 11.82 269 198724 442576 109947730
Urticaria 229.77 11.82 145 198848 318712 110071594
Cardiac operation 229.69 11.82 140 198853 5855 110384451
Catheter site haemorrhage 229.61 11.82 139 198854 5741 110384565
Fibromyalgia 227.71 11.82 22 198971 170887 110219419
Musculoskeletal stiffness 226.58 11.82 110 198883 279712 110110594
Infusion site infection 223.82 11.82 100 198893 2172 110388134
Pulmonary veno-occlusive disease 222.72 11.82 98 198895 2050 110388256
Complication associated with device 219.15 11.82 223 198770 19850 110370456
Rash 218.82 11.82 752 198241 820212 109570094
Mobility decreased 218.59 11.82 77 198916 237345 110152961
Impaired healing 218.47 11.82 44 198949 196673 110193633
Transplant evaluation 217.43 11.82 92 198901 1743 110388563
Epistaxis 214.62 11.82 617 198376 129755 110260551
Device occlusion 213.65 11.82 194 198799 14991 110375315
Wound 210.80 11.82 79 198914 234358 110155948
Toxicity to various agents 201.55 11.82 347 198646 480208 109910098
Hypersensitivity 201.21 11.82 259 198734 403739 109986567
Therapeutic product effect decreased 199.38 11.82 95 198898 244221 110146085
Irritable bowel syndrome 199.35 11.82 29 198964 164186 110226120
Muscle injury 198.97 11.82 14 198979 140793 110249513
Diarrhoea 197.51 11.82 3008 195985 1136497 109253809
Device leakage 196.90 11.82 190 198803 15858 110374448
Blister 195.61 11.82 82 198911 227294 110163012
Pneumonia 190.56 11.82 2410 196583 874304 109516002
Pulmonary hypertensive crisis 189.68 11.82 58 198935 399 110389907
Catheter site rash 189.04 11.82 71 198922 969 110389337
Concomitant disease aggravated 188.19 11.82 187 198806 16177 110374129
Pericardial effusion 183.84 11.82 352 198641 56865 110333441
Myalgia 183.55 11.82 840 198153 221541 110168765
Drug intolerance 182.15 11.82 281 198712 406231 109984075
Type 2 diabetes mellitus 182.10 11.82 47 198946 177185 110213121
C-reactive protein increased 171.37 11.82 89 198904 217830 110172476
Maternal exposure during pregnancy 170.12 11.82 126 198867 254757 110135549
Therapy change 167.35 11.82 141 198852 9856 110380450
Sleep disorder due to general medical condition, insomnia type 166.99 11.82 5 198988 105638 110284668
Systemic lupus erythematosus 166.84 11.82 128 198865 254210 110136096
Product dose omission issue 165.47 11.82 1068 197925 320714 110069592
Bursitis 164.72 11.82 20 198973 129898 110260408
Feeling abnormal 164.55 11.82 703 198290 180008 110210298
Chest discomfort 163.50 11.82 683 198310 173165 110217141
Catheter site irritation 161.82 11.82 56 198937 594 110389712
Confusional state 160.94 11.82 380 198613 468300 109922006
Drug ineffective 155.12 11.82 1873 197120 1518667 108871639
Pruritus 154.54 11.82 533 198460 581027 109809279
Right ventricular dysfunction 151.95 11.82 87 198906 3236 110387070
Lip dry 150.43 11.82 7 198986 100076 110290230
Dialysis 150.21 11.82 181 198812 19438 110370868
Malaise 149.67 11.82 1856 197137 669963 109720343
Cyanopsia 149.62 11.82 36 198957 80 110390226
Inflammation 148.88 11.82 81 198912 193157 110197149
Lower respiratory tract infection 148.73 11.82 131 198862 242975 110147331
Leukopenia 148.06 11.82 42 198951 148749 110241557
Device dislocation 147.79 11.82 230 198763 31474 110358832
Completed suicide 145.42 11.82 133 198860 242248 110148058
N-terminal prohormone brain natriuretic peptide increased 142.79 11.82 105 198888 6016 110384290
Joint range of motion decreased 142.23 11.82 24 198969 121808 110268498
Erection increased 140.72 11.82 44 198949 329 110389977
Paracentesis 139.13 11.82 62 198931 1338 110388968
Ill-defined disorder 139.07 11.82 54 198939 156799 110233507
Condition aggravated 137.94 11.82 1968 197025 732868 109657438
Cyanosis 137.57 11.82 215 198778 29526 110360780
Mucosal inflammation 137.46 11.82 9 198984 96132 110294174
Brain natriuretic peptide increased 136.18 11.82 132 198861 11077 110379229
Priapism 135.51 11.82 100 198893 5761 110384545
Discomfort 134.61 11.82 113 198880 214594 110175712
Myelosuppression 134.39 11.82 9 198984 94331 110295975
Osteoarthritis 134.33 11.82 81 198912 182542 110207764
Catheter site inflammation 133.20 11.82 58 198935 1182 110389124
Hypertension 133.11 11.82 471 198522 509613 109880693
Blood cholesterol increased 133.09 11.82 84 198909 184701 110205605
Liver injury 132.99 11.82 52 198941 150361 110239945
Infusion site swelling 132.75 11.82 123 198870 9754 110380552
Disease progression 131.61 11.82 820 198173 243214 110147092
Presyncope 127.65 11.82 276 198717 48611 110341695
Erectile dysfunction 127.29 11.82 162 198831 18394 110371912
Ascites 127.20 11.82 412 198581 92396 110297910
Exercise tolerance decreased 126.19 11.82 131 198862 11936 110378370
Grip strength decreased 125.97 11.82 4 198989 80170 110310136
Device infusion issue 124.12 11.82 74 198919 2971 110387335
Heart transplant 124.11 11.82 60 198933 1568 110388738
Therapeutic product effect incomplete 123.66 11.82 132 198861 223673 110166633
Thrombocytopenia 123.64 11.82 278 198715 348607 110041699
Heart rate increased 122.12 11.82 548 198445 143286 110247020
General physical health deterioration 118.92 11.82 381 198612 424914 109965392
Blood pressure decreased 115.96 11.82 462 198531 114629 110275677
Neutrophil count decreased 115.14 11.82 37 198956 120904 110269402
Intentional product use issue 113.24 11.82 169 198824 247737 110142569
White blood cell count decreased 113.14 11.82 148 198845 229242 110161064
Atrial flutter 113.07 11.82 176 198817 24086 110366220
Drug-induced liver injury 112.09 11.82 38 198955 120029 110270277
Psoriasis 111.79 11.82 56 198937 139937 110250369
Suspected counterfeit product 111.03 11.82 45 198948 761 110389545
Haemoptysis 110.96 11.82 331 198662 71023 110319283
Walking distance test abnormal 110.90 11.82 44 198949 702 110389604
Cardiac pacemaker insertion 109.88 11.82 91 198902 6210 110384096
Oxygen therapy 105.45 11.82 75 198918 4078 110386228
Vascular device infection 105.21 11.82 139 198854 16373 110373933
Injury 103.10 11.82 100 198893 177165 110213141
Dyspnoea at rest 102.74 11.82 99 198894 8247 110382059
Electrocardiogram QT prolonged 102.56 11.82 34 198959 108926 110281380
Dermatitis contact 102.39 11.82 126 198867 13827 110376479
Drug interaction 101.29 11.82 509 198484 499674 109890632
Delirium 100.54 11.82 59 198934 134966 110255340
Obesity 100.51 11.82 39 198954 113312 110276994
Pain in extremity 100.36 11.82 1327 197666 485791 109904515
Wound infection 100.19 11.82 25 198968 96440 110293866
Inappropriate schedule of product administration 97.76 11.82 134 198859 203503 110186803
Night sweats 97.72 11.82 60 198933 133923 110256383
Pancytopenia 97.58 11.82 141 198852 209472 110180834
Peripheral venous disease 97.24 11.82 17 198976 84100 110306206
Cor pulmonale 96.78 11.82 57 198936 2237 110388069
Asthma 96.56 11.82 190 198803 250101 110140205
Sleep disorder 96.08 11.82 130 198863 198514 110191792
Cardiac ablation 96.05 11.82 60 198933 2622 110387684
Heart and lung transplant 94.14 11.82 28 198965 173 110390133
Influenza 94.14 11.82 573 198420 168528 110221778
Rash maculo-papular 92.68 11.82 12 198981 74210 110316096
Infusion site haemorrhage 92.06 11.82 72 198921 4526 110385780
Catheter site related reaction 91.38 11.82 47 198946 1407 110388899
