tadalafil 🐶 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 2553 171596-29-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zalutia
  • tadalafil
  • tardenafil
  • tildenafil
  • cialis
  • IC351
A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION.
  • Molecular weight: 389.41
  • Formula: C22H19N3O4
  • CLOGP: 2.58
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 74.87
  • ALOGS: -3.19
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.73 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.720 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 6.152 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 49.545 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 5.728 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 6.440 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 19.350 % High 1
herg hERG pIC50 4.718 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 5.662 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 27.925 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 8.790 % High 1
kinase-safety-class ACVR2B,EIF2AK3,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4 8
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 22.284 High 1
mh-clint Mouse hepatocyte intrinsic clearance 36.475 High 1
mppb Mouse plasma protein binding (% unbound) 8.130 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 111.944 High 1
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) 14.230 % High 1
rh-clint Rat hepatocyte intrinsic clearance 37.154 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 46.440 % High 1
rppb Rat plasma protein binding (% unbound) 7.200 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 62.087 uM High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 21, 2003 FDA LILLY

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
Dyspnoea 2382.45 15.35 4043 108231 876912 89639261
Pain in jaw 2075.10 15.35 1066 111208 46919 90469254
Pulmonary arterial hypertension 1994.15 15.35 860 111414 25327 90490846
Fluid retention 1611.02 15.35 1124 111150 86967 90429206
Headache 1518.59 15.35 3306 108968 859440 89656733
Dyspnoea exertional 1273.93 15.35 902 111372 71386 90444787
Right ventricular failure 1155.37 15.35 535 111739 18670 90497503
Death 1080.55 15.35 1984 110290 454567 90061606
Pulmonary hypertension 1075.51 15.35 665 111609 41858 90474315
Hypervolaemia 993.88 15.35 576 111698 32181 90483992
Flushing 990.71 15.35 844 111430 87647 90428526
Drug ineffective 858.05 15.35 325 111949 1383973 89132200
Hospitalisation 814.32 15.35 895 111379 127205 90388968
Diarrhoea 753.08 15.35 2707 109567 936483 89579690
Infusion site pain 649.34 15.35 366 111908 19372 90496801
Nasal congestion 631.65 15.35 640 111634 82774 90433399
Oxygen saturation decreased 631.56 15.35 721 111553 106762 90409411
Catheter site erythema 605.28 15.35 228 112046 4666 90511507
Device related infection 532.29 15.35 355 111919 25431 90490742
Transfusion 520.99 15.35 304 111970 17184 90498989
Cardiac failure 491.24 15.35 641 111633 108855 90407318
Catheter management 481.77 15.35 170 112104 2866 90513307
Catheter site pain 480.10 15.35 200 112074 5379 90510794
Vascular device infection 477.32 15.35 252 112022 11700 90504473
Syncope 468.41 15.35 692 111582 131971 90384202
Infusion related reaction 449.37 15.35 15 112259 416765 90099408
Catheter site pruritus 427.62 15.35 145 112129 2157 90514016
Catheter site discharge 382.67 15.35 135 112139 2274 90513899
Alopecia 379.91 15.35 76 112198 494995 90021178
Palpitations 365.24 15.35 628 111646 136100 90380073
Lung transplant 364.30 15.35 146 112128 3546 90512627
Glossodynia 360.05 15.35 8 112266 321771 90194402
Arthropathy 359.99 15.35 24 112250 366218 90149955
Therapy change 350.95 15.35 182 112092 8140 90508033
Cough 339.21 15.35 1116 111158 367846 90148327
Hypotension 337.34 15.35 1026 111248 324371 90191802
Oxygen consumption increased 333.66 15.35 146 112128 4443 90511730
Infusion site erythema 333.31 15.35 209 112065 13461 90502712
Unevaluable event 320.34 15.35 367 111907 54481 90461692
Catheterisation cardiac 316.55 15.35 144 112130 4812 90511361
Pneumonia 315.26 15.35 1591 110683 636468 89879705
Dizziness 311.45 15.35 1498 110776 587786 89928387
Infusion site infection 311.16 15.35 119 112155 2541 90513632
Nausea 308.89 15.35 2387 109887 1107929 89408244
Therapeutic product effect decreased 302.58 15.35 9 112265 277562 90238611
Contraindicated product administered 300.37 15.35 26 112248 320113 90196060
Chest pain 298.30 15.35 972 111302 318673 90197500
Pulmonary arterial pressure increased 295.84 15.35 128 112146 3788 90512385
Oedema peripheral 292.67 15.35 840 111434 257075 90259098
Hypoxia 291.16 15.35 402 111872 71997 90444176
Rheumatoid arthritis 290.16 15.35 50 112224 362564 90153609
Catheter placement 284.83 15.35 110 112164 2414 90513759
Treatment failure 284.27 15.35 25 112249 303903 90212270
Off label use 280.58 15.35 593 111681 1101659 89414514
Catheter site infection 280.42 15.35 138 112136 5516 90510657
Hepatic enzyme increased 275.27 15.35 56 112218 360680 90155493
Myalgia 266.85 15.35 637 111637 174488 90341685
Dermatitis contact 265.77 15.35 181 112093 13414 90502759
Pulmonary oedema 263.70 15.35 354 111920 61726 90454447
Pericarditis 261.61 15.35 19 112255 270132 90246041
Device occlusion 257.17 15.35 154 112120 9128 90507045
Scleroderma 255.64 15.35 134 112140 6127 90510046
Epistaxis 255.32 15.35 412 111862 84713 90431460
Product use in unapproved indication 254.86 15.35 53 112221 336183 90179990
Therapy interrupted 250.90 15.35 310 111964 49798 90466375
Stomatitis 250.48 15.35 25 112249 274673 90241500
Maternal exposure during pregnancy 248.92 15.35 69 112205 359994 90156179
Helicobacter infection 244.89 15.35 8 112266 226842 90289331
Psoriatic arthropathy 243.18 15.35 9 112265 228326 90287847
Device leakage 239.18 15.35 151 112123 9840 90506333
Folliculitis 237.13 15.35 3 112271 204350 90311823
Device alarm issue 233.74 15.35 88 112186 1797 90514376
Drug hypersensitivity 233.35 15.35 143 112131 463466 90052707
Impaired healing 225.24 15.35 17 112257 234182 90281991
Type 2 diabetes mellitus 223.64 15.35 6 112268 203238 90312935
Wound 223.02 15.35 51 112223 302929 90213244
Blood cholesterol increased 222.19 15.35 8 112266 208004 90308169
Catheter site haemorrhage 213.72 15.35 100 112174 3568 90512605
Systemic lupus erythematosus 212.79 15.35 91 112183 361805 90154368
Catheter site rash 210.51 15.35 66 112208 754 90515419
Joint swelling 208.56 15.35 190 112084 503110 90013063
Central venous catheterisation 206.98 15.35 90 112184 2696 90513477
Hypersensitivity 203.89 15.35 159 112115 454518 90061655
Device dislocation 203.23 15.35 222 112052 31260 90484913
Muscle injury 203.18 15.35 3 112271 176651 90339522
Cardiac failure congestive 202.69 15.35 405 111869 98289 90417884
Pericardial effusion 202.56 15.35 239 112035 36594 90479579
Malaise 201.63 15.35 1328 110946 584658 89931515
Discomfort 198.29 15.35 48 112226 274287 90241886
Device infusion issue 194.53 15.35 85 112189 2577 90513596
Toxicity to various agents 193.66 15.35 58 112216 287788 90228385
Musculoskeletal stiffness 191.93 15.35 64 112210 296468 90219705
Irritable bowel syndrome 191.39 15.35 18 112256 207430 90308743
Infusion site swelling 189.59 15.35 139 112135 11581 90504592
Catheter site swelling 186.42 15.35 74 112200 1751 90514422
Rash 181.30 15.35 454 111820 795646 89720527
Oedema 181.13 15.35 603 111671 199692 90316481
Hypertension 181.01 15.35 180 112094 457352 90058821
Fibromyalgia 175.01 15.35 24 112250 206245 90309928
Neutropenia 173.37 15.35 34 112240 224870 90291303
Complication associated with device 172.80 15.35 163 112111 19286 90496887
Osteoarthritis 170.32 15.35 21 112253 195709 90320464
Injury 167.34 15.35 23 112251 197326 90318847
Product dose omission issue 167.10 15.35 760 111514 290927 90225246
Ascites 166.81 15.35 248 112026 47492 90468681
Liver injury 165.06 15.35 12 112262 170555 90345618
Mobility decreased 164.20 15.35 53 112221 250681 90265492
Feeling abnormal 163.39 15.35 517 111757 166718 90349455
Catheter site irritation 161.70 15.35 51 112223 595 90515578
Drug interaction 161.67 15.35 70 112204 276383 90239790
Transplant evaluation 160.26 15.35 61 112213 1285 90514888
Lower respiratory tract infection 158.89 15.35 56 112218 250603 90265570
Therapy cessation 158.45 15.35 210 112064 36151 90480022
Brain natriuretic peptide increased 157.00 15.35 96 112178 5909 90510264
Therapeutic product effect incomplete 156.60 15.35 26 112248 193870 90322303
Blister 156.53 15.35 60 112214 254938 90261235
C-reactive protein increased 151.77 15.35 22 112252 181367 90334806
Urticaria 151.01 15.35 101 112173 312633 90203540
Confusional state 148.08 15.35 156 112118 386049 90130124
Haemoptysis 147.60 15.35 194 112080 33126 90483047
Infusion site discharge 146.88 15.35 68 112206 2367 90513806
Drug intolerance 146.06 15.35 205 112069 447386 90068787
Concomitant disease aggravated 145.60 15.35 118 112156 11400 90504773
Intentional product use issue 145.31 15.35 44 112230 216848 90299325
Presyncope 145.28 15.35 188 112086 31617 90484556
Dyspnoea at rest 144.55 15.35 84 112190 4707 90511466
Respiratory failure 143.22 15.35 395 111879 118023 90398150
Joint range of motion decreased 138.91 15.35 7 112267 135636 90380537
Bursitis 137.39 15.35 6 112268 131648 90384525
Pain in extremity 135.77 15.35 989 111285 449540 90066633
Pulmonary veno-occlusive disease 131.87 15.35 55 112219 1483 90514690
Infusion site haemorrhage 130.07 15.35 82 112192 5329 90510844
Blood pressure decreased 128.91 15.35 286 111988 74609 90441564
Cardiac disorder 127.21 15.35 242 112032 56630 90459543
Pruritus 126.84 15.35 304 111970 541221 89974952
Heart rate increased 125.20 15.35 365 111909 112537 90403636
Ill-defined disorder 124.76 15.35 37 112237 184854 90331319
Catheter site vesicles 122.18 15.35 37 112237 373 90515800
Completed suicide 120.40 15.35 18 112256 145040 90371133
Disease complication 118.78 15.35 68 112206 3704 90512469
Catheter site inflammation 116.21 15.35 44 112230 913 90515260
Device connection issue 114.50 15.35 44 112230 952 90515221
Psoriasis 112.45 15.35 23 112251 147731 90368442
Pulmonary hypertensive crisis 108.45 15.35 35 112239 442 90515731
Malignant neoplasm progression 107.90 15.35 6 112268 106864 90409309
Hypoaesthesia 107.40 15.35 139 112135 314071 90202102
Lip dry 107.36 15.35 4 112270 100951 90415222
Hypercholesterolaemia 107.29 15.35 4 112270 100888 90415285
Chest discomfort 106.39 15.35 395 111879 137970 90378203
Abdominal distension 105.62 15.35 379 111895 130222 90385951
Prescribed overdose 103.37 15.35 4 112270 97621 90418552
Device related sepsis 101.32 15.35 67 112207 4726 90511447
Obesity 100.43 15.35 8 112266 105499 90410674
Asthma 99.45 15.35 92 112182 242068 90274105
General physical health deterioration 99.37 15.35 180 112094 354935 90161238
Inflammation 98.51 15.35 49 112225 178543 90337630
Grip strength decreased 97.32 15.35 4 112270 92572 90423601
Liver transplant 95.76 15.35 50 112224 2267 90513906
Acute respiratory failure 95.20 15.35 182 112092 42736 90473437
Product use issue 93.41 15.35 166 112108 329753 90186420
Exposure during pregnancy 91.64 15.35 96 112178 238314 90277859
Paracentesis 90.10 15.35 37 112237 958 90515215
Depression 89.92 15.35 146 112128 300455 90215718
Anaemia 89.80 15.35 745 111529 352057 90164116
Cardiac pacemaker insertion 89.29 15.35 60 112214 4347 90511826
Cardiac failure high output 89.23 15.35 30 112244 434 90515739
Red blood cell sedimentation rate increased 88.78 15.35 3 112271 82592 90433581
Haemoglobin increased 86.95 15.35 73 112201 7408 90508765
Atrial flutter 85.84 15.35 85 112189 10673 90505500
Walking distance test abnormal 85.75 15.35 31 112243 562 90515611
Systemic scleroderma 79.44 15.35 39 112235 1550 90514623
Injection site infection 78.72 15.35 44 112230 2288 90513885
Dialysis 78.57 15.35 83 112191 11246 90504927
Delirium 77.85 15.35 17 112257 104342 90411831
Paraesthesia 74.46 15.35 122 112152 250204 90265969
Productive cough 74.05 15.35 237 112037 76826 90439347
Atrial fibrillation 73.31 15.35 344 111930 133267 90382906
Wound infection 72.30 15.35 21 112253 106381 90409792
Gastrointestinal haemorrhage 72.17 15.35 261 112013 89987 90426186
Infusion site abscess 71.14 15.35 24 112250 351 90515822
Epilepsy 71.04 15.35 9 112265 82197 90433976
Contusion 70.54 15.35 127 112147 251089 90265084
Loss of consciousness 70.43 15.35 352 111922 139886 90376287
Infusion site induration 68.34 15.35 35 112239 1524 90514649
Right ventricular dilatation 68.33 15.35 36 112238 1663 90514510
Anaphylactic reaction 67.89 15.35 13 112261 87511 90428662
Injection site discharge 67.76 15.35 34 112240 1417 90514756
Thrombosis in device 67.47 15.35 44 112230 3031 90513142
Seasonal allergy 67.17 15.35 110 112164 22873 90493300
Pleural effusion 67.15 15.35 296 111978 111695 90404478
Oxygen therapy 67.12 15.35 44 112230 3058 90513115
Night sweats 67.07 15.35 38 112236 128728 90387445
Gait inability 67.07 15.35 50 112224 146406 90369767
