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

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1985 FDA VALEANT PHARMS NORTH

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 572.95 9.80 921 64445 228210 63195446
Hyperkalaemia 556.81 9.80 455 64911 53748 63369908
Acute kidney injury 534.75 9.80 965 64401 262450 63161206
Hyponatraemia 393.85 9.80 529 64837 111371 63312285
Cardiac failure congestive 298.03 9.80 419 64947 92014 63331642
Angioedema 250.44 9.80 277 65089 47688 63375968
Pemphigus 166.25 9.80 5 65361 183721 63239935
Cardiac failure 157.04 9.80 308 65058 88834 63334822
Synovitis 156.14 9.80 9 65357 186909 63236747
Alopecia 153.53 9.80 78 65288 337458 63086198
Hypoglycaemia 146.19 9.80 239 65127 59826 63363830
Treatment failure 141.01 9.80 19 65347 199024 63224632
Lactic acidosis 140.61 9.80 185 65181 38102 63385554
Hand deformity 138.51 9.80 6 65360 159451 63264205
Systemic lupus erythematosus 136.57 9.80 25 65341 208893 63214763
Infusion related reaction 133.95 9.80 43 65323 245478 63178178
Joint swelling 130.24 9.80 89 65277 327577 63096079
Hypotension 129.75 9.80 590 64776 272014 63151642
Blood creatinine increased 124.88 9.80 278 65088 87566 63336090
Glossodynia 122.22 9.80 19 65347 178857 63244799
Loss of employment 121.68 9.80 55 65311 2189 63421467
Drug ineffective 119.04 9.80 614 64752 1044151 62379505
Arthropathy 118.05 9.80 47 65319 234745 63188911
Renal failure 116.22 9.80 324 65042 117328 63306328
Myocardial infarction 114.78 9.80 291 65075 99602 63324054
Rhabdomyolysis 108.44 9.80 176 65190 43775 63379881
Hypertensive crisis 108.18 9.80 104 65262 15182 63408474
Pericarditis 107.86 9.80 7 65359 131572 63292084
Maternal exposure during pregnancy 101.26 9.80 50 65316 220012 63203644
Pain 100.35 9.80 408 64958 740220 62683436
Wound 99.50 9.80 23 65343 163240 63260416
Off label use 95.49 9.80 365 65001 674097 62749559
Bradycardia 94.40 9.80 223 65143 73004 63350652
Drug intolerance 93.57 9.80 108 65258 308553 63115103
Rheumatoid arthritis 91.73 9.80 76 65290 253743 63169913
Fatigue 91.55 9.80 539 64827 887489 62536167
Atrioventricular block complete 90.40 9.80 72 65294 8179 63415477
Cerebrovascular accident 89.04 9.80 279 65087 107745 63315911
Syncope 84.03 9.80 289 65077 117096 63306560
Peripheral swelling 81.72 9.80 92 65274 265850 63157806
Inappropriate antidiuretic hormone secretion 80.14 9.80 89 65277 15373 63408283
Swelling 78.53 9.80 101 65265 275277 63148379
Lower respiratory tract infection 77.95 9.80 20 65346 132287 63291369
Sinusitis 76.89 9.80 72 65294 226581 63197075
Duodenal ulcer perforation 70.40 9.80 5 65361 87204 63336452
Hepatic steatosis 69.32 9.80 114 65252 28655 63395001
Discomfort 68.38 9.80 44 65322 167330 63256326
Arthralgia 67.84 9.80 329 65037 569381 62854275
Blood urea increased 66.92 9.80 107 65259 26272 63397384
Renal impairment 65.38 9.80 220 65146 88135 63335521
Broncholithiasis 62.77 9.80 19 65347 234 63423422
Burning mouth syndrome 60.66 9.80 22 65344 489 63423167
Hypokalaemia 60.36 9.80 239 65127 103565 63320091
Rheumatoid factor positive 59.87 9.80 8 65358 84398 63339258
Coronary artery disease 59.56 9.80 114 65252 32263 63391393
Intentional product use issue 58.88 9.80 29 65337 127863 63295793
Toxic epidermal necrolysis 57.84 9.80 98 65268 25236 63398420
Contraindicated product administered 57.81 9.80 84 65282 217564 63206092
Lymph node calcification 57.69 9.80 19 65347 313 63423343
Folliculitis 56.85 9.80 4 65362 70313 63353343
Nasopharyngitis 54.86 9.80 112 65254 254145 63169511
International normalised ratio increased 54.07 9.80 136 65230 46289 63377367
Blood pressure inadequately controlled 53.60 9.80 43 65323 4935 63418721
Dehydration 52.72 9.80 332 65034 173022 63250634
Psoriatic arthropathy 51.71 9.80 15 65351 91505 63332151
Metabolic acidosis 49.35 9.80 129 65237 44940 63378716
Muscle injury 49.31 9.80 5 65361 65340 63358316
Abdominal discomfort 48.96 9.80 168 65198 320717 63102939
Acute myocardial infarction 48.26 9.80 104 65262 32020 63391636
Tongue oedema 48.08 9.80 39 65327 4547 63419109
Irritable bowel syndrome 47.50 9.80 13 65353 82399 63341257
Musculoskeletal stiffness 46.37 9.80 74 65292 184544 63239112
Ill-defined disorder 45.10 9.80 14 65352 81741 63341915
Cystoid macular oedema 45.01 9.80 25 65341 1550 63422106
Hypersensitivity 44.80 9.80 153 65213 292532 63131124
Blood glucose increased 43.29 9.80 186 65180 83570 63340086
Atrial fibrillation 42.29 9.80 234 65132 116402 63307254
Rash 41.76 9.80 373 64993 560498 62863158
Exposure during pregnancy 41.32 9.80 60 65306 155487 63268169
Angina unstable 40.54 9.80 43 65323 7052 63416604
Therapeutic product effect decreased 40.06 9.80 87 65279 193100 63230556
Therapeutic product effect incomplete 39.76 9.80 42 65324 125014 63298642
Wrong patient received product 39.65 9.80 26 65340 2181 63421475
Ventricular hypertrophy 37.68 9.80 30 65336 3406 63420250
Pancreatitis acute 36.37 9.80 84 65282 27082 63396574
C-reactive protein abnormal 36.19 9.80 3 65363 46093 63377563
Product dose omission issue 36.17 9.80 122 65244 234191 63189465
Blister 35.54 9.80 49 65317 129765 63293891
Circulatory collapse 35.24 9.80 73 65293 21865 63401791
Anaemia 34.86 9.80 458 64908 292972 63130684
Fibromyalgia 34.41 9.80 20 65346 80400 63343256
Knee arthroplasty 34.30 9.80 7 65359 54199 63369457
Mobility decreased 33.91 9.80 45 65321 121114 63302542
Amblyopia 33.42 9.80 12 65354 259 63423397
Infection 32.92 9.80 123 65243 229050 63194606
Ischaemic stroke 32.74 9.80 63 65303 17894 63405762
Gastrointestinal disorder 32.57 9.80 53 65313 131186 63292470
Completed suicide 32.39 9.80 63 65303 145610 63278046
Melaena 32.31 9.80 86 65280 30279 63393377
Intestinal angioedema 32.21 9.80 15 65351 640 63423016
Adverse drug reaction 31.13 9.80 22 65344 79692 63343964
Face oedema 31.01 9.80 66 65300 20146 63403510
Haemodialysis 30.94 9.80 42 65324 8905 63414751
Concomitant disease progression 30.89 9.80 22 65344 2112 63421544
Gastrointestinal haemorrhage 30.86 9.80 165 65201 81011 63342645
Bradyphrenia 30.83 9.80 37 65329 6943 63416713
Scleroderma renal crisis 30.77 9.80 12 65354 328 63423328
Hypophagia 30.74 9.80 86 65280 31173 63392483
Bronchial wall thickening 30.25 9.80 19 65347 1480 63422176
Chronic kidney disease 30.07 9.80 109 65257 45289 63378367
Product use in unapproved indication 29.90 9.80 90 65276 178990 63244666
Cardiac arrest 29.84 9.80 180 65186 92365 63331291
Hepatitis cholestatic 29.63 9.80 36 65330 6842 63416814
Hepatic enzyme increased 29.44 9.80 108 65258 202220 63221436
Weight increased 28.99 9.80 154 65212 260638 63163018
Blood pressure increased 28.85 9.80 274 65092 161788 63261868
Transient ischaemic attack 28.79 9.80 95 65271 37658 63385998
Loss of personal independence in daily activities 28.40 9.80 35 65331 97255 63326401
Migraine 28.29 9.80 39 65327 103307 63320349
Hypertensive heart disease 28.16 9.80 22 65344 2430 63421226
Prerenal failure 28.10 9.80 19 65347 1677 63421979
Myopathy 27.84 9.80 45 65321 11146 63412510
Cerebral haemorrhage 27.75 9.80 82 65284 30647 63393009
Electrocardiogram P wave abnormal 27.54 9.80 10 65356 223 63423433
Palatal oedema 27.54 9.80 13 65353 572 63423084
Swollen tongue 26.93 9.80 88 65278 34712 63388944
Hyperamylasaemia 26.77 9.80 12 65354 468 63423188
Hyponatraemic encephalopathy 26.63 9.80 10 65356 246 63423410