Agranulocytosis 90.65 11.82 5 198988 61755 110328551
Chronic obstructive pulmonary disease 90.48 11.82 413 198580 108745 110281561
Red blood cell sedimentation rate increased 90.13 11.82 16 198977 78286 110312020
Hypercholesterolaemia 89.70 11.82 26 198967 90811 110299495
Emergency care 88.53 11.82 46 198947 1407 110388899
Ventilation perfusion mismatch 87.97 11.82 38 198955 759 110389547
Epilepsy 86.37 11.82 36 198957 100173 110290133
Liver transplant 85.75 11.82 69 198924 4520 110385786
Hypoaesthesia 85.37 11.82 285 198708 313938 110076368
Right ventricular dilatation 84.48 11.82 53 198940 2334 110387972
Injection site pain 84.48 11.82 118 198875 177804 110212502
Balloon atrial septostomy 84.40 11.82 23 198970 98 110390208
Hyponatraemia 84.15 11.82 165 198828 217488 110172818
Tracheostomy 83.57 11.82 45 198948 1482 110388824
Prescribed underdose 82.68 11.82 10 198983 65164 110325142
Atrial septal defect repair 82.15 11.82 32 198961 485 110389821
Catheter removal 81.64 11.82 34 198959 618 110389688
High risk sexual behaviour 81.45 11.82 22 198971 90 110390216
Acute kidney injury 81.39 11.82 741 198252 634689 109755617
Medical device change 81.18 11.82 31 198962 444 110389862
Thrombosis in device 80.77 11.82 71 198922 5256 110385050
Nausea 80.23 11.82 2843 196150 1232847 109157459
Chronic respiratory failure 80.06 11.82 62 198931 3841 110386465
Neoplasm progression 79.33 11.82 11 198982 64584 110325722
Injection site reaction 78.38 11.82 31 198962 89039 110301267
Infusion site discharge 77.96 11.82 47 198946 1926 110388380
Mechanical ventilation 77.75 11.82 57 198936 3250 110387056
Cytokine release syndrome 77.46 11.82 16 198977 70290 110320016
Productive cough 77.24 11.82 408 198585 113897 110276409
Anaphylactic reaction 76.88 11.82 56 198937 114244 110276062
Right ventricular hypertrophy 75.92 11.82 44 198949 1675 110388631
Cardioversion 75.80 11.82 49 198944 2274 110388032
Arthralgia 74.69 11.82 972 198021 778660 109611646
Stent placement 74.68 11.82 78 198915 7156 110383150
Sedation 74.45 11.82 17 198976 69666 110320640
Congestive hepatopathy 74.04 11.82 67 198926 5153 110385153
Device connection issue 73.82 11.82 39 198954 1235 110389071
Osteonecrosis of jaw 73.34 11.82 3 198990 48014 110342292
Substance use disorder 72.41 11.82 77 198916 7213 110383093
Visual field defect 72.37 11.82 90 198903 9982 110380324
Medication error 71.68 11.82 51 198942 105315 110284991
Drug reaction with eosinophilia and systemic symptoms 71.54 11.82 29 198964 82066 110308240
Penile abscess 71.27 11.82 21 198972 125 110390181
Vascular resistance pulmonary increased 70.95 11.82 20 198973 99 110390207
Bone marrow failure 70.69 11.82 10 198983 57838 110332468
Aspiration pleural cavity 70.25 11.82 42 198951 1695 110388611
Pulmonary congestion 69.88 11.82 165 198828 30801 110359505
Catheterisation cardiac abnormal 69.47 11.82 25 198968 300 110390006
Viral infection 69.31 11.82 232 198761 52907 110337399
Gait inability 69.29 11.82 86 198907 136290 110254016
Atrial fibrillation 69.15 11.82 674 198319 228968 110161338
Paraesthesia 68.96 11.82 260 198733 276261 110114045
Biopsy liver 68.38 11.82 30 198963 623 110389683
Transplant 68.20 11.82 37 198956 1237 110389069
Systemic scleroderma 67.83 11.82 43 198950 1929 110388377
Disease complication 67.76 11.82 67 198926 5760 110384546
Device related sepsis 67.65 11.82 76 198917 7571 110382735
Catheter site vesicles 66.69 11.82 26 198967 395 110389911
Toxic epidermal necrolysis 66.59 11.82 11 198982 56716 110333590
Cardiac failure acute 66.39 11.82 139 198854 23939 110366367
Loss of consciousness 66.04 11.82 590 198403 195716 110194590
Drug resistance 66.02 11.82 11 198982 56363 110333943
Infusion site irritation 65.35 11.82 35 198958 1140 110389166
Foot deformity 65.19 11.82 6 198987 48474 110341832
Coeliac disease 64.96 11.82 3 198990 43184 110347122
Hepatitis 64.73 11.82 41 198952 90013 110300293
Peripheral swelling 64.37 11.82 1053 197940 402981 109987325
Device breakage 64.32 11.82 100 198893 13669 110376637
Thrombosis corpora cavernosa 63.87 11.82 12 198981 0 110390306
Onychomadesis 63.18 11.82 5 198988 45658 110344648
Internal haemorrhage 62.96 11.82 84 198909 9987 110380319
Respiratory distress 62.68 11.82 268 198725 68606 110321700
Oxygen saturation abnormal 62.45 11.82 63 198930 5548 110384758
Wheezing 62.33 11.82 242 198751 254988 110135318
Abdominal distension 61.87 11.82 532 198461 174571 110215735
Counterfeit product administered 61.82 11.82 22 198971 255 110390051
Sudden death 61.71 11.82 136 198857 24259 110366047
Prescription drug used without a prescription 61.71 11.82 62 198931 5434 110384872
Exostosis 60.97 11.82 6 198987 45950 110344356
Blood potassium decreased 60.03 11.82 224 198769 53890 110336416
Sciatica 59.92 11.82 47 198946 92352 110297954
Lactic acidosis 59.19 11.82 48 198945 92763 110297543
Autoimmune disorder 58.93 11.82 22 198971 65461 110324845
Abdominal cavity drainage 58.85 11.82 30 198963 881 110389425
Cytomegalovirus infection 58.73 11.82 13 198980 54431 110335875
Concomitant disease progression 58.54 11.82 50 198943 3560 110386746
Terminal state 58.32 11.82 61 198932 5606 110384700
Live birth 58.22 11.82 26 198967 69458 110320848
Retinal vein occlusion 57.95 11.82 52 198941 3955 110386351
Blood culture positive 57.86 11.82 76 198917 8900 110381406
Neuropathy peripheral 57.80 11.82 150 198843 179127 110211179
Pulmonary arterial pressure abnormal 57.57 11.82 30 198963 923 110389383
Cardiac arrest 57.53 11.82 574 198419 196179 110194127
Right ventricular systolic pressure increased 57.10 11.82 31 198962 1038 110389268
Infusion site warmth 56.87 11.82 37 198956 1736 110388570
Incorrect route of product administration 56.86 11.82 22 198971 64039 110326267
Dry mouth 55.90 11.82 179 198814 199769 110190537
Injection site bruising 55.78 11.82 12 198981 51251 110339055
Catheter site scab 55.65 11.82 20 198973 239 110390067
Acute right ventricular failure 55.03 11.82 23 198970 422 110389884
Colitis 54.67 11.82 62 198931 102261 110288045
Dizziness postural 54.65 11.82 96 198897 14513 110375793
Intentional overdose 54.24 11.82 97 198896 132404 110257902
Blindness unilateral 54.22 11.82 77 198916 9709 110380597
Taste disorder 53.96 11.82 25 198968 65362 110324944
Infusion site pruritus 53.50 11.82 55 198938 4953 110385353
Patent ductus arteriosus repair 53.39 11.82 13 198980 31 110390275
Therapeutic response decreased 53.18 11.82 57 198936 96442 110293864
Liver function test abnormal 52.82 11.82 255 198738 68695 110321611
Catheter site extravasation 52.61 11.82 24 198969 548 110389758
Lung assist device therapy 52.41 11.82 17 198976 145 110390161
Infusion site induration 52.37 11.82 32 198961 1344 110388962
Pulmonary vein stenosis 52.31 11.82 17 198976 146 110390160
Suicide attempt 51.68 11.82 66 198927 103328 110286978
Pulmonary vascular resistance abnormality 51.59 11.82 18 198975 196 110390110
Right-to-left cardiac shunt 51.23 11.82 20 198973 305 110390001
Arthritis 51.18 11.82 144 198849 167442 110222864
Respiration abnormal 51.16 11.82 75 198918 9734 110380572
Pneumocystis jirovecii pneumonia 50.81 11.82 8 198985 42727 110347579
Sopor 50.57 11.82 4 198989 36542 110353764