Peripheral venous disease 66.09 15.35 12 112262 83909 90432264
Infusion site warmth 65.21 15.35 38 112236 2140 90514033
Faeces soft 64.91 15.35 62 112212 7449 90508724
Thrombocytopenia 63.69 15.35 100 112174 208625 90307548
Cardiac ablation 62.61 15.35 34 112240 1670 90514503
Infusion site pruritus 62.59 15.35 58 112216 6707 90509466
White blood cell count decreased 62.30 15.35 69 112205 167040 90349133
Dizziness postural 62.21 15.35 66 112208 8987 90507186
Osteoporosis 62.10 15.35 21 112253 96510 90419663
Sciatica 61.92 15.35 24 112250 101358 90414815
Catheter site warmth 61.41 15.35 19 112255 207 90515966
Suicide attempt 61.09 15.35 10 112264 75389 90440784
Wheezing 61.06 15.35 127 112147 237953 90278220
Drug abuse 60.24 15.35 14 112260 82333 90433840
Haemorrhage 60.10 15.35 206 112068 69163 90447010
Overdose 60.03 15.35 64 112210 157645 90358528
Cardiac operation 59.76 15.35 45 112229 3904 90512269
Leukopenia 59.62 15.35 25 112249 100685 90415488
Product quality issue 59.01 15.35 13 112261 79312 90436861
Vomiting 58.58 15.35 1332 110942 786961 89729212
Weight decreased 58.32 15.35 723 111551 379187 90136986
Foot deformity 58.25 15.35 4 112270 59647 90456526
Infusion site irritation 58.22 15.35 30 112244 1323 90514850
Exercise tolerance decreased 57.19 15.35 58 112216 7493 90508680
Medication error 56.97 15.35 17 112257 84635 90431538
Internal haemorrhage 56.92 15.35 53 112221 6167 90510006
Disease progression 56.67 15.35 360 111914 156255 90359918
Arthralgia 56.45 15.35 655 111619 777867 89738306
Device breakage 56.44 15.35 78 112196 13966 90502207
Left ventricular failure 55.44 15.35 54 112220 6646 90509527
Atrial septal defect repair 55.16 15.35 18 112256 236 90515937
Stent placement 55.12 15.35 44 112230 4159 90512014
Sleep disorder 54.79 15.35 101 112173 197929 90318244
Blood potassium decreased 54.52 15.35 156 112118 47571 90468602
Cognitive disorder 54.49 15.35 10 112264 69397 90446776
Device issue 54.46 15.35 116 112158 29421 90486752
Head discomfort 54.40 15.35 83 112191 16250 90499923
Injection site reaction 54.28 15.35 23 112251 92057 90424116
Drug-induced liver injury 54.14 15.35 22 112252 90296 90425877
Renal disorder 53.61 15.35 134 112140 37725 90478448
Intentional product misuse 53.43 15.35 22 112252 89582 90426591
Pulmonary arterial pressure abnormal 52.92 15.35 22 112252 588 90515585
Catheter site related reaction 52.46 15.35 26 112248 1055 90515118
Treatment noncompliance 52.37 15.35 162 112112 51565 90464608
Influenza 52.18 15.35 323 111951 138941 90377232
Acute kidney injury 52.11 15.35 212 112062 320175 90195998
Hepatitis 51.80 15.35 12 112262 70727 90445446
Electrocardiogram QT prolonged 51.67 15.35 13 112261 72443 90443730
Throat irritation 51.64 15.35 155 112119 48540 90467633
Mineral supplementation 51.45 15.35 23 112251 737 90515436
Rhabdomyolysis 51.36 15.35 3 112271 51253 90464920
Catheter removal 51.06 15.35 19 112255 375 90515798
Aspiration pleural cavity 50.38 15.35 24 112250 892 90515281
Intentional overdose 49.86 15.35 27 112247 93807 90422366
Haemoglobin decreased 49.46 15.35 357 111917 161599 90354574
Blood pressure systolic increased 48.96 15.35 7 112267 58338 90457835
Autoimmune disorder 48.84 15.35 17 112257 76727 90439446
Joint stiffness 48.45 15.35 18 112256 78024 90438149
Emergency care 48.31 15.35 28 112246 1561 90514612
Blood pressure increased 48.24 15.35 108 112166 197109 90319064
Live birth 47.86 15.35 19 112255 79088 90437085
Suicidal ideation 47.62 15.35 16 112258 73839 90442334
Pulmonary congestion 47.59 15.35 86 112188 19347 90496826
Device physical property issue 47.34 15.35 34 112240 2742 90513431
Dry mouth 47.34 15.35 98 112176 183961 90332212
Metapneumovirus infection 47.29 15.35 26 112248 1309 90514864
Viral infection 45.98 15.35 134 112140 41280 90474893
Blood iron decreased 45.93 15.35 81 112193 17878 90498295
Hot flush 45.83 15.35 170 112104 59318 90456855
Arthritis 45.69 15.35 86 112188 167229 90348944
Dizziness exertional 45.53 15.35 19 112255 513 90515660
Nocturnal dyspnoea 45.45 15.35 26 112248 1414 90514759
N-terminal prohormone brain natriuretic peptide increased 45.37 15.35 34 112240 2928 90513245
Device malfunction 45.34 15.35 88 112186 20889 90495284
Inappropriate schedule of product administration 44.63 15.35 73 112201 149860 90366313
Respiration abnormal 44.31 15.35 52 112222 7911 90508262
Catheterisation cardiac abnormal 44.26 15.35 16 112258 290 90515883
Orthopnoea 43.75 15.35 48 112226 6787 90509386
Hospice care 43.74 15.35 57 112217 9647 90506526
Angioedema 43.71 15.35 13 112261 64863 90451310
Sleep disorder due to a general medical condition 43.69 15.35 3 112271 44735 90471438
Purulent discharge 43.67 15.35 43 112231 5362 90510811
Pulmonary arterial wedge pressure increased 43.19 15.35 17 112257 393 90515780
Right ventricular dysfunction 42.73 15.35 30 112244 2334 90513839
Catheter site erosion 42.52 15.35 11 112263 58 90516115
Multiple sclerosis relapse 42.24 15.35 7 112267 52298 90463875
Drug ineffective for unapproved indication 42.00 15.35 15 112259 66629 90449544
Infusion site inflammation 41.87 15.35 18 112256 524 90515649
Abdominal cavity drainage 41.30 15.35 17 112257 443 90515730
Cardioversion 41.28 15.35 24 112250 1346 90514827
Dysentery 40.90 15.35 22 112252 1060 90515113
Sinus congestion 40.88 15.35 99 112175 27325 90488848
Catheter site discolouration 40.65 15.35 12 112262 110 90516063
Neoplasm progression 40.63 15.35 4 112270 44482 90471691
Therapeutic response decreased 40.60 15.35 31 112243 89698 90426475
Echocardiogram abnormal 40.37 15.35 25 112249 1574 90514599
Rehabilitation therapy 40.29 15.35 27 112247 1947 90514226
Amnesia 40.21 15.35 45 112229 108460 90407713
Injection site bruising 40.08 15.35 8 112266 52299 90463874
Rash maculo-papular 39.24 15.35 3 112271 40930 90475243
Immunodeficiency 39.19 15.35 4 112270 43230 90472943
Colitis ulcerative 38.95 15.35 13 112261 60253 90455920
Catheter site scab 38.92 15.35 14 112260 250 90515923
Cardiac output increased 38.76 15.35 17 112257 520 90515653
Extra dose administered 38.70 15.35 52 112222 9066 90507107
Coeliac disease 38.26 15.35 5 112269 44605 90471568
Hepatotoxicity 37.32 15.35 6 112268 45836 90470337
Chemotherapy 37.32 15.35 25 112249 1802 90514371
Infusion site pustule 37.22 15.35 9 112265 34 90516139
Cor pulmonale 36.91 15.35 26 112248 2034 90514139
Hypoacusis 36.76 15.35 96 112178 27754 90488419
Application site pruritus 36.59 15.35 35 112239 4212 90511961
Oxygen saturation abnormal 36.30 15.35 35 112239 4253 90511920
Incorrect route of product administration 36.26 15.35 9 112265 50617 90465556
Pulmonary artery aneurysm 36.12 15.35 10 112264 71 90516102
Abortion spontaneous 36.11 15.35 11 112263 54045 90462128
Transplant 35.98 15.35 20 112254 1029 90515144
Medical device change 35.80 15.35 14 112260 318 90515855
Gastrointestinal disorder 35.65 15.35 180 112094 256507 90259666
Ear discomfort 35.63 15.35 53 112221 10147 90506026
Gastritis hypertrophic 35.52 15.35 9 112265 43 90516130
Drug titration error 35.51 15.35 21 112253 1216 90514957
Localised oedema 35.39 15.35 41 112233 6153 90510020
Concomitant disease progression 35.03 15.35 26 112248 2206 90513967
Decreased appetite 34.99 15.35 658 111616 375882 90140291
Iron deficiency anaemia 34.82 15.35 85 112189 23577 90492596
Peripheral swelling 34.39 15.35 710 111564 412396 90103777
Clostridium difficile infection 34.38 15.35 111 112163 36134 90480039
Foetal exposure during pregnancy 34.15 15.35 6 112268 42969 90473204
Cholecystectomy 34.00 15.35 56 112218 11699 90504474
Head injury 33.75 15.35 100 112174 31088 90485085
Loss of personal independence in daily activities 33.71 15.35 74 112200 136031 90380142
Telangiectasia 33.34 15.35 21 112253 1362 90514811
Sepsis 33.28 15.35 355 111919 179459 90336714
Skin exfoliation 32.64 15.35 22 112252 67891 90448282
Infection 32.63 15.35 289 111985 361805 90154368
Infusion site discolouration 32.61 15.35 19 112255 1070 90515103
Infusion site rash 32.57 15.35 26 112248 2457 90513716
Middle ear effusion 32.55 15.35 27 112247 2694 90513479
Onychomycosis 32.52 15.35 4 112270 37372 90478801
Vascular device occlusion 32.46 15.35 14 112260 411 90515762
Lymphocyte count decreased 32.41 15.35 3 112271 35047 90481126
Agranulocytosis 32.36 15.35 3 112271 34999 90481174
Gout 31.99 15.35 67 112207 16792 90499381
Neuropathy peripheral 31.88 15.35 77 112197 136893 90379280
Respiratory syncytial virus infection 31.77 15.35 51 112223 10429 90505744
Sinusitis 31.73 15.35 272 112002 342816 90173357
Coma 31.72 15.35 26 112248 72606 90443567
Infusion site cellulitis 31.64 15.35 13 112261 337 90515836
Upper respiratory tract congestion 31.56 15.35 25 112249 2337 90513836
Hypocalcaemia 31.39 15.35 7 112267 42361 90473812
Pulmonary fibrosis 31.37 15.35 53 112221 107450 90408723
Central venous catheter removal 31.02 15.35 14 112260 459 90515714
Ear congestion 30.86 15.35 29 112245 3413 90512760
Macular degeneration 30.84 15.35 5 112269 37965 90478208
Lactic acidosis 30.72 15.35 12 112262 50451 90465722
Disease recurrence 30.49 15.35 5 112269 37648 90478525
Cardiac flutter 30.44 15.35 33 112241 4605 90511568
Walking aid user 30.40 15.35 4 112270 35502 90480671
Right-to-left cardiac shunt 30.38 15.35 12 112262 280 90515893
Intracardiac pressure increased 30.19 15.35 8 112266 47 90516126
Seizure 30.13 15.35 93 112181 152536 90363637
No adverse event 30.11 15.35 24 112250 67958 90448215
Chronic obstructive pulmonary disease 30.04 15.35 175 112099 73654 90442519
Plasma cell myeloma 29.74 15.35 7 112267 40821 90475352
Gastroenteritis viral 29.74 15.35 94 112180 30261 90485912
Disability 29.66 15.35 7 112267 40738 90475435
Oropharyngeal pain 29.64 15.35 244 112030 114943 90401230
Mechanical ventilation 29.60 15.35 20 112254 1462 90514711
Intentional dose omission 29.56 15.35 67 112207 17716 90498457
Platelet transfusion 29.52 15.35 18 112256 1102 90515071
Condition aggravated 29.44 15.35 955 111319 594590 89921583
Cellulitis 29.42 15.35 204 112070 91133 90425040
Heart valve replacement 29.42 15.35 16 112258 788 90515385
Renal failure 29.27 15.35 269 112005 130738 90385435
Decreased activity 29.24 15.35 43 112231 8149 90508024
Bone marrow failure 29.16 15.35 3 112271 32218 90483955
Catheter site extravasation 29.01 15.35 13 112261 419 90515754
Product administration interrupted 28.97 15.35 54 112220 12438 90503735
Cardiomegaly 28.94 15.35 69 112205 18856 90497317
Device use error 28.86 15.35 40 112234 7181 90508992
Pulmonary vascular resistance abnormality 28.85 15.35 9 112265 101 90516072
Hyponatraemia 28.82 15.35 78 112196 133460 90382713
Acute right ventricular failure 28.75 15.35 11 112263 235 90515938
Pancytopenia 28.47 15.35 67 112207 120196 90395977
Depressed level of consciousness 28.29 15.35 29 112245 72755 90443418
Knee arthroplasty 28.17 15.35 37 112237 83145 90433028
Ventilation perfusion mismatch 28.02 15.35 14 112260 578 90515595
Right ventricular systolic pressure increased 27.96 15.35 14 112260 581 90515592
Bronchitis 27.86 15.35 301 111973 152626 90363547
CREST syndrome 27.47 15.35 14 112260 603 90515570
Back pain 27.33 15.35 548 111726 316627 90199546
Systolic dysfunction 27.28 15.35 21 112253 1883 90514290
Abdominal discomfort 27.09 15.35 422 111852 476906 90039267
Infusion site vesicles 26.99 15.35 14 112260 626 90515547
Right ventricular enlargement 26.90 15.35 13 112261 499 90515674
Localised infection 26.76 15.35 97 112177 33465 90482708
Hip fracture 26.72 15.35 96 112178 32981 90483192
Bradycardia 26.69 15.35 39 112235 83808 90432365
Primary biliary cholangitis 26.16 15.35 18 112256 1356 90514817
Catheter site dermatitis 26.04 15.35 8 112266 85 90516088
Oral herpes 25.95 15.35 5 112269 33519 90482654
Drug dependence 25.85 15.35 3 112271 29324 90486849
Agitation 25.78 15.35 27 112247 67071 90449102
Terminal state 25.76 15.35 24 112250 2794 90513379
Cardiac failure acute 25.73 15.35 50 112224 11879 90504294
Paranasal sinus discomfort 25.72 15.35 35 112239 6175 90509998
Pulmonary capillary haemangiomatosis 25.62 15.35 7 112267 47 90516126
Road traffic accident 25.45 15.35 60 112214 107566 90408607
Back injury 25.38 15.35 13 112261 46609 90469564
Therapy non-responder 25.34 15.35 270 112004 136434 90379739
Mouth ulceration 25.18 15.35 9 112265 39965 90476208
Pulmonary alveolar haemorrhage 25.14 15.35 34 112240 5964 90510209
Rhinorrhoea 24.86 15.35 191 112083 88125 90428048
Catheter site induration 24.78 15.35 7 112267 54 90516119
Faeces discoloured 24.65 15.35 70 112204 21250 90494923
Chills 24.61 15.35 261 112013 131720 90384453
Injection site pain 24.56 15.35 121 112153 173578 90342595
Pulmonary pain 24.56 15.35 31 112243 5083 90511090
Taste disorder 24.52 15.35 24 112250 61522 90454651
Blood creatine phosphokinase increased 24.46 15.35 6 112268 34017 90482156
Vascular cauterisation 24.44 15.35 7 112267 57 90516116
Pulmonary artery dilatation 24.33 15.35 11 112263 362 90515811
Blood glucose increased 24.24 15.35 51 112223 95195 90420978
Deep vein thrombosis 24.21 15.35 48 112226 91572 90424601
Surgery 24.18 15.35 115 112159 44772 90471401
