sildenafil 🐶 Veterinary Use | 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: 2.20
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 1
  • TPSA: 109.13
  • ALOGS: -3.01
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

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

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 2634.97 12.96 1181 120490 19138 50464315
Dyspnoea 2194.12 12.96 4342 117329 543266 49940187
Fluid retention 1799.62 12.96 1255 120416 49394 50434059
Right ventricular failure 1692.08 12.96 806 120865 15087 50468366
Pulmonary hypertension 1507.40 12.96 961 120710 32456 50450997
Death 1352.88 12.96 2628 119043 322751 50160702
Pain in jaw 1331.34 12.96 938 120733 37490 50445963
Hypervolaemia 935.62 12.96 645 121026 24854 50458599
Dyspnoea exertional 878.69 12.96 830 120841 50403 50433050
Drug ineffective 808.69 12.96 489 121182 818844 49664609
Headache 693.69 12.96 2721 118950 503814 49979639
Catheter site erythema 669.68 12.96 278 121393 3684 50479769
Oxygen saturation decreased 553.92 12.96 777 120894 72471 50410982
Nasal congestion 541.68 12.96 641 121030 50479 50432974
Lung transplant 538.23 12.96 216 121455 2609 50480844
Transfusion 519.83 12.96 346 121325 12559 50470894
Oedema 513.68 12.96 733 120938 69448 50414005
Hospitalisation 506.73 12.96 716 120955 67221 50416232
Flushing 500.90 12.96 707 120964 66308 50417145
Device related infection 481.22 12.96 399 121272 20336 50463117
Catheter site pruritus 456.45 12.96 174 121497 1813 50481640
Catheter site pain 443.97 12.96 205 121466 3557 50479896
Catheter management 442.12 12.96 186 121485 2553 50480900
Infusion site pain 410.11 12.96 294 121377 12052 50471401
Hypoxia 378.43 12.96 537 121134 50586 50432867
Chest pain 375.38 12.96 1103 120568 175779 50307674
Pulmonary arterial pressure increased 356.69 12.96 170 121501 3178 50480275
Alopecia 354.53 12.96 78 121593 244969 50238484
Infusion related reaction 354.01 12.96 12 121659 169545 50313908
Cardiac failure 348.09 12.96 642 121029 75398 50408055
Catheter site discharge 346.10 12.96 140 121531 1728 50481725
Oedema peripheral 335.99 12.96 986 120685 156975 50326478
Toxicity to various agents 331.96 12.96 56 121615 212443 50271010
Syncope 318.68 12.96 740 120931 102262 50381191
Catheterisation cardiac 315.00 12.96 166 121505 3874 50479579
Catheter site infection 314.15 12.96 169 121502 4117 50479336
Pulmonary oedema 300.47 12.96 471 121200 48467 50434986
Contraindicated product administered 296.04 12.96 15 121656 148943 50334510
Cough 290.83 12.96 1249 120422 240015 50243438
Rheumatoid arthritis 283.88 12.96 69 121602 202481 50280972
Drug hypersensitivity 281.07 12.96 126 121545 250884 50232569
Neutropenia 270.22 12.96 23 121648 147942 50335511
Treatment failure 269.93 12.96 15 121656 137622 50345831
Oxygen consumption increased 269.21 12.96 143 121528 3393 50480060
Pneumonia 265.75 12.96 1685 119986 376716 50106737
Rash 264.91 12.96 402 121269 437069 50046384
Completed suicide 262.96 12.96 13 121658 131876 50351577
Infusion site erythema 251.94 12.96 191 121480 8536 50474917
Central venous catheterisation 244.89 12.96 114 121557 2016 50481437
Respiratory failure 237.19 12.96 613 121058 90568 50392885
Scleroderma 236.10 12.96 146 121525 4655 50478798
Joint swelling 235.19 12.96 150 121521 245136 50238317
Glossodynia 234.92 12.96 10 121661 115559 50367894
Palpitations 229.20 12.96 619 121052 93887 50389566
Catheter site swelling 226.08 12.96 94 121577 1250 50482203
Cardiac failure congestive 223.29 12.96 571 121100 83811 50399642
Device alarm issue 216.50 12.96 92 121579 1296 50482157
Therapeutic product effect decreased 216.49 12.96 34 121637 136016 50347437
Device leakage 216.17 12.96 149 121522 5729 50477724
Catheter placement 213.25 12.96 102 121569 1922 50481531
Hypotension 212.89 12.96 1122 120549 234347 50249106
Arthropathy 211.24 12.96 59 121612 157847 50325606
Catheter site haemorrhage 200.92 12.96 109 121562 2701 50480752
Dizziness 195.79 12.96 1463 120208 344906 50138547
Unevaluable event 193.39 12.96 375 121296 45691 50437762
Disease progression 185.30 12.96 579 121092 95287 50388166
Drug interaction 184.62 12.96 127 121544 199494 50283959
Infusion site infection 184.30 12.96 85 121586 1470 50481983
Febrile neutropenia 181.55 12.96 14 121657 97653 50385800
Transplant evaluation 171.13 12.96 72 121599 988 50482465
Musculoskeletal stiffness 166.32 12.96 51 121620 128430 50355023
Condition aggravated 166.17 12.96 1252 120419 295806 50187647
Stomatitis 164.24 12.96 24 121647 101320 50382133
Cardiac operation 163.39 12.96 95 121576 2700 50480753
Diarrhoea 162.10 12.96 2139 119532 586337 49897116
Cardiac disorder 157.88 12.96 331 121340 42648 50440805
Hypersensitivity 156.41 12.96 172 121499 214989 50268464
Drug intolerance 156.16 12.96 178 121493 218926 50264527
Malaise 153.55 12.96 1351 120320 334181 50149272
Acute respiratory failure 153.50 12.96 260 121411 28522 50454931
Catheter site rash 151.72 12.96 60 121611 695 50482758
Therapy change 150.03 12.96 114 121557 5111 50478342
Concomitant disease aggravated 149.93 12.96 137 121534 7954 50475499
Hepatic enzyme increased 148.90 12.96 72 121599 137308 50346145
Pericarditis 147.03 12.96 11 121660 78678 50404775
Maternal exposure during pregnancy 143.28 12.96 105 121566 159673 50323780
Psoriasis 140.09 12.96 6 121665 68994 50414459
Device occlusion 137.81 12.96 115 121556 5908 50477545
Dialysis 137.50 12.96 140 121531 9298 50474155
Vascular device infection 135.57 12.96 100 121571 4284 50479169
Catheter site irritation 135.04 12.96 50 121621 477 50482976
Dermatitis contact 132.83 12.96 132 121539 8514 50474939
Malignant neoplasm progression 128.78 12.96 9 121662 68115 50415338
Pulmonary veno-occlusive disease 127.25 12.96 57 121614 918 50482535
Epistaxis 126.98 12.96 390 121281 63564 50419889
Urticaria 125.72 12.96 78 121593 129483 50353970
Ascites 123.43 12.96 269 121402 35592 50447861
Wound 123.20 12.96 50 121621 105744 50377709
Drug abuse 122.17 12.96 5 121666 59841 50423612
Pericardial effusion 120.68 12.96 219 121452 25370 50458083
Exercise tolerance decreased 119.76 12.96 97 121574 4777 50478676
Infusion site discharge 119.71 12.96 48 121623 578 50482875
White blood cell count decreased 117.86 12.96 67 121604 116655 50366798
Device infusion issue 117.57 12.96 60 121611 1307 50482146
Dyspnoea at rest 116.87 12.96 85 121586 3562 50479891
Infusion site swelling 116.66 12.96 113 121558 7063 50476390
Hypertension 116.32 12.96 206 121465 210997 50272456
Product dose omission issue 115.38 12.96 797 120874 183041 50300412
Pruritus 115.04 12.96 327 121344 283241 50200212
Injection site pain 114.60 12.96 62 121609 110962 50372491
Chest discomfort 114.42 12.96 484 121187 92238 50391215
Arthralgia 112.10 12.96 609 121062 438093 50045360
Impaired healing 111.96 12.96 17 121654 69769 50413684
Abdominal distension 111.37 12.96 407 121264 72496 50410957
Complication associated with device 105.49 12.96 152 121519 14503 50468950
Catheter site inflammation 105.38 12.96 45 121626 642 50482811
Therapeutic product effect incomplete 105.34 12.96 44 121627 91471 50391982
Paracentesis 105.22 12.96 49 121622 867 50482586
Haemoptysis 104.64 12.96 206 121465 25367 50458086
Pulmonary hypertensive crisis 103.62 12.96 32 121639 163 50483290
Discomfort 102.73 12.96 67 121604 108313 50375140
Device dislocation 101.09 12.96 184 121487 21362 50462091
Systemic lupus erythematosus 97.15 12.96 117 121554 140505 50342948
Anaphylactic reaction 97.00 12.96 9 121662 54046 50429407
N-terminal prohormone brain natriuretic peptide increased 96.99 12.96 57 121614 1653 50481800
Presyncope 96.69 12.96 193 121478 24005 50459448
Brain natriuretic peptide increased 96.52 12.96 83 121588 4444 50479009
Confusional state 96.46 12.96 188 121483 185740 50297713
Blood cholesterol increased 94.42 12.96 11 121660 55204 50428249
Right ventricular dysfunction 93.52 12.96 54 121617 1514 50481939
Catheter site related reaction 92.74 12.96 43 121628 753 50482700
Off label use 92.45 12.96 715 120956 473711 50009742
Productive cough 92.43 12.96 308 121363 52386 50431067
Walking distance test abnormal 91.75 12.96 38 121633 500 50482953
Depression 89.56 12.96 163 121508 165260 50318193
Psoriatic arthropathy 89.51 12.96 6 121665 47026 50436427
Overdose 88.76 12.96 66 121605 99661 50383792
Electrocardiogram QT prolonged 87.09 12.96 11 121660 51875 50431578
Multiple sclerosis relapse 86.33 12.96 4 121667 42960 50440493
Cardiac pacemaker insertion 86.18 12.96 71 121600 3582 50479871
Emergency care 84.74 12.96 41 121630 793 50482660
Helicobacter infection 84.74 12.96 10 121661 49692 50433761
Neutrophil count decreased 84.38 12.96 7 121664 46019 50437434
Mobility decreased 83.44 12.96 44 121627 79904 50403549
Blister 83.43 12.96 51 121620 85367 50398086
Suicidal ideation 83.32 12.96 16 121655 55369 50428084
Mucosal inflammation 83.14 12.96 3 121668 40139 50443314
Leukopenia 81.77 12.96 30 121641 67498 50415955
Injection site erythema 81.57 12.96 39 121632 74897 50408556
Blood pressure increased 81.54 12.96 121 121550 133011 50350442
Myalgia 81.52 12.96 545 121126 123774 50359679
Folliculitis 81 12.96 3 121668 39222 50444231
Intentional overdose 80.50 12.96 25 121646 62479 50420974
Osteoarthritis 78.92 12.96 33 121638 68573 50414880
Influenza 78.85 12.96 424 121247 89114 50394339
Oxygen therapy 78.83 12.96 51 121620 1761 50481692
Heart rate increased 78.63 12.96 381 121290 76869 50406584
Injection site reaction 78.42 12.96 13 121658 50019 50433434
Cardiac ablation 78.34 12.96 45 121626 1249 50482204
Infusion site haemorrhage 76.39 12.96 61 121610 2943 50480510
Neuropathy peripheral 76.30 12.96 72 121599 96685 50386768
Heart transplant 75.95 12.96 31 121640 392 50483061
Cyanosis 75.49 12.96 133 121538 15051 50468402
Atrial flutter 75.28 12.96 99 121572 8664 50474789
Muscle injury 72.84 12.96 4 121667 37107 50446346
Therapy non-responder 72.20 12.96 278 121393 50744 50432709
Blood pressure decreased 72.18 12.96 296 121375 55613 50427840
Injection site bruising 72.05 12.96 4 121667 36764 50446689
Suicide attempt 71.63 12.96 18 121653 51714 50431739
Catheter site vesicles 71.27 12.96 27 121644 276 50483177
Cor pulmonale 69.77 12.96 48 121623 1839 50481614
Infusion site pruritus 69.71 12.96 65 121606 3872 50479581
Lower respiratory tract infection 68.10 12.96 77 121594 95124 50388329
Irritable bowel syndrome 67.29 12.96 20 121651 51421 50432032
Abdominal cavity drainage 64.80 12.96 27 121644 361 50483092
Pancytopenia 64.54 12.96 64 121607 83966 50399487
Coma 64.40 12.96 28 121643 56851 50426602
Disease complication 63.40 12.96 53 121618 2729 50480724
Systemic scleroderma 63.31 12.96 34 121637 825 50482628
Mechanical ventilation 63.27 12.96 38 121633 1148 50482305
Device related sepsis 62.75 12.96 58 121613 3417 50480036
Right ventricular dilatation 62.61 12.96 35 121636 921 50482532
Balloon atrial septostomy 62.61 12.96 18 121653 68 50483385
Lung disorder 61.68 12.96 242 121429 44557 50438896
Oxygen saturation abnormal 60.59 12.96 51 121620 2651 50480802
Wrong technique in product usage process 60.24 12.96 29 121642 55481 50427972
Infusion site induration 60.02 12.96 33 121638 840 50482613
Product use in unapproved indication 59.26 12.96 118 121553 115701 50367752
Acute kidney injury 57.84 12.96 317 121354 227741 50255712
Neoplasm progression 57.67 12.96 3 121668 29154 50454299
Right ventricular systolic pressure increased 57.61 12.96 27 121644 485 50482968
Heart and lung transplant 57.60 12.96 18 121653 96 50483357
Sleep disorder due to general medical condition, insomnia type 57.05 12.96 5 121666 31442 50452011
Pain 56.65 12.96 1016 120655 577887 49905566
Depressed level of consciousness 56.59 12.96 27 121644 51926 50431527
Chronic respiratory failure 56.15 12.96 40 121631 1622 50481831
Ventilation perfusion mismatch 56.11 12.96 21 121650 207 50483246
Deep vein thrombosis 56.10 12.96 56 121615 73248 50410205
Infusion site irritation 55.40 12.96 28 121643 597 50482856
Tracheostomy 55.31 12.96 27 121644 533 50482920
Paraesthesia 55.31 12.96 130 121541 120113 50363340
Pain in extremity 54.81 12.96 941 120730 271924 50211529
Cardioversion 54.22 12.96 34 121637 1111 50482342
Terminal state 53.98 12.96 43 121628 2067 50481386
Thrombocytopenia 53.32 12.96 145 121526 127528 50355925
Catheter removal 53.31 12.96 23 121648 337 50483116
Infusion site cellulitis 52.78 12.96 19 121652 166 50483287
Atrial septal defect repair 52.75 12.96 20 121651 205 50483248
Sedation 52.57 12.96 6 121665 30604 50452849
Thrombosis in device 51.93 12.96 47 121624 2694 50480759
Congestive hepatopathy 51.70 12.96 45 121626 2449 50481004
Type 2 diabetes mellitus 51.55 12.96 10 121661 34365 50449088
Gout 51.34 12.96 96 121575 11374 50472079
Bone marrow failure 51.19 12.96 4 121667 27620 50455833
Fibromyalgia 51.14 12.96 22 121649 44956 50438497
Dependence on oxygen therapy 51.13 12.96 22 121649 320 50483133
Internal haemorrhage 51.10 12.96 58 121613 4359 50479094
Pulmonary arterial pressure abnormal 51.01 12.96 24 121647 435 50483018
Chronic obstructive pulmonary disease 50.43 12.96 258 121413 53177 50430276
Injection site discharge 50.17 12.96 23 121648 392 50483061
Catheter site warmth 49.83 12.96 19 121652 198 50483255
Hypoglycaemia 49.57 12.96 34 121637 53547 50429906
Infusion site warmth 49.57 12.96 35 121636 1399 50482054
Therapeutic response decreased 49.26 12.96 26 121645 47205 50436248
Hypoaesthesia 49.14 12.96 150 121521 127107 50356346
Device connection issue 49.09 12.96 25 121646 542 50482911
Feeling abnormal 48.98 12.96 489 121182 125003 50358450
Intentional product use issue 48.96 12.96 68 121603 76850 50406603
Nausea 48.69 12.96 2115 119556 703283 49780170
Right ventricular hypertrophy 48.22 12.96 26 121645 636 50482817
Injury 48.06 12.96 29 121642 48896 50434557
Pleural effusion 48.00 12.96 348 121323 81106 50402347
Cognitive disorder 47.95 12.96 23 121648 44100 50439353
Drug reaction with eosinophilia and systemic symptoms 47.76 12.96 6 121665 28418 50455035
Blood culture positive 47.19 12.96 55 121616 4253 50479200
Respiratory distress 47.19 12.96 171 121500 30318 50453135
Angioedema 46.87 12.96 16 121655 37660 50445793
Concomitant disease progression 46.69 12.96 39 121632 2006 50481447
Device breakage 46.65 12.96 83 121588 9464 50473989
Injection site swelling 46.60 12.96 21 121650 41752 50441701
Arthritis 46.40 12.96 86 121585 86635 50396818
Ill-defined disorder 46.30 12.96 38 121633 54616 50428837
C-reactive protein increased 46.20 12.96 55 121616 66419 50417034
Medical device change 45.69 12.96 20 121651 304 50483149
Injection site pruritus 45.57 12.96 20 121651 40391 50443062
Rhinovirus infection 45.36 12.96 49 121622 3485 50479968
Hallucination 45.35 12.96 28 121643 46629 50436824
Rehabilitation therapy 45.28 12.96 32 121639 1281 50482172
Inappropriate schedule of product administration 45.22 12.96 64 121607 71767 50411686
Finger amputation 44.90 12.96 23 121648 505 50482948
Aspiration pleural cavity 44.71 12.96 26 121645 739 50482714
Respiration abnormal 44.38 12.96 58 121613 5044 50478409
Infusion site abscess 44.18 12.96 17 121654 182 50483271
Hyponatraemia 44.15 12.96 104 121567 96035 50387418
Peripheral swelling 43.43 12.96 716 120955 205220 50278233
Red blood cell sedimentation rate increased 43.19 12.96 9 121662 29407 50454046
Device physical property issue 43.16 12.96 34 121637 1608 50481845
Transplant 43.12 12.96 24 121647 626 50482827
Stent placement 42.96 12.96 47 121624 3391 50480062
Delirium 42.91 12.96 19 121652 38173 50445280
Abortion spontaneous 42.10 12.96 24 121647 41748 50441705
Catheterisation cardiac abnormal 42.08 12.96 17 121654 209 50483244
Device malfunction 41.68 12.96 104 121567 15017 50468436
Emotional distress 41.61 12.96 9 121662 28654 50454799
Liver transplant 41.26 12.96 37 121634 2095 50481358
Blood creatine phosphokinase increased 40.98 12.96 7 121664 26360 50457093
Lung assist device therapy 40.89 12.96 13 121658 74 50483379
Blood potassium decreased 40.33 12.96 186 121485 36759 50446694
Dizziness postural 40.28 12.96 61 121610 6084 50477369
Biopsy liver 39.43 12.96 19 121652 364 50483089
Cardiac failure acute 39.39 12.96 71 121600 8179 50475274
Lymphocyte count decreased 38.72 12.96 8 121663 26299 50457154
Drug-induced liver injury 38.46 12.96 10 121661 28085 50455368
Exposure during pregnancy 37.80 12.96 156 121515 120859 50362594
Right ventricular enlargement 37.61 12.96 17 121654 280 50483173
Inflammation 37.55 12.96 49 121622 56863 50426590
Catheter site discolouration 37.11 12.96 13 121658 104 50483349
Product quality issue 36.86 12.96 14 121657 30844 50452609
Generalised tonic-clonic seizure 36.72 12.96 9 121662 26301 50457152
Catheter site nodule 36.46 12.96 11 121660 51 50483402
Seizure 36.16 12.96 153 121518 117721 50365732
Plasma cell myeloma 36.12 12.96 15 121656 31307 50452146
Oral herpes 35.75 12.96 4 121667 20721 50462732
Catheter site extravasation 35.59 12.96 16 121655 260 50483193
Left-to-right cardiac shunt 35.30 12.96 13 121658 122 50483331
Hyperglycaemia 35.17 12.96 22 121649 36383 50447070
Pulmonary congestion 35.04 12.96 98 121573 15149 50468304
Renal disorder 35.00 12.96 145 121526 27360 50456093
Foot deformity 34.99 12.96 3 121668 19207 50464246
Blood pressure systolic increased 34.83 12.96 21 121650 35428 50448025
Basal cell carcinoma 34.59 12.96 7 121664 23349 50460104
Disease recurrence 34.33 12.96 4 121667 20077 50463376
Catheter site scab 34.30 12.96 14 121657 177 50483276
Sinus congestion 34.30 12.96 92 121579 13879 50469574
Drug withdrawal syndrome 34.19 12.96 9 121662 25072 50458381
Right-to-left cardiac shunt 34.09 12.96 14 121657 180 50483273
Hepatocellular injury 34.09 12.96 10 121661 25937 50457516
Bone disorder 33.96 12.96 3 121668 18749 50464704
Sopor 33.88 12.96 4 121667 19875 50463578
Lactic acidosis 33.85 12.96 19 121652 33336 50450117
Pulmonary vascular resistance abnormality 33.76 12.96 10 121661 43 50483410
Decreased appetite 33.70 12.96 674 120997 200249 50283204
Drug dependence 33.62 12.96 4 121667 19755 50463698
Balance disorder 33.51 12.96 75 121596 70515 50412938
Drug eruption 33.09 12.96 8 121663 23598 50459855
Acute right ventricular failure 32.69 12.96 13 121658 153 50483300
Sinusitis 32.62 12.96 258 121413 170300 50313153
Asthma 32.59 12.96 108 121563 89229 50394224
Paranasal sinus hypersecretion 32.57 12.96 39 121632 3103 50480350
Swollen tongue 32.55 12.96 14 121657 28616 50454837
Orthopnoea 32.47 12.96 53 121618 5636 50477817
Osteoporosis 32.41 12.96 36 121635 44843 50438610
Bursitis 32.03 12.96 7 121664 22128 50461325
Diabetic ketoacidosis 31.99 12.96 3 121668 17869 50465584
Aggression 31.97 12.96 6 121665 21110 50462343
Drug resistance 31.92 12.96 4 121667 18985 50464468
Hospice care 31.90 12.96 53 121618 5719 50477734
Product supply issue 31.89 12.96 25 121646 1174 50482279
Dysentery 31.83 12.96 21 121650 750 50482703
Central venous catheter removal 31.54 12.96 16 121655 344 50483109
Localised oedema 31.46 12.96 48 121623 4819 50478634
Pulmonary pain 31.30 12.96 33 121638 2282 50481171
Stevens-Johnson syndrome 31.23 12.96 7 121664 21745 50461708
Blood culture negative 31.22 12.96 12 121659 128 50483325
Incorrect route of product administration 31.22 12.96 4 121667 18662 50464791
Atrial fibrillation 31.19 12.96 378 121293 101367 50382086
Adverse drug reaction 31.13 12.96 53 121618 55169 50428284
Retching 30.88 12.96 84 121587 12778 50470675
Treatment noncompliance 30.87 12.96 149 121522 30001 50453452
Infusion site discolouration 30.79 12.96 19 121652 603 50482850
Medication error 30.70 12.96 25 121646 36079 50447374
Multiple sclerosis 30.65 12.96 6 121665 20487 50462966
Pulmonary artery aneurysm 30.51 12.96 9 121662 38 50483415
Blood bilirubin increased 30.44 12.96 155 121516 31883 50451570
Pulmonary artery dilatation 30.15 12.96 14 121657 246 50483207
Infusion site oedema 30.11 12.96 18 121653 539 50482914
Intentional product misuse 30.05 12.96 41 121630 46693 50436760
Endotracheal intubation 29.65 12.96 31 121640 2123 50481330
Orthostatic hypotension 29.62 12.96 17 121654 29464 50453989
Vascular resistance pulmonary decreased 29.34 12.96 10 121661 73 50483380
Systemic-pulmonary artery shunt 29.23 12.96 8 121663 24 50483429
Hepatic steatosis 29.23 12.96 11 121660 24373 50459080
Therapeutic embolisation 29.17 12.96 12 121659 155 50483298
Skin lesion 28.94 12.96 14 121657 26713 50456740
Carbon dioxide increased 28.87 12.96 23 121648 1106 50482347
Seasonal allergy 28.64 12.96 89 121582 14587 50468866
Gastrostomy 28.44 12.96 17 121654 509 50482944
Pulmonary arterial wedge pressure increased 28.24 12.96 14 121657 286 50483167
Metabolic acidosis 28.19 12.96 31 121640 38794 50444659
Dyskinesia 28.09 12.96 16 121655 27845 50455608
Aphasia 27.83 12.96 17 121654 28477 50454976
Agitation 27.62 12.96 54 121617 53330 50430123
Heart valve operation 27.62 12.96 11 121660 130 50483323
Hypocalcaemia 27.61 12.96 15 121656 26801 50456652
Device issue 27.57 12.96 108 121563 19864 50463589
Metastases to bone 27.48 12.96 5 121666 17990 50465463
Application site irritation 27.32 12.96 26 121645 1589 50481864
Foetal exposure during pregnancy 27.17 12.96 16 121655 27343 50456110
Application site pruritus 27.07 12.96 39 121632 3720 50479733
Viral infection 27.05 12.96 143 121528 29843 50453610
Dysarthria 27.01 12.96 30 121641 37373 50446080
Device programming error 26.98 12.96 9 121662 61 50483392
Lymphopenia 26.98 12.96 3 121668 15618 50467835
Sleep study 26.94 12.96 7 121664 16 50483437
Gastrointestinal haemorrhage 26.82 12.96 282 121389 73039 50410414
Accidental exposure to product 26.65 12.96 11 121660 23046 50460407
Patent ductus arteriosus repair 26.65 12.96 7 121664 17 50483436
Pulmonary arterial pressure 26.65 12.96 7 121664 17 50483436
Cardiac output decreased 26.64 12.96 20 121651 880 50482573
Constipation 26.50 12.96 302 121369 185406 50298047
Hyperlipidaemia 26.41 12.96 5 121666 17485 50465968
Dialysis related complication 26.14 12.96 9 121662 68 50483385
Dysphagia 26.06 12.96 97 121574 77421 50406032
Disturbance in attention 26.02 12.96 22 121649 31164 50452289
Sudden death 26.01 12.96 63 121608 8928 50474525
Hernia repair 25.82 12.96 23 121648 1291 50482162
Acute myeloid leukaemia 25.77 12.96 3 121668 15071 50468382
Jugular vein distension 25.69 12.96 19 121652 817 50482636
Pneumonitis 25.64 12.96 20 121651 29490 50453963
Mouth ulceration 25.63 12.96 18 121653 28006 50455447
Generalised oedema 25.63 12.96 82 121589 13649 50469804
Osteonecrosis 25.62 12.96 11 121660 22506 50460947
Therapy cessation 25.52 12.96 127 121544 25884 50457569
Posterior reversible encephalopathy syndrome 25.45 12.96 3 121668 14925 50468528
Infusion site rash 25.40 12.96 23 121648 1319 50482134
Nasopharyngitis 25.32 12.96 625 121046 192302 50291151
Prescribed underdose 25.31 12.96 4 121667 15945 50467508
Full blood count decreased 25.29 12.96 11 121660 22335 50461118
Coronary artery compression 25.17 12.96 5 121666 0 50483453
Anti factor VIII antibody test 25.17 12.96 5 121666 0 50483453
Carpal tunnel syndrome 25.15 12.96 5 121666 16888 50466565
Abnormal behaviour 25.06 12.96 8 121663 19650 50463803
Urinary retention 25.06 12.96 16 121655 26174 50457279
CREST syndrome 24.86 12.96 15 121656 457 50482996
Blood glucose increased 24.80 12.96 88 121583 71236 50412217
Injection site mass 24.73 12.96 4 121667 15676 50467777
Liver function test abnormal 24.72 12.96 187 121484 44152 50439301
Platelet count increased 24.60 12.96 3 121668 14537 50468916
Withdrawal syndrome 24.58 12.96 6 121665 17584 50465869
Head discomfort 24.51 12.96 70 121601 10949 50472504
Blood pressure fluctuation 24.50 12.96 30 121641 35793 50447660
Eczema 24.41 12.96 12 121659 22690 50460763
Ventricular septal defect repair 24.34 12.96 6 121665 10 50483443
Pulmonary embolism 24.32 12.96 144 121527 101560 50381893
Nasal dryness 24.13 12.96 36 121635 3543 50479910
Staphylococcus test positive 24.03 12.96 35 121636 3371 50480082
Immunoglobulin G4 related disease 24.01 12.96 8 121663 54 50483399
Rales 23.79 12.96 65 121606 9913 50473540
Blood alkaline phosphatase increased 23.65 12.96 163 121508 37363 50446090
Rhinorrhoea 23.60 12.96 208 121463 51375 50432078
Somnolence 23.31 12.96 249 121422 154736 50328717
Sinus disorder 23.24 12.96 97 121574 18361 50465092
Infection 23.23 12.96 285 121386 172669 50310784
Respiratory syncytial virus infection 23.21 12.96 43 121628 5059 50478394
Mood swings 23.18 12.96 5 121666 15949 50467504
Skin exfoliation 23.15 12.96 28 121643 33584 50449869
Diagnostic procedure 23.09 12.96 9 121662 100 50483353
Dizziness exertional 23.09 12.96 13 121658 347 50483106
Night sweats 23.09 12.96 28 121643 33546 50449907
Pericardial drainage 22.91 12.96 11 121660 209 50483244
Hyperkalaemia 22.90 12.96 51 121620 48038 50435415
Cardiac failure chronic 22.83 12.96 35 121636 3528 50479925
Joint range of motion decreased 22.78 12.96 8 121663 18504 50464949
Application site odour 22.77 12.96 7 121664 35 50483418
Cardiac flutter 22.71 12.96 34 121637 3356 50480097
Haemorrhage 22.68 12.96 212 121459 53229 50430224
Pulmonary haemorrhage 22.67 12.96 49 121622 6443 50477010
Metastases to liver 22.59 12.96 10 121661 20094 50463359
Drug level increased 22.59 12.96 9 121662 19259 50464194
Hypokalaemia 22.43 12.96 122 121549 87870 50395583
Nocturnal dyspnoea 22.42 12.96 19 121652 997 50482456
Myelosuppression 22.36 12.96 3 121668 13514 50469939
Epilepsy 22.30 12.96 12 121659 21555 50461898
Left ventricular failure 22.27 12.96 41 121630 4800 50478653
Tracheostomy tube removal 22.24 12.96 5 121666 4 50483449
Joint stiffness 22.23 12.96 24 121647 30284 50453169
Musculoskeletal disorder 22.22 12.96 7 121664 17342 50466111
Pancreatitis acute 22.17 12.96 15 121656 23797 50459656
Body temperature decreased 22.13 12.96 6 121665 16389 50467064
Exercise test abnormal 22.11 12.96 9 121662 113 50483340
Hypothyroidism 21.88 12.96 30 121641 34095 50449358
Abdominal discomfort 21.76 12.96 409 121262 231232 50252221
Body temperature increased 21.70 12.96 26 121645 31315 50452138
Sinus bradycardia 21.63 12.96 3 121668 13180 50470273
Altered state of consciousness 21.50 12.96 13 121658 21897 50461556
Catheter culture positive 21.49 12.96 9 121662 122 50483331
Myelodysplastic syndrome 21.46 12.96 5 121666 15127 50468326
Pulmonary arterial pressure decreased 21.45 12.96 8 121663 78 50483375
Pulmonary vein stenosis 21.45 12.96 8 121663 78 50483375
Tracheostomy malfunction 21.44 12.96 7 121664 44 50483409
Hypercalcaemia 21.35 12.96 15 121656 23337 50460116
Gastritis hypertrophic 21.30 12.96 7 121664 45 50483408
Right atrial dilatation 21.23 12.96 15 121656 600 50482853
Tenderness 21.23 12.96 9 121662 18556 50464897
Cholestasis 21.09 12.96 18 121653 25383 50458070
Infusion site inflammation 21.05 12.96 11 121660 252 50483201
Cardiomegaly 21.03 12.96 85 121586 15860 50467593
Herpes zoster 21.01 12.96 93 121578 70693 50412760
Blood pressure abnormal 21.01 12.96 73 121598 12674 50470779
Hypomagnesaemia 21.01 12.96 15 121656 23141 50460312
Tendonitis 20.94 12.96 7 121664 16698 50466755
Loss of personal independence in daily activities 20.82 12.96 92 121579 69958 50413495
Chronic right ventricular failure 20.80 12.96 6 121665 23 50483430
Cor pulmonale chronic 20.78 12.96 10 121661 191 50483262
Large intestinal polypectomy 20.78 12.96 10 121661 191 50483262
Cardiac arrest 20.72 12.96 299 121372 83352 50400101
Ataxia 20.69 12.96 4 121667 13782 50469671
Diet noncompliance 20.63 12.96 11 121660 263 50483190
Aspartate aminotransferase increased 20.61 12.96 282 121389 77716 50405737
Right atrial pressure increased 20.61 12.96 9 121662 136 50483317
Ear tube insertion 20.60 12.96 8 121663 88 50483365
Echocardiogram abnormal 20.46 12.96 19 121652 1126 50482327
Cardiogenic shock 20.45 12.96 83 121588 15516 50467937
Hyperhidrosis 20.14 12.96 129 121542 89297 50394156
Increased ventricular preload 20.13 12.96 4 121667 0 50483453
Cytomegalovirus infection 20.08 12.96 9 121662 17953 50465500
Oxygen consumption 20.05 12.96 8 121663 95 50483358
Intervertebral disc degeneration 20.01 12.96 4 121667 13457 50469996
Injection site rash 19.89 12.96 7 121664 16170 50467283
Status epilepticus 19.89 12.96 4 121667 13402 50470051
Atrial tachycardia 19.74 12.96 25 121646 2107 50481346
Tubulointerstitial nephritis 19.73 12.96 6 121665 15205 50468248
Cardiorenal syndrome 19.71 12.96 14 121657 565 50482888
Skin operation 19.70 12.96 5 121666 10 50483443
Ammonia increased 19.61 12.96 36 121635 4205 50479248
Catheter site dryness 19.52 12.96 6 121665 30 50483423
Bradycardia 19.52 12.96 84 121587 64342 50419111
Cyst 19.47 12.96 3 121668 12184 50471269
Muscular weakness 19.44 12.96 141 121530 94872 50388581
Deafness 19.40 12.96 82 121589 15609 50467844
Catheter site cellulitis 19.38 12.96 10 121661 223 50483230
Cardiac index decreased 19.36 12.96 7 121664 62 50483391
Spinal osteoarthritis 19.32 12.96 5 121666 14087 50469366
Catheter site hypersensitivity 19.26 12.96 8 121663 106 50483347
Speech disorder 19.23 12.96 35 121636 35513 50447940
Proteinuria 19.05 12.96 8 121663 16589 50466864
Dry eye 18.83 12.96 30 121641 32065 50451388
Acne 18.71 12.96 12 121659 19583 50463870
Blood iron decreased 18.70 12.96 66 121605 11549 50471904
Peritonitis 18.54 12.96 7 121664 15479 50467974
Gastrointestinal tube insertion 18.53 12.96 17 121654 992 50482461
Rheumatoid nodule 18.48 12.96 4 121667 12731 50470722
Oesophagogastric fundoplasty 18.44 12.96 7 121664 72 50483381
Vasodilatation 18.43 12.96 25 121646 2254 50481199
Impaired work ability 18.39 12.96 5 121666 13635 50469818
Eosinophilia 18.39 12.96 11 121660 18641 50464812
Osteomyelitis 18.36 12.96 16 121655 22337 50461116
Cerebral infarction 18.32 12.96 15 121656 21589 50461864
Brain natriuretic peptide abnormal 18.26 12.96 11 121660 334 50483119
Colitis 18.23 12.96 41 121630 38488 50444965
Gastric antral vascular ectasia 18.16 12.96 13 121658 531 50482922
Sepsis 18.14 12.96 433 121238 132492 50350961
Cataract 18.07 12.96 56 121615 47244 50436209
Colitis ulcerative 17.99 12.96 9 121662 16845 50466608
Protein-losing gastroenteropathy 17.98 12.96 9 121662 188 50483265
Cavopulmonary anastomosis 17.90 12.96 4 121667 3 50483450
Infusion site ulcer 17.90 12.96 4 121667 3 50483450
Cardiac failure high output 17.89 12.96 10 121661 263 50483190
Ischaemic stroke 17.81 12.96 8 121663 15940 50467513
Infusion site injury 17.80 12.96 5 121666 17 50483436
Sudden visual loss 17.80 12.96 5 121666 17 50483436
Contusion 17.78 12.96 178 121493 112005 50371448
Femur fracture 17.62 12.96 40 121631 37424 50446029
Metastases to central nervous system 17.52 12.96 3 121668 11279 50472174
Toxic skin eruption 17.46 12.96 3 121668 11248 50472205
Head injury 17.37 12.96 108 121563 23912 50459541
Choking sensation 17.31 12.96 29 121642 3151 50480302
Chronic hepatic failure 17.23 12.96 12 121659 469 50482984
Sleep disorder 17.16 12.96 75 121596 57208 50426245
Arteriovenous malformation 17.13 12.96 18 121653 1240 50482213
Choking 17.01 12.96 52 121619 8446 50475007
Hepatitis 16.99 12.96 31 121640 31422 50452031
Hypothermia 16.98 12.96 4 121667 12012 50471441
Metastases to lung 16.96 12.96 3 121668 11017 50472436
Breast cancer 16.94 12.96 50 121621 42840 50440613
Bacteraemia 16.75 12.96 74 121597 14359 50469094
Pulseless electrical activity 16.74 12.96 45 121626 6796 50476657
Radiotherapy 16.71 12.96 10 121661 300 50483153
Encephalopathy 16.67 12.96 35 121636 33676 50449777
Rash erythematous 16.56 12.96 37 121634 34815 50448638
Throat irritation 16.56 12.96 127 121544 30112 50453341
Optic ischaemic neuropathy 16.50 12.96 16 121655 1001 50482452
Pulmonary valve replacement 16.48 12.96 4 121667 6 50483447
Spinal stenosis 16.43 12.96 6 121665 13544 50469909
Catheter site induration 16.42 12.96 6 121665 55 50483398
Life support 16.41 12.96 9 121662 228 50483225
Weight decreased 16.39 12.96 669 121002 220576 50262877
Product administration interrupted 16.34 12.96 16 121655 1013 50482440
Hypercholesterolaemia 16.34 12.96 4 121667 11699 50471754
Coronary artery disease 16.32 12.96 29 121642 29697 50453756
Suture insertion 16.32 12.96 7 121664 101 50483352
Knee arthroplasty 16.27 12.96 39 121632 35807 50447646
Biopsy 16.16 12.96 11 121660 414 50483039
Upper respiratory tract infection 16.10 12.96 235 121436 65663 50417790
Infusion site reaction 16.05 12.96 23 121648 2183 50481270
Hallucination, visual 16.04 12.96 10 121661 16572 50466881
Delusion 16.00 12.96 3 121668 10566 50472887
Coordination abnormal 15.99 12.96 4 121667 11530 50471923
Paranasal sinus discomfort 15.95 12.96 27 121644 2959 50480494
Intra-abdominal haemorrhage 15.94 12.96 23 121648 2197 50481256
Respiratory tract haemorrhage 15.93 12.96 11 121660 424 50483029
Chemotherapy 15.88 12.96 18 121653 1351 50482102
Portopulmonary hypertension 15.84 12.96 7 121664 109 50483344
Biopsy lymph gland 15.80 12.96 5 121666 28 50483425
Diabetes mellitus inadequate control 15.64 12.96 6 121665 13139 50470314
Inferior vena cava dilatation 15.61 12.96 6 121665 64 50483389
Diplopia 15.56 12.96 14 121657 19246 50464207
Biopsy lung 15.56 12.96 8 121663 177 50483276
Tremor 15.55 12.96 189 121482 114714 50368739
Nephrolithiasis 15.55 12.96 38 121633 34655 50448798
Injection site haemorrhage 15.54 12.96 17 121654 21329 50462124
Blood triglycerides increased 15.53 12.96 4 121667 11308 50472145
Ejection fraction decreased 15.53 12.96 13 121658 18507 50464946
Nodule 15.44 12.96 11 121660 16992 50466461
Injection site warmth 15.42 12.96 7 121664 13859 50469594
Angioplasty 15.41 12.96 17 121654 1238 50482215
Biopsy kidney 15.39 12.96 7 121664 117 50483336
Metapneumovirus infection 15.39 12.96 14 121657 808 50482645
Intentional medical device removal by patient 15.34 12.96 7 121664 118 50483335
Implantable defibrillator insertion 15.31 12.96 10 121661 351 50483102
Gait disturbance 15.29 12.96 261 121410 149744 50333709
Mineral supplementation 15.28 12.96 13 121658 686 50482767
Fistula repair 15.23 12.96 5 121666 32 50483421
Ear discomfort 15.16 12.96 43 121628 6701 50476752
Nightmare 15.15 12.96 10 121661 16076 50467377
Jejunostomy 15.10 12.96 3 121668 0 50483453
Breast tumour excision 15.10 12.96 3 121668 0 50483453
Oral pain 15.07 12.96 23 121648 25010 50458443
Bone density decreased 15.05 12.96 4 121667 11071 50472382
Obesity 15.04 12.96 11 121660 16764 50466689
Low cardiac output syndrome 15.04 12.96 9 121662 270 50483183
Pulmonary thrombosis 14.96 12.96 46 121625 7495 50475958
Pneumonia bacterial 14.89 12.96 45 121626 7264 50476189
Heart valve replacement 14.85 12.96 11 121660 474 50482979
Hereditary haemorrhagic telangiectasia 14.85 12.96 5 121666 35 50483418
Wrong dose 14.75 12.96 14 121657 853 50482600
Liver injury 14.73 12.96 23 121648 24783 50458670
Clostridium difficile infection 14.58 12.96 108 121563 25331 50458122
Neutrophil count increased 14.53 12.96 8 121663 14187 50469266
Blood calcium decreased 14.52 12.96 17 121654 20689 50462764
Unevaluable investigation 14.50 12.96 5 121666 38 50483415
Infusion site vesicles 14.42 12.96 10 121661 388 50483065
Intracardiac pressure increased 14.39 12.96 5 121666 39 50483414
Haemodynamic test abnormal 14.39 12.96 5 121666 39 50483414
Cardiac output increased 14.35 12.96 7 121664 138 50483315
Hallucination, auditory 14.34 12.96 4 121667 10724 50472729
Skin irritation 14.29 12.96 46 121625 7681 50475772
Sickle cell anaemia 14.28 12.96 11 121660 503 50482950
Disorientation 14.28 12.96 41 121630 35443 50448010
Product substitution issue 14.27 12.96 8 121663 14049 50469404
Poisoning 14.25 12.96 6 121665 12423 50471030
N-terminal prohormone brain natriuretic peptide abnormal 14.17 12.96 5 121666 41 50483412
Carbon dioxide abnormal 14.17 12.96 7 121664 142 50483311
Vasculitis 14.15 12.96 8 121663 13983 50469470
Mydriasis 14.14 12.96 4 121667 10623 50472830
Vascular device occlusion 14.06 12.96 5 121666 42 50483411
Investigation 14.06 12.96 18 121653 1534 50481919
Product complaint 14.03 12.96 5 121666 11461 50471992
Muscle twitching 13.99 12.96 10 121661 15421 50468032
Pulmonary arteriovenous fistula 13.94 12.96 4 121667 15 50483438
Atrial pressure increased 13.94 12.96 4 121667 15 50483438
Vitamin D deficiency 13.91 12.96 5 121666 11397 50472056
Premature delivery 13.87 12.96 101 121570 23562 50459891
Product prescribing error 13.87 12.96 18 121653 20943 50462510
Joint effusion 13.82 12.96 7 121664 13014 50470439
Cardiac procedure complication 13.82 12.96 7 121664 150 50483303
Vascular resistance pulmonary increased 13.76 12.96 5 121666 45 50483408
Chest tube insertion 13.76 12.96 5 121666 45 50483408
Catheter site bruise 13.75 12.96 9 121662 317 50483136
Decreased activity 13.59 12.96 35 121636 5152 50478301
Cardiopulmonary failure 13.59 12.96 27 121644 3346 50480107
Dysgeusia 13.54 12.96 48 121623 38868 50444585
Abnormal dreams 13.50 12.96 3 121668 9374 50474079
Respiratory depression 13.45 12.96 6 121665 12004 50471449
Leukocytosis 13.35 12.96 21 121650 22558 50460895
Psychomotor hyperactivity 13.34 12.96 3 121668 9298 50474155
Pyelonephritis 13.22 12.96 10 121661 14979 50468474
Eye irritation 13.22 12.96 13 121658 17127 50466326
Suture related complication 13.14 12.96 7 121664 167 50483286
Obstructive airways disorder 13.11 12.96 11 121660 15641 50467812
Malignant melanoma 13.09 12.96 4 121667 10104 50473349
Scar 13.09 12.96 6 121665 11812 50471641
Mitral valve repair 13.07 12.96 7 121664 169 50483284
Drug tolerance decreased 13.05 12.96 3 121668 9157 50474296
Tuberculosis 13.04 12.96 4 121667 10079 50473374
Abdominal pain 13.03 12.96 451 121220 235777 50247676
Catheter site mass 13.01 12.96 4 121667 20 50483433
Urinary tract infection 12.98 12.96 425 121246 223595 50259858
Tooth disorder 12.98 12.96 24 121647 24204 50459249

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 879.04 10.86 417 77317 7032 29489761
Pulmonary hypertension 625.47 10.86 462 77272 18146 29478647
Right ventricular failure 618.40 10.86 335 77399 7555 29489238
Fluid retention 563.97 10.86 479 77255 23081 29473712
Dyspnoea 441.19 10.86 1858 75876 324874 29171919
Headache 399.15 10.86 1180 76554 172827 29323966
Pain in jaw 388.73 10.86 288 77446 11353 29485440
Optic ischaemic neuropathy 360.13 10.86 149 77585 1777 29495016
Cyanopsia 324.15 10.86 77 77657 84 29496709
Death 319.25 10.86 1750 75984 340334 29156459
Flushing 249.65 10.86 343 77391 28649 29468144
Hypervolaemia 237.82 10.86 261 77473 17284 29479509
Erection increased 229.37 10.86 75 77659 427 29496366
Nasal congestion 228.88 10.86 265 77469 18614 29478179
Febrile neutropenia 206.33 10.86 26 77708 112214 29384579
Neutropenia 198.08 10.86 51 77683 131660 29365133
Drug ineffective 189.51 10.86 1611 76123 361559 29135234
Lung transplant 187.96 10.86 92 77642 1664 29495129
Catheter management 156.79 10.86 65 77669 779 29496014
Dyspnoea exertional 155.80 10.86 315 77419 36175 29460618
Oxygen saturation decreased 153.04 10.86 354 77380 44583 29452210
Malignant neoplasm progression 151.77 10.86 11 77723 73848 29422945
Catheter site erythema 140.35 10.86 67 77667 1144 29495649
Infusion site pain 139.14 10.86 90 77644 2835 29493958
Catheterisation cardiac 137.60 10.86 80 77654 2073 29494720
Blindness unilateral 129.61 10.86 95 77639 3679 29493114
Transfusion 126.67 10.86 124 77610 7174 29489619
Thrombocytopenia 122.05 10.86 105 77629 134718 29362075
Acute kidney injury 106.11 10.86 351 77383 264916 29231877
Prescription drug used without a prescription 103.88 10.86 56 77678 1248 29495545
Erectile dysfunction 99.95 10.86 174 77560 17835 29478958
Hospitalisation 99.32 10.86 306 77428 45682 29451111
Oxygen consumption increased 99.00 10.86 54 77680 1233 29495560
Suspected counterfeit product 98.77 10.86 34 77700 232 29496561
Priapism 98.67 10.86 87 77647 4401 29492392
Catheter placement 98.14 10.86 44 77690 646 29496147
Visual impairment 97.78 10.86 231 77503 29477 29467316
Leukopenia 93.93 10.86 16 77718 55187 29441606
Oedema 93.66 10.86 276 77458 40207 29456586
Condition aggravated 93.32 10.86 681 77053 145614 29351179
Pulmonary arterial pressure increased 90.34 10.86 48 77686 1038 29495755
Cardiac operation 87.47 10.86 65 77669 2571 29494222
Catheter site pruritus 86.18 10.86 32 77702 279 29496514
Toxicity to various agents 84.59 10.86 209 77525 173452 29323341
Syncope 83.78 10.86 429 77305 80942 29415851
Infusion site erythema 83.61 10.86 53 77681 1611 29495182
Visual field defect 83.01 10.86 76 77658 4040 29492753
Vision blurred 80.93 10.86 261 77473 39915 29456878
Cardiac failure 79.54 10.86 415 77319 78872 29417921
Chromatopsia 78.72 10.86 27 77707 182 29496611
Catheter site discharge 74.12 10.86 34 77700 528 29496265
Device related infection 72.76 10.86 140 77594 15496 29481297
Pulmonary hypertensive crisis 72.62 10.86 24 77710 142 29496651
Oedema peripheral 71.76 10.86 492 77242 103065 29393728
Pyrexia 70.05 10.86 456 77278 287166 29209627
Hypoxia 68.33 10.86 276 77458 47103 29449690
Peyronie's disease 66.85 10.86 18 77716 44 29496749
Palpitations 66.73 10.86 213 77521 32391 29464402
Catheter site pain 65.89 10.86 40 77694 1124 29495669
Dizziness 64.61 10.86 772 76962 188912 29307881
Central venous catheterisation 62.27 10.86 37 77697 999 29495794
Mucosal inflammation 61.32 10.86 6 77728 31589 29465204
Device alarm issue 60.82 10.86 30 77704 552 29496241
White blood cell count decreased 60.68 10.86 78 77656 83284 29413509
Anaemia 59.97 10.86 298 77436 200653 29296140
Pancytopenia 59.32 10.86 79 77655 83089 29413704
Catheter site infection 58.40 10.86 46 77688 1986 29494807
Neutrophil count decreased 57.95 10.86 21 77713 43546 29453247
Device dislocation 57.28 10.86 65 77669 4462 29492331
Heart transplant 56.86 10.86 32 77702 778 29496015
Blindness 56.36 10.86 108 77626 11915 29484878
Self-medication 56.04 10.86 46 77688 2108 29494685
Retinal vein occlusion 53.75 10.86 39 77695 1486 29495307
Cardiac disorder 53.66 10.86 217 77517 37046 29459747
Electrocardiogram QT prolonged 52.34 10.86 15 77719 36122 29460671
Counterfeit product administered 52.27 10.86 19 77715 155 29496638
Infusion site haemorrhage 52.05 10.86 29 77705 691 29496102
Pain in extremity 51.94 10.86 480 77254 109953 29386840
Complication associated with device 51.70 10.86 66 77668 5125 29491668
Hyponatraemia 51.61 10.86 61 77673 67572 29429221
Chest pain 51.31 10.86 484 77250 111489 29385304
Catheter site irritation 50.96 10.86 17 77717 104 29496689
Catheter site rash 50.45 10.86 19 77715 173 29496620
General physical health deterioration 49.84 10.86 124 77610 102733 29394060
Thrombosis corpora cavernosa 49.44 10.86 10 77724 0 29496793
Bone marrow failure 48.85 10.86 7 77727 27442 29469351
Platelet count decreased 48.55 10.86 129 77605 104543 29392250
Infusion site infection 48.05 10.86 23 77711 395 29496398
Transplant evaluation 47.73 10.86 24 77710 461 29496332
Pulmonary veno-occlusive disease 46.44 10.86 23 77711 427 29496366
Product use in unapproved indication 45.88 10.86 100 77634 86775 29410018
Catheter site swelling 45.27 10.86 20 77714 283 29496510
Infusion related reaction 44.99 10.86 30 77704 43856 29452937
C-reactive protein increased 44.39 10.86 31 77703 44232 29452561
Deafness 44.31 10.86 88 77646 9967 29486826
Deafness unilateral 43.08 10.86 37 77697 1806 29494987
Peripheral swelling 43.01 10.86 301 77433 63438 29433355
Pre-existing condition improved 42.34 10.86 40 77694 2213 29494580
Ventilation perfusion mismatch 42.18 10.86 13 77721 59 29496734
Completed suicide 42.01 10.86 111 77623 90135 29406658
Blindness transient 41.77 10.86 37 77697 1883 29494910
Cytomegalovirus infection 41.12 10.86 6 77728 23209 29473584
Heart and lung transplant 40.67 10.86 13 77721 68 29496725
Transient global amnesia 40.35 10.86 19 77715 314 29496479
Concomitant disease aggravated 39.98 10.86 57 77677 4921 29491872
Therapy change 39.33 10.86 41 77693 2557 29494236
Renal impairment 38.65 10.86 99 77635 81234 29415559
Spontaneous penile erection 38.42 10.86 16 77718 194 29496599
Cardiac failure congestive 38.08 10.86 337 77397 76244 29420549
Abdominal discomfort 37.63 10.86 235 77499 47668 29449125
Dyschromatopsia 37.61 10.86 18 77716 309 29496484
Off label use 37.49 10.86 561 77173 300239 29196554
Hepatic function abnormal 37.42 10.86 29 77705 39230 29457563
Rash maculo-papular 37.23 10.86 9 77725 24280 29472513
Product counterfeit 37.22 10.86 14 77720 127 29496666
Stomatitis 37.20 10.86 26 77708 37087 29459706
Visual brightness 36.98 10.86 10 77724 25 29496768
Vascular device infection 36.97 10.86 39 77695 2466 29494327
Colitis 36.84 10.86 18 77716 31230 29465563
Biopsy liver 36.76 10.86 16 77718 218 29496575
Liver transplant 35.87 10.86 37 77697 2279 29494514
Treatment failure 35.57 10.86 27 77707 36912 29459881
Pulmonary oedema 35.05 10.86 212 77522 42523 29454270
Ventricular assist device insertion 34.99 10.86 9 77725 17 29496776
Pruritus 34.95 10.86 173 77561 116676 29380117
Feeling abnormal 34.92 10.86 254 77480 54191 29442602
Foetal exposure during pregnancy 34.92 10.86 23 77711 33844 29462949
Retinal artery occlusion 34.75 10.86 31 77703 1592 29495201
Dermatitis contact 34.57 10.86 41 77693 2951 29493842
Malaise 34.43 10.86 600 77134 159002 29337791
Spinal cord infarction 34.11 10.86 16 77718 262 29496531
Lymphocyte count abnormal 34.09 10.86 21 77713 606 29496187
Oxygen therapy 33.92 10.86 22 77712 696 29496097
N-terminal prohormone brain natriuretic peptide increased 33.85 10.86 33 77701 1899 29494894
Vascular resistance pulmonary increased 33.72 10.86 9 77725 21 29496772
Device occlusion 33.50 10.86 56 77678 5552 29491241
Brain natriuretic peptide increased 33.33 10.86 48 77686 4182 29492611
Infusion site discharge 33.32 10.86 12 77722 95 29496698
Infusion site swelling 32.87 10.86 32 77702 1838 29494955
Confusional state 32.41 10.86 200 77534 127677 29369116
Viral infection 32.36 10.86 99 77635 14711 29482082
Cyanosis 32.17 10.86 83 77651 11184 29485609
Hyperkalaemia 32.13 10.86 71 77663 61321 29435472
Therapy non-responder 31.78 10.86 163 77571 30748 29466045
Myalgia 31.44 10.86 315 77419 73704 29423089
Disseminated intravascular coagulation 31.42 10.86 7 77727 19973 29476820
Septic shock 31.40 10.86 74 77660 62486 29434307
Biopsy lung 31.14 10.86 12 77722 117 29496676
Painful erection 31.13 10.86 14 77720 207 29496586
Paracentesis 31.13 10.86 17 77717 389 29496404
Drug resistance 31.08 10.86 9 77725 21531 29475262
Walking distance test abnormal 31.05 10.86 13 77721 160 29496633
Dehydration 30.91 10.86 176 77558 114572 29382221
Drug interaction 30.84 10.86 351 77383 197034 29299759
Interstitial lung disease 30.82 10.86 66 77668 57652 29439141
Eosinophilia 30.64 10.86 10 77724 22151 29474642
Catheter site haemorrhage 30.43 10.86 32 77702 2016 29494777
Visual acuity reduced 30.25 10.86 97 77637 14779 29482014
Drug reaction with eosinophilia and systemic symptoms 30.25 10.86 18 77716 27974 29468819
Medical device change 30.23 10.86 11 77723 90 29496703
Tracheostomy 30.20 10.86 20 77714 656 29496137
Pulmonary vein stenosis 30.11 10.86 9 77725 36 29496757
Expired product administered 30.00 10.86 37 77697 2774 29494019
Mechanical ventilation 30.00 10.86 29 77705 1651 29495142
Metabolic acidosis 29.77 10.86 33 77701 37629 29459164
Loss of visual contrast sensitivity 29.66 10.86 6 77728 0 29496793
Drug abuse 29.57 10.86 109 77625 79774 29417019
Scleroderma 29.53 10.86 26 77708 1312 29495481
Thunderclap headache 29.35 10.86 9 77725 40 29496753
Rheumatoid arthritis 29.08 10.86 25 77709 32127 29464666
Pneumonitis 28.97 10.86 19 77715 28025 29468768
Device connection issue 28.75 10.86 15 77719 312 29496481
Fracture of penis 28.56 10.86 13 77721 198 29496595
Delirium 28.50 10.86 37 77697 39360 29457433
Catheter site inflammation 28.39 10.86 13 77721 201 29496592
Right ventricular dysfunction 28.31 10.86 22 77712 931 29495862
Therapeutic response unexpected 28.22 10.86 67 77667 8571 29488222
Optic disc disorder 28.01 10.86 9 77725 48 29496745
Exercise tolerance decreased 27.64 10.86 44 77690 4187 29492606
Macrophages increased 27.60 10.86 12 77722 163 29496630
Sepsis 27.13 10.86 242 77492 142440 29354353
Product use issue 26.92 10.86 229 77505 51215 29445578
Lactic acidosis 26.78 10.86 24 77710 30223 29466570
Onychomycosis 26.76 10.86 30 77704 2032 29494761
Multiple organ dysfunction syndrome 26.16 10.86 82 77652 63034 29433759
Infusion site warmth 25.64 10.86 10 77724 101 29496692
Aspiration pleural cavity 25.58 10.86 19 77715 751 29496042
Osteonecrosis of jaw 25.53 10.86 6 77728 16504 29480289
Penile curvature 25.47 10.86 9 77725 67 29496726
Atrial septal defect repair 25.46 10.86 10 77724 103 29496690
Rash 25.34 10.86 349 77385 189470 29307323
Cor pulmonale 25.06 10.86 18 77716 675 29496118
Hyperglycaemia 25.01 10.86 32 77702 34255 29462538
Sinus congestion 24.85 10.86 44 77690 4568 29492225
Hallucination 24.82 10.86 50 77684 44662 29452131
Hypoglossal nerve paralysis 24.72 10.86 5 77729 0 29496793
Plasma cell myeloma 24.71 10.86 37 77697 37078 29459715
Device infusion issue 24.69 10.86 17 77717 595 29496198
Neoplasm progression 24.69 10.86 9 77725 18603 29478190
Product contamination 24.52 10.86 17 77717 602 29496191
Cardiac index increased 24.48 10.86 7 77727 23 29496770
Chorioretinopathy 24.46 10.86 24 77710 1392 29495401
Infusion site discomfort 24.41 10.86 10 77724 116 29496677
Somnolence 24.28 10.86 146 77588 93809 29402984
Congestive hepatopathy 24.08 10.86 26 77708 1688 29495105
Blood culture negative 24.04 10.86 7 77727 25 29496768
Swelling 24.01 10.86 167 77567 35116 29461677
Chronic obstructive pulmonary disease 23.96 10.86 187 77547 40768 29456025
Patent ductus arteriosus repair 23.81 10.86 6 77728 10 29496783
Ejaculation disorder 23.78 10.86 20 77714 948 29495845
Tumour lysis syndrome 23.66 10.86 4 77730 13880 29482913
Acute myeloid leukaemia 23.64 10.86 7 77727 16506 29480287
Ejaculation failure 23.42 10.86 18 77716 749 29496044
Catheter removal 23.41 10.86 11 77723 181 29496612
Blood cholesterol increased 23.39 10.86 92 77642 15503 29481290
Retinal vascular occlusion 23.12 10.86 10 77724 134 29496659
Hepatotoxicity 23.10 10.86 9 77725 17858 29478935
Retinal vascular disorder 22.60 10.86 10 77724 142 29496651
Weight increased 22.58 10.86 304 77430 76363 29420430
Anorgasmia 22.48 10.86 16 77718 591 29496202
Pneumocystis jirovecii pneumonia 22.45 10.86 8 77726 16771 29480022
Macular degeneration 22.34 10.86 26 77708 1834 29494959
Dysphagia 22.31 10.86 72 77662 54854 29441939
Cardiac ablation 22.28 10.86 17 77717 700 29496093
Cardioversion 22.00 10.86 18 77716 821 29495972
Balloon atrial septostomy 21.91 10.86 6 77728 16 29496777
Infusion site scar 21.84 10.86 7 77727 37 29496756
Blood testosterone decreased 21.83 10.86 38 77696 3892 29492901
Maculopathy 21.74 10.86 18 77716 835 29495958
Infusion site inflammation 21.53 10.86 7 77727 39 29496754
Pneumonia aspiration 21.33 10.86 40 77694 36697 29460096
Neuropathy peripheral 21.31 10.86 105 77629 70922 29425871
Urticaria 21.28 10.86 73 77661 54587 29442206
Inappropriate schedule of product administration 21.21 10.86 54 77680 44418 29452375
Coma 21.15 10.86 45 77689 39405 29457388
Optic atrophy 21.13 10.86 17 77717 757 29496036
Macular oedema 21.01 10.86 29 77705 2429 29494364
Hypotension 20.85 10.86 663 77071 193691 29303102
Candida infection 20.82 10.86 7 77727 15218 29481575
Dizziness exertional 20.78 10.86 9 77725 121 29496672
Drug eruption 20.73 10.86 9 77725 16732 29480061
Blood creatinine increased 20.57 10.86 135 77599 84967 29411826
Sedation 20.55 10.86 10 77724 17395 29479398
Cor pulmonale chronic 20.43 10.86 7 77727 47 29496746
Catheterisation cardiac abnormal 20.31 10.86 7 77727 48 29496745
Myoclonus 20.26 10.86 5 77729 13304 29483489
Catheter site extravasation 20.23 10.86 8 77726 84 29496709
Oxygen saturation abnormal 20.21 10.86 20 77714 1172 29495621
Tinnitus 20.18 10.86 88 77646 15526 29481267
Bronchopulmonary aspergillosis 20.08 10.86 4 77730 12340 29484453
Respiratory syncytial virus infection 19.83 10.86 35 77699 3624 29493169
Palmar-plantar erythrodysaesthesia syndrome 19.81 10.86 7 77727 14752 29482041
Carbon dioxide increased 19.67 10.86 18 77716 956 29495837
Infusion site irritation 19.66 10.86 10 77724 197 29496596
Cough 19.47 10.86 453 77281 126274 29370519
Penis disorder 19.42 10.86 19 77715 1098 29495695
Carotid artery dissection 19.26 10.86 9 77725 146 29496647
Acute respiratory failure 19.17 10.86 127 77607 26275 29470518
Toxic epidermal necrolysis 19.16 10.86 12 77722 18141 29478652
Lung disorder 19.08 10.86 141 77593 30221 29466572
Genital swelling 19.05 10.86 9 77725 150 29496643
Phlebotomy 18.93 10.86 5 77729 11 29496782
Hypocalcaemia 18.77 10.86 16 77718 20649 29476144
Rhabdomyolysis 18.75 10.86 89 77645 60719 29436074
Abdominal pain 18.72 10.86 247 77487 135110 29361683
Suture insertion 18.67 10.86 6 77728 32 29496761
Neutropenic sepsis 18.66 10.86 4 77730 11723 29485070
Micrococcus test positive 18.63 10.86 5 77729 12 29496781
Implant site extravasation 18.49 10.86 12 77722 380 29496413
Myelodysplastic syndrome 18.45 10.86 12 77722 17782 29479011
Photopsia 18.38 10.86 23 77711 1750 29495043
Stent placement 18.15 10.86 37 77697 4269 29492524
Aspergillus infection 18.14 10.86 3 77731 10578 29486215
Seizure 18.10 10.86 157 77577 92966 29403827
Photophobia 17.98 10.86 45 77689 5950 29490843
Haemophagocytic lymphohistiocytosis 17.95 10.86 3 77731 10501 29486292
Conjunctival hyperaemia 17.87 10.86 25 77709 2120 29494673
Sudden death 17.84 10.86 79 77655 14031 29482762
Spontaneous intrahepatic portosystemic venous shunt 17.83 10.86 5 77729 15 29496778
Hepatitis 17.79 10.86 17 77717 20766 29476027
Rhinovirus infection 17.74 10.86 31 77703 3185 29493608
Sudden cardiac death 17.70 10.86 31 77703 3191 29493602
Full blood count decreased 17.68 10.86 10 77724 15982 29480811
Polyneuropathy 17.67 10.86 5 77729 12147 29484646
Lymphadenopathy 17.63 10.86 24 77710 25025 29471768
Unevaluable event 17.29 10.86 136 77598 29715 29467078
Device physical property issue 17.25 10.86 14 77720 631 29496162
Pulmonary embolism 17.21 10.86 124 77610 76410 29420383
Vitreous detachment 17.05 10.86 15 77719 756 29496037
Decreased appetite 17.03 10.86 274 77460 145068 29351725
Hyperbilirubinaemia 17.00 10.86 9 77725 14925 29481868
Tracheitis 16.92 10.86 14 77720 649 29496144
Hypophagia 16.81 10.86 18 77716 20854 29475939
Psoriatic arthropathy 16.51 10.86 9 77725 14682 29482111
Product quality issue 16.46 10.86 84 77650 15811 29480982
Blood pressure abnormal 16.36 10.86 47 77687 6743 29490050
Ocular vascular disorder 16.33 10.86 8 77726 145 29496648
Heart rate increased 16.17 10.86 165 77569 38773 29458020
Respiratory tract infection viral 16.12 10.86 18 77716 1214 29495579
Therapy cessation 16.09 10.86 78 77656 14384 29482409
Infusion site vesicles 16.08 10.86 8 77726 150 29496643
Myelosuppression 16.07 10.86 6 77728 12221 29484572
Blood ethanol increased 16.05 10.86 12 77722 479 29496314
Hernia repair 16.05 10.86 17 77717 1080 29495713
Presyncope 15.95 10.86 84 77650 16005 29480788
Catheter site discolouration 15.83 10.86 5 77729 25 29496768
Blood pressure decreased 15.80 10.86 186 77548 45291 29451502
Lymphopenia 15.64 10.86 8 77726 13525 29483268
Heart valve operation 15.61 10.86 6 77728 58 29496735
Hypercalcaemia 15.57 10.86 7 77727 12752 29484041
Contraindicated product administered 15.57 10.86 15 77719 18251 29478542
Diuretic therapy 15.51 10.86 5 77729 27 29496766
Chest discomfort 15.51 10.86 187 77547 45796 29450997
Hypoacusis 15.48 10.86 77 77657 14346 29482447
Pulmonary vascular resistance abnormality 15.44 10.86 6 77728 60 29496733
Colour blindness 15.42 10.86 9 77725 235 29496558
Chloropsia 15.40 10.86 4 77730 8 29496785
Blood creatine phosphokinase increased 15.33 10.86 55 77679 40589 29456204
Cardiac pacemaker insertion 15.13 10.86 25 77709 2454 29494339
Dialysis 15.13 10.86 60 77674 10148 29486645
Mobility decreased 15.03 10.86 28 77706 25752 29471041
Papilloedema 14.98 10.86 24 77710 2296 29494497
Acute right ventricular failure 14.96 10.86 7 77727 114 29496679
Transplant rejection 14.95 10.86 3 77731 9209 29487584
Viral labyrinthitis 14.83 10.86 3 77731 0 29496793
Orchidopexy 14.83 10.86 3 77731 0 29496793
Device leakage 14.83 10.86 35 77699 4460 29492333
Therapeutic procedure 14.81 10.86 8 77726 179 29496614
Catheter site scab 14.79 10.86 4 77730 10 29496783
Thoracic cavity drainage 14.69 10.86 8 77726 182 29496611
Encephalopathy 14.57 10.86 38 77696 31005 29465788
Ileus 14.55 10.86 10 77724 14392 29482401
Deafness transitory 14.54 10.86 5 77729 34 29496759
Metastases to bone 14.53 10.86 4 77730 9894 29486899
Pulmonary congestion 14.51 10.86 68 77666 12368 29484425
Suicide attempt 14.35 10.86 44 77690 34066 29462727
Dyskinesia 14.34 10.86 19 77715 20042 29476751
Anaphylactic reaction 14.32 10.86 32 77702 27541 29469252
Transplant 14.31 10.86 13 77721 684 29496109
Basal cell carcinoma 14.28 10.86 14 77720 16896 29479897
Device breakage 14.14 10.86 20 77714 1714 29495079
Right ventricular dilatation 14.11 10.86 12 77722 578 29496215
Oesophageal variceal ligation 14.10 10.86 6 77728 77 29496716
Colour blindness acquired 14.10 10.86 6 77728 77 29496716
Chronic respiratory failure 14.10 10.86 17 77717 1245 29495548
Atrial flutter 14.09 10.86 73 77661 13821 29482972
Pulmonary arterial pressure abnormal 14.09 10.86 8 77726 198 29496595
Blood pressure fluctuation 14.06 10.86 19 77715 19875 29476918
Peritonitis 14.06 10.86 11 77723 14813 29481980
Hypokalaemia 14.04 10.86 76 77658 50127 29446666
Lymphocyte count decreased 14.04 10.86 18 77716 19253 29477540
Right atrial pressure increased 14.04 10.86 6 77728 78 29496715
Penile vein thrombosis 14.02 10.86 4 77730 13 29496780
Intentional product misuse 13.98 10.86 146 77588 34515 29462278
Bradycardia 13.95 10.86 108 77626 65521 29431272
Infusion site induration 13.94 10.86 8 77726 202 29496591
Blood lactate dehydrogenase increased 13.93 10.86 18 77716 19191 29477602
Road traffic accident 13.92 10.86 79 77655 15482 29481311
Epstein-Barr virus antibody positive 13.84 10.86 9 77725 286 29496507
Pulmonary arterial pressure decreased 13.80 10.86 4 77730 14 29496779
Constipation 13.77 10.86 214 77520 113946 29382847
Mineral supplementation 13.77 10.86 6 77728 82 29496711
Vertebral artery stenosis 13.76 10.86 7 77727 138 29496655
Substance use 13.74 10.86 11 77723 486 29496307
Metastases to liver 13.71 10.86 7 77727 11849 29484944
Retinal haemorrhage 13.71 10.86 34 77700 4470 29492323
Chest tube insertion 13.70 10.86 6 77728 83 29496710
Neurotoxicity 13.66 10.86 11 77723 14602 29482191
Urinary tract infection 13.61 10.86 123 77611 72231 29424562
Cardiac failure acute 13.60 10.86 54 77680 9138 29487655
Epistaxis 13.60 10.86 201 77533 51503 29445290
Pulmonary capillary haemangiomatosis 13.58 10.86 4 77730 15 29496778
Endarterectomy 13.58 10.86 7 77727 142 29496651
Injection site pain 13.55 10.86 42 77692 32404 29464389
Vasodilatation 13.46 10.86 15 77719 1009 29495784
Exposure during pregnancy 13.44 10.86 3 77731 8551 29488242
Viral upper respiratory tract infection 13.41 10.86 24 77710 2513 29494280
Loss of consciousness 13.37 10.86 271 77463 73785 29423008
Depressed level of consciousness 13.27 10.86 51 77683 36891 29459902
Food interaction 13.26 10.86 14 77720 886 29495907
Bronchopulmonary dysplasia 13.23 10.86 11 77723 513 29496280
Executive dysfunction 13.20 10.86 8 77726 224 29496569
Product taste abnormal 13.19 10.86 15 77719 1032 29495761
Hallucination, visual 13.18 10.86 12 77722 15003 29481790
Renal tubular necrosis 13.10 10.86 11 77723 14304 29482489
Altered state of consciousness 13.07 10.86 20 77714 19869 29476924
Retinitis pigmentosa 13.04 10.86 5 77729 48 29496745
Corneal abrasion 12.98 10.86 8 77726 231 29496562
Glare 12.97 10.86 6 77728 95 29496698
Transaminases increased 12.87 10.86 25 77709 22637 29474156
Respiratory depression 12.87 10.86 10 77724 13513 29483280
Retinopathy of prematurity 12.86 10.86 6 77728 97 29496696
Nodular melanoma 12.81 10.86 6 77728 98 29496695
Sudden hearing loss 12.79 10.86 13 77721 787 29496006
Fasciectomy 12.76 10.86 3 77731 3 29496790
Sensation of blood flow 12.76 10.86 3 77731 3 29496790
Dyspepsia 12.67 10.86 128 77606 29997 29466796
Libido decreased 12.62 10.86 32 77702 4266 29492527
Male orgasmic disorder 12.59 10.86 6 77728 102 29496691
Therapeutic product effect delayed 12.59 10.86 15 77719 1085 29495708
Toxic skin eruption 12.47 10.86 5 77729 9752 29487041
Deep vein thrombosis 12.42 10.86 94 77640 57305 29439488
Emergency care 12.37 10.86 8 77726 252 29496541
Exercise test abnormal 12.30 10.86 3 77731 4 29496789
Right-to-left cardiac shunt 12.28 10.86 5 77729 57 29496736
Retinal tear 12.26 10.86 12 77722 694 29496099
Catheter site mass 12.20 10.86 4 77730 23 29496770
Lung assist device therapy 12.06 10.86 4 77730 24 29496769
Adulterated product 12.06 10.86 4 77730 24 29496769
Cardiac discomfort 12.04 10.86 10 77724 466 29496327
Hypomagnesaemia 12.03 10.86 17 77717 17451 29479342
Vasculitis 12.03 10.86 3 77731 7925 29488868
Retinal vein thrombosis 11.96 10.86 9 77725 363 29496430
Gastrooesophageal reflux disease 11.92 10.86 131 77603 31365 29465428
Infusion site abscess 11.92 10.86 4 77730 25 29496768
Catheter site dermatitis 11.90 10.86 3 77731 5 29496788
Hyperthermia 11.78 10.86 5 77729 9425 29487368
Infusion site reaction 11.73 10.86 12 77722 732 29496061
Glomerular filtration rate abnormal 11.73 10.86 12 77722 732 29496061
Retinal infarction 11.71 10.86 6 77728 120 29496673
Haematuria 11.70 10.86 68 77666 44071 29452722
Hepatocellular injury 11.58 10.86 24 77710 21219 29475574
Lymphocyte count 11.56 10.86 5 77729 67 29496726
Micrococcus infection 11.55 10.86 3 77731 6 29496787
Retinal disorder 11.52 10.86 13 77721 887 29495906
Nephropathy toxic 11.50 10.86 7 77727 10749 29486044
Prostate cancer 11.49 10.86 110 77624 25417 29471376
Hypothyroidism 11.44 10.86 15 77719 15891 29480902
Orgasm abnormal 11.41 10.86 6 77728 127 29496666
Hypothermia 11.38 10.86 5 77729 9234 29487559
Tricuspid valve incompetence 11.38 10.86 48 77686 8346 29488447
Sinus disorder 11.36 10.86 38 77696 5917 29490876
Accident at work 11.31 10.86 11 77723 631 29496162
Vascular operation 11.30 10.86 4 77730 30 29496763
Catheter site vesicles 11.30 10.86 4 77730 30 29496763
Blood calcium decreased 11.27 10.86 5 77729 9177 29487616
Melaena 11.23 10.86 43 77691 31133 29465660
Ventricular dyskinesia 11.18 10.86 7 77727 208 29496585
Gastrointestinal surgery 11.18 10.86 4 77730 31 29496762
Product dose omission issue 11.16 10.86 332 77402 96051 29400742
Psychotic disorder 11.09 10.86 23 77711 20331 29476462
Haemoptysis 11.08 10.86 126 77608 30424 29466369
Angioplasty 11.05 10.86 13 77721 928 29495865
Internal haemorrhage 11.02 10.86 31 77703 4396 29492397
Aggression 10.97 10.86 52 77682 35489 29461304
Intentional overdose 10.96 10.86 58 77676 38470 29458323
Mitral valve replacement 10.88 10.86 6 77728 140 29496653

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pulmonary arterial hypertension 2948.28 11.26 1415 172129 23952 64301236
Dyspnoea 2189.38 11.26 5471 168073 713203 63611985
Fluid retention 2093.48 11.26 1533 172011 58073 64267115
Right ventricular failure 1991.98 11.26 1028 172516 20443 64304745
Pulmonary hypertension 1790.78 11.26 1229 172315 41910 64283278
Pain in jaw 1509.60 11.26 1083 172461 39672 64285516
Death 1326.01 11.26 3543 170001 479162 63846026
Hypervolaemia 1031.58 11.26 842 172702 37443 64287745
Headache 922.31 11.26 3318 170226 526149 63799039
Dyspnoea exertional 822.67 11.26 1003 172541 72727 64252461
Catheter site erythema 691.73 11.26 312 173232 4537 64320651
Lung transplant 616.90 11.26 274 173270 3834 64321354
Nasal congestion 598.93 11.26 770 172774 58888 64266300
Flushing 575.65 11.26 872 172672 77776 64247412
Transfusion 573.30 11.26 437 173107 17557 64307631
Oxygen saturation decreased 547.12 11.26 1011 172533 106165 64219023
Oedema 533.15 11.26 917 172627 91018 64234170
Catheter management 488.51 11.26 219 173325 3136 64322052
Catheter site pruritus 476.00 11.26 189 173355 1959 64323229
Device related infection 473.60 11.26 494 173050 30132 64295056
Neutropenia 438.54 11.26 62 173482 239562 64085626
Infusion site pain 432.83 11.26 297 173247 10100 64315088
Catheter site pain 426.14 11.26 218 173326 4244 64320944
Catheterisation cardiac 422.15 11.26 223 173321 4650 64320538
Hospitalisation 416.21 11.26 735 172809 74472 64250716
Toxicity to various agents 399.66 11.26 242 173302 363271 63961917
Febrile neutropenia 385.29 11.26 32 173512 187625 64137563
Catheter site discharge 367.38 11.26 159 173385 2082 64323106
Chest pain 358.85 11.26 1419 172125 234561 64090627
Pulmonary arterial pressure increased 358.37 11.26 189 173355 3927 64321261
Oedema peripheral 346.18 11.26 1297 172247 209020 64116168
Hypoxia 342.19 11.26 742 172802 87407 64237781
Catheter site infection 326.71 11.26 199 173345 5494 64319694
Infusion related reaction 324.34 11.26 33 173511 164434 64160754
Syncope 322.54 11.26 1045 172499 156590 64168598
Cardiac failure 312.04 11.26 922 172622 131451 64193737
Oxygen consumption increased 304.35 11.26 176 173368 4405 64320783
Completed suicide 293.86 11.26 118 173426 224296 64100892
Catheter placement 283.90 11.26 139 173405 2454 64322734
Central venous catheterisation 276.58 11.26 139 173405 2602 64322586
Pulmonary oedema 269.28 11.26 630 172914 78044 64247144
Infusion site erythema 264.24 11.26 187 173357 6686 64318502
Condition aggravated 248.84 11.26 1784 171760 370642 63954546
Malignant neoplasm progression 246.86 11.26 14 173530 112857 64212331
Palpitations 242.56 11.26 724 172820 103764 64221424
Device alarm issue 239.44 11.26 112 173432 1778 64323410
Catheter site swelling 239.22 11.26 107 173437 1523 64323665
Rheumatoid arthritis 234.40 11.26 75 173469 164219 64160969
Drug interaction 232.81 11.26 385 173159 361698 63963490
Cough 231.89 11.26 1498 172046 300650 64024538
Dizziness 227.49 11.26 1952 171592 428211 63896977
Alopecia 221.99 11.26 84 173460 165606 64159582
Optic ischaemic neuropathy 217.42 11.26 116 173428 2469 64322719
Cardiac disorder 215.55 11.26 469 173075 55347 64269841
Treatment failure 211.74 11.26 31 173513 116785 64208403
Contraindicated product administered 209.04 11.26 23 173521 107806 64217382
Cardiac failure congestive 207.73 11.26 797 172747 129783 64195405
Device leakage 206.25 11.26 174 173370 8092 64317096
Scleroderma 206.14 11.26 140 173404 4678 64320510
Drug hypersensitivity 203.22 11.26 204 173340 237611 64087577
Infusion site infection 201.31 11.26 94 173450 1486 64323702
Unevaluable event 193.54 11.26 423 173121 50066 64275122
Cardiac operation 191.21 11.26 127 173417 4087 64321101
Catheter site haemorrhage 188.37 11.26 130 173414 4461 64320727
Rash 187.56 11.26 621 172923 457928 63867260
Transplant evaluation 187.20 11.26 89 173455 1468 64323720
Acute kidney injury 184.69 11.26 607 172937 448633 63876555
Drug ineffective 181.07 11.26 1423 172121 838824 63486364
Stomatitis 175.19 11.26 40 173504 109565 64215623
Malaise 166.17 11.26 1712 171832 394535 63930653
Catheter site rash 163.49 11.26 70 173474 891 64324297
Concomitant disease aggravated 162.16 11.26 177 173367 11365 64313823
Leukopenia 161.70 11.26 37 173507 101205 64223983
Thrombocytopenia 159.06 11.26 222 173322 223579 64101609
Joint swelling 153.71 11.26 213 173331 215169 64110019
Product dose omission issue 153.15 11.26 972 172572 193775 64131413
Hypotension 151.69 11.26 1629 171915 379345 63945843
Device occlusion 149.80 11.26 158 173386 9755 64315433
Complication associated with device 148.63 11.26 193 173351 14887 64310301
Respiratory failure 146.17 11.26 835 172709 160348 64164840
White blood cell count decreased 145.84 11.26 126 173418 157711 64167477
Pulmonary veno-occlusive disease 142.86 11.26 72 173472 1356 64323832
Catheter site irritation 140.97 11.26 54 173490 504 64324684
Disease progression 139.82 11.26 751 172793 140929 64184259
Pulmonary hypertensive crisis 137.73 11.26 46 173498 275 64324913
Acute respiratory failure 136.30 11.26 367 173177 49567 64275621
Mucosal inflammation 136.09 11.26 8 173536 62576 64262612
Therapy change 133.57 11.26 122 173422 6312 64318876
Off label use 133.06 11.26 1078 172466 631728 63693460
Cyanopsia 132.08 11.26 33 173511 50 64325138
Urticaria 132.02 11.26 121 173423 147196 64177992
Pruritus 131.07 11.26 418 173126 311982 64013206
Infusion site swelling 130.13 11.26 112 173432 5353 64319835
Neutrophil count decreased 129.87 11.26 25 173519 77171 64248017
Pneumonia 127.88 11.26 2164 171380 557412 63767776
Musculoskeletal stiffness 126.96 11.26 88 173456 123118 64202070
Electrocardiogram QT prolonged 126.94 11.26 29 173515 79419 64245769
Arthropathy 126.52 11.26 85 173459 120882 64204306
Glossodynia 124.86 11.26 14 173530 64682 64260506
Drug abuse 123.10 11.26 105 173439 132269 64192919
Catheter site inflammation 122.81 11.26 57 173487 888 64324300
Device dislocation 122.27 11.26 211 173333 20967 64304221
Pancytopenia 121.11 11.26 124 173420 143185 64182003
Diarrhoea 119.73 11.26 2661 170883 720043 63605145
Paracentesis 118.73 11.26 61 173483 1198 64323990
Brain natriuretic peptide increased 117.73 11.26 123 173421 7510 64317678
Device infusion issue 115.34 11.26 67 173477 1691 64323497
Vascular device infection 114.49 11.26 110 173434 6070 64319118
Confusional state 113.33 11.26 344 173200 260800 64064388
N-terminal prohormone brain natriuretic peptide increased 112.37 11.26 86 173458 3473 64321715
Pericarditis 112.31 11.26 17 173527 62499 64262689
Hypersensitivity 111.68 11.26 225 173319 196227 64128961
Therapeutic product effect decreased 111.60 11.26 88 173456 115263 64209925
Hepatic enzyme increased 111.44 11.26 111 173433 129832 64195356
Right ventricular dysfunction 111.24 11.26 71 173473 2132 64323056
Erection increased 109.59 11.26 40 173504 322 64324866
Product use in unapproved indication 108.54 11.26 193 173351 176425 64148763
Exercise tolerance decreased 107.90 11.26 118 173426 7592 64317596
Infusion site discharge 105.83 11.26 44 173500 518 64324670
Epistaxis 104.24 11.26 531 173013 97600 64227588
Injection site pain 104.03 11.26 88 173456 111320 64213868
Myalgia 103.93 11.26 757 172787 157860 64167328
Maternal exposure during pregnancy 102.12 11.26 66 173478 95818 64229370
Oxygen therapy 101.37 11.26 68 173476 2225 64322963
Dialysis 100.87 11.26 171 173373 16749 64308439
Chest discomfort 100.33 11.26 594 172950 115512 64209676
Dermatitis contact 99.52 11.26 122 173422 8878 64316310
Cyanosis 99.35 11.26 198 173346 21957 64303231
Hyponatraemia 98.64 11.26 154 173390 148185 64177003
Ascites 96.51 11.26 376 173168 61625 64263563
Rash maculo-papular 96.48 11.26 8 173536 47018 64278170
Bone marrow failure 96.10 11.26 9 173535 47943 64277245
Anaphylactic reaction 94.98 11.26 33 173511 68631 64256557
Cardiac ablation 94.20 11.26 59 173485 1713 64323475
Heart transplant 93.72 11.26 52 173492 1199 64323989
Osteonecrosis of jaw 93.46 11.26 3 173541 39822 64285366
Pain in extremity 93.15 11.26 1234 172310 301851 64023337
Drug intolerance 90.88 11.26 235 173309 187757 64137431
Cardiac pacemaker insertion 90.40 11.26 88 173456 4935 64320253
Agranulocytosis 89.29 11.26 3 173541 38226 64286962
Infusion site haemorrhage 89.02 11.26 63 173481 2252 64322936
C-reactive protein increased 88.57 11.26 75 173469 94834 64230354
Peripheral swelling 88.53 11.26 906 172638 208247 64116941
Psoriasis 88.50 11.26 41 173503 71662 64253526
Coma 88.38 11.26 64 173480 87551 64237637
Feeling abnormal 86.57 11.26 636 172908 132966 64192222
Pericardial effusion 86.31 11.26 267 173277 38987 64286201
Presyncope 85.99 11.26 248 173296 34841 64290347
Catheter site related reaction 84.92 11.26 45 173499 944 64324244
Emergency care 84.79 11.26 44 173500 883 64324305
Heart and lung transplant 83.89 11.26 28 173516 167 64325021
Walking distance test abnormal 83.15 11.26 40 173504 678 64324510
Therapy non-responder 82.56 11.26 374 173170 65525 64259663
Cor pulmonale 82.28 11.26 57 173487 1968 64323220
Abdominal distension 82.21 11.26 490 173054 95504 64229684
Intentional overdose 81.60 11.26 73 173471 89871 64235317
Erectile dysfunction 81.15 11.26 132 173412 12495 64312693
Mobility decreased 81.13 11.26 67 173477 85773 64239415
Drug reaction with eosinophilia and systemic symptoms 80.44 11.26 23 173521 54194 64270994
Dyspnoea at rest 80.24 11.26 92 173452 6237 64318951
Hypertension 79.92 11.26 392 173152 258869 64066319
Psoriatic arthropathy 77.22 11.26 12 173532 43269 64281919
Influenza 77.11 11.26 521 173023 106010 64219178
Neoplasm progression 76.25 11.26 10 173534 40954 64284234
Balloon atrial septostomy 75.07 11.26 23 173521 99 64325089
Atrial flutter 74.96 11.26 163 173381 19217 64305971
Tracheostomy 74.32 11.26 43 173501 1077 64324111
Haemoptysis 72.74 11.26 293 173251 48755 64276433
Injection site bruising 72.43 11.26 7 173537 36366 64288822
Injection site erythema 72.35 11.26 51 173493 70749 64254439
Overdose 72.20 11.26 206 173338 159360 64165828
Mechanical ventilation 71.89 11.26 56 173488 2322 64322866
Suicide attempt 71.44 11.26 52 173492 70955 64254233
Lung disorder 71.24 11.26 338 173206 60362 64264826
Heart rate increased 71.07 11.26 482 173062 98193 64226995
Impaired healing 70.96 11.26 37 173507 60436 64264752
Chronic obstructive pulmonary disease 70.29 11.26 377 173167 70671 64254517
Rhabdomyolysis 70.21 11.26 86 173458 91640 64233548
Blood pressure increased 70.10 11.26 234 173310 172318 64152870
Catheter removal 70.03 11.26 33 173511 533 64324655
Lactic acidosis 69.97 11.26 39 173505 61371 64263817
Inappropriate schedule of product administration 69.10 11.26 88 173456 92198 64232990
Sedation 68.53 11.26 14 173530 41448 64283740
Delirium 67.91 11.26 52 173492 69142 64256046
Atrial septal defect repair 67.88 11.26 29 173515 367 64324821
Toxic epidermal necrolysis 67.00 11.26 10 173534 37156 64288032
Neuropathy peripheral 66.41 11.26 135 173409 117390 64207798
Lower respiratory tract infection 66.00 11.26 95 173449 94519 64230669
Depressed level of consciousness 65.94 11.26 73 173471 81363 64243825
Infusion site pruritus 65.30 11.26 55 173489 2551 64322637
Medical device change 65.30 11.26 30 173514 456 64324732
Injection site reaction 65.27 11.26 22 173522 46642 64278546
Metabolic acidosis 65.07 11.26 57 173487 70901 64254287
Congestive hepatopathy 64.84 11.26 66 173478 3907 64321281
Drug resistance 64.31 11.26 9 173535 35093 64290095
Sopor 63.85 11.26 4 173540 29657 64295531
Device related sepsis 63.78 11.26 74 173470 5081 64320107
Hallucination 63.75 11.26 61 173483 72727 64252461
Therapeutic product effect incomplete 63.61 11.26 113 173431 103369 64221819
Infusion site irritation 63.59 11.26 29 173515 433 64324755
Catheter site vesicles 63.08 11.26 26 173518 299 64324889
Cytomegalovirus infection 62.66 11.26 12 173532 37187 64288001
Arthralgia 62.42 11.26 827 172717 441433 63883755
Aspiration pleural cavity 62.11 11.26 42 173502 1393 64323795
Folliculitis 62.02 11.26 5 173539 30072 64295116
Blister 61.88 11.26 76 173468 80891 64244297
Right ventricular dilatation 61.84 11.26 42 173502 1403 64323785
Device connection issue 61.68 11.26 35 173509 844 64324344
Oxygen saturation abnormal 61.36 11.26 61 173483 3510 64321678
Helicobacter infection 61.27 11.26 14 173530 38348 64286840
Device breakage 61.05 11.26 95 173449 8660 64316528
Duodenal ulcer perforation 60.87 11.26 10 173534 34615 64290573
Ventilation perfusion mismatch 60.84 11.26 25 173519 285 64324903
Blood pressure decreased 60.84 11.26 419 173125 85780 64239408
Drug-induced liver injury 60.74 11.26 26 173518 47617 64277571
Suspected counterfeit product 60.63 11.26 29 173515 485 64324703
Cardioversion 60.50 11.26 46 173498 1839 64323349
Prescription drug used without a prescription 59.31 11.26 52 173492 2548 64322640
Wound 59.28 11.26 71 173473 76406 64248782
Stent placement 59.16 11.26 74 173470 5497 64319691
Hyperglycaemia 58.33 11.26 47 173497 60921 64264267
Biopsy liver 58.17 11.26 29 173515 533 64324655
Hyperkalaemia 57.27 11.26 116 173428 101013 64224175
Transplant 56.38 11.26 33 173511 845 64324343
Palmar-plantar erythrodysaesthesia syndrome 56.20 11.26 6 173538 28813 64296375
Viral infection 56.09 11.26 219 173325 35921 64289267
Infusion site warmth 55.25 11.26 35 173509 1037 64324151
Cognitive disorder 54.56 11.26 41 173503 55046 64270142
Liver transplant 54.45 11.26 61 173483 4031 64321157
Counterfeit product administered 54.26 11.26 18 173526 105 64325083
Drug eruption 54.21 11.26 15 173529 36121 64289067
Abdominal cavity drainage 53.71 11.26 30 173514 701 64324487
Systemic scleroderma 53.56 11.26 33 173511 930 64324258
Productive cough 53.55 11.26 359 173185 72844 64252344
Device physical property issue 53.41 11.26 45 173499 2088 64323100
Chronic respiratory failure 53.28 11.26 49 173495 2557 64322631
Pneumocystis jirovecii pneumonia 53.27 11.26 6 173538 27628 64297560
Right ventricular hypertrophy 53.26 11.26 37 173507 1283 64323905
Pneumonitis 53.16 11.26 35 173509 50330 64274858
Priapism 52.52 11.26 59 173485 3911 64321277
Sleep disorder due to general medical condition, insomnia type 52.45 11.26 5 173539 26265 64298923
Suicidal ideation 52.40 11.26 61 173483 66481 64258707
Thrombosis in device 51.69 11.26 66 173478 5005 64320183
Eosinophilia 51.46 11.26 19 173525 38057 64287131
Lung assist device therapy 50.85 11.26 17 173527 102 64325086
Disease complication 50.84 11.26 60 173484 4195 64320993
Pulmonary arterial pressure abnormal 50.57 11.26 28 173516 643 64324545
Acute myeloid leukaemia 50.41 11.26 7 173537 27456 64297732
Catheter site extravasation 49.98 11.26 23 173521 351 64324837
Hypocalcaemia 49.80 11.26 25 173519 41728 64283460
Blindness unilateral 49.44 11.26 75 173469 6686 64318502
Thrombosis corpora cavernosa 49.21 11.26 10 173534 0 64325188
Serotonin syndrome 49.19 11.26 22 173522 39260 64285928
Lymphocyte count decreased 49.10 11.26 24 173520 40675 64284513
Catheterisation cardiac abnormal 49.07 11.26 21 173523 267 64324921
General physical health deterioration 48.56 11.26 336 173208 204089 64121099
Blood pressure fluctuation 48.37 11.26 41 173503 51830 64273358
Infusion site abscess 48.10 11.26 19 173525 194 64324994
Sinus congestion 47.80 11.26 119 173425 15320 64309868
Neutropenic sepsis 47.62 11.26 4 173540 23268 64301920
Infusion site induration 47.49 11.26 29 173515 804 64324384
Terminal state 47.14 11.26 59 173485 4385 64320803
Seizure 47.08 11.26 260 173284 166632 64158556
Colitis 47.05 11.26 53 173491 58621 64266567
Deep vein thrombosis 46.68 11.26 137 173407 105045 64220143
Infusion site cellulitis 46.61 11.26 20 173524 256 64324932
Internal haemorrhage 46.38 11.26 78 173466 7589 64317599
Fibromyalgia 46.35 11.26 19 173525 35712 64289476
Injection site pruritus 46.10 11.26 22 173522 37804 64287384
Right ventricular systolic pressure increased 46.09 11.26 29 173515 849 64324339
Blood culture negative 46.07 11.26 18 173526 178 64325010
Rhinovirus infection 46.03 11.26 69 173475 6087 64319101
Somnolence 45.81 11.26 340 173204 203305 64121883
Blood creatine phosphokinase increased 45.77 11.26 54 173490 58504 64266684
Osteoarthritis 45.76 11.26 62 173482 63274 64261914
Concomitant disease progression 45.69 11.26 50 173494 3219 64321969
Hepatocellular injury 45.67 11.26 33 173511 45202 64279986
Dysphagia 45.34 11.26 142 173402 106670 64218518
Inappropriate antidiuretic hormone secretion 45.15 11.26 4 173540 22285 64302903
Catheter site scab 45.04 11.26 18 173526 190 64324998
Blood pressure systolic increased 45.01 11.26 40 173504 49413 64275775
Anaphylactic shock 44.74 11.26 13 173531 30315 64294873
Myoclonus 44.72 11.26 7 173537 25111 64300077
Vascular resistance pulmonary increased 43.99 11.26 14 173530 70 64325118
Left-to-right cardiac shunt 43.92 11.26 15 173529 97 64325091
Psychotic disorder 43.87 11.26 19 173525 34559 64290629
Patent ductus arteriosus repair 43.82 11.26 12 173532 31 64325157
Hernia repair 43.71 11.26 37 173507 1728 64323460
Biopsy lung 43.51 11.26 18 173526 209 64324979
Red blood cell sedimentation rate increased 43.21 11.26 15 173529 31220 64293968
Platelet count decreased 43.19 11.26 269 173275 167442 64157746
Basal cell carcinoma 42.33 11.26 15 173529 30823 64294365
Blood culture positive 42.32 11.26 76 173468 7792 64317396
Discomfort 42.28 11.26 97 173447 80781 64244407
Pyrexia 42.10 11.26 1163 172381 557481 63767707
Therapeutic response decreased 42.00 11.26 47 173497 52141 64273047
Hypercalcaemia 41.91 11.26 16 173528 31400 64293788
Polyneuropathy 41.89 11.26 3 173541 19891 64305297
Intentional self-injury 41.84 11.26 13 173531 29031 64296157
Carbon dioxide increased 41.84 11.26 38 173506 1951 64323237
Neurotoxicity 41.82 11.26 11 173533 27393 64297795
Hypoglycaemia 41.42 11.26 115 173429 89777 64235411
Hepatitis 41.33 11.26 37 173507 45545 64279643
Blood potassium decreased 41.06 11.26 216 173328 40183 64285005
Gout 41.05 11.26 139 173405 21274 64303914
Nausea 40.95 11.26 2541 171003 783259 63541929
Irritable bowel syndrome 40.77 11.26 25 173519 37344 64287844
Tumour lysis syndrome 40.74 11.26 3 173541 19437 64305751
Catheter site warmth 40.57 11.26 18 173526 251 64324937
Right-to-left cardiac shunt 40.53 11.26 16 173528 163 64325025
Cardiac failure acute 40.51 11.26 116 173428 16228 64308960
Pulmonary vascular resistance abnormality 40.44 11.26 15 173529 127 64325061
Medication error 40.21 11.26 45 173499 49921 64275267
Oral herpes 39.84 11.26 6 173538 22146 64303042
Pulmonary congestion 39.76 11.26 148 173396 23732 64301456
Inflammation 39.50 11.26 72 173472 65228 64259960
Myelosuppression 39.48 11.26 8 173536 23822 64301366
Heart valve operation 39.13 11.26 16 173528 180 64325008
Altered state of consciousness 39.12 11.26 27 173517 37875 64287313
Dizziness exertional 39.02 11.26 21 173523 455 64324733
Dependence on oxygen therapy 38.96 11.26 20 173524 392 64324796
Plasma cell myeloma 38.75 11.26 40 173504 46035 64279153
Pulmonary vein stenosis 38.69 11.26 15 173529 145 64325043
Infusion site oedema 38.57 11.26 23 173521 610 64324578
Catheter site discolouration 38.22 11.26 14 173530 114 64325074
Injection site swelling 38.18 11.26 33 173511 41320 64283868
Sudden death 38.13 11.26 130 173414 19966 64305222
Bradycardia 37.98 11.26 176 173368 118043 64207145
Lymphopenia 37.84 11.26 11 173533 25646 64299542
Infusion site rash 37.74 11.26 28 173516 1078 64324110
Intentional product use issue 37.57 11.26 131 173413 95233 64229955
Stevens-Johnson syndrome 37.24 11.26 23 173521 34226 64290962
Endotracheal intubation 37.06 11.26 49 173495 3846 64321342
Device malfunction 36.97 11.26 118 173426 17515 64307673
Dyskinesia 36.89 11.26 31 173513 39357 64285831
Myelodysplastic syndrome 36.87 11.26 14 173530 27565 64297623
Respiratory distress 36.69 11.26 254 173290 52077 64273111
Body temperature decreased 36.65 11.26 12 173532 25916 64299272
Cholestasis 36.57 11.26 40 173504 44832 64280356
Respiratory syncytial virus infection 36.31 11.26 68 173476 7200 64317988
Central venous catheter removal 36.23 11.26 19 173525 390 64324798
Pulmonary embolism 36.02 11.26 238 173306 146118 64179070
Disease recurrence 35.91 11.26 20 173524 31490 64293698
Finger amputation 35.83 11.26 22 173522 616 64324572
Hallucination, visual 35.78 11.26 15 173529 27819 64297369
Muscle rigidity 35.76 11.26 3 173541 17470 64307718
Metastases to bone 35.70 11.26 6 173538 20429 64304759
Ventricular septal defect repair 35.68 11.26 10 173534 29 64325159
Paraesthesia 35.55 11.26 214 173330 134308 64190880
Hypomagnesaemia 35.52 11.26 29 173515 37347 64287841
Dizziness postural 35.43 11.26 80 173464 9672 64315516
Nasopharyngitis 35.42 11.26 732 172812 195341 64129847
Sinus disorder 35.32 11.26 113 173431 16795 64308393
Acute right ventricular failure 35.08 11.26 17 173527 293 64324895
Abortion spontaneous 34.91 11.26 12 173532 25131 64300057
Hypokalaemia 34.87 11.26 189 173355 121714 64203474
Systemic-pulmonary artery shunt 34.71 11.26 10 173534 33 64325155
Cor pulmonale chronic 34.55 11.26 16 173528 248 64324940
Orthostatic hypotension 34.53 11.26 45 173499 46693 64278495
Peyronie's disease 34.45 11.26 9 173535 18 64325170
Muscle injury 34.39 11.26 14 173530 26423 64298765
Product supply issue 34.34 11.26 29 173515 1350 64323838
Paranasal sinus hypersecretion 34.28 11.26 42 173502 3054 64322134
Multiple sclerosis relapse 34.26 11.26 36 173508 41099 64284089
Hypothyroidism 34.16 11.26 35 173509 40422 64284766
Exposure during pregnancy 33.86 11.26 102 173442 77573 64247615
Encephalopathy 33.70 11.26 67 173477 58752 64266436
Aggression 33.66 11.26 45 173499 46187 64279001
Haemophagocytic lymphohistiocytosis 33.50 11.26 4 173540 17605 64307583
Asthma 33.49 11.26 137 173407 95088 64230100
Disseminated intravascular coagulation 33.44 11.26 23 173521 32325 64292863
Nephropathy toxic 33.26 11.26 4 173540 17510 64307678
Visual field defect 33.21 11.26 70 173474 8076 64317112
Osteoporosis 32.67 11.26 39 173505 42041 64283147
Progressive multifocal leukoencephalopathy 32.64 11.26 5 173539 18227 64306961
Suture insertion 32.38 11.26 13 173531 139 64325049
Injection site discharge 32.21 11.26 18 173526 421 64324767
Dysarthria 32.07 11.26 70 173474 59336 64265852
Abdominal pain 31.99 11.26 620 172924 311755 64013433
Seasonal allergy 31.80 11.26 86 173458 11640 64313548
Posterior reversible encephalopathy syndrome 31.77 11.26 11 173533 22935 64302253
Catheter site nodule 31.59 11.26 10 173534 49 64325139
Peritonitis 31.35 11.26 14 173530 25009 64300179
Gastrostomy 31.34 11.26 24 173520 970 64324218
Osteopenia 30.91 11.26 3 173541 15537 64309651
Right atrial pressure increased 30.83 11.26 15 173529 261 64324927
Localised oedema 30.73 11.26 63 173481 7128 64318060
Transplant rejection 30.64 11.26 5 173539 17396 64307792
Metastases to liver 30.62 11.26 13 173531 23928 64301260
Renal disorder 30.56 11.26 181 173363 35184 64290004
Torsade de pointes 30.55 11.26 5 173539 17358 64307830
Aspergillus infection 30.48 11.26 4 173540 16375 64308813
Infusion site inflammation 30.46 11.26 14 173530 213 64324975
Deafness unilateral 30.39 11.26 43 173501 3599 64321589
Muscular weakness 30.37 11.26 209 173335 127129 64198059
Rehabilitation therapy 30.30 11.26 28 173516 1470 64323718
Pulmonary arterial pressure 30.30 11.26 8 173536 17 64325171
Hypothermia 30.24 11.26 8 173536 19848 64305340
Deafness 29.92 11.26 113 173431 18246 64306942
Dystonia 29.90 11.26 7 173537 18858 64306330
Arthritis 29.84 11.26 120 173424 83694 64241494
Fracture of penis 29.75 11.26 12 173532 130 64325058
Right ventricular enlargement 29.67 11.26 18 173526 493 64324695
Systemic lupus erythematosus 29.64 11.26 108 173436 77504 64247684
Proteinuria 29.62 11.26 19 173525 27704 64297484
Respiratory depression 29.55 11.26 13 173531 23430 64301758
Drug level increased 29.54 11.26 29 173515 34167 64291021
Loss of visual contrast sensitivity 29.52 11.26 6 173538 0 64325188
Angioplasty 29.35 11.26 29 173515 1656 64323532
Agitation 29.31 11.26 130 173414 88237 64236951
Skin lesion 29.20 11.26 33 173511 36449 64288739
Renal impairment 29.13 11.26 228 173316 134789 64190399
Heart disease congenital 29.07 11.26 18 173526 512 64324676
Constipation 29.03 11.26 438 173106 228899 64096289
Ill-defined disorder 29.00 11.26 46 173498 44006 64281182
Toxic skin eruption 28.94 11.26 8 173536 19276 64305912
Blood pressure abnormal 28.82 11.26 95 173449 14340 64310848
Pulmonary artery aneurysm 28.66 11.26 12 173532 144 64325044
Pulmonary arterial wedge pressure increased 28.64 11.26 17 173527 447 64324741
Blood lactate dehydrogenase increased 28.63 11.26 28 173516 33050 64292138
Infusion site vesicles 28.53 11.26 16 173528 377 64324811
Skin exfoliation 28.50 11.26 48 173496 44837 64280351
Foot deformity 28.49 11.26 5 173539 16499 64308689
Bronchopulmonary aspergillosis 28.48 11.26 8 173536 19077 64306111
Retching 28.34 11.26 98 173446 15158 64310030
Epilepsy 28.32 11.26 29 173515 33502 64291686
Cytopenia 28.26 11.26 4 173540 15467 64309721
Weight increased 28.26 11.26 763 172781 212585 64112603
Hospice care 28.20 11.26 63 173481 7562 64317626
Painful erection 28.15 11.26 12 173532 151 64325037
Echocardiogram abnormal 27.90 11.26 29 173515 1760 64323428
Vascular resistance pulmonary decreased 27.89 11.26 10 173534 76 64325112
Respiration abnormal 27.78 11.26 56 173488 6259 64318929
Full blood count decreased 27.72 11.26 13 173531 22569 64302619
Dialysis related complication 27.70 11.26 13 173531 208 64324980
Cardiac index increased 27.41 11.26 8 173536 28 64325160
Upper respiratory tract infection 27.34 11.26 308 173236 72477 64252711
Cardiac output decreased 27.25 11.26 28 173516 1676 64323512
Application site irritation 27.22 11.26 27 173517 1549 64323639
Depression 27.16 11.26 339 173205 182952 64142236
Product counterfeit 27.10 11.26 13 173531 219 64324969
Angioedema 27.07 11.26 81 173463 61740 64263448
Aplastic anaemia 26.88 11.26 3 173541 13917 64311271
Wrong technique in product usage process 26.44 11.26 88 173456 64886 64260302
Tracheostomy malfunction 26.42 11.26 11 173533 130 64325058
Prescribed underdose 26.07 11.26 8 173536 18007 64307181
Sleep study 25.87 11.26 7 173537 17 64325171
Therapeutic embolisation 25.84 11.26 16 173528 455 64324733
Acne 25.80 11.26 15 173529 23066 64302122
Vasodilatation 25.73 11.26 36 173508 2982 64322206
Accidental exposure to product 25.62 11.26 20 173524 26344 64298844
Candida infection 25.61 11.26 28 173516 31391 64293797
Application site pruritus 25.51 11.26 39 173505 3500 64321688
Macrophages increased 25.51 11.26 12 173532 193 64324995
Jugular vein distension 25.38 11.26 24 173520 1298 64323890
Spinal cord infarction 25.32 11.26 17 173527 557 64324631
Mouth ulceration 25.26 11.26 30 173514 32414 64292774
Diagnostic procedure 25.15 11.26 11 173533 148 64325040
Left ventricular failure 25.14 11.26 64 173480 8353 64316835
Nocturnal dyspnoea 25.07 11.26 24 173520 1318 64323870
Device issue 25.04 11.26 124 173420 22524 64302664
Cardiomegaly 25.01 11.26 128 173416 23556 64301632
Diabetic ketoacidosis 24.99 11.26 26 173518 29819 64295369
Mineral supplementation 24.81 11.26 19 173525 768 64324420
Transient global amnesia 24.79 11.26 18 173526 670 64324518
Hypoaesthesia 24.67 11.26 247 173297 138861 64186327
Head injury 24.57 11.26 162 173382 32680 64292508
Injection site mass 24.40 11.26 8 173536 17262 64307926
Leukocytosis 24.29 11.26 40 173504 37700 64287488
Hepatic function abnormal 24.23 11.26 90 173454 64223 64260965
CREST syndrome 24.21 11.26 15 173529 427 64324761
Cavopulmonary anastomosis 24.05 11.26 6 173538 9 64325179
Catheter site induration 23.93 11.26 8 173536 48 64325140
Pulmonary pain 23.81 11.26 32 173512 2552 64322636
Head discomfort 23.73 11.26 78 173466 11756 64313432
Visual impairment 23.68 11.26 304 173240 73773 64251415
Eczema 23.66 11.26 27 173517 29693 64295495
Therapy cessation 23.55 11.26 159 173385 32330 64292858
Pancreatitis acute 23.54 11.26 50 173494 42805 64282383
Hereditary haemorrhagic telangiectasia 23.45 11.26 7 173537 27 64325161
Parkinsonism 23.45 11.26 5 173539 14368 64310820
Chest tube insertion 23.45 11.26 10 173534 126 64325062
Hepatotoxicity 23.34 11.26 45 173499 39917 64285271
Abnormal behaviour 23.20 11.26 34 173510 33588 64291600
Haematuria 23.19 11.26 84 173460 60387 64264801
Haemodynamic test abnormal 23.13 11.26 8 173536 54 64325134
Pre-existing condition improved 23.10 11.26 44 173500 4718 64320470
Paranasal sinus discomfort 23.07 11.26 35 173509 3120 64322068
Device programming error 23.04 11.26 9 173535 89 64325099
Thrombotic microangiopathy 23.03 11.26 8 173536 16647 64308541
Catheter site mass 23.00 11.26 8 173536 55 64325133
Multiple organ dysfunction syndrome 22.93 11.26 169 173375 101244 64223944
Transaminases increased 22.89 11.26 54 173490 44540 64280648
Vasculitis 22.86 11.26 10 173534 18085 64307103
Blood calcium decreased 22.86 11.26 21 173523 25533 64299655
Orthopnoea 22.80 11.26 65 173479 9069 64316119
Hypoacusis 22.74 11.26 133 173411 25734 64299454
Chemotherapy 22.73 11.26 24 173520 1483 64323705
Dysentery 22.71 11.26 19 173525 873 64324315
Delusion 22.69 11.26 10 173534 18004 64307184
Cardiorenal syndrome 22.68 11.26 22 173522 1228 64323960
Injury 22.67 11.26 76 173468 55916 64269272
Treatment noncompliance 22.67 11.26 197 173347 43285 64281903
Multiple allergies 22.59 11.26 49 173495 5765 64319423
Chromatopsia 22.58 11.26 16 173528 573 64324615
Bursitis 22.58 11.26 15 173529 21470 64303718
Rash erythematous 22.56 11.26 62 173482 48571 64276617
Renal tubular necrosis 22.48 11.26 16 173528 22094 64303094
Staphylococcus test positive 22.42 11.26 48 173496 5597 64319591
Penile curvature 22.34 11.26 6 173538 14 64325174
Anti factor VIII antibody test 22.26 11.26 5 173539 3 64325185
Coronary artery compression 22.26 11.26 5 173539 3 64325185
Self-medication 22.24 11.26 40 173504 4105 64321083
Diet noncompliance 22.21 11.26 14 173530 411 64324777
Dyschromatopsia 22.16 11.26 17 173527 689 64324499
Atrial fibrillation 22.12 11.26 610 172934 170479 64154709
Obstructive airways disorder 22.02 11.26 18 173526 23167 64302021
Hypoalbuminaemia 21.97 11.26 10 173534 17664 64307524
Phlebotomy 21.77 11.26 6 173538 16 64325172
Diuretic therapy 21.71 11.26 10 173534 153 64325035
Metastases to lung 21.69 11.26 7 173537 15257 64309931
Tracheostomy tube removal 21.68 11.26 5 173539 4 64325184
Psychomotor hyperactivity 21.67 11.26 6 173538 14445 64310743
Hypertensive crisis 21.65 11.26 11 173533 18237 64306951
Retinal vein occlusion 21.64 11.26 33 173511 2955 64322233
Ileus 21.60 11.26 18 173526 22948 64302240
Catheter site dryness 21.52 11.26 7 173537 38 64325150
Grip strength decreased 21.49 11.26 3 173541 11721 64313467
Blood glucose increased 21.43 11.26 165 173379 97908 64227280
Herpes zoster 21.43 11.26 125 173419 79062 64246126
Gastrointestinal tube insertion 21.40 11.26 23 173521 1451 64323737
Pulmonary artery dilatation 21.30 11.26 13 173531 360 64324828
Encephalitis 21.29 11.26 4 173540 12567 64312621
Pulmonary valve replacement 21.26 11.26 6 173538 18 64325170
Pulmonary arterial pressure decreased 21.20 11.26 9 173535 112 64325076
Loss of consciousness 21.20 11.26 536 173008 147829 64177359
Respiratory disorder 21.17 11.26 168 173376 35943 64289245
Spontaneous penile erection 21.13 11.26 9 173535 113 64325075
Labelled drug-drug interaction medication error 21.11 11.26 17 173527 22045 64303143
Immune reconstitution inflammatory syndrome 21.05 11.26 4 173540 12466 64312722
Incorrect route of product administration 21.01 11.26 19 173525 23279 64301909
Akathisia 20.97 11.26 3 173541 11507 64313681
Rhinorrhoea 20.84 11.26 250 173294 59719 64265469
Blood iron decreased 20.84 11.26 76 173468 12066 64313122
Speech disorder 20.83 11.26 64 173480 48377 64276811
Erythema 20.78 11.26 366 173178 186704 64138484
Poisoning 20.76 11.26 17 173527 21862 64303326
Generalised tonic-clonic seizure 20.67 11.26 48 173496 39809 64285379
Tubulointerstitial nephritis 20.61 11.26 32 173512 30877 64294311
Hyperthermia 20.61 11.26 8 173536 15542 64309646
Gastritis hypertrophic 20.53 11.26 7 173537 45 64325143
Disorientation 20.46 11.26 79 173465 55749 64269439
Metastases to central nervous system 20.45 11.26 6 173538 13906 64311282
Urinary tract infection 20.37 11.26 471 173073 231125 64094063
Product prescribing error 20.35 11.26 40 173504 35229 64289959
Enterococcal infection 20.35 11.26 6 173538 13860 64311328
Nasal dryness 20.18 11.26 35 173509 3491 64321697
Congenital arterial malformation 20.13 11.26 6 173538 23 64325165
Bone disorder 20.04 11.26 10 173534 16749 64308439
Cardiac output increased 20 11.26 10 173534 185 64325003
Body temperature increased 19.96 11.26 43 173501 36623 64288565
Atrial tachycardia 19.94 11.26 35 173509 3524 64321664
Ataxia 19.93 11.26 18 173526 22066 64303122
Choking 19.84 11.26 68 173476 10470 64314718
Oxygen consumption 19.80 11.26 8 173536 87 64325101
Penile vein thrombosis 19.68 11.26 4 173540 0 64325188
Increased ventricular preload 19.68 11.26 4 173540 0 64325188
Catheter culture positive 19.62 11.26 10 173534 193 64324995
Pericardial drainage 19.61 11.26 12 173532 334 64324854
Blood bilirubin increased 19.60 11.26 239 173305 57314 64267874
Pulmonary capillary haemangiomatosis 19.55 11.26 7 173537 53 64325135
Tenosynovitis 19.54 11.26 4 173540 11829 64313359
Infusion site reaction 19.47 11.26 26 173518 2060 64323128
Pain 19.47 11.26 1256 172288 552255 63772933
Infective pulmonary exacerbation of cystic fibrosis 19.46 11.26 4 173540 11792 64313396
Therapeutic procedure 19.39 11.26 16 173528 721 64324467
Injection site haemorrhage 19.39 11.26 22 173522 24256 64300932
Disturbance in attention 19.32 11.26 52 173492 41022 64284166
Cytomegalovirus viraemia 19.32 11.26 3 173541 10825 64314363
Type 2 diabetes mellitus 19.27 11.26 39 173505 33981 64291207
Septic shock 19.20 11.26 186 173358 105251 64219937
Pneumonia aspiration 19.17 11.26 88 173456 59183 64266005
Ejaculation failure 19.14 11.26 12 173532 349 64324839
Haemorrhage 19.13 11.26 310 173234 79041 64246147
Sinus bradycardia 19.11 11.26 20 173524 22873 64302315
Liver function test abnormal 19.08 11.26 244 173300 59157 64266031
Application site odour 19.02 11.26 6 173538 29 64325159
Catheter site abscess 19.02 11.26 6 173538 29 64325159
Infusion site discolouration 18.89 11.26 14 173530 538 64324650
Joint stiffness 18.85 11.26 33 173511 30371 64294817
Choking sensation 18.82 11.26 34 173510 3501 64321687
Oral pain 18.78 11.26 28 173516 27465 64297723
Ammonia increased 18.75 11.26 51 173493 6926 64318262
Product administration interrupted 18.75 11.26 19 173525 1119 64324069
Ear tube insertion 18.67 11.26 8 173536 102 64325086
Hepatic cirrhosis 18.64 11.26 128 173416 26170 64299018
Herpes simplex 18.61 11.26 3 173541 10533 64314655
Micrococcus test positive 18.52 11.26 5 173539 12 64325176
Respiratory therapy 18.52 11.26 5 173539 12 64325176
Tracheitis 18.50 11.26 20 173524 1270 64323918
Tuberculosis 18.49 11.26 6 173538 13032 64312156
Peripheral sensory neuropathy 18.48 11.26 4 173540 11374 64313814
Arteriovenous malformation 18.46 11.26 22 173522 1554 64323634
Expired product administered 18.38 11.26 46 173498 5941 64319247
Cardiac flutter 18.25 11.26 37 173507 4152 64321036
Loss of personal independence in daily activities 18.23 11.26 117 173427 72337 64252851
Purpura 18.18 11.26 12 173532 17234 64307954
Enteritis 18.14 11.26 5 173539 12072 64313116
Hypertriglyceridaemia 18.07 11.26 4 173540 11201 64313987
COVID-19 18.07 11.26 102 173442 65038 64260150
Hypogammaglobulinaemia 18.04 11.26 3 173541 10296 64314892
Injection site urticaria 18.02 11.26 4 173540 11177 64314011
Pleural effusion 18.01 11.26 457 173087 126102 64199086
Blood creatinine increased 17.97 11.26 257 173287 135525 64189663
Product use issue 17.97 11.26 535 173009 151180 64174008
Exercise test abnormal 17.94 11.26 7 173537 69 64325119
Injection site rash 17.92 11.26 10 173534 15732 64309456
Tracheostomy infection 17.76 11.26 7 173537 71 64325117
Immunoglobulin G4 related disease 17.75 11.26 8 173536 116 64325072
Spontaneous intrahepatic portosystemic venous shunt 17.71 11.26 5 173539 15 64325173
Large intestine perforation 17.52 11.26 6 173538 12598 64312590
Heart valve replacement 17.50 11.26 15 173529 713 64324475
Skin operation 17.47 11.26 5 173539 16 64325172
Radiotherapy 17.43 11.26 12 173532 410 64324778
Emotional distress 17.43 11.26 45 173499 35993 64289195
Large intestinal polypectomy 17.30 11.26 10 173534 250 64324938
Biopsy bone marrow 17.18 11.26 11 173533 332 64324856
Osteonecrosis 17.18 11.26 31 173513 28198 64296990
Pneumothorax 17.07 11.26 118 173426 24180 64301008
Cardiac failure high output 17.05 11.26 10 173534 257 64324931
Mitral valve replacement 17.04 11.26 11 173533 337 64324851
Withdrawal syndrome 16.96 11.26 23 173521 23469 64301719
Nodule 16.96 11.26 14 173530 17933 64307255
Pyelonephritis 16.90 11.26 13 173531 17253 64307935
Decreased activity 16.87 11.26 50 173494 7130 64318058
Device difficult to use 16.85 11.26 3 173541 9795 64315393
Restlessness 16.80 11.26 53 173491 39732 64285456
Catheter site dermatitis 16.79 11.26 7 173537 83 64325105
Tricuspid valve incompetence 16.65 11.26 90 173454 16913 64308275
Tendonitis 16.61 11.26 18 173526 20264 64304924
Urinary retention 16.54 11.26 72 173472 49129 64276059
Hypophagia 16.53 11.26 53 173491 39534 64285654
Haematotoxicity 16.50 11.26 7 173537 12889 64312299
Ear discomfort 16.45 11.26 50 173494 7230 64317958
Throat irritation 16.43 11.26 147 173397 32564 64292624
Portopulmonary hypertension 16.35 11.26 8 173536 141 64325047
Blindness transient 16.32 11.26 35 173509 4087 64321101
Colitis ulcerative 16.17 11.26 23 173521 23005 64302183
Skin irritation 16.16 11.26 58 173486 9136 64316052
Ventricular assist device insertion 16.15 11.26 6 173538 51 64325137
Visual brightness 16.15 11.26 6 173538 51 64325137
Product contamination 16.08 11.26 17 173527 1052 64324136
Hypoglossal nerve paralysis 16.05 11.26 5 173539 23 64325165
Joint range of motion decreased 16.03 11.26 17 173527 19326 64305862
Biopsy kidney 16 11.26 8 173536 148 64325040
Lymphadenopathy 15.89 11.26 68 173476 46618 64278570
Right atrial dilatation 15.86 11.26 14 173530 692 64324496
Thunderclap headache 15.86 11.26 9 173535 217 64324971
Cataract operation 15.86 11.26 33 173511 3773 64321415
Product storage error 15.84 11.26 8 173536 13310 64311878
Blood cholesterol increased 15.80 11.26 75 173469 49991 64275197
Muscle spasticity 15.75 11.26 13 173531 16656 64308532
Optic disc disorder 15.75 11.26 7 173537 98 64325090
Colonoscopy 15.73 11.26 21 173523 1664 64323524
Pulmonary thrombosis 15.72 11.26 63 173481 10455 64314733
Glare 15.69 11.26 7 173537 99 64325089
Fistula repair 15.66 11.26 6 173538 56 64325132
Gastrointestinal surgery 15.50 11.26 9 173535 227 64324961
Eating disorder symptom 15.48 11.26 6 173538 58 64325130
Catheter site hypersensitivity 15.44 11.26 7 173537 103 64325085
Ejaculation disorder 15.44 11.26 12 173532 496 64324692
Chronic hepatic failure 15.37 11.26 15 173529 844 64324344
Biopsy 15.31 11.26 12 173532 502 64324686
Osteomyelitis 15.31 11.26 32 173512 27555 64297633
Balance disorder 15.30 11.26 148 173396 83778 64241410
Adenotonsillectomy 15.30 11.26 6 173538 60 64325128
Oesophageal dilation procedure 15.30 11.26 6 173538 60 64325128
Thoracic cavity drainage 15.25 11.26 9 173535 234 64324954
Drug level decreased 15.11 11.26 6 173538 11497 64313691
Respiratory tract infection viral 15.11 11.26 26 173518 2577 64322611
Hallucination, auditory 15.06 11.26 14 173530 16925 64308263
Cardiac failure chronic 15.02 11.26 56 173488 8985 64316203
Exostosis 14.97 11.26 6 173538 11432 64313756
Bronchopulmonary dysplasia 14.96 11.26 8 173536 171 64325017
Sudden cardiac death 14.88 11.26 36 173508 4551 64320637
Atrioventricular septal defect 14.87 11.26 6 173538 65 64325123
Catheter site erosion 14.87 11.26 6 173538 65 64325123
Metapneumovirus infection 14.87 11.26 19 173525 1442 64323746
Protein-losing gastroenteropathy 14.77 11.26 12 173532 529 64324659
Primary headache associated with sexual activity 14.76 11.26 3 173541 0 64325188
Orchidopexy 14.76 11.26 3 173541 0 64325188
Pharyngeal injury 14.76 11.26 3 173541 0 64325188
Breast tumour excision 14.76 11.26 3 173541 0 64325188
Infusion site nodule 14.76 11.26 9 173535 249 64324939
Acute hepatic failure 14.73 11.26 30 173514 26082 64299106
Immunodeficiency 14.72 11.26 13 173531 16111 64309077
Injection site warmth 14.69 11.26 9 173535 13453 64311735
Hydronephrosis 14.66 11.26 10 173534 14115 64311073
Polyarthritis 14.63 11.26 4 173540 9711 64315477
Viral upper respiratory tract infection 14.59 11.26 52 173492 8163 64317025
Hypophosphataemia 14.52 11.26 11 173533 14709 64310479
Generalised oedema 14.49 11.26 101 173443 20752 64304436
Oesophagogastric fundoplasty 14.43 11.26 7 173537 121 64325067
Aortic valve repair 14.43 11.26 4 173540 11 64325177
Adrenal insufficiency 14.32 11.26 24 173520 22463 64302725
Retinal artery occlusion 14.30 11.26 27 173517 2876 64322312
Central nervous system lesion 14.27 11.26 7 173537 11842 64313346
Dermatitis exfoliative 14.27 11.26 5 173539 10347 64314841
Right ventricular systolic pressure decreased 14.25 11.26 6 173538 73 64325115
COVID-19 pneumonia 14.25 11.26 14 173530 16490 64308698
Sudden visual loss 14.18 11.26 5 173539 36 64325152
Blood carbon monoxide increased 14.17 11.26 4 173540 12 64325176
Clubbing 14.17 11.26 12 173532 561 64324627
Fibrinous bronchitis 14.06 11.26 5 173539 37 64325151
Extra dose administered 13.99 11.26 45 173499 6705 64318483
Blood alkaline phosphatase increased 13.99 11.26 221 173323 56058 64269130
Retinal vascular disorder 13.99 11.26 9 173535 274 64324914
Administration site infection 13.93 11.26 4 173540 13 64325175
Status epilepticus 13.90 11.26 23 173521 21640 64303548
Therapeutic response shortened 13.87 11.26 5 173539 10165 64315023
Localised infection 13.87 11.26 133 173411 30028 64295160
Oesophagitis 13.85 11.26 23 173521 21607 64303581
Melaena 13.71 11.26 86 173458 53462 64271726
Catheter site bruise 13.68 11.26 9 173535 285 64324903
Limb operation 13.65 11.26 26 173518 2788 64322400
Drain placement 13.65 11.26 7 173537 137 64325051
Pancreatitis 13.63 11.26 99 173445 59508 64265680
Hypernatraemia 13.51 11.26 8 173536 12181 64313007
Catheter site scar 13.49 11.26 4 173540 15 64325173
Musculoskeletal disorder 13.47 11.26 17 173527 17889 64307299
Hepatitis cholestatic 13.44 11.26 8 173536 12147 64313041
Renal injury 13.42 11.26 13 173531 15416 64309772
Vision blurred 13.40 11.26 328 173216 89988 64235200
Hyperhidrosis 13.36 11.26 246 173298 124674 64200514
Application site erythema 13.33 11.26 35 173509 4654 64320534
Infection 13.32 11.26 387 173157 184493 64140695
Maculopathy 13.28 11.26 24 173520 2472 64322716
Liver injury 13.26 11.26 39 173505 29893 64295295
Rash pustular 13.24 11.26 5 173539 9880 64315308
Dermatitis bullous 13.24 11.26 8 173536 12046 64313142
Blindness 13.21 11.26 103 173441 21916 64303272
Intestinal perforation 13.21 11.26 13 173531 15300 64309888
Enterocolitis 13.16 11.26 8 173536 12010 64313178
Human metapneumovirus test positive 13.12 11.26 7 173537 149 64325039
Exposure to fungus 13.07 11.26 6 173538 91 64325097
Aphasia 13.07 11.26 61 173483 40845 64284343
Vertigo 13.02 11.26 99 173445 58912 64266276
Substance use 13.02 11.26 12 173532 628 64324560
Infusion site discomfort 13.00 11.26 13 173531 753 64324435
Spinal stenosis 13.00 11.26 11 173533 13920 64311268
Middle ear effusion 12.98 11.26 21 173523 1978 64323210
Gastric ulcer 12.96 11.26 40 173504 30194 64294994
Cardiac arrest 12.90 11.26 522 173022 153542 64171646
Catheter site cellulitis 12.87 11.26 10 173534 413 64324775
Secretion discharge 12.87 11.26 65 173479 11899 64313289
Collateral circulation 12.84 11.26 5 173539 49 64325139
Endarterectomy 12.81 11.26 9 173535 318 64324870
Subdural haematoma evacuation 12.75 11.26 5 173539 50 64325138
Epstein-Barr virus infection 12.75 11.26 9 173535 12479 64312709
Blood ethanol increased 12.74 11.26 12 173532 646 64324542
Dry eye 12.72 11.26 38 173506 28981 64296207
Conjunctivitis 12.70 11.26 22 173522 20332 64304856
Biopsy colon 12.69 11.26 3 173541 3 64325185
Cell-free and concentrated ascites reinfusion therapy 12.69 11.26 3 173541 3 64325185
Fasciectomy 12.69 11.26 3 173541 3 64325185
Male orgasmic disorder 12.66 11.26 5 173539 51 64325137
Implantable defibrillator insertion 12.65 11.26 13 173531 778 64324410
Nervous system disorder 12.61 11.26 27 173517 23051 64302137
Low cardiac output syndrome 12.60 11.26 13 173531 782 64324406
Skin necrosis 12.55 11.26 12 173532 14317 64310871
Hysterectomy 12.51 11.26 36 173508 5049 64320139
Drug titration error 12.49 11.26 14 173530 926 64324262
Kidney transplant rejection 12.43 11.26 5 173539 9506 64315682
Cardiac discomfort 12.43 11.26 15 173529 1074 64324114
Gastric antral vascular ectasia 12.42 11.26 13 173531 795 64324393
Metastases to lymph nodes 12.38 11.26 4 173540 8713 64316475
Respiratory tract irritation 12.36 11.26 11 173533 550 64324638
Thyroidectomy 12.36 11.26 13 173531 800 64324388
Life support 12.34 11.26 10 173534 439 64324749
Executive dysfunction 12.31 11.26 8 173536 248 64324940
Drug withdrawal syndrome 12.31 11.26 43 173501 31248 64293940
Ejection fraction decreased 12.29 11.26 38 173506 28669 64296519
Annuloplasty 12.23 11.26 3 173541 4 64325184
Hip fracture 12.21 11.26 119 173425 26980 64298208
Bronchitis 12.21 11.26 381 173163 108362 64216826
Abdominal pain upper 12.21 11.26 582 172962 174448 64150740
Polypectomy 12.17 11.26 14 173530 952 64324236
Oesophagogastroduodenoscopy 12.11 11.26 7 173537 175 64325013
Carbon dioxide abnormal 12.08 11.26 8 173536 256 64324932
Cardiac index decreased 12 11.26 6 173538 111 64325077
Atrioventricular block first degree 11.96 11.26 7 173537 10727 64314461
Tongue disorder 11.95 11.26 9 173535 12071 64313117
Brain oedema 11.92 11.26 26 173518 22049 64303139
Needle issue 11.91 11.26 5 173539 9267 64315921
Stress cardiomyopathy 11.88 11.26 5 173539 9252 64315936
Purulent discharge 11.87 11.26 37 173507 5424 64319764
Vertebral artery stenosis 11.86 11.26 7 173537 182 64325006
Platelet count increased 11.86 11.26 20 173524 18676 64306512
Cholecystitis acute 11.84 11.26 8 173536 11352 64313836
Echocardiogram 11.83 11.26 4 173540 25 64325163
Bone density decreased 11.80 11.26 6 173538 9946 64315242
Cardiopulmonary failure 11.78 11.26 40 173504 6130 64319058
Guillain-Barre syndrome 11.77 11.26 3 173541 7632 64317556
Macular detachment 11.76 11.26 7 173537 185 64325003
Dyspepsia 11.72 11.26 291 173253 80021 64245167
Ileus paralytic 11.71 11.26 4 173540 8411 64316777
Sickle cell anaemia 11.69 11.26 11 173533 591 64324597
Gastroenteritis viral 11.68 11.26 92 173452 19637 64305551
Sinusitis 11.66 11.26 301 173243 145627 64179561
Drug dependence 11.66 11.26 48 173496 33264 64291924
Suture related complication 11.63 11.26 8 173536 273 64324915
Cardiogenic shock 11.62 11.26 136 173408 32291 64292897
Epstein-Barr virus antibody positive 11.55 11.26 11 173533 600 64324588
Oesophageal variceal ligation 11.54 11.26 6 173538 121 64325067
Upper limb fracture 11.53 11.26 74 173470 14792 64310396
Emergency care examination 11.52 11.26 5 173539 66 64325122
Tenderness 11.51 11.26 22 173522 19580 64305608
Intestinal adhesion lysis 11.48 11.26 3 173541 6 64325182
Sedative therapy 11.48 11.26 3 173541 6 64325182
Implant site extravasation 11.47 11.26 12 173532 734 64324454
Blood pressure diastolic decreased 11.45 11.26 27 173517 22274 64302914
Spinal osteoarthritis 11.45 11.26 13 173531 14328 64310860
Hyperbilirubinaemia 11.43 11.26 25 173519 21180 64304008
Contusion 11.39 11.26 227 173317 113738 64211450
Night sweats 11.37 11.26 54 173490 35992 64289196
Lung operation 11.37 11.26 7 173537 197 64324991
Injection site infection 11.32 11.26 19 173525 1846 64323342
Hepatic steatosis 11.28 11.26 44 173500 30963 64294225

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G04BE03 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs used in erectile dysfunction
FDA MoA N0000020026 Phosphodiesterase 5 Inhibitors
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 agents
CHEBI has role CHEBI:71942 PDE5 inhibitor

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

External reference:

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

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
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6671 TABLET 20 mg ORAL ANDA 26 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-185 TABLET 20 mg ORAL ANDA 27 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-185 TABLET 20 mg ORAL ANDA 27 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-186 TABLET, FILM COATED 25 mg ORAL ANDA 19 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-186 TABLET, FILM COATED 25 mg ORAL ANDA 19 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-187 TABLET, FILM COATED 50 mg ORAL ANDA 19 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-187 TABLET, FILM COATED 50 mg ORAL ANDA 19 sections
SILDENAFIL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-188 TABLET, FILM COATED 100 mg ORAL ANDA 19 sections
SILDENAFIL 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