Atrioventricular block 26.60 9.80 36 65330 7611 63416045
Sinus bradycardia 26.47 9.80 51 65315 14500 63409156
Hypertension 26.42 9.80 419 64947 278884 63144772
Cerebral microangiopathy 26.22 9.80 10 65356 257 63423399
Stomatitis 25.92 9.80 66 65300 138659 63284997
Lower gastrointestinal haemorrhage 25.73 9.80 36 65330 7854 63415802
Cardiac hypertrophy 25.60 9.80 15 65351 1030 63422626
Cardiomyopathy 25.35 9.80 56 65310 17528 63406128
Anuria 25.34 9.80 46 65320 12505 63411151
Cardiomegaly 25.29 9.80 56 65310 17558 63406098
Gastric disorder 24.98 9.80 90 65276 37279 63386377
Upper gastrointestinal haemorrhage 24.91 9.80 58 65308 18794 63404862
Impaired healing 24.89 9.80 42 65324 102500 63321156
Arrhythmia 24.77 9.80 91 65275 38049 63385607
Cerebral infarction 24.75 9.80 67 65299 23826 63399830
Hypomagnesaemia 24.37 9.80 75 65291 28662 63394994
Hypovolaemic shock 24.22 9.80 31 65335 6210 63417446
Product use issue 24.07 9.80 131 65235 220389 63203267
Blood pressure decreased 23.92 9.80 131 65235 64891 63358765
Cardioactive drug level increased 23.68 9.80 19 65347 2181 63421475
Injection site bruising 23.43 9.80 7 65359 41903 63381753
COVID-19 23.37 9.80 51 65315 113052 63310604
Dialysis 23.36 9.80 40 65326 10387 63413269
Device expulsion 23.18 9.80 4 65362 34918 63388738
Hypoglycaemic coma 23.07 9.80 20 65346 2555 63421101
Depressed level of consciousness 22.79 9.80 125 65241 61953 63361703
Disorientation 22.24 9.80 90 65276 39362 63384294
Blood sodium decreased 22.17 9.80 65 65301 24187 63399469
Oliguria 21.83 9.80 36 65330 9065 63414591
Blood creatine phosphokinase increased 21.81 9.80 75 65291 30355 63393301
Diabetes mellitus inadequate control 21.61 9.80 48 65318 15078 63408578
Blood catecholamines increased 21.58 9.80 5 65361 19 63423637
Injection site swelling 21.56 9.80 11 65355 47561 63376095
Leukaemic infiltration renal 21.37 9.80 5 65361 20 63423636
Adiposis dolorosa 21.29 9.80 9 65357 304 63423352
Cerebellar syndrome 21.20 9.80 22 65344 3517 63420139
Death 20.90 9.80 266 65100 374115 63049541
Ventricular assist device insertion 20.63 9.80 5 65361 24 63423632
Gastritis erosive 20.36 9.80 28 65338 6011 63417645
Acute coronary syndrome 20.30 9.80 37 65329 10089 63413567
Hip arthroplasty 20.17 9.80 12 65354 47634 63376022
Left ventricular hypertrophy 19.99 9.80 26 65340 5289 63418367
Contusion 19.96 9.80 83 65283 149961 63273695
Wheezing 19.84 9.80 43 65323 95552 63328104
Injection site pain 19.73 9.80 68 65298 129732 63293924
Presyncope 19.50 9.80 68 65298 27717 63395939
Gastroenteritis 19.47 9.80 66 65300 26524 63397132
Mitral valve incompetence 19.35 9.80 54 65312 19540 63404116
Cardiac failure acute 19.35 9.80 35 65331 9488 63414168
Injection site reaction 19.34 9.80 19 65347 58505 63365151
Injection site erythema 19.34 9.80 35 65331 83139 63340517
Electrocardiogram QRS complex prolonged 19.22 9.80 27 65339 5911 63417745
Acidosis 18.78 9.80 38 65328 11195 63412461
Haematoma 18.50 9.80 78 65288 34742 63388914
Night sweats 18.37 9.80 14 65352 48800 63374856
Injection site pruritus 18.22 9.80 12 65354 45104 63378552
Paraneoplastic syndrome 18.11 9.80 10 65356 613 63423043
Shock 17.85 9.80 59 65307 23404 63400252
Acquired C1 inhibitor deficiency 17.64 9.80 3 65363 0 63423656
Hypocalcaemia 17.60 9.80 72 65294 31641 63392015
Wound haemorrhage 17.58 9.80 17 65349 2499 63421157
Rabbit syndrome 17.57 9.80 8 65358 324 63423332
Dysphagia 17.39 9.80 153 65213 88432 63335224
Cardiopulmonary failure 17.37 9.80 20 65346 3592 63420064
Arteriosclerosis coronary artery 17.30 9.80 31 65335 8342 63415314
Cardiogenic shock 17.30 9.80 49 65317 17883 63405773
Proteinuria 17.20 9.80 51 65315 19094 63404562
Headache 17.12 9.80 509 64857 632732 62790924
Normetanephrine urine increased 17.10 9.80 4 65362 16 63423640
Cerebral haematoma 17.05 9.80 20 65346 3663 63419993
Resuscitation 17.03 9.80 12 65354 1132 63422524
Pain in jaw 16.99 9.80 12 65354 43484 63380172
Blood lactic acid increased 16.96 9.80 28 65338 7058 63416598
Hypertrichosis 16.94 9.80 12 65354 1142 63422514
Dilatation atrial 16.91 9.80 15 65351 1976 63421680
Live birth 16.87 9.80 3 65363 25627 63398029
Inappropriate schedule of product administration 16.81 9.80 53 65313 103912 63319744
Prothrombin time prolonged 16.76 9.80 33 65333 9531 63414125
Nephrogenic systemic fibrosis 16.69 9.80 22 65344 4534 63419122
Epistaxis 16.62 9.80 130 65236 72595 63351061
Lacrimal gland enlargement 16.54 9.80 4 65362 19 63423637
Electrocardiogram abnormal 16.48 9.80 32 65334 9147 63414509
Gamma-glutamyltransferase increased 16.38 9.80 74 65292 33957 63389699
Haemorrhage intracranial 16.34 9.80 40 65326 13379 63410277
Oedema peripheral 16.31 9.80 280 65086 189231 63234425
Inflammation 16.26 9.80 38 65328 82235 63341421
Arthritis 16.12 9.80 63 65303 115858 63307798
Malignant anorectal neoplasm 16.05 9.80 4 65362 22 63423634
Decerebration 16.00 9.80 5 65361 69 63423587
Renal injury 15.86 9.80 32 65334 9407 63414249
Speech disorder 15.72 9.80 83 65283 40546 63383110
Angina pectoris 15.69 9.80 67 65299 30011 63393645
Pseudo-Bartter syndrome 15.68 9.80 5 65361 74 63423582
Lack of spontaneous speech 15.42 9.80 6 65360 163 63423493
Product complaint 15.41 9.80 38 65328 12771 63410885
Diaphragmatic paralysis 15.40 9.80 9 65357 615 63423041
Hypovolaemia 15.40 9.80 34 65332 10639 63413017
Haemorrhagic stroke 15.38 9.80 24 65342 5768 63417888
Hepatobiliary infection 15.36 9.80 4 65362 27 63423629
Prescribed overdose 15.32 9.80 8 65358 34145 63389511
Colitis ischaemic 15.32 9.80 34 65332 10674 63412982
Anomaly of external ear congenital 15.28 9.80 6 65360 167 63423489
Haemoglobin decreased 15.18 9.80 222 65144 145263 63278393
Hyperglycaemia 15.16 9.80 84 65282 41783 63381873
Ventricular tachycardia 14.99 9.80 50 65316 19929 63403727
Diabetic retinopathy 14.91 9.80 15 65351 2312 63421344
Electrolyte imbalance 14.84 9.80 50 65316 20026 63403630
Blood potassium increased 14.80 9.80 47 65319 18262 63405394
Renal failure neonatal 14.77 9.80 6 65360 183 63423473
Nephrotic syndrome 14.67 9.80 23 65343 5553 63418103
Blood sodium increased 14.63 9.80 16 65350 2716 63420940
Tachypnoea 14.52 9.80 45 65321 17257 63406399
Arteriosclerosis 14.45 9.80 32 65334 10034 63413622
Dysarthria 14.35 9.80 84 65282 42627 63381029
Insomnia 14.31 9.80 147 65219 215105 63208551
Ketoacidosis 14.31 9.80 20 65346 4358 63419298
Dilatation ventricular 14.29 9.80 15 65351 2430 63421226
Renal atrophy 14.28 9.80 12 65354 1470 63422186
Dyspnoea 14.25 9.80 824 64542 660489 62763167
Hypocoagulable state 14.23 9.80 11 65355 1196 63422460
Tubulointerstitial nephritis 14.22 9.80 49 65317 19854 63403802
Condition aggravated 14.14 9.80 311 65055 401906 63021750
Coma 14.13 9.80 114 65252 64250 63359406
Ischaemic cardiomyopathy 14.13 9.80 15 65351 2462 63421194
Glycosylated haemoglobin increased 14.10 9.80 36 65330 12362 63411294
Ventricular fibrillation 14.06 9.80 35 65331 11832 63411824
Hypotelorism of orbit 14.03 9.80 3 65363 7 63423649
Tachycardia induced cardiomyopathy 14.01 9.80 5 65361 106 63423550
Azotaemia 13.99 9.80 20 65346 4451 63419205
Emotional poverty 13.96 9.80 7 65359 352 63423304
Drug abuse 13.93 9.80 34 65332 72484 63351172
Type 2 diabetes mellitus 13.86 9.80 28 65338 63840 63359816
Atrioventricular block first degree 13.86 9.80 26 65340 7247 63416409
Suicide attempt 13.84 9.80 26 65340 60892 63362764
