lisinopril ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
angiotensin-converting enzyme inhibitors 1587 76547-98-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lisinopril
  • linopril
  • nanopril
  • lisinopril hydrate
  • lisinopril dihydrate
  • anhydrous lisinopril
One of the ANGIOTENSIN-CONVERTING ENZYME INHIBITORS (ACE inhibitors), orally active, that has been used in the treatment of hypertension and congestive heart failure.
  • Molecular weight: 405.50
  • Formula: C21H31N3O5
  • CLOGP: -1.82
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 4
  • TPSA: 132.96
  • ALOGS: -3.27
  • ROTB: 12

  • 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) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 97 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 94 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.41 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 25 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.89 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 42 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1987 FDA MERCK

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
Angioedema 1649.58 9.56 1327 212458 36349 50354990
Cardiac failure congestive 594.13 9.56 1183 212602 83199 50308140
Intestinal angioedema 552.99 9.56 173 213612 453 50390886
Myocardial infarction 536.55 9.56 1171 212614 87856 50303483
Swollen tongue 318.20 9.56 491 213294 28139 50363200
Cerebrovascular accident 316.24 9.56 999 212786 93681 50297658
Drug ineffective 309.78 9.56 2113 211672 817220 49574119
Maternal exposure during pregnancy 260.31 9.56 178 213607 159600 50231739
Acute kidney injury 254.61 9.56 1742 212043 226316 50165023
Off label use 253.54 9.56 1088 212697 473338 49918001
Contraindicated product administered 253.45 9.56 158 213627 148800 50242539
Coronary artery disease 238.76 9.56 441 213344 29285 50362054
Drug intolerance 211.60 9.56 376 213409 218728 50172611
Pemphigus 206.41 9.56 126 213659 120040 50271299
Systemic lupus erythematosus 199.54 9.56 180 213605 140442 50250897
Infusion related reaction 193.30 9.56 260 213525 169297 50222042
Synovitis 189.97 9.56 147 213638 123718 50267621
Lip swelling 177.71 9.56 350 213435 24386 50366953
Exposure during pregnancy 176.39 9.56 151 213634 120864 50270475
Pyrexia 174.63 9.56 920 212865 379283 50012056
Completed suicide 157.50 9.56 1025 212760 130864 50260475
Hand deformity 142.41 9.56 128 213657 100071 50291268
Acute myocardial infarction 142.10 9.56 354 213431 28919 50362420
Blood glucose increased 138.46 9.56 633 213152 70691 50320648
C-reactive protein increased 136.27 9.56 55 213730 66419 50324920
Drug hypersensitivity 135.87 9.56 1639 212146 249371 50141968
Glossodynia 128.84 9.56 180 213605 115389 50275950
Lower respiratory tract infection 127.82 9.56 128 213657 95073 50296266
Hyperkalaemia 123.37 9.56 465 213320 47624 50343715
Drug abuse 121.89 9.56 50 213735 59796 50331543
Treatment failure 108.45 9.56 265 213520 137372 50253967
Arthropathy 107.22 9.56 327 213458 157579 50233760
Lactic acidosis 106.73 9.56 347 213438 33008 50358331
Febrile neutropenia 100.24 9.56 161 213624 97506 50293833
Renal failure 99.49 9.56 781 213004 105852 50285487
Dehydration 95.69 9.56 1025 212760 151424 50239915
Alopecia 89.75 9.56 636 213149 244411 50146928
Neutropenia 89.71 9.56 322 213463 147643 50243696
Wound 87.88 9.56 198 213587 105596 50285743
Abortion spontaneous 86.53 9.56 34 213751 41738 50349601
Joint swelling 82.97 9.56 651 213134 244635 50146704
Dizziness 82.09 9.56 1978 211807 344391 50046948
Infection 81.14 9.56 415 213370 172539 50218800
Pericarditis 79.53 9.56 131 213654 78558 50312781
Folliculitis 79.50 9.56 33 213752 39192 50352147
Product dose omission issue 79.18 9.56 1152 212633 182686 50208653
Sleep disorder due to general medical condition, insomnia type 78.90 9.56 18 213767 31429 50359910
Hepatic enzyme increased 78.04 9.56 307 213478 137073 50254266
Psoriasis 77.30 9.56 528 213257 68472 50322867
Muscle injury 75.57 9.56 31 213754 37080 50354259
Interstitial lung disease 75.44 9.56 68 213717 53108 50338231
Therapeutic product effect decreased 74.78 9.56 308 213477 135742 50255597
Product use issue 73.94 9.56 352 213433 149123 50242216
Pancreatitis 73.80 9.56 366 213419 42248 50349091
Coronary arterial stent insertion 71.72 9.56 71 213714 2563 50388776
Swelling face 70.34 9.56 421 213364 52174 50339165
Labile blood pressure 69.45 9.56 57 213728 1603 50389736
Hypovolaemia 69.27 9.56 135 213650 9330 50382009
Anti-cyclic citrullinated peptide antibody positive 69.04 9.56 120 213665 70467 50320872
Chest pain 68.28 9.56 1088 212697 175794 50215545
Hypotensive transfusion reaction 67.86 9.56 19 213766 28 50391311
Rheumatoid arthritis 67.34 9.56 540 213245 202010 50189329
Blood pressure increased 65.74 9.56 855 212930 132277 50259062
Hepatic function abnormal 65.42 9.56 28 213757 32653 50358686
Diarrhoea 64.79 9.56 3071 210714 585405 49805934
Coronary artery bypass 64.65 9.56 63 213722 2230 50389109
Mental status changes 63.85 9.56 313 213472 35959 50355380
Therapeutic product effect incomplete 62.44 9.56 189 213596 91326 50300013
Arthralgia 60.53 9.56 1402 212383 437300 49954039
Premature delivery 60.47 9.56 13 213772 23650 50367689
Abdominal discomfort 60.46 9.56 656 213129 230985 50160354
Nausea 60.01 9.56 3593 210192 701805 49689534
C-reactive protein abnormal 58.65 9.56 22 213763 27787 50363552
Blood pressure inadequately controlled 58.59 9.56 82 213703 4298 50387041
Hypotension 58.22 9.56 1353 212432 234116 50157223
General physical health deterioration 57.97 9.56 358 213427 142076 50249263
Gastrointestinal haemorrhage 57.70 9.56 517 213268 72804 50318535
Nasopharyngitis 57.14 9.56 530 213255 192397 50198942
Asthenia 56.50 9.56 1755 212030 317287 50074052
Chronic kidney disease 55.53 9.56 322 213463 39449 50351890
Pregnancy 55.09 9.56 28 213757 29549 50361790
Cough 53.53 9.56 1366 212419 239898 50151441
Sopor 52.71 9.56 10 213775 19869 50371470
Stomatitis 52.26 9.56 235 213550 101109 50290230
Leukopenia 50.84 9.56 133 213652 67395 50323944
Foetal exposure during pregnancy 50.81 9.56 26 213759 27333 50364006
Malignant neoplasm progression 48.42 9.56 138 213647 67986 50323353
Angina unstable 48.29 9.56 95 213690 6611 50384728
Cytomegalovirus infection 47.71 9.56 9 213776 17953 50373386
Intentional self-injury 47.55 9.56 19 213766 23093 50368246
Gastrointestinal disorder 47.52 9.56 221 213564 94235 50297104
Swelling 46.16 9.56 585 213200 200287 50191052
Injury 45.95 9.56 359 213426 48566 50342773
Overdose 45.77 9.56 241 213544 99486 50291853
Transient ischaemic attack 45.76 9.56 262 213523 31948 50359391
Discomfort 44.82 9.56 271 213514 108109 50283230
Product complaint 43.87 9.56 127 213658 11339 50380000
Agranulocytosis 43.44 9.56 18 213767 21403 50369936
Renal injury 42.69 9.56 105 213680 8506 50382833
Suspected suicide 41.15 9.56 78 213707 5279 50386060
Spinal stenosis 40.69 9.56 138 213647 13412 50377927
Atrioventricular block second degree 40.07 9.56 62 213723 3559 50387780
Pneumocystis jirovecii pneumonia 39.69 9.56 7 213778 14656 50376683
Impaired healing 39.57 9.56 156 213629 69630 50321709
Premature baby 39.52 9.56 14 213771 18323 50373016
Oxygen saturation decreased 39.49 9.56 167 213618 73081 50318258
Atrial fibrillation 39.27 9.56 626 213159 101119 50290220
Arteriosclerosis 39.12 9.56 105 213680 8972 50382367
Pancreatitis acute 38.75 9.56 201 213584 23611 50367728
Hepatotoxicity 38.39 9.56 35 213750 27191 50364148
Glycosylated haemoglobin increased 38.22 9.56 115 213670 10491 50380848
Irritable bowel syndrome 38.20 9.56 102 213683 51339 50340000
Cardiac disorder 37.98 9.56 311 213474 42668 50348671
Type 2 diabetes mellitus 37.86 9.56 262 213523 34113 50357226
Fall 37.34 9.56 1751 212034 333181 50058158
Foetal methotrexate syndrome 36.87 9.56 14 213771 76 50391263
Muscle spasms 36.27 9.56 738 213047 124815 50266524
Drug reaction with eosinophilia and systemic symptoms 36.12 9.56 40 213745 28384 50362955
Arterial occlusive disease 35.70 9.56 69 213716 4739 50386600
Depressed level of consciousness 35.64 9.56 107 213678 51846 50339493
Product use in unapproved indication 35.20 9.56 316 213469 115503 50275836
Pain 35.15 9.56 2045 211740 576858 49814481
Mucosal inflammation 35.07 9.56 73 213712 40069 50351270
Ischaemic cardiomyopathy 35.05 9.56 46 213739 2266 50389073
Blood sodium decreased 34.06 9.56 178 213607 20969 50370370
Product quality issue 33.87 9.56 235 213550 30623 50360716
Somatic delusion 33.74 9.56 24 213761 542 50390797
Suicide attempt 33.06 9.56 110 213675 51622 50339717
Cardiomyopathy 32.99 9.56 142 213643 15444 50375895
Rheumatoid nodule 32.53 9.56 7 213778 12728 50378611
Pulseless electrical activity 32.42 9.56 82 213703 6759 50384580
Memory impairment 32.42 9.56 493 213292 78867 50312472
Ill-defined disorder 32.39 9.56 120 213665 54534 50336805
Hypoaldosteronism 32.35 9.56 15 213770 143 50391196
Thrombocytopenia 32.30 9.56 364 213421 127309 50264030
Atrioventricular block first degree 32.22 9.56 77 213708 6124 50385215
Angina pectoris 32.10 9.56 205 213580 25983 50365356
Hypertension 31.99 9.56 1141 212644 210062 50181277
Vision blurred 31.91 9.56 488 213297 78159 50313180
Inflammation 31.14 9.56 129 213656 56783 50334556
Altered state of consciousness 31.09 9.56 28 213757 21882 50369457
Tenosynovitis 30.99 9.56 4 213781 10561 50380778
Body temperature increased 30.89 9.56 53 213732 31288 50360051
Hyperlipidaemia 30.83 9.56 151 213634 17339 50374000
Blood glucose decreased 30.52 9.56 155 213630 18056 50373283
Allergic cough 30.48 9.56 21 213764 450 50390889
Coma 30.46 9.56 130 213655 56749 50334590
Caesarean section 30.35 9.56 14 213771 15625 50375714
International normalised ratio increased 30.29 9.56 297 213488 42855 50348484
Hepatic ischaemia 30.09 9.56 23 213762 582 50390757
Sedation 29.96 9.56 52 213733 30558 50360781
Drug resistance 29.77 9.56 22 213763 18967 50372372
Myelosuppression 29.69 9.56 10 213775 13507 50377832
Red blood cell sedimentation rate increased 29.68 9.56 49 213736 29367 50361972
Gangrene 29.68 9.56 63 213722 4629 50386710
Status epilepticus 29.30 9.56 10 213775 13396 50377943
Myocardial ischaemia 28.70 9.56 111 213674 11502 50379837
Blood loss anaemia 28.15 9.56 87 213698 8052 50383287
Intentional overdose 28.14 9.56 152 213633 62352 50328987
Abnormal dreams 27.72 9.56 95 213690 9282 50382057
Chronic obstructive pulmonary disease 27.54 9.56 346 213439 53089 50338250
Blood pressure fluctuation 27.38 9.56 70 213715 35753 50355586
Rheumatoid factor positive 27.29 9.56 113 213672 49746 50341593
Tongue oedema 27.18 9.56 54 213731 3785 50387554
Encephalomalacia 26.68 9.56 19 213766 430 50390909
Drug dispensed to wrong patient 26.49 9.56 14 213771 181 50391158
Hypersensitivity 26.47 9.56 699 213086 214462 50176877
Dysgeusia 26.42 9.56 266 213519 38650 50352689
Blood potassium increased 26.39 9.56 138 213647 16260 50375079
Sight disability 26.29 9.56 12 213773 110 50391229
Blood potassium decreased 25.79 9.56 254 213531 36691 50354648
Prescribed overdose 25.70 9.56 126 213659 14474 50376865
Bone erosion 25.06 9.56 9 213776 11678 50379661
Condition aggravated 24.91 9.56 1014 212771 296044 50095295
Depression 24.86 9.56 893 212892 164530 50226809
Coronary artery occlusion 24.85 9.56 79 213706 7424 50383915
Syncope 24.83 9.56 590 213195 102412 50288927
Musculoskeletal stiffness 24.58 9.56 388 213397 128093 50263246
Grip strength decreased 24.56 9.56 109 213676 12012 50379327
Diabetic ketoacidosis 24.49 9.56 144 213641 17728 50373611
