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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1987 FDA MERCK

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Angioedema 1650.09 9.59 1441 254424 46524 63186633
Intestinal angioedema 629.50 9.59 191 255674 464 63232693
Cardiac failure congestive 570.60 9.59 1194 254671 91239 63141918
Myocardial infarction 495.96 9.59 1183 254682 98710 63134447
Swollen tongue 339.43 9.59 548 255317 34252 63198905
Drug ineffective 320.76 9.59 2688 253177 1042077 62191080
Cerebrovascular accident 308.75 9.59 1048 254817 106976 63126181
Off label use 248.77 9.59 1646 254219 672816 62560341
Acute kidney injury 236.45 9.59 1843 254022 261572 62971585
Coronary artery disease 232.85 9.59 446 255419 31931 63201226
Completed suicide 213.62 9.59 1154 254711 144519 63088638
Pyrexia 188.68 9.59 1118 254747 469360 62763797
Maternal exposure during pregnancy 169.64 9.59 399 255466 219663 63013494
Lip swelling 153.03 9.59 367 255498 30696 63202461
Drug hypersensitivity 152.93 9.59 1918 253947 308769 62924388
Drug abuse 145.50 9.59 55 255810 72463 63160694
Contraindicated product administered 140.28 9.59 431 255434 217217 63015940
Acute myocardial infarction 138.77 9.59 361 255504 31763 63201394
Febrile neutropenia 130.99 9.59 171 255694 118278 63114879
Hyperkalaemia 130.99 9.59 498 255367 53705 63179452
Injury 123.10 9.59 603 255262 72644 63160513
Exposure during pregnancy 123.06 9.59 278 255587 155269 63077888
Blood glucose increased 116.31 9.59 654 255211 83102 63150055
C-reactive protein increased 112.87 9.59 129 255736 94578 63138579
Neutropenia 104.77 9.59 358 255507 174647 63058510
Drug intolerance 104.09 9.59 772 255093 307889 62925268
Lactic acidosis 102.79 9.59 364 255501 37923 63195234
Infusion related reaction 101.61 9.59 577 255288 244944 62988213
Type 2 diabetes mellitus 99.71 9.59 515 255350 63353 63169804
Renal failure 94.94 9.59 804 255061 116848 63116309
Systemic lupus erythematosus 94.75 9.59 476 255389 208442 63024715
Abortion spontaneous 94.32 9.59 36 255829 47159 63185998
Dehydration 94.22 9.59 1091 254774 172263 63060894
Interstitial lung disease 86.84 9.59 73 255792 61835 63171322
Pemphigus 84.79 9.59 416 255449 183310 63049847
Synovitis 84.68 9.59 426 255439 186492 63046665
Swelling face 83.75 9.59 489 255376 62986 63170171
Dizziness 82.80 9.59 2293 253572 427632 62805525
Psoriasis 78.12 9.59 609 255256 86348 63146809
Diarrhoea 76.76 9.59 3569 252296 711797 62521360
Premature delivery 75.61 9.59 15 255850 30266 63202891
Blood cholesterol increased 75.53 9.59 642 255223 93390 63139767
Labile blood pressure 74.35 9.59 60 255805 1729 63231428
Hepatic function abnormal 71.49 9.59 30 255835 37112 63196045
Therapeutic product effect incomplete 71.36 9.59 261 255604 124795 63108362
Coronary arterial stent insertion 70.27 9.59 71 255794 2758 63230399
Prescribed overdose 69.11 9.59 297 255568 33856 63199301
Product dose omission issue 69.08 9.59 1327 254538 232986 63000171
Hypotensive transfusion reaction 68.35 9.59 19 255846 29 63233128
Hypovolaemia 68.25 9.59 140 255725 10533 63222624
Chest pain 68.14 9.59 1236 254629 214723 63018434
Lower respiratory tract infection 67.93 9.59 288 255577 132019 63101138
Pancreatitis 66.73 9.59 381 255484 48674 63184483
Coronary artery bypass 65.43 9.59 63 255802 2306 63230851
Fibromyalgia 64.55 9.59 549 255316 79871 63153286
Asthenia 63.73 9.59 2009 253856 381595 62851562
Suspected suicide 63.43 9.59 103 255762 6465 63226692
Myelosuppression 62.97 9.59 10 255855 23693 63209464
Mental status changes 62.97 9.59 321 255544 39278 63193879
Arthropathy 59.35 9.59 632 255233 234160 62998997
Leukopenia 58.79 9.59 141 255724 77149 63156008
Hepatotoxicity 57.95 9.59 39 255826 37002 63196155
Sopor 57.44 9.59 10 255855 22154 63211003
Oxygen saturation decreased 57.30 9.59 175 255690 88410 63144747
Gastrointestinal haemorrhage 56.86 9.59 538 255327 80638 63152519
Blood pressure inadequately controlled 56.36 9.59 84 255781 4894 63228263
Cytomegalovirus infection 55.30 9.59 9 255856 20943 63212214
Foetal exposure during pregnancy 55.11 9.59 30 255835 31932 63201225
Chronic kidney disease 54.32 9.59 341 255524 45057 63188100
Joint swelling 53.72 9.59 963 254902 326703 62906454
Malignant neoplasm progression 53.28 9.59 162 255703 81959 63151198
Adjustment disorder with depressed mood 52.90 9.59 123 255742 10081 63223076
Overdose 52.81 9.59 261 255604 114817 63118340
Glossodynia 50.83 9.59 468 255397 178408 63054749
Intentional self-injury 50.65 9.59 20 255845 25667 63207490
Infection 50.48 9.59 636 255229 228537 63004620
Nausea 50.26 9.59 4044 251821 850427 62382730
Angina unstable 50.09 9.59 97 255768 6998 63226159
Depressed level of consciousness 49.83 9.59 110 255755 61968 63171189
Grip strength decreased 49.15 9.59 199 255666 22088 63211069
Arthralgia 49.02 9.59 1840 254025 567870 62665287
Blood pressure increased 48.12 9.59 919 254946 161143 63072014
Alopecia 48.03 9.59 1016 254849 336520 62896637
Muscle spasms 47.92 9.59 890 254975 155260 63077897
Agranulocytosis 47.26 9.59 21 255844 25113 63208044
Hand deformity 47.13 9.59 413 255452 159044 63074113
Oedema 46.73 9.59 600 255265 97022 63136135
Blood pressure diastolic abnormal 46.70 9.59 3 255862 14539 63218618
Thrombocytopenia 46.24 9.59 388 255477 150769 63082388