Neuropsychiatric syndrome 13.79 9.80 4 65362 42 63423614
Vomiting 13.77 9.80 706 64660 558911 62864745
Stress cardiomyopathy 13.51 9.80 30 65336 9420 63414236
Aortic valve incompetence 13.45 9.80 23 65343 5965 63417691
Aspartate aminotransferase increased 13.36 9.80 147 65219 90130 63333526
Traumatic ulcer 13.31 9.80 4 65362 48 63423608
Gouty tophus 13.27 9.80 6 65360 239 63423417
Tricuspid valve incompetence 13.18 9.80 39 65327 14582 63409074
Meibomianitis 13.16 9.80 4 65362 50 63423606
Carotid artery stenosis 13.15 9.80 21 65345 5149 63418507
Haematemesis 13.07 9.80 64 65302 30348 63393308
Anti-erythropoietin antibody positive 13.02 9.80 7 65359 407 63423249
Haematuria 13.00 9.80 62 65304 29095 63394561
Hypochloraemia 12.97 9.80 13 65353 1996 63421660
Cachexia 12.87 9.80 22 65344 5704 63417952
Incorrect product formulation administered 12.84 9.80 5 65361 136 63423520
Ear pain 12.79 9.80 11 65355 36107 63387549
Acidosis hyperchloraemic 12.77 9.80 7 65359 423 63423233
Cardiac failure chronic 12.71 9.80 19 65347 4399 63419257
Apathy 12.67 9.80 28 65338 8766 63414890
Subileus 12.66 9.80 16 65350 3163 63420493
Haematocrit decreased 12.34 9.80 76 65290 39264 63384392
Ventricular extrasystoles 12.33 9.80 33 65333 11654 63412002
Complement factor C4 decreased 12.30 9.80 6 65360 284 63423372
Enlarged cerebral perivascular spaces 12.28 9.80 3 65363 15 63423641
Long QT syndrome 12.27 9.80 16 65350 3263 63420393
Bicytopenia 12.26 9.80 14 65352 2491 63421165
Dizziness 12.17 9.80 550 64816 429375 62994281
Abdominal wall haemorrhage 12.17 9.80 5 65361 157 63423499
Camptodactyly congenital 12.12 9.80 3 65363 16 63423640
Thromboangiitis obliterans 11.97 9.80 3 65363 17 63423639
Ear infection 11.95 9.80 13 65353 38200 63385456
Stevens-Johnson syndrome 11.81 9.80 54 65312 24896 63398760
Left ventricular dilatation 11.77 9.80 7 65359 494 63423162
Wrong product administered 11.76 9.80 22 65344 6119 63417537
Hyperphosphataemia 11.75 9.80 13 65353 2235 63421421
Mixed liver injury 11.72 9.80 19 65347 4716 63418940
Neuropathy peripheral 11.59 9.80 69 65297 113598 63310058
Carotid bruit 11.58 9.80 8 65358 731 63422925
Atrioventricular block second degree 11.50 9.80 17 65349 3897 63419759
Lip oedema 11.47 9.80 17 65349 3907 63419749
Chest pain 11.37 9.80 297 65069 215662 63207994
Diabetes mellitus 11.26 9.80 97 65269 55713 63367943
Adverse event 11.23 9.80 34 65332 67525 63356131
Blood glucose decreased 11.18 9.80 47 65319 20905 63402751
Upper respiratory tract infection 11.15 9.80 45 65321 82002 63341654
Blood loss anaemia 11.14 9.80 27 65339 8974 63414682
Liver injury 11.14 9.80 29 65337 60491 63363165
Choluria 11.01 9.80 5 65361 201 63423455
Skin warm 10.96 9.80 20 65346 5456 63418200
Sensory disturbance 10.96 9.80 35 65331 13637 63410019
Apnoea 10.95 9.80 25 65341 7997 63415659
Klebsiella infection 10.93 9.80 26 65340 8540 63415116
Diarrhoea 10.74 9.80 865 64501 714501 62709155
Upper respiratory tract congestion 10.72 9.80 12 65354 2090 63421566
Red blood cell sedimentation rate increased 10.68 9.80 18 65348 43964 63379692
Bradyarrhythmia 10.66 9.80 12 65354 2103 63421553
Vasoconstriction 10.65 9.80 7 65359 589 63423067
Natural killer-cell leukaemia 10.63 9.80 4 65362 99 63423557
Precocious puberty 10.53 9.80 5 65361 223 63423433
Paresis 10.50 9.80 13 65353 2517 63421139
Glomerulosclerosis 10.42 9.80 6 65360 399 63423257
Drug hypersensitivity 10.41 9.80 242 65124 310445 63113211
Brain natriuretic peptide increased 10.39 9.80 19 65347 5194 63418462
Pruritus 10.38 9.80 288 65078 361165 63062491
Cerebral ischaemia 10.35 9.80 22 65344 6706 63416950
Laryngeal oedema 10.35 9.80 20 65346 5698 63417958
Pancreatitis 10.29 9.80 86 65280 48969 63374687
Blood creatinine 10.27 9.80 4 65362 109 63423547
Illness 10.23 9.80 22 65344 49037 63374619
Joint range of motion decreased 10.18 9.80 11 65355 32417 63391239
Incorrect route of product administration 10.17 9.80 8 65358 27444 63396212
Hospitalisation 10.14 9.80 49 65317 85032 63338624
Interleukin level increased 10.12 9.80 6 65360 421 63423235
No adverse event 10.01 9.80 17 65349 41388 63382268
Urine output decreased 9.94 9.80 30 65336 11340 63412316
Megacolon 9.88 9.80 11 65355 1904 63421752
Peritoneal dialysis 9.82 9.80 6 65360 445 63423211

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 386.41 10.20 403 62557 36971 34857000
Drug interaction 315.23 10.20 1007 61953 224939 34669032
Acute kidney injury 301.59 10.20 1214 61746 303774 34590197
Hyperkalaemia 261.39 10.20 457 62503 68932 34825039
Myocardial infarction 120.50 10.20 484 62476 120601 34773370
Death 108.57 10.20 362 62598 397687 34496284
Off label use 98.39 10.20 406 62554 419118 34474853
Syncope 78.80 10.20 350 62610 91101 34802870
Drug abuse 75.86 10.20 42 62918 99054 34794917
Cardiac failure 74.71 10.20 344 62616 90904 34803067
Acute myocardial infarction 74.04 10.20 239 62721 53480 34840491
Drug ineffective 73.52 10.20 502 62458 456249 34437722
Cardiac failure congestive 73.48 10.20 321 62639 82949 34811022
Clear cell renal cell carcinoma 68.96 10.20 36 62924 1111 34892860
Coronary artery disease 67.56 10.20 216 62744 48089 34845882
Blood creatinine increased 65.54 10.20 341 62619 94635 34799336
Concomitant disease progression 62.82 10.20 45 62915 2473 34891498
Hypotension 61.27 10.20 639 62321 221010 34672961
Renal failure 57.30 10.20 417 62543 130140 34763831
Hypertensive crisis 56.23 10.20 74 62886 8677 34885294
Hypoglycaemia 55.51 10.20 220 62740 54420 34839551
Intentional product use issue 49.27 10.20 23 62937 59793 34834178
Lactic acidosis 48.16 10.20 155 62805 34617 34859354
Blood urea increased 46.35 10.20 140 62820 30224 34863747
Treatment failure 45.04 10.20 14 62946 46683 34847288
Pharyngeal oedema 44.97 10.20 55 62905 5992 34887979
Lymphoproliferative disorder 44.28 10.20 38 62922 2721 34891250
Atrioventricular block complete 41.17 10.20 66 62894 9253 34884718
Vascular stent thrombosis 40.29 10.20 37 62923 2898 34891073
Carotid sinus syndrome 39.91 10.20 10 62950 28 34893943
Dehydration 39.34 10.20 382 62578 129587 34764384
Product use in unapproved indication 39.06 10.20 97 62863 117402 34776569
Renal impairment 38.67 10.20 297 62663 94216 34799755
Vertigo 38.28 10.20 117 62843 25419 34868552
Drug intolerance 37.85 10.20 31 62929 59539 34834432
Tongue oedema 35.83 10.20 35 62925 2962 34891009
Nephrotic syndrome 34.03 10.20 53 62907 7250 34886721
Blood pressure decreased 33.47 10.20 182 62778 51333 34842638
Myasthenic syndrome 32.88 10.20 17 62943 514 34893457
Pancreatitis acute 31.60 10.20 117 62843 28024 34865947
Arrhythmia 31.51 10.20 138 62822 35670 34858301
Blood potassium increased 30.98 10.20 82 62878 16413 34877558
Angina unstable 30.62 10.20 66 62894 11587 34882384
Completed suicide 30.36 10.20 84 62876 98084 34795887
Hepatic enzyme decreased 30.06 10.20 9 62951 57 34893914
Hospitalisation 29.92 10.20 35 62925 56867 34837104
Pemphigoid 29.90 10.20 55 62905 8611 34885360
Foetal exposure during pregnancy 29.35 10.20 16 62944 38085 34855886
Supernumerary nipple 29.18 10.20 8 62952 35 34893936
Biliary cirrhosis 28.89 10.20 10 62950 106 34893865
Fatigue 28.53 10.20 483 62477 370170 34523801
Toxicity to various agents 27.86 10.20 229 62731 200133 34693838
Swollen tongue 27.83 10.20 73 62887 14532 34879439
Product dose omission issue 27.17 10.20 117 62843 119594 34774377