Factor VII deficiency 24.30 9.56 8 213777 26 50391313
Rash 24.27 9.56 1558 212227 435913 49955426
Progressive multifocal leukoencephalopathy 24.26 9.56 9 213776 11448 50379891
Colitis ischaemic 23.73 9.56 91 213694 9392 50381947
Toxic skin eruption 23.56 9.56 9 213776 11242 50380097
Alanine aminotransferase increased 23.50 9.56 249 213536 88110 50303229
Synostosis 23.24 9.56 9 213776 52 50391287
Neurotoxicity 23.20 9.56 17 213768 14723 50376616
Drug eruption 23.19 9.56 40 213745 23566 50367773
Nodal rhythm 23.17 9.56 31 213754 1556 50389783
Panniculitis 23.14 9.56 4 213781 8499 50382840
Haematotoxicity 23.13 9.56 3 213782 7892 50383447
Thermohypoaesthesia 23.10 9.56 11 213774 112 50391227
Device expulsion 23.06 9.56 55 213730 28767 50362572
Weight decreased 22.99 9.56 1149 212636 220096 50171243
Hepatocellular injury 22.82 9.56 47 213738 25900 50365439
Lymphomatoid papulosis 22.76 9.56 11 213774 116 50391223
Epilepsy 22.63 9.56 35 213750 21532 50369807
Shock 22.50 9.56 157 213628 20493 50370846
Diabetic neuropathy 22.46 9.56 48 213737 3543 50387796
Hepatorenal syndrome 22.38 9.56 32 213753 1711 50389628
Erythema 22.38 9.56 460 213325 145954 50245385
Therapy cessation 22.32 9.56 187 213598 25824 50365515
Osmolar gap increased 22.19 9.56 7 213778 19 50391320
Lymphopenia 22.12 9.56 20 213765 15601 50375738
Muscle relaxant therapy 22.12 9.56 12 213773 164 50391175
Body temperature decreased 22.04 9.56 22 213763 16373 50374966
Foetal death 21.93 9.56 4 213781 8176 50383163
Body height decreased 21.89 9.56 85 213700 8823 50382516
Rotator cuff repair 21.30 9.56 31 213754 1685 50389654
Feeling abnormal 21.26 9.56 687 213098 124805 50266534
Upper gastrointestinal haemorrhage 21.20 9.56 128 213657 15907 50375432
Bone marrow failure 21.10 9.56 54 213731 27570 50363769
Dilatation atrial 21.04 9.56 32 213753 1809 50389530
Product coating issue 20.98 9.56 8 213777 44 50391295
Oedema peripheral 20.93 9.56 841 212944 157120 50234219
Gout 20.91 9.56 100 213685 11370 50379969
Vomiting 20.87 9.56 2237 211548 458521 49932818
Ventricular fibrillation 20.68 9.56 94 213691 10465 50380874
Lichen planus 20.67 9.56 33 213752 1946 50389393
Nodular rash 20.41 9.56 12 213773 193 50391146
Sinus arrhythmia 20.39 9.56 27 213758 1342 50389997
Abortion induced 20.37 9.56 7 213778 9337 50382002
Blood pressure systolic abnormal 20.17 9.56 4 213781 7702 50383637
Neutrophil count decreased 20.13 9.56 113 213672 45913 50345426
Sedation complication 20.12 9.56 6 213779 8760 50382579
Dysphagia 19.90 9.56 448 213337 77070 50314269
Full blood count decreased 19.90 9.56 162 213623 22184 50369155
Product substitution issue 19.74 9.56 114 213671 13943 50377396
Anhedonia 19.57 9.56 86 213699 9438 50381901
Sinusitis 19.44 9.56 560 213225 169998 50221341
Septic shock 19.16 9.56 152 213633 57023 50334316
Oedema 19.10 9.56 409 213376 69772 50321567
Electrocardiogram T wave abnormal 18.81 9.56 34 213751 2219 50389120
Pancytopenia 18.80 9.56 246 213539 83784 50307555
Muscle rigidity 18.77 9.56 9 213776 9820 50381519
Fluid intake reduced 18.69 9.56 41 213744 3081 50388258
Hepatitis 18.67 9.56 69 213716 31384 50359955
Pharyngeal oedema 18.64 9.56 107 213678 13058 50378281
Thrombotic microangiopathy 18.46 9.56 7 213778 8784 50382555
Oedema mouth 18.41 9.56 34 213751 2256 50389083
Hyponatraemia 18.33 9.56 534 213251 95605 50295734
Suspected suicide attempt 18.29 9.56 9 213776 99 50391240
Blood creatinine increased 18.27 9.56 436 213349 75724 50315615
Gamma-glutamyltransferase increased 18.24 9.56 64 213721 29559 50361780
Transcription medication error 18.23 9.56 11 213774 186 50391153
Helicobacter infection 18.14 9.56 129 213656 49573 50341766
Fear 17.89 9.56 114 213671 14435 50376904
Neutropenic sepsis 17.88 9.56 20 213765 14127 50377212
Adactyly 17.85 9.56 7 213778 42 50391297
Peripheral swelling 17.66 9.56 701 213084 205235 50186104
Cholestasis 17.64 9.56 52 213733 25349 50365990
Drug clearance decreased 17.64 9.56 23 213762 1126 50390213
Peripheral vascular disorder 17.59 9.56 57 213728 5410 50385929
Eosinophilic oesophagitis 17.58 9.56 12 213773 253 50391086
Nervousness 17.35 9.56 186 213599 27465 50363874
Dystonia 17.21 9.56 15 213770 11911 50379428
Cholelithiasis 17.12 9.56 240 213545 37733 50353606
Premature labour 17.09 9.56 14 213771 11462 50379877
Liver disorder 17.04 9.56 90 213695 37132 50354207
Charles Bonnet syndrome 16.91 9.56 5 213780 10 50391329
Blood urea increased 16.88 9.56 163 213622 23422 50367917
Ventricular hypertrophy 16.79 9.56 40 213745 3175 50388164
Essential hypertension 16.78 9.56 49 213736 4395 50386944
Therapeutic response unexpected 16.76 9.56 120 213665 15795 50375544
Extrapyramidal disorder 16.75 9.56 15 213770 11755 50379584
Hypoaesthesia 16.73 9.56 677 213108 126580 50264759
Tuberculosis 16.71 9.56 11 213774 10072 50381267
Dry mouth 16.46 9.56 331 213454 55847 50335492
Metastases to liver 16.37 9.56 38 213747 20066 50371273
Haemophagocytic lymphohistiocytosis 16.34 9.56 8 213777 8625 50382714
Expired product administered 16.32 9.56 55 213730 5327 50386012
Amnesia 16.29 9.56 260 213525 42000 50349339
Hypophagia 16.24 9.56 184 213601 27544 50363795
Cerebral thrombosis 16.18 9.56 26 213759 1542 50389797
Colitis ulcerative 16.16 9.56 29 213756 16825 50374514
Rash maculo-papular 16.10 9.56 58 213727 26583 50364756
Blood parathyroid hormone decreased 16.09 9.56 5 213780 7109 50384230
Myalgia 16.03 9.56 660 213125 123659 50267680
Hypergammaglobulinaemia 15.99 9.56 14 213771 431 50390908
Anxiety 15.96 9.56 910 212875 176696 50214643
Multimorbidity 15.79 9.56 15 213770 514 50390825
Pneumonia 15.79 9.56 1380 212405 377021 50014318
Blood pressure abnormal 15.75 9.56 100 213685 12647 50378692
Nephrogenic systemic fibrosis 15.70 9.56 47 213738 4275 50387064
Epstein-Barr virus infection 15.68 9.56 5 213780 6992 50384347
Hypertensive crisis 15.52 9.56 102 213683 13052 50378287
Low birth weight baby 15.50 9.56 3 213782 5878 50385461
Infective pulmonary exacerbation of cystic fibrosis 15.47 9.56 7 213778 7902 50383437
Pneumonitis 15.46 9.56 68 213717 29442 50361897
Duodenal ulcer perforation 15.40 9.56 121 213664 45490 50345849
Dizziness postural 15.40 9.56 59 213726 6086 50385253
Eosinophilia 15.40 9.56 35 213750 18617 50372722
Electrocardiogram T wave peaked 15.29 9.56 10 213775 196 50391143
Unresponsive to stimuli 15.26 9.56 197 213588 30412 50360927
Accelerated hypertension 15.10 9.56 13 213772 391 50390948
Factor VIII inhibition 15.03 9.56 6 213779 38 50391301
BRASH syndrome 14.98 9.56 10 213775 203 50391136
Poor venous access 14.93 9.56 13 213772 10327 50381012
Neuroleptic malignant syndrome 14.88 9.56 15 213770 11115 50380224
Diverticulum 14.85 9.56 86 213699 10528 50380811
Visual acuity reduced 14.82 9.56 140 213645 19999 50371340
Bezoar 14.80 9.56 23 213762 1325 50390014
Device difficult to use 14.80 9.56 12 213773 9874 50381465
Osteoporosis 14.72 9.56 120 213665 44759 50346580
Oral herpes 14.71 9.56 42 213743 20683 50370656
Immunodeficiency 14.68 9.56 25 213760 14803 50376536
Transient psychosis 14.65 9.56 6 213779 41 50391298
Urinary tract infection 14.60 9.56 1117 212668 222903 50168436
Graft versus host disease 14.56 9.56 4 213781 6162 50385177
Respiratory disorder 14.50 9.56 75 213710 31112 50360227
Polyneuropathy 14.42 9.56 18 213767 12113 50379226
Pre-eclampsia 14.41 9.56 8 213777 8036 50383303
Muscle spasticity 14.39 9.56 32 213753 17152 50374187
Non-cardiac chest pain 14.34 9.56 55 213730 5677 50385662
Pulmonary fibrosis 14.25 9.56 54 213731 24383 50366956
Left ventricular hypertrophy 14.25 9.56 49 213736 4796 50386543
Application site nodule 14.24 9.56 4 213781 6 50391333
Urethral prolapse 14.24 9.56 4 213781 6 50391333
Lymphocyte count decreased 14.16 9.56 60 213725 26247 50365092
Stridor 14.00 9.56 37 213748 3132 50388207
Transplant rejection 13.97 9.56 12 213773 9597 50381742
Glomerulonephropathy 13.92 9.56 7 213778 81 50391258
Haemodialysis 13.89 9.56 71 213714 8291 50383048
Eosinophilic pneumonia acute 13.72 9.56 11 213774 299 50391040
Emotional distress 13.67 9.56 183 213602 28480 50362859
Adjustment disorder with depressed mood 13.62 9.56 34 213751 2780 50388559
Uraemic encephalopathy 13.56 9.56 9 213776 181 50391158
Facial nerve disorder 13.55 9.56 14 213771 532 50390807
Cytokine release syndrome 13.54 9.56 10 213775 8624 50382715
Paramnesia 13.52 9.56 4 213781 8 50391331
Hepatic cytolysis 13.21 9.56 9 213776 8094 50383245
Flatulence 13.20 9.56 186 213599 29272 50362067
Ear pain 13.16 9.56 68 213717 28215 50363124
Cerebral atrophy 13.07 9.56 46 213739 4555 50386784
Osteoarthritis 13.05 9.56 381 213404 68225 50323114
Infusion site pain 12.99 9.56 20 213765 12326 50379013
Retching 12.98 9.56 96 213689 12766 50378573
Acne 12.98 9.56 41 213744 19554 50371785
Bradycardia 12.87 9.56 360 213425 64066 50327273
Fear of eating 12.83 9.56 11 213774 329 50391010
Exercise tolerance increased 12.75 9.56 5 213780 30 50391309
Blood electrolytes abnormal 12.69 9.56 18 213767 955 50390384
High density lipoprotein abnormal 12.69 9.56 6 213779 60 50391279
Diabetic gastroparesis 12.66 9.56 9 213776 203 50391136
Gastric ulcer helicobacter 12.64 9.56 4 213781 11 50391328
Productive cough 12.63 9.56 152 213633 52542 50338797
Mitral valve incompetence 12.63 9.56 121 213664 17350 50373989
Gait disturbance 12.60 9.56 764 213021 149241 50242098
Rectal haemorrhage 12.60 9.56 231 213554 38327 50353012
Lacunar infarction 12.60 9.56 35 213750 3052 50388287
Apparent death 12.40 9.56 20 213765 1190 50390149
Mydriasis 12.39 9.56 16 213769 10611 50380728
Chromatopsia 12.36 9.56 12 213773 423 50390916
Carotid artery stenosis 12.33 9.56 46 213739 4685 50386654
Demyelination 12.32 9.56 5 213780 6021 50385318
Aphthous ulcer 12.31 9.56 16 213769 10581 50380758
Hypertensive emergency 12.31 9.56 23 213762 1540 50389799
Sleep disorder due to a general medical condition 12.27 9.56 8 213777 7363 50383976
Immune thrombocytopenia 12.23 9.56 12 213773 9005 50382334
High density lipoprotein decreased 12.14 9.56 24 213761 1676 50389663
Back disorder 12.13 9.56 74 213711 9231 50382108
Respiratory depression 12.12 9.56 20 213765 11990 50379349
Laryngotracheal oedema 12.11 9.56 5 213780 35 50391304
Food allergy 12.03 9.56 10 213775 8127 50383212
Ageusia 12.00 9.56 87 213698 11496 50379843
Catheterisation cardiac 12.00 9.56 41 213744 3999 50387340
Craniosynostosis 11.96 9.56 8 213777 163 50391176
Burn oesophageal 11.92 9.56 8 213777 164 50391175
Bundle branch block left 11.86 9.56 55 213730 6175 50385164
Cardioactive drug level increased 11.82 9.56 26 213759 1958 50389381
Tachycardia 11.76 9.56 326 213459 99437 50291902
Tubulointerstitial nephritis and uveitis syndrome 11.75 9.56 8 213777 168 50391171
Cataract 11.71 9.56 272 213513 47028 50344311
Sarcoma 11.70 9.56 11 213774 372 50390967
Mobility decreased 11.67 9.56 253 213532 79695 50311644
Ventricular tachycardia 11.65 9.56 110 213675 15711 50375628
Blood lactate dehydrogenase increased 11.55 9.56 43 213742 19519 50371820
Erythema marginatum 11.51 9.56 4 213781 16 50391323
Oral candidiasis 11.48 9.56 35 213750 16880 50374459
Bronchiectasis 11.46 9.56 16 213769 10267 50381072
Raynaud's phenomenon 11.46 9.56 19 213766 1157 50390182
Refusal of treatment by patient 11.44 9.56 47 213738 5006 50386333
Shock haemorrhagic 11.44 9.56 11 213774 8333 50383006
Product solubility abnormal 11.43 9.56 15 213770 739 50390600
Poisoning deliberate 11.36 9.56 10 213775 7902 50383437
Ischaemic neuropathy 11.35 9.56 3 213782 3 50391336