Rheumatoid nodule 46.11 9.59 7 255858 17148 63216009
Arterial occlusive disease 45.21 9.59 84 255781 5874 63227283
Hypotension 44.76 9.59 1426 254439 271178 62961979
Premature baby 44.56 9.59 14 255851 20721 63212436
Treatment failure 44.34 9.59 551 255314 198492 63034665
Mucosal inflammation 43.86 9.59 76 255789 46852 63186305
Blood pressure fluctuation 43.30 9.59 75 255790 46242 63186915
Hypertension 43.27 9.59 1451 254414 277852 62955305
Sedation 42.91 9.59 56 255809 38753 63194404
Pain 42.88 9.59 2496 253369 738132 62495025
Hypercholesterolaemia 42.76 9.59 185 255680 21149 63212008
Spinal stenosis 42.75 9.59 145 255720 14780 63218377
Suicide attempt 41.82 9.59 117 255748 60801 63172356
Memory impairment 41.47 9.59 620 255245 103638 63129519
Dry mouth 41.34 9.59 488 255377 77375 63155782
Facet joint syndrome 41.20 9.59 125 255740 12013 63221144
Tenosynovitis 41.07 9.59 4 255861 13791 63219366
Hypoaesthesia 40.86 9.59 927 254938 167466 63065691
Product complaint 40.78 9.59 129 255736 12680 63220477
Renal injury 40.68 9.59 106 255759 9333 63223824
Glycosylated haemoglobin increased 40.52 9.59 126 255739 12272 63220885
Liver injury 40.36 9.59 397 255468 60123 63173034
Osteoarthritis 40.29 9.59 573 255292 94770 63138387
Dislocation of vertebra 39.31 9.59 99 255766 8536 63224621
Pneumocystis jirovecii pneumonia 38.98 9.59 10 255855 16904 63216253
Lip dry 38.91 9.59 144 255721 15326 63217831
Gangrene 38.78 9.59 80 255785 6043 63227114
Atrioventricular block second degree 38.64 9.59 62 255803 3852 63229305
Coma 38.25 9.59 132 255733 64232 63168925
Altered state of consciousness 37.58 9.59 28 255837 25202 63207955
Ischaemic cardiomyopathy 37.36 9.59 48 255817 2429 63230728
Arteriosclerosis 37.35 9.59 107 255758 9959 63223198
Peripheral venous disease 37.21 9.59 142 255723 15335 63217822
Intentional overdose 37.07 9.59 163 255702 73989 63159168
Blood pressure systolic abnormal 37.06 9.59 5 255860 13381 63219776
Product use issue 36.77 9.59 646 255219 219874 63013283
Blood sodium decreased 36.76 9.59 194 255671 24058 63209099
Transient ischaemic attack 36.47 9.59 269 255596 37484 63195673
Sedation complication 36.34 9.59 6 255859 13816 63219341
Somatic delusion 36.12 9.59 25 255840 567 63232590
Drug resistance 36.07 9.59 24 255841 22909 63210248
Body temperature increased 35.89 9.59 59 255806 37133 63196024
Hepatic cytolysis 35.71 9.59 9 255856 15398 63217759
Pancreatitis acute 35.64 9.59 209 255656 26957 63206200
Drug reaction with eosinophilia and systemic symptoms 34.24 9.59 52 255813 33784 63199373
Cardiac disorder 34.20 9.59 334 255531 50482 63182675
Atrial fibrillation 34.13 9.59 660 255205 115976 63117181
Hepatic ischaemia 33.54 9.59 25 255840 639 63232518
Cough 33.25 9.59 1470 254395 291273 62941884
Product quality issue 33.20 9.59 253 255612 35612 63197545
Nasopharyngitis 33.09 9.59 776 255089 253481 62979676
Angina pectoris 32.97 9.59 221 255644 29857 63203300
Foetal methotrexate syndrome 32.84 9.59 14 255851 113 63233044
Alanine aminotransferase increased 32.80 9.59 264 255601 103506 63129651
Cardiomyopathy 32.61 9.59 149 255716 17435 63215722
Erythema 32.53 9.59 505 255360 175246 63057911
Caesarean section 32.39 9.59 14 255851 17018 63216139
Panniculitis 32.13 9.59 4 255861 11381 63221776
Rheumatic fever 31.83 9.59 289 255576 42822 63190335
Decreased appetite 31.52 9.59 1274 254591 249778 62983379
Status epilepticus 31.48 9.59 11 255854 15222 63217935
BRASH syndrome 31.46 9.59 21 255844 448 63232709
Therapeutic product effect decreased 31.23 9.59 569 255296 192618 63040539
Sleep disorder due to general medical condition, insomnia type 31.09 9.59 107 255758 52110 63181047
Pulseless electrical activity 30.93 9.59 83 255782 7438 63225719
International normalised ratio increased 30.69 9.59 304 255561 46121 63187036
Psoriatic arthropathy 30.67 9.59 529 255336 90991 63142166
Hyperlipidaemia 30.66 9.59 158 255707 19413 63213744
Foetal death 30.64 9.59 4 255861 10976 63222181
Hypoaldosteronism 30.62 9.59 15 255850 172 63232985
Abdominal discomfort 30.57 9.59 1023 254842 319862 62913295
Amnesia 29.78 9.59 349 255516 55236 63177921
Gastrointestinal disorder 29.70 9.59 362 255503 130877 63102280
Body temperature decreased 29.69 9.59 23 255842 20296 63212861
Device expulsion 29.60 9.59 60 255805 34862 63198295
Depression 29.44 9.59 1017 254848 195475 63037682
Neutrophil count decreased 29.42 9.59 122 255743 56284 63176873
Myocardial ischaemia 29.30 9.59 116 255749 12743 63220414
Anti-cyclic citrullinated peptide antibody 29.23 9.59 76 255789 6682 63226475
Hepatitis 29.14 9.59 74 255791 39714 63193443
Tongue oedema 29.14 9.59 60 255805 4526 63228631
Pregnancy 28.97 9.59 66 255799 36770 63196387
Rotator cuff repair 28.56 9.59 39 255826 2095 63231062
Encephalomalacia 28.17 9.59 20 255845 473 63232684
Blood loss anaemia 28.06 9.59 90 255775 8911 63224246
Blood glucose decreased 28.01 9.59 162 255703 20790 63212367
Adverse drug reaction 27.89 9.59 464 255401 79250 63153907
Lymphopenia 27.74 9.59 20 255845 18307 63214850
Colitis ulcerative 27.48 9.59 39 255826 26052 63207105
Therapy partial responder 27.20 9.59 5 255860 10653 63222504
Toxic skin eruption 27.16 9.59 9 255856 12876 63220281
Wound infection 26.98 9.59 163 255702 21247 63211910