Angina pectoris 26.94 10.20 120 62840 31243 34862728
COVID-19 26.56 10.20 63 62897 77487 34816484
Ventricular tachycardia 26.16 10.20 106 62854 26473 34867498
Neuropathy peripheral 25.93 10.20 71 62889 83192 34810779
Drug dependence 25.73 10.20 6 62954 24211 34869760
Loss of personal independence in daily activities 25.46 10.20 14 62946 33165 34860806
Haemoconcentration 24.77 10.20 7 62953 35 34893936
Neutropenia 24.71 10.20 173 62787 156605 34737366
Sepsis 24.71 10.20 187 62773 166374 34727597
Cardiac failure chronic 24.69 10.20 48 62912 7831 34886140
Inappropriate antidiuretic hormone secretion 24.57 10.20 64 62896 12689 34881282
Atrial fibrillation 24.50 10.20 332 62628 122061 34771910
Poikiloderma 24.40 10.20 10 62950 174 34893797
Melaena 24.34 10.20 127 62833 35253 34858718
Anuria 24.13 10.20 56 62904 10329 34883642
Phlebitis infective 24.08 10.20 9 62951 121 34893850
Cerebrovascular accident 24.05 10.20 246 62714 84565 34809406
Bradyphrenia 24.02 10.20 36 62924 4762 34889209
Injection site pain 22.73 10.20 22 62938 38983 34854988
Febrile neutropenia 22.56 10.20 149 62811 136700 34757271
Rhabdomyolysis 22.42 10.20 204 62756 67959 34826012
Cardiac failure acute 22.40 10.20 55 62905 10515 34883456
Upper gastrointestinal haemorrhage 22.19 10.20 98 62862 25420 34868551
Congenital hearing disorder 22.15 10.20 8 62952 97 34893874
Therapeutic product effect incomplete 21.66 10.20 36 62924 50505 34843466
Coombs direct test positive 21.60 10.20 11 62949 322 34893649
Arthralgia 21.56 10.20 199 62761 169842 34724129
Nasopharyngitis 21.53 10.20 60 62900 69908 34824063
Drug ineffective for unapproved indication 21.32 10.20 8 62952 23707 34870264
Orthopnoea 21.00 10.20 35 62925 5068 34888903
White blood cell count decreased 20.61 10.20 95 62865 95350 34798621
Systemic scleroderma 20.43 10.20 11 62949 362 34893609
Reticulocytosis 20.38 10.20 10 62950 270 34893701
Inappropriate schedule of product administration 20.24 10.20 52 62908 62244 34831727
Constipation 20.21 10.20 154 62806 136828 34757143
Sinusitis 20.16 10.20 27 62933 41375 34852596
Peripheral swelling 19.78 10.20 71 62889 76470 34817501
Pain 19.76 10.20 255 62705 204420 34689551
Rheumatoid arthritis 19.59 10.20 24 62936 38214 34855757
Acute coronary syndrome 19.31 10.20 61 62899 13484 34880487
Hyponatraemia 18.94 10.20 230 62730 82461 34811510
Anaemia 18.92 10.20 552 62408 232783 34661188
Cardiovascular disorder 18.89 10.20 50 62910 10006 34883965
Adenomatous polyposis coli 18.88 10.20 8 62952 152 34893819
Proteinuria 18.87 10.20 75 62885 18567 34875404
Chest pain 18.87 10.20 327 62633 126435 34767536
Lower gastrointestinal haemorrhage 18.79 10.20 48 62912 9404 34884567
Dizziness 18.55 10.20 520 62440 218001 34675970
Mastitis 18.01 10.20 8 62952 171 34893800
Blood pressure inadequately controlled 18.01 10.20 23 62937 2617 34891354
Rash 17.83 10.20 288 62672 222464 34671507
Asthma 17.71 10.20 31 62929 42625 34851346
Gingival hypertrophy 17.66 10.20 19 62941 1802 34892169
Blood bilirubin unconjugated increased 17.61 10.20 12 62948 608 34893363
Nodal rhythm 17.53 10.20 17 62943 1426 34892545
Ketoacidosis 17.32 10.20 29 62931 4214 34889757
Bronchopneumopathy 17.19 10.20 11 62949 501 34893470
Atrioventricular block 17.13 10.20 42 62918 8021 34885950
Bradycardia 16.94 10.20 209 62751 75209 34818762
Meningorrhagia 16.81 10.20 7 62953 127 34893844
Myocardial ischaemia 16.79 10.20 69 62891 17339 34876632
Ischaemic stroke 16.56 10.20 71 62889 18179 34875792
Cerebral infarction 16.50 10.20 95 62865 27360 34866611
Intentional product misuse 16.47 10.20 36 62924 45575 34848396
Bradyarrhythmia 16.41 10.20 20 62940 2171 34891800
Pneumocystis jirovecii infection 16.35 10.20 18 62942 1752 34892219
Hypovolaemic shock 16.23 10.20 38 62922 7047 34886924
Lymphangitis 16.20 10.20 11 62949 554 34893417
Suicidal ideation 16.19 10.20 30 62930 40358 34853613
Meningitis streptococcal 16.15 10.20 5 62955 36 34893935
Heart valve stenosis 16.10 10.20 6 62954 80 34893891
Musculoskeletal stiffness 15.92 10.20 38 62922 46642 34847329
Bundle branch block right 15.81 10.20 39 62921 7477 34886494
Laryngeal oedema 15.71 10.20 25 62935 3483 34890488
Gamma-glutamyltransferase increased 15.56 10.20 98 62862 29133 34864838
Protein-losing gastroenteropathy 15.46 10.20 9 62951 345 34893626
Aortic bruit 15.38 10.20 8 62952 245 34893726
International normalised ratio increased 15.23 10.20 141 62819 47186 34846785
Lacunar infarction 15.20 10.20 23 62937 3067 34890904
Hypocoagulable state 15.12 10.20 13 62947 933 34893038
Anti-platelet antibody positive 15.12 10.20 8 62952 254 34893717
Product complaint 15.06 10.20 33 62927 5857 34888114
Renin increased 14.93 10.20 6 62954 99 34893872
Pancreatic enzymes increased 14.79 10.20 11 62949 641 34893330
Haemodialysis 14.64 10.20 47 62913 10479 34883492
Overdose 14.57 10.20 100 62860 90959 34803012
Infusion related reaction 14.53 10.20 48 62912 53009 34840962
Pancreatitis necrotising 14.24 10.20 21 62939 2737 34891234
Cholecystitis acute 14.17 10.20 34 62926 6405 34887566
Full blood count abnormal 14.14 10.20 8 62952 18660 34875311
Lymphocyte count decreased 14.08 10.20 12 62948 22610 34871361
Sopor 14.08 10.20 51 62909 12085 34881886
Injury 14.05 10.20 74 62886 20613 34873358
Heart transplant rejection 14.02 10.20 14 62946 1217 34892754
Haptoglobin decreased 13.92 10.20 10 62950 552 34893419
Insomnia 13.85 10.20 120 62840 103787 34790184
Blood aldosterone increased 13.84 10.20 4 62956 22 34893949
Traumatic haematoma 13.76 10.20 11 62949 713 34893258
Therapeutic product effect decreased 13.75 10.20 26 62934 34717 34859254
Sudden death 13.69 10.20 59 62901 15142 34878829
Speech disorder 13.60 10.20 86 62874 25600 34868371
Erythrodermic psoriasis 13.56 10.20 12 62948 895 34893076
Bicytopenia 13.55 10.20 19 62941 2365 34891606
Erosive oesophagitis 13.47 10.20 15 62945 1479 34892492
Oedema mouth 13.46 10.20 14 62946 1277 34892694
Malignant neoplasm progression 13.44 10.20 98 62862 87948 34806023
Appendicitis 13.30 10.20 5 62955 14802 34879169
Hemiparesis 13.27 10.20 60 62900 15718 34878253
Circumoral oedema 13.19 10.20 5 62955 70 34893901
Blood glucose decreased 13.19 10.20 53 62907 13184 34880787
Non-alcoholic steatohepatitis 13.11 10.20 12 62948 936 34893035
Infection 13.03 10.20 103 62857 90812 34803159
Renal injury 12.95 10.20 47 62913 11148 34882823
Blood glucose increased 12.93 10.20 180 62780 66538 34827433
Gastrointestinal disorder 12.92 10.20 26 62934 33922 34860049
Productive cough 12.72 10.20 31 62929 37782 34856189
Gastritis erosive 12.71 10.20 31 62929 5901 34888070
Lumbosacral plexus lesion 12.68 10.20 3 62957 6 34893965
Drug hypersensitivity 12.60 10.20 89 62871 80440 34813531
Bundle branch block left 12.55 10.20 31 62929 5948 34888023
Migraine 12.52 10.20 8 62952 17470 34876501
Pseudolymphoma 12.33 10.20 10 62950 662 34893309
Blood alkaline phosphatase increased 12.19 10.20 97 62863 31078 34862893
Blood creatine phosphokinase increased 12.18 10.20 129 62831 44728 34849243
Skin hypertrophy 12.14 10.20 19 62941 2610 34891361
Muscle haemorrhage 12.08 10.20 23 62937 3695 34890276
Gastrointestinal haemorrhage 12.01 10.20 225 62735 88252 34805719
Tumour lysis syndrome 11.96 10.20 8 62952 17051 34876920
Kidney duplex 11.84 10.20 8 62952 400 34893571
Clostridium difficile infection 11.79 10.20 10 62950 18888 34875083
