enalapril 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
angiotensin-converting enzyme inhibitors 1005 75847-73-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • enalapril
  • enalapril maleate
  • enarenal
Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion.
  • Molecular weight: 376.45
  • Formula: C20H28N2O5
  • CLOGP: 0.67
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 95.94
  • ALOGS: -3.25
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O
10 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 16.40 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.77 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 63.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.031 High 0.82
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.041 High 0.82
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 1.122 10^-6 cm/s High 0.82
dh-clint Dog hepatocyte intrinsic clearance 5.888 uL/min/10^6 cells High 0.82
dppb Dog plasma protein binding (% unbound) 54.930 % High 0.82
fcs-ppb Fetal calf serum protein binding (% unbound) 44.780 % High 0.82
herg hERG pIC50 4.163 pIC50 High 0.82
hh-clint Human hepatocyte intrinsic clearance 5.433 uL/min/10^6 cells High 0.82
hlm-clint Human liver microsomal intrinsic clearance 4.102 uL/min/mg protein High 0.82
hppb Human plasma protein binding (% unbound) 53.730 % High 0.82
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAP3K7,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,STK33,SYK,TEK,TGFBR1 29
kinase-selectivity-class ACVR2B,AXL,BRAF,EPHB4,GRK2,MAP2K6,STK33,TEK,TGFBR1 9
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.741 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.891 High 0.82
mh-clint Mouse hepatocyte intrinsic clearance 43.954 High 0.82
mppb Mouse plasma protein binding (% unbound) 50.460 High 0.82
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.523 High 0.82
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.65
pppb Pig plasma protein binding (% unbound) 51.840 % High 0.82
rat-kpuu-brain Rat brain Kpuu 0.006 % High 1
rh-clint Rat hepatocyte intrinsic clearance 35.892 uL/min/10^6 cells High 0.82
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.980 % High 0.82
rppb Rat plasma protein binding (% unbound) 37.060 % High 0.82
solubility-dd Solubility at pH 7.4 in DMSO 961.612 uM High 0.82

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1985 FDA VALEANT PHARMS NORTH
Nov. 15, 2023 EMA Proveca Pharma Limited

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
Drug interaction 766.99 10.12 1015 70603 275438 90281391
Acute kidney injury 762.26 10.12 1092 70526 319295 90237534
Hyperkalaemia 699.99 10.12 504 71114 64460 90492369
Hyponatraemia 512.04 10.12 578 71040 132960 90423869
Cardiac failure congestive 415.89 10.12 449 71169 98245 90458584
Angioedema 279.95 10.12 299 71319 64577 90492252
Cardiac failure 253.26 10.12 369 71249 109127 90447702
Pemphigus 234.03 10.12 5 71613 326859 90229970
Synovitis 221.73 10.12 9 71609 329743 90227086
Hypoglycaemia 214.15 10.12 270 71348 69578 90487251
Hand deformity 202.99 10.12 7 71611 296355 90260474
Lactic acidosis 197.54 10.12 221 71397 50242 90506587
Systemic lupus erythematosus 191.08 10.12 29 71589 361867 90194962
Loss of employment 186.80 10.12 75 71543 2912 90553917
Glossodynia 183.81 10.12 20 71598 321759 90235070
Infusion related reaction 183.77 10.12 51 71567 416729 90140100
Hypotension 181.96 10.12 618 71000 324779 90232050
Pericarditis 179.51 10.12 8 71610 270143 90286686
Alopecia 178.65 10.12 84 71534 494987 90061842
Renal failure 168.22 10.12 340 71278 130667 90426162
Myocardial infarction 168.16 10.12 301 71317 105671 90451158
Blood creatinine increased 159.62 10.12 287 71331 101099 90455730
Joint swelling 158.91 10.12 101 71517 503199 90053630
Treatment failure 156.69 10.12 26 71592 303902 90252927
Wound 153.82 10.12 27 71591 302953 90253876
Duodenal ulcer perforation 152.30 10.12 5 71613 221283 90335546
Arthropathy 148.55 10.12 52 71566 366190 90190639
Folliculitis 142.87 10.12 4 71614 204349 90352480
Hypertensive crisis 134.59 10.12 112 71506 17672 90539157
Lower respiratory tract infection 130.17 10.12 21 71597 250638 90306191
Hepatic steatosis 128.08 10.12 152 71466 36793 90520036
Bradycardia 127.71 10.12 234 71384 83613 90473216
Rhabdomyolysis 121.72 10.12 175 71443 51081 90505748
Maternal exposure during pregnancy 119.53 10.12 68 71550 359995 90196834
Syncope 119.47 10.12 299 71319 132364 90424465
Cerebrovascular accident 119.29 10.12 286 71332 123247 90433582
Muscle injury 118.08 10.12 5 71613 176649 90380180
Psoriatic arthropathy 116.63 10.12 20 71598 228315 90328514
Irritable bowel syndrome 115.65 10.12 14 71604 207434 90349395
Swelling 109.41 10.12 102 71516 418956 90137873
Off label use 106.09 10.12 480 71138 1101772 89455057
Rheumatoid factor positive 105.11 10.12 8 71610 171642 90385187
Renal impairment 104.95 10.12 247 71371 105174 90451655
Inappropriate antidiuretic hormone secretion 102.46 10.12 100 71518 19405 90537424
Peripheral swelling 101.56 10.12 106 71512 413000 90143829
Fibromyalgia 101.18 10.12 20 71598 206249 90350580
Metabolic acidosis 99.86 10.12 167 71451 55509 90501320
Discomfort 99.68 10.12 46 71572 274289 90282540
Ill-defined disorder 99.40 10.12 14 71604 184877 90371952
Rheumatoid arthritis 98.54 10.12 85 71533 362529 90194300
Atrioventricular block complete 98.48 10.12 73 71545 9738 90547091
Dehydration 97.90 10.12 357 71261 194090 90362739
Sinusitis 96.21 10.12 78 71540 343010 90213819
Hypokalaemia 91.44 10.12 269 71349 130847 90425982
Blood urea increased 87.56 10.12 114 71504 30299 90526530
Intentional product use issue 87.52 10.12 31 71587 216861 90339968
C-reactive protein abnormal 87.23 10.12 3 71615 127426 90429403
Drug intolerance 85.20 10.12 139 71479 447452 90109377
Type 2 diabetes mellitus 83.82 10.12 28 71590 203216 90353613
Mobility decreased 83.68 10.12 47 71571 250687 90306142
Impaired healing 82.42 10.12 41 71577 234158 90322671
Nasopharyngitis 78.81 10.12 125 71493 406979 90149850
Coronary artery disease 78.65 10.12 114 71504 33509 90523320
International normalised ratio increased 78.36 10.12 137 71481 47179 90509650
Blister 77.88 10.12 53 71565 254945 90301884
Tongue oedema 74.44 10.12 49 71569 5405 90551424
Pain 74.02 10.12 473 71145 995868 89560961
Drug ineffective 72.07 10.12 724 70894 1383574 89173255
Fatigue 69.79 10.12 581 71037 1153442 89403387
Atrial fibrillation 69.50 10.12 248 71370 133363 90423466
Wheezing 69.40 10.12 52 71566 238028 90318801
Joint range of motion decreased 68.98 10.12 12 71606 135631 90421198
Acute myocardial infarction 68.45 10.12 109 71509 34781 90522048
Anaemia 67.72 10.12 494 71124 352308 90204521
Musculoskeletal stiffness 67.45 10.12 81 71537 296451 90260378
Stomatitis 64.67 10.12 73 71545 274625 90282204
Broncholithiasis 64.10 10.12 19 71599 288 90556541
Blood pressure inadequately controlled 64.02 10.12 47 71571 6177 90550652
Blood glucose increased 63.16 10.12 192 71426 95054 90461775
Burning mouth syndrome 62.79 10.12 22 71596 581 90556248
Pancreatitis acute 61.18 10.12 99 71519 32016 90524813
Liver injury 59.79 10.12 30 71588 170537 90386292
Lymph node calcification 59.62 10.12 19 71599 371 90556458
Toxic epidermal necrolysis 58.89 10.12 98 71520 32430 90524399
Night sweats 58.09 10.12 15 71603 128751 90428078
Infection 56.16 10.12 127 71491 361967 90194862
Product use in unapproved indication 54.56 10.12 115 71503 336121 90220708
Gastrointestinal haemorrhage 54.38 10.12 176 71442 90072 90466757
Therapeutic product effect incomplete 53.17 10.12 45 71573 193851 90362978
Blood pressure increased 52.46 10.12 300 71318 196917 90359912
Exposure during pregnancy 52.23 10.12 67 71551 238343 90318486
Weight increased 51.65 10.12 164 71454 417763 90139066
Chronic kidney disease 51.45 10.12 119 71499 50072 90506757
Contraindicated product administered 50.69 10.12 111 71507 320028 90236801
Disorientation 50.16 10.12 109 71509 44005 90512824
Hypersensitivity 49.09 10.12 189 71429 454488 90102341
Hepatitis cholestatic 48.95 10.12 46 71572 8515 90548314
Cardiac arrest 48.88 10.12 188 71430 104747 90452082
Prescribed overdose 48.84 10.12 9 71609 97616 90459213
Angina unstable 47.95 10.12 42 71576 7101 90549728
Bursitis 47.90 10.12 22 71596 131632 90425197
Bradyphrenia 47.60 10.12 43 71575 7569 90549260
Arthralgia 47.34 10.12 391 71227 778131 89778698
Abdominal discomfort 46.80 10.12 206 71412 477122 90079707
Migraine 46.56 10.12 49 71569 190343 90366486
Blood cholesterol increased 46.04 10.12 58 71560 207954 90348875
Knee arthroplasty 45.40 10.12 6 71612 83176 90473653
Ventricular hypertrophy 45.15 10.12 30 71588 3361 90553468
Wound infection 45.02 10.12 14 71604 106388 90450441
Inflammation 44.76 10.12 45 71573 178547 90378282
Cystoid macular oedema 44.47 10.12 25 71593 2075 90554754
Circulatory collapse 43.71 10.12 74 71544 24830 90531999
Live birth 42.47 10.12 6 71612 79101 90477728
Amblyopia 42.36 10.12 14 71604 308 90556521
Hepatic enzyme increased 42.19 10.12 145 71473 360591 90196238
Sleep disorder 41.99 10.12 57 71561 197973 90358856
Peripheral venous disease 41.42 10.12 8 71610 83913 90472916
Arrhythmia 40.82 10.12 98 71520 42234 90514595
Haemodialysis 40.71 10.12 42 71576 8705 90548124
Face oedema 40.55 10.12 69 71549 23249 90533580
Hypophagia 39.95 10.12 88 71530 35849 90520980
Melaena 39.58 10.12 86 71532 34711 90522118
Contusion 39.01 10.12 88 71530 251128 90305701
Palatal oedema 38.86 10.12 16 71602 663 90556166
Haematoma 38.30 10.12 91 71527 38957 90517872
Lower limb fracture 38.16 10.12 10 71608 85003 90471826
Rash 38.11 10.12 424 71194 795676 89761153
Cerebral infarction 37.69 10.12 72 71546 26524 90530305
Adverse drug reaction 37.32 10.12 23 71595 116678 90440151
Shock 37.26 10.12 75 71543 28703 90528126
Blood pressure decreased 37.21 10.12 137 71481 74758 90482071
Cardiomegaly 36.95 10.12 59 71559 18866 90537963
Cerebral haemorrhage 36.65 10.12 83 71535 34439 90522390
Autoimmune disorder 36.46 10.12 8 71610 76736 90480093
Transient ischaemic attack 36.43 10.12 95 71523 43081 90513748
Hypoglycaemic coma 36.34 10.12 25 71593 2965 90553864
Concomitant disease progression 35.29 10.12 22 71596 2210 90554619
Blood creatine phosphokinase increased 35.24 10.12 81 71537 33942 90522887
Wrong patient received product 35.18 10.12 26 71592 3451 90553378
Ischaemic stroke 35.17 10.12 63 71555 22103 90534726
Atrioventricular block 35.15 10.12 39 71579 8776 90548053
Hypomagnesaemia 34.97 10.12 83 71535 35505 90521324
