sildenafil Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mysildecard
  • sildenafil
  • sildenafil citrate
  • revatio
A PHOSPHODIESTERASE TYPE-5 INHIBITOR; VASODILATOR AGENT and UROLOGICAL AGENT that is used in the treatment of ERECTILE DYSFUNCTION and PRIMARY PULMONARY HYPERTENSION.
  • Molecular weight: 474.58
  • Formula: C22H30N6O4S
  • CLOGP: 1.98
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 1
  • TPSA: 109.13
  • ALOGS: -3.01
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
March 27, 1998 FDA PFIZER IRELAND

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pulmonary arterial hypertension 3001.59 13.04 1404 114011 24524 46546123
Dyspnoea 2014.65 13.04 4112 111303 511436 46059211
Pulmonary hypertension 1741.90 13.04 1093 114322 34900 46535747
Fluid retention 1631.66 13.04 1199 114216 49847 46520800
Right ventricular failure 1562.46 13.04 773 114642 15320 46555327
Pain in jaw 1193.41 13.04 887 114528 37485 46533162
Death 1105.34 13.04 2505 112910 333043 46237604
Fluid overload 792.93 13.04 605 114810 26580 46544067
Dyspnoea exertional 776.76 13.04 779 114636 49510 46521137
Drug ineffective 673.13 13.04 426 114989 677412 45893235
Catheter site erythema 620.97 13.04 266 115149 3717 46566930
Headache 614.34 13.04 2568 112847 475784 46094863
Nasal congestion 507.23 13.04 610 114805 47503 46523144
Oxygen saturation decreased 491.76 13.04 723 114692 68441 46502206
Lung transplant 490.29 13.04 205 115210 2687 46567960
Oedema 489.74 13.04 710 114705 66361 46504286
Transfusion 486.82 13.04 339 115076 12892 46557755
Hospitalisation 452.61 13.04 664 114751 62721 46507926
Device related infection 452.24 13.04 392 115023 20649 46549998
Flushing 445.74 13.04 666 114749 63948 46506699
Catheter site pruritus 431.10 13.04 168 115247 1811 46568836
Catheter management 423.66 13.04 183 115232 2612 46568035
Catheter site pain 414.79 13.04 198 115217 3608 46567039
Rheumatoid arthritis 386.27 13.04 65 115350 240150 46330497
Infusion site pain 381.29 13.04 263 115152 9844 46560803
Toxicity to various agents 347.81 13.04 54 115361 211712 46358935
Hypoxia 339.95 13.04 522 114893 51316 46519331
Pulmonary arterial pressure increased 320.01 13.04 159 115256 3173 46567474
Chest pain 318.63 13.04 1059 114356 175265 46395382
Catheter site discharge 318.30 13.04 135 115280 1837 46568810
Completed suicide 305.06 13.04 13 115402 145907 46424740
Catheterisation cardiac 299.20 13.04 162 115253 3885 46566762
Drug hypersensitivity 290.10 13.04 120 115295 243705 46326942
Oedema peripheral 278.53 13.04 948 114467 158758 46411889
Catheter site infection 277.52 13.04 163 115252 4590 46566057
Cardiac failure 274.72 13.04 609 114806 79339 46491308
Neutropenia 271.38 13.04 22 115393 143182 46427465
Syncope 266.73 13.04 711 114704 104092 46466555
Cough 250.35 13.04 1179 114236 229070 46341577
Oxygen consumption increased 247.02 13.04 138 115277 3525 46567122
Pulmonary oedema 242.08 13.04 445 114970 50660 46519987
Condition aggravated 237.99 13.04 1215 114200 243837 46326810
Central venous catheterisation 228.52 13.04 108 115307 1922 46568725
Catheter site swelling 221.77 13.04 93 115322 1228 46569419
Scleroderma 219.60 13.04 139 115276 4490 46566157
Infusion site erythema 218.11 13.04 168 115247 7474 46563173
Pneumonia 216.58 13.04 1630 113785 374690 46195957
Infusion related reaction 211.53 13.04 9 115406 101199 46469448
Drug interaction 205.29 13.04 124 115291 202970 46367677
Device leakage 203.27 13.04 140 115275 5225 46565422
Alopecia 202.83 13.04 74 115341 162340 46408307
Catheter placement 199.46 13.04 97 115318 1844 46568803
Device alarm issue 191.17 13.04 85 115330 1305 46569342
Catheter site haemorrhage 190.73 13.04 105 115310 2604 46568043
Palpitations 189.76 13.04 592 114823 94667 46475980
Respiratory failure 186.81 13.04 587 114828 94229 46476418
Treatment failure 185.89 13.04 11 115404 93076 46477571
Febrile neutropenia 183.57 13.04 13 115402 94614 46476033
Disease progression 177.81 13.04 563 114852 90737 46479910
Rash 177.73 13.04 386 115029 356126 46214521
Unevaluable event 173.69 13.04 365 115050 45810 46524837
Infusion site infection 171.57 13.04 80 115335 1379 46569268
Psoriasis 171.18 13.04 5 115410 78599 46492048
Cardiac failure congestive 166.22 13.04 552 114863 91198 46479449
Hypotension 163.77 13.04 1059 114356 231530 46339117
Transplant evaluation 161.59 13.04 70 115345 1006 46569641
Contraindicated product administered 149.41 13.04 13 115402 79934 46490713
Concomitant disease aggravated 141.99 13.04 133 115282 7749 46562898
Dizziness 141.38 13.04 1372 114043 339042 46231605
Cardiac operation 138.96 13.04 85 115330 2581 46568066
Therapy change 136.80 13.04 108 115307 4982 46565665
Catheter site rash 136.42 13.04 56 115359 698 46569949
Catheter site irritation 134.41 13.04 49 115366 432 46570215
Diarrhoea 129.85 13.04 2020 113395 557582 46013065
Acute respiratory failure 129.53 13.04 247 115168 28891 46541756
Drug abuse 128.09 13.04 7 115408 63401 46507246
Cardiac disorder 127.43 13.04 313 115102 43545 46527102
Injection site pain 126.81 13.04 53 115362 107099 46463548
Malignant neoplasm progression 125.68 13.04 9 115406 64917 46505730
White blood cell count decreased 121.25 13.04 63 115352 112168 46458479
Joint swelling 120.25 13.04 140 115275 165933 46404714
Malaise 118.88 13.04 1296 114119 329936 46240711
Dialysis 117.68 13.04 135 115280 9981 46560666
Therapeutic product effect decreased 116.80 13.04 30 115385 82571 46488076
Musculoskeletal stiffness 116.72 13.04 48 115367 97945 46472702
Product dose omission issue 116.44 13.04 764 114651 167756 46402891
Urticaria 116.21 13.04 74 115341 117818 46452829
Depression 116.21 13.04 150 115265 169954 46400693
Pulmonary veno-occlusive disease 116.11 13.04 53 115362 868 46569779
Device occlusion 114.23 13.04 104 115311 5841 46564806
Dermatitis contact 112.87 13.04 119 115296 8004 46562643
Hypertension 110.22 13.04 198 115217 196158 46374489
Exercise tolerance decreased 110.05 13.04 91 115324 4486 46566161
Overdose 106.14 13.04 60 115355 101919 46468728
Epistaxis 105.14 13.04 374 115041 63931 46506716
Dyspnoea at rest 104.84 13.04 80 115335 3508 46567139
Ascites 104.07 13.04 259 115156 36325 46534322
Pulmonary hypertensive crisis 103.23 13.04 32 115383 160 46570487
Paracentesis 102.47 13.04 49 115366 896 46569751
Infusion site swelling 102.34 13.04 96 115319 5603 46565044
Vascular device infection 101.85 13.04 78 115337 3439 46567208
Anaphylactic reaction 100.98 13.04 8 115407 53104 46517543
Infusion site discharge 100.53 13.04 42 115373 549 46570098
Stomatitis 98.11 13.04 24 115391 68273 46502374
Device infusion issue 95.45 13.04 49 115366 1050 46569597
Catheter site inflammation 94.85 13.04 42 115373 638 46570009
Pericardial effusion 93.80 13.04 200 115215 25343 46545304
Therapy non-responder 91.51 13.04 266 115149 40886 46529761
Chest discomfort 91.12 13.04 453 114962 89816 46480831
Suicidal ideation 91.01 13.04 15 115400 56367 46514280
Injection site erythema 91.01 13.04 35 115380 74392 46496255
Intentional overdose 89.14 13.04 25 115390 64919 46505728
Electrocardiogram QT prolonged 89.04 13.04 11 115404 51314 46519333
Therapeutic product effect incomplete 88.75 13.04 41 115374 78112 46492535
Leukopenia 87.19 13.04 30 115385 68313 46502334
Multiple sclerosis relapse 87.15 13.04 4 115411 42121 46528526
Peripheral swelling 86.72 13.04 678 114737 157393 46413254
Pruritus 85.90 13.04 309 115106 242043 46328604
Right ventricular dysfunction 85.84 13.04 51 115364 1467 46569180
Abdominal distension 85.63 13.04 384 115031 72967 46497680
Catheter site related reaction 85.48 13.04 41 115374 755 46569892
N-terminal prohormone brain natriuretic peptide increased 85.23 13.04 53 115362 1658 46568989
Complication associated with device 84.08 13.04 143 115272 15298 46555349
Cardiac pacemaker insertion 83.68 13.04 71 115344 3628 46567019
Injection site reaction 83.64 13.04 10 115405 47839 46522808
Emergency care 83.29 13.04 41 115374 801 46569846
Blood pressure increased 83.11 13.04 115 115300 126551 46444096
Mucosal inflammation 82.98 13.04 3 115412 38973 46531674
Device dislocation 82.71 13.04 173 115242 21629 46549018
Presyncope 82.44 13.04 185 115230 24269 46546378
Walking distance test abnormal 82.07 13.04 35 115380 483 46570164
Haemoptysis 81.53 13.04 192 115223 25997 46544650
Neutrophil count decreased 81.29 13.04 7 115408 43419 46527228
Brain natriuretic peptide increased 80.96 13.04 77 115338 4573 46566074
Suicide attempt 79.71 13.04 19 115396 55017 46515630
Acute kidney injury 79.47 13.04 307 115108 235548 46335099
Arthropathy 78.33 13.04 57 115358 84643 46486004
Maternal exposure during pregnancy 77.97 13.04 83 115332 102466 46468181
Oxygen therapy 76.40 13.04 51 115364 1806 46568841
Hypersensitivity 76.14 13.04 161 115254 150160 46420487
Glossodynia 75.79 13.04 10 115405 44363 46526284
Neuropathy peripheral 75.53 13.04 68 115347 90825 46479822
Productive cough 75.35 13.04 286 115129 50429 46520218
Confusional state 73.89 13.04 180 115235 159712 46410935
Off label use 73.51 13.04 594 114821 379247 46191400
Cardiac ablation 73.03 13.04 43 115372 1216 46569431
Coma 72.06 13.04 27 115388 58322 46512325
Injection site bruising 71.76 13.04 4 115411 35632 46535015
Infusion site haemorrhage 71.40 13.04 52 115363 2122 46568525
Arthralgia 71.09 13.04 569 114846 364034 46206613
Deep vein thrombosis 70.80 13.04 56 115359 79717 46490930
Drug intolerance 70.77 13.04 162 115253 146887 46423760
Pancytopenia 70.24 13.04 64 115351 84994 46485653
Osteoarthritis 69.71 13.04 33 115382 61992 46508655
Catheter site vesicles 69.06 13.04 26 115389 253 46570394
Heart rate increased 68.96 13.04 366 115049 74425 46496222
Cor pulmonale 67.30 13.04 48 115367 1895 46568752
Wrong technique in product usage process 65.85 13.04 26 115389 54396 46516251
Plasma cell myeloma 65.12 13.04 15 115400 44463 46526184
Systemic scleroderma 64.94 13.04 35 115380 831 46569816
Atrial flutter 63.99 13.04 95 115320 9053 46561594
Blood cholesterol increased 63.79 13.04 11 115404 40002 46530645
Thrombocytopenia 62.90 13.04 137 115278 126444 46444203
Paraesthesia 62.68 13.04 122 115293 117315 46453332
Hyponatraemia 62.53 13.04 96 115319 101236 46469411
Infusion site pruritus 62.46 13.04 56 115359 3082 46567565
Hepatic enzyme increased 62.38 13.04 66 115349 81721 46488926
Angioedema 62.32 13.04 11 115404 39331 46531316
Balloon atrial septostomy 61.50 13.04 18 115397 71 46570576
Myalgia 61.00 13.04 516 114899 122572 46448075
Heart transplant 60.69 13.04 27 115388 415 46570232
Influenza 60.51 13.04 403 115012 88867 46481780
Infusion site irritation 60.13 13.04 28 115387 481 46570166
Mechanical ventilation 59.68 13.04 38 115377 1240 46569407
Hypoglycaemia 59.43 13.04 30 115385 54319 46516328
Cyanosis 58.57 13.04 125 115290 15846 46554801
Bone marrow failure 57.73 13.04 4 115411 29665 46540982
Lung disorder 57.68 13.04 236 115179 43068 46527579
Abdominal cavity drainage 57.60 13.04 25 115390 361 46570286
Mobility decreased 57.03 13.04 40 115375 60554 46510093
Heart and lung transplant 56.95 13.04 18 115397 97 46570550
Injury 56.71 13.04 19 115396 44008 46526639
Hallucination 55.48 13.04 27 115388 49924 46520723
Right ventricular dilatation 55.08 13.04 32 115383 882 46569765
Injection site swelling 54.45 13.04 16 115399 40311 46530336
Disease complication 54.40 13.04 51 115364 2974 46567673
Infusion site cellulitis 54.06 13.04 19 115396 149 46570498
Hypoaesthesia 53.96 13.04 135 115280 118734 46451913
Tracheostomy 53.65 13.04 27 115388 554 46570093
Chronic respiratory failure 53.42 13.04 40 115375 1704 46568943
Device related sepsis 52.66 13.04 52 115363 3235 46567412
Impaired healing 52.59 13.04 13 115402 36730 46533917
Ventilation perfusion mismatch 52.29 13.04 20 115395 204 46570443
Drug reaction with eosinophilia and systemic symptoms 52.07 13.04 6 115409 29542 46541105
Right ventricular systolic pressure increased 51.91 13.04 26 115389 528 46570119
Atrial septal defect repair 51.19 13.04 20 115395 217 46570430
Oxygen saturation abnormal 51.15 13.04 47 115368 2671 46567976
Depressed level of consciousness 50.91 13.04 27 115388 47542 46523105
Blood pressure decreased 50.83 13.04 277 115138 56882 46513765
Cardioversion 50.70 13.04 33 115382 1119 46569528
Terminal state 50.45 13.04 43 115372 2211 46568436
Product quality issue 50.27 13.04 13 115402 35635 46535012
Catheter removal 50.18 13.04 22 115393 326 46570321
Emotional distress 49.93 13.04 8 115407 30699 46539948
Nasopharyngitis 49.81 13.04 591 114824 153407 46417240
Asthma 49.79 13.04 94 115321 91448 46479199
Seizure 49.68 13.04 148 115267 122906 46447741
Abortion spontaneous 49.38 13.04 23 115392 43623 46527024
Catheter site warmth 49.23 13.04 19 115396 199 46570448
Gout 48.90 13.04 95 115320 11261 46559386
Injection site pruritus 48.06 13.04 19 115396 39724 46530923
Packed red blood cell transfusion 47.87 13.04 41 115374 2122 46568525
Thrombosis in device 47.48 13.04 47 115368 2932 46567715
Infusion site warmth 46.06 13.04 32 115383 1211 46569436
Exposure during pregnancy 45.99 13.04 127 115288 108085 46462562
Blood creatine phosphokinase increased 45.58 13.04 7 115408 27717 46542930
Therapeutic response decreased 45.42 13.04 25 115390 43120 46527527
Finger amputation 44.34 13.04 23 115392 504 46570143
Device breakage 44.10 13.04 83 115332 9609 46561038
Concomitant disease progression 43.86 13.04 39 115376 2123 46568524
Inappropriate schedule of product administration 43.65 13.04 58 115357 64955 46505692
Pain in extremity 43.62 13.04 889 114526 257791 46312856
Pulmonary arterial pressure abnormal 43.60 13.04 22 115393 454 46570193
Congestive hepatopathy 43.36 13.04 41 115374 2417 46568230
Hepatocellular injury 43.12 13.04 10 115405 29512 46541135
Delirium 43.08 13.04 19 115396 37209 46533438
Infusion site induration 42.90 13.04 26 115389 776 46569871
Lung assist device therapy 42.61 13.04 13 115402 61 46570586
Aspiration pleural cavity 42.34 13.04 26 115389 795 46569852
Blood culture positive 42.33 13.04 54 115361 4458 46566189
Injection site discharge 42.31 13.04 20 115395 356 46570291
Transplant 42.26 13.04 24 115391 633 46570014
Product use in unapproved indication 42.16 13.04 101 115314 90172 46480475
Device physical property issue 41.66 13.04 32 115383 1417 46569230
Multiple sclerosis 41.36 13.04 6 115409 24785 46545862
Dependence on oxygen therapy 40.61 13.04 19 115396 330 46570317
Stent placement 40.59 13.04 47 115368 3509 46567138
Drug withdrawal syndrome 40.55 13.04 9 115406 27375 46543272
Device malfunction 40.48 13.04 97 115318 13277 46557370
Medical device change 40.30 13.04 19 115396 336 46570311
Infusion site abscess 40.05 13.04 16 115399 185 46570462
Generalised tonic-clonic seizure 39.99 13.04 9 115406 27113 46543534
Internal haemorrhage 39.73 13.04 52 115363 4403 46566244
Pulmonary pain 39.62 13.04 33 115382 1643 46569004
Aggression 39.14 13.04 5 115410 22739 46547908
Right ventricular hypertrophy 39.01 13.04 23 115392 652 46569995
Arthritis 38.95 13.04 83 115332 77233 46493414
Device connection issue 38.95 13.04 23 115392 654 46569993
Lymphocyte count decreased 38.73 13.04 8 115407 25581 46545066
Fibromyalgia 38.57 13.04 21 115394 36442 46534205
Foetal exposure during pregnancy 38.34 13.04 14 115401 30733 46539914
Lactic acidosis 38.16 13.04 18 115397 33891 46536756
Bone disorder 38.12 13.04 3 115412 20030 46550617
Rehabilitation therapy 37.99 13.04 28 115387 1164 46569483
C-reactive protein increased 37.60 13.04 54 115361 58536 46512111
Right ventricular enlargement 37.60 13.04 17 115398 272 46570375
Catheterisation cardiac abnormal 37.44 13.04 16 115399 222 46570425
Sedation 37.18 13.04 6 115409 22904 46547743
Biopsy liver 37.02 13.04 19 115396 407 46570240
Swollen tongue 36.98 13.04 13 115402 29219 46541428
Agitation 36.63 13.04 50 115365 55365 46515282
Chronic obstructive pulmonary disease 36.55 13.04 256 115159 57377 46513270
Cognitive disorder 36.52 13.04 23 115392 36860 46533787
Rhinovirus infection 36.48 13.04 45 115370 3591 46567056
Sinus congestion 36.42 13.04 92 115323 13017 46557630
Catheter site nodule 36.16 13.04 11 115404 51 46570596
Catheter site discolouration 36.13 13.04 13 115402 110 46570537
Pulmonary embolism 36.08 13.04 142 115273 108443 46462204
Stevens-Johnson syndrome 35.85 13.04 7 115408 23290 46547357
Osteoporosis 35.40 13.04 29 115386 40579 46530068
Drug dependence 35.17 13.04 4 115411 19897 46550750
Pericarditis 35.16 13.04 8 115407 23919 46546728
Right-to-left cardiac shunt 35.03 13.04 14 115401 162 46570485
Sopor 35.00 13.04 4 115411 19824 46550823
Liver transplant 34.63 13.04 36 115379 2381 46568266
Hyperglycaemia 34.55 13.04 22 115393 35049 46535598
Disease recurrence 34.50 13.04 3 115412 18468 46552179
Drug-induced liver injury 34.37 13.04 10 115405 25358 46545289
Somnolence 34.35 13.04 236 115179 156285 46414362
Cardiac failure acute 34.08 13.04 67 115348 8011 46562636
Oral herpes 34.01 13.04 4 115411 19386 46551261
Catheter site scab 33.86 13.04 14 115401 178 46570469
Pleural effusion 33.58 13.04 333 115082 82619 46488028
Respiratory distress 33.47 13.04 162 115253 31754 46538893
Osteonecrosis 33.35 13.04 11 115404 25733 46544914
Product use issue 33.16 13.04 369 115046 94275 46476372
Dyskinesia 33.10 13.04 15 115400 28910 46541737
Intentional product misuse 32.71 13.04 41 115374 47087 46523560
Central venous catheter removal 32.67 13.04 16 115399 309 46570338
Metabolic acidosis 32.21 13.04 29 115386 38751 46531896
Pulmonary artery dilatation 32.14 13.04 14 115401 204 46570443
Hyperlipidaemia 32.08 13.04 4 115411 18535 46552112
Left-to-right cardiac shunt 32.04 13.04 12 115403 115 46570532
Infusion site oedema 31.93 13.04 18 115397 468 46570179
Dysphagia 31.90 13.04 92 115323 77220 46493427
Basal cell carcinoma 31.86 13.04 6 115409 20481 46550166
Hepatic steatosis 31.62 13.04 10 115405 24032 46546615
Drug eruption 31.60 13.04 7 115408 21322 46549325
Dizziness postural 31.59 13.04 57 115358 6389 46564258
Hospice care 31.46 13.04 51 115364 5244 46565403
Dysentery 31.45 13.04 21 115394 744 46569903
Inflammation 31.26 13.04 45 115370 48736 46521911
Feeling abnormal 31.25 13.04 458 114957 124602 46446045
Acute right ventricular failure 31.04 13.04 13 115402 171 46570476
Pulmonary artery aneurysm 30.65 13.04 9 115406 36 46570611
Pulmonary vascular resistance abnormality 30.65 13.04 9 115406 36 46570611
Hypocalcaemia 30.47 13.04 14 115401 26771 46543876
Bursitis 30.45 13.04 6 115409 19836 46550811
Pulmonary congestion 30.36 13.04 93 115322 14706 46555941
Hyperkalaemia 30.36 13.04 49 115366 50660 46519987
Skin lesion 30.33 13.04 14 115401 26699 46543948
Peritonitis 30.29 13.04 7 115408 20707 46549940
Blood culture negative 29.57 13.04 12 115403 145 46570502
Drug resistance 29.45 13.04 4 115411 17364 46553283
Vascular resistance pulmonary decreased 29.43 13.04 10 115405 70 46570577
Aphasia 29.42 13.04 17 115398 28550 46542097
Paranasal sinus hypersecretion 29.33 13.04 38 115377 3186 46567461
Hypokalaemia 29.31 13.04 115 115300 87909 46482738
Epilepsy 29.28 13.04 11 115404 23727 46546920
Red blood cell sedimentation rate increased 29.26 13.04 10 115405 22879 46547768
Renal disorder 29.11 13.04 137 115278 26549 46544098
Abnormal behaviour 29.08 13.04 8 115407 21050 46549597
Dysarthria 28.87 13.04 30 115385 37468 46533179
Respiration abnormal 28.86 13.04 45 115370 4476 46566171
Product supply issue 28.83 13.04 21 115394 857 46569790
Orthopnoea 28.82 13.04 52 115363 5828 46564819
Endotracheal intubation 28.81 13.04 31 115384 2134 46568513
Blood glucose increased 28.77 13.04 87 115328 71926 46498721
Balance disorder 28.70 13.04 74 115341 64447 46506200
Altered state of consciousness 28.49 13.04 11 115404 23337 46547310
Acute myeloid leukaemia 28.32 13.04 3 115412 15775 46554872
Pulmonary arterial wedge pressure increased 28.19 13.04 14 115401 279 46570368
Disturbance in attention 28.18 13.04 22 115393 31538 46539109
Hernia repair 28.14 13.04 23 115392 1115 46569532
Catheter site extravasation 27.99 13.04 13 115402 222 46570425
Full blood count decreased 27.89 13.04 10 115405 22201 46548446
Systemic-pulmonary artery shunt 27.86 13.04 8 115407 29 46570618
Localised oedema 27.67 13.04 47 115368 5022 46565625
Urinary retention 27.58 13.04 15 115400 26046 46544601
Foot deformity 27.51 13.04 3 115412 15422 46555225
Metastases to bone 27.43 13.04 5 115410 17471 46553176
Accidental exposure to product 27.32 13.04 9 115406 21072 46549575
Incorrect route of product administration 27.25 13.04 4 115411 16379 46554268
Blood pressure systolic increased 27.09 13.04 19 115396 28768 46541879
Therapeutic embolisation 26.88 13.04 11 115404 136 46570511
Posterior reversible encephalopathy syndrome 26.86 13.04 3 115412 15138 46555509
Pancreatitis acute 26.78 13.04 14 115401 24858 46545789
Withdrawal syndrome 26.77 13.04 6 115409 18128 46552519
Gastrostomy 26.61 13.04 17 115398 558 46570089
Blood potassium decreased 26.48 13.04 173 115242 37890 46532757
Pulmonary arterial pressure 26.45 13.04 7 115408 17 46570630
Sleep study 26.45 13.04 7 115408 17 46570630
Constipation 26.38 13.04 289 115126 173808 46396839
Platelet count increased 26.26 13.04 3 115412 14871 46555776
Heart valve operation 26.11 13.04 11 115404 147 46570500
Patent ductus arteriosus repair 25.90 13.04 7 115408 19 46570628
Hyperhidrosis 25.87 13.04 123 115292 89185 46481462
Bradycardia 25.84 13.04 81 115334 66217 46504430
Carbon dioxide increased 25.47 13.04 22 115393 1152 46569495
Device programming error 25.33 13.04 8 115407 43 46570604
Dialysis related complication 25.24 13.04 9 115406 74 46570573
Muscular weakness 25.16 13.04 129 115286 91715 46478932
Pneumonitis 25.14 13.04 20 115395 28400 46542247
Device issue 25.12 13.04 107 115308 19873 46550774
Anti factor VIII antibody test 25.03 13.04 5 115410 0 46570647
Coronary artery compression 25.03 13.04 5 115410 0 46570647
Cholestasis 24.98 13.04 18 115397 26875 46543772
Mouth ulceration 24.87 13.04 18 115397 26814 46543833
Type 2 diabetes mellitus 24.87 13.04 9 115406 19866 46550781
Mood swings 24.76 13.04 5 115410 16247 46554400
Infusion site rash 24.73 13.04 20 115395 955 46569692
Lower respiratory tract infection 24.65 13.04 63 115352 55026 46515621
Skin exfoliation 24.64 13.04 27 115388 32911 46537736
Medication error 24.63 13.04 24 115391 30887 46539760
Nausea 24.54 13.04 1994 113421 685460 45885187
Breast cancer 24.51 13.04 47 115368 45471 46525176
Jugular vein distension 24.43 13.04 19 115396 857 46569790
Herpes zoster 24.34 13.04 86 115329 67786 46502861
Application site pruritus 24.31 13.04 39 115376 3974 46566673
Injection site mass 24.27 13.04 4 115411 15036 46555611
Sinus disorder 24.25 13.04 93 115322 16470 46554177
Ventricular septal defect repair 24.17 13.04 6 115409 10 46570637
Tremor 24.07 13.04 177 115238 115462 46455185
Cerebral infarction 23.93 13.04 14 115401 23352 46547295
Carpal tunnel syndrome 23.91 13.04 5 115410 15854 46554793
Coronary artery disease 23.81 13.04 29 115386 33723 46536924
Sinus bradycardia 23.79 13.04 3 115412 13779 46556868
Cardiac output decreased 23.75 13.04 19 115396 893 46569754
Treatment noncompliance 23.73 13.04 140 115275 29591 46541056
Drug level increased 23.67 13.04 8 115407 18433 46552214
Myelodysplastic syndrome 23.60 13.04 5 115410 15706 46554941
Orthostatic hypotension 23.57 13.04 16 115399 24642 46546005
Weight increased 23.45 13.04 552 114863 163921 46406726
Proteinuria 23.41 13.04 6 115409 16547 46554100
Dizziness exertional 23.37 13.04 13 115402 329 46570318
Retching 23.11 13.04 78 115337 12979 46557668
Diagnostic procedure 23.09 13.04 9 115406 97 46570550
Pain 23.01 13.04 955 114460 475993 46094654
Blood bilirubin increased 22.95 13.04 154 115261 34030 46536617
Joint stiffness 22.84 13.04 20 115395 27088 46543559
Eczema 22.69 13.04 11 115404 20389 46550258
Metastases to liver 22.65 13.04 10 115405 19575 46551072
Speech disorder 22.55 13.04 34 115381 36133 46534514
Hallucination, visual 22.52 13.04 8 115407 17865 46552782
Application site odour 22.42 13.04 7 115408 36 46570611
Blister 22.40 13.04 48 115367 44583 46526064
Application site irritation 22.39 13.04 25 115390 1794 46568853
Anxiety 22.32 13.04 316 115099 181641 46389006
Colitis ulcerative 22.23 13.04 8 115407 17724 46552923
Head discomfort 22.13 13.04 66 115349 10285 46560362
Nocturnal dyspnoea 22.04 13.04 19 115396 992 46569655
Status epilepticus 21.94 13.04 4 115411 13975 46556672
Ataxia 21.83 13.04 4 115411 13926 46556721
CREST syndrome 21.82 13.04 13 115402 376 46570271
Immunoglobulin G4 related disease 21.80 13.04 8 115407 72 46570575
Portopulmonary hypertension 21.79 13.04 9 115406 114 46570533
Acne 21.76 13.04 11 115404 19908 46550739
Decreased appetite 21.67 13.04 630 114785 193206 46377441
Intentional product use issue 21.63 13.04 63 115352 52717 46517930
Pericardial drainage 21.63 13.04 11 115404 231 46570416
Cytomegalovirus infection 21.40 13.04 9 115406 18135 46552512
Viral infection 21.38 13.04 138 115277 30097 46540550
Exercise test abnormal 21.31 13.04 9 115406 121 46570526
Generalised oedema 21.20 13.04 81 115334 14318 46556329
Gastritis hypertrophic 21.11 13.04 7 115408 45 46570602
Hypercalcaemia 21.01 13.04 13 115402 21033 46549614
Femur fracture 20.99 13.04 37 115378 36960 46533687
Hypothyroidism 20.99 13.04 28 115387 31310 46539337
Ear tube insertion 20.97 13.04 8 115407 81 46570566
Pulmonary arterial pressure decreased 20.88 13.04 8 115407 82 46570565
Chronic right ventricular failure 20.84 13.04 6 115409 22 46570625
Osteomyelitis 20.76 13.04 15 115400 22368 46548279
Toxic skin eruption 20.66 13.04 3 115412 12384 46558263
Echocardiogram abnormal 20.63 13.04 18 115397 955 46569692
Pulmonary haemorrhage 20.58 13.04 48 115367 6457 46564190
Cor pulmonale chronic 20.56 13.04 10 115405 190 46570457
Hypomagnesaemia 20.45 13.04 15 115400 22195 46548452
Eosinophilia 20.42 13.04 11 115404 19206 46551441
Adverse drug reaction 20.41 13.04 50 115365 44312 46526335
Catheter culture positive 20.37 13.04 9 115406 136 46570511
Intervertebral disc degeneration 20.35 13.04 4 115411 13248 46557399
Diet noncompliance 20.30 13.04 11 115404 264 46570383
Spinal osteoarthritis 20.26 13.04 5 115410 14146 46556501
Ischaemic stroke 20.21 13.04 8 115407 16714 46553933
Infusion site inflammation 20.15 13.04 10 115405 199 46570448
Injection site rash 20.06 13.04 7 115408 15806 46554841
Increased ventricular preload 20.02 13.04 4 115411 0 46570647
Cyst 20.02 13.04 3 115412 12097 46558550
Vertigo 19.99 13.04 64 115351 51984 46518663
Nightmare 19.96 13.04 8 115407 16590 46554057
Dysgeusia 19.95 13.04 44 115371 40447 46530200
Prescribed underdose 19.91 13.04 3 115412 12050 46558597
Infusion site discolouration 19.87 13.04 14 115401 542 46570105
Oxygen consumption 19.83 13.04 8 115407 95 46570552
Nasal dryness 19.83 13.04 33 115382 3467 46567180
Colitis 19.73 13.04 39 115376 37308 46533339
Tubulointerstitial nephritis 19.72 13.04 6 115409 14782 46555865
Skin operation 19.56 13.04 5 115410 10 46570637
Musculoskeletal disorder 19.51 13.04 7 115408 15538 46555109
Injection site warmth 19.46 13.04 5 115410 13767 46556880
Urinary tract infection 19.42 13.04 406 115009 219860 46350787
Hepatitis 19.40 13.04 31 115384 32184 46538463
Blood triglycerides increased 19.31 13.04 3 115412 11780 46558867
Breast cancer metastatic 19.26 13.04 5 115410 13673 46556974
Staphylococcus test positive 19.26 13.04 33 115382 3551 46567096
Protein-losing gastroenteropathy 19.25 13.04 9 115406 156 46570491
Disorientation 19.12 13.04 39 115376 36879 46533768
Respiratory syncytial virus infection 19.08 13.04 39 115376 4796 46565851
Impaired work ability 19.02 13.04 4 115411 12632 46558015
Gait disturbance 18.99 13.04 249 115166 145014 46425633
Tenderness 18.93 13.04 9 115406 16872 46553775
Rash erythematous 18.91 13.04 35 115380 34315 46536332
Cataract 18.76 13.04 54 115361 45361 46525286
Atrial fibrillation 18.74 13.04 360 115055 103230 46467417
Tendonitis 18.67 13.04 6 115409 14271 46556376
Blood pressure fluctuation 18.62 13.04 29 115386 30419 46540228
Product substitution issue 18.48 13.04 7 115408 15024 46555623
Catheter site dryness 18.45 13.04 6 115409 36 46570611
Dry eye 18.43 13.04 29 115386 30293 46540354
Catheter site cellulitis 18.42 13.04 10 115405 241 46570406
Cardiac failure chronic 18.35 13.04 32 115383 3492 46567155
Wound 18.34 13.04 50 115365 42752 46527895
Left ventricular failure 18.23 13.04 39 115376 4951 46565696
Cardiac flutter 18.21 13.04 31 115384 3318 46567329
Oesophagogastric fundoplasty 18.16 13.04 7 115408 73 46570574
Ammonia increased 18.10 13.04 36 115379 4341 46566306
Poisoning 18.09 13.04 6 115409 13988 46556659
Metastases to central nervous system 18.07 13.04 3 115412 11218 46559429
Hypothermia 18.05 13.04 4 115411 12179 46558468
Seasonal allergy 18.01 13.04 73 115342 13261 46557386
Diplopia 18.00 13.04 13 115402 19392 46551255
Blood alkaline phosphatase increased 18.00 13.04 163 115252 39446 46531201
Delusion 18.00 13.04 3 115412 11185 46559462
Pulmonary vein stenosis 18.00 13.04 7 115408 75 46570572
Cardiac failure high output 17.95 13.04 10 115405 254 46570393
Tracheostomy malfunction 17.91 13.04 6 115409 40 46570607
Product complaint 17.87 13.04 4 115411 12097 46558550
Encephalopathy 17.81 13.04 35 115380 33554 46537093
Infusion site ulcer 17.79 13.04 4 115411 3 46570644
Injection site haemorrhage 17.79 13.04 15 115400 20694 46549953
Rhinorrhoea 17.68 13.04 188 115227 47477 46523170
Right atrial pressure increased 17.58 13.04 8 115407 130 46570517
Large intestinal polypectomy 17.48 13.04 9 115406 194 46570453
Blood pressure abnormal 17.40 13.04 68 115347 12149 46558498
Cavopulmonary anastomosis 17.26 13.04 4 115411 4 46570643
Tracheostomy tube removal 17.26 13.04 4 115411 4 46570643
Cerebrovascular accident 17.24 13.04 163 115252 100876 46469771
Joint range of motion decreased 17.06 13.04 8 115407 15116 46555531
Gastric antral vascular ectasia 17.05 13.04 13 115402 569 46570078
Sudden visual loss 17.03 13.04 5 115410 20 46570627
Mineral supplementation 16.96 13.04 13 115402 574 46570073
Neutrophil count increased 16.93 13.04 7 115408 14246 46556401
Metastases to lung 16.92 13.04 3 115412 10693 46559954
Body temperature decreased 16.90 13.04 6 115409 13403 46557244
Gastrointestinal haemorrhage 16.88 13.04 277 115138 77096 46493551
Optic ischaemic neuropathy 16.87 13.04 16 115399 947 46569700
Erythema 16.82 13.04 250 115165 142570 46428077
Hypervolaemia 16.77 13.04 21 115394 1701 46568946
Oral pain 16.76 13.04 22 115393 24775 46545872
Biopsy 16.74 13.04 11 115404 379 46570268
Hypercholesterolaemia 16.65 13.04 4 115411 11526 46559121
Chronic hepatic failure 16.64 13.04 12 115403 482 46570165
Night sweats 16.62 13.04 26 115389 27224 46543423
Diabetes mellitus inadequate control 16.50 13.04 6 115409 13208 46557439
Deafness 16.45 13.04 81 115334 15987 46554660
Pulmonary valve replacement 16.37 13.04 4 115411 6 46570641
Cardiorenal syndrome 16.33 13.04 13 115402 607 46570040
Infusion site reaction 16.32 13.04 21 115394 1748 46568899
Acute myocardial infarction 16.30 13.04 34 115381 31890 46538757
Diabetes mellitus 16.29 13.04 66 115349 49999 46520648
Right atrial dilatation 16.28 13.04 12 115403 499 46570148
Catheter site induration 16.25 13.04 6 115409 55 46570592
Radiotherapy 16.19 13.04 10 115405 309 46570338
Aspartate aminotransferase increased 16.16 13.04 279 115136 78421 46492226
Discomfort 16.16 13.04 60 115355 46610 46524037
Pyelonephritis 16.01 13.04 9 115406 15348 46555299
Suture insertion 16.01 13.04 7 115408 103 46570544
Abnormal dreams 16.00 13.04 3 115412 10276 46560371
Malignant melanoma 15.91 13.04 3 115412 10231 46560416
Vitamin D deficiency 15.81 13.04 4 115411 11130 46559517
Scar 15.81 13.04 5 115410 12014 46558633
Lip swelling 15.71 13.04 24 115391 25371 46545276
Liver function test abnormal 15.71 13.04 180 115235 46307 46524340
Biopsy lung 15.69 13.04 8 115407 169 46570478
Biopsy lymph gland 15.66 13.04 5 115410 28 46570619
Metapneumovirus infection 15.65 13.04 14 115401 768 46569879
Chemotherapy 15.65 13.04 18 115397 1334 46569313
Leukocytosis 15.57 13.04 21 115394 23377 46547270
Irritability 15.49 13.04 30 115385 28916 46541731
Respiratory disorder 15.43 13.04 118 115297 27182 46543465
No adverse event 15.42 13.04 39 115376 34192 46536455
Coordination abnormal 15.42 13.04 4 115411 10945 46559702
Nephrolithiasis 15.40 13.04 37 115378 33014 46537633
Ejection fraction decreased 15.40 13.04 13 115402 17924 46552723
Abdominal pain 15.36 13.04 442 114973 229589 46341058
Sudden death 15.28 13.04 55 115360 9449 46561198
Loss of personal independence in daily activities 15.27 13.04 81 115334 57102 46513545
Biopsy kidney 15.21 13.04 7 115408 117 46570530
Paranasal sinus discomfort 15.16 13.04 25 115390 2607 46568040
Spinal stenosis 15.16 13.04 6 115409 12537 46558110
Blood lactate dehydrogenase increased 15.12 13.04 17 115398 20483 46550164
Hallucination, auditory 15.02 13.04 4 115411 10752 46559895
Breast tumour excision 15.02 13.04 3 115412 0 46570647
Therapy cessation 14.99 13.04 115 115300 26514 46544133
Brain natriuretic peptide abnormal 14.88 13.04 10 115405 358 46570289
Gastrointestinal tube insertion 14.80 13.04 16 115399 1107 46569540
Erythema multiforme 14.76 13.04 3 115412 9701 46560946
Muscle twitching 14.73 13.04 9 115406 14663 46555984
Unevaluable investigation 14.72 13.04 5 115410 35 46570612
Haemodynamic test abnormal 14.59 13.04 5 115410 36 46570611
Mydriasis 14.59 13.04 4 115411 10549 46560098
Psychomotor hyperactivity 14.56 13.04 3 115412 9610 46561037
Vasculitis 14.35 13.04 8 115407 13703 46556944
Low cardiac output syndrome 14.35 13.04 9 115406 286 46570361
Cardiogenic shock 14.29 13.04 79 115336 16305 46554342
Infusion site injury 14.27 13.04 4 115411 13 46570634
Cardiac output increased 14.25 13.04 7 115408 136 46570511
Intracardiac pressure increased 14.25 13.04 5 115410 39 46570608
Heart valve replacement 14.24 13.04 11 115404 491 46570156
Bacteraemia 14.17 13.04 71 115344 14108 46556539
Tuberculosis 13.99 13.04 4 115411 10261 46560386
Choking 13.92 13.04 49 115366 8327 46562320
Clostridium difficile infection 13.91 13.04 108 115307 24995 46545652
Catheter site hypersensitivity 13.80 13.04 6 115409 87 46570560
Pulmonary thrombosis 13.79 13.04 45 115370 7357 46563290
Anger 13.79 13.04 6 115409 11846 46558801
Nodule 13.78 13.04 11 115404 15594 46555053
Carbon dioxide abnormal 13.76 13.04 7 115408 147 46570500
Haemorrhage 13.71 13.04 201 115214 54668 46515979
Dermatitis allergic 13.71 13.04 7 115408 12596 46558051
Throat irritation 13.68 13.04 120 115295 28781 46541866
Chest tube insertion 13.62 13.04 5 115410 45 46570602
Pulmonary capillary haemangiomatosis 13.62 13.04 4 115411 16 46570631
Blood iron decreased 13.62 13.04 59 115356 11038 46559609
Illness 13.51 13.04 63 115352 12161 46558486
Infusion site discomfort 13.50 13.04 12 115403 653 46569994
Tooth disorder 13.50 13.04 23 115392 23280 46547367
Haematuria 13.38 13.04 29 115386 26829 46543818
Arteriovenous malformation 13.37 13.04 16 115399 1237 46569410
Product prescribing error 13.33 13.04 18 115397 20029 46550618
Respiratory depression 13.29 13.04 6 115409 11594 46559053
Urinary incontinence 13.25 13.04 32 115383 28498 46542149
Atrial pressure increased 13.25 13.04 4 115411 18 46570629
Tracheostomy infection 13.25 13.04 4 115411 18 46570629
Angioplasty 13.23 13.04 16 115399 1251 46569396
Restlessness 13.19 13.04 27 115388 25497 46545150
Eye irritation 13.12 13.04 13 115402 16601 46554046
Cardiomegaly 13.11 13.04 81 115334 17401 46553246
Head injury 13.10 13.04 105 115310 24531 46546116
Body temperature increased 13.10 13.04 26 115389 24835 46545812
Sensory disturbance 13.07 13.04 7 115408 12260 46558387

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pulmonary arterial hypertension 1095.29 10.99 509 73054 8792 29870123
Pulmonary hypertension 776.11 10.99 518 73045 18518 29860397
Right ventricular failure 591.83 10.99 320 73243 7716 29871199
Fluid retention 526.85 10.99 459 73104 24539 29854376
Dyspnoea 416.67 10.99 1766 71797 331529 29547386
Optic ischaemic neuropathy 368.04 10.99 150 73413 1848 29877067
Pain in jaw 354.81 10.99 270 73293 11886 29867029
Headache 350.35 10.99 1112 72451 181194 29697721
Cyanopsia 320.81 10.99 77 73486 103 29878812
Death 274.82 10.99 1652 71911 355631 29523284
Erectile dysfunction 247.51 10.99 262 73301 17840 29861075
Flushing 244.83 10.99 331 73232 29161 29849754
Drug ineffective 234.06 10.99 1530 72033 338857 29540058
Nasal congestion 224.70 10.99 252 73311 18314 29860601
Erection increased 212.39 10.99 72 73491 504 29878411
Fluid overload 200.66 10.99 241 73322 18851 29860064
Febrile neutropenia 183.47 10.99 23 73540 106670 29772245
Neutropenia 175.89 10.99 49 73514 128491 29750424
Lung transplant 171.54 10.99 87 73476 1829 29877086
Catheter management 159.91 10.99 66 73497 841 29878074
Dyspnoea exertional 156.16 10.99 298 73265 35132 29843783
Oxygen saturation decreased 146.28 10.99 327 73236 43113 29835802
Catheter site erythema 145.59 10.99 67 73496 1127 29877788
Catheterisation cardiac 137.33 10.99 79 73484 2152 29876763
Malignant neoplasm progression 136.13 10.99 11 73552 72276 29806639
Blindness unilateral 131.03 10.99 95 73468 3877 29875038
Transfusion 127.69 10.99 122 73441 7339 29871576
Infusion site pain 127.26 10.99 80 73483 2570 29876345
Condition aggravated 123.87 10.99 666 72897 137200 29741715
Thrombocytopenia 118.05 10.99 98 73465 136946 29741969
Acute kidney injury 112.76 10.99 324 73239 273518 29605397
Catheter placement 98.91 10.99 44 73519 681 29878234
Suspected counterfeit product 97.70 10.99 34 73529 260 29878655
Priapism 97.61 10.99 86 73477 4657 29874258
Oxygen consumption increased 96.76 10.99 52 73511 1236 29877679
Visual impairment 93.45 10.99 221 73342 30217 29848698
Hospitalisation 92.66 10.99 279 73284 44040 29834875
Prescription drug used without a prescription 92.15 10.99 50 73513 1212 29877703
Toxicity to various agents 90.64 10.99 187 73376 176996 29701919
Leukopenia 89.75 10.99 15 73548 56144 29822771
Oedema 88.33 10.99 269 73294 42724 29836191
Pulmonary arterial pressure increased 86.96 10.99 46 73517 1058 29877857
Catheter site pruritus 84.67 10.99 31 73532 279 29878636
Visual field defect 84.50 10.99 77 73486 4359 29874556
Cardiac operation 81.82 10.99 60 73503 2492 29876423
Chromatopsia 81.51 10.99 28 73535 205 29878710
Vision blurred 78.86 10.99 254 73309 41562 29837353
Infusion site erythema 77.31 10.99 49 73514 1597 29877318
Pulmonary hypertensive crisis 77.16 10.99 25 73538 149 29878766
Catheter site discharge 76.79 10.99 34 73529 520 29878395
Catheter site pain 71.62 10.99 40 73523 1028 29877887
Foetal exposure during pregnancy 71.12 10.99 5 73558 36866 29842049
Syncope 70.65 10.99 402 73161 84501 29794414
Hypoxia 68.95 10.99 266 73297 47588 29831327
Device related infection 67.52 10.99 137 73426 16878 29862037
Pyrexia 67.16 10.99 436 73127 294053 29584862
Oedema peripheral 66.85 10.99 467 73096 105365 29773550
Central venous catheterisation 66.24 10.99 37 73526 951 29877964
Cardiac failure 66.17 10.99 390 73173 83028 29795887
Peyronie's disease 63.29 10.99 18 73545 63 29878852
Heart transplant 63.16 10.99 29 73534 485 29878430
Pancytopenia 62.49 10.99 70 73493 84982 29793933
White blood cell count decreased 58.55 10.99 72 73491 83875 29795040
Blindness 58.52 10.99 107 73456 12202 29866713
Retinal vein occlusion 55.36 10.99 39 73524 1520 29877395
Anaemia 55.29 10.99 293 73270 207699 29671216
Device alarm issue 54.53 10.99 30 73533 748 29878167
Pain in extremity 53.78 10.99 458 73105 109763 29769152
Mucosal inflammation 53.78 10.99 6 73557 30488 29848427
Catheter site infection 53.09 10.99 46 73517 2435 29876480
Drug abuse 52.53 10.99 75 73488 81997 29796918
Bone marrow failure 52.18 10.99 6 73557 29779 29849136
Neutrophil count decreased 51.29 10.99 20 73543 42434 29836481
Palpitations 51.14 10.99 190 73373 33383 29845532
Catheter site swelling 50.68 10.99 20 73543 225 29878690
Catheter site rash 50.49 10.99 19 73544 186 29878729
Device dislocation 50.38 10.99 62 73501 4969 29873946
Infusion site haemorrhage 50.18 10.99 24 73539 442 29878473
Thrombosis corpora cavernosa 50.12 10.99 10 73553 0 29878915
Peripheral swelling 49.35 10.99 287 73276 60787 29818128
Completed suicide 49.12 10.99 107 73456 99385 29779530
Counterfeit product administered 48.87 10.99 18 73545 165 29878750
Plasma cell myeloma 48.78 10.99 36 73527 53426 29825489
Catheter site irritation 48.74 10.99 16 73547 100 29878815
Platelet count decreased 48.49 10.99 119 73444 106010 29772905
Infusion related reaction 47.55 10.99 20 73543 40544 29838371
Cardiac disorder 47.40 10.99 209 73354 39684 29839231
Transplant evaluation 47.29 10.99 24 73539 505 29878410
Deafness unilateral 46.62 10.99 37 73526 1731 29877184
Electrocardiogram QT prolonged 46.51 10.99 15 73548 35820 29843095
Hyponatraemia 46.47 10.99 58 73505 67144 29811771
Dizziness 46.20 10.99 703 72860 194206 29684709
Self-medication 46.02 10.99 41 73522 2253 29876662
Deafness 45.64 10.99 87 73476 10238 29868677
Pulmonary veno-occlusive disease 44.86 10.99 22 73541 429 29878486
Biopsy liver 44.20 10.99 16 73547 139 29878776
Ventilation perfusion mismatch 44.16 10.99 13 73550 53 29878862
Complication associated with device 44.11 10.99 62 73501 5658 29873257
Blindness transient 43.30 10.99 37 73526 1922 29876993
General physical health deterioration 42.63 10.99 116 73447 99828 29779087
Pre-existing condition improved 42.62 10.99 37 73526 1964 29876951
Concomitant disease aggravated 41.66 10.99 57 73506 5072 29873843
Heart and lung transplant 41.38 10.99 13 73550 69 29878846
Rheumatoid arthritis 41.27 10.99 25 73538 41172 29837743
Chest pain 41.22 10.99 456 73107 117171 29761744
Product use issue 40.98 10.99 222 73341 45794 29833121
Transient global amnesia 40.94 10.99 19 73544 326 29878589
Infusion site infection 40.79 10.99 19 73544 329 29878586
Dyschromatopsia 40.44 10.99 18 73545 279 29878636
Renal impairment 38.75 10.99 94 73469 84090 29794825
C-reactive protein increased 38.73 10.99 30 73533 43443 29835472
Hepatic function abnormal 38.58 10.99 28 73535 41917 29836998
Cytomegalovirus infection 38.54 10.99 6 73557 23668 29855247
Spinal cord infarction 38.20 10.99 16 73547 212 29878703
Product counterfeit 38.15 10.99 15 73548 167 29878748
Dehydration 36.82 10.99 167 73396 123372 29755543
Visual brightness 36.33 10.99 10 73553 30 29878885
Confusional state 36.29 10.99 189 73374 134645 29744270
Brain natriuretic peptide increased 36.08 10.99 47 73516 3988 29874927
Rash maculo-papular 36.02 10.99 9 73554 25409 29853506
Pulmonary oedema 35.74 10.99 207 73356 43768 29835147
Vascular device infection 35.63 10.99 32 73531 1777 29877138
Stomatitis 35.45 10.99 24 73539 37255 29841660
Oxygen therapy 35.37 10.99 22 73541 693 29878222
Colitis 34.85 10.99 16 73547 30804 29848111
Pruritus 34.51 10.99 161 73402 118043 29760872
Biopsy lung 34.34 10.99 12 73551 93 29878822
Ventricular assist device insertion 34.32 10.99 9 73554 21 29878894
Therapy change 34.29 10.99 37 73526 2572 29876343
Abdominal discomfort 34.17 10.99 221 73342 48570 29830345
Retinal artery occlusion 33.59 10.99 30 73533 1654 29877261
Hyperkalaemia 33.39 10.99 70 73493 65940 29812975
Therapy non-responder 33.25 10.99 152 73411 29301 29849614
Hallucination 33.22 10.99 43 73520 49016 29829899
Disseminated intravascular coagulation 33.11 10.99 7 73556 22164 29856751
Expired product administered 33.09 10.99 38 73525 2831 29876084
Viral infection 33.04 10.99 97 73466 15088 29863827
Paracentesis 32.77 10.99 17 73546 375 29878540
Infusion site swelling 32.65 10.99 29 73534 1587 29877328
Dermatitis contact 32.65 10.99 40 73523 3191 29875724
Visual acuity reduced 32.38 10.99 99 73464 15747 29863168
Exercise tolerance decreased 31.92 10.99 43 73520 3769 29875146
Painful erection 31.57 10.99 14 73549 215 29878700
Malaise 31.36 10.99 580 72983 166382 29712533
Scleroderma 31.26 10.99 26 73537 1301 29877614
Mechanical ventilation 31.18 10.99 29 73534 1685 29877230
Interstitial lung disease 31.15 10.99 63 73500 60134 29818781
Coma 31.12 10.99 32 73531 40417 29838498
Lymphocyte count abnormal 31.11 10.99 19 73544 579 29878336
Eosinophilia 31.10 10.99 8 73555 22152 29856763
Infusion site discharge 31.09 10.99 10 73553 58 29878857
Feeling abnormal 30.96 10.99 242 73321 56514 29822401
Right ventricular dysfunction 30.85 10.99 22 73541 874 29878041
Walking distance test abnormal 30.49 10.99 12 73551 134 29878781
Device occlusion 30.10 10.99 54 73509 6066 29872849
Loss of visual contrast sensitivity 30.07 10.99 6 73557 0 29878915
Cardiac failure congestive 29.90 10.99 328 73235 84079 29794836
Fracture of penis 29.77 10.99 13 73550 192 29878723
Treatment failure 29.55 10.99 25 73538 34654 29844261
Pulmonary vein stenosis 29.43 10.99 9 73554 43 29878872
Sepsis 29.20 10.99 225 73338 146170 29732745
Myalgia 29.05 10.99 302 73261 76365 29802550
Drug reaction with eosinophilia and systemic symptoms 28.93 10.99 17 73546 28471 29850444
Liver transplant 28.81 10.99 35 73528 2767 29876148
Spontaneous penile erection 28.66 10.99 13 73550 211 29878704
Septic shock 28.50 10.99 72 73491 63535 29815380
Macrophages increased 28.45 10.99 12 73551 162 29878753
Optic disc disorder 28.31 10.99 9 73554 50 29878865
Tracheostomy 27.84 10.99 19 73544 703 29878212
Cyanosis 27.67 10.99 78 73485 11857 29867058
Osteonecrosis of jaw 27.55 10.99 6 73557 18612 29860303
Product use in unapproved indication 27.48 10.99 91 73472 73602 29805313
Drug interaction 27.44 10.99 336 73227 199232 29679683
Onychomycosis 27.25 10.99 30 73533 2133 29876782
Catheter site haemorrhage 27.15 10.99 30 73533 2142 29876773
Medical device change 27.09 10.99 11 73552 134 29878781
Pneumonitis 27.02 10.99 17 73546 27437 29851478
Somnolence 26.95 10.99 134 73429 96629 29782286
Drug resistance 26.89 10.99 8 73555 20125 29858790
Infusion site scar 26.79 10.99 7 73556 16 29878899
Penile curvature 26.67 10.99 9 73554 62 29878853
Therapeutic response unexpected 26.61 10.99 64 73499 8839 29870076
Swelling 26.45 10.99 165 73398 35810 29843105
Cardiac ablation 26.23 10.99 17 73546 576 29878339
Delirium 26.11 10.99 37 73526 40594 29838321
Rash 26.02 10.99 324 73239 191565 29687350
Weight increased 26.02 10.99 290 73273 74623 29804292
Vascular resistance pulmonary increased 25.94 10.99 7 73556 19 29878896
Peritonitis 25.93 10.99 10 73553 21365 29857550
Aspiration pleural cavity 25.76 10.99 19 73544 796 29878119
Infusion site discomfort 25.51 10.99 9 73554 72 29878843
Metabolic acidosis 25.19 10.99 33 73530 37428 29841487
Cardiac index increased 25.19 10.99 7 73556 22 29878893
Retinal vascular occlusion 25.07 10.99 10 73553 116 29878799
Hypoglossal nerve paralysis 25.06 10.99 5 73558 0 29878915
Retinitis pigmentosa 25.06 10.99 5 73558 0 29878915
Product contamination 24.84 10.99 17 73546 632 29878283
Lactic acidosis 24.81 10.99 24 73539 31189 29847726
Blood culture negative 24.51 10.99 7 73556 25 29878890
Ejaculation disorder 24.40 10.99 20 73543 980 29877935
Acute myeloid leukaemia 24.33 10.99 7 73556 17999 29860916
Patent ductus arteriosus repair 24.21 10.99 6 73557 10 29878905
Catheter site inflammation 24.02 10.99 12 73551 244 29878671
Respiratory syncytial virus infection 23.76 10.99 35 73528 3333 29875582
Hyperglycaemia 23.68 10.99 31 73532 35169 29843746
Infusion site warmth 23.66 10.99 9 73554 91 29878824
Sinus congestion 23.65 10.99 42 73521 4680 29874235
Blood creatinine increased 23.50 10.99 130 73433 91245 29787670
Psoriatic arthropathy 23.48 10.99 5 73558 15756 29863159
Chorioretinopathy 23.44 10.99 23 73540 1429 29877486
Atrial septal defect repair 23.40 10.99 9 73554 94 29878821
Psoriasis 23.28 10.99 43 73520 42463 29836452
Catheter removal 23.28 10.99 11 73552 197 29878718
Anorgasmia 23.28 10.99 16 73547 599 29878316
Infusion site irritation 23.25 10.99 10 73553 142 29878773
Blood testosterone decreased 23.19 10.99 40 73523 4356 29874559
Retinal vascular disorder 22.94 10.99 10 73553 147 29878768
Cor pulmonale 22.73 10.99 17 73546 728 29878187
Acute macular outer retinopathy 22.72 10.99 5 73558 3 29878912
Candida infection 22.63 10.99 5 73558 15357 29863558
Neoplasm progression 22.59 10.99 8 73555 18015 29860900
Cardioversion 22.57 10.99 18 73545 848 29878067
Device infusion issue 22.36 10.99 15 73548 539 29878376
Balloon atrial septostomy 22.31 10.99 6 73557 16 29878899
Infusion site inflammation 22.31 10.99 7 73556 37 29878878
Penis disorder 22.25 10.99 20 73543 1112 29877803
Optic atrophy 22.11 10.99 17 73546 759 29878156
Pulmonary capillary haemangiomatosis 22.05 10.99 6 73557 17 29878898
Maculopathy 22.03 10.99 18 73545 878 29878037
Multiple organ dysfunction syndrome 21.91 10.99 81 73482 63406 29815509
Ejaculation failure 21.69 10.99 17 73546 781 29878134
Congestive hepatopathy 21.59 10.99 25 73538 1879 29877036
Tumour lysis syndrome 21.58 10.99 3 73560 12882 29866033
Dizziness exertional 21.37 10.99 9 73554 121 29878794
Device connection issue 21.30 10.99 14 73549 486 29878429
Hepatotoxicity 21.18 10.99 9 73554 18136 29860779
Dysphagia 21.14 10.99 70 73493 56628 29822287
Decreased appetite 21.11 10.99 251 73312 149659 29729256
Carotid artery dissection 21.04 10.99 9 73554 126 29878789
Pneumonia aspiration 20.88 10.99 38 73525 37742 29841173
Pneumocystis jirovecii pneumonia 20.78 10.99 8 73555 17112 29861803
Cough 20.70 10.99 428 73135 125214 29753701
Urticaria 20.65 10.99 67 73496 54539 29824376
Neuropathy peripheral 20.54 10.99 96 73467 70379 29808536
Tinnitus 20.41 10.99 86 73477 16002 29862913
Macular degeneration 20.32 10.99 25 73538 2003 29876912
Rhinovirus infection 20.30 10.99 30 73533 2865 29876050
Myoclonus 20.30 10.99 4 73559 13308 29865607
Rhabdomyolysis 20.11 10.99 84 73479 63496 29815419
Drug eruption 19.97 10.99 9 73554 17517 29861398
Catheterisation cardiac abnormal 19.95 10.99 7 73556 55 29878860
Blood ethanol increased 19.91 10.99 12 73551 357 29878558
Acute respiratory failure 19.91 10.99 120 73443 25730 29853185
Palmar-plantar erythrodysaesthesia syndrome 19.69 10.99 6 73557 14864 29864051
Blood cholesterol increased 19.46 10.99 88 73475 16882 29862033
Myelodysplastic syndrome 19.36 10.99 11 73552 18767 29860148
Seizure 19.31 10.99 152 73411 98323 29780592
Phlebotomy 19.27 10.99 5 73558 11 29878904
Micrococcus test positive 18.97 10.99 5 73558 12 29878903
Hyperbilirubinaemia 18.84 10.99 9 73554 16933 29861982
Device leakage 18.69 10.99 33 73530 3661 29875254
Photophobia 18.58 10.99 43 73520 5793 29873122
Stent placement 18.22 10.99 37 73526 4559 29874356
Respiratory tract infection viral 18.22 10.99 18 73545 1128 29877787
Spontaneous intrahepatic portosystemic venous shunt 18.16 10.99 5 73558 15 29878900
Conjunctival hyperaemia 18.12 10.99 25 73538 2242 29876673
Depressed level of consciousness 18.11 10.99 42 73521 38180 29840735
Bronchopulmonary aspergillosis 18.09 10.99 4 73559 12280 29866635
Abdominal pain 18.01 10.99 230 73333 135424 29743491
Chloropsia 17.82 10.99 4 73559 3 29878912
Toxic epidermal necrolysis 17.80 10.99 11 73552 17929 29860986
Executive dysfunction 17.80 10.99 8 73555 127 29878788
Implant site extravasation 17.75 10.99 12 73551 437 29878478
Suture insertion 17.70 10.99 6 73557 42 29878873
Ocular vascular disorder 17.69 10.99 8 73555 129 29878786
Suicide attempt 17.65 10.99 40 73523 36657 29842258
Heart valve operation 17.58 10.99 6 73557 43 29878872
Hypocalcaemia 17.50 10.99 16 73547 21360 29857555
Product dose omission issue 17.40 10.99 319 73244 91312 29787603
Vitreous detachment 17.38 10.99 15 73548 790 29878125
Catheter site extravasation 17.26 10.99 7 73556 85 29878830
Hallucination, visual 17.25 10.99 9 73554 16104 29862811
Prostate cancer 17.06 10.99 109 73454 23848 29855067
Unevaluable event 17.03 10.99 135 73428 31650 29847265
Hernia repair 16.92 10.99 17 73546 1087 29877828
Hepatitis 16.84 10.99 18 73545 22338 29856577
Hypoacusis 16.72 10.99 74 73489 14065 29864850
Chest discomfort 16.67 10.99 178 73385 45302 29833613
Chronic obstructive pulmonary disease 16.66 10.99 180 73383 45946 29832969
Colour blindness 16.55 10.99 9 73554 219 29878696
Contraindicated product administered 16.51 10.99 11 73552 17220 29861695
Full blood count decreased 16.50 10.99 9 73554 15708 29863207
Pulmonary vascular resistance abnormality 16.49 10.99 6 73557 53 29878862
Tracheitis 16.46 10.99 13 73550 604 29878311
Blood creatine phosphokinase increased 16.44 10.99 54 73509 43794 29835121
Acute right ventricular failure 16.43 10.99 7 73556 97 29878818
Sedation 16.30 10.99 10 73553 16363 29862552
Neutropenic sepsis 16.24 10.99 4 73559 11405 29867510
Catheter site discolouration 16.16 10.99 5 73558 25 29878890
Photopsia 16.09 10.99 21 73542 1785 29877130
Papilloedema 15.93 10.99 24 73539 2332 29876583
Diuretic therapy 15.84 10.99 5 73558 27 29878888
Heart rate increased 15.84 10.99 155 73408 38566 29840349
Pulmonary congestion 15.84 10.99 66 73497 12221 29866694
Transplant 15.83 10.99 13 73550 639 29878276
Infusion site vesicles 15.81 10.99 7 73556 107 29878808
Hypotension 15.80 10.99 622 72941 199943 29678972
Aspergillus infection 15.72 10.99 3 73560 10211 29868704
Cardiac discomfort 15.69 10.99 10 73553 329 29878586
Pulmonary arterial pressure abnormal 15.61 10.99 8 73555 172 29878743
Pulmonary embolism 15.60 10.99 120 73443 78015 29800900
Hepatocellular injury 15.57 10.99 24 73539 25447 29853468
Encephalopathy 15.57 10.99 35 73528 32170 29846745
Hypophagia 15.56 10.99 19 73544 22217 29856698
Premature baby 15.53 10.99 11 73552 16680 29862235
Device physical property issue 15.45 10.99 13 73550 661 29878254
Therapeutic procedure 15.36 10.99 8 73555 178 29878737
Sudden death 15.34 10.99 77 73486 15415 29863500
Presyncope 15.34 10.99 79 73484 15977 29862938
Polyneuropathy 15.25 10.99 5 73558 11818 29867097
Right atrial pressure increased 15.24 10.99 6 73557 67 29878848
Altered state of consciousness 15.05 10.99 16 73547 19903 29859012
Viral labyrinthitis 15.04 10.99 3 73560 0 29878915
Dyskinesia 14.92 10.99 19 73544 21815 29857100
Lymphadenopathy 14.87 10.99 23 73540 24353 29854562
Atrial flutter 14.87 10.99 72 73491 14209 29864706
Inappropriate schedule of product administration 14.84 10.99 49 73514 39679 29839236
Haemophagocytic lymphohistiocytosis 14.81 10.99 3 73560 9788 29869127
Ileus 14.81 10.99 10 73553 15545 29863370
Ascites 14.80 10.99 144 73419 35777 29843138
Urinary tract infection 14.76 10.99 113 73450 73546 29805369
Device breakage 14.69 10.99 19 73544 1601 29877314
Deafness transitory 14.63 10.99 5 73558 36 29878879
Lymphopenia 14.62 10.99 7 73556 13156 29865759
Injection site pain 14.61 10.99 33 73530 30277 29848638
Retinal infarction 14.57 10.99 6 73557 76 29878839
Blood pressure abnormal 14.55 10.99 44 73519 6955 29871960
Cardiac pacemaker insertion 14.54 10.99 24 73539 2521 29876394
Deep vein thrombosis 14.52 10.99 88 73475 60413 29818502
Chest tube insertion 14.50 10.99 6 73557 77 29878838
Colour blindness acquired 14.50 10.99 6 73557 77 29878838
Food interaction 14.39 10.99 14 73549 861 29878054
Carbon dioxide increased 14.29 10.99 15 73548 1010 29877905
N-terminal prohormone brain natriuretic peptide increased 14.15 10.99 17 73546 1329 29877586
Mineral supplementation 14.09 10.99 6 73557 83 29878832
Retinal haemorrhage 14.07 10.99 34 73529 4709 29874206
Pulmonary arterial pressure decreased 14.07 10.99 4 73559 14 29878901
Infusion site cellulitis 14.06 10.99 5 73558 41 29878874
Blood lactate dehydrogenase increased 14 10.99 18 73545 20583 29858332
Metastases to liver 13.86 10.99 6 73557 11959 29866956
Chronic respiratory failure 13.82 10.99 16 73547 1202 29877713
Intentional product misuse 13.81 10.99 138 73425 34529 29844386
Nodular melanoma 13.72 10.99 6 73557 89 29878826
Endarterectomy 13.68 10.99 7 73556 150 29878765
Exposure during pregnancy 13.67 10.99 3 73560 9258 29869657
Catheter site scab 13.65 10.99 4 73559 16 29878899
Lymphocyte count decreased 13.63 10.99 16 73547 19039 29859876
Mobility decreased 13.62 10.99 27 73536 25972 29852943
Toxic skin eruption 13.61 10.99 5 73558 11010 29867905
Blood pressure decreased 13.60 10.99 176 73387 46899 29832016
Transaminases increased 13.50 10.99 23 73540 23434 29855481
Sudden cardiac death 13.47 10.99 29 73534 3723 29875192
Penile vein thrombosis 13.46 10.99 4 73559 17 29878898
Epstein-Barr virus antibody positive 13.38 10.99 9 73554 325 29878590
Vasodilatation 13.36 10.99 14 73549 941 29877974
Dialysis 13.35 10.99 58 73505 10938 29867977
Hypercalcaemia 13.35 10.99 7 73556 12488 29866427
Therapeutic product effect delayed 13.32 10.99 15 73548 1094 29877821
Lung assist device therapy 13.27 10.99 4 73559 18 29878897
Schizophrenia 13.22 10.99 3 73560 9045 29869870
Basal cell carcinoma 13.18 10.99 12 73551 16056 29862859
Retinal tear 13.10 10.99 12 73551 684 29878231
Anaphylactic reaction 13.05 10.99 31 73532 27951 29850964
Renal tubular necrosis 12.98 10.99 11 73552 15240 29863675
Orchidopexy 12.96 10.99 3 73560 3 29878912
Sensation of blood flow 12.96 10.99 3 73560 3 29878912
Retinal vein thrombosis 12.90 10.99 9 73554 345 29878570
Epistaxis 12.84 10.99 192 73371 52789 29826126
Libido decreased 12.77 10.99 32 73531 4534 29874381
Glare 12.77 10.99 6 73557 106 29878809
Loss of proprioception 12.72 10.99 8 73555 257 29878658
Corneal abrasion 12.70 10.99 8 73555 258 29878657
Constipation 12.65 10.99 198 73365 112708 29766207
Metastases to bone 12.60 10.99 4 73559 9654 29869261
Catheter site mass 12.47 10.99 4 73559 23 29878892
Thoracic cavity drainage 12.46 10.99 7 73556 182 29878733
Bradycardia 12.44 10.99 102 73461 65424 29813491
Cor pulmonale chronic 12.38 10.99 5 73558 60 29878855
Oesophageal variceal ligation 12.38 10.99 5 73558 60 29878855
Internal haemorrhage 12.38 10.99 31 73532 4391 29874524
Viral upper respiratory tract infection 12.37 10.99 23 73540 2655 29876260
Right-to-left cardiac shunt 12.32 10.99 4 73559 24 29878891
Emergency care 12.32 10.99 7 73556 186 29878729
Stevens-Johnson syndrome 12.29 10.99 15 73548 17541 29861374
Infective pulmonary exacerbation of cystic fibrosis 12.21 10.99 3 73560 8569 29870346
Therapy cessation 12.12 10.99 71 73492 15066 29863849
Off label use 12.12 10.99 495 73068 248795 29630120
Optic disc haemorrhage 12.05 10.99 4 73559 26 29878889
Infusion site abscess 12.05 10.99 4 73559 26 29878889
Hypokalaemia 12.04 10.99 73 73490 50119 29828796
Haemoptysis 12.03 10.99 123 73440 30955 29847960
Orgasm abnormal 12.01 10.99 6 73557 122 29878793
Thunderclap headache 11.89 10.99 5 73558 67 29878848
Accident at work 11.80 10.99 11 73552 641 29878274
Hyperthermia 11.80 10.99 5 73558 10094 29868821
Oesophagogastroduodenoscopy 11.80 10.99 4 73559 28 29878887
Intentional overdose 11.79 10.99 57 73506 41424 29837491
Infusion site rash 11.63 10.99 8 73555 300 29878615
Psychotic disorder 11.57 10.99 22 73541 21493 29857422
Dyspnoea at rest 11.57 10.99 22 73541 2584 29876331
Product taste abnormal 11.55 10.99 14 73549 1104 29877811
Leukocytosis 11.55 10.99 22 73541 21480 29857435
Exercise test abnormal 11.44 10.99 3 73560 7 29878908
Epilepsy 11.40 10.99 20 73543 20149 29858766
Retinal disorder 11.24 10.99 13 73550 976 29877939
Catheter site vesicles 11.23 10.99 4 73559 33 29878882
Vascular operation 11.23 10.99 4 73559 33 29878882
Catheter site dermatitis 11.16 10.99 3 73560 8 29878907
Secretion discharge 11.13 10.99 27 73536 3748 29875167
Mitral valve replacement 11.11 10.99 6 73557 144 29878771
Sudden hearing loss 11.03 10.99 12 73551 842 29878073
Delusion 11.02 10.99 8 73555 11981 29866934

Pharmacologic Action:

SourceCodeDescription
ATC G04BE03 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs used in erectile dysfunction
FDA MoA N0000020026 Phosphodiesterase 5 Inhibitors
FDA EPC N0000175599 Phosphodiesterase 5 Inhibitor
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D058986 Phosphodiesterase 5 Inhibitors
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D064804 Urological Agents
MeSH PA D014665 Vasodilator Agents
CHEBI has role CHEBI:35620 vasodilator
CHEBI has role CHEBI:71942 pde5 inhibitors

Drug Use (View source of the data)

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

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4024110 VUID
N0000022115 NUI
D02229 KEGG_DRUG
171599-83-0 SECONDARY_CAS_RN
4021093 VANDF
4024110 VANDF
C1614029 UMLSCUI
CHEBI:58987 CHEBI
VIA PDB_CHEM_ID
CHEMBL192 ChEMBL_ID
CHEMBL1737 ChEMBL_ID
D000068677 MESH_DESCRIPTOR_UI
4743 IUPHAR_LIGAND_ID
7374 INN_ID
DB00203 DRUGBANK_ID
3M7OB98Y7H UNII
135413523 PUBCHEM_CID
136411 RXNORM
147641 MMSL
194438 MMSL
26866 MMSL
29679 MMSL
5460 MMSL
69683 MMSL
d04299 MMSL
007448 NDDF
007449 NDDF
108482004 SNOMEDCT_US
109123009 SNOMEDCT_US
372572000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Revatio HUMAN PRESCRIPTION DRUG LABEL 1 0069-0336 POWDER, FOR SUSPENSION 10 mg ORAL NDA 28 sections
Revatio HUMAN PRESCRIPTION DRUG LABEL 1 0069-0338 INJECTION, SOLUTION 0.80 mg INTRAVENOUS NDA 28 sections
Revatio HUMAN PRESCRIPTION DRUG LABEL 1 0069-4190 TABLET, FILM COATED 20 mg ORAL NDA 28 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 0069-4200 TABLET, FILM COATED 25 mg ORAL NDA 28 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 0069-4210 TABLET, FILM COATED 50 mg ORAL NDA 28 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 0069-4220 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5341 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5342 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5343 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-5517 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0378-1657 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0378-1658 TABLET, FILM COATED 25 mg ORAL ANDA 29 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0378-1659 TABLET, FILM COATED 50 mg ORAL ANDA 29 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0378-1660 TABLET, FILM COATED 100 mg ORAL ANDA 29 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 0591-4050 POWDER, FOR SUSPENSION 10 mg ORAL ANDA 26 sections
SILDENULLFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6671 TABLET 20 mg ORAL ANDA 26 sections
SILDENULLFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-185 TABLET 20 mg ORAL ANDA 26 sections
SILDENULLFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-186 TABLET, FILM COATED 25 mg ORAL ANDA 19 sections
SILDENULLFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-187 TABLET, FILM COATED 50 mg ORAL ANDA 19 sections
SILDENULLFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-188 TABLET, FILM COATED 100 mg ORAL ANDA 19 sections
Sildenafil Human Prescription Drug Label 1 17224-460 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Sildenafil Citrate HUMAN PRESCRIPTION DRUG LABEL 1 17856-8100 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 21695-157 TABLET, FILM COATED 50 mg ORAL NDA 14 sections
Viagra HUMAN PRESCRIPTION DRUG LABEL 1 21695-158 TABLET, FILM COATED 100 mg ORAL NDA 14 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-067 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-068 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Sildenafil Citrate Human Prescription Drug Label 1 27241-069 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Sildenafil Human Prescription Drug Label 1 27241-124 TABLET 20 mg ORAL ANDA 27 sections
Sildenafil Human Prescription Drug Label 1 27241-175 POWDER, FOR SUSPENSION 10 mg ORAL ANDA 26 sections
Sildenafil HUMAN PRESCRIPTION DRUG LABEL 1 31722-136 FOR SUSPENSION 10 mg ORAL ANDA 25 sections