Device physical property issue 50.51 11.82 47 198946 3747 110386559
Device malfunction 50.06 11.82 129 198864 25429 110364877
Eosinophilia 49.62 11.82 21 198972 57915 110332391
Carbon dioxide increased 49.44 11.82 41 198952 2803 110387503
Cardiomegaly 49.00 11.82 139 198854 28991 110361315
Rhinovirus infection 48.75 11.82 81 198912 11708 110378598
Anaphylactic shock 48.65 11.82 16 198977 51530 110338776
Sinusitis 48.17 11.82 324 198669 296364 110093942
Hypocalcaemia 48.03 11.82 29 198964 65337 110324969
Infusion site cellulitis 47.91 11.82 21 198972 435 110389871
Retinal artery occlusion 47.83 11.82 48 198945 4201 110386105
Head injury 47.66 11.82 178 198815 42839 110347467
Infusion site abscess 47.55 11.82 20 198973 373 110389933
Therapy cessation 47.54 11.82 183 198810 44674 110345632
Deafness 47.44 11.82 130 198863 26579 110363727
Catheter site warmth 47.28 11.82 19 198974 314 110389992
Hernia repair 47.11 11.82 38 198955 2498 110387808
Hepatic cytolysis 47.08 11.82 20 198973 55033 110335273
Biopsy lung 46.93 11.82 18 198975 261 110390045
Colitis ulcerative 46.90 11.82 42 198951 77321 110312985
Blood pressure systolic increased 46.88 11.82 48 198945 82943 110307363
Blood culture negative 46.68 11.82 18 198975 265 110390041
Pleural effusion 46.54 11.82 507 198486 177202 110213104
Retinitis 46.28 11.82 3 198990 32324 110357982
Injection site erythema 46.16 11.82 61 198932 94115 110296191
Inappropriate antidiuretic hormone secretion 46.03 11.82 4 198989 33847 110356459
Pneumonitis 45.86 11.82 42 198951 76489 110313817
Polyneuropathy 45.75 11.82 3 198990 32009 110358297
Acute myeloid leukaemia 45.61 11.82 7 198986 38103 110352203
Renal disorder 45.38 11.82 193 198800 49286 110341020
Eczema 45.34 11.82 38 198955 72255 110318051
Vasodilatation 45.31 11.82 44 198949 3700 110386606
Joint stiffness 45.14 11.82 33 198960 67210 110323096
Left-to-right cardiac shunt 45.00 11.82 16 198977 185 110390121
Haemorrhage 44.66 11.82 337 198656 106355 110283951
Blood pressure increased 44.56 11.82 277 198716 258096 110132210
Metabolic acidosis 44.55 11.82 69 198924 99675 110290631
Localised oedema 44.51 11.82 68 198925 9155 110381151
Seasonal allergy 44.40 11.82 105 198888 19617 110370689
Depressed level of consciousness 44.35 11.82 84 198909 112194 110278112
Osteoporosis 44.22 11.82 55 198938 87097 110303209
Neurotoxicity 43.70 11.82 11 198982 42196 110348110
COVID-19 43.69 11.82 260 198733 244800 110145506
Tumour lysis syndrome 43.68 11.82 3 198990 30798 110359508
Drug eruption 43.53 11.82 21 198972 53638 110336668
Heart valve operation 43.23 11.82 16 198977 209 110390097
Endotracheal intubation 42.71 11.82 54 198939 6090 110384216
Lymphocyte count decreased 42.62 11.82 25 198968 57218 110333088
Loss of visual contrast sensitivity 42.58 11.82 8 198985 0 110390306
Hypothyroidism 42.51 11.82 41 198952 72858 110317448
Pulmonary capillary haemangiomatosis 42.44 11.82 13 198980 90 110390216
Treatment noncompliance 42.30 11.82 250 198743 72740 110317566
Contusion 41.91 11.82 247 198746 233114 110157192
Palmar-plantar erythrodysaesthesia syndrome 41.89 11.82 11 198982 41014 110349292
Catheter site discolouration 41.46 11.82 14 198979 137 110390169
Gout 41.09 11.82 152 198841 36414 110353892
Pulmonary artery dilatation 40.51 11.82 21 198972 639 110389667
Ventricular septal defect repair 40.46 11.82 10 198983 26 110390280
Hypoacusis 40.14 11.82 147 198846 35044 110355262
Dizziness exertional 40.08 11.82 22 198971 753 110389553
Muscular weakness 39.50 11.82 273 198720 248195 110142111
Orthopnoea 39.39 11.82 71 198922 10950 110379356
Maculopathy 39.34 11.82 37 198956 2990 110387316
Peyronie's disease 39.10 11.82 9 198984 15 110390291
Left ventricular failure 38.97 11.82 72 198921 11317 110378989
Systemic-pulmonary artery shunt 38.93 11.82 10 198983 32 110390274
Gastrointestinal disorder 38.88 11.82 265 198728 241687 110148619
Dependence on oxygen therapy 38.71 11.82 21 198972 702 110389604
Pulmonary arterial pressure 38.47 11.82 10 198983 34 110390272
Deafness unilateral 38.43 11.82 44 198949 4475 110385831
Loss of personal independence in daily activities 38.07 11.82 140 198853 149880 110240426
Cognitive disorder 37.70 11.82 62 198931 87449 110302857
Finger amputation 37.64 11.82 22 198971 851 110389455
Paranasal sinus hypersecretion 37.53 11.82 44 198949 4590 110385716
Haemophagocytic lymphohistiocytosis 37.31 11.82 6 198987 31553 110358753
Cytopenia 37.28 11.82 5 198988 30111 110360195
Penile vein thrombosis 37.26 11.82 7 198986 0 110390306
Rehabilitation therapy 37.25 11.82 31 198962 2130 110388176
Vision blurred 37.02 11.82 375 198618 128647 110261659
Metastases to bone 37.01 11.82 6 198987 31366 110358940
Lymphopenia 36.99 11.82 13 198980 40157 110350149
Product administration interrupted 36.91 11.82 70 198923 11222 110379084
Dyschromatopsia 36.67 11.82 25 198968 1269 110389037
Pyrexia 36.60 11.82 1286 197707 896979 109493327
Gastrointestinal haemorrhage 36.56 11.82 457 198536 165061 110225245
Depression 36.35 11.82 380 198613 316955 110073351
Frequent bowel movements 36.27 11.82 45 198948 71345 110318961
Hyperglycaemia 35.99 11.82 61 198932 85029 110305277
Serotonin syndrome 35.99 11.82 32 198961 59121 110331185
Right atrial pressure increased 35.96 11.82 16 198977 344 110389962
Application site irritation 35.93 11.82 29 198964 1908 110388398
Respiratory syncytial virus infection 35.79 11.82 80 198913 14404 110375902
Blood iron decreased 35.61 11.82 95 198898 19119 110371187
Hospice care 35.55 11.82 73 198920 12400 110377906
Angioplasty 35.49 11.82 29 198964 1942 110388364
Nephropathy toxic 35.39 11.82 4 198989 27474 110362832
Sinus congestion 35.39 11.82 128 198865 30331 110359975
Echocardiogram abnormal 35.36 11.82 33 198960 2641 110387665
Myoclonus 35.35 11.82 8 198985 32990 110357316
Pulmonary arterial wedge pressure increased 35.25 11.82 19 198974 627 110389679
Infection 35.16 11.82 450 198543 361750 110028556
Skin exfoliation 35.12 11.82 65 198928 87586 110302720
Central venous catheter removal 35.11 11.82 18 198975 535 110389771
Catheter site nodule 35.07 11.82 10 198983 52 110390254
Infusion site rash 35.07 11.82 31 198962 2312 110387994
Retching 35.04 11.82 105 198888 22577 110367729
Gastrostomy 34.83 11.82 26 198967 1524 110388782
Heart disease congenital 34.81 11.82 19 198974 643 110389663
Application site pruritus 34.53 11.82 40 198953 4120 110386186
Right ventricular enlargement 34.46 11.82 22 198971 999 110389307
Device issue 34.26 11.82 138 198855 34397 110355909
Pulmonary artery aneurysm 34.12 11.82 13 198980 185 110390121
Blood bilirubin increased 34.10 11.82 244 198749 75728 110314578
Dialysis related complication 34.03 11.82 15 198978 315 110389991
Hypomagnesaemia 34.00 11.82 35 198958 60335 110329971
Hypercalcaemia 33.86 11.82 21 198972 46636 110343670
Infusion site oedema 33.65 11.82 25 198968 1455 110388851
Intentional self-injury 32.97 11.82 13 198980 37416 110352890
Aplastic anaemia 32.71 11.82 3 198990 24305 110366001
Hallucination 32.58 11.82 85 198908 101347 110288959
Cor pulmonale chronic 32.58 11.82 16 198977 433 110389873
Fracture of penis 32.50 11.82 13 198980 212 110390094
Vascular resistance pulmonary decreased 32.31 11.82 10 198983 72 110390234