Lower gastrointestinal haemorrhage 34.87 10.12 39 71579 8853 90547976
Road traffic accident 34.71 10.12 21 71597 107605 90449224
Sinus bradycardia 34.69 10.12 54 71564 16898 90539931
Pulmonary oedema 33.78 10.12 117 71501 61963 90494866
Diarrhoea 33.31 10.12 974 70644 938216 89618613
Haemoglobin decreased 32.88 10.12 230 71388 161726 90395103
Cardiomyopathy 32.79 10.12 58 71560 20148 90536681
Intestinal angioedema 32.30 10.12 15 71603 833 90555996
Hypertensive heart disease 31.91 10.12 22 71596 2618 90554211
Myopathy 31.85 10.12 46 71572 13472 90543357
Depressed level of consciousness 31.15 10.12 127 71491 72657 90484172
Blood sodium decreased 31.13 10.12 68 71550 27545 90529284
Hypovolaemic shock 31.11 10.12 33 71585 7061 90549768
Loss of personal independence in daily activities 31.11 10.12 37 71581 136068 90420761
Presyncope 31.06 10.12 74 71544 31731 90525098
Sciatica 31.02 10.12 21 71597 101361 90455468
Hypercholesterolaemia 30.74 10.12 21 71597 100871 90455958
Scleroderma renal crisis 30.53 10.12 12 71606 440 90556389
Wound haemorrhage 30.28 10.12 22 71596 2845 90553984
Dyspnoea 30.24 10.12 910 70708 880045 89676784
Electrocardiogram P wave abnormal 30.13 10.12 10 71608 223 90556606
Musculoskeletal pain 29.96 10.12 56 71562 171195 90385634
Choluria 29.10 10.12 10 71608 249 90556580
Insomnia 29.09 10.12 150 71468 333324 90223505
Product dose omission issue 29.09 10.12 125 71493 291562 90265267
Coma 28.94 10.12 124 71494 72508 90484321
Swollen tongue 28.93 10.12 91 71527 45865 90510964
Prerenal failure 28.86 10.12 19 71599 2096 90554733
Dialysis 28.84 10.12 40 71578 11289 90545540
Acute coronary syndrome 28.76 10.12 39 71579 10774 90546055
Bronchial wall thickening 28.73 10.12 19 71599 2112 90554717
Upper gastrointestinal haemorrhage 28.70 10.12 59 71559 22917 90533912
Anuria 28.66 10.12 46 71572 14772 90542057
Hyperamylasaemia 28.34 10.12 12 71606 534 90556295
Proteinuria 28.15 10.12 59 71559 23232 90533597
Gastrointestinal disorder 28.12 10.12 106 71512 256581 90300248
Haemorrhagic stroke 28.10 10.12 30 71588 6466 90550363
Left ventricular hypertrophy 27.69 10.12 29 71589 6115 90550714
Cardiac hypertrophy 27.63 10.12 15 71603 1163 90555666
Cerebral microangiopathy 27.50 10.12 10 71608 295 90556534
Hyponatraemic encephalopathy 27.46 10.12 10 71608 296 90556533
Gait inability 27.33 10.12 46 71572 146410 90410419
Hip arthroplasty 27.31 10.12 13 71605 76195 90480634
Aspartate aminotransferase increased 26.97 10.12 156 71462 102781 90454048
Injection site reaction 26.95 10.12 20 71598 92060 90464769
Cardioactive drug level increased 26.80 10.12 19 71599 2365 90554464
Hypocalcaemia 26.77 10.12 84 71534 42284 90514545
Liver function test increased 26.74 10.12 17 71601 84838 90471991
Gastric disorder 26.69 10.12 72 71546 33312 90523517
Acidosis 26.66 10.12 41 71577 12695 90544134
Gamma-glutamyltransferase increased 26.56 10.12 78 71540 37874 90518955
Asthma 26.52 10.12 100 71518 242060 90314769
Epistaxis 26.34 10.12 135 71483 84990 90471839
Oliguria 26.28 10.12 37 71581 10587 90546242
Arteriosclerosis coronary artery 26.10 10.12 35 71583 9568 90547261
Obesity 25.96 10.12 27 71591 105480 90451349
Tubulointerstitial nephritis 25.87 10.12 60 71558 25283 90531546
Therapeutic product effect decreased 25.84 10.12 122 71496 277449 90279380
Respiratory failure 25.71 10.12 171 71447 118247 90438582
Gastroenteritis 25.36 10.12 65 71553 29164 90527665
Linear IgA disease 25.28 10.12 18 71600 2256 90554573
Product use issue 25.19 10.12 155 71463 329764 90227065
Hyperglycaemia 25.12 10.12 93 71525 50877 90505952
Sleep disorder due to a general medical condition 24.96 10.12 3 71615 44735 90512094
Fall 24.88 10.12 526 71092 481284 90075545
Diabetes mellitus inadequate control 24.55 10.12 49 71569 18635 90538194
Cerebellar syndrome 24.46 10.12 22 71596 3850 90552979
Cardiac failure acute 24.41 10.12 38 71580 11891 90544938
Exostosis 24.32 10.12 6 71612 53128 90503701
Bone erosion 24.25 10.12 6 71612 53015 90503814
Red blood cell sedimentation rate increased 24.10 10.12 18 71600 82577 90474252
Haemorrhage intracranial 23.94 10.12 43 71575 15119 90541710
Pulmonary fibrosis 23.75 10.12 30 71588 107473 90449356
Gastritis erosive 23.75 10.12 28 71590 6727 90550102
Dysphagia 23.69 10.12 161 71457 112117 90444712
Prescribed underdose 23.68 10.12 15 71603 75004 90481825
Colitis ulcerative 23.64 10.12 9 71609 60257 90496572
Adiposis dolorosa 23.57 10.12 9 71609 305 90556524
Ear infection 23.37 10.12 13 71605 69762 90487067
Nephrogenic systemic fibrosis 23.35 10.12 22 71596 4086 90552743
Speech disorder 23.16 10.12 84 71534 45501 90511328
Cardiopulmonary failure 22.99 10.12 22 71596 4166 90552663
Electrolyte imbalance 22.92 10.12 55 71563 23690 90533139
Taste disorder 22.83 10.12 10 71608 61536 90495293
Alanine aminotransferase increased 22.81 10.12 166 71452 118172 90438657
Adverse event 22.73 10.12 36 71582 117382 90439447
Prothrombin time prolonged 22.66 10.12 33 71585 9739 90547090
Mitral valve incompetence 22.64 10.12 53 71565 22471 90534358
Osteoarthritis 22.64 10.12 79 71539 195651 90361178
Leukaemic infiltration renal 22.49 10.12 5 71613 21 90556808
Electrocardiogram QT prolonged 22.48 10.12 115 71503 72341 90484488
Lung disorder 22.06 10.12 54 71564 149829 90407000
Renal-limited thrombotic microangiopathy 22.03 10.12 8 71610 235 90556594
Ventricular assist device insertion 21.95 10.12 5 71613 24 90556805
Injury 21.93 10.12 81 71537 197268 90359561
Cough 21.77 10.12 411 71207 368551 90188278
Dyspepsia 21.58 10.12 82 71536 198078 90358751
Multiple organ dysfunction syndrome 21.58 10.12 109 71509 68227 90488602
Electrocardiogram abnormal 21.34 10.12 33 71585 10265 90546564
Nail disorder 21.28 10.12 10 71608 59057 90497772
Memory impairment 21.24 10.12 82 71536 197162 90359667
Haematocrit decreased 21.18 10.12 77 71541 41755 90515074
Ileus paralytic 21.15 10.12 23 71595 5062 90551767
Lip oedema 21.09 10.12 22 71596 4617 90552212
Pulmonary embolism 21.06 10.12 176 71442 130644 90426185
Resuscitation 21.06 10.12 13 71605 1283 90555546
Product complaint 20.95 10.12 38 71580 13462 90543367
Hypochloraemia 20.85 10.12 17 71601 2605 90554224
Cutaneous vasculitis 20.76 10.12 27 71591 7166 90549663
Dilatation atrial 20.47 10.12 15 71603 1966 90554863
Arthritis 20.39 10.12 66 71552 167249 90389580
Electrocardiogram QRS complex prolonged 20.30 10.12 27 71591 7321 90549508
Cachexia 20.13 10.12 26 71592 6852 90549977
Renal injury 20.08 10.12 32 71586 10211 90546618
Paraneoplastic syndrome 20 10.12 10 71608 654 90556175
Frequent bowel movements 19.96 10.12 10 71608 56925 90499904
Blood potassium increased 19.96 10.12 48 71570 20701 90536128
Acidosis hyperchloraemic 19.77 10.12 11 71607 895 90555934
Urine glucose/creatinine ratio increased 19.63 10.12 7 71611 195 90556634
Haematemesis 19.61 10.12 65 71553 33661 90523168
Colitis ischaemic 19.47 10.12 35 71583 12311 90544518
Oedema peripheral 19.47 10.12 299 71319 257616 90299213
Blood lactic acid increased 19.42 10.12 29 71589 8749 90548080
Rabbit syndrome 19.42 10.12 8 71610 332 90556497
Hypovolaemia 19.30 10.12 35 71583 12396 90544433
Stevens-Johnson syndrome 19.26 10.12 59 71559 29317 90527512
Laryngitis 19.22 10.12 8 71610 50745 90506084
Renal artery stenosis 19.20 10.12 15 71603 2162 90554667
Loss of consciousness 19.15 10.12 182 71436 140056 90416773
Hyperuricaemia 19.05 10.12 25 71593 6694 90550135
Ear pain 18.97 10.12 11 71607 57691 90499138
Cerebral haematoma 18.89 10.12 20 71598 4269 90552560
Injection site swelling 18.84 10.12 12 71606 59827 90497002
Diabetes mellitus 18.77 10.12 101 71517 64774 90492055
Foot deformity 18.73 10.12 12 71606 59639 90497190
Arteriosclerosis 18.72 10.12 32 71586 10821 90546008
Dysarthria 18.70 10.12 89 71529 54393 90502436
Blood catecholamines increased 18.51 10.12 5 71613 53 90556776
Acquired C1 inhibitor deficiency 18.43 10.12 3 71615 0 90556829
Inappropriate schedule of product administration 18.37 10.12 59 71559 149874 90406955
Jaundice 18.32 10.12 62 71556 32455 90524374
Decerebration 18.18 10.12 5 71613 57 90556772
Lethargy 18.07 10.12 98 71520 63041 90493788
Dilatation ventricular 18.05 10.12 15 71603 2361 90554468
Therapy non-responder 18.03 10.12 52 71566 136652 90420177
Blood sodium increased 18.01 10.12 17 71601 3165 90553664
Device expulsion 17.99 10.12 5 71613 40881 90515948
Gastric ulcer 17.87 10.12 55 71563 27393 90529436
Cardiogenic shock 17.81 10.12 51 71567 24417 90532412
Aortic valve incompetence 17.78 10.12 24 71594 6600 90550229
Ketoacidosis 17.73 10.12 22 71596 5573 90551256
Ventricular extrasystoles 17.71 10.12 35 71583 13215 90543614
Forced vital capacity abnormal 17.65 10.12 5 71613 64 90556765
Dizziness 17.61 10.12 599 71019 588685 89968144
Hypoaesthesia 17.60 10.12 161 71457 314049 90242780
Malignant anorectal neoplasm 17.59 10.12 4 71614 19 90556810
Normetanephrine urine increased 17.59 10.12 4 71614 19 90556810
Injection site pain 17.57 10.12 74 71544 173625 90383204
Onychomycosis 17.54 10.12 4 71614 37372 90519457
Tricuspid valve incompetence 17.51 10.12 40 71578 16691 90540138
Ventricular tachycardia 17.50 10.12 51 71567 24657 90532172
Ventricular fibrillation 17.47 10.12 36 71582 14008 90542821
Haematuria 17.43 10.12 64 71554 34873 90521956
Nephrotic syndrome 17.33 10.12 25 71593 7314 90549515
Urea renal clearance decreased 17.26 10.12 4 71614 21 90556808
Atrioventricular block first degree 17.26 10.12 27 71591 8484 90548345
Glycosylated haemoglobin increased 17.17 10.12 38 71580 15524 90541305
Injection site bruising 17.15 10.12 10 71608 52297 90504532
Hypertrichosis 17.12 10.12 12 71606 1467 90555362
Atrophic glossitis 17.11 10.12 4 71614 22 90556807
Tachypnoea 17.07 10.12 46 71572 21263 90535566
Joint stiffness 17.01 10.12 22 71596 78020 90478809
Carotid artery stenosis 16.94 10.12 21 71597 5313 90551516
Azotaemia 16.90 10.12 21 71597 5327 90551502
Megacolon 16.87 10.12 14 71604 2200 90554629
Toxic skin eruption 16.83 10.12 38 71580 15736 90541093
Lacrimal gland enlargement 16.81 10.12 4 71614 24 90556805
Ischaemic cardiomyopathy 16.81 10.12 15 71603 2598 90554231
Anomaly of external ear congenital 16.73 10.12 6 71612 170 90556659
Diaphragmatic paralysis 16.71 10.12 9 71609 687 90556142
Angina pectoris 16.49 10.12 68 71550 39092 90517737
Hepatobiliary infection 16.41 10.12 4 71614 27 90556802
Diabetic retinopathy 16.38 10.12 15 71603 2687 90554142
Blood glucose decreased 16.25 10.12 48 71570 23381 90533448
Incorrect route of product administration 16.15 10.12 10 71608 50616 90506213