Red blood cell sedimentation rate increased 26.95 9.59 89 255776 43893 63189264
Atrioventricular block first degree 26.69 9.59 77 255788 7196 63225961
Bronchiectasis 26.62 9.59 16 255849 16126 63217031
Fall 26.45 9.59 1878 253987 390456 62842701
Progressive multifocal leukoencephalopathy 25.74 9.59 10 255855 12961 63220196
Wound 25.71 9.59 483 255382 162780 63070377
Coronary artery occlusion 25.63 9.59 82 255783 8109 63225048
Blood pressure systolic increased 25.04 9.59 102 255763 47295 63185862
Sight disability 25.01 9.59 12 255853 131 63233026
Abnormal dreams 24.88 9.59 96 255769 10420 63222737
Pancytopenia 24.83 9.59 260 255605 96673 63136484
Blood potassium increased 24.76 9.59 142 255723 18167 63214990
Colitis ischaemic 24.72 9.59 97 255768 10611 63222546
Factor VII deficiency 24.67 9.59 8 255857 26 63233131
Oedema peripheral 24.53 9.59 965 254900 188546 63044611
Vision blurred 24.50 9.59 513 255352 91411 63141746
Joint range of motion decreased 24.25 9.59 218 255647 32210 63200947
Stomatitis 24.20 9.59 403 255462 138322 63094835
Septic shock 24.18 9.59 163 255702 66466 63166691
Abdominal pain upper 24.16 9.59 1040 254825 205404 63027753
Dysphagia 24.14 9.59 496 255369 88089 63145068
Blood parathyroid hormone decreased 24.13 9.59 5 255860 9786 63223371
Hepatorenal syndrome 23.90 9.59 34 255831 1898 63231259
Walking aid user 23.87 9.59 96 255769 10621 63222536
Cytokine release syndrome 23.87 9.59 14 255851 14300 63218857
Synostosis 23.65 9.59 9 255856 52 63233105
Gamma-glutamyltransferase increased 23.62 9.59 65 255800 33966 63199191
Epilepsy 23.37 9.59 46 255819 27019 63206138
Vomiting 23.22 9.59 2585 253280 557032 62676125
Sleep disorder due to a general medical condition 23.21 9.59 10 255855 12178 63220979
Allergic cough 23.12 9.59 21 255844 713 63232444
Diabetic neuropathy 23.03 9.59 50 255815 3914 63229243
Drug dispensed to wrong patient 23.01 9.59 15 255850 307 63232850
Eosinophilia 23 9.59 35 255830 22721 63210436
Thrombotic microangiopathy 22.93 9.59 7 255858 10554 63222603
Therapy cessation 22.90 9.59 205 255660 30252 63202905
Rash maculo-papular 22.84 9.59 60 255805 31836 63201321
Thermohypoaesthesia 22.77 9.59 11 255854 122 63233035
Haematotoxicity 22.68 9.59 5 255860 9371 63223786
Neurotoxicity 22.66 9.59 21 255844 16969 63216188
Lymphomatoid papulosis 22.62 9.59 11 255854 124 63233033
Blood potassium decreased 22.57 9.59 264 255601 41762 63191395
Muscle relaxant therapy 22.46 9.59 12 255853 167 63232990
Deep vein thrombosis postoperative 22.33 9.59 98 255767 11271 63221886
Obesity 22.22 9.59 201 255664 29751 63203406
Oedema mouth 22.17 9.59 37 255828 2376 63230781
Cholestasis 22.13 9.59 54 255811 29380 63203777
Drug eruption 22.09 9.59 52 255813 28642 63204515
Nodal rhythm 22.05 9.59 31 255834 1712 63231445
Abortion induced 21.86 9.59 7 255858 10235 63222922
Bone marrow failure 21.82 9.59 54 255811 29236 63203921
Diabetic ketoacidosis 21.48 9.59 149 255716 20356 63212801
Hepatic enzyme increased 21.43 9.59 636 255229 201692 63031465
Chronic obstructive pulmonary disease 21.23 9.59 363 255502 62323 63170834
Syncope 21.08 9.59 621 255244 116764 63116393
Nodular rash 20.94 9.59 12 255853 193 63232964
Hepatocellular injury 20.77 9.59 50 255815 27331 63205826
Breast cancer stage III 20.76 9.59 90 255775 10296 63222861
Pemphigoid 20.73 9.59 71 255794 7273 63225884
Gout 20.69 9.59 107 255758 13164 63219993
Swelling 20.67 9.59 903 254962 274475 62958682
Ill-defined disorder 20.65 9.59 220 255645 81535 63151622
Dysgeusia 20.64 9.59 283 255582 46427 63186730
Lupus vulgaris 20.60 9.59 62 255803 5932 63227225
Rash 20.51 9.59 1964 253901 558907 62674250
Pneumonitis 20.41 9.59 73 255792 35149 63198008
Anhedonia 20.36 9.59 93 255772 10881 63222276
Lichen planus 20.35 9.59 35 255830 2303 63230854
Shock 20.33 9.59 163 255702 23300 63209857
Dilatation atrial 20.29 9.59 32 255833 1959 63231198
Anxiety 20.17 9.59 1071 254794 216470 63016687
Poisoning deliberate 20.13 9.59 10 255855 11208 63221949
Aphthous ulcer 20.08 9.59 16 255849 13922 63219235
Full blood count decreased 20 9.59 176 255689 25848 63207309
Neutropenic sepsis 20.00 9.59 22 255843 16416 63216741
Sinus arrhythmia 19.84 9.59 27 255838 1446 63231711
Skin exfoliation 19.81 9.59 263 255602 42839 63190318
Haemophagocytic lymphohistiocytosis 19.79 9.59 9 255856 10618 63222539
Immunodeficiency 19.67 9.59 32 255833 20222 63212935
Pharyngeal oedema 19.60 9.59 108 255757 13613 63219544
Muscle rigidity 19.53 9.59 11 255854 11489 63221668
Pneumonia 19.40 9.59 1581 254284 455186 62777971
Electrocardiogram T wave abnormal 19.20 9.59 35 255830 2412 63230745
Body height decreased 19.14 9.59 86 255779 9992 63223165
Cognitive disorder 19.05 9.59 139 255726 55676 63177481
Low birth weight baby 18.95 9.59 3 255862 7126 63226031
Creatinine renal clearance decreased 18.58 9.59 23 255842 16285 63216872
Dystonia 18.52 9.59 17 255848 13802 63219355
Hyponatraemia 18.49 9.59 586 255279 111314 63121843
Polyneuropathy 18.34 9.59 19 255846 14570 63218587
Product coating issue 18.31 9.59 8 255857 69 63233088
Essential hypertension 18.19 9.59 53 255812 4980 63228177
Gait inability 18.05 9.59 307 255558 52652 63180505
Ventricular fibrillation 18.03 9.59 95 255770 11772 63221385
Adactyly 17.90 9.59 7 255858 44 63233113
Food allergy 17.84 9.59 12 255853 11389 63221768