Body temperature decreased 32.26 11.82 13 198980 36922 110353384
Blood pressure fluctuation 32.24 11.82 53 198940 74771 110315535
Cardiac output decreased 32.22 11.82 28 198965 2041 110388265
Heart sounds 32.20 11.82 22 198971 1121 110389185
Fall 32.19 11.82 1360 197633 602122 109788184
Therapy non-responder 32.08 11.82 428 198565 156879 110233427
Neutropenic sepsis 31.86 11.82 8 198985 30738 110359568
Tricuspid valve incompetence 31.81 11.82 105 198888 23768 110366538
Immunodeficiency 31.81 11.82 15 198978 38823 110351483
Jugular vein distension 31.70 11.82 25 198968 1591 110388715
Psychotic disorder 31.67 11.82 27 198966 50910 110339396
Substance abuser 31.67 11.82 16 198977 461 110389845
CREST syndrome 31.51 11.82 16 198977 466 110389840
Myelodysplastic syndrome 31.44 11.82 14 198979 37470 110352836
Hallucination, visual 31.37 11.82 16 198977 39589 110350717
Injection site swelling 31.34 11.82 39 198954 61751 110328555
Pre-existing condition improved 31.33 11.82 48 198945 6478 110383828
Progressive multifocal leukoencephalopathy 31.24 11.82 4 198989 24952 110365354
Disease recurrence 31.21 11.82 38 198955 60746 110329560
Therapeutic embolisation 31.21 11.82 17 198976 573 110389733
Blood pressure abnormal 31.12 11.82 100 198893 22324 110367982
Oral herpes 31.02 11.82 13 198980 36067 110354239
Product counterfeit 30.96 11.82 14 198979 313 110389993
Injection site pruritus 30.86 11.82 28 198965 51230 110339076
Transient global amnesia 30.84 11.82 21 198972 1064 110389242
Blood alkaline phosphatase increased 30.78 11.82 226 198767 70709 110319597
Basal cell carcinoma 30.67 11.82 22 198971 45248 110345058
Transplant rejection 30.60 11.82 4 198989 24563 110365743
Cardiac index increased 30.60 11.82 8 198985 28 110390278
Ammonia increased 30.58 11.82 54 198939 8196 110382110
Overdose 30.57 11.82 271 198722 233523 110156783
Hyperkalaemia 30.48 11.82 133 198860 135663 110254643
Nocturnal dyspnoea 30.47 11.82 26 198967 1849 110388457
Exposure during pregnancy 30.17 11.82 177 198816 167247 110223059
Mineral supplementation 30.10 11.82 19 198974 846 110389460
Visual impairment 30.05 11.82 372 198621 134056 110256250
Knee arthroplasty 29.90 11.82 44 198949 64904 110325402
Flatulence 29.82 11.82 178 198815 51971 110338335
Staphylococcus test positive 29.62 11.82 50 198943 7320 110382986
Pulmonary thrombosis 29.27 11.82 72 198921 13791 110376515
Bronchopulmonary aspergillosis 28.66 11.82 9 198984 29854 110360452
Cardiac flutter 28.57 11.82 43 198950 5714 110384592
Infusion site inflammation 28.54 11.82 15 198978 470 110389836
Pulmonary valve replacement 28.38 11.82 7 198986 18 110390288
Rhinorrhoea 28.31 11.82 296 198697 102370 110287936
Spinal cord infarction 28.27 11.82 20 198973 1078 110389228
Painful erection 28.18 11.82 12 198981 231 110390075
Tracheostomy malfunction 28.16 11.82 11 198982 168 110390138
Renal failure 28.11 11.82 568 198425 226006 110164300
Obstructive airways disorder 28.04 11.82 25 198968 46124 110344182
Aspergillus infection 27.86 11.82 6 198987 25610 110364696
Sleep study 27.84 11.82 7 198986 20 110390286
Product contamination 27.81 11.82 25 198968 1906 110388400
Stevens-Johnson syndrome 27.79 11.82 26 198967 46875 110343431
Hip fracture 27.64 11.82 131 198862 35020 110355286
Diagnostic procedure 27.58 11.82 11 198982 178 110390128
Pain 27.58 11.82 1421 197572 953534 109436772
Muscle rigidity 27.46 11.82 5 198988 24026 110366280
Infusion site vesicles 27.37 11.82 16 198977 619 110389687
Macrophages increased 27.10 11.82 12 198981 255 110390051
Infusion site discolouration 27.02 11.82 18 198975 879 110389427
Poisoning deliberate 27.00 11.82 7 198986 26324 110363982
Metastases to liver 26.99 11.82 15 198978 35371 110354935
Drug tolerance decreased 26.97 11.82 8 198985 27532 110362774
Toxic skin eruption 26.93 11.82 8 198985 27507 110362799
Abortion spontaneous 26.93 11.82 14 198979 34268 110356038
Therapeutic procedure 26.91 11.82 19 198974 1021 110389285
Haemodynamic test abnormal 26.82 11.82 8 198985 50 110390256
Myocardial infarction 26.71 11.82 490 198503 191593 110198713
Pulmonary fibrosis 26.70 11.82 94 198899 101948 110288358
Suture insertion 26.57 11.82 13 198980 349 110389957
Coronary artery compression 26.45 11.82 6 198987 9 110390297
Cavopulmonary anastomosis 26.45 11.82 6 198987 9 110390297
Chest tube insertion 26.39 11.82 10 198983 140 110390166
Bronchitis 26.36 11.82 413 198580 156619 110233687
Posterior reversible encephalopathy syndrome 26.35 11.82 14 198979 33847 110356459
Hepatotoxicity 26.31 11.82 46 198947 63354 110326952
Choking sensation 26.21 11.82 36 198957 4400 110385906
Prolonged expiration 26.20 11.82 22 198971 1530 110388776
Dystonia 26.19 11.82 7 198986 25798 110364508
Supraventricular tachycardia 26.18 11.82 100 198893 24322 110365984
Chromatopsia 26.08 11.82 16 198977 677 110389629
Self-medication 26.01 11.82 43 198950 6189 110384117
Pneumothorax 25.95 11.82 129 198864 35156 110355150
Pericardial drainage 25.92 11.82 14 198979 464 110389842
Aspartate aminotransferase increased 25.85 11.82 418 198575 159518 110230788
Increased ventricular preload 25.84 11.82 7 198986 29 110390277
Plasma cell myeloma 25.82 11.82 46 198947 62890 110327416
Abdominal pain 25.81 11.82 714 198279 512275 109878031
Deep vein thrombosis 25.68 11.82 147 198846 139740 110250566
Hypogammaglobulinaemia 25.66 11.82 3 198990 20073 110370233
Myasthenia gravis 25.63 11.82 4 198989 21507 110368799
Catheter site induration 25.56 11.82 8 198985 60 110390246
Diet noncompliance 25.41 11.82 15 198978 591 110389715
Musculoskeletal pain 25.33 11.82 209 198784 182814 110207492
Atrial tachycardia 25.32 11.82 53 198940 9125 110381181
Injection site discharge 25.28 11.82 21 198972 1439 110388867
Torsade de pointes 25.19 11.82 5 198988 22595 110367711
Retinal vascular disorder 25.07 11.82 13 198980 396 110389910
Pemphigoid 25.05 11.82 3 198990 19704 110370602
Aphthous ulcer 25.03 11.82 4 198989 21132 110369174
Muscle spasticity 24.93 11.82 17 198976 35898 110354408
Cellulitis 24.92 11.82 341 198652 125675 110264631
Penile curvature 24.73 11.82 6 198987 14 110390292
Dyskinesia 24.53 11.82 34 198959 51412 110338894
Catheter site mass 24.49 11.82 8 198985 70 110390236
Bronchiectasis 24.38 11.82 18 198975 36475 110353831
Choking 24.35 11.82 71 198922 15039 110375267
Drug level increased 24.33 11.82 30 198963 47689 110342617
Pulmonary haemorrhage 24.32 11.82 75 198918 16381 110373925
Catheter site dryness 24.30 11.82 7 198986 38 110390268
Sleep disorder due to a general medical condition 24.29 11.82 35 198958 52077 110338229
Anti factor VIII antibody test 24.27 11.82 5 198988 3 110390303
Decreased activity 24.24 11.82 58 198935 10916 110379390
Gastrointestinal tube insertion 24.14 11.82 24 198969 2077 110388229
Cardiorenal syndrome 24.08 11.82 23 198970 1895 110388411
Hypophosphataemia 23.99 11.82 15 198978 33167 110357139
Cholestasis 23.99 11.82 50 198943 64468 110325838
Head discomfort 23.93 11.82 82 198911 18918 110371388
Proteinuria 23.93 11.82 22 198971 39996 110350310
Rales 23.86 11.82 98 198895 24641 110365665
Pulmonary arterial pressure decreased 23.82 11.82 9 198984 125 110390181
Arteriovenous malformation 23.75 11.82 23 198970 1928 110388378