Blood alkaline phosphatase increased 16.11 10.12 78 71540 48001 90508828
Upper respiratory tract congestion 16.08 10.12 14 71604 2348 90554481
Upper respiratory tract infection 16.07 10.12 50 71568 128268 90428561
Cardiac failure chronic 15.99 10.12 21 71597 5625 90551204
Lack of spontaneous speech 15.92 10.12 6 71612 196 90556633
Pseudo-Bartter syndrome 15.77 10.12 5 71613 96 90556733
Pulmonary hypertension 15.73 10.12 71 71547 42452 90514377
Renal failure neonatal 15.67 10.12 6 71612 205 90556624
Coagulopathy 15.48 10.12 47 71571 23242 90533587
Injection site pruritus 15.36 10.12 12 71606 53822 90503007
Urine output decreased 15.31 10.12 32 71586 12571 90544258
Apnoea 15.25 10.12 27 71591 9387 90547442
Anti-erythropoietin antibody positive 15.24 10.12 7 71611 379 90556450
Mixed liver injury 15.20 10.12 24 71594 7599 90549230
Blood loss anaemia 15.05 10.12 28 71590 10112 90546717
Autoimmune lung disease 15.05 10.12 5 71613 112 90556717
Brain natriuretic peptide increased 14.98 10.12 21 71597 5984 90550845
Emotional poverty 14.93 10.12 7 71611 397 90556432
Injection site erythema 14.88 10.12 35 71583 98467 90458362
Renal atrophy 14.74 10.12 12 71606 1836 90554993
Pruritus 14.72 10.12 321 71297 541204 90015625
Hypertension 14.66 10.12 469 71149 457063 90099766
Hepatic cirrhosis 14.66 10.12 17 71601 63236 90493593
Long QT syndrome 14.64 10.12 17 71601 4020 90552809
Finger deformity 14.51 10.12 4 71614 32893 90523936
Subileus 14.32 10.12 16 71602 3628 90553201
Adverse reaction 14.31 10.12 3 71615 29709 90527120
Left ventricular dilatation 14.31 10.12 8 71610 657 90556172
Psoriasis 14.30 10.12 64 71554 147690 90409139
Blood lactate dehydrogenase 14.28 10.12 3 71615 9 90556820
Treponema test positive 14.28 10.12 3 71615 9 90556820
Meibomianitis 14.28 10.12 4 71614 49 90556780
Gouty tophus 14.25 10.12 6 71612 263 90556566
Skin discolouration 14.21 10.12 71 71547 44244 90512585
Pleural effusion 14.14 10.12 143 71475 111848 90444981
Sensory disturbance 14.13 10.12 35 71583 15378 90541451
Hypocoagulable state 14.07 10.12 11 71607 1588 90555241
Hypotelorism of orbit 14.04 10.12 3 71615 10 90556819
Cerebellar cognitive affective syndrome 14.04 10.12 3 71615 10 90556819
Pregnancy 14.03 10.12 17 71601 62030 90494799
Myelosuppression 14.00 10.12 13 71605 53578 90503251
Haemangioma of bone 14.00 10.12 6 71612 275 90556554
Polydipsia 13.99 10.12 17 71601 4214 90552615
Joint dislocation 13.95 10.12 9 71609 44573 90512256
Cardiovascular disorder 13.84 10.12 32 71586 13460 90543369
Back injury 13.81 10.12 10 71608 46612 90510217
Lupus-like syndrome 13.80 10.12 11 71607 48835 90507994
Dry mouth 13.76 10.12 87 71531 183972 90372857
Wrong product administered 13.75 10.12 23 71595 7642 90549187
Carotid bruit 13.74 10.12 8 71610 710 90556119
Traumatic ulcer 13.66 10.12 4 71614 58 90556771
Respiratory distress 13.64 10.12 64 71554 38882 90517947
Complement factor C4 decreased 13.57 10.12 6 71612 297 90556532
Congenital uterine anomaly 13.51 10.12 5 71613 155 90556674
Cerebral ischaemia 13.45 10.12 22 71596 7174 90549655
Condition aggravated 13.45 10.12 363 71255 595182 89961647
Apathy 13.38 10.12 28 71590 11012 90545817
Illness 13.30 10.12 28 71590 81941 90474888
Atrioventricular block second degree 13.30 10.12 17 71601 4435 90552394
Urticaria 13.20 10.12 171 71447 312563 90244266
Abdominal wall haemorrhage 13.13 10.12 5 71613 168 90556661
Metabolic encephalopathy 13.11 10.12 21 71597 6731 90550098
Enlarged cerebral perivascular spaces 13.07 10.12 3 71615 15 90556814
Product monitoring error 13.02 10.12 17 71601 4527 90552302
Neuropsychiatric syndrome 12.96 10.12 4 71614 70 90556759
Stress cardiomyopathy 12.96 10.12 31 71587 13324 90543505
Camptodactyly congenital 12.91 10.12 3 71615 16 90556813
Cardiac disorder 12.87 10.12 83 71535 56789 90500040
Hip fracture 12.81 10.12 56 71562 33021 90523808
Visual acuity reduced 12.63 10.12 44 71574 23366 90533463
Incorrect product formulation administered 12.58 10.12 5 71613 189 90556640
Paresis 12.57 10.12 13 71605 2701 90554128
Metabolic syndrome 12.50 10.12 11 71607 1871 90554958
Vomiting 12.46 10.12 751 70867 787542 89769287
Skin warm 12.39 10.12 22 71596 7665 90549164
Ventricular dysfunction 12.35 10.12 15 71603 3716 90553113
Klebsiella infection 12.34 10.12 26 71592 10271 90546558
Headache 12.30 10.12 557 71061 862189 89694640
Myocardial ischaemia 12.28 10.12 31 71587 13783 90543046
Head injury 12.23 10.12 53 71565 31135 90525694
Cerebrovascular disorder 12.21 10.12 13 71605 2793 90554036
Vasoplegia syndrome 12.18 10.12 13 71605 2801 90554028
Labelled drug-disease interaction medication error 12.17 10.12 5 71613 206 90556623
Product quality issue 12.13 10.12 28 71590 79297 90477532
Pain in jaw 12.12 10.12 12 71606 47973 90508856
Tracheobronchitis 12.03 10.12 10 71608 1575 90555254
COVID-19 12.02 10.12 81 71537 168762 90388067
IgA nephropathy 11.97 10.12 8 71610 905 90555924
Hypoxia 11.97 10.12 98 71520 72301 90484528
Bradyarrhythmia 11.78 10.12 12 71606 2449 90554380
Distributive shock 11.72 10.12 14 71604 3410 90553419
Blood lactate dehydrogenase increased 11.69 10.12 46 71572 25886 90530943
Toxicity to various agents 11.68 10.12 304 71314 287542 90269287
Petechiae 11.64 10.12 33 71585 15708 90541121
Natural killer-cell leukaemia 11.59 10.12 4 71614 101 90556728
Sepsis 11.53 10.12 203 71415 179611 90377218
Pulmonary valve incompetence 11.52 10.12 10 71608 1671 90555158
Tumour inflammation 11.51 10.12 4 71614 103 90556726
Tachycardia induced cardiomyopathy 11.51 10.12 4 71614 103 90556726
Laryngeal oedema 11.49 10.12 20 71598 6861 90549968
Urinary tract infection enterococcal 11.44 10.12 13 71605 3003 90553826
Blood chloride decreased 11.39 10.12 19 71599 6300 90550529
Subretinal fluid 11.28 10.12 7 71611 697 90556132
Blood creatinine 11.23 10.12 4 71614 111 90556718
No adverse event 11.22 10.12 23 71595 67959 90488870
Ageusia 11.21 10.12 33 71585 16043 90540786
Myoclonus 11.20 10.12 37 71581 19131 90537698
Drug hypersensitivity 11.14 10.12 280 71338 463329 90093500
Disseminated varicella zoster virus infection 11.14 10.12 6 71612 458 90556371
Hepatic necrosis 11.12 10.12 19 71599 6419 90550410
Thromboangiitis obliterans 11.09 10.12 3 71615 32 90556797
Onychomadesis 11.05 10.12 12 71606 45986 90510843
International normalised ratio decreased 11.02 10.12 16 71602 4708 90552121
Endocarditis 11.01 10.12 20 71598 7093 90549736
Vasculitic rash 10.92 10.12 9 71609 1401 90555428
Peritoneal dialysis 10.90 10.12 6 71612 478 90556351
Sudden cardiac death 10.90 10.12 11 71607 2221 90554608
Pulmonary congestion 10.90 10.12 37 71581 19396 90537433
Femur fracture 10.89 10.12 68 71550 46014 90510815
Septic shock 10.88 10.12 108 71510 84052 90472777
Atrial thrombosis 10.85 10.12 11 71607 2234 90554595
Hypertensive encephalopathy 10.83 10.12 7 71611 748 90556081
Extensor plantar response 10.82 10.12 9 71609 1418 90555411
Bicytopenia 10.64 10.12 14 71604 3757 90553072
Leukoencephalopathy 10.64 10.12 16 71602 4857 90551972
Prescription drug used without a prescription 10.64 10.12 13 71605 3242 90553587
Left ventricular failure 10.57 10.12 19 71599 6681 90550148
Glomerulosclerosis 10.50 10.12 6 71612 514 90556315
Posterior reversible encephalopathy syndrome 10.38 10.12 40 71578 22299 90534530
Respiratory rate increased 10.36 10.12 32 71586 15969 90540860
Orthopnoea 10.30 10.12 19 71599 6816 90550013
Cerebral arteriosclerosis 10.28 10.12 5 71613 308 90556521
Pulmonary arterial pressure increased 10.23 10.12 14 71604 3902 90552927
Toxic neuropathy 10.21 10.12 6 71612 542 90556287
Cardio-respiratory arrest 10.19 10.12 85 71533 63055 90493774
Macular degeneration 10.17 10.12 9 71609 37961 90518868
Precocious puberty 10.16 10.12 5 71613 316 90556513
Blood cholinesterase increased 10.15 10.12 3 71615 45 90556784

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 427.42 10.59 431 69018 42046 42509840
Drug interaction 356.74 10.59 1098 68351 265901 42285985
Acute kidney injury 355.64 10.59 1356 68093 365981 42185905
Hyperkalaemia 302.75 10.59 501 68948 79957 42471929
Off label use 156.74 10.59 527 68922 637808 41914078
Myocardial infarction 147.61 10.59 491 68958 123518 42428368
Drug ineffective 119.92 10.59 575 68874 629622 41922264
Syncope 114.16 10.59 389 69060 99017 42452869
Death 113.28 10.59 392 69057 470793 42081093
Cardiac failure 98.15 10.59 389 69060 106467 42445419
Hypotension 94.95 10.59 731 68718 256900 42294986
Cardiac failure congestive 93.06 10.59 329 69120 85273 42466613
Hypoglycaemia 91.68 10.59 259 69190 59595 42492291
Acute myocardial infarction 87.44 10.59 250 69199 57915 42493971
Blood creatinine increased 83.57 10.59 378 69071 109625 42442261
Lactic acidosis 79.48 10.59 206 69243 45055 42506831
Renal failure 75.82 10.59 446 69003 143280 42408606
Clear cell renal cell carcinoma 74.36 10.59 38 69411 1243 42550643
Product use in unapproved indication 72.48 10.59 118 69331 184338 42367548
Coronary artery disease 69.49 10.59 219 69230 53501 42498385
Concomitant disease progression 67.13 10.59 45 69404 2458 42549428
Drug abuse 64.51 10.59 46 69403 104725 42447161
Blood urea increased 58.33 10.59 150 69299 32643 42519243
Treatment failure 56.45 10.59 16 69433 62608 42489278
Dehydration 55.89 10.59 409 69040 141358 42410528
Renal impairment 55.49 10.59 338 69111 109890 42441996
Intentional product use issue 55.08 10.59 24 69425 71809 42480077
Hypertensive crisis 53.13 10.59 74 69375 10132 42541754
Pharyngeal oedema 49.29 10.59 55 69394 6013 42545873
Atrioventricular block complete 47.06 10.59 74 69375 11290 42540596
Lymphoproliferative disorder 45.58 10.59 40 69409 3267 42548619
Tongue oedema 45.55 10.59 40 69409 3270 42548616
Vascular stent thrombosis 44.26 10.59 39 69410 3203 42548683
Blood pressure decreased 42.43 10.59 198 69251 58134 42493752
Carotid sinus syndrome 41.73 10.59 10 69439 25 42551861
Pancreatitis acute 40.82 10.59 134 69315 33430 42518456
Nephrotic syndrome 39.23 10.59 59 69390 8659 42543227
Loss of personal independence in daily activities 39.22 10.59 16 69433 49800 42502086
Anuria 36.99 10.59 67 69382 11465 42540421
Drug intolerance 35.90 10.59 47 69402 80377 42471509
Angina unstable 34.81 10.59 65 69384 11383 42540503
Hepatic enzyme decreased 34.77 10.59 11 69438 96 42551790
Blood potassium increased 34.22 10.59 86 69363 18450 42533436
Febrile neutropenia 34.12 10.59 171 69278 185532 42366354
Angina pectoris 33.64 10.59 124 69325 32772 42519114
Hospitalisation 33.63 10.59 43 69406 74287 42477599