Product substitution issue 17.81 9.59 118 255747 15878 63217279
Poor venous access 17.75 9.59 20 255845 14765 63218392
Pulmonary toxicity 17.62 9.59 8 255857 9447 63223710
Blood urea increased 17.56 9.59 173 255692 26206 63206951
Transcription medication error 17.50 9.59 11 255854 211 63232946
Swollen joint count increased 17.41 9.59 222 255643 35832 63197325
Fear 17.37 9.59 116 255749 15650 63217507
Deformity 17.36 9.59 13 255852 11671 63221486
Uveitis 17.36 9.59 15 255850 12538 63220619
Adverse event 17.34 9.59 375 255490 67184 63165973
Lymphocyte count decreased 17.34 9.59 63 255802 30194 63202963
Tuberculosis 17.27 9.59 12 255853 11199 63221958
Productive cough 17.24 9.59 167 255698 63041 63170116
Premature labour 17.22 9.59 15 255850 12489 63220668
Infective pulmonary exacerbation of cystic fibrosis 17.16 9.59 7 255858 8810 63224347
Charles Bonnet syndrome 17.14 9.59 5 255860 10 63233147
Extrapyramidal disorder 17.04 9.59 17 255848 13267 63219890
Gait disturbance 17.01 9.59 902 254963 182276 63050881
Wheezing 16.96 9.59 505 255360 95090 63138067
Upper gastrointestinal haemorrhage 16.90 9.59 132 255733 18720 63214437
Fluid intake reduced 16.84 9.59 42 255823 3599 63229558
Blood pressure diastolic decreased 16.80 9.59 42 255823 22664 63210493
Peripheral vascular disorder 16.73 9.59 58 255807 5977 63227180
Hypophagia 16.62 9.59 196 255669 31063 63202094
Pre-eclampsia 16.60 9.59 8 255857 9125 63224032
Hypergammaglobulinaemia 16.59 9.59 15 255850 506 63232651
Metastases to liver 16.52 9.59 45 255820 23594 63209563
Epstein-Barr virus infection 16.32 9.59 6 255859 8044 63225113
Weight decreased 16.28 9.59 1311 254554 275487 62957670
Ventricular hypertrophy 16.28 9.59 40 255825 3396 63229761
Oral candidiasis 16.23 9.59 43 255822 22755 63210402
Suspected suicide attempt 16.14 9.59 9 255856 137 63233020
Muscular weakness 16.05 9.59 624 255241 121729 63111428
Transplant rejection 16.01 9.59 12 255853 10768 63222389
Neuroleptic malignant syndrome 15.96 9.59 15 255850 12041 63221116
Feeling abnormal 15.91 9.59 741 255124 147651 63085506
Device difficult to use 15.71 9.59 17 255848 12779 63220378
Blood pressure abnormal 15.66 9.59 110 255755 15088 63218069
Jaundice cholestatic 15.64 9.59 5 255860 7319 63225838
Cerebral thrombosis 15.63 9.59 26 255839 1665 63231492
Graft versus host disease 15.58 9.59 4 255861 6759 63226398
Nephrogenic systemic fibrosis 15.54 9.59 47 255818 4509 63228648
Blood lactate dehydrogenase increased 15.42 9.59 45 255820 23071 63210086
Oropharyngeal pain 15.34 9.59 278 255587 94209 63138948
Hereditary angioedema with normal C1 esterase inhibitor 15.32 9.59 4 255861 4 63233153
Gastrointestinal toxicity 15.31 9.59 6 255859 7735 63225422
Condition aggravated 15.16 9.59 1405 254460 400812 62832345
Infusion site pain 15.15 9.59 28 255837 16841 63216316
Expired product administered 15.10 9.59 57 255808 6124 63227033
Eosinophilic oesophagitis 15.07 9.59 12 255853 339 63232818
Electrocardiogram T wave peaked 14.99 9.59 10 255855 213 63232944
Respiratory depression 14.94 9.59 20 255845 13695 63219462
Factor VIII inhibition 14.92 9.59 6 255859 41 63233116
Multimorbidity 14.92 9.59 15 255850 579 63232578
Schizophrenia 14.88 9.59 11 255854 9941 63223216
Shock haemorrhagic 14.71 9.59 11 255854 9884 63223273
Torsade de pointes 14.57 9.59 98 255767 13253 63219904
Haemodialysis 14.55 9.59 73 255792 8874 63224283
Mydriasis 14.55 9.59 16 255849 11940 63221217
Disease progression 14.50 9.59 380 255485 122378 63110779
Oral herpes 14.48 9.59 55 255810 26019 63207138
Visual acuity reduced 14.46 9.59 143 255722 21683 63211474
Application site nodule 14.43 9.59 4 255861 6 63233151
Urethral prolapse 14.43 9.59 4 255861 6 63233151
Acne 14.36 9.59 47 255818 23246 63209911
Inflammation 14.34 9.59 239 255626 82034 63151123
Blood creatinine increased 14.24 9.59 459 255406 87385 63145772
Transient psychosis 14.23 9.59 6 255859 47 63233110
Nervousness 14.23 9.59 189 255676 30790 63202367
Accelerated hypertension 14.20 9.59 13 255852 446 63232711
Unresponsive to stimuli 14.18 9.59 203 255662 33613 63199544
Immune thrombocytopenia 14.13 9.59 13 255852 10543 63222614
Delirium 14.10 9.59 284 255581 50257 63182900
Dizziness postural 14.05 9.59 63 255802 7313 63225844
Glomerulonephropathy 14.01 9.59 7 255858 84 63233073
Therapeutic response unexpected 13.97 9.59 126 255739 18633 63214524
Drug clearance decreased 13.96 9.59 23 255842 1461 63231696
Ankylosing spondylitis 13.90 9.59 13 255852 10461 63222696
Mouth ulceration 13.89 9.59 77 255788 32907 63200250
Non-cardiac chest pain 13.83 9.59 56 255809 6216 63226941
Device dislocation 13.78 9.59 55 255810 25650 63207507
Chronic sinusitis 13.72 9.59 19 255846 12824 63220333
Paramnesia 13.71 9.59 4 255861 8 63233149
Stridor 13.70 9.59 38 255827 3472 63229685
Facial nerve disorder 13.62 9.59 14 255851 555 63232602
Diffuse large B-cell lymphoma 13.61 9.59 5 255860 6707 63226450
Pharyngitis 13.59 9.59 39 255826 20104 63213053
Conjunctivitis 13.50 9.59 41 255824 20755 63212402
Bezoar 13.49 9.59 23 255842 1503 63231654
Cerebral atrophy 13.45 9.59 48 255817 5018 63228139
Muscle injury 13.39 9.59 184 255681 65161 63167996
Withdrawal hypertension 13.37 9.59 8 255857 140 63233017
Rheumatoid arthritis 13.26 9.59 863 255002 252956 62980201