Chemotherapy 23.71 11.82 24 198969 2122 110388184
Tracheostomy tube removal 23.68 11.82 5 198988 4 110390302
Hepatocellular injury 23.61 11.82 34 198959 50608 110339698
Metastases to central nervous system 23.52 11.82 6 198987 22811 110367495
Bronchopulmonary dysplasia 23.42 11.82 11 198982 269 110390037
Laryngitis 23.42 11.82 25 198968 42386 110347920
Adrenal insufficiency 23.40 11.82 25 198968 42365 110347941
Product label confusion 23.31 11.82 6 198987 22671 110367635
Gastritis hypertrophic 23.30 11.82 7 198986 45 110390261
Hereditary haemorrhagic telangiectasia 23.28 11.82 8 198985 83 110390223
Oxygen consumption 23.28 11.82 8 198985 83 110390223
Nodule 23.25 11.82 15 198978 32616 110357690
Peritonitis 23.22 11.82 15 198978 32592 110357714
Diuretic therapy 23.18 11.82 10 198983 199 110390107
Colour blindness 23.17 11.82 14 198979 576 110389730
Food allergy 23.12 11.82 4 198989 19944 110370362
Upper respiratory tract infection 23.04 11.82 348 198645 130980 110259326
Dysarthria 23.02 11.82 76 198917 84045 110306261
Tubulointerstitial nephritis 22.88 11.82 39 198954 54245 110336061
Ejaculation failure 22.83 11.82 12 198981 376 110389930
Product supply issue 22.79 11.82 31 198962 3755 110386551
Localised infection 22.76 11.82 144 198849 42904 110347402
Viral upper respiratory tract infection 22.60 11.82 54 198939 10154 110380152
Injection site mass 22.60 11.82 8 198985 24605 110365701
Pulseless electrical activity 22.60 11.82 74 198919 16683 110373623
Osteopenia 22.59 11.82 6 198987 22203 110368103
Somnolence 22.47 11.82 388 198605 297061 110093245
Hot flush 22.46 11.82 199 198794 65837 110324469
Portopulmonary hypertension 22.38 11.82 9 198984 149 110390157
Rhabdomyolysis 22.38 11.82 126 198867 120275 110270031
Second primary malignancy 22.37 11.82 3 198990 18065 110372241
Arrhythmia 22.30 11.82 207 198786 69368 110320938
Dysentery 22.26 11.82 19 198974 1352 110388954
Sinus disorder 22.22 11.82 117 198876 32611 110357695
Disseminated intravascular coagulation 22.07 11.82 25 198968 41261 110349045
Altered state of consciousness 21.98 11.82 44 198949 57582 110332724
Accidental exposure to product 21.94 11.82 35 198958 49973 110340333
Dysphagia 21.90 11.82 174 198819 153426 110236880
Painful ejaculation 21.86 11.82 8 198985 101 110390205
Colitis ischaemic 21.85 11.82 3 198990 17747 110372559
Generalised oedema 21.70 11.82 111 198882 30593 110359713
Exercise test abnormal 21.66 11.82 7 198986 59 110390247
Catheter culture positive 21.62 11.82 10 198983 236 110390070
Application site odour 21.58 11.82 6 198987 28 110390278
Back pain 21.58 11.82 844 198149 370152 110020154
Adverse drug reaction 21.55 11.82 107 198886 105452 110284854
Iron deficiency anaemia 21.55 11.82 113 198880 31446 110358860
Respiratory therapy 21.48 11.82 5 198988 9 110390297
Congenital arterial malformation 21.40 11.82 6 198987 29 110390277
Cardiac failure chronic 21.40 11.82 64 198929 13747 110376559
Disability 21.39 11.82 14 198979 30209 110360097
Blindness 21.36 11.82 125 198868 36234 110354072
Encephalitis 21.35 11.82 4 198989 18835 110371471
Colonoscopy 21.26 11.82 23 198970 2197 110388109
Sudden cardiac death 21.03 11.82 37 198956 5600 110384706
Spontaneous penile erection 20.91 11.82 9 198984 178 110390128
Haemoglobin decreased 20.91 11.82 591 198402 248136 110142170
Micrococcus test positive 20.82 11.82 5 198988 11 110390295
Akathisia 20.81 11.82 3 198990 17110 110373196
Nasal dryness 20.70 11.82 37 198956 5669 110384637
Candida infection 20.69 11.82 34 198959 47975 110342331
Catheter site bruise 20.61 11.82 13 198980 578 110389728
Therapeutic response shortened 20.54 11.82 14 198979 29569 110360737
Tracheitis 20.41 11.82 20 198973 1701 110388605
Multiple sclerosis relapse 20.36 11.82 37 198956 50203 110340103
Male orgasmic disorder 20.25 11.82 7 198986 74 110390232
Pulmonary embolism 20.23 11.82 268 198725 214206 110176100
Throat irritation 20.12 11.82 165 198828 53387 110336919
Skin lesion 20.06 11.82 39 198954 51592 110338714
Back injury 20.03 11.82 34 198959 47365 110342941
Vaginal discharge 19.88 11.82 4 198989 17904 110372402
Application site erythema 19.87 11.82 36 198957 5574 110384732
Respiratory depression 19.85 11.82 17 198976 31984 110358322
Enteritis 19.82 11.82 5 198988 19151 110371155
Hypoalbuminaemia 19.73 11.82 14 198979 28960 110361346
Spontaneous intrahepatic portosystemic venous shunt 19.71 11.82 5 198988 15 110390291
Rash erythematous 19.70 11.82 78 198915 81754 110308552
Encephalopathy 19.68 11.82 77 198916 80978 110309328
Blindness transient 19.57 11.82 37 198956 5919 110384387
Polyarthritis 19.52 11.82 5 198988 18958 110371348
Expired product administered 19.50 11.82 45 198948 8275 110382031
Phlebotomy 19.38 11.82 7 198986 85 110390221
Lower limb fracture 19.32 11.82 70 198923 75278 110315028
Suicidal ideation 19.30 11.82 95 198898 93842 110296464
Dry eye 19.29 11.82 45 198948 55748 110334558
Penile swelling 19.19 11.82 14 198979 792 110389514
Middle ear effusion 19.19 11.82 24 198969 2677 110387629
Ear tube insertion 19.18 11.82 8 198985 146 110390160
Eating disorder symptom 19.09 11.82 7 198986 89 110390217
Mouth ulceration 19.02 11.82 36 198957 48102 110342204
Diffuse large B-cell lymphoma 18.84 11.82 3 198990 15895 110374411
Tracheostomy infection 18.84 11.82 8 198985 153 110390153
Injection site urticaria 18.79 11.82 4 198989 17211 110373095
Bedridden 18.75 11.82 60 198933 13365 110376941
Metastases to lung 18.75 11.82 9 198984 23054 110367252
Life support 18.53 11.82 11 198982 438 110389868
Liver disorder 18.53 11.82 165 198828 142078 110248228
Ventricular assist device insertion 18.52 11.82 6 198987 51 110390255
Paraesthesia oral 18.42 11.82 20 198973 33651 110356655
Ankylosing spondylitis 18.38 11.82 3 198990 15609 110374697
Right atrial dilatation 18.35 11.82 15 198978 1005 110389301
Catheter site hypersensitivity 18.35 11.82 7 198986 100 110390206
Prescribed overdose 18.33 11.82 88 198905 87493 110302813
Ejaculation disorder 18.28 11.82 12 198981 572 110389734
Ear discomfort 18.26 11.82 53 198940 11196 110379110
Acne 18.24 11.82 20 198973 33500 110356806
Intra-abdominal fluid collection 18.23 11.82 28 198965 3786 110386520
Catheter site dermatitis 18.16 11.82 7 198986 103 110390203
Circulatory collapse 18.10 11.82 136 198857 42857 110347449
Biopsy bone marrow 18.07 11.82 11 198982 459 110389847
Enterococcal infection 18.06 11.82 7 198986 20359 110369947
Orthostatic hypotension 18.03 11.82 60 198933 66189 110324117
Biopsy 17.92 11.82 13 198980 729 110389577
Cardiopulmonary failure 17.71 11.82 42 198951 7861 110382445
Galectin-3 increased 17.70 11.82 5 198988 25 110390281
Cytomegalovirus viraemia 17.69 11.82 5 198988 17759 110372547
Paranasal sinus discomfort 17.68 11.82 37 198956 6368 110383938
Extra dose administered 17.58 11.82 55 198938 12104 110378202
Pathogen resistance 17.55 11.82 5 198988 17667 110372639
Device programming error 17.54 11.82 10 198983 369 110389937
Hypoglossal nerve paralysis 17.54 11.82 5 198988 26 110390280
Hypertransaminasaemia 17.49 11.82 11 198982 24244 110366062
Haematotoxicity 17.49 11.82 8 198985 21074 110369232
Chronic hepatic failure 17.41 11.82 16 198977 1255 110389051
Visual brightness 17.39 11.82 6 198987 63 110390243