Heart and lung transplant 23.97 15.35 8 112266 113 90516060
Paraesthesia oral 23.93 15.35 5 112269 31654 90484519
Application site hypersensitivity 23.86 15.35 10 112264 273 90515900
Lower limb fracture 23.82 15.35 43 112231 84970 90431203
Colitis 23.80 15.35 31 112243 69911 90446262
Hallucination 23.74 15.35 28 112246 65931 90450242
Pericardial drainage 23.62 15.35 10 112264 280 90515893
Joint dislocation 23.43 15.35 13 112261 44569 90471604
Cardiac output decreased 23.38 15.35 15 112259 1005 90515168
Swelling 23.26 15.35 372 111902 418686 90097487
Medical procedure 23.19 15.35 12 112262 534 90515639
Hepatocellular injury 23.10 15.35 4 112270 28954 90487219
Bendopnoea 22.90 15.35 7 112267 73 90516100
Accidental exposure to product 22.79 15.35 12 112262 42354 90473819
First bite syndrome 22.67 15.35 5 112269 11 90516162
Diet noncompliance 22.60 15.35 11 112263 429 90515744
Dehydration 22.46 15.35 352 111922 194095 90322078
Gastric varices 22.44 15.35 9 112265 219 90515954
Systemic sclerosis pulmonary 22.40 15.35 6 112268 37 90516136
Ejection fraction decreased 22.38 15.35 3 112271 26250 90489923
Flatulence 22.30 15.35 106 112168 41261 90474912
Hepatic steatosis 22.14 15.35 9 112265 36936 90479237
Gastric haemorrhage 22.13 15.35 35 112239 7068 90509105
Respiratory distress 21.88 15.35 101 112173 38845 90477328
Altered state of consciousness 21.83 15.35 6 112268 31526 90484647
Muscular weakness 21.81 15.35 158 112116 206508 90309665
Feeling cold 21.58 15.35 79 112195 27386 90488787
Infusion site oedema 21.38 15.35 15 112259 1166 90515007
Sinus disorder 21.36 15.35 92 112182 34355 90481818
Hypercalcaemia 21.08 15.35 8 112266 34232 90481941
Pregnancy test positive 21.04 15.35 8 112266 168 90516005
N-terminal prohormone brain natriuretic peptide 20.94 15.35 6 112268 49 90516124
Ureteral disorder 20.86 15.35 10 112264 377 90515796
Catheter culture positive 20.78 15.35 8 112266 174 90515999
Memory impairment 20.71 15.35 151 112123 197093 90319080
Swollen tongue 20.63 15.35 16 112258 45940 90470233
Polypectomy 20.57 15.35 14 112260 1036 90515137
Cytomegalovirus infection 20.52 15.35 4 112270 26598 90489575
Endotracheal intubation 20.46 15.35 23 112251 3341 90512832
Infusion site nodule 20.41 15.35 17 112257 1706 90514467
Pneumonitis 20.31 15.35 15 112259 44155 90472018
Pulmonary haemorrhage 20.31 15.35 36 112238 7977 90508196
Liver function test increased 20.30 15.35 47 112227 84808 90431365
Emotional distress 20.29 15.35 10 112264 36652 90479521
Hyperglycaemia 20.16 15.35 20 112254 50950 90465223
Skin irritation 20.16 15.35 49 112225 13554 90502619
Infusion site dermatitis 20.07 15.35 5 112269 22 90516151
Tracheostomy 19.98 15.35 12 112262 715 90515458
Catheter site mass 19.89 15.35 5 112269 23 90516150
Sclerema 19.89 15.35 5 112269 23 90516150
Arteriovenous malformation 19.80 15.35 16 112258 1539 90514634
Psychotic disorder 19.73 15.35 7 112267 31223 90484950
Scleroderma associated digital ulcer 19.72 15.35 5 112269 24 90516149
Portopulmonary hypertension 19.62 15.35 7 112267 122 90516051
Eczema 19.51 15.35 22 112252 52848 90463325
Cor pulmonale acute 19.49 15.35 10 112264 437 90515736
Wrong technique in product usage process 19.34 15.35 37 112237 71534 90444639
Metastases to bone 19.33 15.35 4 112270 25501 90490672
Cardiac resynchronisation therapy 19.23 15.35 5 112269 27 90516146
Heart transplant 19.16 15.35 11 112263 602 90515571
Adverse drug reaction 19.09 15.35 77 112197 116624 90399549
Drug tolerance decreased 18.97 15.35 8 112266 32122 90484051
Blood carbon monoxide increased 18.74 15.35 4 112270 7 90516166
Prophylaxis 18.74 15.35 4 112270 7 90516166
Portal hypertension 18.73 15.35 26 112248 4675 90511498
Eosinophilia 18.71 15.35 6 112268 28527 90487646
Blood culture positive 18.65 15.35 27 112247 5045 90511128
Basal cell carcinoma 18.64 15.35 9 112265 33380 90482793
Lymphopenia 18.61 15.35 3 112271 22878 90493295
Catheter site urticaria 18.51 15.35 5 112269 32 90516141
Cholestasis 18.49 15.35 11 112263 36288 90479885
Brain operation 18.43 15.35 11 112263 648 90515525
Vasculitis 18.40 15.35 3 112271 22690 90493483
Infusion site hypersensitivity 18.37 15.35 5 112269 33 90516140
Wrong dose 18.34 15.35 17 112257 1967 90514206
Drug titration 18.25 15.35 5 112269 34 90516139
Senile dementia 18.20 15.35 8 112266 246 90515927
Mitral valve replacement 18.16 15.35 10 112264 505 90515668
Skin lesion 18.09 15.35 12 112262 37353 90478820
Female sterilisation 18.06 15.35 11 112263 672 90515501
Posterior reversible encephalopathy syndrome 18.01 15.35 3 112271 22336 90493837
Muscle twitching 17.93 15.35 4 112270 24198 90491975
Microstomia 17.88 15.35 5 112269 37 90516136
Stevens-Johnson syndrome 17.86 15.35 7 112267 29369 90486804
Hepatic cytolysis 17.78 15.35 8 112266 30908 90485265
Obstructive airways disorder 17.76 15.35 5 112269 25864 90490309
Injection site mass 17.74 15.35 3 112271 22087 90494086
Body temperature decreased 17.51 15.35 4 112270 23812 90492361
Injection site erosion 17.46 15.35 6 112268 93 90516080
Kidney infection 17.46 15.35 71 112203 25845 90490328
Product administered to patient of inappropriate age 17.45 15.35 25 112249 4628 90511545
Puncture site pain 17.41 15.35 6 112268 94 90516079
Staphylococcal infection 17.29 15.35 111 112163 48328 90467845
Bedridden 17.20 15.35 43 112231 12105 90504068
Hyperkalaemia 17.19 15.35 34 112240 64930 90451243
Cardiac fibroma 17.08 15.35 3 112271 0 90516173
Oropharyngeal surgery 17.08 15.35 3 112271 0 90516173
Catheter site exfoliation 17.08 15.35 3 112271 0 90516173
Normal newborn 17.03 15.35 4 112270 23358 90492815
Oxygen consumption 16.95 15.35 6 112268 102 90516071
Disturbance in attention 16.95 15.35 20 112254 47089 90469084
Gallbladder operation 16.94 15.35 19 112255 2752 90513421
Gastric disorder 16.89 15.35 84 112190 33300 90482873
Colon cancer 16.84 15.35 40 112234 10904 90505269
Aggression 16.81 15.35 6 112268 26662 90489511
Sluggishness 16.71 15.35 28 112246 5931 90510242
Nasal dryness 16.69 15.35 27 112247 5556 90510617
Osteopenia 16.65 15.35 4 112270 22998 90493175
Bacteraemia 16.57 15.35 63 112211 22237 90493936
Hypomagnesaemia 16.48 15.35 12 112262 35576 90480597
Osteonecrosis 16.37 15.35 6 112268 26235 90489938
Vasodilatation 16.33 15.35 19 112255 2865 90513308
Diabetes mellitus 16.28 15.35 35 112239 64840 90451333
Haemorrhoidal haemorrhage 16.27 15.35 26 112248 5297 90510876
Blood viscosity decreased 16.20 15.35 5 112269 54 90516119
Acute hepatic failure 16.18 15.35 4 112270 22557 90493616
Incarcerated umbilical hernia 16.17 15.35 4 112270 17 90516156
Ammonia increased 16.13 15.35 25 112249 4961 90511212
Dyskinesia 16.05 15.35 13 112261 36521 90479652
Pregnancy 15.97 15.35 33 112241 62014 90454159
Suture related complication 15.95 15.35 8 112266 333 90515840
Asthenia 15.91 15.35 811 111463 532940 89983233
Gait disturbance 15.89 15.35 227 112047 260269 90255904
Catheter site cellulitis 15.86 15.35 8 112266 337 90515836
Multiple allergies 15.85 15.35 48 112226 15098 90501075
Blood pressure abnormal 15.85 15.35 57 112217 19588 90496585
Ischaemic stroke 15.76 15.35 4 112270 22162 90494011
Metastases to liver 15.73 15.35 8 112266 28799 90487374
Catheter site nodule 15.72 15.35 5 112269 60 90516113
Mastectomy 15.67 15.35 16 112258 2083 90514090
Uterine haemorrhage 15.62 15.35 24 112250 4728 90511445
Dry eye 15.61 15.35 30 112244 57901 90458272
Palliative care 15.43 15.35 11 112263 877 90515296

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
Headache 694.21 12.32 1250 61314 238119 42320652
Pulmonary arterial hypertension 561.75 12.32 282 62282 9905 42548866
Dyspnoea 498.08 12.32 1599 60965 441022 42117749
Fluid retention 493.91 12.32 393 62171 31226 42527545
Pain in jaw 491.89 12.32 291 62273 14211 42544560
Right ventricular failure 402.72 12.32 221 62343 9334 42549437
Pulmonary hypertension 317.74 12.32 269 62295 23300 42535471
Dyspnoea exertional 316.44 12.32 379 62185 49769 42509002
Flushing 279.39 12.32 307 62257 36721 42522050
Hypervolaemia 210.55 12.32 212 62352 22913 42535858
Death 197.98 12.32 1273 61291 469912 42088859
Nasal congestion 189.33 12.32 225 62339 29276 42529495
Infusion site pain 182.18 12.32 108 62456 5287 42553484
Febrile neutropenia 168.28 12.32 34 62530 185669 42373102
Brain natriuretic peptide increased 166.88 12.32 111 62453 6659 42552112
Myalgia 159.60 12.32 401 62163 95679 42463092
Lung transplant 158.35 12.32 75 62489 2311 42556460
Vision blurred 150.27 12.32 277 62287 53422 42505349
Oedema 146.47 12.32 269 62295 51732 42507039
Catheterisation cardiac 141.32 12.32 73 62491 2721 42556050
Fractional exhaled nitric oxide increased 139.73 12.32 61 62503 1548 42557223
Hospitalisation 137.03 12.32 323 62241 74007 42484764
Optic ischaemic neuropathy 127.53 12.32 68 62496 2707 42556064
Back pain 121.55 12.32 470 62094 141306 42417465
Acute kidney injury 119.24 12.32 224 62340 367113 42191658
Oxygen saturation decreased 118.02 12.32 280 62284 64407 42494364
Cardiac disorder 113.22 12.32 233 62331 48699 42510072
Sensation of foreign body 108.27 12.32 67 62497 3546 42555225
Diarrhoea 105.42 12.32 1085 61479 459764 42099007
Therapy interrupted 105.39 12.32 146 62418 22104 42536667
Plantar fasciitis 105.07 12.32 62 62502 3008 42555763
Catheter management 102.40 12.32 43 62521 989 42557782
Pain in extremity 102.30 12.32 465 62099 150139 42408632
Cyanopsia 100.74 12.32 29 62535 199 42558572
Transfusion 100.49 12.32 99 62465 10415 42548356
Neutropenia 98.11 12.32 89 62475 199342 42359429
Toxicity to various agents 97.25 12.32 116 62448 229020 42329751
Myoglobin blood increased 94.70 12.32 62 62502 3620 42555151
Syncope 92.98 12.32 339 62225 99067 42459704
Catheter site erythema 91.62 12.32 47 62517 1726 42557045
Infusion site infection 91.10 12.32 34 62530 566 42558205
Thrombocytopenia 89.97 12.32 88 62476 190191 42368580
Dizziness 86.62 12.32 644 61920 248610 42310161
Cough 84.15 12.32 497 62067 177606 42381165
Feeling abnormal 81.10 12.32 256 62308 69530 42489241
Therapy change 79.51 12.32 58 62506 4037 42554734
Malignant neoplasm progression 79.20 12.32 30 62534 108370 42450401
Concomitant disease aggravated 78.28 12.32 70 62494 6516 42552255
Device related infection 75.73 12.32 119 62445 20160 42538611
Visual impairment 73.65 12.32 182 62382 42931 42515840
Transplant evaluation 73.48 12.32 28 62536 495 42558276
Priapism 72.03 12.32 66 62498 6341 42552430
Nasopharyngitis 68.28 12.32 274 62290 83722 42475049
Pancytopenia 67.41 12.32 45 62519 117698 42441073
Leukopenia 66.97 12.32 14 62550 74732 42484039
Product use in unapproved indication 66.52 12.32 105 62459 184351 42374420
Oxygen consumption increased 66.12 12.32 37 62527 1622 42557149
Off label use 65.61 12.32 611 61953 637724 41921047
Infusion site erythema 65.16 12.32 49 62515 3573 42555198
Device occlusion 63.57 12.32 70 62494 8380 42550391
Erection increased 63.42 12.32 25 62539 486 42558285
Pulmonary arterial pressure increased 63.20 12.32 35 62529 1503 42557268
Peripheral swelling 62.92 12.32 281 62283 89989 42468782
Pulmonary veno-occlusive disease 61.67 12.32 26 62538 604 42558167
Device alarm issue 59.12 12.32 27 62537 764 42558007
Catheter site discharge 58.03 12.32 27 62537 798 42557973
Drug interaction 56.33 12.32 202 62362 266797 42291974
Faeces soft 56.00 12.32 51 62513 4861 42553910
Rhabdomyolysis 54.67 12.32 23 62541 77996 42480775
Catheter placement 54.54 12.32 27 62537 918 42557853
Catheter site pruritus 50.65 12.32 19 62545 321 42558450
Gastrooesophageal reflux disease 50.31 12.32 163 62401 44860 42513911
Exostosis 50.09 12.32 51 62513 5580 42553191
Surgery 49.39 12.32 91 62473 17525 42541246
Infusion related reaction 49.37 12.32 14 62550 60792 42497979
Erectile dysfunction 48.86 12.32 111 62453 24802 42533969
Secretion discharge 48.57 12.32 58 62506 7577 42551194
Muscle spasms 48.50 12.32 252 62312 85792 42472979
Septic shock 47.34 12.32 39 62525 91633 42467138
Catheter site pain 46.99 12.32 30 62534 1677 42557094
Mucosal inflammation 46.88 12.32 8 62556 49366 42509405
Chest discomfort 46.56 12.32 201 62363 63415 42495356
Milk-alkali syndrome 46.23 12.32 22 62542 685 42558086
Deafness unilateral 45.71 12.32 32 62532 2087 42556684
Therapy cessation 44.50 12.32 95 62469 20355 42538416
Drug reaction with eosinophilia and systemic symptoms 44.22 12.32 5 62559 42070 42516701
Dyspepsia 43.78 12.32 147 62417 41205 42517566
Hyponatraemia 43.36 12.32 51 62513 101411 42457360
Right ventricular dysfunction 41.89 12.32 26 62538 1383 42557388
Unevaluable event 41.86 12.32 128 62436 34160 42524611
Cardiac operation 41.41 12.32 38 62526 3657 42555114
Fatigue 40.58 12.32 879 61685 434762 42124009
Cardiac pacemaker insertion 39.55 12.32 35 62529 3213 42555558
Neutrophil count decreased 39.39 12.32 22 62542 63393 42495378
Multiple organ dysfunction syndrome 39.12 12.32 51 62513 96984 42461787
Depressed level of consciousness 39.02 12.32 11 62553 47959 42510812
Dermatitis contact 38.63 12.32 40 62524 4463 42554308
Palpitations 38.33 12.32 162 62402 50635 42508136
Lactic acidosis 37.53 12.32 10 62554 45251 42513520