Sciatica 13.20 9.59 203 255662 34121 63199036
Female genital tract fistula 13.17 9.59 7 255858 7552 63225605
Macular degeneration 13.16 9.59 52 255813 24324 63208833
Exercise tolerance increased 12.98 9.59 5 255860 30 63233127
Left ventricular hypertrophy 12.97 9.59 49 255816 5266 63227891
Gastric ulcer helicobacter 12.83 9.59 4 255861 11 63233146
Impaired healing 12.75 9.59 315 255550 102227 63130930
Demyelination 12.67 9.59 6 255859 6914 63226243
Tachycardia 12.60 9.59 371 255494 117785 63115372
Osmolar gap increased 12.58 9.59 7 255858 106 63233051
Apparent death 12.47 9.59 20 255845 1242 63231915
Acute myeloid leukaemia 12.47 9.59 32 255833 17115 63216042
Chromatopsia 12.47 9.59 12 255853 439 63232718
Concomitant disease aggravated 12.46 9.59 11 255854 9101 63224056
Laryngotracheal oedema 12.33 9.59 5 255860 35 63233122
Lacunar infarction 12.30 9.59 35 255830 3245 63229912
Peripheral swelling 12.28 9.59 914 254951 265028 62968129
Sinus disorder 12.20 9.59 152 255713 24401 63208756
Blood electrolytes abnormal 12.15 9.59 18 255847 1043 63232114
Blood calcium decreased 12.12 9.59 60 255805 26391 63206766
Carotid artery stenosis 12.07 9.59 47 255818 5123 63228034
Craniosynostosis 12.05 9.59 8 255857 169 63232988
Lip oedema 12.02 9.59 39 255826 3885 63229272
Cholelithiasis 11.98 9.59 246 255619 43679 63189478
Fear of eating 11.93 9.59 11 255854 381 63232776
Hypogammaglobulinaemia 11.93 9.59 7 255858 7148 63226009
Diverticulum 11.90 9.59 86 255779 11905 63221252
Sinusitis 11.77 9.59 771 255094 225882 63007275
Temperature regulation disorder 11.72 9.59 5 255860 6127 63227030
Occult blood positive 11.72 9.59 37 255828 3633 63229524
Catheterisation cardiac 11.70 9.59 43 255822 4560 63228597
Erythema marginatum 11.70 9.59 4 255861 16 63233141
Hypertensive urgency 11.58 9.59 10 255855 317 63232840
Dysarthria 11.58 9.59 239 255626 42472 63190685
Emotional distress 11.58 9.59 190 255675 32359 63200798
Hypertrophic cardiomyopathy 11.58 9.59 22 255843 1565 63231592
Raynaud's phenomenon 11.56 9.59 19 255846 1205 63231952
Hypertensive crisis 11.55 9.59 103 255762 15183 63217974
Generalised tonic-clonic seizure 11.54 9.59 69 255796 28947 63204210
Liver function test increased 11.54 9.59 81 255784 32730 63200427
Blood pressure diastolic increased 11.53 9.59 14 255851 9996 63223161
Back disorder 11.51 9.59 80 255785 10937 63222220
Ischaemic neuropathy 11.49 9.59 3 255862 3 63233154
Hyperthermia 11.42 9.59 12 255853 9144 63224013
Premature rupture of membranes 11.41 9.59 3 255862 4990 63228167
Forced expiratory volume decreased 11.33 9.59 3 255862 4965 63228192
Burn oesophageal 11.28 9.59 8 255857 189 63232968
Pericarditis 11.24 9.59 425 255440 131154 63102003
Retching 11.23 9.59 99 255766 14546 63218611
Myalgia 11.19 9.59 709 255156 145820 63087337
Herpes zoster 11.18 9.59 250 255615 82212 63150945
Treatment noncompliance 11.18 9.59 212 255653 37113 63196044
General physical health deterioration 11.17 9.59 681 255184 200721 63032436
Eosinophilic pneumonia acute 11.15 9.59 11 255854 415 63232742
Autoimmune disorder 11.12 9.59 112 255753 17065 63216092
C-reactive protein 11.09 9.59 44 255821 4838 63228319
Fracture 11.08 9.59 41 255824 19543 63213614
Aspartate aminotransferase increased 11.04 9.59 278 255587 89999 63143158
Rhinitis 11.00 9.59 18 255847 11348 63221809
Weight increased 10.99 9.59 903 254962 259889 62973268
Uraemic encephalopathy 10.90 9.59 9 255856 268 63232889
Venoocclusive liver disease 10.87 9.59 3 255862 4832 63228325
Hyperbilirubinaemia 10.87 9.59 18 255847 11296 63221861
Cardioactive drug level increased 10.84 9.59 26 255839 2174 63230983
Retroperitoneal oedema 10.83 9.59 4 255861 21 63233136
Joint effusion 10.81 9.59 34 255831 17026 63216131
Laboratory test abnormal 10.67 9.59 160 255705 26752 63206405
Ovarian cyst 10.66 9.59 31 255834 15914 63217243
SUNCT syndrome 10.63 9.59 3 255862 5 63233152
Fear of injection 10.61 9.59 8 255857 7156 63226001
Product solubility abnormal 10.58 9.59 15 255850 835 63232322
Coronary artery surgery 10.55 9.59 5 255860 53 63233104
Osteoporosis 10.51 9.59 165 255700 57173 63175984
Refusal of treatment by patient 10.51 9.59 47 255818 5450 63227707
Hereditary angioedema 10.50 9.59 9 255856 7553 63225604
Foetal growth restriction 10.47 9.59 9 255856 7544 63225613
Tonsillitis 10.46 9.59 5 255860 5730 63227427
Folliculitis 10.46 9.59 210 255655 70107 63163050
Bradycardia 10.45 9.59 377 255488 72850 63160307
Second primary malignancy 10.41 9.59 10 255855 7943 63225214
Visceral oedema 10.39 9.59 4 255861 24 63233133
Bundle branch block left 10.38 9.59 56 255809 7003 63226154
Asphyxia 10.37 9.59 6 255859 6175 63226982
Acute generalised exanthematous pustulosis 10.35 9.59 18 255847 11081 63222076
Normal newborn 10.33 9.59 11 255854 8330 63224827
Foreign body in reproductive tract 10.33 9.59 14 255851 747 63232410
Gallbladder abscess 10.28 9.59 3 255862 6 63233151
Autonomic failure syndrome 10.28 9.59 3 255862 6 63233151
Purpura senile 10.26 9.59 12 255853 551 63232606
Optic ischaemic neuropathy 10.26 9.59 18 255847 1204 63231953
Intestinal ischaemia 10.15 9.59 58 255807 7410 63225747
Choroidal effusion 10.13 9.59 11 255854 465 63232692
Diabetic gastroparesis 10.12 9.59 9 255856 297 63232860
Electrocardiogram ST segment depression 10.12 9.59 30 255835 2847 63230310