Administration site infection 17.38 11.82 5 198988 27 110390279
Leukocytosis 17.37 11.82 45 198948 53783 110336523
Tenosynovitis 17.34 11.82 4 198989 16279 110374027
Multiple allergies 17.30 11.82 55 198938 12208 110378098
Right ventricular systolic pressure decreased 17.29 11.82 7 198986 118 110390188
Upper limb fracture 17.27 11.82 79 198914 20809 110369497
Blood ethanol increased 17.26 11.82 12 198981 629 110389677
Chronic sinusitis 17.24 11.82 12 198981 25072 110365234
Cardiac failure high output 17.24 11.82 11 198982 499 110389807
Skin operation 17.14 11.82 6 198987 66 110390240
Optic disc disorder 17.03 11.82 7 198986 123 110390183
Catheter site erosion 16.98 11.82 6 198987 68 110390238
Clubbing 16.98 11.82 13 198980 792 110389514
Dilatation ventricular 16.85 11.82 28 198965 4047 110386259
Blood lactate dehydrogenase increased 16.78 11.82 34 198959 44300 110346006
Blood calcium decreased 16.78 11.82 24 198969 35821 110354485
Oropharyngeal pain 16.73 11.82 339 198654 134937 110255369
Vascular device occlusion 16.72 11.82 12 198981 662 110389644
Therapeutic response unexpected 16.71 11.82 86 198907 23757 110366549
Bendopnoea 16.60 11.82 6 198987 73 110390233
Pulmonary artery therapeutic procedure 16.53 11.82 5 198988 33 110390273
Myositis 16.46 11.82 19 198974 31097 110359209
Ruptured cerebral aneurysm 16.40 11.82 12 198981 682 110389624
Sudden visual loss 16.38 11.82 6 198987 76 110390230
Purpura 16.33 11.82 12 198981 24376 110365930
Atrial septal defect 16.32 11.82 20 198973 2185 110388121
Thrombotic microangiopathy 16.30 11.82 17 198976 29132 110361174
Heart valve replacement 16.28 11.82 15 198978 1181 110389125
Purulent discharge 16.26 11.82 38 198955 7045 110383261
Genital swelling 16.26 11.82 10 198983 425 110389881
Hyperthermia 16.25 11.82 9 198984 21263 110369043
Constipation 16.22 11.82 505 198488 357281 110033025
Infusion site nodule 16.22 11.82 10 198983 427 110389879
Gastrointestinal surgery 16.21 11.82 9 198984 315 110389991
Application site rash 16.19 11.82 21 198972 2429 110387877
Chronic right ventricular failure 16.17 11.82 6 198987 79 110390227
Leg amputation 16.14 11.82 28 198965 4190 110386116
Catheter site cellulitis 16.05 11.82 11 198982 563 110389743
Ammonia abnormal 16.01 11.82 9 198984 323 110389983
Thunderclap headache 15.99 11.82 11 198982 567 110389739
Obstructive shock 15.97 11.82 7 198986 145 110390161
Pharyngeal injury 15.97 11.82 3 198990 0 110390306
Orchidopexy 15.97 11.82 3 198990 0 110390306
Disruption of the photoreceptor inner segment-outer segment 15.97 11.82 3 198990 0 110390306
Biopsy colon 15.97 11.82 3 198990 0 110390306
Primary headache associated with sexual activity 15.97 11.82 3 198990 0 110390306
Large intestinal polypectomy 15.95 11.82 10 198983 440 110389866
Walking aid user 15.95 11.82 13 198980 25062 110365244
Heart rate irregular 15.91 11.82 111 198882 34163 110356143
Pulmonary pain 15.82 11.82 35 198958 6258 110384048
Device difficult to use 15.81 11.82 7 198986 18798 110371508
Limb operation 15.78 11.82 27 198966 3997 110386309
Anomalous pulmonary venous connection 15.77 11.82 4 198989 12 110390294
Suspected suicide 15.66 11.82 4 198989 15195 110375111
Drug titration error 15.66 11.82 17 198976 1630 110388676
Fistula repair 15.64 11.82 6 198987 87 110390219
Protein-losing gastroenteropathy 15.62 11.82 13 198980 893 110389413
Weight decreased 15.59 11.82 1009 197984 467048 109923258
Transaminases increased 15.53 11.82 60 198933 63330 110326976
Full blood count decreased 15.52 11.82 21 198972 32078 110358228
Procedural pain 15.50 11.82 25 198968 35540 110354766
Telangiectasia 15.50 11.82 18 198975 1859 110388447
Thoracic cavity drainage 15.50 11.82 9 198984 344 110389962
Vasodilation procedure 15.48 11.82 5 198988 42 110390264
Product storage error 15.47 11.82 10 198983 21718 110368588
Drug level decreased 15.44 11.82 7 198986 18541 110371765
Cardiac output increased 15.43 11.82 11 198982 600 110389706
Hypokalaemia 15.43 11.82 233 198760 182215 110208091
Investigation 15.43 11.82 20 198973 2312 110387994
Metastases to lymph nodes 15.40 11.82 4 198989 15028 110375278
Adenotonsillectomy 15.40 11.82 6 198987 91 110390215
Immune reconstitution inflammatory syndrome 15.38 11.82 5 198988 16221 110374085
Biopsy kidney 15.36 11.82 8 198985 246 110390060
Aortic valve repair 15.30 11.82 4 198989 14 110390292
Therapy partial responder 15.28 11.82 27 198966 37034 110353272
Hypertriglyceridaemia 15.27 11.82 5 198988 16149 110374157
Human metapneumovirus test positive 15.27 11.82 8 198985 249 110390057
Injection site infection 15.26 11.82 21 198972 2572 110387734
Skin irritation 15.23 11.82 64 198929 16255 110374051
Oesophagogastric fundoplasty 15.22 11.82 7 198986 163 110390143
Faeces discoloured 15.21 11.82 109 198884 33839 110356467
Mitral valve replacement 15.19 11.82 11 198982 615 110389691
Glare 15.18 11.82 7 198986 164 110390142
Thyroidectomy 15.13 11.82 14 198979 1108 110389198
Respiratory tract infection viral 15.13 11.82 33 198960 5845 110384461
Cataract operation 15.11 11.82 33 198960 5850 110384456
Performance enhancing product use 15.10 11.82 7 198986 166 110390140
Injection site rash 15.07 11.82 12 198981 23407 110366899
Infective pulmonary exacerbation of cystic fibrosis 15.01 11.82 4 198989 14767 110375539
Joint dislocation 14.93 11.82 24 198969 34166 110356140
Gastric disorder 14.89 11.82 107 198886 33250 110357056
Secretion discharge 14.88 11.82 74 198919 20170 110370136
Face injury 14.87 11.82 28 198965 4464 110385842
Hypercapnia 14.80 11.82 49 198944 11110 110379196
Spinal fracture 14.74 11.82 80 198913 22553 110367753
Blood calcium increased 14.72 11.82 7 198986 18033 110372273
Road traffic accident 14.69 11.82 123 198870 107275 110283031
Metapneumovirus infection 14.69 11.82 20 198973 2424 110387882
Suture related complication 14.60 11.82 9 198984 384 110389922
Blood carbon monoxide increased 14.50 11.82 4 198989 18 110390288
Catheter site scar 14.50 11.82 4 198989 18 110390288
Diabetic ketoacidosis 14.48 11.82 34 198959 42024 110348282
Endarterectomy 14.43 11.82 9 198984 392 110389914
Atrioventricular septal defect 14.41 11.82 6 198987 109 110390197
Cardiac cirrhosis 14.36 11.82 8 198985 282 110390024
Peripheral sensory neuropathy 14.36 11.82 6 198987 16674 110373632
Tuberculosis 14.35 11.82 7 198986 17767 110372539
Labelled drug-drug interaction medication error 14.34 11.82 19 198974 29283 110361023
Brain natriuretic peptide 14.29 11.82 5 198988 55 110390251
Large intestine perforation 14.28 11.82 6 198987 16623 110373683
Delusion 14.27 11.82 13 198980 23742 110366564
Subarachnoid haemorrhage 14.27 11.82 97 198896 29605 110360701
Ataxia 14.25 11.82 20 198973 30088 110360218
Epstein-Barr virus antibody positive 14.24 11.82 11 198982 679 110389627
Platelet count decreased 14.22 11.82 311 198682 230132 110160174
Penis disorder 14.18 11.82 13 198980 1017 110389289
Aortic valve replacement 14.11 11.82 16 198977 1610 110388696
Affect lability 14.07 11.82 8 198985 18629 110371677
Hydronephrosis 14.05 11.82 10 198983 20655 110369651
Cardiac discomfort 14.04 11.82 15 198978 1413 110388893
Personality disorder 13.98 11.82 3 198990 12834 110377472
Mixed connective tissue disease 13.95 11.82 9 198984 416 110389890