Wrong technique in product usage process 11.71 10.20 30 62930 35956 34858015
Nail toxicity 11.59 10.20 4 62956 42 34893929
Bronchopulmonary aspergillosis 11.52 10.20 6 62954 14653 34879318
Cellulitis gangrenous 11.44 10.20 6 62954 187 34893784
Shunt malfunction 11.41 10.20 6 62954 188 34893783
Gastric mucosal lesion 11.36 10.20 9 62951 576 34893395
Haematuria 11.34 10.20 139 62821 49927 34844044
Ischaemic cardiomyopathy 11.23 10.20 31 62929 6358 34887613
IPEX syndrome 11.16 10.20 3 62957 12 34893959
Depressed mood 11.13 10.20 11 62949 19306 34874665
Creatinine renal clearance decreased 11.09 10.20 21 62939 3360 34890611
Dry skin 11.04 10.20 25 62935 31262 34862709
Osteitis 10.98 10.20 14 62946 1590 34892381
Atrioventricular dissociation 10.96 10.20 5 62955 114 34893857
Colitis microscopic 10.94 10.20 17 62943 2320 34891651
Electrocardiogram T wave peaked 10.91 10.20 9 62951 610 34893361
Platelet count decreased 10.86 10.20 151 62809 119566 34774405
Ventricular hypokinesia 10.83 10.20 28 62932 5524 34888447
Product use issue 10.82 10.20 68 62892 63148 34830823
Dumping syndrome 10.79 10.20 3 62957 14 34893957
Gastric ulcer 10.64 10.20 56 62904 15594 34878377
Lower respiratory tract infection 10.59 10.20 26 62934 31611 34862360
Meningioma 10.58 10.20 13 62947 1423 34892548
Breast neoplasm 10.46 10.20 3 62957 16 34893955
Accidental exposure to product 10.42 10.20 5 62955 12797 34881174
Acute pulmonary oedema 10.40 10.20 33 62927 7310 34886661
Oedema peripheral 10.39 10.20 286 62674 119526 34774445
Hypercholesterolaemia 10.31 10.20 37 62923 8725 34885246

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 918.38 9.55 1867 108240 413316 79220965
Acute kidney injury 768.66 9.55 1993 108114 517411 79116870
Hyperkalaemia 698.77 9.55 825 109282 113573 79520708
Angioedema 583.69 9.55 618 109489 75417 79558864
Cardiac failure congestive 305.76 9.55 634 109473 141768 79492513
Hyponatraemia 276.62 9.55 697 109410 177151 79457130
Myocardial infarction 251.02 9.55 687 109420 183442 79450839
Cardiac failure 200.38 9.55 567 109540 154275 79480006
Hypoglycaemia 191.21 9.55 429 109678 101165 79533116
Synovitis 188.51 9.55 4 110103 150730 79483551
Renal failure 182.26 9.55 651 109456 200317 79433964
Lactic acidosis 172.16 9.55 331 109776 70028 79564253
Off label use 169.41 9.55 663 109444 906552 78727729
Blood creatinine increased 163.16 9.55 528 109579 154529 79479752
Hypotension 153.04 9.55 1086 109021 439231 79195050
Coronary artery disease 144.49 9.55 295 109812 65179 79569102
Treatment failure 141.74 9.55 31 110076 170455 79463826
Alopecia 140.45 9.55 72 110035 231283 79402998
Joint swelling 138.51 9.55 117 109990 288529 79345752
Drug ineffective 134.82 9.55 908 109199 1080005 78554276
Syncope 130.42 9.55 542 109565 178907 79455374
Hypertensive crisis 130.24 9.55 152 109955 20618 79613663
Atrioventricular block complete 129.08 9.55 136 109971 16474 79617807
Pain 128.82 9.55 518 109589 703284 78930997
Acute myocardial infarction 128.16 9.55 310 109797 76726 79557555
Infusion related reaction 126.41 9.55 81 110026 230156 79404125
Rhabdomyolysis 124.03 9.55 368 109739 102763 79531518
Hand deformity 121.79 9.55 5 110102 103914 79530367
Arthropathy 113.77 9.55 51 110056 177060 79457221
Rheumatoid arthritis 112.18 9.55 75 110032 208395 79425886
Fatigue 111.80 9.55 789 109318 928938 78705343
Drug intolerance 111.57 9.55 120 109987 263999 79370282
Arthralgia 106.97 9.55 417 109690 571386 79062895
Renal impairment 104.94 9.55 464 109643 157319 79476962
Blood urea increased 104.30 9.55 217 109890 48573 79585708
Cerebrovascular accident 101.26 9.55 454 109653 154838 79479443
Sinusitis 99.06 9.55 75 110032 195426 79438855
Dehydration 98.52 9.55 633 109474 247554 79386727
Peripheral swelling 97.58 9.55 138 109969 269479 79364802
Intentional product use issue 97.38 9.55 44 110063 152068 79482213
Loss of employment 96.24 9.55 54 110053 2533 79631748
Systemic lupus erythematosus 94.85 9.55 25 110082 121124 79513157
Pemphigus 91.58 9.55 14 110093 99568 79534713
Maternal exposure during pregnancy 91.38 9.55 37 110070 136501 79497780
Bradycardia 91.16 9.55 400 109707 135157 79499124
Pericarditis 86.52 9.55 19 110088 104217 79530064
Nasopharyngitis 85.99 9.55 136 109971 253745 79380536
Glossodynia 85.45 9.55 19 110088 103318 79530963
Inappropriate antidiuretic hormone secretion 83.89 9.55 139 109968 26174 79608107
Lower respiratory tract infection 80.21 9.55 39 110068 129181 79505100
Tongue oedema 77.28 9.55 70 110037 7047 79627234
Wound 76.90 9.55 32 110075 116147 79518134
Drug abuse 76.69 9.55 67 110040 162624 79471657
Swelling 74.41 9.55 115 109992 216596 79417685
Musculoskeletal stiffness 71.14 9.55 82 110025 174926 79459355
Duodenal ulcer perforation 69.11 9.55 6 110101 66205 79568076
Angina unstable 67.67 9.55 98 110009 16429 79617852
Atrial fibrillation 66.17 9.55 484 109623 197402 79436879
Helicobacter infection 65.95 9.55 9 110098 69695 79564586
Pancreatitis acute 65.40 9.55 183 109924 49421 79584860
Death 64.84 9.55 487 109620 566027 79068254
Completed suicide 61.48 9.55 157 109950 245610 79388671
Product use in unapproved indication 61.05 9.55 162 109945 250197 79384084
Concomitant disease progression 60.56 9.55 45 110062 3428 79630853
Irritable bowel syndrome 58.97 9.55 8 110099 62233 79572048
Rheumatoid factor positive 58.37 9.55 7 110100 59832 79574449
Weight increased 57.89 9.55 193 109914 277193 79357088
Folliculitis 57.85 9.55 5 110102 55375 79578906
Blood pressure decreased 57.60 9.55 281 109826 99185 79535096
Clear cell renal cell carcinoma 55.57 9.55 38 110069 2538 79631743
Therapeutic product effect incomplete 54.76 9.55 69 110038 141576 79492705
International normalised ratio increased 54.66 9.55 247 109860 84474 79549807
Broncholithiasis 54.09 9.55 18 110089 224 79634057
Upper gastrointestinal haemorrhage 53.90 9.55 152 109955 41228 79593053
Anaemia 53.79 9.55 888 109219 444127 79190154
Exposure during pregnancy 53.55 9.55 37 110070 101095 79533186
Burning mouth syndrome 52.70 9.55 22 110085 531 79633750
Bradyphrenia 52.44 9.55 69 110038 10571 79623710
Psoriatic arthropathy 52.40 9.55 21 110086 77978 79556303
Product dose omission issue 51.81 9.55 172 109935 247365 79386916
Vascular stent thrombosis 51.50 9.55 42 110065 3668 79630613
Nephrotic syndrome 51.30 9.55 70 110037 11104 79623177
Hypersensitivity 51.00 9.55 188 109919 262051 79372230
Melaena 50.68 9.55 192 109915 60698 79573583
Loss of personal independence in daily activities 48.63 9.55 42 110065 102538 79531743
Lower gastrointestinal haemorrhage 48.50 9.55 83 110024 16042 79618239
Ischaemic stroke 48.45 9.55 127 109980 33004 79601277
Infection 47.19 9.55 173 109934 241539 79392742
Angina pectoris 47.16 9.55 168 109939 51564 79582717
Muscle injury 46.59 9.55 6 110101 48555 79585726
Haemodialysis 46.30 9.55 87 110020 18081 79616200
Gastrointestinal disorder 45.72 9.55 61 110046 122144 79512137
Discomfort 45.69 9.55 64 110043 125553 79508728
Rash 45.65 9.55 545 109562 577813 79056468
Lymph node calcification 44.62 9.55 18 110089 397 79633884
Abdominal discomfort 44.14 9.55 187 109920 250540 79383741
COVID-19 44.00 9.55 95 110012 157579 79476702
Therapeutic product effect decreased 43.87 9.55 101 110006 163762 79470519
Blood potassium increased 43.61 9.55 113 109994 29162 79605119
Ventricular tachycardia 43.32 9.55 142 109965 41793 79592488
Atrioventricular block 43.19 9.55 73 110034 13968 79620313
Injection site pain 42.56 9.55 71 110036 129767 79504514
Migraine 42.48 9.55 35 110072 87458 79546823
Ventricular hypertrophy 42.21 9.55 50 110057 6888 79627393
Anuria 42.20 9.55 91 110016 20872 79613409
Gastrointestinal haemorrhage 41.98 9.55 348 109759 147371 79486910
Acute coronary syndrome 41.70 9.55 91 110016 21042 79613239
Arrhythmia 41.30 9.55 181 109926 61091 79573190
Mobility decreased 40.81 9.55 66 110041 122109 79512172
Knee arthroplasty 39.94 9.55 6 110101 43242 79591039
Fibromyalgia 39.04 9.55 20 110087 64320 79569961
Inappropriate schedule of product administration 38.55 9.55 79 110028 133549 79500732
Blood pressure inadequately controlled 38.38 9.55 45 110062 6132 79628149
Chronic kidney disease 38.37 9.55 187 109920 65967 79568314
Ill-defined disorder 37.75 9.55 22 110085 65853 79568428
Contraindicated product administered 37.58 9.55 103 110004 157435 79476846
Blood creatine phosphokinase increased 37.04 9.55 185 109922 65905 79568376
Swollen tongue 36.89 9.55 136 109971 42434 79591847
Hepatic steatosis 35.64 9.55 124 109983 37614 79596667
Cerebral infarction 35.54 9.55 141 109966 45535 79588746
Proteinuria 35.33 9.55 112 109995 32390 79601891
Headache 35.04 9.55 664 109443 653108 78981173
Ketoacidosis 34.25 9.55 48 110059 7806 79626475
Hypovolaemic shock 34.08 9.55 61 110046 12215 79622066
Pemphigoid 33.76 9.55 69 110038 15246 79619035
Cardiac failure acute 33.43 9.55 78 110029 18851 79615430
Lymphoproliferative disorder 33.39 9.55 40 110067 5575 79628706
Blood glucose increased 33.27 9.55 272 109835 114703 79519578
Circulatory collapse 33.20 9.55 121 109986 37547 79596734
Cystoid macular oedema 33.07 9.55 25 110082 1955 79632326
Adverse drug reaction 32.93 9.55 26 110081 66366 79567915
Myocardial ischaemia 32.51 9.55 93 110014 25426 79608855
Myopathy 32.32 9.55 81 110026 20482 79613799
Toxic epidermal necrolysis 31.82 9.55 134 109973 44447 79589834
Cardiovascular disorder 31.54 9.55 74 110033 17951 79616330
Injection site erythema 31.37 9.55 37 110070 78160 79556121
Amblyopia 31.02 9.55 12 110095 236 79634045
Drug hypersensitivity 30.86 9.55 264 109843 298652 79335629
Cardiac arrest 30.23 9.55 367 109740 171729 79462552
Arthritis 29.79 9.55 72 110035 114808 79519473
Pharyngeal oedema 29.78 9.55 68 110039 16204 79618077
Myasthenic syndrome 29.77 9.55 17 110090 825 79633456
Injection site swelling 29.58 9.55 14 110093 47118 79587163
Haematuria 29.39 9.55 179 109928 68657 79565624
Cardiac failure chronic 29.22 9.55 54 110053 11081 79623200
Transient ischaemic attack 29.17 9.55 147 109960 52548 79581733
Renal injury 29.08 9.55 69 110038 16858 79617423
Hypocoagulable state 29.04 9.55 24 110083 2135 79632146
Hypokalaemia 28.80 9.55 315 109792 143725 79490556
Stomatitis 28.65 9.55 105 110002 146652 79487629
Insomnia 28.33 9.55 210 109897 244960 79389321
Prerenal failure 28.23 9.55 30 110077 3668 79630613
Cerebral haemorrhage 27.89 9.55 155 109952 57518 79576763
Gamma-glutamyltransferase increased 27.82 9.55 149 109958 54531 79579750
Blood sodium decreased 27.78 9.55 105 110002 33150 79601131
Injection site reaction 27.75 9.55 21 110086 54764 79579517
Wrong patient received product 27.63 9.55 33 110074 4585 79629696
Depressed level of consciousness 27.61 9.55 228 109879 96424 79537857
Speech disorder 27.45 9.55 148 109959 54297 79579984
Injection site pruritus 27.41 9.55 12 110095 42271 79592010
Drug dependence 27.34 9.55 11 110096 40758 79593523
Bicytopenia 27.33 9.55 33 110074 4637 79629644
Biliary cirrhosis 27.04 9.55 10 110097 173 79634108
Cardiomyopathy 26.70 9.55 94 110013 28680 79605601
Carotid sinus syndrome 26.57 9.55 10 110097 182 79634099
Product use issue 26.55 9.55 175 109932 209647 79424634
Gastritis erosive 26.47 9.55 51 110056 10796 79623485
Intestinal angioedema 26.41 9.55 16 110091 867 79633414
Blister 26.38 9.55 81 110026 119395 79514886
Face oedema 26.18 9.55 92 110015 28044 79606237
Palatal oedema 25.98 9.55 19 110088 1412 79632869
Impaired healing 25.98 9.55 51 110056 87604 79546677
Cerebral microangiopathy 25.96 9.55 11 110096 276 79634005
Metabolic acidosis 25.93 9.55 199 109908 82330 79551951
Tachypnoea 25.77 9.55 100 110007 31963 79602318
Asthma 25.49 9.55 98 110009 134997 79499284
Bradyarrhythmia 25.42 9.55 30 110077 4116 79630165
Hypertensive heart disease 25.07 9.55 30 110077 4176 79630105
Hip arthroplasty 25.06 9.55 9 110098 35747 79598534
Hyperamylasaemia 24.93 9.55 17 110090 1130 79633151
Diabetes mellitus inadequate control 24.91 9.55 82 110025 24182 79610099
Hepatitis cholestatic 24.38 9.55 57 110050 13795 79620486
Systemic scleroderma 24.28 9.55 17 110090 1180 79633101
Hepatic enzyme decreased 24.26 9.55 9 110098 157 79634124
Hyponatraemic encephalopathy 24.17 9.55 11 110096 329 79633952
Night sweats 23.88 9.55 22 110085 52073 79582208
Hospitalisation 23.69 9.55 60 110047 94176 79540105
Protein-losing gastroenteropathy 23.03 9.55 13 110094 617 79633664
Device expulsion 22.96 9.55 4 110103 25857 79608424
Neuropathy peripheral 22.68 9.55 109 109998 141196 79493085
Cardiomegaly 22.67 9.55 84 110023 26268 79608013
Full blood count abnormal 22.51 9.55 14 110093 40460 79593821
Gastroenteritis 22.45 9.55 100 110007 33982 79600299
Dialysis 22.29 9.55 66 110041 18396 79615885
Sinus bradycardia 22.16 9.55 81 110026 25166 79609115
Electrocardiogram QRS complex prolonged 21.77 9.55 47 110060 10786 79623495
Cardiac hypertrophy 21.68 9.55 18 110089 1612 79632669
Chest pain 21.51 9.55 526 109581 281778 79352503
White blood cell count decreased 21.40 9.55 162 109945 188126 79446155
Gingival hypertrophy 21.39 9.55 24 110083 3118 79631163
Electrocardiogram abnormal 21.32 9.55 61 110046 16676 79617605
Hypophagia 21.32 9.55 121 109986 45246 79589035
Hepatic enzyme increased 21.28 9.55 156 109951 182454 79451827
Hypovolaemia 21.12 9.55 63 110044 17628 79616653
Lacunar infarction 21.08 9.55 33 110074 5924 79628357
Rhinorrhoea 21.07 9.55 46 110061 76028 79558253
Scleroderma renal crisis 20.89 9.55 12 110095 589 79633692
Vertigo 20.83 9.55 165 109942 68917 79565364
Pruritus 20.73 9.55 402 109705 394246 79240035
Adenomatous polyposis coli 20.69 9.55 9 110098 241 79634040
Intentional product misuse 20.67 9.55 65 110042 95100 79539181
Constipation 20.67 9.55 271 109836 282779 79351502
Cardiogenic shock 20.50 9.55 113 109994 41801 79592480
Mitral valve incompetence 20.49 9.55 86 110021 28479 79605802
Lymphocyte count decreased 20.48 9.55 21 110086 47268 79587013
Pancreatitis necrotising 20.28 9.55 26 110081 3882 79630399
Joint stiffness 20.23 9.55 16 110091 40814 79593467
Oropharyngeal pain 20.20 9.55 80 110027 109273 79525008
Electrocardiogram P wave abnormal 20.10 9.55 10 110097 366 79633915
Wheezing 19.90 9.55 88 110019 116576 79517705
Contusion 19.89 9.55 122 109985 148654 79485627
Prescribed overdose 19.86 9.55 14 110093 37869 79596412
Cardioactive drug level increased 19.76 9.55 25 110082 3684 79630597
Drug ineffective for unapproved indication 19.75 9.55 25 110082 51213 79583068
Neutropenia 19.73 9.55 279 109828 287431 79346850
Muscle haemorrhage 19.70 9.55 33 110074 6267 79628014
Glycosylated haemoglobin increased 19.69 9.55 65 110042 19195 79615086
Inflammation 19.69 9.55 65 110042 93688 79540593
Presyncope 19.62 9.55 110 109997 40944 79593337
Cellulitis gangrenous 19.62 9.55 9 110098 274 79634007