Hypertensive emergency 10.10 9.59 23 255842 1859 63231298
Hypoglycaemic unconsciousness 10.10 9.59 14 255851 763 63232394
Macular fibrosis 10.08 9.59 10 255855 380 63232777
Neoplasm progression 10.03 9.59 96 255769 36332 63196825
Multiple fractures 9.98 9.59 12 255853 8606 63224551
Haemorrhage intracranial 9.92 9.59 90 255775 13329 63219828
Adrenal insufficiency 9.81 9.59 38 255827 17877 63215280
Eye swelling 9.80 9.59 143 255722 23775 63209382
Alanine aminotransferase abnormal 9.75 9.59 3 255862 4501 63228656
Neutrophil count increased 9.75 9.59 34 255831 16493 63216664
Tubulointerstitial nephritis and uveitis syndrome 9.73 9.59 8 255857 237 63232920
Urinary tract candidiasis 9.72 9.59 12 255853 583 63232574
Electrocardiogram QT prolonged 9.71 9.59 175 255690 59355 63173802
Pathogen resistance 9.66 9.59 7 255858 6391 63226766
Drug use disorder 9.63 9.59 4 255861 4980 63228177
Discomfort 9.62 9.59 564 255301 166810 63066347
Glomerulonephritis 9.61 9.59 22 255843 1784 63231373
Ageusia 9.61 9.59 91 255774 13637 63219520
Mitral valve incompetence 9.61 9.59 121 255744 19473 63213684
Restrictive cardiomyopathy 9.61 9.59 9 255856 318 63232839

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 11128.91 10.93 5073 200499 32301 34719058
Myocardial infarction 649.90 10.93 1869 203703 119216 34632143
Cardiac failure congestive 645.68 10.93 1477 204095 81793 34669566
Hyperkalaemia 597.82 10.93 1284 204288 68105 34683254
Swollen tongue 530.01 10.93 535 205037 14070 34737289
Lip swelling 483.73 10.93 533 205039 15547 34735812
Off label use 477.51 10.93 1107 204465 418417 34332942
Completed suicide 380.72 10.93 1356 204216 96812 34654547
Coronary artery disease 365.37 10.93 849 204723 47456 34703903
Acute kidney injury 341.42 10.93 3002 202570 301986 34449373
Drug abuse 298.36 10.93 105 205467 98991 34652368
Febrile neutropenia 291.29 10.93 227 205345 136622 34614737
Cerebrovascular accident 284.94 10.93 1119 204453 83692 34667667
Swelling face 239.55 10.93 462 205110 22643 34728716
Pyrexia 233.91 10.93 1086 204486 331927 34419432
General physical health deterioration 232.19 10.93 247 205325 128022 34623337
Hypotension 215.76 10.93 2119 203453 219530 34531829
Neutropenia 204.10 10.93 382 205190 156396 34594963
Acute myocardial infarction 182.88 10.93 712 204860 53007 34698352
Interstitial lung disease 165.02 10.93 89 205483 65193 34686166
Dizziness 152.72 10.93 1958 203614 216563 34534796
Foetal exposure during pregnancy 135.86 10.93 29 205543 38072 34713287
Drug hypersensitivity 126.44 10.93 859 204713 79670 34671689
Intestinal angioedema 125.29 10.93 48 205524 179 34751180
Drug ineffective 125.24 10.93 1913 203659 454838 34296521
Coronary arterial stent insertion 122.63 10.93 136 205436 3993 34747366
Hepatic function abnormal 121.94 10.93 54 205518 44309 34707050
Pancreatitis 117.63 10.93 497 205075 38394 34712965
Condition aggravated 106.78 10.93 677 204895 191519 34559840
Psoriasis 106.71 10.93 482 205090 38330 34713029
Coronary artery bypass 103.84 10.93 136 205436 4766 34746593
C-reactive protein increased 103.68 10.93 99 205473 53999 34697360
Thrombocytopenia 102.63 10.93 521 205051 155726 34595633
Septic shock 101.54 10.93 166 205406 71668 34679691
Dehydration 101.16 10.93 1189 204383 128780 34622579
Product use in unapproved indication 100.50 10.93 354 205218 117145 34634214
Suspected suicide 96.37 10.93 129 205443 4619 34746740
Pharyngeal oedema 94.39 10.93 145 205427 5902 34745457
Leukopenia 93.84 10.93 140 205432 62716 34688643
Anaphylactic reaction 87.94 10.93 400 205172 31901 34719458
Cholestasis 87.35 10.93 25 205547 26923 34724436
Drug resistance 86.01 10.93 23 205549 25904 34725455
Product dose omission issue 82.70 10.93 1071 204501 118640 34632719
Cytomegalovirus infection 81.53 10.93 26 205546 26109 34725250
Hypotensive transfusion reaction 77.63 10.93 20 205552 6 34751353
Blood potassium increased 77.21 10.93 243 205329 16252 34735107
Myelosuppression 76.67 10.93 11 205561 19254 34732105
Treatment failure 75.71 10.93 98 205474 46599 34704760
BRASH syndrome 74.39 10.93 44 205528 502 34750857
Agranulocytosis 73.78 10.93 24 205548 23797 34727562
Disseminated intravascular coagulation 73.04 10.93 19 205553 21797 34729562
Bronchopulmonary aspergillosis 69.94 10.93 4 205568 14655 34736704
Hepatocellular injury 69.46 10.93 22 205550 22189 34729170
Intentional product use issue 68.20 10.93 157 205415 59659 34691700
Altered state of consciousness 65.90 10.93 26 205546 22867 34728492
Blood glucose increased 64.20 10.93 637 204935 66081 34685278
Chest pain 63.16 10.93 1072 204500 125690 34625669
Lactic acidosis 61.28 10.93 382 205190 34390 34716969
Product use issue 59.85 10.93 182 205390 63034 34688325
Pancytopenia 59.77 10.93 322 205250 94835 34656524
Mental status changes 59.57 10.93 406 205166 37677 34713682
Syncope 59.31 10.93 809 204763 90642 34660717
Neutrophil count decreased 59.18 10.93 133 205439 50971 34700388
Hypovolaemia 58.78 10.93 152 205420 9082 34742277
Synovitis 58.45 10.93 7 205565 14059 34737300
Blood pressure inadequately controlled 57.09 10.93 74 205498 2566 34748793
Cough 56.41 10.93 1216 204356 148924 34602435
Epilepsy 56.23 10.93 28 205544 21467 34729892
Bone marrow failure 55.49 10.93 54 205518 29199 34722160
Fatigue 55.13 10.93 2685 202887 367968 34383391