Cholecystectomy 13.92 11.82 47 198946 10762 110379544
Hysterectomy 13.92 11.82 39 198954 8075 110382231
Suture rupture 13.92 11.82 11 198982 702 110389604
Skeletal dysplasia 13.89 11.82 3 198990 3 110390303
Cell-free and concentrated ascites reinfusion therapy 13.89 11.82 3 198990 3 110390303
Infusion site cyst 13.89 11.82 3 198990 3 110390303
Fasciectomy 13.89 11.82 3 198990 3 110390303
Hypertensive crisis 13.87 11.82 14 198979 24358 110365948
Aneurysm 13.84 11.82 27 198966 4419 110385887
Pyelonephritis 13.81 11.82 15 198978 25235 110365071
Muscle strain 13.81 11.82 48 198945 11154 110379152
Coordination abnormal 13.79 11.82 15 198978 25213 110365093
Brain natriuretic peptide abnormal 13.56 11.82 12 198981 896 110389410
Psychomotor hyperactivity 13.54 11.82 10 198983 20267 110370039
Insulin autoimmune syndrome 13.53 11.82 11 198982 731 110389575
Retinal vein thrombosis 13.48 11.82 11 198982 735 110389571
Respiratory tract irritation 13.46 11.82 11 198982 737 110389569
Foetal death 13.45 11.82 6 198987 16039 110374267
Bone density decreased 13.44 11.82 6 198987 16036 110374270
Hyperammonaemia 13.43 11.82 4 198989 13728 110376578
International normalised ratio abnormal 13.40 11.82 33 198960 6324 110383982
Low cardiac output syndrome 13.39 11.82 13 198980 1093 110389213
Angioedema 13.39 11.82 113 198880 98387 110291919
Drain placement 13.36 11.82 7 198986 218 110390088
Implant site extravasation 13.34 11.82 12 198981 916 110389390
Proctitis 13.17 11.82 7 198986 16920 110373386
Enterocolitis 13.11 11.82 9 198984 18940 110371366
Oral pain 13.11 11.82 30 198963 37414 110352892
Medical device implantation 13.06 11.82 10 198983 609 110389697
Herpes simplex 13.05 11.82 6 198987 15758 110374548
Hallucination, auditory 13.03 11.82 17 198976 26380 110363926
Polypectomy 13.03 11.82 15 198978 1534 110388772
Pulmonary arteriovenous fistula 13.02 11.82 4 198989 28 110390278
Status epilepticus 13.02 11.82 23 198970 31548 110358758
Jejunostomy 13.01 11.82 5 198988 73 110390233
Jaundice cholestatic 12.99 11.82 5 198988 14603 110375703
Needle issue 12.99 11.82 8 198985 17832 110372474
Cardiogenic shock 12.95 11.82 159 198834 57179 110333127
Pancreatitis acute 12.94 11.82 60 198933 60214 110330092
Hypoglycaemia 12.89 11.82 140 198853 115964 110274342
Vertebral artery stenosis 12.82 11.82 7 198986 237 110390069
Mixed liver injury 12.80 11.82 3 198990 12076 110378230
Infusion site pustule 12.78 11.82 4 198989 30 110390276
Subdural haematoma evacuation 12.76 11.82 5 198988 77 110390229
Walking disability 12.71 11.82 19 198974 2509 110387797
Vena cava filter insertion 12.69 11.82 6 198987 149 110390157
Intestinal adhesion lysis 12.68 11.82 3 198990 6 110390300
Facial pain 12.67 11.82 58 198935 15281 110375025
Fibrinous bronchitis 12.65 11.82 6 198987 150 110390156
Body temperature increased 12.64 11.82 53 198940 54660 110335646
Onychomycosis 12.59 11.82 32 198961 38499 110351807
Collateral circulation 12.59 11.82 5 198988 80 110390226
Cardiothoracic ratio increased 12.59 11.82 5 198988 80 110390226
Infusion site discomfort 12.54 11.82 16 198977 1821 110388485
Gastric antral vascular ectasia 12.52 11.82 13 198980 1184 110389122
Macular detachment 12.51 11.82 7 198986 249 110390057
Implantable defibrillator insertion 12.51 11.82 13 198980 1186 110389120
Catheter site urticaria 12.45 11.82 4 198989 33 110390273
Premature delivery 12.39 11.82 96 198897 30536 110359770
Exposure to chemical pollution 12.37 11.82 3 198990 7 110390299
Annuloplasty 12.37 11.82 3 198990 7 110390299
Arterial aneurysm repair 12.37 11.82 3 198990 7 110390299
Blood pressure diastolic decreased 12.36 11.82 29 198964 35856 110354450
Blood phosphorus increased 12.36 11.82 7 198986 16333 110373973
Oesophagogastroduodenoscopy 12.36 11.82 7 198986 255 110390051
Parkinsonism 12.34 11.82 13 198980 22174 110368132
Hepatic function abnormal 12.33 11.82 102 198891 89193 110301113
Radiculopathy 12.33 11.82 10 198983 19326 110370980
Myocarditis 12.30 11.82 22 198971 30033 110360273
Anorgasmia 12.30 11.82 15 198978 1631 110388675
Immunosuppressant drug level increased 12.25 11.82 3 198990 11721 110378585
Debridement 12.23 11.82 16 198977 1867 110388439
Drug delivery system malfunction 12.22 11.82 12 198981 1023 110389283
Retinal toxicity 12.20 11.82 15 198978 1644 110388662
Oesophageal dilation procedure 12.20 11.82 6 198987 163 110390143
Procedural complication 12.14 11.82 38 198955 8367 110381939
Alanine aminotransferase increased 12.10 11.82 424 198569 183349 110206957
Respiratory disorder 12.07 11.82 188 198805 71194 110319112
Cardiac index decreased 11.97 11.82 6 198987 170 110390136
Injection site haemorrhage 11.94 11.82 26 198967 33002 110357304
Oesophageal variceal ligation 11.93 11.82 6 198987 171 110390135
Erythrasma 11.86 11.82 4 198989 39 110390267
Echocardiogram 11.86 11.82 4 198989 39 110390267
Urinary retention 11.85 11.82 75 198918 69608 110320698

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G04BE03 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs used in erectile dysfunction
FDA MoA N0000020026 Phosphodiesterase 5 Inhibitors
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D014665 Vasodilator Agents
MeSH PA D058986 Phosphodiesterase 5 Inhibitors
MeSH PA D064804 Urological Agents
FDA EPC N0000175599 Phosphodiesterase 5 Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:71942 EC 3.1.4.35 (3,5-cyclic-GMP phosphodiesterase) inhibitor
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:233423 antifibrotic agent
CHEBI has role CHEBI:66981 ophthalmology drug

Related Drugs by ATC class:

G04BE Drugs used in erectile dysfunction 9 drugs
alprostadilapomorphineavanafilmoxisylytepapaverinetadalafiludenafilvardenafilyohimbine

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Impotence indication 397803000
Induratio penis plastica contraindication 1335005 DOID:8616
Priapism contraindication 6273006 DOID:9286
Hearing loss contraindication 15188001
Myocardial infarction contraindication 22298006 DOID:5844
Fibrosis of corpus cavernosum contraindication 32608004
Dehydration contraindication 34095006
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Aortic valve stenosis contraindication 60573004 DOID:1712
Pulmonary veno-occlusive disease contraindication 89420002 DOID:5453
Leukemia, disease contraindication 93143009 DOID:1240
Multiple myeloma contraindication 109989006 DOID:9538
Hb SS disease contraindication 127040003 DOID:10923
Cerebrovascular accident contraindication 230690007
Penis bent contraindication 249247007
Esophageal dysmotility contraindication 266434009 DOID:9192
Idiopathic hypertrophic subaortic stenosis contraindication 360465008
Acute coronary syndrome contraindication 394659003
Anterior ischemic optic neuropathy contraindication 404659001
Hypertensive urgency contraindication 443482000
Pigmentary Retinopathy contraindication
Severe Autonomic Insufficiency contraindication
Hereditary Degeneration of Retina contraindication
Life-Threatening Cardiac Arrhythmias contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.35 acidic
pKa2 7.72 Basic
pKa3 3.61 Basic