Blood glucose decreased 19.62 9.55 80 110027 26154 79608127
Febrile neutropenia 19.60 9.55 214 109893 230785 79403496
Laryngeal oedema 19.57 9.55 38 110069 8091 79626190
Leukaemic infiltration renal 19.53 9.55 5 110102 22 79634259
Aortic bruit 19.50 9.55 9 110098 278 79634003
Bundle branch block right 19.48 9.55 46 110061 11205 79623076
Poikiloderma 19.45 9.55 10 110097 393 79633888
Haematoma 19.37 9.55 131 109976 52064 79582217
Injection site bruising 19.17 9.55 17 110090 40985 79593296
Hypertrichosis 18.83 9.55 15 110092 1267 79633014
Carotid artery stenosis 18.76 9.55 39 110068 8719 79625562
Adiposis dolorosa 18.76 9.55 9 110098 304 79633977
Haematemesis 18.70 9.55 130 109977 52134 79582147
Blood alkaline phosphatase increased 18.62 9.55 151 109956 63513 79570768
Ischaemic cardiomyopathy 18.56 9.55 36 110071 7659 79626622
Left ventricular hypertrophy 18.56 9.55 45 110062 11146 79623135
Clostridium difficile infection 18.44 9.55 19 110088 42666 79591615
Disorientation 18.42 9.55 149 109958 62627 79571654
Condition aggravated 18.41 9.55 539 109568 500585 79133696
Blood pressure increased 18.32 9.55 401 109706 210959 79423322
Haptoglobin decreased 18.17 9.55 15 110092 1332 79632949
Memory impairment 18.04 9.55 86 110021 111648 79522633
Ventricular extrasystoles 17.96 9.55 64 110043 19640 79614641
Haemorrhagic stroke 17.87 9.55 44 110063 11002 79623279
Hepatobiliary infection 17.84 9.55 5 110102 33 79634248
Illness 17.61 9.55 23 110084 46488 79587793
Oedema peripheral 17.43 9.55 464 109643 251824 79382457
Leukocytosis 17.30 9.55 111 109996 43344 79590937
Pain in jaw 17.29 9.55 23 110084 46128 79588153
Reticulocytosis 17.26 9.55 10 110097 499 79633782
Blood catecholamines increased 17.23 9.55 5 110102 38 79634243
Sudden death 17.11 9.55 69 110038 22442 79611839
Blood bilirubin unconjugated increased 17.11 9.55 13 110094 1024 79633257
Low cardiac output syndrome 17.02 9.55 13 110094 1032 79633249
Azotaemia 16.74 9.55 36 110071 8240 79626041
Heart transplant rejection 16.69 9.55 15 110092 1495 79632786
Multiple sclerosis relapse 16.62 9.55 24 110083 46509 79587772
Hemiparesis 16.53 9.55 91 110016 33642 79600639
Live birth 16.42 9.55 3 110104 18741 79615540
Dizziness 16.19 9.55 885 109222 525556 79108725
Atrioventricular block second degree 16.18 9.55 33 110074 7279 79627002
Normetanephrine urine increased 16.13 9.55 4 110103 15 79634266
Coombs direct test positive 16.04 9.55 9 110098 422 79633859
Upper respiratory tract infection 16.02 9.55 68 110039 91100 79543181
Urine output decreased 15.97 9.55 58 110049 17964 79616317
Pancreatic enzymes increased 15.96 9.55 14 110093 1351 79632930
Sudden cardiac death 15.85 9.55 27 110080 5198 79629083
Gastric mucosal lesion 15.84 9.55 12 110095 941 79633340
Ventricular assist device insertion 15.84 9.55 5 110102 52 79634229
Arteriosclerosis 15.60 9.55 58 110049 18169 79616112
Neutropenic sepsis 15.56 9.55 9 110098 27055 79607226
Bronchopneumopathy 15.48 9.55 11 110096 782 79633499
Anti-platelet antibody positive 15.47 9.55 8 110099 318 79633963
Erectile dysfunction 15.45 9.55 50 110057 14614 79619667
Product complaint 15.43 9.55 47 110060 13302 79620979
Tubulointerstitial nephritis 15.42 9.55 98 110009 38137 79596144
Rhythm idioventricular 15.38 9.55 10 110097 614 79633667
Musculoskeletal pain 15.26 9.55 81 110026 102273 79532008
Blood pH decreased 15.17 9.55 25 110082 4686 79629595
Hypertensive cardiomyopathy 15.16 9.55 8 110099 332 79633949
Orthopnoea 15.12 9.55 39 110068 10034 79624247
Gastric ulcer 15 9.55 89 110018 33816 79600465
Influenza 14.96 9.55 111 109996 129495 79504786
Nodal rhythm 14.94 9.55 20 110087 3115 79631166
Cerebellar syndrome 14.92 9.55 27 110080 5453 79628828
Blood sodium increased 14.83 9.55 25 110082 4773 79629508
Shock 14.81 9.55 107 110000 43441 79590840
Dilatation ventricular 14.72 9.55 23 110084 4121 79630160
Erosive oesophagitis 14.68 9.55 19 110088 2863 79631418
Arteriosclerosis coronary artery 14.67 9.55 56 110051 17760 79616521
Rabbit syndrome 14.66 9.55 8 110099 355 79633926
Pneumocystis jirovecii infection 14.62 9.55 19 110088 2875 79631406
Renin increased 14.57 9.55 7 110100 237 79634044
Language disorder 14.55 9.55 20 110087 3194 79631087
Necrosis 14.51 9.55 37 110070 9456 79624825
Atrioventricular block first degree 14.46 9.55 44 110063 12447 79621834
Bronchial wall thickening 14.39 9.55 18 110089 2623 79631658
Serotonin syndrome 14.38 9.55 109 109998 44918 79589363
Duodenal ulcer haemorrhage 14.31 9.55 31 110076 7132 79627149
Hypomagnesaemia 14.12 9.55 112 109995 46799 79587482
Haematocrit decreased 14.10 9.55 138 109969 61174 79573107
Diabetic ketoacidosis 14.10 9.55 88 110019 34034 79600247
Bradykinesia 14.05 9.55 33 110074 8010 79626271
Suicidal ideation 14.00 9.55 56 110051 76284 79557997
Blood lactic acid increased 13.93 9.55 44 110063 12700 79621581
Blood pressure fluctuation 13.79 9.55 47 110060 67098 79567183
Ear pain 13.78 9.55 15 110092 32854 79601427
Dilatation atrial 13.78 9.55 21 110086 3683 79630598
Sensory disturbance 13.77 9.55 49 110058 15028 79619253
Blood lactate dehydrogenase increased 13.76 9.55 97 110010 39073 79595208
Hypoglycaemic coma 13.66 9.55 24 110083 4736 79629545
Neutrophil count decreased 13.65 9.55 75 110032 93884 79540397
Bronchiectasis 13.52 9.55 7 110100 22379 79611902
Incorrect route of product administration 13.51 9.55 17 110090 34912 79599369
Pseudo-Bartter syndrome 13.49 9.55 5 110102 87 79634194
Therapy interrupted 13.48 9.55 14 110093 31327 79602954
Hypochloraemia 13.48 9.55 17 110090 2498 79631783
Respiratory depression 13.47 9.55 11 110096 27619 79606662
Lumbosacral plexus lesion 13.47 9.55 3 110104 6 79634275
Heart valve stenosis 13.42 9.55 6 110101 172 79634109
Toxicity to various agents 13.40 9.55 462 109645 421078 79213203
Lip oedema 13.38 9.55 28 110079 6288 79627993
Pseudolymphoma 13.37 9.55 12 110095 1193 79633088
Bone erosion 13.37 9.55 4 110103 17843 79616438
Wound haemorrhage 13.29 9.55 22 110085 4139 79630142
Cerebral haematoma 13.24 9.55 32 110075 7910 79626371
Mixed liver injury 13.14 9.55 31 110076 7547 79626734
Loss of consciousness 13.10 9.55 314 109793 167629 79466652
Dysarthria 13.10 9.55 147 109960 67475 79566806
Cardiopulmonary failure 13.09 9.55 29 110078 6772 79627509
Joint range of motion decreased 13.08 9.55 16 110091 33266 79601015
Blood loss anaemia 13.00 9.55 49 110058 15449 79618832
Sopor 12.94 9.55 84 110023 32926 79601355
Thalamus haemorrhage 12.80 9.55 14 110093 1768 79632513
Paraneoplastic syndrome 12.74 9.55 11 110096 1039 79633242
Suicide attempt 12.71 9.55 65 110042 82867 79551414
Traumatic haematoma 12.69 9.55 15 110092 2061 79632220
Acidosis hyperchloraemic 12.68 9.55 10 110097 832 79633449
Meningorrhagia 12.64 9.55 7 110100 320 79633961
Gastric ulcer haemorrhage 12.59 9.55 34 110073 8993 79625288
Wrong technique in product usage process 12.43 9.55 56 110051 73819 79560462
Cardiac death 12.43 9.55 13 110094 1561 79632720
Cerebrovascular disorder 12.39 9.55 20 110087 3685 79630596
Metabolic syndrome 12.33 9.55 17 110090 2723 79631558
Myelosuppression 12.33 9.55 23 110084 40273 79594008
Hypocalcaemia 12.29 9.55 114 109993 49810 79584471
Diaphragmatic paralysis 12.20 9.55 11 110096 1101 79633180
Status epilepticus 12.17 9.55 10 110097 25031 79609250
Decerebration 12.12 9.55 5 110102 117 79634164