Sopor 53.09 10.93 5 205567 12131 34739228
Mucosal inflammation 52.94 10.93 91 205481 38531 34712828
Sepsis 52.29 10.93 678 204894 165883 34585476
Renal injury 51.54 10.93 164 205408 11031 34740328
Device interaction 49.80 10.93 35 205537 547 34750812
Premature baby 49.24 10.93 27 205545 19606 34731753
Blood lactate dehydrogenase increased 48.99 10.93 38 205534 22952 34728407
Renal tubular necrosis 47.87 10.93 201 205371 15479 34735880
Injury 47.51 10.93 244 205328 20443 34730916
Oral allergy syndrome 47.41 10.93 14 205558 16 34751343
Hypertensive emergency 46.98 10.93 43 205529 997 34750362
Multiple organ dysfunction syndrome 46.48 10.93 262 205310 76304 34675055
Malignant neoplasm progression 46.33 10.93 315 205257 87731 34663628
International normalised ratio increased 46.06 10.93 453 205119 46874 34704485
Dysphagia 45.96 10.93 565 205007 61816 34689543
Coma 45.79 10.93 128 205444 45550 34705809
Cardiac disorder 44.54 10.93 418 205154 42708 34708651
Hepatic cytolysis 44.20 10.93 15 205557 14481 34736878
Gamma-glutamyltransferase increased 42.75 10.93 66 205506 29165 34722194
Pneumocystis jirovecii pneumonia 42.74 10.93 32 205540 19678 34731681
Lymphocyte count decreased 41.49 10.93 43 205529 22579 34728780
Tongue oedema 41.45 10.93 68 205504 2929 34748430
Alanine aminotransferase increased 41.10 10.93 292 205280 80523 34670836
Lymphopenia 40.20 10.93 23 205549 16312 34735047
Hyperthermia 39.92 10.93 7 205565 10570 34740789
Pancreatitis acute 39.91 10.93 293 205279 27848 34723511
Toxic skin eruption 39.90 10.93 9 205563 11376 34739983
Liver disorder 38.91 10.93 85 205487 32912 34718447
Aspergillus infection 38.56 10.93 12 205560 12242 34739117
Pneumonia 38.54 10.93 1742 203830 360885 34390474
Blood urea increased 38.51 10.93 308 205264 30056 34721303
Vascular graft 38.25 10.93 46 205526 1476 34749883
Cytokine release syndrome 38.12 10.93 47 205525 22830 34728529
Renal failure 37.96 10.93 1021 204551 129536 34621823
Angina unstable 37.63 10.93 152 205420 11501 34739858
Hypophagia 37.50 10.93 256 205316 23766 34727593
Immune reconstitution inflammatory syndrome 37.29 10.93 4 205568 8755 34742604
Therapeutic product effect incomplete 36.95 10.93 162 205410 50379 34700980
Electrocardiogram T wave peaked 36.92 10.93 30 205542 589 34750770
Feeling abnormal 36.81 10.93 549 205023 62686 34688673
Fear 36.54 10.93 140 205432 10336 34741023
Drug dependence 36.07 10.93 54 205518 24163 34727196
Hepatitis 35.89 10.93 53 205519 23851 34727508
Cardiac failure 35.85 10.93 353 205219 90895 34660464
Drug reaction with eosinophilia and systemic symptoms 35.75 10.93 89 205483 32923 34718436
Anhedonia 35.73 10.93 112 205460 7473 34743886
Lung disorder 35.69 10.93 96 205476 34600 34716759
Infection 35.60 10.93 352 205220 90563 34660796
Eosinophilia 34.83 10.93 63 205509 26159 34725200
Platelet count decreased 34.76 10.93 495 205077 119222 34632137
Blood creatinine increased 34.60 10.93 766 204806 94210 34657149
Intentional self-injury 34.45 10.93 19 205553 13752 34737607
Infusion related reaction 34.15 10.93 178 205394 52879 34698480
Rheumatoid arthritis 34.14 10.93 113 205459 38125 34713234
Dysphonia 34.04 10.93 245 205327 23138 34728221
Drug intolerance 33.94 10.93 208 205364 59362 34691997
Bronchiectasis 33.85 10.93 8 205564 9793 34741566
Product quality issue 33.76 10.93 193 205379 16842 34734517
Aplastic anaemia 33.42 10.93 8 205564 9708 34741651
Vision blurred 33.28 10.93 415 205157 45548 34705811
Orbital myositis 32.96 10.93 16 205556 118 34751241
Muscle spasms 32.96 10.93 622 204950 74379 34676980
Therapy partial responder 32.91 10.93 8 205564 9608 34741751
Asthenia 32.73 10.93 1759 203813 243492 34507867
Low birth weight baby 32.68 10.93 4 205568 7901 34743458
Bradycardia 32.64 10.93 624 204948 74794 34676565
Thrombotic microangiopathy 32.41 10.93 11 205561 10619 34740740
Pelvic mass 32.33 10.93 19 205553 214 34751145
Pathogen resistance 32.23 10.93 8 205564 9474 34741885
Pneumonitis 31.72 10.93 98 205474 33780 34717579
Blood glucose decreased 31.71 10.93 158 205414 13079 34738280
Ischaemic cardiomyopathy 31.64 10.93 96 205476 6293 34745066
Drug-induced liver injury 31.01 10.93 78 205494 28754 34722605
Haemophagocytic lymphohistiocytosis 30.89 10.93 19 205553 12954 34738405
Venoocclusive liver disease 30.66 10.93 5 205567 7961 34743398
Myocardial ischaemia 30.51 10.93 191 205381 17217 34734142
Intentional dose omission 30.33 10.93 65 205507 3435 34747924
Anaemia 30.29 10.93 1095 204477 232240 34519119
Emotional distress 30.28 10.93 171 205401 14855 34736504
Blood urea abnormal 30.04 10.93 30 205542 778 34750581
Ageusia 29.81 10.93 130 205442 10178 34741181
Neuroleptic malignant syndrome 29.72 10.93 37 205535 17897 34733462
Haematotoxicity 29.69 10.93 6 205566 8188 34743171
Drooling 29.53 10.93 63 205509 3319 34748040
Exposure during pregnancy 29.49 10.93 8 205564 8926 34742433
Pharyngeal swelling 29.35 10.93 50 205522 2222 34749137
Pneumonia aspiration 29.02 10.93 137 205435 41766 34709593
Graft versus host disease 28.82 10.93 13 205559 10556 34740803
Hyperbilirubinaemia 28.71 10.93 34 205538 16809 34734550
Therapy cessation 28.37 10.93 184 205388 16789 34734570
Pulmonary renal syndrome 28.26 10.93 16 205556 167 34751192
Mouth swelling 28.26 10.93 44 205528 1812 34749547