pKa4 2.92 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE/ML LIQREV CMP DEV LLC N214952 April 28, 2023 DISCN SUSPENSION ORAL 11337979 Dec. 24, 2038 LIQREV IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING
EQ 10MG BASE/ML LIQREV CMP DEV LLC N214952 April 28, 2023 DISCN SUSPENSION ORAL 11464778 Dec. 24, 2038 LIQREV IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING
EQ 10MG BASE/ML LIQREV CMP DEV LLC N214952 April 28, 2023 DISCN SUSPENSION ORAL 11759468 Dec. 24, 2038 LIQREV IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING
EQ 10MG BASE/ML LIQREV CMP DEV LLC N214952 April 28, 2023 DISCN SUSPENSION ORAL 12005062 Dec. 24, 2038 LIQREV IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING
EQ 10MG BASE/ML LIQREV CMP DEV LLC N214952 April 28, 2023 DISCN SUSPENSION ORAL 12186321 Dec. 24, 2038 LIQREV IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 20MG BASE REVATIO VIATRIS N021845 June 3, 2005 RX TABLET ORAL Jan. 31, 2026 LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) REVATIO VIATRIS N022473 Nov. 18, 2009 RX SOLUTION INTRAVENOUS Jan. 31, 2026 LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)
EQ 10MG BASE/ML REVATIO VIATRIS N203109 Aug. 30, 2012 DISCN FOR SUSPENSION ORAL Jan. 31, 2026 LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)
EQ 100MG BASE VYBRIQUE IBSA N210858 Dec. 16, 2025 RX FILM ORAL Dec. 16, 2028 NEW PRODUCT
EQ 25MG BASE VYBRIQUE IBSA N210858 Dec. 16, 2025 RX FILM ORAL Dec. 16, 2028 NEW PRODUCT
EQ 50MG BASE VYBRIQUE IBSA N210858 Dec. 16, 2025 RX FILM ORAL Dec. 16, 2028 NEW PRODUCT
EQ 75MG BASE VYBRIQUE IBSA N210858 Dec. 16, 2025 RX FILM ORAL Dec. 16, 2028 NEW PRODUCT
EQ 20MG BASE REVATIO VIATRIS N021845 June 3, 2005 RX TABLET ORAL Jan. 31, 2030 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP I) IN PEDIATRIC PATIENTS 1 TO 17 YEARS OLD TO IMPROVE EXERCISE ABILITY AND, IN PEDIATRIC PATIENTS TOO YOUNG TO PERFORM STANDARDIZED EXERCISE TESTING, PULMONARY HEMODYNAMICS THOUGHT TO UNDERLY IMPROVEMENTS IN EXERCISE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme INHIBITOR IC50 9 IUPHAR CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.48 CHEMBL
Adenosine receptor A1 GPCR Ki 6.06 DRUG MATRIX
Multidrug resistance-associated protein 5 Transporter Ki 5.92 CHEMBL
Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha Enzyme WOMBAT-PK
Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A Enzyme IC50 5.64 CHEMBL
cAMP and cAMP-inhibited cGMP 3',5'-cyclic phosphodiesterase 10A Enzyme IC50 5.51 CHEMBL
cAMP-specific 3',5'-cyclic phosphodiesterase 4D Enzyme IC50 4.70 CHEMBL
cGMP-dependent 3',5'-cyclic phosphodiesterase Enzyme IC50 4.20 CHEMBL
High affinity cAMP-specific 3',5'-cyclic phosphodiesterase 7A Enzyme IC50 5.33 CHEMBL
Cone cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha' Enzyme IC50 7.41 CHEMBL
High affinity cGMP-specific 3',5'-cyclic phosphodiesterase 9A Enzyme IC50 5.47 CHEMBL
High affinity cAMP-specific and IBMX-insensitive 3',5'-cyclic phosphodiesterase 8A Enzyme IC50 4 CHEMBL
Phosphodiesterase 3 Enzyme IC50 5.15 CHEMBL
Phosphodiesterase 4 Enzyme IC50 5.11 CHEMBL
Phosphodiesterase 1 Enzyme IC50 6.57 CHEMBL
Solute carrier organic anion transporter family member 1B3 Transporter INHIBITOR IC50 6.10 IUPHAR
Adenosine receptor A2a GPCR Ki 6.70 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 6.09 DRUG MATRIX
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme Ki 8.74 CHEMBL
Uncharacterized protein Enzyme IC50 5.04 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme IC50 8.22 CHEMBL
Cone cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha' Enzyme IC50 7.48 CHEMBL
Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha Enzyme IC50 6.85 CHEMBL
Indoleamine 2,3-dioxygenase 2 Enzyme IC50 5.35 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme IC50 9 CHEMBL
Phosphodiesterase 4 Enzyme IC50 5.34 CHEMBL
Phosphodiesterase 1 Enzyme IC50 6.40 CHEMBL
Phosphodiesterase 6 Enzyme IC50 7.70 CHEMBL
Phosphodiesterase 1 Enzyme IC50 6.59 CHEMBL
Phosphodiesterase 2A Enzyme IC50 4.37 CHEMBL

External reference:

IDSource
4024110 VUID
N0000022115 NUI
D02229 KEGG_DRUG
171599-83-0 SECONDARY_CAS_RN
4021093 VANDF
4024110 VANDF
C1318700 UMLSCUI
CHEBI:9139 CHEBI
VIA PDB_CHEM_ID
CHEMBL192 ChEMBL_ID
CHEMBL1737 ChEMBL_ID
D000068677 MESH_DESCRIPTOR_UI
DB00203 DRUGBANK_ID
4743 IUPHAR_LIGAND_ID
7374 INN_ID
3M7OB98Y7H UNII
135398744 PUBCHEM_CID
136411 RXNORM
147641 MMSL
194438 MMSL
26866 MMSL
29679 MMSL
5460 MMSL
69683 MMSL
d04299 MMSL
007448 NDDF
007449 NDDF
108482004 SNOMEDCT_US
109123009 SNOMEDCT_US
372572000 SNOMEDCT_US
3M7OB98Y7H INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Revatio HUMAN PRESCRIPTION DRUG LABEL 1 0069-0336 POWDER, FOR SUSPENSION 10 mg ORAL NDA 31 sections
Revatio HUMAN PRESCRIPTION DRUG LABEL 1 0069-0338 INJECTION, SOLUTION 0.80 mg INTRAVENOUS NDA 31 sections
Revatio HUMAN PRESCRIPTION DRUG LABEL 1 0069-4190 TABLET, FILM COATED 20 mg ORAL NDA 31 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 0069-4200 TABLET, FILM COATED 25 mg ORAL NDA 28 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 0069-4210 TABLET, FILM COATED 50 mg ORAL NDA 28 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 0069-4220 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5341 TABLET, FILM COATED 25 mg ORAL ANDA 25 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5342 TABLET, FILM COATED 50 mg ORAL ANDA 25 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5343 TABLET, FILM COATED 100 mg ORAL ANDA 25 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0591-4050 POWDER, FOR SUSPENSION 10 mg ORAL ANDA 26 sections
SILDENAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0904-6671 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 13668-185 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-186 TABLET, FILM COATED 25 mg ORAL ANDA 19 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-187 TABLET, FILM COATED 50 mg ORAL ANDA 19 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-188 TABLET, FILM COATED 100 mg ORAL ANDA 19 sections
Sildenafil Human Prescription Drug Label 1 17224-460 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Sildenafil Citrate HUMAN PRESCRIPTION DRUG LABEL 1 17856-8100 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 21695-157 TABLET, FILM COATED 50 mg ORAL NDA 14 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 21695-158 TABLET, FILM COATED 100 mg ORAL NDA 14 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-067 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-067 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-068 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-068 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-069 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-069 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Sildenafil Human Prescription Drug Label 1 27241-124 TABLET 20 mg ORAL ANDA 27 sections
Sildenafil Human Prescription Drug Label 1 27241-124 TABLET 20 mg ORAL ANDA 27 sections
Sildenafil Human Prescription Drug Label 1 27241-175 POWDER, FOR SUSPENSION 10 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 31722-136 FOR SUSPENSION 10 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 31722-709 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections