tadalafil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
inhibitors of phosphodiesterase PDE5 with vasodilator action 2553 171596-29-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.73 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 16 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Nov. 21, 2003 FDA LILLY

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 2029.28 15.65 3654 95568 657659 62732141
Pulmonary arterial hypertension 1801.17 15.65 821 98401 21756 63368044
Pain in jaw 1699.18 15.65 977 98245 42519 63347281
Fluid retention 1560.82 15.65 1038 98184 58648 63331152
Headache 1309.29 15.65 2975 96247 630266 62759534
Dyspnoea exertional 1053.10 15.65 821 98401 59481 63330319
Drug ineffective 971.95 15.65 225 98997 1044540 62345260
Right ventricular failure 943.35 15.65 484 98738 16704 63373096
Pulmonary hypertension 863.56 15.65 601 98621 36522 63353278
Hypervolaemia 795.16 15.65 516 98706 27897 63361903
Flushing 788.64 15.65 765 98457 74322 63315478
Death 676.84 15.65 1674 97548 372707 63017093
Hospitalisation 639.39 15.65 725 98497 84356 63305444
Diarrhoea 580.99 15.65 2427 96795 712939 62676861
Nasal congestion 565.21 15.65 601 98621 65059 63324741
Catheter site erythema 548.63 15.65 218 99004 4058 63385742
Infusion site pain 548.56 15.65 337 98885 16532 63373268
Oxygen saturation decreased 505.90 15.65 657 98565 87928 63301872
Transfusion 487.17 15.65 301 98921 14916 63374884
Catheter site pain 443.99 15.65 193 99029 4542 63385258
Catheter management 442.37 15.65 169 99053 2818 63386982
Device related infection 433.06 15.65 330 98892 23062 63366738
Vascular device infection 418.79 15.65 212 99010 7100 63382700
Catheter site pruritus 402.57 15.65 144 99078 1976 63387824
Catheter site discharge 353.29 15.65 129 99093 1884 63387916
Cardiac failure 327.67 15.65 537 98685 88605 63301195
Infusion related reaction 327.40 15.65 13 99209 245508 63144292
Alopecia 321.27 15.65 68 99154 337468 63052332
Oedema 315.10 15.65 555 98667 97067 63292733
Syncope 313.34 15.65 615 98607 116770 63273030
Chest pain 304.27 15.65 882 98340 215077 63174723
Palpitations 302.42 15.65 592 98630 112178 63277622
Lung transplant 301.45 15.65 130 99092 2998 63386802
Therapy change 284.54 15.65 154 99068 5927 63383873
Arthropathy 280.83 15.65 23 99199 234769 63155031
Therapeutic product effect decreased 276.86 15.65 5 99217 193182 63196618
Oxygen consumption increased 274.49 15.65 130 99092 3754 63386046
Dizziness 273.29 15.65 1360 97862 428565 62961235
Contraindicated product administered 272.74 15.65 17 99205 217631 63172169
Rheumatoid arthritis 272.56 15.65 37 99185 253782 63136018
Infusion site erythema 271.18 15.65 189 99033 11490 63378310
Oedema peripheral 263.01 15.65 770 98452 188741 63201059
Infusion site infection 260.27 15.65 100 99122 1694 63388106
Toxicity to various agents 258.58 15.65 39 99183 247211 63142589
Unevaluable event 257.79 15.65 358 98864 51028 63338772
Catheter placement 257.07 15.65 106 99116 2178 63387622
Pulmonary arterial pressure increased 256.13 15.65 121 99101 3474 63386326
Cough 255.30 15.65 1018 98204 291725 63098075
Pneumonia 254.48 15.65 1393 97829 455374 62934426
Catheter site infection 251.20 15.65 132 99090 4782 63385018
Glossodynia 250.88 15.65 6 99216 178870 63210930
Treatment failure 245.09 15.65 17 99205 199026 63190774
Catheterisation cardiac 242.01 15.65 126 99096 4477 63385323
Device leakage 233.80 15.65 143 99079 6953 63382847
Off label use 225.48 15.65 447 98775 674015 62715785
Scleroderma 221.79 15.65 126 99096 5336 63384464
Nausea 217.10 15.65 2159 97063 852312 62537488
Dermatitis contact 216.35 15.65 161 99061 10847 63378953
Malaise 210.02 15.65 1236 97986 414718 62975082
Maternal exposure during pregnancy 207.85 15.65 45 99177 220017 63169783
Hypotension 206.32 15.65 908 98314 271696 63118104
Drug hypersensitivity 204.16 15.65 116 99106 310571 63079229
Infusion site discharge 198.26 15.65 64 99158 628 63389172
Myalgia 195.20 15.65 587 98635 145942 63243858
Catheter site haemorrhage 193.41 15.65 96 99126 3079 63386721
Catheter site rash 191.30 15.65 64 99158 709 63389091
Drug interaction 189.57 15.65 61 99161 229070 63160730
Hypoxia 189.02 15.65 337 98885 59455 63330345
Neutropenia 189.00 15.65 25 99197 174980 63214820
Device alarm issue 182.41 15.65 74 99148 1456 63388344
Joint swelling 178.57 15.65 150 99072 327516 63062284
Pulmonary oedema 178.26 15.65 313 98909 54560 63335240
Catheter site swelling 177.65 15.65 72 99150 1413 63388387
Hepatic enzyme increased 174.34 15.65 50 99172 202278 63187522
Device occlusion 172.56 15.65 120 99102 7267 63382533
Rash 171.09 15.65 391 98831 560480 62829320
Completed suicide 169.40 15.65 16 99206 145657 63244143
Central venous catheterisation 168.51 15.65 82 99140 2517 63387283
Product use in unapproved indication 166.29 15.65 38 99184 179042 63210758
Device infusion issue 161.99 15.65 74 99148 1964 63387836
Infusion site swelling 157.37 15.65 127 99095 9643 63380157
Device dislocation 156.53 15.65 197 99025 25508 63364292
Transplant evaluation 153.45 15.65 61 99161 1136 63388664
Musculoskeletal stiffness 152.94 15.65 49 99173 184569 63205231
Therapeutic product effect incomplete 150.13 15.65 12 99210 125044 63264756
Pericarditis 148.96 15.65 16 99206 131563 63258237
Concomitant disease aggravated 143.71 15.65 117 99105 8995 63380805
Hypersensitivity 142.90 15.65 148 99074 292537 63097263
Stomatitis 142.39 15.65 23 99199 138702 63251098
Discomfort 141.18 15.65 43 99179 167331 63222469
Systemic lupus erythematosus 140.03 15.65 76 99146 208842 63180958
Catheter site irritation 137.95 15.65 46 99176 504 63389296
Drug intolerance 129.40 15.65 176 99046 308485 63081315
Complication associated with device 127.86 15.65 145 99077 16833 63372967
Ascites 126.70 15.65 228 98994 40500 63349300
Hypertension 125.63 15.65 151 99071 279152 63110648
Wound 125.51 15.65 49 99173 163214 63226586
Psoriatic arthropathy 124.82 15.65 4 99218 91516 63298284
Brain natriuretic peptide increased 122.50 15.65 85 99137 5128 63384672
Blood cholesterol increased 121.87 15.65 6 99216 94026 63295774
Pain in extremity 121.50 15.65 910 98312 330576 63059224
Epistaxis 120.99 15.65 316 98906 72409 63317391
Product dose omission issue 120.96 15.65 701 98521 233612 63156188
Presyncope 115.23 15.65 177 99045 27608 63362192
Catheter site vesicles 114.52 15.65 35 99187 282 63389518
Helicobacter infection 113.92 15.65 8 99214 92777 63297023
Cardiac failure congestive 112.50 15.65 359 98863 92074 63297726
Abdominal distension 112.42 15.65 344 98878 86271 63303529
Catheter site inflammation 110.40 15.65 44 99178 825 63388975
Dyspnoea at rest 108.95 15.65 72 99150 4007 63385793
Infusion site haemorrhage 108.10 15.65 78 99144 5008 63384792
Feeling abnormal 108.04 15.65 489 98733 147903 63241897
Product use issue 107.02 15.65 112 99110 220408 63169392
Impaired healing 105.22 15.65 17 99205 102525 63287275
Haemoptysis 104.01 15.65 172 99050 28554 63361246
Device connection issue 102.86 15.65 39 99183 636 63389164
Pulmonary veno-occlusive disease 99.59 15.65 44 99178 1077 63388723
Intentional product use issue 98.92 15.65 38 99184 127854 63261946
Pericardial effusion 95.70 15.65 170 99052 29888 63359912
Pruritus 91.63 15.65 276 98946 361177 63028623
Psoriasis 90.15 15.65 14 99208 86943 63302857
C-reactive protein increased 90.09 15.65 19 99203 94688 63295112
Confusional state 89.07 15.65 145 99077 236235 63153565
Osteoarthritis 88.92 15.65 20 99202 95323 63294477
Muscle injury 88.59 15.65 3 99219 65342 63324458
Heart rate increased 88.59 15.65 336 98886 93902 63295898
Lower respiratory tract infection 87.35 15.65 49 99173 132258 63257542
Chest discomfort 85.01 15.65 369 98853 109600 63280200
Disease complication 84.15 15.65 56 99166 3153 63386647
Type 2 diabetes mellitus 82.99 15.65 4 99218 63864 63325936
Device related sepsis 82.96 15.65 61 99161 4033 63385767
Blood pressure decreased 82.27 15.65 256 98966 64766 63325034
Intentional overdose 81.44 15.65 10 99212 74142 63315658
Respiratory failure 81.21 15.65 345 98877 101513 63288287
Paracentesis 79.55 15.65 36 99186 934 63388866
Liver transplant 77.60 15.65 47 99175 2244 63387556
Acute kidney injury 77.36 15.65 187 99035 263228 63126572
Mobility decreased 76.96 15.65 47 99175 121112 63268688
Drug abuse 76.73 15.65 11 99211 72507 63317293
Irritable bowel syndrome 75.44 15.65 18 99204 82394 63307406
White blood cell count decreased 75.25 15.65 64 99158 139040 63250760
Exposure during pregnancy 74.31 15.65 80 99142 155467 63234333
Cardiac disorder 73.71 15.65 210 99012 50606 63339194
Cardiac pacemaker insertion 73.68 15.65 57 99165 4069 63385731
Blister 73.62 15.65 57 99165 129757 63260043
Urticaria 73.04 15.65 91 99131 165711 63224089
Walking distance test abnormal 72.70 15.65 29 99193 545 63389255
Overdose 71.22 15.65 46 99176 115032 63274768
Injection site discharge 70.30 15.65 32 99190 842 63388958
Thrombocytopenia 68.65 15.65 81 99141 151076 63238724
Atrial flutter 67.77 15.65 80 99142 9692 63380108
Anaphylactic reaction 67.71 15.65 11 99211 66089 63323711
Infusion site abscess 65.42 15.65 21 99201 202 63389598
Fibromyalgia 63.68 15.65 23 99199 80397 63309403
Leukopenia 63.10 15.65 21 99201 77269 63312531
Suicide attempt 62.71 15.65 10 99212 60908 63328892
Acute respiratory failure 62.69 15.65 155 99067 34330 63355470
Dialysis 62.02 15.65 79 99143 10348 63379452
Oxygen therapy 61.97 15.65 40 99182 2138 63387662
Depression 61.28 15.65 135 99087 196357 63193443
Infusion site warmth 60.82 15.65 37 99185 1781 63388019
Cognitive disorder 60.15 15.65 8 99214 55807 63333993
Blood pressure systolic increased 58.42 15.65 4 99218 47393 63342407
Liver injury 57.84 15.65 12 99210 60508 63329292
Catheter site warmth 57.49 15.65 19 99203 202 63389598
Infusion site induration 57.31 15.65 31 99191 1191 63388609
Blood pressure increased 56.82 15.65 104 99118 161958 63227842
Arthralgia 56.39 15.65 594 98628 569116 62820684
Rhabdomyolysis 56.32 15.65 3 99219 43948 63345852
Injury 56.23 15.65 22 99200 73225 63316575
Injection site infection 56.06 15.65 36 99186 1907 63387893
Therapy interrupted 55.98 15.65 143 99079 32312 63357488
General physical health deterioration 55.98 15.65 147 99075 201255 63188545
Therapy non-responder 55.84 15.65 251 98971 75650 63314150
Cardiac failure high output 55.21 15.65 20 99202 285 63389515
Multiple sclerosis relapse 54.57 15.65 6 99216 48472 63341328
Suicidal ideation 54.50 15.65 15 99207 62406 63327394
Electrocardiogram QT prolonged 54.48 15.65 13 99209 59517 63330283
Intentional product misuse 54.40 15.65 14 99208 60903 63328897
Cardiac ablation 54.29 15.65 32 99190 1453 63388347
Injection site bruising 53.27 15.65 3 99219 41907 63347893
Seizure 53.13 15.65 78 99144 132556 63257244
Thrombosis in device 52.72 15.65 41 99181 2949 63386851
Hypoaesthesia 52.25 15.65 116 99106 168277 63221523
Atrial septal defect repair 51.27 15.65 18 99204 233 63389567
Pulmonary arterial pressure abnormal 51.26 15.65 22 99200 501 63389299
Stent placement 50.52 15.65 44 99178 3711 63386089
Infusion site irritation 50.45 15.65 26 99196 904 63388896
Emergency care 49.69 15.65 27 99195 1047 63388753
Paraesthesia 49.63 15.65 107 99115 156859 63232941
Sinus congestion 49.53 15.65 96 99126 18027 63371773
Vomiting 49.41 15.65 1183 98039 558434 62831366
Pulmonary hypertensive crisis 49.28 15.65 19 99203 325 63389475
Dizziness postural 48.88 15.65 59 99163 7317 63382483
Disease progression 47.67 15.65 342 98880 122416 63267384
Ill-defined disorder 47.49 15.65 35 99187 81720 63308080
Decreased appetite 47.43 15.65 600 98622 250452 63139348
Cardiac operation 47.12 15.65 40 99182 3258 63386542
Device breakage 47.11 15.65 73 99149 11469 63378331
Catheter site related reaction 46.96 15.65 25 99197 930 63388870
Anaemia 46.72 15.65 680 98542 292750 63097050
Aspiration pleural cavity 46.34 15.65 24 99198 843 63388957
Systemic scleroderma 46.33 15.65 25 99197 956 63388844
Infusion site pruritus 46.21 15.65 52 99170 5983 63383817
Catheter removal 46.04 15.65 19 99203 391 63389409
Right ventricular dilatation 46.02 15.65 28 99194 1348 63388452
Coma 45.18 15.65 22 99200 64342 63325458
Exercise tolerance decreased 44.91 15.65 49 99173 5448 63384352
Inappropriate schedule of product administration 44.79 15.65 58 99164 103907 63285893
Treatment noncompliance 44.50 15.65 144 99078 37181 63352619
Contusion 44.41 15.65 106 99116 149938 63239862
Atrial fibrillation 44.17 15.65 323 98899 116313 63273487
Abortion spontaneous 43.80 15.65 10 99212 47185 63342615
Seasonal allergy 43.31 15.65 99 99123 20851 63368949
Hepatotoxicity 43.21 15.65 4 99218 37037 63352763
Head discomfort 42.86 15.65 76 99146 13339 63376461
Productive cough 42.78 15.65 204 99018 63004 63326796
Pancytopenia 41.83 15.65 54 99168 96879 63292921
Faeces soft 41.81 15.65 48 99174 5644 63384156
Peripheral swelling 41.81 15.65 615 98607 265327 63124473
Hyponatraemia 41.77 15.65 69 99153 111831 63277969
Bradycardia 41.70 15.65 32 99190 73195 63316605
Neuropathy peripheral 41.59 15.65 71 99151 113596 63276204
Cardiac output increased 41.33 15.65 15 99207 215 63389585
Nocturnal dyspnoea 41.17 15.65 25 99197 1199 63388601
Angioedema 41.00 15.65 12 99210 47953 63341847
Mineral supplementation 40.80 15.65 21 99201 728 63389072
Delirium 40.79 15.65 14 99208 50527 63339273
Influenza 40.55 15.65 300 98922 108422 63281378
Therapy cessation 40.46 15.65 122 99100 30335 63359465
Asthma 40.28 15.65 87 99135 127474 63262326
Dizziness exertional 40.19 15.65 17 99205 373 63389427
Loss of consciousness 40.18 15.65 319 98903 117802 63271998
Catheter site erosion 39.98 15.65 11 99211 58 63389742
Osteoporosis 39.64 15.65 20 99202 57318 63332482
Device issue 39.18 15.65 103 99119 23678 63366122
Abdominal cavity drainage 39.10 15.65 17 99205 400 63389400
Prescribed overdose 39.02 15.65 4 99218 34149 63355651
Internal haemorrhage 38.69 15.65 44 99178 5121 63384679
Dysentery 38.56 15.65 22 99200 939 63388861
Left ventricular failure 38.52 15.65 46 99176 5641 63384159
Catheter site scab 38.43 15.65 14 99208 203 63389597
Bursitis 38.30 15.65 6 99216 37035 63352765
Agitation 38.19 15.65 23 99199 59734 63330066
Depressed level of consciousness 38.14 15.65 25 99197 62053 63327747
Injection site reaction 38.14 15.65 22 99200 58502 63331298
Catheter site discolouration 38.09 15.65 12 99210 108 63389692
Medication error 38.04 15.65 17 99205 52267 63337533
Deep vein thrombosis 37.93 15.65 45 99177 83755 63306045
Blood glucose increased 37.89 15.65 45 99177 83711 63306089
Blood iron decreased 37.84 15.65 76 99146 14645 63375155
Catheterisation cardiac abnormal 37.57 15.65 14 99208 217 63389583
Therapeutic response decreased 37.50 15.65 25 99197 61500 63328300
Inflammation 37.43 15.65 44 99178 82229 63307571
Infusion site inflammation 37.17 15.65 16 99206 367 63389433
Throat irritation 36.82 15.65 136 99086 37511 63352289
Renal disorder 36.44 15.65 124 99098 32850 63356950
Device physical property issue 36.37 15.65 28 99194 1984 63387816
Lymphocyte count decreased 36.02 15.65 3 99219 30254 63359546
Foetal exposure during pregnancy 35.86 15.65 4 99218 31958 63357842
Injection site pain 35.85 15.65 95 99127 129705 63260095
Blood potassium decreased 35.54 15.65 145 99077 41881 63347919
Cardioversion 35.50 15.65 23 99199 1237 63388563
Chemotherapy 35.36 15.65 25 99197 1554 63388246
Pleural effusion 35.21 15.65 258 98964 92952 63296848
Condition aggravated 35.03 15.65 849 98373 401368 62988432
Bone marrow failure 34.61 15.65 3 99219 29287 63360513
N-terminal prohormone brain natriuretic peptide increased 34.60 15.65 28 99194 2133 63387667
Plasma cell myeloma 34.56 15.65 7 99215 35898 63353902
Wrong technique in product usage process 34.54 15.65 28 99194 62312 63327488
Extra dose administered 34.48 15.65 46 99176 6304 63383496
Rehabilitation therapy 34.37 15.65 25 99197 1625 63388175
Weight decreased 34.14 15.65 615 98607 276183 63113617
Metapneumovirus infection 33.99 15.65 21 99201 1039 63388761
Hallucination 33.78 15.65 22 99200 54795 63335005
Drug titration error 33.45 15.65 19 99203 804 63388996
Gastritis hypertrophic 33.45 15.65 9 99213 43 63389757
Arthritis 33.43 15.65 83 99139 115838 63273962
Purulent discharge 33.42 15.65 39 99183 4667 63385133
Medical device change 32.69 15.65 14 99208 317 63389483
Metabolic acidosis 32.25 15.65 15 99207 45054 63344746
Incorrect route of product administration 31.93 15.65 3 99219 27449 63362351
Cor pulmonale 31.60 15.65 26 99196 2028 63387772
Infusion site pustule 31.50 15.65 8 99214 29 63389771
Blood creatine phosphokinase increased 31.30 15.65 5 99217 30425 63359375
Hypocalcaemia 30.90 15.65 6 99216 31707 63358093
Concomitant disease progression 30.73 15.65 26 99196 2108 63387692
Product quality issue 30.60 15.65 9 99213 35856 63353944
Mouth ulceration 30.58 15.65 7 99215 32977 63356823
Hepatitis 30.45 15.65 12 99210 39776 63350024
Orthopnoea 30.45 15.65 43 99179 6218 63383582
Loss of personal independence in daily activities 30.18 15.65 67 99155 97223 63292577
Infusion site rash 30.18 15.65 25 99197 1969 63387831
Lung disorder 29.93 15.65 183 99039 62078 63327722
Joint stiffness 29.86 15.65 14 99208 41855 63347945
Joint range of motion decreased 29.83 15.65 7 99215 32421 63357379
Hepatocellular injury 29.32 15.65 4 99218 27377 63362423
Pulmonary congestion 29.27 15.65 76 99146 17342 63372458
Upper respiratory tract congestion 29.03 15.65 25 99197 2077 63387723
Paranasal sinus discomfort 28.99 15.65 35 99187 4341 63385459
Pulmonary artery aneurysm 28.95 15.65 8 99214 43 63389757
Transplant 28.66 15.65 17 99205 781 63389019
Agranulocytosis 28.57 15.65 3 99219 25131 63364669
Lactic acidosis 28.57 15.65 12 99210 38275 63351525
Platelet transfusion 28.50 15.65 17 99205 789 63389011
Pulmonary pain 28.32 15.65 31 99191 3459 63386341
Application site pruritus 28.27 15.65 33 99189 3951 63385849
Nasopharyngitis 28.26 15.65 556 98666 253701 63136099
Catheter site extravasation 28.21 15.65 13 99209 352 63389448
Ear discomfort 28.16 15.65 47 99175 7859 63381941
Respiratory syncytial virus infection 28.10 15.65 44 99178 6974 63382826
Hospice care 28.04 15.65 47 99175 7885 63381915
Oxygen saturation abnormal 28.04 15.65 31 99191 3498 63386302
Gastrointestinal haemorrhage 28.02 15.65 220 99002 80956 63308844
Disease recurrence 27.96 15.65 5 99217 28025 63361775
Right ventricular dysfunction 27.93 15.65 23 99199 1796 63388004
Infusion site cellulitis 27.56 15.65 11 99211 207 63389593
Intracardiac pressure increased 27.53 15.65 8 99214 53 63389747
Mechanical ventilation 27.52 15.65 20 99202 1298 63388502
Iron deficiency anaemia 27.48 15.65 81 99141 19888 63369912
Oral herpes 27.47 15.65 4 99218 26070 63363730
Skin exfoliation 26.97 15.65 17 99205 43085 63346715
Hot flush 26.93 15.65 154 99068 51005 63338795
Ear congestion 26.85 15.65 27 99195 2732 63387068
Tremor 26.72 15.65 111 99111 132128 63257672
Obesity 26.52 15.65 7 99215 29945 63359855
Diabetes mellitus 26.31 15.65 29 99193 55781 63334019
Central venous catheter removal 26.30 15.65 13 99209 413 63389387
Hypercalcaemia 26.28 15.65 6 99216 28316 63361484
Pulmonary arterial wedge pressure increased 26.18 15.65 12 99210 321 63389479
Cholecystectomy 26.11 15.65 54 99168 10623 63379177
Stevens-Johnson syndrome 25.89 15.65 4 99218 24946 63364854
Basal cell carcinoma 25.83 15.65 6 99216 27985 63361815
Right-to-left cardiac shunt 25.81 15.65 11 99211 246 63389554
Gout 25.56 15.65 61 99161 13210 63376590
Terminal state 25.33 15.65 24 99198 2258 63387542
Clostridium difficile infection 25.11 15.65 103 99119 29819 63359981
Infusion site discolouration 25.03 15.65 16 99206 841 63388959
Hepatic steatosis 24.95 15.65 7 99215 28762 63361038
Heart valve replacement 24.94 15.65 14 99208 579 63389221
Psychotic disorder 24.77 15.65 5 99217 25707 63364093
Hepatic cirrhosis 24.73 15.65 90 99132 24644 63365156
Emotional distress 24.61 15.65 10 99212 32539 63357261
Ejection fraction decreased 24.54 15.65 3 99219 22329 63367471
Grip strength decreased 24.48 15.65 3 99219 22284 63367516
Cardiac flutter 24.31 15.65 31 99191 4065 63385735
Haemoglobin decreased 24.24 15.65 340 98882 145145 63244655
Hyperglycaemia 24.21 15.65 18 99204 41849 63347951
Device malfunction 24.16 15.65 72 99150 17785 63372015
Altered state of consciousness 24.11 15.65 5 99217 25225 63364575
Respiration abnormal 24.00 15.65 39 99183 6378 63383422
Adverse drug reaction 23.83 15.65 56 99166 79658 63310142
Knee arthroplasty 23.59 15.65 30 99192 54176 63335624
Gastroenteritis viral 23.50 15.65 86 99136 23614 63366186
Sinus disorder 23.43 15.65 88 99134 24465 63365335
Hypoglycaemia 23.39 15.65 36 99186 60029 63329771
Infusion site vesicles 23.37 15.65 13 99209 528 63389272
Drug ineffective for unapproved indication 23.37 15.65 12 99210 34051 63355749
Localised oedema 23.34 15.65 35 99187 5343 63384457
CREST syndrome 23.26 15.65 13 99209 533 63389267
Right ventricular systolic pressure increased 23.24 15.65 13 99209 534 63389266
Catheter site induration 23.17 15.65 7 99215 54 63389746
Hypercholesterolaemia 23.12 15.65 3 99219 21331 63368469
Haemorrhage 23.09 15.65 169 99053 60853 63328947
Application site hypersensitivity 23.09 15.65 10 99212 233 63389567
Somnolence 23.00 15.65 174 99048 178511 63211289
Macular degeneration 22.95 15.65 5 99217 24371 63365429
Swollen tongue 22.79 15.65 13 99209 34787 63355013
Epilepsy 22.71 15.65 7 99215 27058 63362742
Dysarthria 22.66 15.65 20 99202 42691 63347109
Cytomegalovirus infection 22.58 15.65 3 99219 20949 63368851
No adverse event 22.44 15.65 19 99203 41386 63348414
Acute right ventricular failure 22.38 15.65 9 99213 173 63389627
Primary biliary cholangitis 22.36 15.65 17 99205 1182 63388618
Intentional dose omission 22.34 15.65 43 99179 8032 63381768
Skin lesion 22.33 15.65 10 99212 30711 63359089
Vascular cauterisation 22.32 15.65 7 99215 62 63389738
Chronic obstructive pulmonary disease 22.25 15.65 171 99051 62515 63327285
Echocardiogram abnormal 22.15 15.65 18 99204 1380 63388420
Aggression 21.76 15.65 5 99217 23493 63366307
Gastric varices 21.69 15.65 9 99213 188 63389612
Immunodeficiency 21.59 15.65 3 99219 20251 63369549
Pericardial drainage 21.56 15.65 10 99212 275 63389525
First bite syndrome 21.52 15.65 5 99217 11 63389789
Pulmonary artery dilatation 21.43 15.65 10 99212 279 63389521
Osteonecrosis 21.21 15.65 6 99216 24524 63365276
Head injury 21.20 15.65 92 99130 27304 63362496
Endotracheal intubation 21.02 15.65 23 99199 2565 63387235
Colitis 20.97 15.65 27 99195 48501 63341299
Polypectomy 20.94 15.65 14 99208 794 63389006
Pregnancy test positive 20.90 15.65 8 99214 134 63389666
Dyskinesia 20.89 15.65 12 99210 31990 63357810
Catheter site dermatitis 20.89 15.65 7 99215 78 63389722
Vascular device occlusion 20.85 15.65 8 99214 135 63389665
Muscle twitching 20.76 15.65 3 99219 19665 63370135
Cholestasis 20.75 15.65 10 99212 29424 63360376
Hyperkalaemia 20.61 15.65 33 99189 54170 63335630
Pneumonitis 20.55 15.65 15 99207 35207 63354593
Viral infection 20.54 15.65 110 99112 35553 63354247
Metastases to bone 20.43 15.65 4 99218 21015 63368785
Product prescribing error 20.00 15.65 8 99214 26281 63363519
Middle ear effusion 20.00 15.65 22 99200 2469 63387331
Obstructive airways disorder 19.99 15.65 4 99218 20695 63369105
Drug-induced liver injury 19.97 15.65 20 99202 40202 63349598
Hypomagnesaemia 19.90 15.65 10 99212 28727 63361073
Drug eruption 19.84 15.65 10 99212 28684 63361116
Infection 19.81 15.65 246 98976 228927 63160873
Infusion site dermatitis 19.71 15.65 5 99217 18 63389782
Dyspepsia 19.58 15.65 245 98977 101951 63287849
N-terminal prohormone brain natriuretic peptide 19.56 15.65 6 99216 49 63389751
Cardiac resynchronisation therapy 19.50 15.65 5 99217 19 63389781
Pancreatitis acute 19.50 15.65 9 99213 27157 63362643
Ureteral disorder 19.47 15.65 10 99212 345 63389455
Catheter culture positive 19.42 15.65 8 99214 164 63389636
Injection site mass 19.34 15.65 3 99219 18653 63371147
Systemic sclerosis pulmonary 19.30 15.65 5 99217 20 63389780
Migraine 19.05 15.65 246 98976 103100 63286700
Rhinorrhoea 19.05 15.65 171 99051 65406 63324394
Withdrawal syndrome 19.03 15.65 4 99218 19993 63369807
Disturbance in attention 18.94 15.65 19 99203 38170 63351630
Eosinophilia 18.89 15.65 6 99216 22750 63367050
Lymphopenia 18.88 15.65 3 99219 18324 63371476
Device use error 18.87 15.65 33 99189 5728 63384072
Bone disorder 18.85 15.65 5 99217 21321 63368479
Bronchitis 18.85 15.65 287 98935 124648 63265152
Respiratory tract congestion 18.78 15.65 66 99156 17766 63372034
Osteopenia 18.74 15.65 4 99218 19781 63370019
Catheter site mass 18.74 15.65 5 99217 23 63389777
Vasculitis 18.71 15.65 3 99219 18206 63371594
Cardiac output decreased 18.61 15.65 14 99208 958 63388842
Bendopnoea 18.56 15.65 5 99217 24 63389776
Diet noncompliance 18.52 15.65 10 99212 383 63389417
Oropharyngeal pain 18.31 15.65 227 98995 94260 63295540
Infusion site oedema 18.00 15.65 13 99209 836 63388964
Tracheostomy 17.99 15.65 12 99210 678 63389122
Infusion site reaction 17.98 15.65 25 99197 3562 63386238
Blood carbon monoxide increased 17.82 15.65 4 99218 7 63389793
Wrong dose 17.60 15.65 15 99207 1228 63388572
Cardiac failure acute 17.51 15.65 43 99179 9480 63380320
Alanine aminotransferase increased 17.48 15.65 93 99129 103677 63286123
Prophylaxis 17.47 15.65 4 99218 8 63389792
Catheter site urticaria 17.36 15.65 5 99217 32 63389768
Pulmonary embolism 17.29 15.65 109 99113 116575 63273225
Portopulmonary hypertension 17.29 15.65 7 99215 137 63389663
Right ventricular enlargement 17.28 15.65 9 99213 320 63389480
Blood calcium decreased 17.15 15.65 10 99212 26441 63363359
Infusion site nodule 17.15 15.65 16 99206 1476 63388324
Acute myocardial infarction 17.09 15.65 15 99207 32109 63357691
Injection site erosion 16.93 15.65 6 99216 80 63389720
Accidental exposure to product 16.88 15.65 11 99211 27394 63362406
Pain 16.80 15.65 967 98255 739661 62650139
Female sterilisation 16.78 15.65 11 99211 604 63389196
Colitis ulcerative 16.73 15.65 10 99212 26081 63363719
Metastases to liver 16.71 15.65 8 99214 23631 63366169
Cardiomegaly 16.70 15.65 63 99159 17551 63372249
Decreased activity 16.69 15.65 33 99189 6287 63383513
Amnesia 16.65 15.65 39 99183 55546 63334254
Hyperlipidaemia 16.53 15.65 5 99217 19566 63370234
Laboratory test abnormal 16.31 15.65 11 99211 26901 63362899
Ischaemic stroke 16.27 15.65 4 99218 17953 63371847
Hypothyroidism 16.17 15.65 26 99196 42606 63347194
Paraesthesia oral 16.12 15.65 5 99217 19251 63370549
Generalised tonic-clonic seizure 16.11 15.65 13 99209 29003 63360797
Blood pressure fluctuation 15.97 15.65 30 99192 46287 63343513
Ventilation perfusion mismatch 15.95 15.65 10 99212 508 63389292
Abdominal pain upper 15.93 15.65 429 98793 206015 63183785
Mastectomy 15.92 15.65 16 99206 1617 63388183
Oxygen consumption 15.87 15.65 6 99216 97 63389703
Abdominal discomfort 15.87 15.65 381 98841 320504 63069296
Disseminated intravascular coagulation 15.86 15.65 5 99217 19046 63370754
Drug resistance 15.85 15.65 8 99214 22925 63366875
Orthostatic hypotension 15.74 15.65 20 99202 36140 63353660
Hypoacusis 15.65 15.65 77 99145 24074 63365726

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Headache 666.45 12.64 1104 49547 199531 34706749
Pulmonary arterial hypertension 548.10 12.64 263 50388 8476 34897804
Fluid retention 480.48 12.64 360 50291 26527 34879753
Pain in jaw 454.32 12.64 265 50386 12775 34893505
Dyspnoea 421.89 12.64 1347 49304 375435 34530845
Right ventricular failure 366.74 12.64 201 50450 8583 34897697
Pulmonary hypertension 276.98 12.64 235 50416 20689 34885591
Flushing 274.55 12.64 284 50367 32136 34874144
Dyspnoea exertional 229.72 12.64 298 50353 42981 34863299
Hypervolaemia 198.89 12.64 190 50461 19519 34886761
Nasal congestion 172.17 12.64 189 50462 22868 34883412
Infusion site pain 163.13 12.64 89 50562 3762 34902518
Vision blurred 154.31 12.64 255 50396 45708 34860572
Lung transplant 145.60 12.64 67 50584 1957 34904323
Myalgia 139.51 12.64 348 50303 83762 34822518
Oedema 136.70 12.64 241 50410 45500 34860780
Brain natriuretic peptide increased 129.11 12.64 88 50563 5571 34900709
Febrile neutropenia 126.05 12.64 23 50628 136826 34769454
Optic ischaemic neuropathy 122.46 12.64 60 50591 2022 34904258
Back pain 120.38 12.64 419 50232 121370 34784910
Catheterisation cardiac 119.33 12.64 64 50587 2613 34903667
Death 113.11 12.64 971 49680 397078 34509202
Transfusion 112.68 12.64 96 50555 8489 34897791
Oxygen saturation decreased 111.45 12.64 243 50408 53575 34852705
Hospitalisation 108.94 12.64 249 50402 56653 34849627
Pain in extremity 106.30 12.64 413 50238 126100 34780180
Cyanopsia 105.16 12.64 29 50622 169 34906111
Fractional exhaled nitric oxide increased 104.31 12.64 44 50607 1038 34905242
Toxicity to various agents 103.82 12.64 83 50568 200279 34706001
Catheter management 102.32 12.64 42 50609 923 34905357
Catheter site erythema 99.54 12.64 46 50605 1357 34904923
Diarrhoea 95.32 12.64 921 49730 388991 34517289
Acute kidney injury 88.81 12.64 194 50457 304794 34601486
Device related infection 84.14 12.64 114 50537 17123 34889157
Infusion site infection 83.70 12.64 30 50621 449 34905831
Concomitant disease aggravated 83.64 12.64 68 50583 5633 34900647
Plantar fasciitis 81.67 12.64 46 50605 2070 34904210
Therapy change 80.22 12.64 52 50599 3025 34903255
Sensation of foreign body 79.94 12.64 50 50601 2733 34903547
Feeling abnormal 75.36 12.64 232 50419 63003 34843277
Dizziness 74.25 12.64 556 50095 217965 34688315
Thrombocytopenia 72.15 12.64 72 50579 156175 34750105
Transplant evaluation 71.11 12.64 27 50624 479 34905801
Oxygen consumption increased 67.53 12.64 35 50616 1331 34904949
Peripheral swelling 66.76 12.64 253 50398 76288 34829992
Neutropenia 66.01 12.64 78 50573 156700 34749580
Cardiac disorder 65.78 12.64 173 50478 42953 34863327
Syncope 65.24 12.64 284 50367 91167 34815113
Pulmonary arterial pressure increased 64.23 12.64 33 50618 1232 34905048
Malignant neoplasm progression 63.59 12.64 24 50627 88022 34818258
Erection increased 62.98 12.64 25 50626 502 34905778
Myoglobin blood increased 61.91 12.64 44 50607 2979 34903301
Priapism 61.79 12.64 54 50597 4940 34901340
Infusion site erythema 60.70 12.64 39 50612 2234 34904046
Visual impairment 59.13 12.64 148 50503 35654 34870626
Leukopenia 59.05 12.64 10 50641 62846 34843434
Catheter site discharge 58.18 12.64 25 50626 618 34905662
Cough 57.87 12.64 394 50257 149746 34756534
Drug interaction 56.04 12.64 156 50495 225790 34680490
Rhabdomyolysis 55.56 12.64 15 50636 68148 34838132
Drug abuse 55.18 12.64 38 50613 99058 34807222
Nasopharyngitis 55.11 12.64 224 50427 69744 34836536
Catheter site pain 54.12 12.64 30 50621 1308 34904972
Catheter site pruritus 51.00 12.64 19 50632 319 34905961
Milk-alkali syndrome 49.78 12.64 22 50629 583 34905697
Secretion discharge 48.62 12.64 51 50600 5854 34900426
Infusion related reaction 48.62 12.64 9 50642 53048 34853232
Product use in unapproved indication 47.80 12.64 60 50591 117439 34788841
Pancytopenia 46.04 12.64 42 50609 95115 34811165
Catheter placement 43.97 12.64 22 50629 776 34905504
Deafness unilateral 43.20 12.64 30 50621 1957 34904323
Pulmonary veno-occlusive disease 42.56 12.64 19 50632 516 34905764
Device alarm issue 42.24 12.64 20 50631 624 34905656
Unevaluable event 42.03 12.64 123 50528 32467 34873813
Faeces soft 41.54 12.64 37 50614 3471 34902809
Device occlusion 40.97 12.64 49 50602 6496 34899784
Dermatitis contact 39.23 12.64 36 50615 3510 34902770
Mucosal inflammation 38.91 12.64 5 50646 38617 34867663
Palpitations 38.90 12.64 137 50514 39849 34866431
Suspected counterfeit product 38.51 12.64 15 50636 286 34905994
Dyspepsia 38.49 12.64 129 50522 36603 34869677
Hyponatraemia 38.24 12.64 38 50613 82653 34823627
Cardiac operation 37.25 12.64 33 50618 3074 34903206
Malaise 37.11 12.64 422 50229 185403 34720877
Septic shock 36.82 12.64 30 50621 71804 34834476
Vascular device infection 35.99 12.64 37 50614 4148 34902132
Depressed level of consciousness 35.72 12.64 9 50642 42832 34863448
Cardiac pacemaker insertion 35.18 12.64 31 50620 2867 34903413
Injection site discharge 34.96 12.64 13 50638 217 34906063
Muscle spasms 33.87 12.64 205 50446 74796 34831484
Right ventricular dysfunction 33.45 12.64 21 50630 1155 34905125
Haematospermia 33.23 12.64 14 50637 329 34905951
Visual acuity reduced 32.35 12.64 72 50579 16077 34890203
Neutrophil count decreased 32.06 12.64 17 50634 51087 34855193
Sinus congestion 31.91 12.64 40 50611 5565 34900715
Confusional state 31.77 12.64 105 50546 144055 34762225
Drug reaction with eosinophilia and systemic symptoms 31.56 12.64 5 50646 33007 34873273
Infusion site discharge 31.55 12.64 10 50641 100 34906180
Device dislocation 31.51 12.64 42 50609 6207 34900073
Off label use 31.11 12.64 425 50226 419099 34487181
Fracture of penis 31.09 12.64 12 50639 223 34906057
Erectile dysfunction 30.65 12.64 82 50569 20555 34885725
Heart and lung transplant 30.18 12.64 9 50642 72 34906208
General physical health deterioration 29.96 12.64 91 50560 128178 34778102
Oedema peripheral 29.51 12.64 284 50367 119528 34786752
Catheter site haemorrhage 29.45 12.64 25 50626 2199 34904081
Accommodation disorder 29.43 12.64 12 50639 259 34906021
Multiple organ dysfunction syndrome 29.18 12.64 41 50610 76525 34829755
Hyperkalaemia 28.65 12.64 35 50616 69354 34836926
Catheter removal 28.42 12.64 11 50640 206 34906074
Catheter site rash 28.22 12.64 11 50640 210 34906070
Fatigue 28.16 12.64 719 49932 369934 34536346
Rash maculo-papular 27.91 12.64 4 50647 28447 34877833
Chest discomfort 27.84 12.64 154 50497 54376 34851904
Hypoxia 27.73 12.64 155 50496 54940 34851340
Chromatopsia 27.22 12.64 12 50639 316 34905964
Bradycardia 27.16 12.64 42 50609 75376 34830904
Eye symptom 27.00 12.64 6 50645 11 34906269
Blindness unilateral 26.79 12.64 33 50618 4509 34901771
Bone marrow failure 26.71 12.64 5 50646 29248 34877032
Walking distance test abnormal 26.57 12.64 10 50641 173 34906107
Central venous catheterisation 26.30 12.64 19 50632 1320 34904960
Seizure 26.23 12.64 72 50579 104785 34801495
Catheter site infection 26.11 12.64 25 50626 2572 34903708
Lactic acidosis 25.90 12.64 9 50642 34763 34871517
Chest pain 25.78 12.64 289 50362 126473 34779807
Hallucination 25.78 12.64 22 50629 51476 34854804
Macular degeneration 25.77 12.64 23 50628 2163 34904117
Infusion site warmth 25.66 12.64 9 50642 126 34906154
Colour blindness acquired 25.51 12.64 8 50643 77 34906203
Retinal detachment 25.31 12.64 35 50616 5356 34900924
Rheumatoid arthritis 25.07 12.64 12 50639 38226 34868054
Cytomegalovirus infection 24.89 12.64 4 50647 26131 34880149
Therapeutic product effect incomplete 24.80 12.64 22 50629 50519 34855761
Liver transplant 24.73 12.64 24 50627 2510 34903770
Spontaneous penile erection 24.56 12.64 10 50641 215 34906065
Ejaculation failure 24.41 12.64 15 50636 794 34905486
Exostosis 24.21 12.64 32 50619 4691 34901589
Metabolic acidosis 23.97 12.64 17 50634 43663 34862617
Visual field defect 23.95 12.64 31 50620 4452 34901828
Pyrexia 23.70 12.64 340 50311 332673 34573607
Anorgasmia 23.62 12.64 15 50636 842 34905438
Injection site infection 23.51 12.64 16 50635 1010 34905270
Haematopoietic stem cell mobilisation 23.48 12.64 9 50642 164 34906116
Treatment failure 23.31 12.64 20 50631 46677 34859603
Suicide attempt 23.12 12.64 14 50637 39102 34867178
Oxygen therapy 23.01 12.64 15 50636 881 34905399
Cardiac failure 22.80 12.64 217 50434 91031 34815249
Stomatitis 22.73 12.64 17 50634 42497 34863783
Gastrooesophageal reflux disease 22.73 12.64 112 50539 37812 34868468
Drug hypersensitivity 22.70 12.64 52 50599 80477 34825803
Visual brightness 22.69 12.64 6 50645 29 34906251
Completed suicide 22.66 12.64 70 50581 98098 34808182
Agitation 22.61 12.64 30 50621 57369 34848911
Sepsis 22.56 12.64 145 50506 166416 34739864
Hyperglycaemia 22.14 12.64 15 50636 39465 34866815
Product dose omission issue 22.14 12.64 268 50383 119443 34786837
Blood pressure decreased 22.11 12.64 139 50512 51376 34854904
Abdominal discomfort 21.80 12.64 155 50496 59680 34846600
Pulmonary arterial pressure abnormal 21.50 12.64 9 50642 208 34906072
Infusion site haemorrhage 21.46 12.64 15 50636 989 34905291
Medical device change 21.38 12.64 8 50643 136 34906144
Hypokalaemia 21.36 12.64 32 50619 58182 34848098
Product substitution issue 21.34 12.64 46 50605 10049 34896231
Viral infection 21.28 12.64 65 50586 17558 34888722
Infusion site oedema 21.27 12.64 9 50642 214 34906066
Infusion site swelling 21.14 12.64 22 50629 2502 34903778
Rash 20.94 12.64 214 50437 222538 34683742
Device infusion issue 20.75 12.64 14 50637 871 34905409
Product counterfeit 20.47 12.64 8 50643 154 34906126
Hypocalcaemia 20.45 12.64 5 50646 24284 34881996
Gastric ischaemia 19.88 12.64 5 50646 19 34906261
Counterfeit product administered 19.87 12.64 8 50643 167 34906113
Blindness 19.74 12.64 57 50594 14929 34891351
Blindness transient 19.72 12.64 20 50631 2206 34904074
Complication associated with device 19.69 12.64 33 50618 5973 34900307
Epistaxis 19.56 12.64 148 50503 58103 34848177
Intentional product use issue 19.07 12.64 36 50615 59780 34846500
Deafness 19.04 12.64 47 50604 11218 34895062
Loss of consciousness 18.90 12.64 193 50458 82474 34823806
Gout 18.75 12.64 66 50585 19187 34887093
C-reactive protein increased 18.65 12.64 31 50620 54067 34852213
Dysphonia 18.50 12.64 75 50576 23308 34882972
Anaphylactic reaction 18.48 12.64 12 50639 32289 34873991
Sedation 18.33 12.64 4 50647 21002 34885278
Penis disorder 18.28 12.64 15 50636 1258 34905022
Overdose 18.25 12.64 69 50582 90990 34815290
Chorioretinopathy 18.18 12.64 16 50635 1477 34904803
Disorientation 18.10 12.64 13 50638 33175 34873105
Diagnostic procedure 18.01 12.64 5 50646 30 34906250
Hyperinsulinaemic hypoglycaemia 17.95 12.64 6 50645 72 34906208
Tinnitus 17.92 12.64 67 50584 20051 34886229
Aggression 17.90 12.64 18 50633 38946 34867334
Catheter site inflammation 17.90 12.64 8 50643 218 34906062
Cardiothoracic ratio increased 17.87 12.64 5 50646 31 34906249
White blood cell count increased 17.79 12.64 20 50631 41131 34865149
Lower respiratory tract infection 17.77 12.64 12 50639 31625 34874655
Throat irritation 17.72 12.64 44 50607 10541 34895739
Device breakage 17.41 12.64 19 50632 2281 34903999
Ocular vascular disorder 17.39 12.64 7 50644 146 34906134
Delirium 17.31 12.64 23 50628 43968 34862312
Acute respiratory distress syndrome 17.25 12.64 8 50643 25961 34880319
Pulmonary oedema 17.24 12.64 123 50528 47406 34858874
Drug resistance 17.20 12.64 8 50643 25919 34880361
Blood testosterone decreased 17.12 12.64 26 50625 4331 34901949
Psychotic disorder 17.09 12.64 7 50644 24445 34881835
Ventilation perfusion mismatch 16.91 12.64 6 50645 87 34906193
Pulmonary haemosiderosis 16.88 12.64 4 50647 11 34906269
Creatinine renal clearance abnormal 16.88 12.64 8 50643 250 34906030
Coma 16.86 12.64 25 50626 45653 34860627
Tubulointerstitial nephritis 16.43 12.64 5 50646 21019 34885261
Cardiac output increased 16.34 12.64 5 50646 44 34906236
Nausea 16.34 12.64 624 50027 339284 34566996
Dialysis 16.10 12.64 44 50607 11164 34895116
Cardiac ablation 16.01 12.64 13 50638 1075 34905205
Haemoptysis 15.99 12.64 96 50555 34910 34871370
Surgery 15.97 12.64 51 50600 14106 34892174
Insulin autoimmune syndrome 15.84 12.64 8 50643 288 34905992
Platelet count decreased 15.80 12.64 105 50546 119612 34786668
Hypomagnesaemia 15.69 12.64 6 50645 21845 34884435
Swelling 15.57 12.64 110 50541 42256 34864024
Scleroderma 15.55 12.64 15 50636 1557 34904723
Cardioversion 15.53 12.64 12 50639 923 34905357
Product administration interrupted 15.52 12.64 16 50635 1799 34904481
Neutrophil count increased 15.51 12.64 3 50648 17143 34889137
Paracentesis 15.46 12.64 9 50642 431 34905849
Road traffic accident 15.45 12.64 58 50593 17392 34888888
Blood lactate dehydrogenase increased 15.40 12.64 7 50644 22983 34883297
Migraine 15.40 12.64 58 50593 17420 34888860
Pulmonary capillary haemangiomatosis 15.36 12.64 4 50647 18 34906262
Catheter site irritation 15.28 12.64 6 50645 117 34906163
Left ventricular failure 15.21 12.64 27 50624 5117 34901163
Mitral perforation 15.18 12.64 4 50647 19 34906261
Pneumonitis 15.16 12.64 16 50635 33862 34872418
Acute myeloid leukaemia 14.92 12.64 4 50647 18266 34888014
Acute respiratory failure 14.89 12.64 86 50565 30842 34875438
Catheterisation cardiac abnormal 14.88 12.64 5 50646 61 34906219
Dizziness exertional 14.85 12.64 7 50644 216 34906064
Emergency care 14.68 12.64 8 50643 337 34905943
Heart rate increased 14.59 12.64 116 50535 46227 34860053
Abdominal distension 14.55 12.64 139 50512 58353 34847927
White blood cell count decreased 14.54 12.64 80 50571 95365 34810915
Retinal vein occlusion 14.42 12.64 15 50636 1704 34904576
Drug titration error 14.30 12.64 9 50642 497 34905783
Scrotal haematocoele 14.27 12.64 4 50647 25 34906255
Blood creatinine increased 14.25 12.64 80 50571 94896 34811384
Myelodysplastic syndrome 14.25 12.64 5 50646 19203 34887077
Cancer surgery 14.21 12.64 9 50642 503 34905777
Pericardial effusion 14.19 12.64 72 50579 24590 34881690
Weight increased 14.15 12.64 201 50450 92832 34813448
Biliary catheter insertion 14.13 12.64 5 50646 72 34906208
Thoracotomy 14.13 12.64 5 50646 72 34906208
Systemic scleroderma 14.10 12.64 8 50643 365 34905915
Hypoglycaemia 14.04 12.64 37 50614 54603 34851677
Blood pressure systolic increased 13.86 12.64 8 50643 22944 34883336
Colour blindness 13.86 12.64 7 50644 252 34906028
Catheter site swelling 13.84 12.64 8 50643 378 34905902
Gastrointestinal cancer metastatic 13.82 12.64 5 50646 77 34906203
Sinus tachycardia 13.80 12.64 4 50647 17356 34888924
Spinal operation 13.65 12.64 19 50632 2925 34903355
Electrocardiogram QT prolonged 13.63 12.64 24 50627 40928 34865352
Systolic hypertension 13.44 12.64 7 50644 269 34906011
Therapy interrupted 13.37 12.64 47 50604 13650 34892630
Immunoglobulin therapy 13.33 12.64 3 50648 6 34906274
Drug ineffective for unapproved indication 13.31 12.64 9 50642 23706 34882574
Abdominal cavity drainage 13.31 12.64 8 50643 407 34905873
Obstructive airways disorder 13.31 12.64 51 50600 15443 34890837
Diuretic therapy 13.20 12.64 4 50647 34 34906246
Hepatocellular injury 13.05 12.64 8 50643 22203 34884077
Hepatic function abnormal 13.02 12.64 28 50623 44335 34861945
Drug ineffective 12.96 12.64 536 50115 456215 34450065
Urethral haemorrhage 12.94 12.64 8 50643 428 34905852
Sleep apnoea syndrome 12.89 12.64 61 50590 20260 34886020
Therapy non-responder 12.88 12.64 99 50552 39047 34867233
Infusion site cellulitis 12.76 12.64 5 50646 97 34906183
Catheter site extravasation 12.76 12.64 5 50646 97 34906183
Presyncope 12.66 12.64 58 50593 19001 34887279

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 2004.60 12.25 4292 123557 852733 78763806
Pulmonary arterial hypertension 1998.17 12.25 954 126895 27412 79589127
Pain in jaw 1914.74 12.25 1088 126761 45063 79571476
Fluid retention 1818.30 12.25 1223 126626 68586 79547953
Headache 1665.07 12.25 3395 124454 650377 78966162
Right ventricular failure 1147.10 12.25 617 127232 22880 79593659
Dyspnoea exertional 966.22 12.25 925 126924 86148 79530391
Pulmonary hypertension 965.21 12.25 719 127130 47361 79569178
Hypervolaemia 867.16 12.25 643 127206 42047 79574492
Flushing 859.07 12.25 873 126976 87395 79529144
Death 791.85 12.25 2341 125508 564173 79052366
Nasal congestion 620.23 12.25 687 127162 75865 79540674
Drug ineffective 573.65 12.25 536 127313 1080377 78536162
Catheter site erythema 569.81 12.25 239 127610 5001 79611538
Diarrhoea 553.74 12.25 2824 125025 877665 78738874
Transfusion 552.91 12.25 373 127476 20957 79595582
Infusion site pain 533.57 12.25 314 127535 13862 79602677
Oxygen saturation decreased 488.85 12.25 799 127050 128248 79488291
Catheter management 476.58 12.25 190 127659 3473 79613066
Hospitalisation 462.26 12.25 658 127191 93578 79522961
Device related infection 461.20 12.25 406 127443 33888 79582651
Catheter site pain 443.22 12.25 202 127647 5194 79611345
Oedema 428.20 12.25 722 127127 118858 79497681
Lung transplant 378.58 12.25 172 127677 4389 79612150
Catheter site pruritus 373.43 12.25 140 127709 2151 79614388
Catheter site discharge 359.26 12.25 138 127711 2274 79614265
Toxicity to various agents 358.40 12.25 115 127734 421425 79195114
Catheterisation cardiac 326.68 12.25 167 127682 5561 79610978
Vascular device infection 313.41 12.25 199 127650 10077 79606462
Syncope 300.75 12.25 794 127055 178655 79437884
Infusion related reaction 297.23 12.25 18 127831 230219 79386320
Dizziness 294.60 12.25 1638 126211 524803 79091736
Myalgia 278.79 12.25 789 127060 184852 79431687
Febrile neutropenia 278.42 12.25 25 127824 230974 79385565
Unevaluable event 278.16 12.25 392 127457 55193 79561346
Oxygen consumption increased 277.69 12.25 143 127706 4836 79611703
Catheter placement 275.12 12.25 121 127728 2853 79613686
Pulmonary arterial pressure increased 272.02 12.25 137 127712 4418 79612121
Infusion site infection 269.20 12.25 103 127746 1678 79614861
Palpitations 254.97 12.25 601 127248 126009 79490530
Infusion site erythema 253.69 12.25 169 127680 9291 79607248
Oedema peripheral 253.23 12.25 934 126915 251354 79365185
Chest pain 252.93 12.25 1008 126841 281296 79335243
Therapy change 250.17 12.25 153 127696 7246 79609293
Cardiac failure 247.15 12.25 673 127176 154169 79462370
Drug interaction 243.39 12.25 186 127663 414997 79201542
Catheter site infection 241.30 12.25 145 127704 6650 79609889
Off label use 231.76 12.25 718 127131 906497 78710042
Neutropenia 229.69 12.25 87 127762 287623 79328916
Concomitant disease aggravated 224.85 12.25 179 127670 12988 79603551
Rheumatoid arthritis 216.14 12.25 37 127812 208433 79408106
Cough 215.35 12.25 1157 126692 365632 79250907
Synovitis 213.71 12.25 6 127843 150728 79465811
Transplant evaluation 196.62 12.25 81 127768 1616 79614923
Device alarm issue 196.50 12.25 86 127763 2003 79614536
Malaise 194.41 12.25 1397 126452 488472 79128067
Scleroderma 194.16 12.25 117 127732 5393 79611146
Device leakage 192.72 12.25 151 127698 10705 79605834
Nausea 189.11 12.25 2351 125498 954845 78661694
Acute kidney injury 188.23 12.25 341 127508 519063 79097476
Catheter site rash 188.12 12.25 68 127781 937 79615602
Device occlusion 185.06 12.25 153 127696 11713 79604826
Central venous catheterisation 184.98 12.25 95 127754 3194 79613345
Therapeutic product effect decreased 183.92 12.25 23 127826 163840 79452699
Pain in extremity 182.41 12.25 1102 126747 363436 79253103
Product use in unapproved indication 181.75 12.25 87 127762 250272 79366267
Arthropathy 180.17 12.25 33 127816 177078 79439461
Alopecia 179.60 12.25 73 127776 231282 79385257
Product dose omission issue 179.27 12.25 829 127020 246708 79369831
Completed suicide 179.03 12.25 85 127764 245682 79370857
Catheter site haemorrhage 178.62 12.25 108 127741 5009 79611530
Contraindicated product administered 177.08 12.25 22 127827 157516 79459023
Dermatitis contact 171.52 12.25 142 127707 10891 79605648
Drug hypersensitivity 169.89 12.25 138 127711 298778 79317761
Treatment failure 168.69 12.25 34 127815 170452 79446087
Device dislocation 166.72 12.25 207 127642 25763 79590776
Hypoxia 160.92 12.25 445 127404 102798 79513741
Brain natriuretic peptide increased 154.12 12.25 122 127727 8778 79607761
Malignant neoplasm progression 152.82 12.25 19 127830 135971 79480568
Catheter site swelling 150.76 12.25 69 127780 1791 79614748
Pneumonia 150.05 12.25 1667 126182 658579 78957960
Therapeutic product effect incomplete 147.09 12.25 25 127824 141620 79474919
Pulmonary oedema 146.14 12.25 389 127460 87865 79528674
Feeling abnormal 145.21 12.25 572 127277 158627 79457912
Infusion site discharge 143.00 12.25 49 127800 571 79615968
Infusion site swelling 139.23 12.25 109 127740 7717 79608822
Drug abuse 135.19 12.25 46 127803 162645 79453894
Thrombocytopenia 134.55 12.25 136 127713 265123 79351416
Stomatitis 129.99 12.25 37 127812 146720 79469819
Complication associated with device 129.60 12.25 150 127699 17346 79599193
Glossodynia 122.27 12.25 12 127837 103325 79513214
Epistaxis 122.03 12.25 425 127424 111090 79505449
Device infusion issue 121.68 12.25 64 127785 2262 79614277
Joint swelling 119.88 12.25 173 127676 288473 79328066
Hepatic enzyme increased 118.57 12.25 73 127776 182537 79434002
Catheter site irritation 118.06 12.25 42 127807 551 79615988
Pulmonary veno-occlusive disease 117.66 12.25 56 127793 1592 79614947
Rash 117.30 12.25 503 127346 577855 79038684
Catheter site inflammation 117.24 12.25 50 127799 1091 79615448
Hypotension 116.93 12.25 1148 126701 439169 79177370
Maternal exposure during pregnancy 116.26 12.25 37 127812 136501 79480038
Infusion site haemorrhage 115.83 12.25 73 127776 3647 79612892
Pericarditis 113.67 12.25 16 127833 104220 79512319
Musculoskeletal stiffness 112.19 12.25 71 127778 174937 79441602
Leukopenia 111.62 12.25 25 127824 116488 79500051
Rhabdomyolysis 109.76 12.25 17 127832 103114 79513425
Abdominal distension 109.14 12.25 430 127419 119220 79497319
Drug intolerance 108.00 12.25 160 127689 263959 79352580
Catheter site vesicles 107.18 12.25 34 127815 305 79616234
Mucosal inflammation 107.13 12.25 3 127846 75577 79540962
Intentional product use issue 107.10 12.25 55 127794 152057 79464482
Cardiac disorder 105.98 12.25 287 127562 65470 79551069
Cardiac pacemaker insertion 105.55 12.25 82 127767 5740 79610799
Confusional state 102.75 12.25 223 127626 317774 79298765
Peripheral swelling 97.61 12.25 753 127096 268864 79347675
Presyncope 97.23 12.25 208 127641 40846 79575693
Pericardial effusion 96.82 12.25 223 127626 46014 79570525
Hypertension 96.63 12.25 245 127604 330747 79285792
Neutrophil count decreased 96.62 12.25 17 127832 93942 79522597
Device connection issue 91.67 12.25 41 127808 1007 79615532
Psoriatic arthropathy 89.84 12.25 10 127839 77989 79538550
Pancytopenia 88.63 12.25 81 127768 165664 79450875
Overdose 88.27 12.25 99 127750 184107 79432432
Injection site discharge 87.71 12.25 37 127812 785 79615754
C-reactive protein increased 87.39 12.25 49 127800 128978 79487561
Helicobacter infection 85.40 12.25 7 127842 69697 79546842
Lower respiratory tract infection 84.78 12.25 51 127798 129169 79487370
Walking distance test abnormal 84.74 12.25 35 127814 703 79615836
Haemoptysis 82.92 12.25 237 127612 55762 79560777
Drug reaction with eosinophilia and systemic symptoms 82.91 12.25 5 127844 64239 79552300
Anaphylactic reaction 82.18 12.25 17 127832 83726 79532813
Device related sepsis 82.10 12.25 73 127776 6167 79610372
Paracentesis 81.91 12.25 41 127808 1304 79615235
Ascites 80.93 12.25 286 127563 75276 79541263
Hypersensitivity 80.53 12.25 189 127660 262050 79354489
Cardiac failure congestive 79.15 12.25 443 127406 141959 79474580
Blood pressure decreased 78.53 12.25 342 127507 99124 79517415
Faeces soft 78.44 12.25 81 127768 8242 79608297
Heart rate increased 78.35 12.25 392 127457 120332 79496207
Discomfort 77.73 12.25 53 127796 125564 79490975
Hyponatraemia 77.39 12.25 103 127746 177745 79438794
Dyspnoea at rest 76.02 12.25 75 127774 7227 79609312
Folliculitis 75.65 12.25 3 127846 55377 79561162
Seizure 74.65 12.25 117 127732 188717 79427822
General physical health deterioration 73.33 12.25 213 127636 275025 79341514
Liver transplant 73.11 12.25 59 127790 4364 79612175
Blood cholesterol increased 72.49 12.25 22 127827 83698 79532841
Impaired healing 72.42 12.25 25 127824 87630 79528909
Bradycardia 71.58 12.25 67 127782 135490 79481049
Suicide attempt 71.43 12.25 22 127827 82910 79533629
Blood pressure systolic increased 71.37 12.25 11 127838 66975 79549564
Depressed level of consciousness 70.98 12.25 33 127816 96619 79519920
Cardiac operation 70.69 12.25 61 127788 4951 79611588
Infusion site warmth 70.38 12.25 38 127811 1417 79615122
Rash maculo-papular 67.69 12.25 6 127843 56072 79560467
Chest discomfort 66.11 12.25 413 127436 137631 79478908
White blood cell count decreased 65.90 12.25 126 127723 188162 79428377
Sinus congestion 65.69 12.25 116 127733 19780 79596759
Optic ischaemic neuropathy 65.51 12.25 47 127802 2914 79613625
Wound 65.47 12.25 54 127795 116125 79500414
Coma 64.25 12.25 41 127808 100608 79515931
Sedation 64.17 12.25 5 127844 51890 79564649
Urticaria 63.89 12.25 125 127724 185076 79431463
Device breakage 63.61 12.25 82 127767 10593 79605946
Oxygen therapy 63.37 12.25 45 127804 2745 79613794
Agitation 63.13 12.25 41 127808 99674 79516865
Pruritus 62.87 12.25 373 127476 394275 79222264
Cardiac ablation 62.22 12.25 41 127808 2212 79614327
Muscle injury 62.00 12.25 4 127845 48557 79567982
Electrocardiogram QT prolonged 61.67 12.25 34 127815 90352 79526187
Atrial flutter 61.23 12.25 118 127731 21507 79595032
Acute respiratory failure 60.89 12.25 222 127627 59319 79557220
Metabolic acidosis 60.87 12.25 28 127821 82501 79534038
Infusion site abscess 60.76 12.25 20 127829 204 79616335
Mobility decreased 60.35 12.25 64 127785 122111 79494428
Lactic acidosis 59.99 12.25 19 127830 70340 79546199
Osteoarthritis 59.34 12.25 33 127816 87276 79529263
Dialysis 58.85 12.25 106 127743 18356 79598183
Intentional overdose 58.78 12.25 50 127799 105910 79510629
Pulmonary arterial pressure abnormal 58.49 12.25 27 127822 715 79615824
Systemic lupus erythematosus 58.14 12.25 65 127784 121084 79495455
Bone marrow failure 57.74 12.25 7 127842 51100 79565439
Cognitive disorder 57.67 12.25 20 127829 69906 79546633
Disease complication 57.61 12.25 54 127795 4883 79611656
Blister 57.45 12.25 64 127785 119412 79497127
Sleep disorder due to general medical condition, insomnia type 57.41 12.25 3 127846 43553 79572986
Type 2 diabetes mellitus 57.29 12.25 11 127838 57111 79559428
Catheter site warmth 57.17 12.25 20 127829 249 79616290
Atrial septal defect repair 56.86 12.25 23 127826 437 79616102
Infusion site induration 55.90 12.25 30 127819 1105 79615434
Injection site infection 55.67 12.25 38 127811 2174 79614365
Vision blurred 55.26 12.25 324 127525 105574 79510965
Red blood cell sedimentation rate increased 55.22 12.25 5 127844 45937 79570602
Catheter removal 55.08 12.25 25 127824 636 79615903
Liver injury 54.51 12.25 12 127837 56602 79559937
Hyperkalaemia 54.22 12.25 62 127787 114336 79502203
Dizziness postural 54.15 12.25 79 127770 11470 79605069
Delirium 53.29 12.25 35 127814 84592 79531947
Right ventricular dilatation 53.07 12.25 35 127814 1891 79614648
Cytomegalovirus infection 53.03 12.25 4 127845 42640 79573899
Irritable bowel syndrome 52.73 12.25 17 127832 62224 79554315
Myelosuppression 52.41 12.25 3 127846 40293 79576246
Dizziness exertional 51.95 12.25 23 127826 551 79615988
Stent placement 51.85 12.25 58 127791 6462 79610077
Injury 51.65 12.25 30 127819 77466 79539073
Hypocalcaemia 51.39 12.25 9 127840 49915 79566624
Hallucination 50.65 12.25 38 127811 85707 79530832
Cardioversion 50.35 12.25 35 127814 2063 79614476
Infusion site pruritus 49.91 12.25 46 127803 4072 79612467
Cyanopsia 49.89 12.25 14 127835 78 79616461
Nasopharyngitis 49.83 12.25 624 127225 253257 79363282
Right ventricular dysfunction 49.70 12.25 38 127811 2597 79613942
Neoplasm progression 49.67 12.25 11 127838 51671 79564868
Fibromyalgia 48.75 12.25 21 127828 64319 79552220
Pulmonary hypertensive crisis 47.97 12.25 19 127830 341 79616198
Medical device change 47.90 12.25 21 127828 491 79616048
Product use issue 47.79 12.25 174 127675 209648 79406891
Psoriasis 47.61 12.25 44 127805 89543 79526996
Therapy non-responder 47.24 12.25 281 127568 92024 79524515
Respiratory failure 46.56 12.25 469 127380 180442 79436097
Chemotherapy 46.17 12.25 31 127818 1726 79614813
Emergency care 46.08 12.25 26 127823 1058 79615481
Aspiration pleural cavity 46.05 12.25 30 127819 1587 79614952
Cardiac failure high output 46.02 12.25 18 127831 312 79616227
Cardiac output increased 45.47 12.25 17 127832 259 79616280
Infusion site irritation 45.42 12.25 23 127826 750 79615789
Condition aggravated 45.03 12.25 1086 126763 500038 79116501
Loss of consciousness 44.97 12.25 439 127410 167504 79449035
Drug resistance 44.81 12.25 7 127842 42206 79574333
Angioedema 44.52 12.25 34 127815 76001 79540538
Hyperglycaemia 44.41 12.25 29 127820 70306 79546233
Drug titration error 44.40 12.25 26 127823 1136 79615403
Abdominal cavity drainage 43.88 12.25 23 127826 807 79615732
Intentional product misuse 43.57 12.25 53 127796 95112 79521427
Blood creatine phosphokinase increased 43.45 12.25 26 127823 66064 79550475
Extra dose administered 43.04 12.25 60 127789 8355 79608184
Left ventricular failure 42.70 12.25 64 127785 9517 79607022
Thrombosis in device 42.57 12.25 48 127801 5394 79611145
Exercise tolerance decreased 42.45 12.25 62 127787 9009 79607530
Blood iron decreased 42.21 12.25 83 127766 15351 79601188
Throat irritation 42.14 12.25 153 127696 40793 79575746
Hepatocellular injury 42.12 12.25 12 127837 47581 79568958
Lymphocyte count decreased 41.71 12.25 12 127837 47277 79569262
Inappropriate schedule of product administration 41.23 12.25 96 127753 133532 79483007
Systemic scleroderma 41.10 12.25 25 127824 1172 79615367
Hepatitis 40.95 12.25 19 127830 55708 79560831
Blood lactate dehydrogenase increased 40.45 12.25 7 127842 39163 79577376
Deafness unilateral 40.31 12.25 41 127808 4097 79612442
Suicidal ideation 39.97 12.25 38 127811 76302 79540237
Renal disorder 39.73 12.25 153 127696 41952 79574587
Deep vein thrombosis 39.66 12.25 84 127765 120835 79495704
Heart and lung transplant 39.33 12.25 14 127835 184 79616355
Disease progression 39.14 12.25 460 127389 183902 79432637
Tubulointerstitial nephritis 39.12 12.25 7 127842 38228 79578311
Blood pressure increased 39.02 12.25 190 127659 211170 79405369
Back pain 38.70 12.25 694 127155 303486 79313053
Pneumonitis 38.55 12.25 25 127824 60835 79555704
Head discomfort 38.47 12.25 77 127772 14425 79602114
Device issue 38.46 12.25 113 127736 26995 79589544
Catheter site related reaction 38.09 12.25 24 127825 1198 79615341
Gout 37.86 12.25 106 127743 24643 79591896
Neuropathy peripheral 37.86 12.25 109 127740 141196 79475343
Asthma 37.83 12.25 102 127747 134993 79481546
Psychotic disorder 37.46 12.25 10 127839 41392 79575147
Dysarthria 37.39 12.25 32 127817 67590 79548949
Eosinophilia 37.34 12.25 13 127836 45332 79571207
Medication error 37.33 12.25 33 127816 68609 79547930
Body temperature decreased 37.32 12.25 4 127845 32141 79584398
Hypoglycaemia 37.29 12.25 66 127783 101528 79515011
Mouth ulceration 37.24 12.25 8 127841 38386 79578153
Device physical property issue 37.08 12.25 32 127817 2598 79613941
Catheterisation cardiac abnormal 37.03 12.25 15 127834 286 79616253
Treatment noncompliance 36.96 12.25 174 127675 52094 79564445
Agranulocytosis 36.92 12.25 13 127836 45017 79571522
Injection site bruising 36.92 12.25 10 127839 40992 79575547
Exposure during pregnancy 36.85 12.25 66 127783 101066 79515473
Injection site reaction 36.80 12.25 21 127828 54764 79561775
Blood potassium decreased 36.75 12.25 160 127689 46352 79570187
Seasonal allergy 36.42 12.25 81 127768 16325 79600214
Osteonecrosis of jaw 36.27 12.25 12 127837 43214 79573325
Fatigue 36.26 12.25 1829 126020 927898 78688641
Neutrophil count increased 35.87 12.25 3 127846 29393 79587146
Multiple organ dysfunction syndrome 35.81 12.25 88 127761 120158 79496381
Bursitis 35.74 12.25 7 127842 35837 79580702
Hallucination, visual 35.73 12.25 5 127844 32724 79583815
Dyspepsia 35.68 12.25 297 127552 108390 79508149
Viral infection 35.55 12.25 150 127699 42866 79573673
Iron deficiency anaemia 35.45 12.25 106 127743 25566 79590973
Drug ineffective for unapproved indication 35.35 12.25 19 127830 51219 79565320
Infusion site rash 35.34 12.25 26 127823 1676 79614863
Intentional self-injury 35.28 12.25 5 127844 32414 79584125
Inflammation 35.24 12.25 60 127789 93693 79522846
Internal haemorrhage 35.16 12.25 56 127793 8777 79607762
Product prescribing error 34.96 12.25 14 127835 44799 79571740
Pulmonary arterial wedge pressure increased 34.94 12.25 17 127832 508 79616031
Tremor 34.92 12.25 147 127702 169936 79446603
Cor pulmonale 34.85 12.25 29 127820 2239 79614300
Atrial septal defect 34.69 12.25 27 127822 1895 79614644
Hypomagnesaemia 34.46 12.25 16 127833 46895 79569644
Hypokalaemia 34.43 12.25 117 127732 143923 79472616
Nocturnal dyspnoea 34.13 12.25 25 127824 1601 79614938
Fracture of penis 34.11 12.25 12 127837 152 79616387
Hot flush 34.04 12.25 176 127673 54701 79561838
Application site pruritus 33.97 12.25 36 127813 3774 79612765
Hospice care 33.83 12.25 60 127789 10264 79606275
Influenza 33.81 12.25 337 127512 129269 79487270
Pulmonary congestion 33.81 12.25 108 127741 26992 79589547
Productive cough 33.75 12.25 250 127599 88081 79528458
Aggression 33.57 12.25 20 127829 50938 79565601
Infusion site cellulitis 33.45 12.25 14 127835 291 79616248
Catheter site scab 33.41 12.25 13 127836 222 79616317
Product administration interrupted 33.28 12.25 36 127813 3863 79612676
Gastritis hypertrophic 33.22 12.25 9 127840 43 79616496
Rehabilitation therapy 33.08 12.25 26 127823 1851 79614688
Catheter site discolouration 33.00 12.25 11 127838 117 79616422
Stevens-Johnson syndrome 32.64 12.25 11 127838 39155 79577384
Hepatic cytolysis 32.51 12.25 3 127846 27148 79589391
Swollen tongue 32.08 12.25 14 127835 42556 79573983
Cytokine release syndrome 32.00 12.25 9 127840 35989 79580550
Disorientation 32.00 12.25 32 127817 62744 79553795
Palmar-plantar erythrodysaesthesia syndrome 31.94 12.25 7 127842 33127 79583412
Osteoporosis 31.93 12.25 24 127825 54088 79562451
Therapy cessation 31.83 12.25 132 127717 37430 79579109
Terminal state 31.42 12.25 39 127810 4850 79611689
Drug dependence 31.38 12.25 13 127836 40756 79575783
Blood glucose increased 31.30 12.25 88 127761 114887 79501652
Inappropriate antidiuretic hormone secretion 31.26 12.25 3 127846 26310 79590229
Posterior reversible encephalopathy syndrome 31.21 12.25 3 127846 26278 79590261
Dysentery 31.09 12.25 21 127828 1181 79615358
Acute myeloid leukaemia 30.86 12.25 6 127843 30879 79585660
Priapism 30.67 12.25 37 127812 4468 79612071
Incorrect route of product administration 30.56 12.25 9 127840 34920 79581619
Depression 30.34 12.25 213 127636 216577 79399962
Migraine 30.29 12.25 242 127607 87251 79529288
Right ventricular systolic pressure increased 30.26 12.25 19 127830 943 79615596
Milk-alkali syndrome 30.18 12.25 22 127827 1398 79615141
Oxygen saturation abnormal 30.17 12.25 37 127812 4545 79611994
Mineral supplementation 30.02 12.25 18 127831 822 79615717
Cholecystectomy 29.86 12.25 54 127795 9378 79607161
Localised oedema 29.73 12.25 49 127800 7903 79608636
Contusion 29.67 12.25 130 127719 148646 79467893
Multiple sclerosis relapse 29.63 12.25 19 127830 46514 79570025
Somnolence 29.57 12.25 243 127606 238738 79377801
Upper respiratory tract congestion 29.47 12.25 28 127821 2575 79613964
Prescribed overdose 29.29 12.25 12 127837 37871 79578668
Right-to-left cardiac shunt 29.10 12.25 12 127837 240 79616299
N-terminal prohormone brain natriuretic peptide increased 29.08 12.25 37 127812 4718 79611821
Obesity 29.04 12.25 10 127839 35115 79581424
Infusion site oedema 28.82 12.25 18 127831 885 79615654
Hernia repair 28.72 12.25 25 127824 2053 79614486
Infusion site inflammation 28.53 12.25 13 127836 334 79616205
Myoclonus 28.44 12.25 5 127844 27655 79588884
Cholestasis 28.39 12.25 25 127824 52084 79564455
Lymphopenia 28.38 12.25 7 127842 30550 79585989
Scleroderma associated digital ulcer 28.15 12.25 7 127842 22 79616517
Mechanical ventilation 28.05 12.25 28 127821 2736 79613803
Sinus tachycardia 28.03 12.25 12 127837 36896 79579643
Drug eruption 27.89 12.25 18 127831 43917 79572622
Altered state of consciousness 27.76 12.25 18 127831 43804 79572735
Pulmonary artery dilatation 27.69 12.25 14 127835 455 79616084
Pleural effusion 27.60 12.25 355 127494 144907 79471632
Erection increased 27.40 12.25 13 127836 367 79616172
Paraesthesia 27.32 12.25 168 127681 176155 79440384
Poisoning 27.26 12.25 4 127845 25268 79591271
Blood pressure fluctuation 27.09 12.25 41 127808 67104 79549435
Drug-induced liver injury 27.04 12.25 40 127809 66077 79550462
Vasculitis 27.02 12.25 4 127845 25098 79591441
Injection site pain 26.78 12.25 112 127737 129726 79486813
Ear congestion 26.77 12.25 28 127821 2891 79613648
Skin lesion 26.76 12.25 17 127832 41827 79574712
Disease recurrence 26.76 12.25 19 127830 44090 79572449
Catheter site dermatitis 26.57 12.25 9 127840 101 79616438
Infusion site vesicles 26.28 12.25 14 127835 508 79616031
Ventilation perfusion mismatch 26.26 12.25 15 127834 625 79615914
Respiratory syncytial virus infection 26.24 12.25 51 127798 9351 79607188
Catheter site erosion 26.13 12.25 8 127841 63 79616476
Abdominal pain upper 26.13 12.25 504 127345 223315 79393224
Concomitant disease progression 26.10 12.25 30 127819 3443 79613096
Heart valve replacement 25.97 12.25 17 127832 907 79615632
Obstructive airways disorder 25.93 12.25 9 127840 31450 79585089
Creatinine renal clearance abnormal 25.91 12.25 14 127835 523 79616016
Diabetes mellitus inadequate control 25.81 12.25 4 127845 24260 79592279
Metapneumovirus infection 25.75 12.25 22 127827 1762 79614777
Gastroenteritis viral 25.73 12.25 93 127756 24738 79591801
Chronic obstructive pulmonary disease 25.72 12.25 229 127620 85190 79531349
Infusion site nodule 25.58 12.25 12 127837 330 79616209
Encephalopathy 25.45 12.25 43 127806 67354 79549185
Anaphylactic shock 25.34 12.25 13 127836 35983 79580556
Withdrawal syndrome 25.24 12.25 6 127843 26848 79589691
Abortion spontaneous 25.10 12.25 8 127841 29499 79587040
Catheter site extravasation 25.07 12.25 13 127836 446 79616093
Dyskinesia 24.98 12.25 21 127828 44752 79571787
Sinus disorder 24.88 12.25 86 127763 22378 79594161
Cardiac flutter 24.86 12.25 35 127814 4919 79611620
Infusion site discolouration 24.84 12.25 15 127834 694 79615845
Pulmonary embolism 24.83 12.25 167 127682 171487 79445052
Multiple allergies 24.76 12.25 53 127796 10407 79606132
Bronchitis 24.70 12.25 319 127530 130325 79486214
Transaminases increased 24.56 12.25 28 127821 51715 79564824
Immunodeficiency 24.54 12.25 3 127846 21765 79594774
Emotional distress 24.53 12.25 17 127832 39952 79576587
Myocarditis 24.49 12.25 3 127846 21730 79594809
Diabetes mellitus 24.43 12.25 56 127793 78334 79538205
Diuretic therapy 24.30 12.25 10 127839 199 79616340
Central venous catheter removal 24.05 12.25 13 127836 486 79616053
Haematopoietic stem cell mobilisation 23.98 12.25 10 127839 206 79616333
Osteonecrosis 23.79 12.25 10 127839 31085 79585454
Ejection fraction decreased 23.59 12.25 13 127836 34564 79581975
Polyneuropathy 23.49 12.25 5 127844 24146 79592393
Joint range of motion decreased 23.46 12.25 12 127837 33270 79583269
Loss of personal independence in daily activities 23.38 12.25 85 127764 102495 79514044
Ear discomfort 23.28 12.25 46 127803 8537 79608002
Pulmonary artery aneurysm 23.22 12.25 9 127840 152 79616387
Paranasal sinus discomfort 23.13 12.25 32 127817 4424 79612115
Catheter culture positive 23.00 12.25 10 127839 229 79616310
Plasma cell myeloma 22.99 12.25 31 127818 53228 79563311
Joint stiffness 22.97 12.25 19 127830 40811 79575728
Weight decreased 22.90 12.25 738 127111 354460 79262079
Drug level increased 22.87 12.25 18 127831 39633 79576906
Orthopnoea 22.66 12.25 50 127799 10023 79606516
Accidental exposure to product 22.52 12.25 11 127838 31311 79585228
Pulmonary capillary haemangiomatosis 22.35 12.25 7 127842 60 79616479
Catheter site mass 22.35 12.25 7 127842 60 79616479
Haemophagocytic lymphohistiocytosis 22.34 12.25 4 127845 21833 79594706
Life support 22.19 12.25 12 127837 449 79616090
Acute right ventricular failure 21.97 12.25 11 127838 350 79616189
Female sterilisation 21.94 12.25 10 127839 257 79616282
Atrial fibrillation 21.88 12.25 442 127407 197444 79419095
Acute respiratory distress syndrome 21.85 12.25 23 127826 44044 79572495
Haematospermia 21.83 12.25 10 127839 260 79616279
Intracardiac pressure increased 21.76 12.25 6 127843 31 79616508
CREST syndrome 21.76 12.25 12 127837 467 79616072
Cardiothoracic ratio increased 21.66 12.25 7 127842 67 79616472
Blood calcium decreased 21.65 12.25 12 127837 31807 79584732
Colitis 21.55 12.25 54 127795 73253 79543286
Sinus bradycardia 21.20 12.25 7 127842 25240 79591299
Transplant rejection 21.14 12.25 3 127846 19434 79597105
Platelet count increased 21.07 12.25 5 127844 22401 79594138
Hepatic cirrhosis 20.99 12.25 111 127738 34795 79581744
Respiratory depression 20.96 12.25 9 127840 27621 79588918
Toxic skin eruption 20.91 12.25 5 127844 22288 79594251
Haematuria 20.79 12.25 50 127799 68786 79547753
Arthritis 20.77 12.25 104 127745 114776 79501763
Weight increased 20.74 12.25 587 127262 276799 79339740
Oral herpes 20.73 12.25 9 127840 27445 79589094
Septic shock 20.62 12.25 114 127735 122687 79493852
Progressive multifocal leukoencephalopathy 20.59 12.25 4 127845 20596 79595943
Eczema 20.58 12.25 21 127828 40797 79575742
COVID-19 20.57 12.25 158 127691 157516 79459023
Muscle twitching 20.56 12.25 7 127842 24757 79591782
Mitral valve replacement 20.55 12.25 11 127838 403 79616136
Systemic sclerosis pulmonary 20.53 12.25 5 127844 14 79616525
Wrong technique in product usage process 20.51 12.25 56 127793 73819 79542720
Rhinorrhoea 20.41 12.25 199 127650 75875 79540664
Primary biliary cholangitis 20.36 12.25 16 127833 1139 79615400
Grip strength decreased 20.33 12.25 5 127844 21864 79594675
Device malfunction 20.28 12.25 78 127771 21370 79595169
Cytopenia 20.28 12.25 4 127845 20379 79596160
Right ventricular enlargement 20.26 12.25 13 127836 670 79615869
Therapeutic procedure 20.22 12.25 14 127835 820 79615719
Transplant 20.04 12.25 15 127834 993 79615546
Subcutaneous drug absorption impaired 20.04 12.25 5 127844 16 79616523
Colon operation 20.02 12.25 11 127838 425 79616114
Sluggishness 20.01 12.25 37 127812 6535 79610004
Dyschromatopsia 19.87 12.25 14 127835 843 79615696
Vomiting 19.87 12.25 1279 126570 664549 78951990
Feeling cold 19.84 12.25 95 127754 28634 79587905
Application site hypersensitivity 19.81 12.25 10 127839 324 79616215
Muscle spasticity 19.79 12.25 5 127844 21470 79595069
Disseminated intravascular coagulation 19.77 12.25 17 127832 35825 79580714
Cardio-respiratory arrest 19.75 12.25 98 127751 108412 79508127
Erectile dysfunction 19.73 12.25 60 127789 14604 79601935
Proteinuria 19.71 12.25 14 127835 32488 79584051
Osteopenia 19.59 12.25 3 127846 18361 79598178
Acute hepatic failure 19.58 12.25 12 127837 30101 79586438
Epilepsy 19.51 12.25 22 127827 40838 79575701
Vascular cauterisation 19.46 12.25 7 127842 95 79616444
Labelled drug-drug interaction medication error 19.44 12.25 10 127839 27640 79588899
Decreased activity 19.38 12.25 43 127806 8651 79607888
Gastric ischaemia 19.37 12.25 5 127844 19 79616520
Clostridium difficile infection 19.36 12.25 126 127723 42559 79573980
Poor venous access 19.28 12.25 3 127846 18146 79598393
Pregnancy test positive 19.20 12.25 7 127842 99 79616440
Skin necrosis 19.20 12.25 3 127846 18084 79598455
Hyperthermia 19.12 12.25 3 127846 18034 79598505
Bronchopulmonary aspergillosis 19.04 12.25 6 127843 22288 79594251
Ill-defined disorder 19.00 12.25 49 127800 65826 79550713
Catheter site nodule 18.99 12.25 6 127843 53 79616486
Product quality issue 18.84 12.25 16 127833 33924 79582615
Wrong dose 18.76 12.25 18 127831 1676 79614863
Cardiac pacemaker replacement 18.76 12.25 11 127838 482 79616057
Blood testosterone decreased 18.65 12.25 21 127828 2356 79614183
Bone disorder 18.50 12.25 4 127845 19109 79597430
Nervous system disorder 18.46 12.25 10 127839 26846 79589693
Alanine aminotransferase increased 18.45 12.25 169 127680 162401 79454138
Hypoaesthesia 18.44 12.25 191 127658 179161 79437378
Pancreatitis acute 18.40 12.25 32 127817 49572 79566967
Delusion 18.35 12.25 5 127844 20418 79596121
Nephropathy toxic 18.34 12.25 5 127844 20414 79596125
Balloon atrial septostomy 18.24 12.25 7 127842 115 79616424
Cardiac resynchronisation therapy 18.07 12.25 6 127843 63 79616476
Bendopnoea 17.95 12.25 5 127844 27 79616512
N-terminal prohormone brain natriuretic peptide 17.74 12.25 6 127843 67 79616472
Cancer surgery 17.70 12.25 13 127836 836 79615703
Polypectomy 17.69 12.25 15 127834 1189 79615350
Adrenal insufficiency 17.64 12.25 12 127837 28475 79588064
Cor pulmonale acute 17.62 12.25 12 127837 684 79615855
Blood triglycerides increased 17.38 12.25 6 127843 21034 79595505
Prophylaxis 17.37 12.25 4 127845 8 79616531
First bite syndrome 17.37 12.25 5 127844 31 79616508
Heart valve operation 17.36 12.25 8 127841 211 79616328
Multiple sclerosis 17.32 12.25 7 127842 22275 79594264
Pulmonary pain 17.31 12.25 28 127821 4445 79612094
Catheter site urticaria 17.23 12.25 5 127844 32 79616507
Myelodysplastic syndrome 17.17 12.25 14 127835 30287 79586252
Arthralgia 17.10 12.25 746 127103 571057 79045482
Product substitution issue 17.02 12.25 71 127778 20185 79596354
Jugular vein distension 17.00 12.25 16 127833 1454 79615085
Patient-device incompatibility 16.97 12.25 7 127842 140 79616399
Tracheostomy 16.97 12.25 15 127834 1257 79615282
Medical procedure 16.96 12.25 9 127840 324 79616215
Pericardial drainage 16.95 12.25 10 127839 443 79616096
Pulmonary vein occlusion 16.88 12.25 7 127842 142 79616397
Blood creatinine increased 16.83 12.25 163 127686 154894 79461645
Respiratory tract congestion 16.81 12.25 70 127779 19884 79596655
Infusion site dermatitis 16.75 12.25 4 127845 10 79616529
Hypothyroidism 16.67 12.25 37 127812 52355 79564184
Skin exfoliation 16.66 12.25 40 127809 55060 79561479
Oropharyngeal pain 16.64 12.25 257 127592 109096 79507443
Coagulopathy 16.53 12.25 20 127829 35986 79580553
Vascular device occlusion 16.49 12.25 9 127840 343 79616196
Application site irritation 16.48 12.25 17 127832 1727 79614812
Arteriovenous malformation 16.34 12.25 17 127832 1744 79614795
Drug withdrawal syndrome 16.24 12.25 19 127830 34699 79581840
Thrombotic microangiopathy 16.23 12.25 6 127843 20163 79596376
Mastectomy 16.21 12.25 14 127835 1138 79615401
Lung disorder 16.20 12.25 199 127650 80358 79536181
Head injury 16.16 12.25 109 127740 37260 79579279
Decreased appetite 16.13 12.25 687 127162 341731 79274808
Hyperhidrosis 16.12 12.25 160 127689 151332 79465207
Orthostatic hypotension 16.02 12.25 42 127807 56122 79560417
Therapeutic embolisation 15.98 12.25 10 127839 493 79616046
Hip fracture 15.96 12.25 94 127755 30667 79585872
Hypophosphataemia 15.90 12.25 6 127843 19907 79596632
Basal cell carcinoma 15.88 12.25 22 127827 37353 79579186
Biopsy bone marrow 15.87 12.25 9 127840 370 79616169
Bedridden 15.86 12.25 49 127800 12030 79604509
Klebsiella infection 15.82 12.25 3 127846 15717 79600822
Pulmonary haemosiderosis 15.76 12.25 4 127845 14 79616525
Intentional dose omission 15.75 12.25 40 127809 8777 79607762
Brain operation 15.74 12.25 11 127838 654 79615885
Infection 15.61 12.25 283 127566 241429 79375110
Platelet transfusion 15.56 12.25 19 127830 2323 79614216
Cataract operation 15.55 12.25 29 127820 5156 79611383
Hepatopulmonary syndrome 15.46 12.25 5 127844 48 79616491
Hypertensive crisis 15.39 12.25 7 127842 20763 79595776
Pericardial excision 15.37 12.25 5 127844 49 79616490
Uveitis 15.35 12.25 4 127845 16826 79599713
Colitis ischaemic 15.31 12.25 3 127846 15356 79601183