Pharyngitis 11.33 9.56 37 213748 17466 50373873
Renal cyst 11.27 9.56 69 213716 8618 50382721
Muscular weakness 11.25 9.56 500 213285 94513 50296826
Occult blood positive 11.22 9.56 35 213750 3256 50388083
Lung disorder 11.21 9.56 128 213657 44671 50346668
Skin exfoliation 11.20 9.56 202 213583 33410 50357929
Torsade de pointes 11.19 9.56 87 213698 11748 50379591
Pathogen resistance 11.18 9.56 5 213780 5684 50385655
Haemorrhage intracranial 11.18 9.56 90 213695 12284 50379055
Blood triglycerides increased 11.17 9.56 84 213701 11228 50380111
Diffuse large B-cell lymphoma 11.09 9.56 5 213780 5657 50385682
Blood pressure decreased 11.05 9.56 312 213473 55597 50335742
Mouth swelling 10.99 9.56 39 213746 3877 50387462
Electrocardiogram ST segment depression 10.98 9.56 30 213755 2590 50388749
Creatinine renal clearance decreased 10.90 9.56 21 213764 11860 50379479
Blood cholesterol increased 10.88 9.56 308 213477 54907 50336432
Decreased appetite 10.88 9.56 988 212797 199935 50191404
Second primary malignancy 10.85 9.56 8 213777 6906 50384433
Pharyngeal swelling 10.76 9.56 43 213742 4523 50386816
Premature rupture of membranes 10.76 9.56 3 213782 4577 50386762
Urinary tract candidiasis 10.72 9.56 12 213773 500 50390839
Concomitant disease aggravated 10.71 9.56 11 213774 8080 50383259
Optic ischaemic neuropathy 10.68 9.56 17 213768 1000 50390339
Retroperitoneal oedema 10.64 9.56 4 213781 21 50391318
Sinus disorder 10.59 9.56 122 213663 18336 50373003
Feeling jittery 10.53 9.56 82 213703 11078 50380261
SUNCT syndrome 10.49 9.56 3 213782 5 50391334
Weight increased 10.48 9.56 723 213062 201168 50190171
Dialysis 10.43 9.56 72 213713 9366 50381973
Hypoglycaemic unconsciousness 10.39 9.56 14 213771 708 50390631
Lethargy 10.38 9.56 278 213507 49154 50342185
Acute myeloid leukaemia 10.37 9.56 31 213754 15043 50376296
Plasma cell myeloma 10.36 9.56 188 213597 31134 50360205
Gastric disorder 10.36 9.56 179 213606 29369 50361970
Coronary artery surgery 10.32 9.56 5 213780 53 50391286
Cognitive disorder 10.30 9.56 128 213657 43995 50347344
Intestinal ischaemia 10.28 9.56 56 213729 6701 50384638
Generalised tonic-clonic seizure 10.24 9.56 67 213718 26243 50365096
Foot deformity 10.22 9.56 44 213741 19166 50372173
Tonsillitis 10.20 9.56 4 213781 4919 50386420
Visceral oedema 10.20 9.56 4 213781 24 50391315
Ovarian cyst 10.20 9.56 28 213757 13968 50377371
Laboratory test abnormal 10.19 9.56 146 213639 23062 50368277
Eosinophilic fasciitis 10.18 9.56 6 213779 97 50391242
Glomerulonephritis membranous 10.15 9.56 12 213773 531 50390808
Autonomic failure syndrome 10.14 9.56 3 213782 6 50391333
Venous angioma of brain 10.14 9.56 3 213782 6 50391333
Gallbladder abscess 10.14 9.56 3 213782 6 50391333
Choroidal effusion 10.13 9.56 11 213774 443 50390896
Therapy non-responder 10.12 9.56 153 213632 50869 50340470
Deep vein thrombosis 10.10 9.56 392 213393 72912 50318427
Forced expiratory volume decreased 10.10 9.56 3 213782 4391 50386948
Product odour abnormal 9.96 9.56 17 213768 1060 50390279
Fracture 9.94 9.56 37 213748 16796 50374543
Device dislocation 9.91 9.56 52 213733 21494 50369845
Impaired driving ability 9.90 9.56 38 213747 3923 50387416
Restrictive cardiomyopathy 9.88 9.56 9 213776 292 50391047
Uveitis 9.87 9.56 15 213770 9295 50382044
Chorioretinitis 9.84 9.56 11 213774 458 50390881
Haemorrhagic stroke 9.84 9.56 46 213739 5182 50386157
Macular fibrosis 9.83 9.56 10 213775 373 50390966
Thrombosis 9.80 9.56 307 213478 55526 50335813
Coronary artery stenosis 9.80 9.56 40 213745 4249 50387090
Fear of injection 9.66 9.56 7 213778 6096 50385243
Upper airway obstruction 9.63 9.56 12 213773 561 50390778
Venoocclusive liver disease 9.63 9.56 3 213782 4258 50387081
Speech disorder 9.61 9.56 207 213578 35341 50355998
Blood urea abnormal 9.60 9.56 12 213773 563 50390776
Small intestinal ulcer haemorrhage 9.57 9.56 5 213780 63 50391276

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
Angioedema 10695.97 10.64 4858 188603 27057 29354009
Myocardial infarction 611.11 10.64 1844 191617 108452 29272614
Cardiac failure congestive 604.00 10.64 1459 192002 75122 29305944
Hyperkalaemia 543.42 10.64 1224 192237 60168 29320898
Swollen tongue 521.34 10.64 514 192947 11752 29369314
Lip swelling 485.15 10.64 497 192964 11913 29369153
Off label use 363.51 10.64 904 192557 299896 29081170
Coronary artery disease 346.99 10.64 841 192620 43349 29337717
Acute kidney injury 298.58 10.64 2842 190619 262425 29118641
Completed suicide 275.46 10.64 1245 192216 89001 29292065
Drug abuse 260.99 10.64 98 193363 79785 29301281
Febrile neutropenia 258.33 10.64 213 193248 112027 29269039
Cerebrovascular accident 255.93 10.64 1089 192372 75822 29305244
Pyrexia 234.62 10.64 1027 192434 286595 29094471
Swelling face 220.60 10.64 441 193020 19909 29361157
General physical health deterioration 206.32 10.64 221 193240 102636 29278430
Neutropenia 200.61 10.64 346 193115 131365 29249701
Hypotension 184.84 10.64 2013 191448 192341 29188725
Interstitial lung disease 184.84 10.64 73 193388 57645 29323421
Acute myocardial infarction 168.12 10.64 695 192766 47743 29333323
Dizziness 136.80 10.64 1865 191596 187819 29193247
Foetal exposure during pregnancy 135.72 10.64 28 193433 33839 29347227
Hepatic function abnormal 123.48 10.64 51 193410 39208 29341858
Product use in unapproved indication 118.27 10.64 244 193217 86631 29294435
Drug hypersensitivity 117.89 10.64 809 192652 67597 29313469
Coronary arterial stent insertion 113.89 10.64 134 193327 3763 29377303
Pancreatitis 109.50 10.64 482 192979 34032 29347034
Thrombocytopenia 104.36 10.64 490 192971 134333 29246733
Septic shock 103.92 10.64 155 193306 62405 29318661
Drug ineffective 95.21 10.64 1739 191722 361431 29019635
Psoriasis 94.70 10.64 440 193021 31787 29349279
Leukopenia 93.41 10.64 135 193326 55068 29325998
C-reactive protein increased 92.17 10.64 92 193369 44171 29336895
Coronary artery bypass 91.43 10.64 132 193329 4553 29376513
Intestinal angioedema 89.89 10.64 38 193423 170 29380896
Dehydration 88.67 10.64 1143 192318 113605 29267461
Pharyngeal oedema 88.60 10.64 145 193316 5589 29375477
Cholestasis 83.15 10.64 25 193436 23437 29357629
Cytomegalovirus infection 81.80 10.64 25 193436 23190 29357876
Anaphylactic reaction 80.67 10.64 376 193085 27197 29353869
Hepatocellular injury 80.23 10.64 20 193441 21223 29359843
Drug resistance 79.97 10.64 21 193440 21519 29359547
Blood potassium increased 77.13 10.64 241 193220 14410 29366656
Agranulocytosis 77.11 10.64 19 193442 20321 29360745
Disseminated intravascular coagulation 77.05 10.64 18 193443 19962 29361104
Hypotensive transfusion reaction 75.52 10.64 20 193441 6 29381060
Product dose omission issue 72.71 10.64 956 192505 95427 29285639
Treatment failure 72.17 10.64 81 193380 36858 29344208
Suspected suicide 70.88 10.64 108 193353 3912 29377154
Condition aggravated 69.47 10.64 617 192844 145678 29235388
Pancytopenia 66.22 10.64 299 193162 82869 29298197
Bronchopulmonary aspergillosis 64.74 10.64 4 193457 12340 29368726
Blood glucose increased 63.41 10.64 627 192834 58357 29322709
Altered state of consciousness 62.27 10.64 26 193435 19863 29361203
Bone marrow failure 61.93 10.64 53 193408 27396 29353670
Product use issue 59.14 10.64 158 193303 51286 29329780
Neutrophil count decreased 58.71 10.64 123 193338 43444 29337622
Chest pain 57.29 10.64 1040 192421 110933 29270133
Coma 56.92 10.64 107 193354 39343 29341723
Hypovolaemia 55.63 10.64 146 193315 7899 29373167
Blood pressure inadequately controlled 55.23 10.64 73 193388 2313 29378753
Pneumonia 54.09 10.64 1639 191822 318533 29062533
Sopor 53.23 10.64 5 193456 10929 29370137
Epilepsy 53.19 10.64 27 193434 18405 29362661
Lactic acidosis 52.81 10.64 359 193102 29888 29351178
Mental status changes 52.57 10.64 400 193061 34527 29346539
Cough 51.78 10.64 1138 192323 125589 29255477
Syncope 51.26 10.64 782 192679 80589 29300477
Malignant neoplasm progression 49.96 10.64 281 193180 73578 29307488
Premature baby 48.85 10.64 26 193435 17254 29363812
Sepsis 48.75 10.64 649 192812 142033 29239033
Synovitis 48.01 10.64 7 193454 10883 29370183
Myelosuppression 47.17 10.64 11 193450 12216 29368850
Drug interaction 46.35 10.64 962 192499 196423 29184643
Mucosal inflammation 46.19 10.64 85 193376 31510 29349556
Oral allergy syndrome 45.94 10.64 14 193447 16 29381050
Blood lactate dehydrogenase increased 45.94 10.64 35 193426 19174 29361892
Renal injury 45.80 10.64 159 193302 10043 29371023
Gamma-glutamyltransferase increased 45.59 10.64 65 193396 26672 29354394
Fatigue 45.11 10.64 2517 190944 314304 29066762
Lymphocyte count decreased 43.73 10.64 37 193424 19234 29361832
Pneumocystis jirovecii pneumonia 43.53 10.64 28 193433 16751 29364315
Device interaction 43.47 10.64 33 193428 522 29380544
Intentional product use issue 43.40 10.64 138 193323 42360 29338706
Multiple organ dysfunction syndrome 42.75 10.64 240 193221 62876 29318190
Injury 42.63 10.64 241 193220 18805 29362261
Cardiac disorder 41.94 10.64 400 193061 36863 29344203
Alanine aminotransferase increased 41.69 10.64 282 193179 70662 29310404
Electrocardiogram T wave peaked 39.49 10.64 30 193431 475 29380591
Hyperthermia 39.46 10.64 7 193454 9423 29371643
Dysphagia 38.98 10.64 539 192922 54387 29326679
Tongue oedema 38.45 10.64 64 193397 2502 29378564
Pancreatitis acute 38.23 10.64 282 193179 24103 29356963
International normalised ratio increased 38.08 10.64 451 193010 43921 29337145
Aspergillus infection 37.99 10.64 11 193450 10570 29370496
Platelet count decreased 37.99 10.64 470 192991 104202 29276864
Renal tubular necrosis 37.40 10.64 189 193272 14126 29366940
Toxic skin eruption 37.20 10.64 9 193452 9748 29371318
Hepatitis 36.97 10.64 49 193412 20734 29360332
Immune reconstitution inflammatory syndrome 36.86 10.64 4 193457 7798 29373268
Intentional self-injury 36.34 10.64 18 193443 12443 29368623
Vascular graft 36.32 10.64 45 193416 1335 29379731
Liver disorder 36.00 10.64 80 193381 27669 29353397
Lung disorder 35.84 10.64 92 193369 30270 29350796
Infection 35.80 10.64 325 193136 76426 29304640
Fear 35.03 10.64 139 193322 9365 29371701
Infusion related reaction 34.77 10.64 158 193303 43728 29337338
Lymphopenia 34.54 10.64 23 193438 13510 29367556
Cardiac failure 34.32 10.64 342 193119 78945 29302121
Feeling abnormal 33.41 10.64 521 192940 53924 29327142
Neuroleptic malignant syndrome 33.10 10.64 34 193427 16114 29364952
Pneumonitis 33.09 10.64 85 193376 27959 29353107
Drug dependence 32.89 10.64 54 193407 20927 29360139
Hypophagia 32.50 10.64 241 193220 20631 29360435
Exposure during pregnancy 32.40 10.64 8 193453 8546 29372520
Angina unstable 32.38 10.64 149 193312 10716 29370350
Pelvic mass 32.12 10.64 19 193442 193 29380873
Pathogen resistance 31.91 10.64 7 193454 8109 29372957
Orbital myositis 31.81 10.64 16 193445 114 29380952
Rheumatoid arthritis 31.72 10.64 106 193355 32046 29349020
Lower respiratory tract infection 31.52 10.64 80 193381 26422 29354644
Drug reaction with eosinophilia and systemic symptoms 31.39 10.64 87 193374 27905 29353161
Anhedonia 31.27 10.64 111 193350 7089 29373977
Haemophagocytic lymphohistiocytosis 30.89 10.64 15 193446 10489 29370577
Ischaemic cardiomyopathy 30.84 10.64 94 193367 5544 29375522
Wheezing 30.37 10.64 342 193119 32898 29348168
Hyperbilirubinaemia 29.99 10.64 32 193429 14902 29366164
Blood urea increased 29.78 10.64 298 193163 27814 29353252
Low birth weight baby 29.71 10.64 4 193457 6604 29374462
Muscle spasms 29.65 10.64 594 192867 64488 29316578