Cytokine release syndrome 36.61 12.32 10 62554 44517 42514254
Vascular device infection 36.56 12.32 45 62519 6065 42552706
Suspected counterfeit product 36.25 12.32 15 62549 332 42558439
Obstructive airways disorder 34.60 12.32 97 62467 24662 42534109
Dysphonia 34.53 12.32 106 62458 28344 42530427
Malaise 33.84 12.32 467 62097 211689 42347082
Sepsis 33.79 12.32 164 62400 199170 42359601
Hyperkalaemia 33.77 12.32 41 62523 80417 42478354
Rash maculo-papular 33.63 12.32 7 62557 37496 42521275
Device dislocation 33.55 12.32 49 62515 7782 42550989
Pyrexia 33.42 12.32 394 62170 393648 42165123
Sinus congestion 33.34 12.32 46 62518 6934 42551837
Fracture of penis 33.22 12.32 14 62550 325 42558446
Haematospermia 33.18 12.32 14 62550 326 42558445
Pulmonary arterial pressure abnormal 33.18 12.32 14 62550 326 42558445
Hallucination 32.86 12.32 22 62542 57485 42501286
Liver transplant 32.77 12.32 29 62535 2662 42556109
Bone marrow failure 32.22 12.32 5 62559 33088 42525683
Haemoglobin increased 32.22 12.32 39 62525 5167 42553604
Metabolic acidosis 32.19 12.32 18 62546 51840 42506931
Catheter site haemorrhage 32.11 12.32 28 62536 2520 42556251
Suicide attempt 31.64 12.32 14 62550 46086 42512685
Cardiac failure 31.45 12.32 266 62298 106590 42452181
Seizure 31.20 12.32 83 62481 120478 42438293
Cytomegalovirus infection 31.19 12.32 5 62559 32301 42526470
Catheter site rash 30.94 12.32 12 62552 223 42558548
Heart and lung transplant 30.17 12.32 9 62555 71 42558700
General physical health deterioration 30.16 12.32 117 62447 151129 42407642
Right-to-left cardiac shunt 30.11 12.32 11 62553 172 42558599
Increased upper airway secretion 30.04 12.32 27 62537 2529 42556242
Walking distance test abnormal 29.87 12.32 11 62553 176 42558595
Oedema peripheral 29.73 12.32 318 62246 135758 42423013
Chest pain 29.53 12.32 324 62240 139206 42419565
Bradycardia 29.52 12.32 50 62514 85434 42473337
Confusional state 29.50 12.32 136 62428 167461 42391310
Complication associated with device 28.91 12.32 42 62522 6639 42552132
Hypoxia 28.65 12.32 188 62376 69598 42489173
Catheter removal 28.48 12.32 11 62553 202 42558569
Central venous catheterisation 28.37 12.32 22 62542 1679 42557092
Infusion site discharge 28.14 12.32 13 62551 378 42558393
Chromatopsia 28.03 12.32 12 62552 290 42558481
Visual acuity reduced 27.78 12.32 72 62492 17478 42541293
Stomatitis 27.77 12.32 20 62544 50309 42508462
Accommodation disorder 27.61 12.32 12 62552 301 42558470
Drug resistance 27.58 12.32 8 62556 34240 42524531
Foreign body in throat 26.61 12.32 14 62550 542 42558229
Generalised bullous fixed drug eruption 26.48 12.32 13 62551 434 42558337
Pneumocystis jirovecii pneumonia 26.44 12.32 3 62561 25178 42533593
Drug ineffective 26.25 12.32 715 61849 629482 41929289
Tubulointerstitial nephritis 26.10 12.32 7 62557 31541 42527230
Rheumatoid arthritis 25.96 12.32 15 62549 42425 42516346
Medical device change 25.41 12.32 9 62555 128 42558643
Retinal detachment 25.34 12.32 39 62525 6486 42552285
Pulmonary hypertensive crisis 25.20 12.32 10 62554 198 42558573
Blindness unilateral 24.97 12.32 35 62529 5353 42553418
Sedation 24.76 12.32 7 62557 30468 42528303
Pulmonary oedema 24.66 12.32 148 62416 53124 42505647
Injection site discharge 24.50 12.32 13 62551 512 42558259
Epistaxis 24.44 12.32 175 62389 66651 42492120
Macular degeneration 24.41 12.32 24 62540 2517 42556254
Injection site infection 24.28 12.32 17 62547 1109 42557662
Product administration interrupted 24.13 12.32 33 62531 4933 42553838
Catheter site infection 23.99 12.32 26 62538 3057 42555714
Premature baby 23.71 12.32 3 62561 23150 42535621
Ejaculation failure 23.70 12.32 15 62549 826 42557945
Oxygen therapy 23.61 12.32 18 62546 1340 42557431
Coronary artery disease 23.45 12.32 147 62417 53573 42505198
Visual brightness 23.34 12.32 6 62558 25 42558746
Treatment failure 23.16 12.32 35 62529 62589 42496182
Colour blindness acquired 22.70 12.32 8 62556 112 42558659
Overdose 22.57 12.32 79 62485 105185 42453586
Tumour lysis syndrome 22.48 12.32 3 62561 22228 42536543
Drug hypersensitivity 22.39 12.32 73 62491 99316 42459455
Pseudocellulitis 22.23 12.32 10 62554 273 42558498
Drug abuse 22.21 12.32 79 62485 104692 42454079
Hepatic cytolysis 22.12 12.32 6 62558 26838 42531933
Hypokalaemia 22.06 12.32 45 62519 71676 42487095
Blood pressure decreased 22.06 12.32 154 62410 58178 42500593
Spontaneous penile erection 21.93 12.32 10 62554 282 42558489
Product substitution issue 21.80 12.32 50 62514 11240 42547531
Psychotic disorder 21.45 12.32 8 62556 29200 42529571
Infection parasitic 21.39 12.32 11 62553 406 42558365
Visual field defect 21.30 12.32 31 62533 4907 42553864
Gastrointestinal bacterial infection 21.18 12.32 13 62551 678 42558093
Rash 21.15 12.32 283 62281 276671 42282100
Cancer surgery 21.13 12.32 12 62552 541 42558230
Hypocalcaemia 20.96 12.32 9 62555 30164 42528607
Infusion site swelling 20.92 12.32 25 62539 3267 42555504
Pneumothorax 20.89 12.32 79 62485 23464 42535307
Infusion site warmth 20.89 12.32 9 62555 221 42558550
Systemic scleroderma 20.66 12.32 12 62552 565 42558206
Performance enhancing product use 20.36 12.32 8 62556 154 42558617
White blood cell count decreased 20.36 12.32 88 62476 110308 42448463
Product dose omission issue 20.36 12.32 329 62235 154036 42404735
Product counterfeit 20.22 12.32 8 62556 157 42558614
Aggression 20.17 12.32 21 62543 44142 42514629
Micturition urgency 20.06 12.32 50 62514 11848 42546923
Ventilation perfusion mismatch 19.99 12.32 8 62556 162 42558609
Device infusion issue 19.95 12.32 15 62549 1093 42557678
Cardiac output increased 19.93 12.32 6 62558 49 42558722
Pulmonary embolism 19.90 12.32 99 62465 119513 42439258
Anorgasmia 19.61 12.32 15 62549 1122 42557649
Acute respiratory distress syndrome 19.35 12.32 10 62554 30098 42528673
Ocular vascular disorder 19.25 12.32 8 62556 179 42558592
Agitation 19.23 12.32 41 62523 64273 42494498
Eye symptom 19.13 12.32 6 62558 57 42558714
Post angioplasty restenosis 19.05 12.32 5 62559 23 42558748
Counterfeit product administered 18.77 12.32 9 62555 285 42558486
Penis disorder 18.57 12.32 16 62548 1417 42557354
Anaemia 18.40 12.32 295 62269 279983 42278788
Abdominal discomfort 18.39 12.32 180 62384 75075 42483696
Acute myeloid leukaemia 18.29 12.32 5 62559 22251 42536520
Blindness 18.22 12.32 63 62501 17915 42540856
Intentional product use issue 18.16 12.32 50 62514 71783 42486988
Disorientation 18.14 12.32 16 62548 36373 42522398
Penile necrosis 18.10 12.32 6 62558 69 42558702
Diagnostic procedure 18.09 12.32 5 62559 29 42558742
Infusion site haemorrhage 18.07 12.32 15 62549 1262 42557509
Right atrial pressure increased 18.05 12.32 7 62557 130 42558641
Left ventricular failure 17.98 12.32 32 62532 5999 42552772
Catheterisation cardiac abnormal 17.72 12.32 6 62558 74 42558697
Road traffic accident 17.72 12.32 65 62499 19028 42539743
Abdominal cavity drainage 17.69 12.32 10 62554 447 42558324
Chorioretinopathy 17.65 12.32 16 62548 1515 42557256
Hyperglycaemia 17.57 12.32 25 62539 45834 42512937
Loss of consciousness 17.52 12.32 210 62354 92144 42466627
Spinal operation 17.49 12.32 26 62538 4194 42554577
Scleroderma 17.47 12.32 17 62547 1761 42557010
Renal tubular necrosis 17.36 12.32 3 62561 18351 42540420
Pericardial effusion 17.35 12.32 87 62477 29188 42529583
Incorrect route of product administration 17.28 12.32 7 62557 24298 42534473
Cardiothoracic ratio increased 17.28 12.32 5 62559 35 42558736
Blood testosterone decreased 17.24 12.32 28 62536 4874 42553897
Haemophagocytic lymphohistiocytosis 17.19 12.32 3 62561 18219 42540552
Device embolisation 17.16 12.32 5 62559 36 42558735
Paracentesis 17.16 12.32 10 62554 474 42558297
Myelodysplastic syndrome 17.10 12.32 6 62558 22739 42536032
Haematopoietic stem cell mobilisation 17.00 12.32 9 62555 353 42558418
Delirium 16.97 12.32 32 62532 52487 42506284
Infusion site oedema 16.97 12.32 10 62554 484 42558287
Deafness 16.92 12.32 50 62514 13090 42545681
Drug ineffective for unapproved indication 16.87 12.32 26 62538 46137 42512634
Ischaemic stroke 16.83 12.32 71 62493 22162 42536609
Pulmonary haemosiderosis 16.83 12.32 4 62560 11 42558760
Bronchopulmonary aspergillosis 16.67 12.32 4 62560 19425 42539346
Catheter site inflammation 16.67 12.32 8 62556 254 42558517
Hot flush 16.63 12.32 71 62493 22280 42536491
Infusion site cellulitis 16.63 12.32 7 62557 162 42558609
Cardiac function test 16.58 12.32 3 62561 0 42558771
Nausea 16.56 12.32 726 61838 396073 42162698
Transient ischaemic attack 16.42 12.32 95 62469 33644 42525127
Viral infection 16.41 12.32 71 62493 22412 42536359
Dizziness exertional 16.38 12.32 8 62556 264 42558507
Blood lactate dehydrogenase increased 16.26 12.32 9 62555 26072 42532699
Lower respiratory tract infection 16.25 12.32 22 62542 41184 42517587
Somnolence 16.16 12.32 131 62433 140974 42417797
Hypomagnesaemia 16.14 12.32 11 62553 28477 42530294
Thoracotomy 16.07 12.32 6 62558 100 42558671
Blood creatine phosphokinase increased 16.02 12.32 29 62535 48309 42510462
Dysarthria 15.95 12.32 21 62543 39786 42518985
Cardiac ablation 15.90 12.32 14 62550 1276 42557495
Pulmonary congestion 15.83 12.32 55 62509 15675 42543096
Blindness transient 15.82 12.32 20 62544 2769 42556002
Dialysis 15.81 12.32 46 62518 11940 42546831
Weight increased 15.70 12.32 234 62330 107749 42451022
Atrial fibrillation 15.69 12.32 290 62274 139303 42419468
Electrocardiogram QT prolonged 15.68 12.32 29 62535 47916 42510855
C-reactive protein increased 15.51 12.32 45 62519 63515 42495256
Haemorrhoid operation 15.39 12.32 6 62558 113 42558658
Completed suicide 15.39 12.32 81 62483 96384 42462387
Neoplasm progression 15.38 12.32 12 62552 28988 42529783
Hepatic function abnormal 15.31 12.32 33 62531 51534 42507237
Abdominal pain upper 15.30 12.32 187 62377 82422 42476349
Platelet count decreased 15.26 12.32 130 62434 138451 42420320
Catheter site irritation 15.20 12.32 6 62558 117 42558654
Pulmonary artery dilatation 15.10 12.32 8 62556 314 42558457
Pulmonary arterial wedge pressure increased 15.06 12.32 6 62558 120 42558651
Congenital hiatus hernia 14.98 12.32 30 62534 6144 42552627
Limb discomfort 14.96 12.32 47 62517 12720 42546051
Hypophosphataemia 14.95 12.32 6 62558 20939 42537832
Neuropathy peripheral 14.90 12.32 88 62476 101765 42457006
Gastric ischaemia 14.89 12.32 5 62559 60 42558711
Right ventricular dilatation 14.87 12.32 11 62553 782 42557989
Wheezing 14.87 12.32 134 62430 54647 42504124
Hepatitis 14.86 12.32 11 62553 27289 42531482
Arthralgia 14.73 12.32 400 62164 204838 42353933
Eczema 14.69 12.32 17 62547 34069 42524702
Cardioversion 14.67 12.32 12 62552 989 42557782
Coma 14.51 12.32 36 62528 53518 42505253
Malignant melanoma in situ 14.38 12.32 19 62545 2748 42556023
Scrotal haematocoele 14.35 12.32 4 62560 24 42558747
Hyperinsulinaemic hypoglycaemia 14.33 12.32 6 62558 137 42558634
Blood pressure systolic increased 14.30 12.32 12 62552 27956 42530815
Myocarditis 14.23 12.32 5 62559 18933 42539838
Retinal vein occlusion 14.19 12.32 16 62548 1965 42556806
Creatinine renal clearance abnormal 14.08 12.32 8 62556 361 42558410
Blood creatinine increased 14.07 12.32 99 62465 109904 42448867
Subcutaneous drug absorption impaired 14.04 12.32 3 62561 4 42558767
Abdominal distension 13.99 12.32 164 62400 71571 42487200
Nervous system disorder 13.88 12.32 4 62560 17191 42541580
Cerebral vasoconstriction 13.88 12.32 7 62557 248 42558523
Tongue biting 13.81 12.32 12 62552 1075 42557696
Deep vein thrombosis 13.79 12.32 62 62502 76895 42481876
Acute respiratory failure 13.76 12.32 101 62463 38757 42520014
Biliary catheter insertion 13.75 12.32 5 62559 77 42558694
Infusion site reaction 13.72 12.32 13 62551 1303 42557468
Myoclonus 13.72 12.32 4 62560 17061 42541710
Renal impairment 13.71 12.32 100 62464 110128 42448643
Neutrophil count increased 13.61 12.32 6 62558 19798 42538973
Hepatocellular injury 13.60 12.32 9 62555 23669 42535102
Pulmonary capillary haemangiomatosis 13.59 12.32 4 62560 30 42558741
Vasculitis 13.57 12.32 5 62559 18389 42540382
Scrotal swelling 13.57 12.32 14 62550 1555 42557216
Transaminases increased 13.54 12.32 17 62547 32868 42525903
Hypotension 13.43 12.32 483 62081 257148 42301623
Dizziness postural 13.40 12.32 33 62531 7762 42551009
Stevens-Johnson syndrome 13.33 12.32 8 62556 22170 42536601
Heart rate increased 13.31 12.32 128 62436 53127 42505644
Subclavian vein stenosis 13.29 12.32 3 62561 6 42558765
Immunoglobulin therapy 13.29 12.32 3 62561 6 42558765
Eye operation 13.23 12.32 9 62555 560 42558211
Glaucoma 13.22 12.32 34 62530 8214 42550557
Diuretic therapy 13.15 12.32 4 62560 34 42558737
Gastrointestinal cancer metastatic 13.14 12.32 5 62559 88 42558683
Drug titration error 13.07 12.32 10 62554 748 42558023
Radiation proctitis 13.07 12.32 6 62558 172 42558599
Insomnia 13.05 12.32 245 62319 118008 42440763
Device breakage 13.05 12.32 21 62543 3628 42555143
Mitral perforation 13.04 12.32 4 62560 35 42558736
Anaphylactic reaction 12.99 12.32 27 62537 42716 42516055
Pneumonitis 12.97 12.32 26 62538 41692 42517079
Cardiac pacemaker replacement 12.81 12.32 6 62558 180 42558591
Chronic coronary syndrome 12.78 12.32 7 62557 294 42558477
Throat irritation 12.62 12.32 45 62519 12991 42545780
Chronic obstructive pulmonary disease 12.62 12.32 145 62419 62969 42495802
Sinus headache 12.59 12.32 12 62552 1211 42557560
Terminal state 12.59 12.32 23 62541 4400 42554371
Agranulocytosis 12.42 12.32 16 62548 30596 42528175
Eye haemorrhage 12.36 12.32 24 62540 4806 42553965

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
Dyspnoea 2327.76 12.25 4768 143077 1102104 109339350
Pain in jaw 2215.78 12.25 1167 146678 50010 110391444
Pulmonary arterial hypertension 2155.63 12.25 992 146853 31576 110409878
Fluid retention 1861.60 12.25 1299 146546 93008 110348446
Headache 1777.63 12.25 3740 144105 878637 109562817
Right ventricular failure 1367.49 12.25 676 147169 25278 110416176
Death 1342.56 12.25 2909 144936 695960 109745494
Dyspnoea exertional 1254.97 12.25 1070 146775 102990 110338464
Pulmonary hypertension 1160.53 12.25 791 147054 54429 110387025
Hypervolaemia 1009.74 12.25 696 147149 48764 110392690
Flushing 1001.60 12.25 945 146900 103791 110337663
Nasal congestion 689.11 12.25 750 147095 97532 110343922
Diarrhoea 664.94 12.25 3142 144703 1136363 109305091
Infusion site pain 614.04 12.25 347 147498 17072 110424382
Catheter site erythema 603.22 12.25 246 147599 5782 110435672
Oxygen saturation decreased 584.22 12.25 874 146971 156108 110285346
Hospitalisation 571.70 12.25 822 147023 141671 110299783
Transfusion 563.88 12.25 377 147468 25095 110416359
Drug ineffective 532.59 12.25 758 147087 1519782 108921672
Device related infection 526.98 12.25 431 147414 39088 110402366
Catheter management 510.15 12.25 191 147654 3544 110437910
Catheter site pain 462.97 12.25 208 147637 6238 110435216
Syncope 444.72 12.25 893 146952 201643 110239811
Lung transplant 442.59 12.25 190 147655 5096 110436358
Infusion related reaction 407 12.25 26 147819 381136 110060318
Catheter site pruritus 401.18 12.25 141 147704 2165 110439289
Catheterisation cardiac 398.16 12.25 185 147660 6006 110435448
Catheter site discharge 380.30 12.25 145 147700 2834 110438620
Cardiac failure 370.45 12.25 792 147053 186834 110254620
Myalgia 369.07 12.25 876 146969 221505 110219949
Unevaluable event 337.20 12.25 406 147439 58821 110382633
Synovitis 336.20 12.25 6 147839 274086 110167368
Vascular device infection 324.25 12.25 227 147618 16285 110425169
Dizziness 320.69 12.25 1804 146041 696389 109745065
Catheter placement 313.53 12.25 130 147715 3190 110438264
Infusion site infection 305.98 12.25 115 147730 2157 110439297
Off label use 305.43 12.25 1011 146834 1499174 108942280
Oxygen consumption increased 305.04 12.25 150 147695 5535 110435919
Oedema 301.77 12.25 783 147062 209193 110232261
Febrile neutropenia 301.73 12.25 35 147810 316732 110124722
Infusion site erythema 298.86 12.25 191 147654 11768 110429686
Pulmonary arterial pressure increased 298.35 12.25 143 147702 4984 110436470
Cough 297.81 12.25 1314 146531 460327 109981127
Palpitations 291.39 12.25 652 147193 158560 110282894
Therapy change 283.45 12.25 173 147672 9824 110431630
Oedema peripheral 282.11 12.25 1023 146822 327637 110113817
Device occlusion 280.24 12.25 201 147644 14984 110426470
Product use in unapproved indication 276.61 12.25 126 147719 447251 109994203
Chest pain 269.47 12.25 1106 146739 375269 110066185
Alopecia 267.24 12.25 78 147767 364675 110076779
Arthropathy 265.93 12.25 35 147810 287487 110153967
Catheter site infection 256.89 12.25 150 147695 7850 110433604
Device alarm issue 252.20 12.25 102 147743 2344 110439110
Toxicity to various agents 251.22 12.25 167 147678 480388 109961066
Brain natriuretic peptide increased 245.88 12.25 165 147680 11044 110430410
Rheumatoid arthritis 240.76 12.25 53 147792 299560 110141894
Glossodynia 237.29 12.25 15 147830 221989 110219465
Neutropenia 232.31 12.25 105 147740 374515 110066939
Stomatitis 231.41 12.25 41 147804 270201 110171253
Nausea 231.05 12.25 2593 145252 1233097 109208357
Hypoxia 228.71 12.25 523 147322 128992 110312462
Concomitant disease aggravated 225.55 12.25 182 147663 16182 110425272
Contraindicated product administered 225.36 12.25 32 147813 248235 110193219
Pulmonary oedema 223.31 12.25 446 147399 100213 110341241
Scleroderma 222.59 12.25 126 147719 6215 110435239
Drug hypersensitivity 220.06 12.25 171 147674 453919 109987535
Pericarditis 219.50 12.25 20 147825 219094 110222360
Epistaxis 214.41 12.25 512 147333 129860 110311594
Product dose omission issue 214.18 12.25 925 146920 320857 110120597
Therapeutic product effect decreased 213.74 12.25 35 147810 244281 110197173
Treatment failure 212.95 12.25 54 147791 277180 110164274
Hepatic enzyme increased 211.72 12.25 82 147763 320810 110120644
Cardiac disorder 211.65 12.25 372 147473 75908 110365546
Helicobacter infection 208.02 12.25 8 147837 181869 110259585
Catheter site rash 205.73 12.25 70 147775 970 110440484
Transplant evaluation 204.74 12.25 81 147764 1754 110439700
Folliculitis 204.19 12.25 4 147841 167649 110273805
Feeling abnormal 200.77 12.25 614 147231 180097 110261357
Hypotension 197.06 12.25 1286 146559 522563 109918891
Central venous catheterisation 196.13 12.25 98 147747 3744 110437710
Catheter site haemorrhage 196.10 12.25 113 147732 5767 110435687
Maternal exposure during pregnancy 195.08 12.25 50 147795 254833 110186621
Pain in extremity 193.16 12.25 1212 146633 485906 109955548
Device dislocation 193.09 12.25 225 147620 31479 110409975
Dermatitis contact 191.91 12.25 155 147690 13798 110427656
Psoriatic arthropathy 189.16 12.25 21 147824 196740 110244714
Drug interaction 187.53 12.25 236 147609 499947 109941507
Pericardial effusion 186.64 12.25 300 147545 56917 110384537
Type 2 diabetes mellitus 183.50 12.25 14 147831 177218 110264236
Device leakage 178.99 12.25 158 147687 15890 110425564
Pneumonia 171.25 12.25 1857 145988 874857 109566597
Joint swelling 170.13 12.25 205 147640 442640 109998814
Pulmonary veno-occlusive disease 169.33 12.25 74 147771 2074 110439380
Muscle injury 168.95 12.25 4 147841 140803 110300651
Complication associated with device 168.89 12.25 169 147676 19904 110421550
Malaise 168.71 12.25 1500 146345 670319 109771135
Therapy cessation 168.43 12.25 251 147594 44606 110396848
Impaired healing 161.67 12.25 33 147812 196684 110244770
Acute kidney injury 157.38 12.25 389 147456 635041 109806413
Lower respiratory tract infection 157.24 12.25 64 147781 243042 110198412
Therapy interrupted 156.75 12.25 257 147588 49565 110391889
Blood cholesterol increased 156.07 12.25 29 147816 184756 110256698
Infusion site swelling 155.87 12.25 119 147726 9758 110431696
Irritable bowel syndrome 154.18 12.25 19 147826 164196 110277258
Fibromyalgia 152.82 12.25 23 147822 170886 110270568
Wound 151.17 12.25 62 147783 234375 110207079
Catheter site swelling 151.16 12.25 70 147775 2254 110439200
Drug intolerance 151.07 12.25 193 147652 406319 110035135
Musculoskeletal stiffness 149.15 12.25 95 147750 279727 110161727
Intentional product use issue 148.20 12.25 73 147772 247833 110193621
Systemic lupus erythematosus 147.41 12.25 78 147767 254260 110187194
Cardiac failure congestive 145.79 12.25 489 147356 150511 110290943
Bursitis 144.30 12.25 7 147838 129911 110311543
Malignant neoplasm progression 141.97 12.25 30 147815 174537 110266917
Confusional state 141.00 12.25 257 147588 468423 109973031
Device infusion issue 138.93 12.25 72 147773 2973 110438481
Catheter site irritation 137.45 12.25 46 147799 604 110440850
Liver injury 137.37 12.25 19 147826 150394 110291060
Mobility decreased 137.32 12.25 73 147772 237349 110204105
Thrombocytopenia 131.31 12.25 164 147681 348721 110092733
Rash 131.24 12.25 608 147237 820356 109621098
Osteoarthritis 130.13 12.25 41 147804 182582 110258872
Blister 129.91 12.25 71 147774 227305 110214149
Therapeutic product effect incomplete 127.70 12.25 70 147775 223735 110217719
C-reactive protein increased 127.51 12.25 66 147779 217853 110223601
Cardiac pacemaker insertion 126.92 12.25 88 147757 6213 110435241
Sleep disorder due to general medical condition, insomnia type 126.74 12.25 3 147842 105640 110335814
Injury 125.95 12.25 40 147805 177225 110264229
Urticaria 123.04 12.25 147 147698 318710 110122744
Faeces soft 122.29 12.25 109 147736 11101 110430353
Catheter site inflammation 121.99 12.25 50 147795 1190 110440264
Infusion site haemorrhage 121.29 12.25 76 147769 4522 110436932
Discomfort 119.84 12.25 69 147776 214638 110226816
Joint range of motion decreased 119.66 12.25 12 147833 121820 110319634
Presyncope 116.13 12.25 223 147622 48664 110392790
Hypertension 115.02 12.25 327 147518 509757 109931697
Catheter site vesicles 114.27 12.25 36 147809 385 110441069
Blood pressure decreased 109.55 12.25 371 147474 114720 110326734
Completed suicide 109.01 12.25 98 147747 242283 110199171
Myelosuppression 108.37 12.25 4 147841 94336 110347118
Leukopenia 106.73 12.25 33 147812 148758 110292696
Chest discomfort 105.89 12.25 487 147358 173361 110268093
Infusion site discharge 105.68 12.25 52 147793 1921 110439533
Hypersensitivity 104.93 12.25 241 147604 403757 110037697
Dyspnoea at rest 104.92 12.25 88 147757 8258 110433196
Device connection issue 104.05 12.25 45 147800 1229 110440225
Lip dry 103.32 12.25 8 147837 100075 110341379
Heart rate increased 102.95 12.25 423 147422 143411 110298043
Mucosal inflammation 101.21 12.25 7 147838 96134 110345320
General physical health deterioration 100.06 12.25 267 147578 425028 110016426
Abdominal distension 98.97 12.25 480 147365 174623 110266831
Walking distance test abnormal 97.71 12.25 37 147808 709 110440745
Obesity 97.41 12.25 17 147828 113334 110328120
Device related sepsis 96.89 12.25 81 147764 7566 110433888
Ascites 96.23 12.25 308 147537 92500 110348954
Neutrophil count decreased 95.87 12.25 22 147823 120919 110320535
Pulmonary hypertensive crisis 95.29 12.25 32 147813 425 110441029
Liver transplant 94.57 12.25 65 147780 4524 110436930
Paracentesis 93.66 12.25 43 147802 1357 110440097
Inflammation 93.20 12.25 73 147772 193165 110248289
Haemoptysis 93.19 12.25 257 147588 71097 110370357
Rhabdomyolysis 89.47 12.25 25 147820 120376 110321078
Drug reaction with eosinophilia and systemic symptoms 89.35 12.25 5 147840 82090 110359364
Cardiac operation 87.57 12.25 69 147776 5926 110435528
Pruritus 87.38 12.25 440 147405 581120 109860334
Respiratory failure 85.89 12.25 537 147308 214795 110226659
Grip strength decreased 83.92 12.25 6 147839 80168 110361286
Pancytopenia 82.58 12.25 95 147750 209518 110231936
Red blood cell sedimentation rate increased 81.56 12.25 6 147839 78296 110363158
Disease complication 80.70 12.25 65 147780 5762 110435692
Systemic scleroderma 79.69 12.25 43 147802 1929 110439525
Ill-defined disorder 78.53 12.25 57 147788 156796 110284658
Acute respiratory failure 78.23 12.25 250 147595 75010 110366444
Right ventricular dilatation 77.28 12.25 45 147800 2342 110439112
Injection site discharge 76.77 12.25 38 147807 1422 110440032
Overdose 75.91 12.25 122 147723 233672 110207782
Suicide attempt 75.84 12.25 22 147823 103372 110338082
Dialysis 75.39 12.25 111 147734 19508 110421946
Surgery 75.36 12.25 169 147676 41114 110400340
Vision blurred 75.29 12.25 357 147488 128665 110312789
Atrial flutter 74.75 12.25 124 147721 24138 110417316
Delirium 74.47 12.25 44 147801 134981 110306473
Prescribed overdose 73.39 12.25 14 147831 87567 110353887
Loss of consciousness 73.02 12.25 481 147364 195825 110245629
Cardiac failure high output 73.01 12.25 27 147818 483 110440971
Pulmonary arterial pressure abnormal 72.43 12.25 32 147813 921 110440533
Anaphylactic reaction 72.41 12.25 31 147814 114269 110327185
Product use issue 71.53 12.25 198 147647 311497 110129957
Injection site infection 71.28 12.25 44 147801 2549 110438905
Sedation 70.73 12.25 6 147839 69677 110371777
Dizziness postural 70.13 12.25 92 147753 14517 110426937
Optic ischaemic neuropathy 69.95 12.25 52 147793 4095 110437359
Cardiac ablation 69.91 12.25 44 147801 2638 110438816
Infusion site warmth 69.81 12.25 38 147807 1735 110439719
Peripheral venous disease 69.32 12.25 14 147831 84103 110357351
Peripheral swelling 68.72 12.25 834 147011 403200 110038254
Wound infection 68.10 12.25 22 147823 96443 110345011
Lactic acidosis 67.61 12.25 20 147825 92791 110348663
Rash maculo-papular 66.31 12.25 10 147835 74212 110367242
Back pain 66.26 12.25 773 147072 370223 110071231
Right ventricular dysfunction 65.97 12.25 46 147799 3277 110438177
Hepatotoxicity 65.63 12.25 5 147840 63395 110378059
Oxygen therapy 65.45 12.25 50 147795 4103 110437351
Epilepsy 65.38 12.25 26 147819 100183 110341271
Fractional exhaled nitric oxide increased 65.31 12.25 28 147817 748 110440706
Device breakage 65.00 12.25 86 147759 13683 110427771
Right-to-left cardiac shunt 64.78 12.25 22 147823 303 110441151
Nail disorder 64.72 12.25 3 147842 57932 110383522
Hot flush 64.71 12.25 215 147630 65821 110375633
Hepatitis 64.53 12.25 20 147825 90034 110351420
Infusion site abscess 64.45 12.25 23 147822 370 110441084
Infusion site pruritus 63.36 12.25 53 147792 4955 110436499
Atrial fibrillation 62.24 12.25 522 147323 229120 110212334
Blood pressure systolic increased 62.09 12.25 17 147828 82974 110358480
Drug abuse 62.00 12.25 88 147757 177323 110264131
Asthma 62.00 12.25 153 147692 250138 110191316
Cytokine release syndrome 61.61 12.25 10 147835 70296 110371158
Left ventricular failure 61.43 12.25 76 147769 11313 110430141
Infusion site induration 61.24 12.25 32 147813 1344 110440110
Hyponatraemia 60.45 12.25 125 147720 217528 110223926
Fatigue 60.01 12.25 2084 145761 1213874 109227580
Injection site reaction 59.96 12.25 22 147823 89048 110352406
Catheter removal 59.78 12.25 25 147820 627 110440827
Exposure during pregnancy 59.55 12.25 82 147763 167342 110274112
Stent placement 59.19 12.25 60 147785 7174 110434280
Pulmonary congestion 59.04 12.25 129 147716 30837 110410617
Drug ineffective for unapproved indication 58.87 12.25 32 147813 102806 110338648
Dizziness exertional 58.83 12.25 26 147819 749 110440705
Depressed level of consciousness 58.58 12.25 39 147806 112239 110329215
Medication error 58.57 12.25 34 147811 105332 110336122
White blood cell count decreased 58.57 12.25 138 147707 229252 110212202
Atrial septal defect repair 58.31 12.25 23 147822 494 110440960
Night sweats 58.06 12.25 56 147789 133927 110307527
Productive cough 57.30 12.25 303 147542 114002 110327452
Product administration interrupted 57.16 12.25 73 147772 11219 110430235
Catheter site warmth 56.55 12.25 20 147825 313 110441141
Thrombosis in device 56.53 12.25 51 147794 5276 110436178
Sinus congestion 55.94 12.25 125 147720 30334 110411120
Cardioversion 55.32 12.25 36 147809 2287 110439167
Electrocardiogram QT prolonged 55.31 12.25 39 147806 108921 110332533
Cytomegalovirus infection 54.41 12.25 5 147840 54439 110387015
Bone marrow failure 53.54 12.25 7 147838 57841 110383613
Bradycardia 53.50 12.25 78 147767 155439 110286015
Seizure 53.38 12.25 137 147708 221048 110220406
Pulmonary arterial wedge pressure increased 53.35 12.25 23 147822 623 110440831
Medical device change 53.11 12.25 21 147824 454 110441000
Contusion 52.96 12.25 149 147696 233212 110208242
Live birth 52.42 12.25 14 147831 69470 110371984
Psoriasis 52.41 12.25 66 147779 139927 110301527
Abdominal cavity drainage 51.76 12.25 25 147820 886 110440568
Aspiration pleural cavity 51.66 12.25 31 147814 1706 110439748
Viral infection 51.17 12.25 172 147673 52967 110388487
Depression 51.14 12.25 234 147611 317101 110124353
Renal disorder 51.09 12.25 164 147681 49315 110392139
Hypoaesthesia 51.06 12.25 231 147614 313992 110127462
Product quality issue 50.52 12.25 20 147825 77279 110364175
Cognitive disorder 50.43 12.25 27 147818 87484 110353970
Blood potassium decreased 50.21 12.25 173 147672 53941 110387513
Paraesthesia 50.05 12.25 195 147650 276326 110165128
Drug-induced liver injury 49.94 12.25 52 147793 120015 110321439
Foot deformity 49.68 12.25 4 147841 48476 110392978
Heart and lung transplant 49.66 12.25 16 147829 185 110441269
Internal haemorrhage 49.24 12.25 64 147781 10007 110431447
Cyanopsia 49.20 12.25 14 147831 102 110441352
Osteoporosis 48.62 12.25 28 147817 87124 110354330
Infusion site irritation 48.54 12.25 26 147819 1149 110440305
Incorrect route of product administration 48.15 12.25 13 147832 64048 110377406
Seasonal allergy 48.11 12.25 91 147754 19631 110421823
Hallucination 48.03 12.25 39 147806 101393 110340061
Hyperkalaemia 47.80 12.25 67 147778 135729 110305725
Hypocalcaemia 47.77 12.25 14 147831 65352 110376102
Device issue 47.70 12.25 127 147718 34408 110407046
Pleural effusion 47.63 12.25 403 147442 177306 110264148
Exercise tolerance decreased 47.42 12.25 69 147776 11998 110429456
Blood iron decreased 47.30 12.25 89 147756 19125 110422329
Hospice care 47.11 12.25 70 147775 12403 110429051
Priapism 46.84 12.25 48 147797 5813 110435641
Iron deficiency anaemia 46.61 12.25 119 147726 31440 110410014
Catheter site related reaction 45.99 12.25 27 147818 1427 110440027
Coma 45.78 12.25 54 147791 117815 110323639
Catheterisation cardiac abnormal 45.77 12.25 17 147828 308 110441146
Chemotherapy 45.65 12.25 31 147814 2115 110439339
Head discomfort 45.52 12.25 87 147758 18913 110422541
Deafness unilateral 45.49 12.25 42 147803 4477 110436977
Gait inability 45.35 12.25 70 147775 136306 110305148
Throat irritation 45.23 12.25 166 147679 53386 110388068
Neoplasm progression 45.12 12.25 15 147830 64580 110376874
Cardiac output increased 44.78 12.25 20 147825 591 110440863
Neurotoxicity 44.63 12.25 3 147842 42204 110399250
Erectile dysfunction 44.50 12.25 85 147760 18471 110422983
Device physical property issue 43.60 12.25 38 147807 3756 110437698
N-terminal prohormone brain natriuretic peptide increased 43.35 12.25 47 147798 6074 110435380
Sciatica 43.17 12.25 36 147809 92363 110349091
Colitis ulcerative 42.95 12.25 25 147820 77338 110364116
Extra dose administered 42.75 12.25 66 147779 12093 110429361
Autoimmune disorder 42.70 12.25 17 147828 65466 110375988
Ventilation perfusion mismatch 42.67 12.25 21 147824 776 110440678
Angioedema 41.72 12.25 42 147803 98458 110342996
Chronic obstructive pulmonary disease 41.50 12.25 269 147576 108889 110332565
Cor pulmonale 41.49 12.25 30 147815 2264 110439190
Mineral supplementation 41.04 12.25 21 147824 844 110440610
Emergency care 40.82 12.25 25 147820 1428 110440026
Intentional product misuse 40.68 12.25 72 147773 132832 110308622
Agitation 40.57 12.25 55 147790 112996 110328458
Treatment noncompliance 40.43 12.25 199 147646 72791 110368663
Drug titration error 40.39 12.25 26 147819 1621 110439833
Fracture of penis 40.07 12.25 14 147831 211 110441243
Pneumocystis jirovecii pneumonia 39.96 12.25 5 147840 42730 110398724
Nocturnal dyspnoea 39.69 12.25 27 147818 1848 110439606
Drug resistance 39.53 12.25 13 147832 56361 110385093
Intentional overdose 39.46 12.25 73 147772 132428 110309026
Tubulointerstitial nephritis 38.99 12.25 12 147833 54272 110387182
Application site pruritus 38.68 12.25 37 147808 4123 110437331
Inappropriate schedule of product administration 38.53 12.25 141 147704 203496 110237958
Rehabilitation therapy 38.49 12.25 28 147817 2133 110439321
Sleep disorder due to a general medical condition 38.38 12.25 11 147834 52101 110389353
Coeliac disease 38.16 12.25 6 147839 43181 110398273
Localised oedema 38.09 12.25 54 147791 9169 110432285
Hepatic cytolysis 38.07 12.25 13 147832 55040 110386414
Atrial septal defect 37.98 12.25 28 147817 2177 110439277
Pulmonary capillary haemangiomatosis 37.32 12.25 11 147834 92 110441362
Pulmonary artery dilatation 37.16 12.25 18 147827 642 110440812
Agranulocytosis 37.16 12.25 18 147827 61742 110379712
Infusion site cellulitis 36.89 12.25 16 147829 440 110441014
Suicidal ideation 36.52 12.25 43 147802 93894 110347560
Blood creatine phosphokinase increased 35.99 12.25 27 147818 73050 110368404
Hypercholesterolaemia 35.94 12.25 41 147804 90796 110350658
Terminal state 35.81 12.25 41 147804 5626 110435828
Cholecystectomy 35.68 12.25 57 147788 10752 110430702
Lymphocyte count decreased 35.50 12.25 16 147829 57227 110384227
Metapneumovirus infection 35.42 12.25 28 147817 2416 110439038
Right ventricular enlargement 35.06 12.25 20 147825 1001 110440453
Gastritis hypertrophic 34.84 12.25 9 147836 43 110441411
Catheter site scab 34.48 12.25 13 147832 246 110441208
Metabolic acidosis 34.32 12.25 50 147795 99694 110341760
Infusion site rash 34.29 12.25 27 147818 2316 110439138
Right ventricular systolic pressure increased 34.20 12.25 20 147825 1049 110440405
Hyperglycaemia 34.11 12.25 38 147807 85052 110356402
Influenza 34.09 12.25 361 147484 168740 110272714
Vasculitis 34.03 12.25 4 147841 35869 110405585
Gout 34.01 12.25 117 147728 36449 110405005
Psychotic disorder 33.58 12.25 13 147832 50924 110390530
Intentional self-injury 33.53 12.25 5 147840 37424 110404030
Blood lactate dehydrogenase increased 33.31 12.25 9 147836 44325 110397129
Device malfunction 33.31 12.25 92 147753 25466 110415988
Hepatocellular injury 33.26 12.25 13 147832 50629 110390825
Disease progression 33.24 12.25 484 147361 243550 110197904
Catheter site discolouration 33.18 12.25 11 147834 140 110441314
Pneumonitis 33.14 12.25 32 147813 76499 110364955
Immunodeficiency 32.98 12.25 6 147839 38832 110402622
Bronchitis 32.96 12.25 338 147507 156694 110284760
Joint stiffness 32.92 12.25 25 147820 67218 110374236
Swollen tongue 32.81 12.25 20 147825 60342 110381112
Oxygen saturation abnormal 32.80 12.25 39 147806 5572 110435882
Infusion site inflammation 32.77 12.25 15 147830 470 110440984
Telangiectasia 32.70 12.25 24 147821 1853 110439601
Weight decreased 32.66 12.25 838 147007 467219 109974235
Stevens-Johnson syndrome 32.57 12.25 11 147834 46890 110394564
Dysentery 32.05 12.25 21 147824 1350 110440104
Infusion site discolouration 31.96 12.25 18 147827 879 110440575
Dry mouth 31.86 12.25 148 147697 199800 110241654
Wheezing 31.83 12.25 205 147640 255025 110186429
Hallucination, visual 31.79 12.25 7 147838 39598 110401856
Muscle spasticity 31.71 12.25 5 147840 35910 110405544
Scleroderma associated digital ulcer 31.54 12.25 8 147837 35 110441419
Altered state of consciousness 31.45 12.25 19 147826 57607 110383847
Palmar-plantar erythrodysaesthesia syndrome 31.45 12.25 8 147837 41017 110400437
Multiple organ dysfunction syndrome 31.44 12.25 101 147744 151609 110289845
Neuropathy peripheral 31.43 12.25 128 147717 179149 110262305
Hip fracture 31.42 12.25 111 147734 35040 110406414
Anaphylactic shock 31.05 12.25 15 147830 51531 110389923
Transplant 30.97 12.25 20 147825 1254 110440200
Orthopnoea 30.88 12.25 54 147791 10967 110430487
Body temperature decreased 30.74 12.25 6 147839 36929 110404525
Mouth ulceration 30.57 12.25 13 147832 48125 110393329
Osteonecrosis of jaw 30.44 12.25 13 147832 48004 110393450
Eczema 30.41 12.25 31 147814 72262 110369192
Gastric disorder 30.39 12.25 106 147739 33251 110408203
Cardiac flutter 30.38 12.25 38 147807 5719 110435735
Cancer surgery 30.36 12.25 18 147827 969 110440485
Haemorrhoid operation 30.34 12.25 14 147831 447 110441007
Tumour lysis syndrome 30.32 12.25 3 147842 30798 110410656
Upper respiratory tract congestion 30.29 12.25 28 147817 2989 110438465
Pulmonary artery aneurysm 30.26 12.25 11 147834 187 110441267
Hypomagnesaemia 30.12 12.25 22 147823 60348 110381106
Acute myeloid leukaemia 30.06 12.25 7 147838 38103 110403351
Erection increased 29.89 12.25 13 147832 360 110441094
Concomitant disease progression 29.64 12.25 30 147815 3580 110437874
Head injury 29.57 12.25 125 147720 42892 110398562
Drug delivery system malfunction 29.57 12.25 18 147827 1017 110440437
Respiratory syncytial virus infection 29.52 12.25 62 147783 14422 110427032
Gastrointestinal disorder 29.33 12.25 196 147649 241756 110199698
Ear congestion 29.26 12.25 30 147815 3635 110437819
Posterior reversible encephalopathy syndrome 29.26 12.25 5 147840 33856 110407598
Deep vein thrombosis 29.08 12.25 93 147752 139794 110301660
Plantar fasciitis 29.07 12.25 35 147810 5066 110436388
Ear discomfort 28.81 12.25 53 147792 11196 110430258
Nasopharyngitis 28.67 12.25 710 147135 393651 110047803
Onychomycosis 28.62 12.25 8 147837 38523 110402931
Haemorrhage 28.60 12.25 242 147603 106450 110335004
Blood pressure increased 28.54 12.25 215 147630 258158 110183296
Medical procedure 28.53 12.25 14 147831 514 110440940
Feeling cold 28.40 12.25 105 147740 33882 110407572
Hernia repair 28.34 12.25 25 147820 2511 110438943
Infusion site oedema 28.25 12.25 20 147825 1460 110439994
Gastroenteritis viral 28.25 12.25 99 147746 31127 110410327
Catheter site dermatitis 28.18 12.25 9 147836 101 110441353
Dysarthria 28.14 12.25 43 147802 84078 110357376
Mechanical ventilation 28.11 12.25 28 147817 3279 110438175
Vascular device occlusion 28.09 12.25 15 147830 659 110440795
Multiple allergies 27.97 12.25 55 147790 12208 110429246
Central venous catheter removal 27.92 12.25 14 147831 539 110440915
Sluggishness 27.91 12.25 42 147803 7525 110433929
Aggression 27.74 12.25 23 147822 59187 110382267
Condition aggravated 27.51 12.25 1223 146622 733613 109707841
Renal tubular necrosis 27.46 12.25 4 147841 30471 110410983
Catheter site erosion 27.24 12.25 8 147837 66 110441388
Heart valve replacement 27.18 12.25 18 147827 1178 110440276
Milk-alkali syndrome 26.99 12.25 22 147823 1983 110439471
Myocarditis 26.96 12.25 4 147841 30051 110411403
Creatinine renal clearance abnormal 26.89 12.25 15 147830 719 110440735
CREST syndrome 26.70 12.25 13 147832 469 110440985
Sleep disorder 26.61 12.25 156 147689 198488 110242966
Drug dependence 26.60 12.25 17 147828 50003 110391451
Product prescribing error 26.54 12.25 18 147827 51313 110390141
Rhinorrhoea 26.54 12.25 231 147614 102435 110339019
Product substitution issue 26.17 12.25 79 147766 22982 110418472
Myoclonus 26.15 12.25 6 147839 32992 110408462
Cardiothoracic ratio increased 26.15 12.25 8 147837 77 110441377
Arthritis 26.14 12.25 125 147720 167461 110273993
Diuretic therapy 26.06 12.25 10 147835 199 110441255
Systemic sclerosis pulmonary 25.67 12.25 6 147839 17 110441437