Uterine haemorrhage 15.30 12.25 21 127828 2882 79613657
Flatulence 15.24 12.25 119 127730 42605 79573934
Colitis ulcerative 15.22 12.25 20 127829 34722 79581817
Catheter site induration 15.19 12.25 5 127844 51 79616488
Anorgasmia 15.18 12.25 14 127835 1240 79615299
Right atrial pressure increased 15.18 12.25 8 127841 284 79616255
Infusion site pustule 15.10 12.25 5 127844 52 79616487
Middle ear effusion 15.10 12.25 19 127830 2396 79614143
Endotracheal intubation 15.01 12.25 27 127822 4670 79611869
White blood cell count increased 15.00 12.25 65 127784 74568 79541971
Urinary retention 14.93 12.25 44 127805 56586 79559953
Aspergillus infection 14.92 12.25 6 127843 19155 79597384
Graft versus host disease 14.84 12.25 3 127846 15023 79601516
Therapeutic response decreased 14.84 12.25 56 127793 66797 79549742
Generalised tonic-clonic seizure 14.82 12.25 30 127819 43880 79572659
Mitral perforation 14.78 12.25 4 127845 19 79616520
Insulin autoimmune syndrome 14.77 12.25 9 127840 423 79616116
Thoracotomy 14.74 12.25 6 127843 116 79616423
Diet noncompliance 14.73 12.25 10 127839 567 79615972
Peritonitis 14.62 12.25 14 127835 28022 79588517
Diabetic ketoacidosis 14.59 12.25 20 127829 34102 79582437
Gallbladder operation 14.53 12.25 17 127832 1988 79614551
Shock 14.48 12.25 30 127819 43518 79573021
Tinnitus 14.46 12.25 121 127728 44212 79572327
Dialysis device insertion 14.31 12.25 5 127844 62 79616477
Blood culture negative 14.30 12.25 7 127842 212 79616327
Herpes zoster 14.25 12.25 89 127760 92994 79523545
Infusion site lymphadenopathy 14.24 12.25 3 127846 3 79616536
Catheter site exfoliation 14.24 12.25 3 127846 3 79616536
Vocal cord operation 14.24 12.25 3 127846 3 79616536
Spontaneous penile erection 14.24 12.25 6 127843 127 79616412
Oral candidiasis 14.09 12.25 16 127833 29612 79586927
Pseudomonas infection 14.06 12.25 8 127841 20895 79595644
Therapeutic response shortened 14.04 12.25 4 127845 15859 79600680
Abnormal behaviour 13.97 12.25 23 127826 36398 79580141
Hypercholesterolaemia 13.94 12.25 10 127839 23085 79593454
Second primary malignancy 13.90 12.25 3 127846 14347 79602192
Catheter site cellulitis 13.85 12.25 9 127840 474 79616065
Gastrointestinal tube insertion 13.83 12.25 15 127834 1615 79614924
Purpura 13.82 12.25 7 127842 19520 79597019
Blood culture positive 13.78 12.25 37 127812 8392 79608147
Gastric disorder 13.76 12.25 105 127744 37328 79579211
Retching 13.73 12.25 60 127789 17407 79599132
Pulmonary alveolar haemorrhage 13.69 12.25 45 127804 11412 79605127
Pyrexia 13.66 12.25 921 126928 677788 78938751
Application site vesicles 13.54 12.25 14 127835 1426 79615113
Vena cava filter insertion 13.50 12.25 6 127843 145 79616394
Schizophrenia 13.47 12.25 4 127845 15436 79601103
Biliary catheter insertion 13.39 12.25 6 127843 148 79616391
Myositis 13.38 12.25 7 127842 19161 79597378
Skin irritation 13.30 12.25 44 127805 11196 79605343
Parkinsonism 13.24 12.25 5 127844 16579 79599960
Red cell distribution width increased 13.20 12.25 4 127845 15238 79601301
Injection site mass 13.18 12.25 8 127841 20176 79596363
Dermatitis 13.18 12.25 9 127840 21312 79595227
Endarterectomy 13.15 12.25 8 127841 375 79616164
Limb discomfort 13.13 12.25 94 127755 32756 79583783
Biopsy lung 13.04 12.25 7 127842 258 79616281
Erythema multiforme 12.99 12.25 6 127843 17645 79598894
Mydriasis 12.98 12.25 6 127843 17637 79598902
Metastases to bone 12.97 12.25 12 127837 24415 79592124
Hyperinsulinaemic hypoglycaemia 12.96 12.25 6 127843 160 79616379
Injection site pustule 12.76 12.25 5 127844 87 79616452
Anhedonia 12.74 12.25 4 127845 14894 79601645
Portopulmonary hypertension 12.72 12.25 6 127843 167 79616372
Immunoglobulin therapy 12.71 12.25 3 127846 7 79616532
Product counterfeit 12.68 12.25 7 127842 273 79616266
Acute myocardial infarction 12.66 12.25 72 127777 76964 79539575
Product supply issue 12.62 12.25 16 127833 2032 79614507
Oxygen consumption 12.61 12.25 5 127844 90 79616449
Hepatic steatosis 12.55 12.25 26 127823 37712 79578827
Respiration abnormal 12.55 12.25 34 127815 7754 79608785
Heart rate decreased 12.51 12.25 64 127785 70252 79546287
Product complaint 12.51 12.25 3 127846 13346 79603193
Gastric varices 12.49 12.25 10 127839 731 79615808
Intra-abdominal fluid collection 12.47 12.25 20 127829 3152 79613387
Ureteral disorder 12.46 12.25 9 127840 564 79615975
Device use error 12.46 12.25 32 127817 7069 79609470
Fracture 12.44 12.25 10 127839 21791 79594748
Akathisia 12.38 12.25 3 127846 13256 79603283
Thoracic cavity drainage 12.38 12.25 7 127842 286 79616253
Infusion site mass 12.37 12.25 14 127835 1579 79614960
Connective tissue disorder 12.37 12.25 13 127836 1350 79615189
Cardiac output decreased 12.36 12.25 15 127834 1823 79614716
Infusion site reaction 12.36 12.25 21 127828 3472 79613067
Diagnostic procedure 12.34 12.25 6 127843 179 79616360
Haemorrhoidal haemorrhage 12.32 12.25 31 127818 6764 79609775
Systemic-pulmonary artery shunt 12.31 12.25 4 127845 39 79616500
Disturbance in attention 12.31 12.25 41 127808 50760 79565779
Myopathy 12.29 12.25 9 127840 20554 79595985

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX52 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
ATC C02KX54 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
ATC G04BE08 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs used in erectile dysfunction
ATC G04CA54 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CB51 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Testosterone-5-alpha reductase inhibitors
FDA MoA N0000020026 Phosphodiesterase 5 Inhibitors
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D058986 Phosphodiesterase 5 Inhibitors
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D064804 Urological Agents
MeSH PA D014665 Vasodilator Agents
FDA EPC N0000175599 Phosphodiesterase 5 Inhibitor
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:71942 PDE5 inhibitor

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

DiseaseRelationSNOMED_IDDOID
Pulmonary hypertension indication 70995007 DOID:6432
Benign prostatic hyperplasia indication 266569009
Impotence indication 397803000
Induratio penis plastica contraindication 1335005 DOID:8616
Priapism contraindication 6273006 DOID:9286
Hearing loss contraindication 15188001
Myocardial infarction contraindication 22298006 DOID:5844
Alcohol intoxication contraindication 25702006
Fibrosis of corpus cavernosum contraindication 32608004
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Aortic valve stenosis contraindication 60573004 DOID:1712
Blood coagulation disorder contraindication 64779008 DOID:1247
Leukemia, disease contraindication 93143009 DOID:1240
Multiple myeloma contraindication 109989006 DOID:9538
Hb SS disease contraindication 127040003 DOID:10923
Seizure disorder contraindication 128613002
Acute peptic ulcer contraindication 196682000
Cerebrovascular accident contraindication 230690007
Penis bent contraindication 249247007
Exercise-induced angina contraindication 300995000
Functional visual loss contraindication 313165001
Idiopathic hypertrophic subaortic stenosis contraindication 360465008
Acute coronary syndrome contraindication 394659003
Anterior ischemic optic neuropathy contraindication 404659001
Hypertensive urgency contraindication 443482000
Pigmentary Retinopathy contraindication
Severe Autonomic Insufficiency contraindication
Life-Threatening Cardiac Arrhythmias contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.3 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
20MG/5ML TADLIQ CMP DEV LLC N214522 June 17, 2022 RX SUSPENSION ORAL 11382917 Dec. 24, 2038 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML TADLIQ CMP DEV LLC N214522 June 17, 2022 RX SUSPENSION ORAL 11666576 Dec. 24, 2038 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY

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 Ki 8 CHEMBL CHEMBL
Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A Enzyme IC50 7.48 CHEMBL
Phosphodiesterase 6 Enzyme IC50 6.01 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4 CHEMBL
Nuclear receptor subfamily 2 group E member 1 Nuclear hormone receptor EC50 5.30 CHEMBL
Acetylcholinesterase Enzyme IC50 4.58 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme Ki 8.30 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme IC50 8.48 CHEMBL
Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha Enzyme IC50 5.52 CHEMBL
Phosphodiesterase 6 Enzyme IC50 5.29 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4462 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4462 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4462 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4463 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4463 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4463 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4464 TABLET, FILM COATED 20 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4464 TABLET, FILM COATED 20 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4464 TABLET, FILM COATED 20 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4465 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4465 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Cialis HUMAN PRESCRIPTION DRUG LABEL 1 0002-4465 TABLET, FILM COATED 2.50 mg ORAL NDA 34 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3016 TABLET, FILM COATED 2.50 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3016 TABLET, FILM COATED 2.50 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3017 TABLET, FILM COATED 5 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3017 TABLET, FILM COATED 5 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3018 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3018 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3019 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Tadalafil HUMAN PRESCRIPTION DRUG LABEL 1 0093-3019 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
ALYQ HUMAN PRESCRIPTION DRUG LABEL 1 0093-3334 TABLET, FILM COATED 20 mg ORAL ANDA 27 sections
ALYQ HUMAN PRESCRIPTION DRUG LABEL 1 0093-3334 TABLET, FILM COATED 20 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-565 TABLET 2.50 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-565 TABLET 2.50 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-565 TABLET 2.50 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-566 TABLET 5 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-566 TABLET 5 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-566 TABLET 5 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-567 TABLET 10 mg ORAL ANDA 27 sections
TADALAFIL HUMAN PRESCRIPTION DRUG LABEL 1 13668-567 TABLET 10 mg ORAL ANDA 27 sections