Eosinophilia 29.48 10.64 63 193398 22098 29358968
Graft versus host disease 29.48 10.64 13 193448 9615 29371451
Thrombotic microangiopathy 29.43 10.64 10 193451 8671 29372395
Pneumonia aspiration 29.26 10.64 132 193329 36605 29344461
Venoocclusive liver disease 29.24 10.64 5 193456 6912 29374154
Ageusia 29.22 10.64 126 193335 8812 29372254
Blood urea abnormal 29.13 10.64 30 193431 723 29380343
Dysphonia 28.96 10.64 220 193241 18976 29362090
Vision blurred 28.80 10.64 395 193066 39781 29341285
Depressed level of consciousness 28.67 10.64 134 193327 36808 29344258
Drug intolerance 28.56 10.64 192 193269 48187 29332879
Product quality issue 28.54 10.64 190 193271 15705 29365361
Aplastic anaemia 28.49 10.64 7 193454 7503 29373563
Seizure 28.44 10.64 433 193028 92690 29288376
Aspartate aminotransferase increased 28.24 10.64 252 193209 59473 29321593
Drooling 27.52 10.64 61 193400 2960 29378106
Pulmonary renal syndrome 27.43 10.64 16 193445 158 29380908
Therapeutic product effect incomplete 27.40 10.64 148 193313 39157 29341909
Myocardial ischaemia 27.23 10.64 189 193272 15839 29365227
Emotional distress 26.73 10.64 169 193292 13726 29367340
Mydriasis 26.62 10.64 4 193457 6081 29374985
Blood creatinine increased 26.56 10.64 737 192724 84365 29296701
Renal failure 26.56 10.64 987 192474 117612 29263454
Blood glucose decreased 26.54 10.64 152 193309 11917 29369149
Substance abuse 26.39 10.64 6 193455 6781 29374285
Anaemia 26.36 10.64 1061 192400 199890 29181176
Asthenia 26.35 10.64 1688 191773 213562 29167504
Bradycardia 26.33 10.64 588 192873 65041 29316025
Dysgeusia 26.31 10.64 245 193216 22429 29358637
Hypoglycaemia 26.09 10.64 453 193008 47893 29333173
Orthostatic hypotension 26.00 10.64 244 193217 22385 29358681
Potassium wasting nephropathy 25.92 10.64 13 193448 92 29380974
Mouth swelling 25.91 10.64 41 193420 1535 29379531
Haematotoxicity 25.90 10.64 6 193455 6693 29374373
Diabetic neuropathy 25.83 10.64 68 193393 3685 29377381
Pharyngeal swelling 25.41 10.64 40 193421 1491 29379575
Ulnar nerve palsy 25.12 10.64 7 193454 4 29381062
Transaminases increased 24.99 10.64 71 193390 22591 29358475
Toxic epidermal necrolysis 24.66 10.64 51 193410 18102 29362964
Product substitution issue 24.59 10.64 122 193339 9050 29372016
Allergic cough 24.53 10.64 9 193452 25 29381041
Transplant rejection 24.41 10.64 15 193446 9197 29371869
Encephalopathy 23.85 10.64 113 193348 30930 29350136
Transient ischaemic attack 23.85 10.64 245 193216 23025 29358041
Therapy partial responder 23.73 10.64 3 193458 5196 29375870
Labelled drug-drug interaction medication error 23.37 10.64 27 193434 12132 29368934
Cytokine release syndrome 23.26 10.64 31 193430 13088 29367978
Pancreatitis necrotising 23.22 10.64 49 193412 2298 29378768
Blood electrolytes abnormal 23.21 10.64 29 193432 868 29380198
Hypertensive emergency 23.20 10.64 28 193433 808 29380258
Post transplant lymphoproliferative disorder 23.15 10.64 4 193457 5489 29375577
Drug-induced liver injury 23.04 10.64 69 193392 21586 29359480
Status epilepticus 22.96 10.64 22 193439 10772 29370294
Accelerated hypertension 22.90 10.64 16 193445 221 29380845
Laryngeal oedema 22.82 10.64 57 193404 2991 29378075
Prostate cancer recurrent 22.75 10.64 29 193432 886 29380180
Oropharyngeal swelling 22.62 10.64 21 193440 444 29380622
Neurotoxicity 22.55 10.64 38 193423 14575 29366491
Oxygen saturation decreased 22.40 10.64 187 193274 44750 29336316
Hyperlipidaemia 22.30 10.64 150 193311 12440 29368626
Pseudomonas infection 22.07 10.64 23 193438 10829 29370237
Increased tendency to bruise 21.98 10.64 62 193399 3500 29377566
Anal abscess 21.75 10.64 4 193457 5247 29375819
Bronchiectasis 21.61 10.64 8 193453 6577 29374489
Cystitis haemorrhagic 21.61 10.64 3 193458 4839 29376227
Similar reaction on previous exposure to drug 21.52 10.64 9 193452 39 29381027
Product complaint 21.51 10.64 81 193380 5324 29375742
Blood pressure increased 21.32 10.64 633 192828 73170 29307896
Nausea 21.22 10.64 2181 191280 287074 29093992
Vitreous floaters 20.93 10.64 56 193405 3065 29378001
Encephalitis 20.79 10.64 8 193453 6422 29374644
Death 20.69 10.64 1942 191519 340142 29040924
Swelling 20.64 10.64 335 193126 34948 29346118
Second primary malignancy 20.61 10.64 9 193452 6696 29374370
Erythema 20.61 10.64 359 193102 75247 29305819
Pancreatitis haemorrhagic 20.52 10.64 17 193444 307 29380759
No reaction on previous exposure to drug 20.51 10.64 10 193451 66 29381000
Enterocolitis 20.41 10.64 9 193452 6657 29374409
Sedation 20.34 10.64 53 193408 17352 29363714
Hepatic cytolysis 20.23 10.64 15 193446 8332 29372734
Nodular rash 19.72 10.64 11 193450 99 29380967
Eosinophil count increased 19.52 10.64 12 193449 7357 29373709
Acute hepatic failure 19.45 10.64 30 193431 11922 29369144
Posterior reversible encephalopathy syndrome 19.44 10.64 18 193443 8958 29372108
Myelodysplastic syndrome 19.44 10.64 56 193405 17738 29363328
Blood alkaline phosphatase increased 19.23 10.64 108 193353 28298 29352768
Asthma 19.15 10.64 136 193325 33713 29347353
Hepatic failure 19.13 10.64 124 193337 31388 29349678
Productive cough 18.98 10.64 123 193338 31136 29349930
Glycosylated haemoglobin increased 18.97 10.64 116 193345 9310 29371756
Hepatotoxicity 18.96 10.64 57 193404 17810 29363256
Generalised tonic-clonic seizure 18.94 10.64 63 193398 19076 29361990
Coronary artery occlusion 18.94 10.64 122 193339 9972 29371094
Product coating issue 18.93 10.64 7 193454 20 29381046
Burning sensation 18.88 10.64 173 193288 15765 29365301
Tumour lysis syndrome 18.86 10.64 39 193422 13845 29367221
Blood bilirubin increased 18.78 10.64 137 193324 33756 29347310
Azotaemia 18.72 10.64 69 193392 4488 29376578
Epstein-Barr virus infection 18.70 10.64 10 193451 6619 29374447
Therapy cessation 18.69 10.64 160 193301 14302 29366764
Tuberculosis 18.67 10.64 12 193449 7184 29373882
Pemphigus 18.67 10.64 30 193431 1138 29379928
Arteriosclerosis coronary artery 18.58 10.64 126 193335 10479 29370587
Myalgia 18.53 10.64 624 192837 73395 29307671
Acute respiratory distress syndrome 18.50 10.64 82 193379 22853 29358213
Drug level increased 18.48 10.64 62 193399 18725 29362341
Unevaluable event 18.43 10.64 286 193175 29565 29351501
Polyneuropathy 18.38 10.64 32 193429 12120 29368946
Delirium 18.28 10.64 167 193294 39230 29341836
Progressive multifocal leukoencephalopathy 18.28 10.64 18 193443 8701 29372365
Electrocardiogram change 18.01 10.64 21 193440 584 29380482
Postural orthostatic tachycardia syndrome 17.90 10.64 8 193453 42 29381024
Cytopenia 17.78 10.64 23 193438 9836 29371230
Eye swelling 17.72 10.64 107 193354 8550 29372516
Cholangitis 17.68 10.64 14 193447 7523 29373543
Overdose 17.52 10.64 393 193068 79426 29301640
Circulatory collapse 17.45 10.64 63 193398 18610 29362456
Miosis 17.42 10.64 16 193445 7993 29373073
Renal impairment neonatal 17.39 10.64 6 193455 13 29381053
Maternal exposure during pregnancy 17.38 10.64 3 193458 4120 29376946
Electrocardiogram QT prolonged 17.29 10.64 152 193309 35985 29345081
Paraesthesia 17.26 10.64 468 192993 53377 29327689
Renal artery stenosis 17.20 10.64 39 193422 1922 29379144
Cytomegalovirus viraemia 17.15 10.64 10 193451 6310 29374756
Chronic kidney disease 17.12 10.64 334 193127 36082 29344984
Renal tubular acidosis 17.10 10.64 37 193424 1766 29379300
Dizziness postural 17.04 10.64 75 193386 5292 29375774
Colitis 16.98 10.64 127 193334 31121 29349945
Blood glucose abnormal 16.88 10.64 72 193389 5011 29376055
Chronic graft versus host disease 16.84 10.64 3 193458 4026 29377040
Acquired acrodermatitis enteropathica 16.75 10.64 5 193456 5 29381061
Infective pulmonary exacerbation of cystic fibrosis 16.74 10.64 10 193451 6226 29374840
Stent placement 16.70 10.64 64 193397 4242 29376824
Atrial fibrillation 16.67 10.64 848 192613 104798 29276268
Tachycardia 16.62 10.64 354 193107 72056 29309010
Hypoaesthesia oral 16.51 10.64 55 193406 3401 29377665
Akathisia 16.49 10.64 12 193449 6730 29374336
Neutrophil count increased 16.39 10.64 46 193415 14696 29366370
Carcinoid tumour of the gastrointestinal tract 16.38 10.64 8 193453 53 29381013
Spur cell anaemia 16.26 10.64 8 193453 54 29381012
Hypoaesthesia 16.10 10.64 461 193000 53006 29328060
Hepatitis cholestatic 15.93 10.64 13 193448 6880 29374186
Cachexia 15.92 10.64 11 193450 6338 29374728
Aggression 15.91 10.64 152 193309 35389 29345677
Enlarged uvula 15.86 10.64 11 193450 150 29380916
Device related infection 15.80 10.64 51 193410 15585 29365481
Paraesthesia oral 15.76 10.64 55 193406 3482 29377584
White blood cell count decreased 15.69 10.64 420 193041 82942 29298124
Diarrhoea 15.66 10.64 2441 191020 330257 29050809
Oedema mouth 15.44 10.64 28 193433 1173 29379893
Respiratory tract oedema 15.41 10.64 15 193446 337 29380729
Acute myeloid leukaemia 15.24 10.64 56 193405 16457 29364609
Kidney transplant rejection 15.23 10.64 14 193447 6991 29374075
Hepatitis acute 15.16 10.64 12 193449 6450 29374616
Jaundice 15.01 10.64 121 193340 29175 29351891
Blood cholesterol increased 14.95 10.64 162 193299 15433 29365633
Haemorrhage intracranial 14.85 10.64 153 193308 14389 29366677
Hypotonia 14.76 10.64 14 193447 6888 29374178
Oral candidiasis 14.66 10.64 30 193431 10692 29370374
Pulmonary tuberculosis 14.57 10.64 5 193456 4310 29376756
Stridor 14.57 10.64 40 193421 2223 29378843
Inflammation 14.54 10.64 88 193373 22640 29358426
Benign gastrointestinal neoplasm 14.50 10.64 10 193451 135 29380931
Diabetic foot infection 14.47 10.64 19 193442 598 29380468
Urine oxalate increased 14.44 10.64 5 193456 11 29381055
Complications of transplanted kidney 14.40 10.64 4 193457 3950 29377116
Lymphomatoid papulosis 14.33 10.64 11 193450 177 29380889
Neutropenic sepsis 14.25 10.64 35 193426 11692 29369374
Pericarditis 14.23 10.64 22 193439 8735 29372331
Carcinoid tumour of the stomach 14.14 10.64 7 193454 48 29381018
Arteriosclerosis 14.07 10.64 115 193346 10141 29370925
Stomatitis 14.07 10.64 165 193296 36948 29344118
Rash maculo-papular 14.03 10.64 97 193364 24192 29356874
Psychomotor hyperactivity 13.97 10.64 20 193441 8193 29372873
Osteonecrosis of jaw 13.95 10.64 58 193403 16452 29364614
Erythema multiforme 13.92 10.64 18 193443 7699 29373367
Tympanic membrane disorder 13.90 10.64 7 193454 50 29381016
Hypogammaglobulinaemia 13.82 10.64 11 193450 5896 29375170
Toxicity to various agents 13.81 10.64 964 192497 172697 29208369
Intentional dose omission 13.78 10.64 37 193424 2029 29379037
Body temperature decreased 13.62 10.64 31 193430 10633 29370433
Adenovirus infection 13.62 10.64 6 193455 4441 29376625
Pleural effusion 13.61 10.64 362 193099 71546 29309520
Gallbladder oedema 13.59 10.64 11 193450 192 29380874
Hyperuricaemia 13.57 10.64 15 193446 6874 29374192
Colitis ulcerative 13.36 10.64 41 193420 12728 29368338
Endometriosis male 13.35 10.64 5 193456 15 29381051
Cardiovascular disorder 13.25 10.64 102 193359 8833 29372233
Lip oedema 13.25 10.64 38 193423 2166 29378900
Respiratory tract infection 13.21 10.64 55 193406 15596 29365470
Intestinal obstruction 13.20 10.64 73 193388 19204 29361862
Alcoholic ketoacidosis 13.11 10.64 5 193456 16 29381050
Non-cardiac chest pain 13.10 10.64 56 193405 3901 29377165
Cataract nuclear 13.09 10.64 16 193445 468 29380598
Cerebral infarction 13.07 10.64 101 193360 24574 29356492
Lymphoma 13.02 10.64 28 193433 9800 29371266
Oedema genital 12.99 10.64 14 193447 356 29380710
Rash pruritic 12.95 10.64 212 193249 22151 29358915
Liver abscess 12.88 10.64 3 193458 3335 29377731
Throat tightness 12.87 10.64 85 193376 7006 29374060