Upper gastrointestinal haemorrhage 33.35 10.59 117 69332 30182 42521704
Therapeutic product effect incomplete 33.19 10.59 40 69409 70899 42480987
Melaena 33.09 10.59 138 69311 38608 42513278
Myasthenic syndrome 32.76 10.59 19 69430 802 42551084
Cardiac failure chronic 32.36 10.59 57 69392 9544 42542342
Asthma 31.48 10.59 33 69416 62281 42489605
Drug dependence 31.17 10.59 5 69444 29089 42522797
Arrhythmia 30.91 10.59 139 69310 40178 42511708
Gingival hypertrophy 30.65 10.59 28 69421 2411 42549475
Diverticulitis intestinal perforated 30.31 10.59 13 69436 283 42551603
Fatigue 30.19 10.59 514 68935 435127 42116759
Foetal exposure during pregnancy 30.13 10.59 20 69429 47291 42504595
COVID-19 30.08 10.59 93 69356 115855 42436031
Supernumerary nipple 29.97 10.59 8 69441 35 42551851
Neuropathy peripheral 29.89 10.59 77 69372 101776 42450110
Neutropenia 29.48 10.59 197 69252 199234 42352652
Bradycardia 29.40 10.59 239 69210 85245 42466641
Adenomatous polyposis coli 28.93 10.59 11 69438 173 42551713
Drug ineffective for unapproved indication 28.75 10.59 20 69429 46143 42505743
Pemphigoid 28.70 10.59 60 69389 11407 42540479
Injection site pain 27.66 10.59 32 69417 57766 42494120
Atrial fibrillation 27.55 10.59 348 69101 139245 42412641
Vertigo 27.53 10.59 120 69329 34227 42517659
Myelosuppression 27.29 10.59 16 69433 40445 42511441
Inappropriate schedule of product administration 27.00 10.59 74 69375 95828 42456058
Full blood count abnormal 26.25 10.59 8 69441 29868 42522018
Rhabdomyolysis 26.22 10.59 217 69232 77802 42474084
Cerebrovascular accident 25.90 10.59 257 69192 96903 42454983
Ventricular tachycardia 25.42 10.59 107 69342 30053 42521833
Coombs direct test positive 25.26 10.59 12 69437 334 42551552
Biliary cirrhosis 25.11 10.59 10 69439 179 42551707
Phlebitis infective 24.96 10.59 9 69440 121 42551765
Hypovolaemic shock 24.89 10.59 48 69401 8611 42543275
Intentional product misuse 24.83 10.59 39 69410 61861 42490025
Inappropriate antidiuretic hormone secretion 24.74 10.59 71 69378 16470 42535416
Nodular melanoma 24.71 10.59 10 69439 187 42551699
Dizziness 24.30 10.59 554 68895 248700 42303186
Bradyphrenia 24.23 10.59 36 69413 5226 42546660
Haemoconcentration 23.98 10.59 7 69442 45 42551841
Reticulocytosis 23.74 10.59 11 69438 289 42551597
Hemiparesis 23.53 10.59 72 69377 17304 42534582
Myocardial ischaemia 23.49 10.59 73 69376 17689 42534197
Sepsis 23.32 10.59 210 69239 199124 42352762
Chronic kidney disease 23.20 10.59 144 69305 47097 42504789
Congenital hearing disorder 23.16 10.59 8 69441 94 42551792
Poikiloderma 22.55 10.59 11 69438 325 42551561
Orthopnoea 22.05 10.59 35 69414 5382 42546504
Product dose omission issue 22.04 10.59 154 69295 154211 42397675
Chest pain 21.90 10.59 334 69115 139196 42412690
Cardiac failure acute 21.84 10.59 60 69389 13573 42538313
Hyponatraemia 21.76 10.59 257 69192 101205 42450681
Acute coronary syndrome 21.45 10.59 63 69386 14802 42537084
Atrioventricular block 21.42 10.59 48 69401 9567 42542319
Pain 21.38 10.59 276 69173 244572 42307314
Bradyarrhythmia 21.30 10.59 24 69425 2651 42549235
Nodal rhythm 21.17 10.59 19 69430 1598 42550288
Peripheral swelling 20.94 10.59 76 69373 90194 42461692
Swollen tongue 20.84 10.59 79 69370 21152 42530734
Dry skin 20.81 10.59 29 69420 48309 42503577
Nasopharyngitis 20.64 10.59 69 69380 83927 42467959
Cerebral infarction 20.64 10.59 103 69346 31066 42520820
Proteinuria 20.52 10.59 83 69366 22900 42528986
Rash 20.38 10.59 323 69126 276631 42275255
Constipation 20.30 10.59 168 69281 162123 42389763
International normalised ratio increased 20.12 10.59 141 69308 48027 42503859
White blood cell count decreased 20.06 10.59 102 69347 110294 42441592
Arthralgia 19.95 10.59 226 69223 205012 42346874
Blood pressure inadequately controlled 19.95 10.59 24 69425 2844 42549042
Musculoskeletal stiffness 19.92 10.59 40 69409 57725 42494161
Blood bilirubin unconjugated increased 19.86 10.59 13 69436 682 42551204
Systemic scleroderma 19.50 10.59 12 69437 565 42551321
Bronchopneumopathy 19.09 10.59 12 69437 587 42551299
Appendicitis 19.07 10.59 5 69444 20608 42531278
Migraine 18.68 10.59 9 69440 25405 42526481
Toxicity to various agents 18.65 10.59 262 69187 228874 42323012
Anti-platelet antibody positive 18.33 10.59 9 69440 270 42551616
Haemodialysis 18.31 10.59 47 69402 10213 42541673
Mastitis 18.25 10.59 8 69441 184 42551702
Anaemia 18.19 10.59 591 68858 279687 42272199
Lymphangitis 18.16 10.59 12 69437 640 42551246
Gastrointestinal disorder 18.14 10.59 30 69419 46623 42505263
Illness 18.07 10.59 9 69440 24921 42526965
Meningorrhagia 17.80 10.59 7 69442 121 42551765
Suicidal ideation 17.79 10.59 32 69417 48129 42503757
Lower gastrointestinal haemorrhage 17.75 10.59 48 69401 10760 42541126
Blood creatine phosphokinase increased 17.62 10.59 137 69312 48201 42503685
Bundle branch block right 17.54 10.59 40 69409 8066 42543820
Bundle branch block left 17.52 10.59 35 69414 6441 42545445
Blood glucose increased 17.30 10.59 190 69259 73509 42478377
Gamma-glutamyltransferase increased 17.19 10.59 101 69348 32396 42519490
Heart valve stenosis 17.18 10.59 6 69443 73 42551813
Ketoacidosis 17.04 10.59 31 69418 5321 42546565
Product complaint 17.02 10.59 33 69416 5944 42545942
Accidental exposure to product 16.97 10.59 6 69443 20387 42531499
Haptoglobin decreased 16.84 10.59 12 69437 724 42551162
Productive cough 16.69 10.59 37 69412 51530 42500356
Ischaemic stroke 16.55 10.59 76 69373 22157 42529729
Aortic bruit 16.54 10.59 8 69441 232 42551654
Laryngeal oedema 16.45 10.59 26 69423 3982 42547904
Injury 16.40 10.59 76 69373 22240 42529646
Drug hypersensitivity 16.31 10.59 95 69354 99294 42452592
Sinusitis 16.09 10.59 33 69416 47259 42504627
Lacunar infarction 16.02 10.59 23 69426 3237 42548649
Synovitis 15.97 10.59 3 69446 15564 42536322
Cardiac arrest 15.75 10.59 258 69191 109062 42442824
Malignant neoplasm progression 15.54 10.59 108 69341 108292 42443594
Hypocoagulable state 15.48 10.59 13 69436 1000 42550886
Haematuria 15.45 10.59 153 69296 57646 42494240
Pancreatitis necrotising 15.44 10.59 24 69425 3625 42548261
Sopor 15.42 10.59 52 69397 13150 42538736
Depressed level of consciousness 15.35 10.59 132 69317 47838 42504048
Disease progression 15.23 10.59 155 69294 143501 42408385
Gastroenteritis 15.16 10.59 60 69389 16389 42535497
Cardiovascular disorder 15.04 10.59 52 69397 13313 42538573
Blood alkaline phosphatase increased 15.01 10.59 100 69349 33497 42518389
Rheumatoid arthritis 14.96 10.59 29 69420 42411 42509475
Hypertrophic cardiomyopathy 14.96 10.59 15 69434 1450 42550436
Gastrointestinal haemorrhage 14.59 10.59 232 69217 97494 42454392
Muscle haemorrhage 14.56 10.59 25 69424 4100 42547786
Incorrect route of product administration 14.52 10.59 11 69438 24294 42527592
Therapeutic product effect decreased 14.47 10.59 26 69423 39124 42512762
Erosive oesophagitis 14.40 10.59 15 69434 1516 42550370
Protein-losing gastroenteropathy 14.39 10.59 9 69440 436 42551450
Creatinine renal clearance decreased 14.23 10.59 23 69426 3590 42548296
Skin hypertrophy 14.18 10.59 20 69429 2769 42549117
Oedema mouth 14.04 10.59 14 69435 1344 42550542
Blood glucose decreased 14.03 10.59 53 69396 14166 42537720
Oedema peripheral 14.03 10.59 305 69144 135771 42416115
Duodenal ulcer 14.02 10.59 48 69401 12231 42539655
Renal injury 14.02 10.59 48 69401 12232 42539654
Sudden death 14.01 10.59 59 69390 16570 42535316
Infection 14.01 10.59 116 69333 111952 42439934
Impaired quality of life 13.98 10.59 3 69446 14174 42537712
Traumatic haematoma 13.94 10.59 11 69438 775 42551111
Blood aldosterone increased 13.80 10.59 4 69445 25 42551861
Insomnia 13.63 10.59 125 69324 118128 42433758
Hypoxia 13.53 10.59 63 69386 69723 42482163
Circulatory collapse 13.51 10.59 75 69374 23561 42528325
Diabetes mellitus inadequate control 13.28 10.59 55 69394 15335 42536551
Speech disorder 13.20 10.59 87 69362 29034 42522852
Meningitis streptococcal 13.13 10.59 5 69444 79 42551807
Sleep disorder due to a general medical condition 13.11 10.59 6 69443 17447 42534439
Therapeutic response shortened 13.10 10.59 3 69446 13551 42538335
Osteitis 13.08 10.59 15 69434 1689 42550197
Pseudolymphoma 13.04 10.59 10 69439 675 42551211
Sinus node dysfunction 13.01 10.59 26 69423 4786 42547100
Meningioma 12.92 10.59 15 69434 1712 42550174
Infarction 12.89 10.59 20 69429 3015 42548871
Electrocardiogram QRS complex prolonged 12.89 10.59 29 69420 5794 42546092
Gastritis erosive 12.88 10.59 31 69418 6472 42545414
Ischaemic cardiomyopathy 12.82 10.59 31 69418 6491 42545395
Pancreatic enzymes increased 12.79 10.59 11 69438 874 42551012
Erythrodermic psoriasis 12.74 10.59 12 69437 1074 42550812
Cholecystitis acute 12.71 10.59 34 69415 7572 42544314
Lymphocyte count decreased 12.66 10.59 16 69433 27793 42524093
Heart transplant rejection 12.62 10.59 14 69435 1520 42550366
Necrotising colitis 12.61 10.59 13 69436 1298 42550588
Stress 12.52 10.59 34 69415 44178 42507708
Kidney duplex 12.51 10.59 8 69441 403 42551483
Pneumocystis jirovecii infection 12.36 10.59 19 69430 2841 42549045
Lower respiratory tract infection 12.19 10.59 31 69418 41175 42510711
Therapy partial responder 12.04 10.59 9 69440 20012 42531874
Intentional product misuse to child 11.98 10.59 4 69445 42 42551844
Pruritus 11.98 10.59 226 69223 188545 42363341
Cerebral congestion 11.96 10.59 5 69444 102 42551784
Ventricular hypertrophy 11.82 10.59 25 69424 4791 42547095
Renin increased 11.53 10.59 6 69443 204 42551682
Thrombosis 11.50 10.59 65 69384 68446 42483440
Platelet count decreased 11.42 10.59 158 69291 138423 42413463
Cholelithiasis 11.35 10.59 71 69378 23275 42528611
Neutrophil count decreased 11.28 10.59 59 69390 63356 42488530
Low cardiac output syndrome 11.27 10.59 9 69440 645 42551241
IPEX syndrome 11.26 10.59 3 69446 13 42551873
Wrong technique in product usage process 11.19 10.59 34 69415 42601 42509285
Hypercholesterolaemia 11.15 10.59 46 69403 12803 42539083
Nail toxicity 11.08 10.59 4 69445 54 42551832
Aspergillus infection 11.06 10.59 6 69443 15831 42536055
Lumbosacral plexus lesion 10.91 10.59 3 69446 15 42551871
Iliac artery stenosis 10.91 10.59 5 69444 128 42551758
Bicytopenia 10.85 10.59 19 69430 3165 42548721
Micturition frequency decreased 10.73 10.59 7 69442 365 42551521
Ventricular hypokinesia 10.73 10.59 30 69419 6854 42545032
Hyperaldosteronism 10.71 10.59 6 69443 237 42551649
Respiratory depression 10.69 10.59 9 69440 18859 42533027
Gastric mucosal lesion 10.62 10.59 9 69440 701 42551185
Tachypnoea 10.61 10.59 66 69383 21596 42530290

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
Drug interaction 1191.83 9.84 2046 120311 498137 109968805
Acute kidney injury 1077.92 9.84 2248 120109 633182 109833760
Hyperkalaemia 869.05 9.84 903 121454 134893 110332049
Angioedema 653.42 9.84 668 121689 97832 110369110
Cardiac failure congestive 439.84 9.84 678 121679 150322 110316620
Hyponatraemia 361.17 9.84 765 121592 216888 110250054
Myocardial infarction 351.51 9.84 703 121654 191380 110275562
Cardiac failure 325.87 9.84 672 121685 186954 110279988
Hypoglycaemia 305.81 9.84 498 121859 115606 110351336
Synovitis 270.24 9.84 7 122350 274085 110192857
Renal failure 264.18 9.84 694 121663 225880 110241062
Lactic acidosis 260.71 9.84 410 121947 92401 110374541
Hypotension 254.48 9.84 1200 121157 522649 109944293
Off label use 227.80 9.84 874 121483 1499311 108967631
Blood creatinine increased 223.22 9.84 570 121787 182319 110284623
Hand deformity 206.71 9.84 8 122349 218498 110248444
Syncope 201.94 9.84 586 121771 201950 110264992
Alopecia 194.53 9.84 80 122277 364673 110102269
Treatment failure 185.54 9.84 40 122317 277194 110189748
Systemic lupus erythematosus 182.28 9.84 31 122326 254307 110212635
Pemphigus 181.18 9.84 15 122342 214555 110252387
Joint swelling 180.17 9.84 136 122221 442709 110024233
Infusion related reaction 178.23 9.84 100 122257 381062 110085880
Coronary artery disease 175.95 9.84 298 122059 71392 110395550
Acute myocardial infarction 175.64 9.84 325 122032 83452 110383490
Glossodynia 173.19 9.84 21 122336 221983 110244959
Renal impairment 172.45 9.84 529 121828 187916 110279026
Pericarditis 167.84 9.84 22 122335 219092 110247850
Duodenal ulcer perforation 166.41 9.84 7 122350 177693 110289249
Dehydration 164.03 9.84 678 121679 278833 110188109
Arthropathy 161.68 9.84 58 122299 287464 110179478
Helicobacter infection 161.36 9.84 10 122347 181867 110285075
Folliculitis 159.04 9.84 6 122351 167647 110299295
Loss of employment 154.41 9.84 75 122282 3269 110463673
Rhabdomyolysis 151.79 9.84 380 121977 120021 110346921
Atrioventricular block complete 149.27 9.84 145 122212 19937 110447005
Wound 146.69 9.84 39 122318 234398 110232544
Hypertensive crisis 146.62 9.84 157 122200 24215 110442727
Maternal exposure during pregnancy 144.01 9.84 51 122306 254832 110212110
Irritable bowel syndrome 142.81 9.84 10 122347 164205 110302737
Lower respiratory tract infection 141.94 9.84 46 122311 243060 110223882
Intentional product use issue 141.10 9.84 49 122308 247857 110219085
Psoriatic arthropathy 140.93 9.84 24 122333 196737 110270205
Blood urea increased 139.59 9.84 232 122125 54725 110412217
Bradycardia 138.94 9.84 433 121924 155084 110311858
Cerebrovascular accident 131.95 9.84 471 121886 180813 110286129
Swelling 131.31 9.84 117 122240 350924 110116018
Sinusitis 128.65 9.84 85 122272 296603 110170339
Rheumatoid arthritis 128.36 9.84 87 122270 299526 110167416
Muscle injury 127.16 9.84 7 122350 140800 110326142
Peripheral swelling 127.14 9.84 156 122201 403878 110063064
Drug intolerance 124.74 9.84 160 122197 406352 110060590
Drug ineffective 124.26 9.84 1082 121275 1519458 108947484
Fibromyalgia 122.06 9.84 21 122336 170888 110296054
Nasopharyngitis 118.15 9.84 158 122199 394203 110072739
Pain 117.35 9.84 601 121756 954354 109512588
Rheumatoid factor positive 114.51 9.84 8 122349 131632 110335310
Product use in unapproved indication 114.10 9.84 200 122157 447177 110019765
Tongue oedema 113.76 9.84 85 122272 8171 110458771
Pancreatitis acute 105.81 9.84 217 122140 60057 110406885
Inappropriate antidiuretic hormone secretion 105.52 9.84 157 122200 33694 110433248
Musculoskeletal stiffness 104.94 9.84 93 122264 279729 110187213
Ill-defined disorder 104.16 9.84 23 122334 156830 110310112
Mobility decreased 101.60 9.84 69 122288 237353 110229589
Atrial fibrillation 101.10 9.84 512 121845 229130 110237812
Fatigue 99.25 9.84 865 121492 1215093 109251849
Impaired healing 91.32 9.84 52 122305 196665 110270277
Type 2 diabetes mellitus 89.47 9.84 42 122315 177190 110289752
Blood pressure decreased 88.00 9.84 304 122053 114787 110352155
Lip dry 87.29 9.84 6 122351 100077 110366865
Arthralgia 87.21 9.84 506 121851 779126 109687816
Anaemia 87.19 9.84 957 121400 546129 109920813
Hepatic steatosis 87.13 9.84 177 122180 48654 110418288
Weight increased 85.58 9.84 213 122144 419431 110047511
International normalised ratio increased 83.46 9.84 248 122109 86524 110380418
Joint range of motion decreased 82.65 9.84 17 122340 121815 110345127
Discomfort 82.14 9.84 70 122287 214637 110252305
Chronic kidney disease 82.06 9.84 227 122130 76064 110390878
Therapeutic product effect incomplete 81.97 9.84 76 122281 223729 110243213
Angina unstable 81.95 9.84 96 122261 16336 110450606
Night sweats 80.60 9.84 24 122333 133959 110332983
Bursitis 80.51 9.84 22 122335 129896 110337046
Migraine 80.21 9.84 45 122312 171607 110295335
Exposure during pregnancy 79.52 9.84 43 122314 167381 110299561
Upper gastrointestinal haemorrhage 78.26 9.84 172 122185 49924 110417018
Stomatitis 78.15 9.84 111 122246 270131 110196811
Wheezing 76.65 9.84 102 122255 255128 110211814
Melaena 72.39 9.84 203 122154 68554 110398388
Gastrointestinal haemorrhage 71.39 9.84 367 121990 165151 110301791
Asthma 70.22 9.84 105 122252 250186 110216756
Bradyphrenia 69.57 9.84 75 122282 11653 110455289
Infection 69.13 9.84 190 122167 362010 110104932
Blister 68.14 9.84 91 122266 227285 110239657
Concomitant disease progression 67.98 9.84 45 122312 3565 110463377
Clear cell renal cell carcinoma 66.01 9.84 40 122317 2716 110464226
Nephrotic syndrome 64.36 9.84 78 122279 13753 110453189
Hypersensitivity 63.69 9.84 231 122126 403767 110063175
Haemodialysis 62.27 9.84 87 122270 17632 110449310
Vascular stent thrombosis 62.20 9.84 45 122312 4116 110462826
Inflammation 61.37 9.84 74 122283 193164 110273778
Blood creatine phosphokinase increased 61.14 9.84 199 122158 72878 110394064
Loss of personal independence in daily activities 61.01 9.84 46 122311 149974 110316968
Metabolic acidosis 60.83 9.84 245 122112 99499 110367443
Anuria 60.79 9.84 102 122255 24239 110442703
Cardiac arrest 60.58 9.84 399 121958 196354 110270588
Atrioventricular block 58.02 9.84 82 122275 16795 110450147
Lower gastrointestinal haemorrhage 57.99 9.84 86 122271 18400 110448542
Arrhythmia 57.79 9.84 189 122168 69386 110397556
Blood cholesterol increased 57.38 9.84 72 122285 184713 110282229
Abdominal discomfort 57.06 9.84 233 122124 393625 110073317
Sleep disorder 57.01 9.84 82 122275 198562 110268380
Blood potassium increased 56.35 9.84 118 122239 33131 110433811
Live birth 55.60 9.84 6 122351 69478 110397464
Cerebral infarction 55.50 9.84 154 122203 51684 110415258
Acute coronary syndrome 55.27 9.84 95 122262 23017 110443925
Angina pectoris 55.18 9.84 173 122184 62122 110404820
Liver injury 55.16 9.84 51 122306 150362 110316580
Broncholithiasis 54.69 9.84 18 122339 274 110466668
Peripheral venous disease 54.51 9.84 13 122344 84104 110382838
Circulatory collapse 54.47 9.84 136 122221 42857 110424085
Ischaemic stroke 53.83 9.84 132 122225 41131 110425811
Hypokalaemia 53.76 9.84 366 121991 182082 110284860
Hypovolaemic shock 53.34 9.84 73 122284 14510 110452432
Drug abuse 53.15 9.84 71 122286 177340 110289602
Burning mouth syndrome 52.99 9.84 22 122335 659 110466283
Ventricular hypertrophy 52.60 9.84 51 122306 6994 110459948
Blood glucose increased 52.49 9.84 287 122070 132209 110334733
Gastrointestinal disorder 52.31 9.84 119 122238 241833 110225109
Proteinuria 52.19 9.84 128 122229 39890 110427052
Prescribed overdose 52.11 9.84 16 122341 87565 110379377
Insomnia 51.18 9.84 215 122142 360375 110106567
Knee arthroplasty 50.98 9.84 6 122351 64942 110402000
Myocardial ischaemia 50.33 9.84 99 122258 26585 110440357
Ventricular tachycardia 49.10 9.84 144 122213 49865 110417077
Blepharospasm 48.68 9.84 3 122354 54848 110412094
Rash 48.51 9.84 629 121728 820335 109646607
Musculoskeletal pain 48.26 9.84 80 122277 182943 110283999
Blood pressure inadequately controlled 47.37 9.84 50 122307 7583 110459359
Depressed level of consciousness 47.05 9.84 247 122110 112031 110354911
Lymph node calcification 46.36 9.84 18 122339 451 110466491
Lower limb fracture 46.23 9.84 13 122344 75335 110391607
Cardiac failure chronic 45.85 9.84 66 122291 13745 110453197
Memory impairment 45.78 9.84 93 122264 196851 110270091
Hepatitis cholestatic 45.73 9.84 75 122282 17491 110449451
Wound infection 45.47 9.84 25 122332 96440 110370502
Disorientation 45.02 9.84 176 122181 70495 110396447
Adverse drug reaction 44.70 9.84 31 122326 105528 110361414
Injection site pain 43.98 9.84 81 122276 177841 110289101
Drug hypersensitivity 43.86 9.84 308 122049 453782 110013160
Haematuria 43.71 9.84 195 122162 82810 110384132
Lung disorder 43.60 9.84 83 122274 179964 110286978
Injection site reaction 43.58 9.84 22 122335 89048 110377894
Death 43.29 9.84 530 121827 698339 109768603
Myelosuppression 42.27 9.84 26 122331 94314 110372628
Sciatica 42.05 9.84 25 122332 92374 110374568
Pemphigoid 41.97 9.84 77 122280 19630 110447312
Osteoarthritis 41.80 9.84 87 122270 182536 110284406
Arthritis 41.69 9.84 76 122281 167510 110299432
Cardiac failure acute 41.44 9.84 86 122271 23992 110442950
Contraindicated product administered 41.08 9.84 139 122218 248128 110218814
Gamma-glutamyltransferase increased 40.95 9.84 155 122202 61154 110405788
Shock 40.47 9.84 141 122216 53447 110413495
Toxic epidermal necrolysis 40.05 9.84 146 122211 56581 110410361
Pharyngeal oedema 39.91 9.84 68 122289 16360 110450582
Hepatic enzyme increased 39.78 9.84 201 122156 320691 110146251
Therapeutic product effect decreased 39.60 9.84 138 122219 244178 110222764
Myopathy 39.32 9.84 86 122271 24874 110442068
Cerebral haemorrhage 39.14 9.84 159 122198 64809 110402133
Road traffic accident 38.68 9.84 37 122320 107361 110359581
Blood sodium decreased 38.25 9.84 111 122246 38208 110428734
Ketoacidosis 37.66 9.84 51 122306 10036 110456906
Hypoaesthesia 37.17 9.84 200 122157 314023 110152919
Contusion 37.03 9.84 133 122224 233228 110233714
Product dose omission issue 36.86 9.84 207 122150 321575 110145367
Speech disorder 36.55 9.84 150 122207 61419 110405523
Inappropriate schedule of product administration 36.49 9.84 110 122247 203527 110263415
Coeliac disease 36.49 9.84 3 122354 43184 110423758
Renal injury 35.99 9.84 70 122287 18643 110448299
Haematoma 35.94 9.84 144 122213 58332 110408610
Sleep disorder due to a general medical condition 35.91 9.84 7 122350 52105 110414837
Lymphoproliferative disorder 35.71 9.84 42 122315 7176 110459766
Nail disorder 35.53 9.84 10 122347 57925 110409017
Gingival hypertrophy 35.47 9.84 33 122324 4298 110462644
Autoimmune disorder 35.45 9.84 14 122343 65469 110401473
Face oedema 35.40 9.84 99 122258 33370 110433572
Cardiomyopathy 35.30 9.84 99 122258 33426 110433516
Amblyopia 35.14 9.84 13 122344 284 110466658
Swollen tongue 35.00 9.84 146 122211 60216 110406726
Pruritus 34.88 9.84 444 121913 581116 109885826
Bone erosion 34.67 9.84 5 122352 46366 110420576
Diabetes mellitus inadequate control 34.42 9.84 91 122266 29684 110437258
Cardiovascular disorder 34.25 9.84 77 122280 22683 110444259
Palatal oedema 33.99 9.84 22 122335 1678 110465264
Joint stiffness 33.82 9.84 16 122341 67227 110399715
Liver function test increased 33.69 9.84 29 122328 88519 110378423
Bradyarrhythmia 33.65 9.84 34 122323 4900 110462042
Frequent bowel movements 32.93 9.84 19 122338 71371 110395571
Gait inability 32.90 9.84 63 122294 136313 110330629
Headache 32.87 9.84 735 121622 881642 109585300
Blood pressure increased 32.74 9.84 433 121924 257940 110209002
Pulmonary oedema 32.72 9.84 207 122150 100452 110366490
Obesity 32.31 9.84 47 122310 113304 110353638
Gastritis erosive 32.27 9.84 52 122305 11948 110454994
Taste disorder 32.22 9.84 16 122341 65371 110401571
Gastroenteritis 31.86 9.84 105 122252 38695 110428247
COVID-19 31.81 9.84 151 122206 244909 110222033
Myasthenic syndrome 31.81 9.84 19 122338 1257 110465685
Tachypnoea 31.80 9.84 106 122251 39289 110427653
Pulmonary fibrosis 31.42 9.84 40 122317 102002 110364940
Transient ischaemic attack 31.23 9.84 147 122210 63835 110403107
Blood alkaline phosphatase increased 31.06 9.84 158 122199 70777 110396165
Sinus bradycardia 30.98 9.84 87 122270 29396 110437546
Cardiomegaly 30.65 9.84 86 122271 29044 110437898
Diarrhoea 30.41 9.84 1546 120811 1137959 109328983
Cystoid macular oedema 30.30 9.84 25 122332 2775 110464167
Adenomatous polyposis coli 30.28 9.84 12 122345 318 110466624
Hip arthroplasty 30.10 9.84 12 122345 55801 110411141
Urticaria 29.92 9.84 218 122139 318639 110148303
Product use issue 29.78 9.84 212 122145 311483 110155459
Haematemesis 29.73 9.84 137 122220 58971 110407971
Hypocoagulable state 29.67 9.84 24 122333 2591 110464351
Adverse event 29.20 9.84 47 122310 108762 110358180
Electrocardiogram QRS complex prolonged 29.16 9.84 52 122305 12969 110453973
Dialysis 29.11 9.84 66 122291 19553 110447389
Prerenal failure 29.09 9.84 30 122327 4429 110462513
Drug ineffective for unapproved indication 28.96 9.84 43 122314 102795 110364147
Carotid sinus syndrome 28.94 9.84 10 122347 178 110466764
Illness 28.79 9.84 29 122328 82142 110384800
X-ray abnormal 28.76 9.84 4 122353 38113 110428829
Hospitalisation 28.48 9.84 73 122284 142420 110324522
Hypertensive heart disease 28.33 9.84 30 122327 4566 110462376
Respiratory failure 28.17 9.84 363 121994 214969 110251973
Hypophagia 27.98 9.84 124 122233 52502 110414440
Electrocardiogram abnormal 27.83 9.84 63 122294 18646 110448296
Dyspepsia 27.61 9.84 113 122244 190852 110276090
Cutaneous vasculitis 27.44 9.84 50 122307 12679 110454263
Bundle branch block right 27.41 9.84 49 122308 12242 110454700
Hyperamylasaemia 27.40 9.84 17 122340 1204 110465738
Presyncope 27.38 9.84 117 122240 48770 110418172
Dry mouth 27.26 9.84 121 122236 199827 110267115
Full blood count abnormal 27.19 9.84 14 122343 56038 110410904
Haemorrhagic stroke 27.03 9.84 52 122305 13737 110453205
Incorrect route of product administration 26.88 9.84 19 122338 64042 110402900
Drug dependence 26.58 9.84 11 122346 50009 110416933
Intestinal angioedema 26.48 9.84 16 122341 1081 110465861
Biliary cirrhosis 26.47 9.84 10 122347 232 110466710
Injection site swelling 26.36 9.84 18 122339 61772 110405170
Colitis ulcerative 26.32 9.84 28 122329 77335 110389607
Exostosis 26.27 9.84 9 122348 45947 110420995
Glycosylated haemoglobin increased 26.11 9.84 71 122286 23548 110443394
Muscle haemorrhage 26.06 9.84 35 122322 6834 110460108
Choluria 25.95 9.84 12 122345 468 110466474
Injection site erythema 25.92 9.84 40 122317 94136 110372806
Back injury 25.88 9.84 10 122347 47389 110419553
Loss of consciousness 25.71 9.84 331 122026 195975 110270967
Blood lactate dehydrogenase increased 25.52 9.84 107 122250 44227 110422715
Haematocrit decreased 25.36 9.84 142 122215 65975 110400967
Lacunar infarction 25.34 9.84 33 122324 6253 110460689
Wrong patient received product 25.31 9.84 34 122323 6640 110460302
Blood glucose decreased 25.29 9.84 81 122276 29407 110437535
Duodenal ulcer 25 9.84 62 122295 19452 110447490
Ventricular extrasystoles 24.96 9.84 68 122289 22573 110444369
Hyponatraemic encephalopathy 24.84 9.84 11 122346 387 110466555
Nodular melanoma 24.82 9.84 10 122347 277 110466665
Left ventricular hypertrophy 24.81 9.84 49 122308 13195 110453747
Hypovolaemia 24.81 9.84 66 122291 21608 110445334
Cerebral microangiopathy 24.63 9.84 11 122346 395 110466547
Injection site pruritus 24.57 9.84 13 122344 51245 110415697
Mitral valve incompetence 24.56 9.84 87 122270 33242 110433700
Leukocytosis 24.35 9.84 121 122236 53707 110413235
Systemic scleroderma 24.30 9.84 19 122338 1953 110464989
Vertigo 24.24 9.84 172 122185 86698 110380244
Oedema peripheral 24.24 9.84 504 121853 328156 110138786
Linear IgA disease 24.18 9.84 27 122330 4362 110462580
Hypertrophic cardiomyopathy 23.81 9.84 23 122334 3140 110463802
Hypoglycaemic coma 23.81 9.84 30 122327 5503 110461439
Red blood cell sedimentation rate increased 23.79 9.84 31 122326 78271 110388671
Finger deformity 23.76 9.84 4 122353 33088 110433854
Gastric ulcer 23.61 9.84 97 122260 39730 110427212
Bicytopenia 23.60 9.84 33 122324 6691 110460251
Ear pain 23.38 9.84 15 122342 53211 110413731
Cardioactive drug level increased 23.33 9.84 25 122332 3857 110463085
Lip oedema 23.32 9.84 35 122322 7565 110459377
Ischaemic cardiomyopathy 23.32 9.84 36 122321 7975 110458967
Epistaxis 23.01 9.84 233 122124 130139 110336803
Pregnancy 22.98 9.84 14 122343 51053 110415889
Intentional product misuse 22.95 9.84 73 122284 132831 110334111
Dizziness 22.82 9.84 967 121390 697226 109769716
Sudden death 22.76 9.84 69 122288 24326 110442616
Hypomagnesaemia 22.72 9.84 129 122228 60241 110406701
Poikiloderma 22.61 9.84 11 122346 481 110466461
Wound haemorrhage 22.50 9.84 27 122330 4711 110462231
Anaemia vitamin B12 deficiency 22.39 9.84 15 122342 1212 110465730
Cardiac hypertrophy 22.37 9.84 18 122339 1929 110465013
Pancreatitis necrotising 22.37 9.84 29 122328 5472 110461470
Hypocalcaemia 22.23 9.84 136 122221 65230 110401712
Bundle branch block left 22.14 9.84 46 122311 12842 110454100
Carotid artery stenosis 22.05 9.84 38 122319 9225 110457717
Aortic bruit 21.95 9.84 9 122348 261 110466681
Haptoglobin decreased 21.95 9.84 17 122340 1724 110465218
Tubulointerstitial nephritis 21.76 9.84 118 122239 54166 110412776
Hyperglycaemia 21.75 9.84 165 122192 84925 110382017
Laryngeal oedema 21.75 9.84 39 122318 9768 110457174
Electrocardiogram P wave abnormal 21.57 9.84 10 122347 392 110466550
Ventricular assist device insertion 21.40 9.84 6 122351 51 110466891
Low cardiac output syndrome 21.35 9.84 14 122343 1092 110465850
Protein-losing gastroenteropathy 21.32 9.84 13 122344 893 110466049
Onychomadesis 21.28 9.84 12 122345 45651 110421291
Cardiogenic shock 21.23 9.84 122 122235 57216 110409726
Urine output decreased 21.22 9.84 59 122298 19817 110447125
Condition aggravated 21.22 9.84 635 121722 734201 109732741
Hypochloraemia 21.22 9.84 23 122334 3595 110463347
Diabetic ketoacidosis 20.79 9.84 97 122260 41961 110424981
Product complaint 20.73 9.84 47 122310 13925 110453017
Adiposis dolorosa 20.64 9.84 9 122348 305 110466637
Haemoglobin decreased 20.54 9.84 388 121969 248339 110218603
Drug tolerance decreased 20.52 9.84 3 122354 27537 110439405
Blood bilirubin unconjugated increased 20.51 9.84 14 122343 1167 110465775
Nodal rhythm 20.50 9.84 22 122335 3401 110463541
Adverse reaction 20.34 9.84 4 122353 29590 110437352
Aspartate aminotransferase increased 20.23 9.84 268 122089 159668 110307274
Rhinorrhoea 20.20 9.84 53 122304 102613 110364329
Sopor 20.11 9.84 87 122270 36459 110430483
Upper respiratory tract infection 20.07 9.84 76 122281 131252 110335690
Laryngitis 19.97 9.84 11 122346 42400 110424542
Muscle spasms 19.92 9.84 204 122153 277953 110188989
Reticulocytosis 19.88 9.84 11 122346 629 110466313
Orthopnoea 19.72 9.84 40 122317 10981 110455961
Anti-platelet antibody positive 19.70 9.84 9 122348 341 110466601
Blood pH decreased 19.59 9.84 25 122332 4644 110462298
Device expulsion 19.57 9.84 5 122352 30886 110436056
Leukaemic infiltration renal 19.49 9.84 5 122352 29 110466913
Hemiparesis 19.37 9.84 98 122259 43805 110423137
Product quality issue 19.26 9.84 35 122322 77264 110389678
Blood sodium increased 19.23 9.84 27 122330 5496 110461446
Hepatotoxicity 19.15 9.84 128 122229 63272 110403670
Dyspnoea 19.10 9.84 1446 120911 1105426 109361516
Atrioventricular block first degree 19.08 9.84 46 122311 14179 110452763
Dilatation ventricular 18.99 9.84 23 122334 4052 110462890
Coombs direct test positive 18.90 9.84 10 122347 523 110466419
Hepatobiliary infection 18.81 9.84 5 122352 34 110466908
Sudden cardiac death 18.80 9.84 27 122330 5610 110461332
Necrosis 18.77 9.84 40 122317 11366 110455576
Erectile dysfunction 18.76 9.84 54 122303 18502 110448440
Atrioventricular block second degree 18.74 9.84 33 122324 8148 110458794
Coma 18.61 9.84 206 122151 117663 110349279
Scleroderma renal crisis 18.59 9.84 12 122345 911 110466031
Azotaemia 18.52 9.84 37 122320 10048 110456894
Gastric ulcer haemorrhage 18.49 9.84 37 122320 10057 110456885
Bronchopneumopathy 18.47 9.84 12 122345 921 110466021
Foot deformity 18.29 9.84 16 122341 48464 110418478
Blood bicarbonate decreased 18.23 9.84 27 122330 5770 110461172
Onychomycosis 18.14 9.84 10 122347 38521 110428421
Neuropathy peripheral 18.07 9.84 120 122237 179157 110287785
Cellulitis gangrenous 18.02 9.84 9 122348 417 110466525
Cerebellar syndrome 17.90 9.84 28 122329 6274 110460668
Ear infection 17.89 9.84 26 122331 62706 110404236
Dysarthria 17.66 9.84 156 122201 83965 110382977
Haemorrhage intracranial 17.53 9.84 71 122286 28898 110438044
Hypertrichosis 17.44 9.84 15 122342 1763 110465179
Cerebrovascular disorder 17.38 9.84 21 122336 3690 110463252
Urinary retention 17.18 9.84 134 122223 69549 110397393
Erosive oesophagitis 17.11 9.84 19 122338 3050 110463892
Cardiopulmonary failure 16.98 9.84 31 122326 7872 110459070
Acidosis hyperchloraemic 16.83 9.84 14 122343 1572 110465370
Dilatation atrial 16.75 9.84 21 122336 3831 110463111
Cardio-respiratory arrest 16.74 9.84 199 122158 115637 110351305
Duodenal ulcer haemorrhage 16.61 9.84 31 122326 8006 110458936
Therapeutic response shortened 16.55 9.84 6 122351 29577 110437365
Hyperuricaemia 16.38 9.84 44 122313 14487 110452455
Sinus node dysfunction 16.38 9.84 33 122324 9014 110457928
Arteriosclerosis coronary artery 16.36 9.84 63 122294 25055 110441887
Head injury 16.24 9.84 92 122265 42925 110424017
Blood chloride decreased 16.21 9.84 33 122324 9082 110457860
Sensory disturbance 15.98 9.84 49 122308 17380 110449562
Constipation 15.98 9.84 289 122068 357497 110109445
Normetanephrine urine increased 15.92 9.84 4 122353 21 110466921
Multiple organ dysfunction syndrome 15.91 9.84 246 122111 151464 110315478
Blood loss anaemia 15.90 9.84 50 122307 17975 110448967
Rabbit syndrome 15.81 9.84 8 122349 381 110466561
Hypertensive cardiomyopathy 15.79 9.84 8 122349 382 110466560
Heart transplant rejection 15.79 9.84 15 122342 2006 110464936
Chest pain 15.79 9.84 536 121821 375839 110091103
Pancreatic enzymes increased 15.78 9.84 14 122343 1715 110465227
Blood test abnormal 15.63 9.84 6 122351 28548 110438394
Red blood cell sedimentation rate abnormal 15.46 9.84 4 122353 24505 110442437
Pseudolymphoma 15.44 9.84 12 122345 1223 110465719
Gastric mucosal lesion 15.41 9.84 12 122345 1227 110465715
Prothrombin time prolonged 15.34 9.84 48 122309 17213 110449729
Rhythm idioventricular 15.30 9.84 10 122347 775 110466167
Traumatic haematoma 15.28 9.84 16 122341 2405 110464537
Aortic valve incompetence 15.26 9.84 36 122321 10945 110455997
Language disorder 15.24 9.84 20 122337 3818 110463124
Tendon rupture 15.24 9.84 42 122315 14036 110452906
Amylase increased 15.23 9.84 39 122318 12480 110454462
Arteriosclerosis 15.22 9.84 61 122296 24706 110442236
Pulmonary hypertension 15.21 9.84 109 122248 55111 110411831
Mixed liver injury 15.08 9.84 38 122319 12041 110454901
Blood lactic acid increased 15.00 9.84 45 122312 15776 110451166
Craniocerebral injury 14.99 9.84 25 122332 5909 110461033
Accidental exposure to product 14.98 9.84 20 122337 49988 110416954
Cerebral haematoma 14.96 9.84 33 122324 9599 110457343
IgA nephropathy 14.93 9.84 18 122339 3155 110463787
Hypercholesterolaemia 14.92 9.84 51 122306 90786 110376156
Depression 14.91 9.84 254 122103 317081 110149861
Lymphangitis 14.89 9.84 13 122344 1559 110465383
Injection site bruising 14.86 9.84 21 122336 51242 110415700
Blood pressure diastolic abnormal 14.85 9.84 5 122352 25810 110441132
Bronchial wall thickening 14.78 9.84 18 122339 3189 110463753
Ventricular hypokinesia 14.76 9.84 36 122321 11178 110455764
Dry skin 14.75 9.84 65 122292 107588 110359354
Metabolic syndrome 14.60 9.84 18 122339 3229 110463713
Respiratory distress 14.60 9.84 128 122229 68746 110398196
Lethargy 14.53 9.84 163 122194 93413 110373529
Heart valve stenosis 14.47 9.84 6 122351 179 110466763
Blood catecholamines increased 14.47 9.84 5 122352 89 110466853
Paresis 14.43 9.84 22 122335 4822 110462120
Nephropathy 14.40 9.84 40 122317 13427 110453515
Ventricular dysfunction 14.32 9.84 28 122329 7483 110459459
Atrial flutter 14.31 9.84 59 122298 24203 110442739
Thalamus haemorrhage 14.26 9.84 14 122343 1950 110464992
Dysphagia 14.22 9.84 244 122113 153356 110313586
Serotonin syndrome 14.17 9.84 113 122244 59040 110407902
Gouty tophus 14.06 9.84 8 122349 483 110466459
Cardiac death 14.04 9.84 13 122344 1683 110465259
Oliguria 14.01 9.84 49 122308 18608 110448334
Decerebration 13.97 9.84 5 122352 99 110466843
Electrocardiogram repolarisation abnormality 13.97 9.84 15 122342 2320 110464622
Acute pulmonary oedema 13.96 9.84 46 122311 16950 110449992
C-reactive protein increased 13.93 9.84 164 122193 217755 110249187
Hyperbilirubinaemia 13.91 9.84 69 122288 30602 110436340
Therapy interrupted 13.86 9.84 21 122336 49801 110417141
Bronchiectasis 13.82 9.84 12 122345 36481 110430461
Completed suicide 13.78 9.84 187 122170 242194 110224748
Tracheobronchitis 13.76 9.84 16 122341 2700 110464242
Impaired work ability 13.73 9.84 6 122351 26413 110440529
Fall 13.69 9.84 807 121550 602675 109864267
Atrophic glossitis 13.68 9.84 4 122353 40 110466902
Colitis ischaemic 13.66 9.84 47 122310 17703 110449239
Iron deficiency anaemia 13.61 9.84 70 122287 31489 110435453
Oedema mouth 13.51 9.84 17 122340 3113 110463829
Urea renal clearance decreased 13.51 9.84 4 122353 42 110466900
Hypertensive encephalopathy 13.50 9.84 11 122346 1200 110465742
Megacolon 13.46 9.84 20 122337 4285 110462657
Urogenital haemorrhage 13.45 9.84 10 122347 954 110465988
Oropharyngeal pain 13.41 9.84 91 122266 135185 110331757
Hypoxic-ischaemic encephalopathy 13.39 9.84 30 122327 8817 110458125
Muscle spasticity 13.37 9.84 12 122345 35903 110431039
Pseudo-Bartter syndrome 13.36 9.84 5 122352 113 110466829
Renin increased 13.36 9.84 7 122350 359 110466583
Sinus disorder 13.35 9.84 10 122347 32718 110434224
Lymphocyte count decreased 13.32 9.84 27 122330 57216 110409726
Hypothermia 13.25 9.84 61 122296 26241 110440701
Renal-limited thrombotic microangiopathy 13.25 9.84 8 122349 540 110466402
Diabetes mellitus 13.18 9.84 168 122189 99213 110367729
Febrile neutropenia 13.17 9.84 259 122098 316508 110150434
Pneumocystis jirovecii infection 13.13 9.84 20 122337 4380 110462562
Injury 13.10 9.84 129 122228 177136 110289806
Renal cell carcinoma 13.08 9.84 27 122330 7503 110459439
White blood cell count decreased 13.03 9.84 177 122180 229213 110237729
Meningorrhagia 12.99 9.84 7 122350 380 110466562
Osteoporosis 12.95 9.84 51 122306 87101 110379841
Coronary artery stenosis 12.92 9.84 39 122318 13719 110453223
Ventricular arrhythmia 12.87 9.84 32 122325 10055 110456887
Diaphragmatic paralysis 12.86 9.84 11 122346 1283 110465659
Epilepsy 12.85 9.84 62 122295 100147 110366795
Cardiac disorder 12.82 9.84 135 122222 76145 110390797
Cerebellar cognitive affective syndrome 12.81 9.84 3 122354 11 110466931
Pancreatitis 12.78 9.84 159 122198 93374 110373568
Renal tubular necrosis 12.73 9.84 67 122290 30408 110436534
Cholestasis 12.70 9.84 118 122239 64400 110402542
Endocarditis 12.64 9.84 38 122319 13333 110453609
Fear 12.59 9.84 55 122302 23138 110443804
Focal segmental glomerulosclerosis 12.59 9.84 19 122338 4126 110462816
Prescribed underdose 12.55 9.84 34 122323 65140 110401802
Dengue fever 12.54 9.84 11 122346 1328 110465614
Embolic stroke 12.52 9.84 29 122328 8714 110458228
Paraneoplastic syndrome 12.51 9.84 11 122346 1331 110465611
Psoriasis 12.51 9.84 97 122260 139896 110327046
Tricuspid valve incompetence 12.50 9.84 56 122301 23817 110443125
Bradykinesia 12.50 9.84 33 122324 10755 110456187
Coronary arterial stent insertion 12.45 9.84 23 122334 5892 110461050
Status epilepticus 12.43 9.84 10 122347 31561 110435381
IPEX syndrome 12.42 9.84 3 122354 13 110466929
Upper respiratory tract congestion 12.41 9.84 16 122341 3001 110463941
Skin hypertrophy 12.40 9.84 21 122336 5026 110461916
Hypotonia 12.38 9.84 42 122315 15703 110451239
Rash pruritic 12.38 9.84 61 122296 98008 110368934
Dysentery 12.31 9.84 11 122346 1360 110465582
Urine glucose/creatinine ratio increased 12.29 9.84 5 122352 142 110466800
Lack of spontaneous speech 12.28 9.84 6 122351 265 110466677
Therapeutic response decreased 12.20 9.84 60 122297 96439 110370503
Erythrodermic psoriasis 12.18 9.84 13 122344 1997 110464945
Electrocardiogram change 12.17 9.84 11 122346 1380 110465562
Cerebellar haematoma 12.17 9.84 8 122349 626 110466316
Intracardiac thrombus 12.17 9.84 19 122338 4249 110462693
Asthenia 12.16 9.84 902 121455 688097 109778845
Coronary artery bypass 12.11 9.84 23 122334 6019 110460923
Osteitis 12.08 9.84 19 122338 4277 110462665
Anxiety 12.08 9.84 290 122067 344788 110122154
Lumbosacral plexus lesion 12.07 9.84 3 122354 15 110466927
Enlarged cerebral perivascular spaces 12.07 9.84 3 122354 15 110466927
Pain in jaw 12.03 9.84 24 122333 51153 110415789
Amnesia 11.95 9.84 68 122289 105340 110361602
Ulcer haemorrhage 11.93 9.84 5 122352 22566 110444376
Atrial enlargement 11.88 9.84 10 122347 1141 110465801
Cold sweat 11.78 9.84 52 122305 21979 110444963
Intestinal ischaemia 11.72 9.84 42 122315 16137 110450805
Brain natriuretic peptide increased 11.70 9.84 33 122324 11176 110455766
Ventricular fibrillation 11.64 9.84 82 122275 41231 110425711
Cardiac dysfunction 11.63 9.84 23 122334 6200 110460742
Acquired C1 inhibitor deficiency 11.61 9.84 3 122354 18 110466924
Blood pressure systolic decreased 11.60 9.84 37 122320 13404 110453538
Coronary artery restenosis 11.58 9.84 10 122347 1182 110465760
Weight fluctuation 11.56 9.84 5 122352 22140 110444802
Forced vital capacity abnormal 11.53 9.84 4 122353 72 110466870
Cardiac tamponade 11.52 9.84 33 122324 11274 110455668
Right ventricular failure 11.49 9.84 58 122299 25896 110441046
Pleurothotonus 11.48 9.84 14 122343 2484 110464458
Auricular swelling 11.45 9.84 5 122352 170 110466772
Peripheral arterial occlusive disease 11.38 9.84 29 122328 9251 110457691
Left ventricular failure 11.37 9.84 33 122324 11356 110455586
Malignant anorectal neoplasm 11.28 9.84 4 122353 77 110466865
Resuscitation 11.21 9.84 15 122342 2918 110464024
Renal artery stenosis 11.21 9.84 17 122340 3709 110463233
Incarcerated inguinal hernia 11.20 9.84 6 122351 322 110466620
Immunodeficiency 11.17 9.84 16 122341 38822 110428120
Sedation complication 11.16 9.84 4 122353 19851 110447091
Toxic skin eruption 11.16 9.84 60 122297 27455 110439487
Anhedonia 11.14 9.84 40 122317 15388 110451554
Alanine aminotransferase increased 11.09 9.84 274 122083 183499 110283443
Cerebral ischaemia 11.07 9.84 34 122323 12070 110454872
Basal ganglia haemorrhage 11.07 9.84 12 122345 1876 110465066
Poor peripheral circulation 11.03 9.84 18 122339 4179 110462763
Orthostatic hypotension 11.02 9.84 117 122240 66132 110400810
Jaundice 11.00 9.84 107 122250 59129 110407813
Cryoglobulinaemia 10.97 9.84 10 122347 1269 110465673
Hepatic enzyme decreased 10.96 9.84 9 122348 993 110465949
Extremity necrosis 10.95 9.84 17 122340 3785 110463157
Infusion site reaction 10.94 9.84 3 122354 17679 110449263
Pathogen resistance 10.93 9.84 3 122354 17669 110449273
Potentiating drug interaction 10.93 9.84 33 122324 11610 110455332
Meibomianitis 10.92 9.84 4 122353 85 110466857
Stevens-Johnson syndrome 10.91 9.84 89 122268 46812 110420130