Middle ear effusion 25.07 12.25 24 147821 2677 110438777
Polyneuropathy 25.01 12.25 6 147839 32006 110409448
Localised infection 25.01 12.25 119 147726 42929 110398525
Sensation of foreign body 24.89 12.25 41 147804 7934 110433520
Infusion site nodule 24.85 12.25 12 147833 425 110441029
Cytopenia 24.84 12.25 5 147840 30111 110411343
Acute right ventricular failure 24.65 12.25 12 147833 433 110441021
Flatulence 24.61 12.25 136 147709 52013 110389441
Catheter site extravasation 24.60 12.25 13 147832 559 110440895
Life support 24.54 12.25 12 147833 437 110441017
Adrenal insufficiency 24.54 12.25 13 147832 42377 110399077
Therapeutic procedure 24.48 12.25 16 147829 1024 110440430
Catheter culture positive 24.48 12.25 10 147835 236 110441218
Cellulitis 24.46 12.25 267 147578 125749 110315705
Hypophosphataemia 24.44 12.25 7 147838 33175 110408279
Withdrawal syndrome 24.29 12.25 6 147839 31374 110410080
Infection 24.07 12.25 340 147505 361860 110079594
Myoglobin blood increased 24.05 12.25 29 147816 4203 110437251
Right atrial pressure increased 23.90 12.25 11 147834 349 110441105
Abortion spontaneous 23.87 12.25 8 147837 34274 110407180
Limb discomfort 23.78 12.25 113 147732 40741 110400713
Drug eruption 23.74 12.25 22 147823 53637 110387817
Decreased activity 23.57 12.25 48 147797 10926 110430528
Cholestasis 23.54 12.25 31 147814 64487 110376967
Haematospermia 23.54 12.25 10 147835 261 110441193
Hypokalaemia 23.53 12.25 145 147700 182303 110259151
Inappropriate antidiuretic hormone secretion 23.40 12.25 8 147837 33843 110407611
Infusion site vesicles 23.32 12.25 13 147832 622 110440832
Haemoglobin increased 23.30 12.25 43 147802 9104 110432350
Cardiac pacemaker replacement 23.30 12.25 12 147833 489 110440965
Ejection fraction decreased 22.99 12.25 13 147832 40867 110400587
Multiple sclerosis relapse 22.94 12.25 20 147825 50220 110391234
Gastrointestinal haemorrhage 22.81 12.25 329 147516 165189 110276265
Disorientation 22.80 12.25 37 147808 70634 110370820
Injection site bruising 22.70 12.25 21 147824 51242 110390212
Transplant rejection 22.67 12.25 3 147842 24564 110416890
Poor venous access 22.61 12.25 3 147842 24519 110416935
Neutrophil count increased 22.58 12.25 9 147836 34643 110406811
Anaemia 22.58 12.25 920 146925 546166 109895288
Transaminases increased 22.58 12.25 31 147814 63359 110378095
Catheter site mass 22.55 12.25 7 147838 71 110441383
Disease recurrence 22.39 12.25 29 147816 60755 110380699
Intracardiac pressure increased 22.38 12.25 6 147839 34 110441420
Hypertransaminasaemia 22.29 12.25 3 147842 24252 110417202
Lymphopenia 22.27 12.25 13 147832 40157 110401297
Therapeutic response shortened 22.24 12.25 6 147839 29577 110411877
Loss of personal independence in daily activities 22.19 12.25 114 147731 149906 110291548
Blood testosterone decreased 22.18 12.25 23 147822 2825 110438629
Clostridium difficile infection 22.02 12.25 132 147713 51997 110389457
Lower limb fracture 22.00 12.25 42 147803 75306 110366148
Oropharyngeal pain 21.98 12.25 277 147568 134999 110306455
Haematopoietic stem cell mobilisation 21.97 12.25 11 147834 422 110441032
Primary biliary cholangitis 21.97 12.25 17 147828 1422 110440032
Skin lesion 21.88 12.25 22 147823 51609 110389845
Drug tolerance decreased 21.84 12.25 5 147840 27535 110413919
Nephropathy toxic 21.77 12.25 5 147840 27473 110413981
Osteonecrosis 21.61 12.25 9 147836 33732 110407722
Female sterilisation 21.54 12.25 10 147835 324 110441130
Vascular cauterisation 21.41 12.25 7 147838 85 110441369
Diabetes mellitus 21.41 12.25 65 147780 99316 110342138
Faeces discoloured 21.31 12.25 96 147749 33852 110407602
Encephalopathy 21.29 12.25 48 147797 81007 110360447
Sinus tachycardia 21.20 12.25 17 147828 44476 110396978
Respiration abnormal 21.18 12.25 43 147802 9766 110431688
Cor pulmonale acute 21.15 12.25 13 147832 747 110440707
Application site hypersensitivity 21.14 12.25 10 147835 338 110441116
Walking aid user 21.02 12.25 4 147841 25071 110416383
Therapy non-responder 21.02 12.25 311 147534 156996 110284458
Hypoacusis 20.97 12.25 98 147747 35093 110406361
Progressive multifocal leukoencephalopathy 20.88 12.25 4 147841 24952 110416502
Polypectomy 20.86 12.25 17 147828 1532 110439922
Increased upper airway secretion 20.68 12.25 30 147815 5202 110436252
Diabetes mellitus inadequate control 20.64 12.25 7 147838 29768 110411686
Skin exfoliation 20.59 12.25 55 147790 87596 110353858
Performance enhancing product use 20.58 12.25 8 147837 165 110441289
Kidney infection 20.49 12.25 78 147767 25521 110415933
Generalised bullous fixed drug eruption 20.48 12.25 13 147832 791 110440663
Platelet count increased 20.45 12.25 5 147840 26329 110415125
Haemoglobin decreased 20.26 12.25 455 147390 248272 110193182
Catheter site exfoliation 20.24 12.25 4 147841 3 110441451
Tremor 20.15 12.25 173 147672 202059 110239395
Sinus disorder 20.14 12.25 92 147753 32636 110408818
Spinal operation 20.12 12.25 45 147800 10927 110430527
Paranasal sinus discomfort 20.09 12.25 33 147812 6372 110435082
Supraventricular tachycardia 20.03 12.25 75 147770 24347 110417107
Thrombotic microangiopathy 19.95 12.25 7 147838 29142 110412312
Toxic skin eruption 19.91 12.25 6 147839 27509 110413945
Septic shock 19.90 12.25 126 147719 157402 110284052
Gallbladder operation 19.86 12.25 20 147825 2373 110439081
Catheter site nodule 19.78 12.25 6 147839 56 110441398
Aspergillus infection 19.63 12.25 5 147840 25611 110415843
Balloon atrial septostomy 19.54 12.25 7 147838 114 110441340
Cardiomegaly 19.52 12.25 84 147761 29046 110412408
Dyskinesia 19.52 12.25 24 147821 51422 110390032
Post angioplasty restenosis 19.51 12.25 5 147840 23 110441431
Application site irritation 19.49 12.25 18 147827 1919 110439535
Foreign body in throat 19.45 12.25 14 147831 1049 110440405
Normal newborn 19.44 12.25 3 147842 21893 110419561
Proteinuria 19.43 12.25 15 147830 40003 110401451
Cataract operation 19.39 12.25 31 147814 5852 110435602
Arteriovenous malformation 19.38 12.25 18 147827 1933 110439521
Pregnancy test positive 19.37 12.25 7 147838 117 110441337
Colon operation 19.33 12.25 11 147834 548 110440906
Haemophagocytic lymphohistiocytosis 19.29 12.25 9 147836 31550 110409904
Hypothyroidism 19.28 12.25 43 147802 72856 110368598
Muscle twitching 19.14 12.25 8 147837 29927 110411527
N-terminal prohormone brain natriuretic peptide 19.14 12.25 6 147839 63 110441391
Emotional distress 19.13 12.25 19 147826 44828 110396626
Bronchopulmonary aspergillosis 19.07 12.25 8 147837 29855 110411599
Penile necrosis 19.06 12.25 6 147839 64 110441390
Pulmonary embolism 18.99 12.25 189 147656 214285 110227169
Acute respiratory distress syndrome 18.96 12.25 26 147819 53172 110388282
Pseudocellulitis 18.81 12.25 10 147835 435 110441019
Therapeutic response decreased 18.79 12.25 66 147779 96433 110345021
Hyperthermia 18.69 12.25 3 147842 21269 110420185
Sinus bradycardia 18.66 12.25 8 147837 29475 110411979
Infusion site pustule 18.55 12.25 5 147840 29 110441425
Heart valve operation 18.55 12.25 8 147837 217 110441237
Diet noncompliance 18.50 12.25 11 147834 595 110440859
Drug level increased 18.38 12.25 22 147823 47697 110393757
Bendopnoea 18.34 12.25 6 147839 73 110441381
Biopsy bone marrow 18.30 12.25 10 147835 460 110440994
Poisoning 18.26 12.25 8 147837 29097 110412357
Respiratory depression 18.25 12.25 10 147835 31991 110409463
Jugular vein distension 18.20 12.25 16 147829 1600 110439854
Mitral valve replacement 18.17 12.25 11 147834 615 110440839
Bedridden 18.17 12.25 49 147796 13376 110428078
Pericardial drainage 18.14 12.25 10 147835 468 110440986
Catheter site urticaria 18.13 12.25 5 147840 32 110441422
Somnolence 18.10 12.25 284 147561 297165 110144289
Heart transplant 18.10 12.25 16 147829 1612 110439842
Prophylaxis 18.09 12.25 4 147841 8 110441446
Congenital hiatus hernia 17.97 12.25 31 147814 6228 110435226
Nervous system disorder 17.96 12.25 10 147835 31711 110409743
Multiple sclerosis 17.89 12.25 6 147839 25692 110415762
First bite syndrome 17.87 12.25 5 147840 34 110441420
Osteopenia 17.68 12.25 4 147841 22205 110419249
Enterococcal infection 17.61 12.25 3 147842 20363 110421091
Intentional dose omission 17.59 12.25 63 147782 20017 110421437
Plasma cell myeloma 17.58 12.25 36 147809 62900 110378554
Chills 17.57 12.25 355 147490 190225 110251229
Vomiting 17.55 12.25 1429 146416 909246 109532208
Amnesia 17.40 12.25 77 147768 105331 110336123
Microstomia 17.39 12.25 5 147840 38 110441416
Myositis 17.35 12.25 10 147835 31106 110410348
Secretion discharge 17.30 12.25 63 147782 20181 110421273
Senile dementia 17.29 12.25 8 147837 257 110441197
Klebsiella infection 17.19 12.25 3 147842 20006 110421448
Pregnancy 17.18 12.25 26 147819 51041 110390413
Infusion site hypersensitivity 17.16 12.25 5 147840 40 110441414
Uveitis 17.10 12.25 4 147841 21706 110419748
Product administered to patient of inappropriate age 17.08 12.25 35 147810 8001 110433453
Cardiac resynchronisation therapy 17.08 12.25 6 147839 92 110441362
Myelodysplastic syndrome 17.02 12.25 15 147830 37469 110403985
Dyschromatopsia 17.00 12.25 14 147831 1280 110440174
Platelet transfusion 17.00 12.25 20 147825 2826 110438628
Systolic dysfunction 16.99 12.25 25 147820 4390 110437064
Tracheostomy 16.96 12.25 15 147830 1512 110439942
Liver function test increased 16.95 12.25 61 147784 88487 110352967
Taste disorder 16.95 12.25 39 147806 65348 110376106
Injection site pain 16.94 12.25 154 147691 177768 110263686
Oral herpes 16.92 12.25 14 147831 36066 110405388
Cardiac function test 16.86 12.25 3 147842 0 110441454
Cardiac fibroma 16.86 12.25 3 147842 0 110441454
Uterine haemorrhage 16.76 12.25 22 147823 3472 110437982
Hypoglycaemia 16.73 12.25 89 147756 116015 110325439
Application site vesicles 16.65 12.25 15 147830 1549 110439905
Cardiac output decreased 16.64 12.25 17 147828 2052 110439402
Brain operation 16.57 12.25 12 147833 908 110440546
Catheter site cellulitis 16.44 12.25 10 147835 564 110440890
Status epilepticus 16.42 12.25 11 147834 31560 110409894
Radiculopathy 16.39 12.25 3 147842 19333 110422121
Echocardiogram abnormal 16.32 12.25 19 147826 2655 110438799
Thoracotomy 16.29 12.25 7 147838 188 110441266
Therapeutic embolisation 16.19 12.25 10 147835 580 110440874
Pericardial excision 16.08 12.25 5 147840 51 110441403
Acute hepatic failure 16.08 12.25 15 147830 36453 110405001
Polyarthritis 15.95 12.25 3 147842 18960 110422494
Gastrointestinal bacterial infection 15.89 12.25 14 147831 1404 110440050
Infusion site dermatitis 15.87 12.25 4 147841 17 110441437
Skin irritation 15.86 12.25 53 147792 16266 110425188
Delusion 15.76 12.25 6 147839 23749 110417705
Parkinsonism 15.76 12.25 5 147840 22182 110419272
Medical device implantation 15.75 12.25 10 147835 609 110440845
Pulmonary vascular resistance abnormality 15.67 12.25 7 147838 207 110441247
Colon cancer 15.63 12.25 53 147792 16390 110425064
Blood culture positive 15.55 12.25 36 147809 8940 110432514
Blood calcium decreased 15.50 12.25 15 147830 35830 110405624
Therapy partial responder 15.47 12.25 16 147829 37045 110404409
Drug level decreased 15.46 12.25 3 147842 18545 110422909
Psychomotor hyperactivity 15.46 12.25 4 147841 20273 110421181
Dermatitis 15.44 12.25 9 147836 27828 110413626
Radiation proctitis 15.39 12.25 7 147838 216 110441238
Portal hypertension 15.36 12.25 35 147810 8602 110432852
Gastric ischaemia 15.35 12.25 5 147840 60 110441394
Sclerema 15.35 12.25 5 147840 60 110441394
Hip surgery 15.34 12.25 23 147822 4107 110437347
Blood pressure abnormal 15.29 12.25 65 147780 22359 110419095
Intra-abdominal fluid collection 15.26 12.25 22 147823 3792 110437662
Cytomegalovirus infection reactivation 15.21 12.25 3 147842 18330 110423124
Dialysis device insertion 15.20 12.25 5 147840 62 110441392
Arthralgia 15.20 12.25 870 146975 778762 109662692
Pulmonary vein occlusion 15.16 12.25 6 147839 130 110441324
Catheter site induration 15.13 12.25 5 147840 63 110441391
Mastectomy 15.12 12.25 14 147831 1497 110439957
Back injury 15.12 12.25 25 147820 47374 110394080
Patient-device incompatibility 15.10 12.25 7 147838 226 110441228
Disability 15.10 12.25 11 147834 30212 110411242
Malignant melanoma in situ 15.02 12.25 21 147824 3521 110437933
Intentional medical device removal by patient 14.94 12.25 9 147836 499 110440955
Second primary malignancy 14.90 12.25 3 147842 18065 110423389
Disseminated intravascular coagulation 14.90 12.25 20 147825 41266 110400188
Pulmonary haemosiderosis 14.87 12.25 4 147841 23 110441431
Purpura 14.84 12.25 7 147838 24381 110417073
Wrong dose 14.81 12.25 18 147827 2631 110438823
Respiratory distress 14.81 12.25 149 147696 68725 110372729
Infusion site lymphadenopathy 14.78 12.25 3 147842 3 110441451
Paraesthesia oral 14.67 12.25 14 147831 33657 110407797
Bone disorder 14.66 12.25 5 147840 21187 110420267
Gastrointestinal tube insertion 14.65 12.25 16 147829 2085 110439369
Haemorrhoidal haemorrhage 14.62 12.25 33 147812 8060 110433394
Infection parasitic 14.61 12.25 11 147834 883 110440571
Large intestine polyp 14.61 12.25 49 147796 15068 110426386