Hepatic encephalopathy 12.84 10.64 43 193418 12992 29368074
Epiglottic oedema 12.82 10.64 10 193451 165 29380901
Myxoedema coma 12.76 10.64 12 193449 258 29380808
Food allergy 12.74 10.64 23 193438 960 29380106
Conjunctival scar 12.74 10.64 7 193454 61 29381005
Hyperammonaemia 12.69 10.64 11 193450 5652 29375414
Penile swelling 12.66 10.64 20 193441 748 29380318
Extrapyramidal disorder 12.64 10.64 33 193428 10798 29370268
Weaning failure 12.60 10.64 11 193450 214 29380852
Adenocarcinoma pancreas 12.53 10.64 26 193435 1205 29379861
Gastric cancer 12.43 10.64 8 193453 4786 29376280
Peripheral vascular disorder 12.42 10.64 61 193400 4506 29376560
Endotracheal intubation complication 12.40 10.64 13 193448 320 29380746
Osteonecrosis 12.37 10.64 46 193415 13473 29367593
Anti-neutrophil cytoplasmic antibody positive vasculitis 12.29 10.64 19 193442 697 29380369
Immunosuppressant drug level increased 12.29 10.64 8 193453 4757 29376309
Pneumopericardium 12.26 10.64 8 193453 98 29380968
Serotonin syndrome 12.17 10.64 66 193395 17446 29363620
Pain 12.15 10.64 1290 192171 170142 29210924
Sleep attacks 12.14 10.64 9 193452 137 29380929
Dilatation atrial 12.13 10.64 33 193428 1824 29379242
Fall 12.11 10.64 1330 192131 175848 29205218
Lipoedema 12.11 10.64 3 193458 0 29381066
Hepatocellular carcinoma 12.10 10.64 17 193444 7021 29374045
Atrial septal defect 12.08 10.64 16 193445 6773 29374293
Gastrointestinal haemorrhage 12.05 10.64 636 192825 78897 29302169
BK virus infection 12.01 10.64 8 193453 4699 29376367
Skin odour abnormal 12.01 10.64 21 193440 855 29380211
Candida infection 11.94 10.64 55 193406 15170 29365896
Pneumatosis intestinalis 11.93 10.64 3 193458 3166 29377900
Dystonia 11.92 10.64 29 193432 9720 29371346
Application site infection 11.90 10.64 6 193455 43 29381023
Terminal state 11.89 10.64 4 193457 3490 29377576
Vomiting projectile 11.85 10.64 17 193444 583 29380483
Musculoskeletal chest pain 11.82 10.64 97 193364 8563 29372503
Meniere's disease 11.78 10.64 6 193455 44 29381022
Blood sodium decreased 11.75 10.64 148 193313 14619 29366447
Disease recurrence 11.61 10.64 59 193402 15855 29365211
Diverticulum 11.55 10.64 76 193385 6256 29374810
Dyspnoea 11.55 10.64 2362 191099 324370 29056696
Speech disorder 11.50 10.64 217 193244 23299 29357767
Tenosynovitis 11.49 10.64 5 193456 3728 29377338
Klebsiella infection 11.44 10.64 19 193442 7330 29373736
Bronchospasm 11.43 10.64 29 193432 9580 29371486
Hypoglycaemic unconsciousness 11.39 10.64 19 193442 744 29380322
Anaesthesia 11.35 10.64 6 193455 48 29381018
Graft versus host disease in skin 11.27 10.64 4 193457 3375 29377691
Blood pressure fluctuation 11.22 10.64 80 193381 19814 29361252
Acute cutaneous lupus erythematosus 11.21 10.64 7 193454 79 29380987
Gout 11.20 10.64 164 193297 16747 29364319
Pelvic neoplasm 11.20 10.64 4 193457 10 29381056
Albumin urine present 11.19 10.64 13 193448 360 29380706
Pollakiuria 11.19 10.64 164 193297 16752 29364314
Clostridium difficile infection 11.12 10.64 61 193400 16080 29364986
Organising pneumonia 11.08 10.64 10 193451 5038 29376028
Hypertriglyceridaemia 11.02 10.64 20 193441 7455 29373611
Diabetic retinopathy 11.00 10.64 29 193432 1573 29379493
Fungal infection 11.00 10.64 49 193412 13636 29367430
Sinus node dysfunction 10.97 10.64 51 193410 3683 29377383
Osteoporosis 10.97 10.64 35 193426 10734 29370332
Macroglossia 10.97 10.64 13 193448 368 29380698
Diverticulum intestinal haemorrhagic 10.92 10.64 34 193427 2028 29379038
Pulmonary arterial hypertension 10.92 10.64 20 193441 7429 29373637
Anal fistula 10.88 10.64 7 193454 4188 29376878
Appendicitis 10.83 10.64 26 193435 8753 29372313
Haemolysis 10.81 10.64 18 193443 6938 29374128
Type 2 diabetes mellitus 10.76 10.64 136 193325 13445 29367621
Faeces discoloured 10.70 10.64 134 193327 13217 29367849
Contrast media reaction 10.65 10.64 19 193442 786 29380280

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
Angioedema 11982.78 9.81 5931 314661 55890 64122250
Myocardial infarction 1326.33 9.81 2694 317898 163127 64015013
Cardiac failure congestive 1255.56 9.81 2294 318298 128286 64049854
Swollen tongue 745.06 9.81 894 319698 34060 64144080
Hyperkalaemia 744.35 9.81 1589 319003 99540 64078600
Coronary artery disease 687.28 9.81 1144 319448 59289 64118851
Acute kidney injury 674.03 9.81 4171 316421 445069 63733071
Intestinal angioedema 618.98 9.81 210 320382 622 64177518
Lip swelling 601.07 9.81 767 319825 31140 64147000
Cerebrovascular accident 599.90 9.81 1771 318821 135812 64042328
Off label use 507.48 9.81 1543 319049 631263 63546877
Completed suicide 480.59 9.81 2298 318294 222116 63956024
Acute myocardial infarction 369.41 9.81 964 319628 68754 64109386
Drug abuse 337.64 9.81 118 320474 132256 64045884
Drug ineffective 325.56 9.81 2648 317944 837599 63340541
Pyrexia 316.69 9.81 1565 319027 557079 63621061
Febrile neutropenia 286.31 9.81 306 320286 187351 63990789
Neutropenia 244.98 9.81 515 320077 239109 63939031
Hypotension 234.26 9.81 2907 317685 378067 63800073
Swelling face 219.94 9.81 721 319871 58445 64119695
Drug intolerance 201.49 9.81 393 320199 187599 63990541
Coronary arterial stent insertion 196.38 9.81 188 320404 5504 64172636
Synovitis 192.25 9.81 128 320464 98962 64079178
Interstitial lung disease 185.93 9.81 129 320463 97603 64080537
C-reactive protein increased 184.94 9.81 122 320470 94787 64083353
Infusion related reaction 180.45 9.81 339 320253 164128 64014012
General physical health deterioration 177.33 9.81 479 320113 203946 63974194
Coronary artery bypass 174.51 9.81 178 320414 5637 64172503
Lactic acidosis 169.34 9.81 679 319913 60731 64117409
Dehydration 167.33 9.81 1730 318862 215033 63963107
Maternal exposure during pregnancy 152.20 9.81 151 320441 95733 64082407
Pancreatitis 151.69 9.81 643 319949 58964 64119176
Contraindicated product administered 151.20 9.81 188 320404 107641 64070499
Hepatic function abnormal 149.65 9.81 66 320526 64247 64113893
Dizziness 142.28 9.81 2961 317631 427202 63750938
Hypotensive transfusion reaction 141.22 9.81 39 320553 39 64178101
Renal failure 140.61 9.81 1451 319141 180237 63997903
Exposure during pregnancy 133.14 9.81 114 320478 77561 64100579
Blood glucose increased 125.16 9.81 876 319716 97197 64080943
Lower respiratory tract infection 120.45 9.81 177 320415 94437 64083703
Hypovolaemia 120.34 9.81 249 320343 15237 64162903
Product use in unapproved indication 117.65 9.81 465 320127 176153 64001987
Suspected suicide 116.43 9.81 177 320415 8477 64169663
Mental status changes 111.39 9.81 599 319993 60563 64117577
Cytomegalovirus infection 107.93 9.81 26 320566 37173 64140967
Nasopharyngitis 107.37 9.81 555 320037 195518 63982622
Thrombocytopenia 106.10 9.81 664 319928 223137 63955003
Infection 105.41 9.81 516 320076 184364 63993776
Product dose omission issue 103.89 9.81 1449 319143 193298 63984842
Leukopenia 101.32 9.81 220 320372 101022 64077118
Sopor 100.50 9.81 14 320578 29647 64148493
Chest pain 98.38 9.81 1684 318908 234296 63943844
Agranulocytosis 92.52 9.81 37 320555 38192 64139948
Syncope 88.18 9.81 1183 319409 156452 64021688
Renal injury 87.52 9.81 219 320373 15210 64162930
Septic shock 86.94 9.81 253 320339 105184 64072956
Angina unstable 86.12 9.81 218 320374 15249 64162891
Blood potassium increased 85.46 9.81 304 320288 25676 64152464
Pharyngeal oedema 83.47 9.81 216 320376 15315 64162825
Systemic lupus erythematosus 83.29 9.81 162 320430 77450 64100690
Hand deformity 83.29 9.81 114 320478 62657 64115483
Treatment failure 82.00 9.81 301 320291 116515 64061625
Drug resistance 81.69 9.81 36 320556 35066 64143074
Gastrointestinal haemorrhage 81.59 9.81 1011 319581 131301 64046839
C-reactive protein abnormal 81.01 9.81 22 320570 29025 64149115
Sleep disorder due to general medical condition, insomnia type 78.94 9.81 17 320575 26253 64151887
Malignant neoplasm progression 77.81 9.81 293 320299 112578 64065562
Drug hypersensitivity 77.42 9.81 1634 318958 236181 63941959
Joint swelling 77.27 9.81 691 319901 214691 63963449
Product use issue 77.21 9.81 440 320152 151275 64026865
Cardiac disorder 76.81 9.81 508 320084 55308 64122832
Hepatocellular injury 76.76 9.81 67 320525 45168 64132972
Altered state of consciousness 76.17 9.81 47 320545 37855 64140285
Coma 73.14 9.81 209 320383 87406 64090734
Injury 73.09 9.81 503 320089 55489 64122651
Bronchopulmonary aspergillosis 72.31 9.81 6 320586 19079 64159061
Pancreatitis acute 72.20 9.81 411 320181 42444 64135696
Myocardial ischaemia 71.35 9.81 266 320326 22985 64155155
Bone marrow failure 71.05 9.81 80 320512 47872 64130268
Arthropathy 71.02 9.81 334 320258 120633 64057507
Transient ischaemic attack 70.07 9.81 417 320175 43765 64134375
Psoriasis 70.06 9.81 602 319990 71101 64107039
Rheumatoid arthritis 69.55 9.81 504 320088 163790 64014350
Ischaemic cardiomyopathy 69.20 9.81 123 320469 6715 64171425
Asthenia 69.03 9.81 2690 317902 425354 63752786
Product quality issue 68.60 9.81 312 320280 29487 64148653
Cholestasis 68.54 9.81 73 320519 44799 64133341
Tongue oedema 67.50 9.81 113 320479 5877 64172263
Hypophagia 66.92 9.81 380 320212 39207 64138933
Blood pressure inadequately controlled 66.68 9.81 106 320486 5278 64172862
International normalised ratio increased 66.35 9.81 643 319949 78524 64099616
Condition aggravated 66.16 9.81 1380 319212 371046 63807094
Neutrophil count decreased 66.02 9.81 182 320410 77014 64101126
Electrocardiogram T wave peaked 66.02 9.81 45 320547 798 64177342
Pericarditis 65.78 9.81 132 320460 62384 64115756
Dysphagia 65.77 9.81 816 319776 105996 64072144
Intentional self-injury 65.70 9.81 31 320561 29013 64149127
Arthralgia 65.63 9.81 1685 318907 440575 63737565
Hepatic enzyme increased 65.49 9.81 378 320214 129565 64048575
Blood creatinine increased 64.75 9.81 991 319601 134791 64043349
Blood pressure fluctuation 64.11 9.81 99 320493 51772 64126368
Mucosal inflammation 63.43 9.81 135 320457 62449 64115691
Myelosuppression 62.89 9.81 20 320572 23810 64154330
Therapeutic product effect incomplete 61.76 9.81 284 320308 103198 64074942
Stomatitis 61.23 9.81 308 320284 109297 64068843
Pancytopenia 60.95 9.81 439 320153 142870 64035270
Abortion spontaneous 59.76 9.81 25 320567 25118 64153022
Blood urea increased 59.63 9.81 400 320192 43753 64134387
Pneumocystis jirovecii pneumonia 58.75 9.81 32 320560 27602 64150538
Gastrointestinal disorder 58.55 9.81 238 320354 89471 64088669
Pneumonia 56.29 9.81 2243 318349 557333 63620807
Labile blood pressure 55.85 9.81 60 320532 2020 64176120
Depressed level of consciousness 55.08 9.81 213 320379 81223 64096917
Oxygen saturation decreased 54.96 9.81 310 320282 106866 64071274
Epilepsy 54.12 9.81 52 320540 33479 64144661
Premature delivery 53.91 9.81 13 320579 18576 64159564
Atrial fibrillation 53.85 9.81 1170 319422 169919 64008221
Folliculitis 52.93 9.81 43 320549 30034 64148106
Pemphigus 52.74 9.81 142 320450 60559 64117581
Aspergillus infection 52.60 9.81 9 320583 16370 64161770
Hyperlipidaemia 51.73 9.81 239 320353 22737 64155403
Renal tubular necrosis 51.27 9.81 232 320360 21878 64156262
Anhedonia 50.88 9.81 167 320425 13539 64164601
Chronic kidney disease 50.80 9.81 475 320117 57444 64120696
Inflammation 50.74 9.81 161 320431 65139 64113001
Muscle injury 50.12 9.81 35 320557 26402 64151738
Disseminated intravascular coagulation 50.11 9.81 52 320540 32296 64145844
Bradycardia 50.04 9.81 846 319746 117373 64060767
Lymphocyte count decreased 49.98 9.81 78 320514 40621 64137519
Wound 49.84 9.81 203 320389 76274 64101866