Gastrooesophageal reflux disease 10.91 9.84 137 122220 179839 110287103
Underdose 10.90 9.84 35 122322 63519 110403423
Tumour inflammation 10.87 9.84 4 122353 86 110466856
Salivary gland adenoma 10.86 9.84 3 122354 24 110466918
Continuous haemodiafiltration 10.83 9.84 12 122345 1923 110465019
Glucose urine present 10.80 9.84 13 122344 2276 110464666
Post angioplasty restenosis 10.75 9.84 3 122354 25 110466917
Ischaemia 10.74 9.84 28 122329 9055 110457887
Extensor plantar response 10.72 9.84 12 122345 1943 110464999
Pancreatolithiasis 10.72 9.84 6 122351 351 110466591
Lipase increased 10.70 9.84 45 122312 18627 110448315
Respiratory tract congestion 10.68 9.84 11 122346 30846 110436096
Coronary artery occlusion 10.63 9.84 40 122317 15732 110451210
Complement factor C4 decreased 10.63 9.84 6 122351 357 110466585
Long QT syndrome 10.62 9.84 24 122333 7094 110459848
Multiple sclerosis relapse 10.61 9.84 25 122332 50215 110416727
Cerebral artery occlusion 10.60 9.84 12 122345 1968 110464974
Labelled drug-disease interaction medication error 10.58 9.84 6 122351 360 110466582
Subretinal fluid 10.55 9.84 10 122347 1334 110465608
Abdominal strangulated hernia 10.54 9.84 4 122353 94 110466848
Generalised oedema 10.51 9.84 64 122293 30640 110436302
Cachexia 10.50 9.84 35 122322 12970 110453972
Gastric disorder 10.47 9.84 68 122289 33289 110433653
Sneezing 10.41 9.84 12 122345 31972 110434970
Congestive cardiomyopathy 10.38 9.84 37 122320 14182 110452760
International normalised ratio decreased 10.37 9.84 26 122331 8210 110458732
Blood pressure fluctuation 10.36 9.84 45 122312 74779 110392163
Diabetic retinopathy 10.35 9.84 16 122341 3548 110463394
Peripheral embolism 10.33 9.84 12 122345 2023 110464919
Neuropsychiatric syndrome 10.29 9.84 5 122352 218 110466724
Excessive granulation tissue 10.27 9.84 9 122348 1085 110465857
Coagulopathy 10.27 9.84 79 122278 40832 110426110
Ejaculation failure 10.25 9.84 6 122351 382 110466560
Device difficult to use 10.21 9.84 4 122353 18801 110448141
Autoimmune lung disease 10.21 9.84 5 122352 222 110466720
Blood aldosterone increased 10.21 9.84 5 122352 222 110466720
Retinal artery thrombosis 10.20 9.84 4 122353 103 110466839
Hypochromic anaemia 10.19 9.84 15 122342 3186 110463756
Atrioventricular dissociation 10.17 9.84 6 122351 388 110466554
Natural killer-cell leukaemia 10.16 9.84 4 122353 104 110466838
Vasoconstriction 10.15 9.84 9 122348 1101 110465841
Iliac artery stenosis 10.15 9.84 5 122352 225 110466717
Haemoconcentration 10.12 9.84 5 122352 226 110466716
Nephrogenic diabetes insipidus 10.11 9.84 13 122344 2432 110464510
Cerebral congestion 10.10 9.84 5 122352 227 110466715
Blood lactate dehydrogenase 10.09 9.84 3 122354 32 110466910
Left ventricular dilatation 10.07 9.84 10 122347 1412 110465530
Meningitis streptococcal 10.06 9.84 5 122352 229 110466713
Subdural haematoma 10.06 9.84 72 122285 36382 110430560
Metabolic encephalopathy 10.05 9.84 31 122326 11029 110455913
Vasoplegia syndrome 10.04 9.84 20 122337 5419 110461523
Diaphragmatic hernia 10.00 9.84 7 122350 608 110466334
Neutropenia 9.99 9.84 327 122030 374293 110092649
Incorrect product formulation administered 9.98 9.84 5 122352 233 110466709
Peroneal nerve palsy 9.97 9.84 24 122333 7390 110459552
Therapy partial responder 9.95 9.84 16 122341 37045 110429897
Joint dislocation 9.92 9.84 14 122343 34176 110432766
Hepatic failure 9.89 9.84 118 122239 68621 110398321
Polyneuropathy 9.89 9.84 65 122292 31947 110434995
Nephropathy toxic 9.87 9.84 58 122299 27420 110439522
Female genital tract fistula 9.86 9.84 3 122354 16516 110450426
Traumatic ulcer 9.85 9.84 4 122353 113 110466829
Emotional distress 9.85 9.84 84 122273 44763 110422179
Shock hypoglycaemic 9.85 9.84 5 122352 240 110466702

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09AA02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, PLAIN
ACE inhibitors, plain
ATC C09BA02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and diuretics
ATC C09BB02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BB06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
FDA MoA N0000000181 Angiotensin-converting Enzyme Inhibitors
FDA EPC N0000175562 Angiotensin Converting Enzyme Inhibitor
MeSH PA D000806 Angiotensin-Converting Enzyme Inhibitors
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35457 EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:76595 nephroprotective agent
FDA PE N0000178477 Decreased Blood Pressure

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Congestive heart failure indication 42343007 DOID:6000
Asymptomatic left ventricular systolic dysfunction indication 698592004
Angioedema contraindication 41291007 DOID:1558
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Idiopathic angioedema contraindication 402382008




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Heart failure Indication

🐶 Veterinary products

ProductApplicantIngredients
Enacard Tablets For Dogs Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.14 acidic
pKa2 5.91 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 8778366 Nov. 6, 2032 METHOD OF TREATING HYPERTENSION
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 8778366 Nov. 6, 2032 METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 8778366 Nov. 6, 2032 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 8778366 Nov. 6, 2032 TREATMENT OF HEART FAILURE
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 8778366 Nov. 6, 2032 TREATMENT OF HYPERTENSION
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 9968553 Nov. 6, 2032 METHOD OF TREATING HYPERTENSION
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 9968553 Nov. 6, 2032 METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 9968553 Nov. 6, 2032 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 9968553 Nov. 6, 2032 TREATMENT OF HEART FAILURE
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** EPANED KIT AZURITY N204308 Aug. 13, 2013 DISCN FOR SOLUTION ORAL 9968553 Nov. 6, 2032 TREATMENT OF HYPERTENSION
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 10154987 March 25, 2036 METHOD OF TREATING HYPERTENSION
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 10154987 March 25, 2036 METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 10154987 March 25, 2036 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 10154987 March 25, 2036 TREATMENT OF HEART FAILURE
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 10154987 March 25, 2036 TREATMENT OF HYPERTENSION
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 9808442 March 25, 2036 METHOD OF TREATING HYPERTENSION
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 9808442 March 25, 2036 METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 9808442 March 25, 2036 METHOD OF TREATMENT OF HEART FAILURE
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 9808442 March 25, 2036 TREATMENT OF HEART FAILURE
1MG/ML EPANED AZURITY N208686 Sept. 20, 2016 RX SOLUTION ORAL 9808442 March 25, 2036 TREATMENT OF HYPERTENSION

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 4.30 IUPHAR IUPHAR
Angiotensin-converting enzyme Enzyme IC50 6.10 CHEMBL
Angiotensin-converting enzyme Enzyme IC50 6.85 CHEMBL

External reference:

IDSource
4019744 VUID
N0000147835 NUI
D00621 KEGG_DRUG
76095-16-4 SECONDARY_CAS_RN
4017954 VANDF
4019497 VANDF
4019744 VANDF
C0014025 UMLSCUI
CHEBI:4784 CHEBI
CHEMBL578 ChEMBL_ID
CHEMBL1200659 ChEMBL_ID
DB00584 DRUGBANK_ID
D004656 MESH_DESCRIPTOR_UI
5388962 PUBCHEM_CID
6322 IUPHAR_LIGAND_ID
5117 INN_ID
69PN84IO1A UNII
203123 RXNORM
37933 MMSL
37934 MMSL
4655 MMSL
4656 MMSL
4657 MMSL
d00013 MMSL
000657 NDDF
004500 NDDF
007388 NDDF
15222008 SNOMEDCT_US
372658000 SNOMEDCT_US
387165009 SNOMEDCT_US
414092003 SNOMEDCT_US
48052001 SNOMEDCT_US
C0014027 UMLSCUI
DB09477 DRUGBANK_ID
5462501 PUBCHEM_CID
D015773 MESH_DESCRIPTOR_UI
CHEBI:4786 CHEBI
69PN84IO1A INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vasotec HUMAN PRESCRIPTION DRUG LABEL 1 0187-0140 TABLET 2.50 mg ORAL NDA 23 sections
Vasotec HUMAN PRESCRIPTION DRUG LABEL 1 0187-0141 TABLET 5 mg ORAL NDA 23 sections
Vasotec HUMAN PRESCRIPTION DRUG LABEL 1 0187-0142 TABLET 10 mg ORAL NDA 23 sections
Vasotec HUMAN PRESCRIPTION DRUG LABEL 1 0187-0143 TABLET 20 mg ORAL NDA 23 sections
Vaseretic HUMAN PRESCRIPTION DRUG LABEL 2 0187-0146 TABLET 10 mg ORAL NDA 24 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7309 TABLET 2.50 mg ORAL ANDA 17 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7310 TABLET 5 mg ORAL ANDA 17 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7311 TABLET 10 mg ORAL ANDA 17 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7312 TABLET 20 mg ORAL ANDA 17 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 10544-170 TABLET 10 mg ORAL ANDA 17 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 10544-195 TABLET 10 mg ORAL ANDA 24 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 10544-293 TABLET 5 mg ORAL ANDA 24 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 10544-632 TABLET 10 mg ORAL ANDA 24 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 10544-633 TABLET 20 mg ORAL ANDA 24 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 16590-277 TABLET 10 mg ORAL ANDA 12 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-442 TABLET 2.50 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-442 TABLET 2.50 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-443 TABLET 5 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-443 TABLET 5 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-444 TABLET 10 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-444 TABLET 10 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-445 TABLET 20 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 16714-445 TABLET 20 mg ORAL ANDA 23 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 21695-487 TABLET 5 mg ORAL ANDA 13 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 21695-488 TABLET 10 mg ORAL ANDA 13 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 21695-489 TABLET 20 mg ORAL ANDA 13 sections
Enalapril Maleate and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 21695-780 TABLET 10 mg ORAL ANDA 25 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 23155-704 TABLET 2.50 mg ORAL ANDA 16 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 23155-705 TABLET 5 mg ORAL ANDA 16 sections
Enalapril maleate HUMAN PRESCRIPTION DRUG LABEL 1 23155-706 TABLET 10 mg ORAL ANDA 16 sections