Colitis ischaemic 14.53 12.25 3 147842 17747 110423707
Colitis 14.43 12.25 79 147766 102244 110339210
Vena cava filter insertion 14.40 12.25 6 147839 149 110441305
Blood triglycerides increased 14.35 12.25 7 147838 23919 110417535
Portopulmonary hypertension 14.29 12.25 6 147839 152 110441302
Activated partial thromboplastin time prolonged 14.27 12.25 6 147839 22362 110419092
Coordination abnormal 14.22 12.25 8 147837 25220 110416234
Labelled drug-drug interaction medication error 14.21 12.25 11 147834 29291 110412163
Endarterectomy 14.16 12.25 8 147837 393 110441061
Retching 14.13 12.25 64 147781 22618 110418836
Anorgasmia 14.11 12.25 14 147831 1632 110439822
Pulmonary pain 14.08 12.25 28 147817 6265 110435189
Chronic sinusitis 14.07 12.25 8 147837 25076 110416378
Purulent discharge 14.07 12.25 30 147815 7053 110434401
Mydriasis 14.04 12.25 6 147839 22151 110419303
Blood pressure fluctuation 14.02 12.25 52 147793 74772 110366682
Shoulder operation 13.98 12.25 20 147825 3425 110438029
Micturition urgency 13.95 12.25 57 147788 19263 110422191
Biliary catheter insertion 13.94 12.25 6 147839 162 110441292
Oral candidiasis 13.92 12.25 24 147821 44736 110396718
Injection site urticaria 13.90 12.25 3 147842 17212 110424242
Biopsy lung 13.90 12.25 7 147838 272 110441182
Pulmonary haemorrhage 13.88 12.25 51 147794 16405 110425049
Muscular weakness 13.87 12.25 241 147604 248227 110193227
Corpora cavernosa surgery 13.81 12.25 5 147840 84 110441370
Blood culture negative 13.80 12.25 7 147838 276 110441178
Blood pressure diastolic increased 13.79 12.25 4 147841 18803 110422651
Graft versus host disease 13.79 12.25 4 147841 18802 110422652
Akathisia 13.79 12.25 3 147842 17110 110424344
Sinusitis 13.75 12.25 297 147548 296391 110145063
Drug titration 13.73 12.25 4 147841 32 110441422
Oxygen consumption 13.70 12.25 5 147840 86 110441368
Pyrexia 13.66 12.25 1025 146820 897240 109544214
Ureteral disorder 13.66 12.25 9 147836 584 110440870
Scrotal swelling 13.66 12.25 12 147833 1199 110440255
Accidental exposure to product 13.64 12.25 29 147816 49979 110391475
Oesophageal variceal ligation 13.64 12.25 6 147839 171 110441283
Diabetic ketoacidosis 13.59 12.25 22 147823 42036 110399418
Infusion site mass 13.54 12.25 14 147831 1714 110439740
Malignant melanoma 13.53 12.25 3 147842 16888 110424566
Retinal detachment 13.53 12.25 39 147806 11061 110430393
Eye swelling 13.52 12.25 83 147762 32965 110408489
Chronic coronary syndrome 13.48 12.25 7 147838 290 110441164
Pulmonary alveolar haemorrhage 13.42 12.25 58 147787 20092 110421362
Blood pressure diastolic abnormal 13.42 12.25 9 147836 25806 110415648
Mitral perforation 13.41 12.25 4 147841 35 110441419
Puncture site pain 13.38 12.25 6 147839 179 110441275
Endotracheal intubation 13.35 12.25 27 147818 6117 110435337
Oesophageal dilatation 13.33 12.25 9 147836 608 110440846
Right atrial dilatation 13.33 12.25 11 147834 1009 110440445
Spontaneous penile erection 13.32 12.25 6 147839 181 110441273
Diagnostic procedure 13.26 12.25 6 147839 183 110441271
Immunoglobulin therapy 13.25 12.25 3 147842 7 110441447
Adverse reaction 13.25 12.25 12 147833 29582 110411872
Penis disorder 13.24 12.25 11 147834 1019 110440435
Penile haematoma 13.23 12.25 6 147839 184 110441270
Drug tolerance 13.17 12.25 3 147842 16582 110424872
Chronic hepatic failure 13.16 12.25 12 147833 1259 110440195
Device use error 13.14 12.25 34 147811 9055 110432399
Systemic-pulmonary artery shunt 13.12 12.25 4 147841 38 110441416
Ammonia increased 13.12 12.25 32 147813 8218 110433236
Renal failure 13.06 12.25 396 147449 226178 110215276
Wound treatment 13.05 12.25 6 147839 190 110441264
Renal stone removal 13.05 12.25 6 147839 190 110441264
Injection site pustule 13.01 12.25 5 147840 100 110441354
Dysphonia 12.99 12.25 157 147688 75772 110365682
Connective tissue disorder 12.98 12.25 14 147831 1798 110439656
Drug use disorder 12.97 12.25 4 147841 18070 110423384
Respiratory tract congestion 12.94 12.25 78 147767 30779 110410675
Joint dislocation 12.92 12.25 16 147829 34174 110407280
Biopsy liver 12.87 12.25 9 147836 644 110440810
Pyelonephritis 12.86 12.25 9 147836 25241 110416213
Product counterfeit 12.85 12.25 7 147838 320 110441134
Catheter site dryness 12.85 12.25 4 147841 41 110441413
Pneumothorax 12.82 12.25 86 147759 35199 110406255
Vaginal discharge 12.79 12.25 4 147841 17904 110423550
Vasodilatation 12.71 12.25 20 147825 3724 110437730
Hypertriglyceridaemia 12.68 12.25 3 147842 16151 110425303
Device maintenance issue 12.65 12.25 5 147840 108 110441346
Hepatopulmonary syndrome 12.60 12.25 6 147839 206 110441248
Peritonitis 12.59 12.25 15 147830 32592 110408862
Gastric varices 12.59 12.25 10 147835 869 110440585
Ataxia 12.56 12.25 13 147832 30095 110411359
Bone density decreased 12.55 12.25 3 147842 16039 110425415
Pathogen resistance 12.52 12.25 4 147841 17668 110423786
Pulse abnormal 12.51 12.25 21 147824 4128 110437326
Red cell distribution width increased 12.45 12.25 4 147841 17598 110423856
Sclerotherapy 12.43 12.25 4 147841 46 110441408
Vascular resistance pulmonary increased 12.40 12.25 5 147840 114 110441340
Portal hypertensive gastropathy 12.39 12.25 14 147831 1894 110439560
Dermatitis bullous 12.36 12.25 4 147841 17525 110423929
Thoracic cavity drainage 12.35 12.25 7 147838 346 110441108
Cardiorenal syndrome 12.33 12.25 14 147831 1904 110439550
Liver disorder 12.32 12.25 126 147719 142117 110299337
Brain natriuretic peptide abnormal 12.30 12.25 10 147835 898 110440556
Febrile bone marrow aplasia 12.29 12.25 4 147841 17461 110423993
Influenza like illness 12.28 12.25 176 147669 88236 110353218

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX52 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
ATC C02KX54 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
ATC G04BE08 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs used in erectile dysfunction
ATC G04CA54 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CB51 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Testosterone-5-alpha reductase inhibitors
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:35469 antidepressant
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:50864 insulin-sensitizing drug
CHEBI has role CHEBI:55324 gastrointestinal drug
CHEBI has role CHEBI:71942 EC 3.1.4.35 (3,5-cyclic-GMP phosphodiesterase) inhibitor
CHEBI has role CHEBI:74518 anti-obesity agent

Related Drugs by ATC class:

C02KX Antihypertensives for pulmonary arterial hypertension 6 drugs
ambrisentanbosentanmacitentanriociguatsitaxentansotatercept-csrk
G04BE Drugs used in erectile dysfunction 9 drugs
alprostadilapomorphineavanafilmoxisylytepapaverinesildenafiludenafilvardenafilyohimbine
G04CA Alpha-adrenoreceptor antagonists 8 drugs
alfuzosindoxazosindutasteridefinasteridesilodosinsolifenacintamsulosinterazosin
G04CB Testosterone-5-alpha reductase inhibitors 2 drugs
dutasteridefinasteride

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

DiseaseRelationSNOMED_IDDOID
Pulmonary hypertension indication 70995007 DOID:6432
Benign prostatic hyperplasia indication 266569009
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
Alcohol intoxication contraindication 25702006
Fibrosis of corpus cavernosum contraindication 32608004
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
Blood coagulation disorder contraindication 64779008 DOID:1247
Leukemia, disease contraindication 93143009 DOID:1240
Multiple myeloma contraindication 109989006 DOID:9538
Hb SS disease contraindication 127040003 DOID:10923
Seizure disorder contraindication 128613002
Acute peptic ulcer contraindication 196682000
Cerebrovascular accident contraindication 230690007
Penis bent contraindication 249247007
Exercise-induced angina contraindication 300995000
Functional visual loss contraindication 313165001
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
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 8.3 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 10946015 Sept. 11, 2026 USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 10946015 Sept. 11, 2026 USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 8268847 April 18, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 8268847 April 18, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL
20MG/5ML TADLIQ CMP DEV LLC N214522 June 17, 2022 RX SUSPENSION ORAL 11382917 Dec. 24, 2038 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML TADLIQ CMP DEV LLC N214522 June 17, 2022 RX SUSPENSION ORAL 11666576 Dec. 24, 2038 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML TADLIQ CMP DEV LLC N214522 June 17, 2022 RX SUSPENSION ORAL 11975006 Dec. 24, 2038 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML TADLIQ CMP DEV LLC N214522 June 17, 2022 RX SUSPENSION ORAL 12186322 Dec. 24, 2038 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2027 NEW PRODUCT
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2027 NEW PRODUCT
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2027 PEDIATRIC EXCLUSIVITY
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2027 PEDIATRIC EXCLUSIVITY
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2031 CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2031 CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2031 PEDIATRIC EXCLUSIVITY
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2031 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme INHIBITOR Ki 8 CHEMBL CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4 CHEMBL
Acetylcholinesterase Enzyme IC50 4.58 CHEMBL
Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A Enzyme IC50 7.48 CHEMBL
Phosphodiesterase 6 Enzyme IC50 6.01 CHEMBL
Nuclear receptor subfamily 2 group E member 1 Nuclear hormone receptor EC50 5.30 CHEMBL
Acetylcholinesterase Enzyme IC50 4.58 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme Ki 8.30 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme IC50 8.48 CHEMBL
Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha Enzyme IC50 5.52 CHEMBL
Phosphodiesterase 6 Enzyme IC50 5.29 CHEMBL

External reference:

IDSource
4021415 VUID
N0000148829 NUI
D02008 KEGG_DRUG
4021415 VANDF
C1176316 UMLSCUI
CHEBI:71940 CHEBI
CIA PDB_CHEM_ID
CHEMBL779 ChEMBL_ID
DB00820 DRUGBANK_ID
D000068581 MESH_DESCRIPTOR_UI
110635 PUBCHEM_CID
7299 IUPHAR_LIGAND_ID
8136 INN_ID
742SXX0ICT UNII
303263 RXNORM
17580 MMSL
245338 MMSL
47489 MMSL
d04896 MMSL
009874 NDDF
407111005 SNOMEDCT_US
407734006 SNOMEDCT_US
742SXX0ICT INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4462 TABLET, FILM COATED 5 mg ORAL NDA 33 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4463 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4464 TABLET, FILM COATED 20 mg ORAL NDA 33 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0480-2309 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0480-2310 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0480-2311 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
ALYQ HUMAN PRESCRIPTION DRUG LABEL 1 0480-9277 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-565 TABLET 2.50 mg ORAL ANDA 25 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-566 TABLET 5 mg ORAL ANDA 25 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-567 TABLET 10 mg ORAL ANDA 25 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-568 TABLET 20 mg ORAL ANDA 25 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-581 TABLET 20 mg ORAL ANDA 29 sections
CIALIS HUMAN PRESCRIPTION DRUG LABEL 1 16590-905 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Tadalafil Human Prescription Drug Label 1 16714-074 TABLET, FILM COATED 2.50 mg ORAL ANDA 29 sections
Tadalafil Human Prescription Drug Label 1 16714-075 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Tadalafil Human Prescription Drug Label 1 16714-076 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Tadalafil Human Prescription Drug Label 1 16714-077 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 16729-369 TABLET, FILM COATED 2.50 mg ORAL ANDA 30 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 16729-370 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 16729-371 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 16729-372 TABLET, FILM COATED 20 mg ORAL ANDA 30 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 21695-028 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 21695-029 TABLET, FILM COATED 20 mg ORAL NDA 30 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 24979-727 TABLET, FILM COATED 2.50 mg ORAL ANDA 31 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 24979-728 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 24979-729 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 24979-730 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
Tadalafil Human Prescription Drug Label 1 27241-111 TABLET 2.50 mg ORAL ANDA 28 sections
Tadalafil Human Prescription Drug Label 1 27241-112 TABLET 5 mg ORAL ANDA 28 sections
Tadalafil Human Prescription Drug Label 1 27241-113 TABLET 10 mg ORAL ANDA 28 sections