Toxic skin eruption 49.46 9.81 17 320575 19267 64158873
Liver disorder 49.28 9.81 121 320471 53230 64124910
Anaphylactic reaction 49.12 9.81 540 320052 68124 64110016
Alopecia 48.85 9.81 557 320035 165133 64013007
Vascular graft 48.82 9.81 53 320539 1806 64176334
Therapeutic product effect decreased 48.73 9.81 354 320238 114997 64063143
Erythema 48.32 9.81 647 319945 186423 63991717
Anti-cyclic citrullinated peptide antibody positive 47.69 9.81 110 320482 49452 64128688
Sedation 47.63 9.81 83 320509 41379 64136761
Fear 47.03 9.81 212 320380 19959 64158181
Drug reaction with eosinophilia and systemic symptoms 46.22 9.81 128 320464 54089 64124051
Thrombotic microangiopathy 45.73 9.81 13 320579 16642 64161498
Arteriosclerosis 45.72 9.81 178 320414 15699 64162441
Shock 45.53 9.81 336 320256 37904 64140236
Hepatitis 44.80 9.81 100 320492 45482 64132658
Lymphopenia 44.76 9.81 37 320555 25620 64152520
Pregnancy 44.60 9.81 24 320568 20841 64157299
Cardiomyopathy 44.58 9.81 246 320346 25110 64153030
Immune reconstitution inflammatory syndrome 44.40 9.81 5 320587 12465 64165675
Febrile bone marrow aplasia 44.17 9.81 3 320589 11252 64166888
Gamma-glutamyltransferase increased 44.04 9.81 111 320481 48399 64129741
Haematotoxicity 43.89 9.81 6 320586 12890 64165250
Status epilepticus 41.97 9.81 28 320564 21635 64156505
Alanine aminotransferase increased 41.91 9.81 465 320127 138566 64039574
Therapy cessation 41.88 9.81 291 320301 32198 64145942
Type 2 diabetes mellitus 41.69 9.81 301 320291 33719 64144421
Tenosynovitis 41.50 9.81 5 320587 11828 64166312
Oral allergy syndrome 40.92 9.81 13 320579 29 64178111
Hepatotoxicity 40.66 9.81 86 320506 39876 64138264
Nodular rash 40.03 9.81 23 320569 297 64177843
Osteoporosis 40.00 9.81 94 320498 41986 64136154
Therapy partial responder 39.45 9.81 3 320589 10245 64167895
Glycosylated haemoglobin increased 39.34 9.81 171 320421 15848 64162292
Product complaint 38.56 9.81 139 320453 11815 64166325
Blood urea abnormal 38.12 9.81 38 320554 1170 64176970
Haemophagocytic lymphohistiocytosis 38.01 9.81 20 320572 17589 64160551
Neuroleptic malignant syndrome 37.80 9.81 41 320551 24955 64153185
Coronary artery occlusion 37.79 9.81 153 320439 13738 64164402
Progressive multifocal leukoencephalopathy 37.49 9.81 22 320570 18210 64159930
Blood pressure diastolic abnormal 37.29 9.81 7 320585 11910 64166230
Dizziness postural 37.26 9.81 120 320472 9632 64168508
Blood glucose decreased 37.14 9.81 219 320373 22904 64155236
Lymphomatoid papulosis 37.01 9.81 22 320570 304 64177836
Haemorrhage intracranial 36.95 9.81 224 320368 23660 64154480
Blood electrolytes abnormal 36.82 9.81 45 320547 1746 64176394
Oedema mouth 36.18 9.81 57 320535 2816 64175324
Neurotoxicity 36.11 9.81 50 320542 27354 64150786
Lung disorder 35.96 9.81 167 320425 60533 64117607
Product coating issue 35.96 9.81 13 320579 49 64178091
Pathogen resistance 35.93 9.81 9 320583 12534 64165606
Blood sodium decreased 35.64 9.81 260 320332 29222 64148918
Emotional distress 35.42 9.81 303 320289 35735 64142405
Spinal stenosis 35.20 9.81 150 320442 13781 64164359
Pneumonitis 35.18 9.81 130 320462 50235 64127905
Cytokine release syndrome 35.16 9.81 31 320561 20798 64157342
Productive cough 34.73 9.81 217 320375 72986 64105154
Blood lactate dehydrogenase increased 34.66 9.81 70 320522 33008 64145132
Wheezing 34.59 9.81 578 320014 80001 64098139
Overdose 34.58 9.81 571 320021 158995 64019145
Body temperature decreased 34.48 9.81 47 320545 25881 64152259
Tuberculosis 34.30 9.81 11 320581 13027 64165113
Device interaction 33.94 9.81 28 320564 670 64177470
Product substitution issue 33.92 9.81 177 320415 17684 64160456
Gout 33.88 9.81 202 320390 21211 64156929
Blood pressure increased 33.26 9.81 1107 319485 171445 64006695
Eosinophilia 33.13 9.81 89 320503 37987 64140153
Transplant rejection 33.03 9.81 23 320569 17378 64160762
Orbital myositis 32.92 9.81 16 320576 143 64177997
Muscle spasms 32.86 9.81 926 319666 140097 64038043
Vision blurred 32.80 9.81 631 319961 89685 64088455
Rheumatoid nodule 32.71 9.81 11 320581 12640 64165500
Asthma 32.17 9.81 310 320282 94915 64083225
Mydriasis 32.16 9.81 18 320574 15294 64162846
Nausea 32.12 9.81 4414 316178 781386 63396754
Diabetic ketoacidosis 32.05 9.81 256 320336 29589 64148551
Drooling 31.76 9.81 77 320515 5242 64172898
Hyperthermia 31.64 9.81 19 320573 15531 64162609
Hypertensive emergency 31.25 9.81 47 320545 2229 64175911
Ill-defined disorder 31.23 9.81 113 320479 43939 64134201
Musculoskeletal stiffness 31.12 9.81 428 320164 122778 64055362
Glossodynia 31.10 9.81 191 320401 64505 64113635
Arteriosclerosis coronary artery 30.96 9.81 156 320436 15373 64162767
Graft versus host disease 30.85 9.81 15 320577 13798 64164342
Hyperbilirubinaemia 30.74 9.81 36 320556 21169 64156971
Accelerated hypertension 30.63 9.81 25 320567 589 64177551
Epstein-Barr virus infection 30.36 9.81 12 320580 12476 64165664
Angina pectoris 30.18 9.81 350 320242 44731 64133409
Pelvic mass 30.01 9.81 32 320560 1068 64177072
Hypoglycaemia 29.96 9.81 620 319972 89272 64088868
Pharyngeal swelling 29.55 9.81 77 320515 5482 64172658
Red blood cell sedimentation rate increased 29.51 9.81 70 320522 31165 64146975
Laryngeal oedema 29.45 9.81 90 320502 7023 64171117
Post transplant lymphoproliferative disorder 29.04 9.81 6 320586 9538 64168602
Cystitis haemorrhagic 28.81 9.81 3 320589 7953 64170187
Dilatation atrial 28.62 9.81 57 320535 3393 64174747
Sedation complication 28.58 9.81 8 320584 10346 64167794
Stridor 28.50 9.81 70 320522 4804 64173336
Generalised tonic-clonic seizure 28.41 9.81 102 320490 39755 64138385
Prostate cancer recurrent 28.38 9.81 26 320566 719 64177421
Atrioventricular block first degree 28.23 9.81 117 320475 10617 64167523
Second primary malignancy 28.16 9.81 13 320579 12324 64165816
Somatic delusion 28.09 9.81 25 320567 665 64177475
Multiple organ dysfunction syndrome 27.92 9.81 346 320246 101067 64077073
Upper gastrointestinal haemorrhage 27.53 9.81 282 320310 34938 64143202
Extrapyramidal disorder 27.48 9.81 34 320558 19518 64158622
Drug eruption 27.44 9.81 90 320502 36046 64142094
Cognitive disorder 27.33 9.81 161 320431 54926 64123214
Full blood count decreased 27.21 9.81 199 320393 22383 64155757
Diabetic neuropathy 27.17 9.81 75 320517 5526 64172614
Venoocclusive liver disease 27.16 9.81 8 320584 10007 64168133
Irritable bowel syndrome 27.06 9.81 95 320497 37274 64140866
Aplastic anaemia 26.96 9.81 18 320574 13902 64164238
Rash maculo-papular 26.91 9.81 131 320461 46895 64131245
Bone erosion 26.81 9.81 12 320580 11583 64166557
Myelodysplastic syndrome 26.70 9.81 61 320531 27518 64150622
Pancreatitis necrotising 26.50 9.81 53 320539 3164 64174976
Mouth swelling 26.39 9.81 70 320522 5037 64173103
Neutropenic sepsis 26.35 9.81 47 320545 23225 64154915
Panniculitis 26.16 9.81 6 320586 8873 64169267
Impaired healing 25.81 9.81 185 320407 60288 64117852
Ventricular hypertrophy 25.64 9.81 81 320511 6435 64171705
Caesarean section 25.55 9.81 12 320580 11262 64166878
Similar reaction on previous exposure to drug 25.41 9.81 12 320580 100 64178040
Body temperature increased 25.37 9.81 95 320497 36571 64141569
Suicide attempt 25.34 9.81 228 320364 70779 64107361
Erectile dysfunction 25.28 9.81 127 320465 12500 64165640
Atrioventricular block second degree 25.19 9.81 80 320512 6374 64171766
Bronchiectasis 25.15 9.81 20 320572 14120 64164020
Chronic obstructive pulmonary disease 24.99 9.81 494 320098 70554 64107586
Oral herpes 24.85 9.81 45 320547 22107 64156033
Polyneuropathy 24.55 9.81 38 320554 19856 64158284
Intentional product use issue 24.54 9.81 330 320262 95034 64083106
Osteonecrosis of jaw 24.53 9.81 108 320484 39717 64138423
Pneumonia aspiration 24.49 9.81 183 320409 59088 64119052
Ageusia 24.27 9.81 134 320458 13679 64164461
Aplasia 24.23 9.81 3 320589 6950 64171190
Cardiac arrest 24.22 9.81 966 319626 153098 64025042
Mitral valve incompetence 24.20 9.81 213 320379 25325 64152815
Potassium wasting nephropathy 23.82 9.81 13 320579 151 64177989
Dysgeusia 23.81 9.81 347 320245 46700 64131440
Arterial occlusive disease 23.73 9.81 83 320509 6950 64171190
Feeling abnormal 23.70 9.81 849 319743 132753 64045387
Ulnar nerve palsy 23.61 9.81 7 320585 11 64178129
Hepatic cytolysis 23.60 9.81 21 320571 14028 64164112
Diarrhoea 23.57 9.81 4009 316583 718695 63459445
Platelet count decreased 23.47 9.81 644 319948 167067 64011073
Blood pressure systolic abnormal 23.44 9.81 10 320582 9932 64168208
Oedema genital 23.37 9.81 19 320573 445 64177695
Diabetic foot infection 23.32 9.81 23 320569 699 64177441
Acute myeloid leukaemia 23.29 9.81 65 320527 27398 64150742
Blood loss anaemia 23.24 9.81 133 320459 13759 64164381
Haemodialysis 23.23 9.81 155 320437 16922 64161218
Pulmonary tuberculosis 23.22 9.81 4 320588 7240 64170900
Infective pulmonary exacerbation of cystic fibrosis 23.19 9.81 15 320577 11781 64166359
Factor VII deficiency 23.03 9.81 8 320584 26 64178114
Aspartate aminotransferase increased 22.97 9.81 438 320154 119350 64058790
Weight increased 22.94 9.81 848 319744 212500 63965640
Transaminases increased 22.84 9.81 129 320463 44465 64133675
Unevaluable event 22.71 9.81 365 320227 50124 64128016
Herpes zoster 22.62 9.81 268 320324 78919 64099221
Stent placement 22.61 9.81 70 320522 5501 64172639
Cough 22.58 9.81 1769 318823 300379 63877761
Blood cholesterol increased 22.54 9.81 362 320230 49704 64128436
Myalgia 22.53 9.81 984 319608 157633 64020507
Non-cardiac chest pain 22.35 9.81 94 320498 8586 64169554
Fall 22.29 9.81 2382 318210 414444 63763696
Cardiac failure 22.13 9.81 495 320097 131878 64046262
Suspected suicide attempt 22.10 9.81 15 320577 264 64177876
Aphthous ulcer 22.03 9.81 19 320573 12887 64165253
Gangrene 21.72 9.81 83 320509 7255 64170885
Pulmonary renal syndrome 21.65 9.81 20 320572 559 64177581
Acne 21.58 9.81 52 320540 23029 64155111
Electrocardiogram T wave abnormal 21.57 9.81 50 320542 3306 64174834
Osmolar gap increased 21.57 9.81 8 320584 33 64178107
Angiotensin converting enzyme inhibitor foetopathy 21.55 9.81 5 320587 0 64178140
Poor venous access 21.54 9.81 18 320574 12399 64165741
Azotaemia 21.51 9.81 84 320508 7418 64170722
Sight disability 21.49 9.81 11 320581 111 64178029
Rectal haemorrhage 21.47 9.81 429 320163 61388 64116752
Dystonia 21.45 9.81 38 320554 18827 64159313
Enterocolitis 21.37 9.81 17 320575 12001 64166139
Drug dependence 21.34 9.81 89 320503 33223 64144917
Chronic graft versus host disease 21.17 9.81 3 320589 6273 64171867
No reaction on previous exposure to drug 21.05 9.81 14 320578 238 64177902
Cytomegalovirus viraemia 20.97 9.81 14 320578 10814 64167326
Device related infection 20.77 9.81 80 320512 30546 64147594
Metabolic acidosis 20.65 9.81 480 320112 70478 64107662
Rotator cuff repair 20.65 9.81 31 320561 1468 64176672
Peripheral vascular disorder 20.58 9.81 81 320511 7180 64170960
Acute coronary syndrome 20.39 9.81 165 320427 19145 64158995
Ovarian cyst 20.34 9.81 15 320577 11003 64167137
Muscle relaxant therapy 20.30 9.81 12 320580 164 64177976
Memory impairment 20.05 9.81 563 320029 85119 64093021
Raynaud's phenomenon 20.04 9.81 25 320567 991 64177149
Diverticulum 19.92 9.81 123 320469 13075 64165065
Hepatic ischaemia 19.92 9.81 25 320567 997 64177143
Colitis ulcerative 19.90 9.81 54 320538 22974 64155166
Hypoaldosteronism 19.80 9.81 15 320577 316 64177824
Blood parathyroid hormone decreased 19.76 9.81 6 320586 7360 64170780
Encephalitis 19.70 9.81 20 320572 12551 64165589
Penile swelling 19.68 9.81 19 320573 562 64177578