Neuropsychiatric syndrome 12.04 9.55 5 110102 119 79634162
Hepatotoxicity 12.02 9.55 116 109991 51236 79583045
Bronchopulmonary aspergillosis 12.01 9.55 8 110099 22286 79611995
Ventricular hypokinesia 12.00 9.55 34 110073 9245 79625036
IPEX syndrome 11.95 9.55 3 110104 12 79634269
Bundle branch block left 11.90 9.55 39 110068 11474 79622807
Lack of spontaneous speech 11.85 9.55 6 110101 228 79634053
Urinary retention 11.85 9.55 125 109982 56505 79577776
Lymphangitis 11.79 9.55 12 110095 1396 79632885
Sinus node dysfunction 11.75 9.55 30 110077 7671 79626610
Type 2 diabetes mellitus 11.72 9.55 40 110067 57082 79577199
Vasoconstriction 11.71 9.55 9 110098 721 79633560
Electrocardiogram repolarisation abnormality 11.64 9.55 15 110092 2252 79632029
Blood chloride decreased 11.60 9.55 31 110076 8146 79626135
Hot flush 11.55 9.55 38 110069 54839 79579442
Dysentery 11.46 9.55 11 110096 1191 79633090
Enlarged cerebral perivascular spaces 11.41 9.55 3 110104 15 79634266
Urogenital haemorrhage 11.38 9.55 10 110097 967 79633314
Accidental exposure to product 11.34 9.55 16 110091 31306 79602975
Traumatic ulcer 11.34 9.55 4 110103 60 79634221
Incorrect product formulation administered 11.29 9.55 5 110102 140 79634141
Erythrodermic psoriasis 11.24 9.55 13 110094 1745 79632536
Choluria 11.23 9.55 7 110100 399 79633882
Hypoaesthesia 11.22 9.55 177 109930 179175 79455106
Pathogen resistance 11.14 9.55 3 110104 14339 79619942
Throat irritation 11.14 9.55 25 110082 40921 79593360
Acute pulmonary oedema 11.12 9.55 44 110063 14186 79620095
Epistaxis 11.11 9.55 216 109891 111299 79522982
Potentiating drug interaction 11.10 9.55 32 110075 8787 79625494
Acquired C1 inhibitor deficiency 11.09 9.55 3 110104 17 79634264
Pancreatitis 11.07 9.55 144 109963 68431 79565850
Lichenoid keratosis 11.06 9.55 20 110087 4037 79630244
Hypotonia 11.05 9.55 41 110066 12829 79621452
Blood pressure systolic decreased 10.99 9.55 37 110070 11039 79623242
Red blood cell sedimentation rate increased 10.98 9.55 30 110077 45912 79588369
Craniocerebral injury 10.97 9.55 23 110084 5173 79629108
Electrocardiogram change 10.95 9.55 11 110096 1260 79633021
Oedema mouth 10.93 9.55 17 110090 3034 79631247
Coronary artery stenosis 10.91 9.55 40 110067 12444 79621837
Tricuspid valve incompetence 10.91 9.55 55 110052 19657 79614624
Sedation complication 10.88 9.55 4 110103 15665 79618616
Colitis ischaemic 10.83 9.55 46 110061 15313 79618968
Atrial enlargement 10.82 9.55 10 110097 1033 79633248
Diabetes mellitus 10.79 9.55 160 109947 78230 79556051
Acne 10.76 9.55 13 110094 27177 79607104
Abortion spontaneous 10.76 9.55 15 110092 29492 79604789
Duodenal ulcer 10.76 9.55 48 110059 16321 79617960
Impaired work ability 10.68 9.55 7 110100 19674 79614607
Azoospermia 10.67 9.55 5 110102 160 79634121
Cryoglobulinaemia 10.67 9.55 9 110098 824 79633457
Hyperglycaemia 10.65 9.55 146 109961 70189 79564092
Nasal congestion 10.63 9.55 62 110045 76490 79557791
Herpes zoster 10.61 9.55 80 110027 93003 79541278
Ventricular fibrillation 10.60 9.55 78 110029 31848 79602433
Malignant anorectal neoplasm 10.57 9.55 4 110103 74 79634207
Immune reconstitution inflammatory syndrome 10.56 9.55 3 110104 13838 79620443
Cerebellar haematoma 10.55 9.55 8 110099 628 79633653
Salivary gland adenoma 10.55 9.55 3 110104 21 79634260
Drug resistance 10.51 9.55 27 110080 42186 79592095
Aortic valve incompetence 10.50 9.55 33 110074 9497 79624784
Blood cholesterol increased 10.49 9.55 70 110037 83650 79550631
Haemorrhage intracranial 10.48 9.55 67 110040 26126 79608155
Auricular swelling 10.47 9.55 5 110102 167 79634114
Cutaneous vasculitis 10.44 9.55 30 110077 8222 79626059
Red cell distribution width increased 10.41 9.55 4 110103 15238 79619043
Paresis 10.36 9.55 20 110087 4241 79630040
Dysphagia 10.34 9.55 231 109876 121905 79512376
Meningitis streptococcal 10.31 9.55 5 110102 173 79634108
Asthenia 10.28 9.55 830 109277 510859 79123422
Meibomianitis 10.28 9.55 4 110103 80 79634201
Hypertension 10.26 9.55 557 109550 330435 79303846
Cold sweat 10.23 9.55 52 110055 18647 79615634
Post angioplasty restenosis 10.20 9.55 3 110104 24 79634257
Dengue fever 10.14 9.55 9 110098 882 79633399
Blood test abnormal 10.03 9.55 6 110101 17704 79616577
Haemoconcentration 9.93 9.55 5 110102 188 79634093
Adverse event 9.92 9.55 46 110061 60168 79574113
Injection site warmth 9.92 9.55 4 110103 14803 79619478
Product storage error 9.91 9.55 5 110102 16221 79618060
Focal segmental glomerulosclerosis 9.86 9.55 17 110090 3304 79630977
Blood bicarbonate decreased 9.84 9.55 22 110085 5169 79629112
Cerebral artery occlusion 9.80 9.55 12 110095 1710 79632571
Hypertrophic cardiomyopathy 9.76 9.55 14 110093 2326 79631955
Peroneal nerve palsy 9.70 9.55 24 110083 6018 79628263
Therapy partial responder 9.70 9.55 6 110101 17391 79616890
Coronary arterial stent insertion 9.70 9.55 24 110083 6020 79628261
Atrioventricular dissociation 9.66 9.55 6 110101 340 79633941
Respiratory tract congestion 9.66 9.55 8 110099 19946 79614335
Bursitis 9.66 9.55 22 110085 35822 79598459
Excessive granulation tissue 9.63 9.55 9 110098 943 79633338
Glucose urine present 9.62 9.55 12 110095 1744 79632537
Abdominal strangulated hernia 9.60 9.55 4 110103 96 79634185
Urticaria 9.60 9.55 189 109918 185012 79449269
Complement factor C4 decreased 9.60 9.55 6 110101 344 79633937
Cardiac dysfunction 9.59 9.55 19 110088 4105 79630176
Drug tolerance decreased 9.56 9.55 3 110104 12975 79621306

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
CHEBI has role CHEBI:35457 ACE inhibitor
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:176497 geroprotectors
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
FDA PE N0000178477 Decreased Blood Pressure

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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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 SILVERGATE PHARMS 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
CHEBI:4786 CHEBI
CHEMBL578 ChEMBL_ID
DB00584 DRUGBANK_ID
CHEMBL1200659 ChEMBL_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
D015773 MESH_DESCRIPTOR_UI
5462501 PUBCHEM_CID

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
Vaseretic HUMAN PRESCRIPTION DRUG LABEL 2 0187-0146 TABLET 10 mg ORAL NDA 24 sections
Enalapril Maleate and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0713-1044 TABLET 5 mg ORAL ANDA 20 sections
Enalapril Maleate and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0713-1052 TABLET 10 mg ORAL ANDA 20 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5441 TABLET 2.50 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5442 TABLET 5 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5443 TABLET 10 mg ORAL ANDA 23 sections
Enalapril Maleate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5444 TABLET 20 mg ORAL ANDA 23 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5502 TABLET 5 mg ORAL ANDA 17 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5609 TABLET 2.50 mg ORAL ANDA 17 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5610 TABLET 10 mg ORAL ANDA 17 sections
ENALAPRIL MALEATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5611 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 16714-443 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 16714-445 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