Unresponsive to stimuli 19.65 9.81 356 320236 50037 64128103
Foetal death 19.62 9.81 3 320589 5927 64172213
Colitis ischaemic 19.62 9.81 124 320468 13290 64164850
Dermatitis exfoliative generalised 19.56 9.81 3 320589 5913 64172227
Cardiac murmur 19.54 9.81 111 320481 11452 64166688
Speech disorder 19.52 9.81 344 320248 48097 64130043
Pseudomonas infection 19.46 9.81 37 320555 17846 64160294
Thermohypoaesthesia 19.44 9.81 10 320582 102 64178038
Substance abuse 19.41 9.81 11 320581 9281 64168859
Electrocardiogram change 19.35 9.81 26 320566 1110 64177030
Carcinoid tumour of the gastrointestinal tract 19.26 9.81 9 320583 73 64178067
Premature labour 19.06 9.81 7 320585 7613 64170527
Hypogammaglobulinaemia 19.04 9.81 14 320578 10285 64167855
Oral candidiasis 18.90 9.81 56 320536 23156 64154984
Renal artery stenosis 18.83 9.81 44 320548 2925 64175215
Blood glucose abnormal 18.81 9.81 91 320501 8822 64169318
Mouth ulceration 18.78 9.81 90 320502 32354 64145786
Pulseless electrical activity 18.78 9.81 118 320474 12621 64165519
Renal tubular acidosis 18.73 9.81 44 320548 2935 64175205
Anal abscess 18.61 9.81 7 320585 7501 64170639
Concomitant disease aggravated 18.51 9.81 18 320574 11524 64166616
Oropharyngeal swelling 18.40 9.81 26 320566 1165 64176975
Rhabdomyolysis 18.31 9.81 591 320001 91135 64087005
Candida infection 18.28 9.81 87 320505 31332 64146808
Spur cell anaemia 18.27 9.81 9 320583 83 64178057
Graft versus host disease in gastrointestinal tract 18.21 9.81 3 320589 5609 64172531
Eye swelling 18.18 9.81 180 320412 22101 64156039
Lip oedema 18.17 9.81 62 320530 5127 64173013
Grip strength decreased 18.16 9.81 110 320482 11614 64166526
Acquired acrodermatitis enteropathica 18.11 9.81 5 320587 5 64178135
Dialysis 18.09 9.81 145 320447 16775 64161365
Drug dispensed to wrong patient 18.08 9.81 15 320577 362 64177778
BRASH syndrome 18.08 9.81 15 320577 362 64177778
Enthesopathy 17.95 9.81 13 320579 9625 64168515
Rheumatoid factor positive 17.93 9.81 101 320491 34837 64143303
Immunodeficiency 17.87 9.81 33 320559 16091 64162049
Miosis 17.69 9.81 24 320568 13242 64164898
Adenovirus infection 17.59 9.81 7 320585 7248 64170892
Tachycardia 17.57 9.81 588 320004 148991 64029149
Lid lag 17.43 9.81 8 320584 62 64178078
Eosinophil count increased 17.37 9.81 27 320565 14085 64164055
Body height decreased 17.31 9.81 79 320513 7475 64170665
Poisoning deliberate 17.29 9.81 25 320567 13433 64164707
Lethargy 17.27 9.81 478 320114 72116 64106024
Urethral prolapse 17.24 9.81 4 320588 0 64178140
Respiratory disorder 17.15 9.81 107 320485 36004 64142136
Myxoedema coma 17.03 9.81 19 320573 668 64177472
Uveitis 16.93 9.81 23 320569 12685 64165455
Posterior reversible encephalopathy syndrome 16.84 9.81 58 320534 22888 64155252
Hypertension 16.83 9.81 1502 319090 257759 63920381
Sinusitis 16.82 9.81 575 320017 145353 64032787
Hyponatraemia 16.80 9.81 900 319692 147439 64030701
Benign gastrointestinal neoplasm 16.77 9.81 10 320582 139 64178001
Therapeutic response decreased 16.74 9.81 172 320420 52016 64126124
Carotid artery stenosis 16.70 9.81 81 320511 7860 64170280
Pulmonary fibrosis 16.65 9.81 84 320508 29794 64148346
Conjunctivitis 16.65 9.81 49 320543 20305 64157835
Electrocardiogram QT prolonged 16.64 9.81 286 320306 79162 64098978
Device dislocation 16.60 9.81 52 320540 21126 64157014
Depression 16.58 9.81 1090 319502 182201 63995939
Essential hypertension 16.42 9.81 60 320532 5134 64173006
Hyperammonaemia 16.40 9.81 15 320577 9889 64168251
Expired product administered 16.33 9.81 66 320526 5921 64172219
Cholelithiasis 16.20 9.81 317 320275 45189 64132951
Toxic epidermal necrolysis 16.20 9.81 113 320479 37053 64141087
Torsade de pointes 16.03 9.81 144 320448 17219 64160921
Macroglossia 15.97 9.81 23 320569 1049 64177091
Pancreatitis haemorrhagic 15.93 9.81 17 320575 568 64177572
Device expulsion 15.80 9.81 53 320539 21083 64157057
Peripheral sensory neuropathy 15.77 9.81 20 320572 11358 64166782
Dyspnoea 15.76 9.81 3911 316681 714763 63463377
Abortion induced 15.76 9.81 6 320586 6382 64171758
Hypoaesthesia 15.75 9.81 844 319748 138264 64039876
Pollakiuria 15.74 9.81 232 320360 31298 64146842
Migraine 15.72 9.81 218 320374 62459 64115681
Tricuspid valve incompetence 15.69 9.81 141 320451 16862 64161278
Respiratory tract infection 15.69 9.81 115 320477 37292 64140848
Facial nerve disorder 15.68 9.81 18 320574 653 64177487
Sleep disorder due to a general medical condition 15.48 9.81 11 320581 8223 64169917
Product monitoring error 15.46 9.81 4 320588 5450 64172690
Blood pressure systolic increased 15.45 9.81 164 320428 49289 64128851
Abnormal dreams 15.31 9.81 96 320496 10260 64167880
Acute respiratory distress syndrome 15.25 9.81 122 320470 38813 64139327
Charles Bonnet syndrome 15.21 9.81 5 320587 13 64178127
Eczema 15.20 9.81 86 320506 29634 64148506
Hepatitis acute 15.20 9.81 27 320565 13362 64164778
Therapeutic response unexpected 15.19 9.81 140 320452 16861 64161279
Immune-mediated myositis 15.17 9.81 38 320554 2640 64175500
BK virus infection 15.16 9.81 9 320583 7403 64170737
Tonsillitis 15.15 9.81 5 320587 5815 64172325
Amnesia 15.13 9.81 330 320262 47939 64130201
Pre-eclampsia 15.12 9.81 6 320586 6225 64171915
Helicobacter infection 15.12 9.81 120 320472 38242 64139898
Diverticulum intestinal haemorrhagic 15.10 9.81 43 320549 3226 64174914
Conjunctival scar 15.03 9.81 8 320584 88 64178052
Hepatitis B reactivation 15.03 9.81 3 320589 4886 64173254
Cardiomegaly 15.02 9.81 182 320410 23502 64154638
Graft versus host disease in skin 15.00 9.81 4 320588 5343 64172797
Ileus paralytic 14.85 9.81 12 320580 8403 64169737
Fluid intake reduced 14.73 9.81 58 320534 5142 64172998
Refusal of treatment by patient 14.72 9.81 81 320511 8258 64169882
Endometriosis male 14.69 9.81 5 320587 15 64178125
Haemolysis 14.69 9.81 20 320572 11019 64167121
Paradoxical drug reaction 14.68 9.81 6 320586 6114 64172026
Alanine aminotransferase abnormal 14.61 9.81 8 320584 6880 64171260
Prescribed overdose 14.58 9.81 160 320432 20171 64157969
Nephrogenic systemic fibrosis 14.55 9.81 63 320529 5829 64172311
Alcoholic ketoacidosis 14.45 9.81 5 320587 16 64178124
Prostate examination abnormal 14.44 9.81 9 320583 136 64178004
Drug use disorder 14.42 9.81 6 320586 6048 64172092
Seizure 14.41 9.81 680 319912 166212 64011928
Inappropriate schedule of product administration 14.33 9.81 349 320243 91937 64086203
Encephalomalacia 14.23 9.81 22 320570 1069 64177071
Discomfort 14.22 9.81 300 320292 80578 64097562
Blood glucose fluctuation 14.19 9.81 63 320529 5892 64172248
Enlarged uvula 14.14 9.81 13 320579 361 64177779
Herpes simplex 14.11 9.81 19 320573 10517 64167623
Oropharyngeal pain 14.09 9.81 335 320257 88532 64089608
Labelled drug-drug interaction medication error 14.09 9.81 59 320533 22003 64156137
Neutrophil count increased 13.90 9.81 71 320521 25103 64153037
Fear of injection 13.85 9.81 6 320586 5906 64172234
Ear pain 13.82 9.81 71 320521 25065 64153075
Retching 13.82 9.81 126 320466 15130 64163010
Neutropenic colitis 13.69 9.81 3 320589 4578 64173562
Tumour lysis syndrome 13.69 9.81 50 320542 19390 64158750
End stage renal disease 13.60 9.81 94 320498 10381 64167759
Gastric ulcer helicobacter 13.60 9.81 5 320587 20 64178120
Penile contusion 13.55 9.81 8 320584 109 64178031
Blood bilirubin increased 13.45 9.81 203 320389 57350 64120790
Malaise 13.40 9.81 1745 318847 394502 63783638
Fracture 13.36 9.81 48 320544 18707 64159433
Laryngotracheal oedema 13.35 9.81 6 320586 44 64178096
Drug-induced liver injury 13.31 9.81 162 320430 47481 64130659
Foot deformity 13.31 9.81 40 320552 16464 64161676
Hypertensive crisis 13.27 9.81 144 320448 18104 64160036
Pseudomembranous colitis 13.20 9.81 4 320588 4912 64173228
Schizophrenia 13.15 9.81 22 320570 11146 64166994
Occult blood positive 13.13 9.81 64 320528 6223 64171917
Gastric cancer 13.12 9.81 8 320584 6485 64171655
Paraesthesia 13.07 9.81 805 319787 133717 64044423
Sepsis 13.01 9.81 977 319615 229364 63948776
Anaemia 13.00 9.81 1666 318926 377014 63801126
Fear of eating 13.00 9.81 13 320579 402 64177738
Liver abscess 12.96 9.81 5 320587 5275 64172865
Hypertensive heart disease 12.93 9.81 45 320547 3759 64174381
Respiratory tract oedema 12.88 9.81 17 320575 713 64177427
Respiratory distress 12.85 9.81 346 320246 51985 64126155
Device difficult to use 12.79 9.81 18 320574 9780 64168360
Product physical issue 12.78 9.81 42 320550 3407 64174733
Cystitis 12.74 9.81 143 320449 42532 64135608
Erythema multiforme 12.70 9.81 38 320554 15663 64162477
Fistula 12.67 9.81 18 320574 9743 64168397
Pulse absent 12.65 9.81 82 320510 8864 64169276
Orthostatic hypotension 12.63 9.81 313 320279 46425 64131715
Uvulitis 12.57 9.81 4 320588 9 64178131
Sinus node dysfunction 12.51 9.81 67 320525 6761 64171379
Dyspnoea at rest 12.51 9.81 8 320584 6321 64171819
Nodal rhythm 12.50 9.81 37 320555 2837 64175303
Sleep attacks 12.49 9.81 9 320583 175 64177965
Hypoglycaemic unconsciousness 12.44 9.81 21 320571 1100 64177040
Bundle branch block left 12.42 9.81 89 320503 9945 64168195
Foetal disorder 12.39 9.81 8 320584 129 64178011
Brain oedema 12.34 9.81 62 320530 22013 64156127
Lymphoproliferative disorder 12.25 9.81 5 320587 5098 64173042
Fatigue 12.19 9.81 4025 316567 744705 63433435
Skin toxicity 12.17 9.81 9 320583 6593 64171547
Coronary artery surgery 12.15 9.81 9 320583 183 64177957
Cytopenia 12.12 9.81 38 320554 15433 64162707
Deep vein thrombosis 12.07 9.81 639 319953 104543 64073597
Lacunar infarction 12.05 9.81 57 320535 5475 64172665
Sinus bradycardia 12.04 9.81 170 320422 22723 64155417
Immunosuppressant drug level increased 12.02 9.81 11 320581 7248 64170892
Vitreous floaters 11.99 9.81 63 320529 6310 64171830
Duodenal ulcer perforation 11.99 9.81 112 320480 34513 64143627
Mobility decreased 11.90 9.81 330 320262 85510 64092630
Intestinal obstruction 11.88 9.81 119 320473 36167 64141973
Metastases to liver 11.86 9.81 70 320522 23871 64154269
Gastrooesophageal reflux disease 11.84 9.81 516 320076 82627 64095513
Exercise tolerance increased 11.83 9.81 5 320587 31 64178109
Eosinophilic oesophagitis 11.79 9.81 13 320579 451 64177689
Hypertransaminasaemia 11.78 9.81 11 320581 7180 64170960
Pneumopericardium 11.78 9.81 8 320584 141 64177999
Dysphonia 11.77 9.81 308 320284 46074 64132066
Infusion site pain 11.77 9.81 21 320571 10376 64167764
Epiglottic oedema 11.65 9.81 10 320582 253 64177887
Endotracheal intubation complication 11.61 9.81 16 320576 700 64177440
Eyelid margin crusting 11.58 9.81 16 320576 702 64177438
Thrombosis 11.57 9.81 445 320147 70197 64107943
Apathy 11.57 9.81 24 320568 11208 64166932
Gastrointestinal toxicity 11.55 9.81 6 320586 5316 64172824
Clonus 11.54 9.81 8 320584 6059 64172081
Transient psychosis 11.51 9.81 6 320586 63 64178077
Nodule 11.46 9.81 48 320544 17899 64160241
Hepatocellular carcinoma 11.41 9.81 15 320577 8388 64169752
Palatal swelling 11.40 9.81 8 320584 149 64177991
Treatment noncompliance 11.40 9.81 290 320302 43192 64134948
Cerebral thrombosis 11.37 9.81 30 320562 2152 64175988
Behaviour disorder 11.33 9.81 4 320588 4458 64173682
Acute lymphocytic leukaemia recurrent 11.32 9.81 3 320589 4023 64174117
Hepatic encephalopathy 11.30 9.81 60 320532 21006 64157134
Shock haemorrhagic 11.30 9.81 44 320548 16747 64161393
Depressed mood 11.25 9.81 140 320452 40872 64137268
Pain in jaw 11.23 9.81 139 320453 40616 64137524
Neurological decompensation 11.22 9.81 4 320588 4432 64173708
Body temperature 11.20 9.81 5 320587 36 64178104
Multiple injuries 11.19 9.81 39 320553 3260 64174880
High density lipoprotein decreased 11.17 9.81 44 320548 3902 64174238
Asphyxia 11.12 9.81 19 320573 9547 64168593
Skin odour abnormal 11.12 9.81 27 320565 1840 64176300
Albumin urine present 11.06 9.81 15 320577 646 64177494
Product solubility abnormal 11.06 9.81 17 320575 822 64177318
Transcription medication error 11 9.81 11 320581 340 64177800
Small intestinal ulcer haemorrhage 11.00 9.81 7 320585 110 64178030
Muscle rigidity 10.99 9.81 47 320545 17426 64160714
Pseudomonal sepsis 10.98 9.81 6 320586 5166 64172974
Ludwig angina 10.92 9.81 9 320583 215 64177925
Pharyngitis 10.91 9.81 53 320539 18986 64159154
Drug specific antibody present 10.91 9.81 6 320586 5148 64172992
Erythema marginatum 10.88 9.81 4 320588 16 64178124
Gastrointestinal vascular malformation 10.87 9.81 5 320587 39 64178101
Pulse volume decreased 10.86 9.81 3 320589 3 64178137
Hospice care 10.85 9.81 70 320522 7555 64170585
Parkinsonism 10.77 9.81 36 320556 14337 64163803
Disturbance in social behaviour 10.73 9.81 3 320589 3884 64174256
Mixed liver injury 10.73 9.81 7 320585 5474 64172666
Facet joint syndrome 10.72 9.81 27 320565 1882 64176258
Acute generalised exanthematous pustulosis 10.68 9.81 35 320557 14023 64164117
Skin necrosis 10.66 9.81 36 320556 14293 64163847
Skin induration 10.58 9.81 45 320547 4130 64174010
Cataract nuclear 10.57 9.81 18 320574 949 64177191
Contrast media reaction 10.57 9.81 26 320566 1786 64176354
Blood immunoglobulin E increased 10.55 9.81 3 320589 3841 64174299
Nystagmus 10.55 9.81 18 320574 9050 64169090
Metastases to bone 10.52 9.81 59 320533 20376 64157764
Anxiety 10.51 9.81 1156 319436 201493 63976647
Uraemic encephalopathy 10.49 9.81 13 320579 512 64177628
Burning sensation 10.44 9.81 322 320270 49342 64128798
Metastases to lymph nodes 10.42 9.81 17 320575 8700 64169440
Cerebellar syndrome 10.39 9.81 6 320586 5010 64173130
Oedema peripheral 10.26 9.81 1195 319397 209122 63969018
Atrioventricular block 10.26 9.81 98 320494 11917 64166223
Subileus 10.24 9.81 6 320586 4971 64173169
Dry mouth 10.23 9.81 382 320210 60036 64118104
Anti-neutrophil cytoplasmic antibody positive vasculitis 10.21 9.81 35 320557 2901 64175239
Enterococcal infection 10.21 9.81 35 320557 13831 64164309
Hepatic failure 10.17 9.81 204 320388 55190 64122950
Visceral oedema 10.17 9.81 4 320588 20 64178120
Lichen planus 10.15 9.81 30 320562 2298 64175842
Transplant dysfunction 10.15 9.81 11 320581 6697 64171443
Lower gastrointestinal haemorrhage 10.14 9.81 110 320482 13829 64164311
Fungal infection 10.14 9.81 115 320477 34136 64144004
Anaphylactic shock 10.12 9.81 99 320493 30229 64147911
Blood pressure diastolic decreased 10.12 9.81 67 320525 22234 64155906
Kidney transplant rejection 10.07 9.81 20 320572 9491 64168649
Peripheral artery stenosis 10.06 9.81 20 320572 1189 64176951
Drug level increased 10.05 9.81 115 320477 34081 64144059
Sinus arrhythmia 10.04 9.81 26 320566 1844 64176296
Dilatation ventricular 10.03 9.81 42 320550 3828 64174312
Coronary artery dissection 10.03 9.81 17 320575 893 64177247
Therapy non-responder 10.02 9.81 250 320342 65649 64112491
Retroperitoneal oedema 10.01 9.81 4 320588 21 64178119
Toxic shock syndrome staphylococcal 10.01 9.81 3 320589 5 64178135
Pulmonary toxicity 9.96 9.81 17 320575 8544 64169596
Carotid artery occlusion 9.95 9.81 43 320549 3974 64174166
Granuloma 9.92 9.81 11 320581 6630 64171510
Diabetes mellitus inadequate control 9.91 9.81 155 320437 21166 64156974
Peripancreatic fluid collection 9.89 9.81 5 320587 49 64178091
Carcinoid tumour of the stomach 9.89 9.81 8 320584 186 64177954
Throat tightness 9.88 9.81 166 320426 22994 64155146
Toe amputation 9.88 9.81 39 320553 3461 64174679
Prostatic specific antigen increased 9.88 9.81 76 320516 8684 64169456
Chronic sinusitis 9.87 9.81 10 320582 6282 64171858
Electrocardiogram ST-T change 9.87 9.81 23 320569 1526 64176614
Poor quality device used 9.86 9.81 27 320565 1980 64176160

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09AA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, PLAIN
ACE inhibitors, plain
ATC C09BA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and diuretics
ATC C09BB03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C10BX07 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
CHEBI has role CHEBI:35674 antihypertensive drugs
MeSH PA D000806 Angiotensin-Converting Enzyme Inhibitors
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002316 Cardiotonic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
MeSH PA D020011 Protective Agents

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

DiseaseRelationSNOMED_IDDOID
Myocardial infarction indication 22298006 DOID:5844
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Superficial Ocular Infection indication
Diabetic retinopathy off-label use 4855003 DOID:8947
Atrial fibrillation off-label use 49436004 DOID:0060224
Blepharoconjunctivitis off-label use 68659002 DOID:2456
Dacryocystitis off-label use 85777005 DOID:9938
Corneal ulcer off-label use 91514001 DOID:8463
Diabetic renal disease off-label use 127013003
Bacterial conjunctivitis off-label use 128350005 DOID:9700
Acute scleroderma renal crisis off-label use 236503001
Meibomianitis off-label use 309779001
Infective blepharitis off-label use 312219000
Bacterial keratitis off-label use 314557000
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Migraine Prevention off-label use
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Jaundice contraindication 18165001
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Acute cerebrovascular insufficiency contraindication 29322000
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Immunosuppression contraindication 38013005
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Aortic valve stenosis contraindication 60573004 DOID:1712
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Disorder of connective tissue contraindication 105969002 DOID:65
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Acute hepatic failure contraindication 197270009
Acute pancreatitis contraindication 197456007 DOID:2913
Hypertrophic cardiomyopathy contraindication 233873004 DOID:11984
Disease of liver contraindication 235856003 DOID:409
Disorder of electrolytes contraindication 237840007
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Azotemia contraindication 445009001
Hemodialysis with High-Flux Membrane contraindication
Intestinal Angioedema contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.18 acidic
pKa2 3.18 acidic
pKa3 11.0 Basic
pKa4 6.95 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 ACUTE MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 METHOD OF TREATING HYPERTENSION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 REDUCTION OF MORTALITY IN ACUTE MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 TREATMENT OF HEART FAILURE
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 TREATMENT OF HYPERTENSION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10039800 Nov. 6, 2035 TREATMENT OF MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 ACUTE MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 METHOD OF TREATING HYPERTENSION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 REDUCTION OF MORTALITY IN ACUTE MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 TREATMENT OF HEART FAILURE
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 TREATMENT OF HYPERTENSION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 10406199 Nov. 6, 2035 TREATMENT OF MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 ACUTE MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 METHOD OF TREATING HYPERTENSION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 REDUCTION OF MORTALITY IN ACUTE MYOCARDIAL INFARCTION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 TREATMENT OF HEART FAILURE
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 TREATMENT OF HYPERTENSION
1MG/ML QBRELIS AZURITY N208401 July 29, 2016 RX SOLUTION ORAL 9616096 Nov. 6, 2035 TREATMENT OF MYOCARDIAL INFARCTION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Angiotensin-converting enzyme Enzyme INHIBITOR IC50 8.92 WOMBAT-PK CHEMBL
Angiotensin-converting enzyme Enzyme Ki 7.29 CHEMBL

External reference:

IDSource
4019380 VUID
N0000147537 NUI
D00362 KEGG_DRUG
4019380 VANDF
C0065374 UMLSCUI
CHEBI:6503 CHEBI
LPR PDB_CHEM_ID
CHEMBL1237 ChEMBL_ID
CHEMBL1729579 ChEMBL_ID
CHEMBL419213 ChEMBL_ID
D017706 MESH_DESCRIPTOR_UI
DB00722 DRUGBANK_ID
5362119 PUBCHEM_CID
6360 IUPHAR_LIGAND_ID
E7199S1YWR UNII
29046 RXNORM
31907 MMSL
44066 MMSL
4985 MMSL
d00732 MMSL
000658 NDDF
108575001 SNOMEDCT_US
341000220102 SNOMEDCT_US
386873009 SNOMEDCT_US
83915-83-7 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lisinopril with Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0143-1262 TABLET 10 mg ORAL ANDA 24 sections
Lisinopril with Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0143-1263 TABLET 20 mg ORAL ANDA 24 sections
Lisinopril with Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0143-1264 TABLET 20 mg ORAL ANDA 24 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0143-9713 TABLET 20 mg ORAL ANDA 26 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0143-9714 TABLET 10 mg ORAL ANDA 26 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0143-9715 TABLET 5 mg ORAL ANDA 26 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0025 TABLET 2.50 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0101 TABLET 10 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0102 TABLET 20 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0103 TABLET 30 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0104 TABLET 40 mg ORAL ANDA 25 sections
Lisinopril and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0185-0152 TABLET 20 mg ORAL ANDA 22 sections
Lisinopril and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0185-0173 TABLET 20 mg ORAL ANDA 22 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0602 TABLET 2.50 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0605 TABLET 5 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0610 TABLET 10 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0620 TABLET 20 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0630 TABLET 30 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-0640 TABLET 40 mg ORAL ANDA 25 sections
lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0185-5400 TABLET 5 mg ORAL ANDA 25 sections
Lisinopril and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0185-7100 TABLET 10 mg ORAL ANDA 22 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0440-7674 TABLET 5 mg ORAL ANDA 21 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0591-0405 TABLET 2.50 mg ORAL ANDA 26 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0591-0406 TABLET 5 mg ORAL ANDA 26 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0591-0407 TABLET 10 mg ORAL ANDA 26 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0591-0408 TABLET 20 mg ORAL ANDA 26 sections
Lisinopril HUMAN PRESCRIPTION DRUG LABEL 1 0591-0409 TABLET 40 mg ORAL ANDA 26 sections
Lisinopril and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0591-0860 TABLET 10 mg ORAL ANDA 20 sections
Lisinopril and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0591-0861 TABLET 20 mg ORAL ANDA 20 sections
Lisinopril and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0591-0862 TABLET 20 mg ORAL ANDA 20 sections