Product substitution issue 28.20 10.93 126 205446 9969 34741390
Drug interaction 28.05 10.93 1066 204506 224880 34526479
Allergic cough 27.98 10.93 10 205562 29 34751330
Toxic epidermal necrolysis 27.87 10.93 53 205519 21593 34729766
Glycosylated haemoglobin increased 27.50 10.93 136 205436 11224 34740135
Potassium wasting nephropathy 27.23 10.93 13 205559 92 34751267
Orthostatic hypotension 27.15 10.93 252 205320 25667 34725692
Dysgeusia 26.94 10.93 256 205316 26241 34725118
Mydriasis 26.86 10.93 5 205567 7232 34744127
Hypoglycaemia 26.41 10.93 460 205112 54180 34697179
Transaminases increased 26.26 10.93 76 205496 26747 34724612
Ulnar nerve palsy 25.85 10.93 7 205565 4 34751355
Labelled drug-drug interaction medication error 25.63 10.93 30 205542 14909 34736450
Diabetic neuropathy 25.60 10.93 68 205504 4129 34747230
Aspartate aminotransferase increased 25.47 10.93 265 205307 67518 34683841
Status epilepticus 25.45 10.93 22 205550 12592 34738767
Post transplant lymphoproliferative disorder 25.35 10.93 4 205568 6524 34744835
Lower respiratory tract infection 25.25 10.93 98 205474 31539 34719820
Appendicitis 25.12 10.93 30 205542 14777 34736582
Neurotoxicity 25.07 10.93 42 205530 17968 34733391
Pancreatitis necrotising 24.81 10.93 52 205520 2706 34748653
Transplant rejection 24.69 10.93 15 205557 10296 34741063
Hyperlipidaemia 24.59 10.93 158 205414 14371 34736988
Blood electrolytes abnormal 23.91 10.93 29 205543 939 34750420
Oxygen saturation decreased 23.82 10.93 202 205370 53616 34697743
Laryngeal oedema 23.63 10.93 59 205513 3449 34747910
Product complaint 23.31 10.93 82 205490 5808 34745551
Enterocolitis 23.29 10.93 9 205563 8017 34743342
Accelerated hypertension 23.21 10.93 16 205556 242 34751117
Cystitis haemorrhagic 23.17 10.93 3 205569 5676 34745683
Substance abuse 23.13 10.93 8 205564 7633 34743726
Oropharyngeal swelling 23.12 10.93 21 205551 482 34750877
Anal abscess 22.92 10.93 5 205567 6468 34744891
Prostate cancer recurrent 22.86 10.93 29 205543 984 34750375
Unevaluable event 22.63 10.93 292 205280 32298 34719061
Second primary malignancy 22.62 10.93 9 205563 7877 34743482
Productive cough 22.61 10.93 130 205442 37683 34713676
Acute hepatic failure 22.33 10.93 30 205542 14044 34737315
Hypoaesthesia oral 22.32 10.93 65 205507 4164 34747195
Blood pressure increased 22.26 10.93 677 204895 87425 34663934
Coronary artery occlusion 22.25 10.93 125 205447 10837 34740522
Transient ischaemic attack 22.04 10.93 254 205318 27359 34724000
Increased tendency to bruise 22.00 10.93 63 205509 3998 34747361
Myalgia 21.97 10.93 649 204923 83461 34667898
Similar reaction on previous exposure to drug 21.91 10.93 9 205563 42 34751317
Seizure 21.89 10.93 460 205112 104397 34646962
Vitreous floaters 21.78 10.93 58 205514 3527 34747832
Tumour lysis syndrome 21.76 10.93 42 205530 17017 34734342
Polyneuropathy 21.43 10.93 34 205538 14862 34736497
Encephalitis 21.38 10.93 8 205564 7269 34744090
Pancreatitis haemorrhagic 21.30 10.93 17 205555 325 34751034
Nausea 21.28 10.93 2296 203276 337612 34413747
Wheezing 21.26 10.93 352 205220 41050 34710309
Eosinophil count increased 21.19 10.93 12 205560 8560 34742799
Depressed level of consciousness 21.19 10.93 156 205416 42685 34708674
No reaction on previous exposure to drug 21.16 10.93 10 205562 69 34751290
Hepatotoxicity 20.94 10.93 61 205511 21424 34729935
Nodular rash 20.72 10.93 11 205561 100 34751259
Disease progression 20.60 10.93 481 205091 107596 34643763
Azotaemia 20.39 10.93 70 205502 4897 34746462
Burning sensation 20.36 10.93 181 205391 18213 34733146
Epstein-Barr virus infection 19.85 10.93 10 205562 7618 34743741
Asthma 19.83 10.93 158 205414 42498 34708861
Tuberculosis 19.82 10.93 13 205559 8564 34742795
Diarrhoea 19.67 10.93 2598 202974 387314 34364045
Product coating issue 19.66 10.93 7 205565 20 34751339
Erythema 19.56 10.93 386 205186 88394 34662965
Gallbladder oedema 19.43 10.93 14 205558 228 34751131
Hypoaesthesia 19.43 10.93 486 205086 60958 34690401
COVID-19 19.33 10.93 330 205242 77220 34674139
Posterior reversible encephalopathy syndrome 19.31 10.93 18 205554 9936 34741423
Cytopenia 19.31 10.93 28 205544 12695 34738664
Akathisia 19.13 10.93 12 205560 8097 34743262
Maternal exposure during pregnancy 19.13 10.93 3 205569 4915 34746444
Acute respiratory distress syndrome 19.12 10.93 83 205489 25886 34725473
Fall 19.07 10.93 1412 204160 201473 34549886
Pseudomonas infection 19.03 10.93 27 205545 12355 34739004
Cytomegalovirus viraemia 18.95 10.93 10 205562 7420 34743939
Colitis 18.89 10.93 137 205435 37613 34713746
Miosis 18.79 10.93 17 205555 9518 34741841
Atrial fibrillation 18.78 10.93 890 204682 121503 34629856
Progressive multifocal leukoencephalopathy 18.54 10.93 18 205554 9746 34741613
Pericarditis 18.29 10.93 25 205547 11620 34739739
Tachycardia 18.25 10.93 370 205202 84402 34666957
Sedation 18.12 10.93 63 205509 20943 34730416
Paraesthesia 18.10 10.93 500 205072 63672 34687687
Renal impairment neonatal 18.01 10.93 6 205566 13 34751346
Paraesthesia oral 17.98 10.93 60 205512 4137 34747222
Blood glucose abnormal 17.93 10.93 76 205496 5876 34745483
Chronic kidney disease 17.83 10.93 341 205231 40869 34710490
Swelling 17.80 10.93 349 205223 42017 34709342
Electrocardiogram change 17.78 10.93 21 205551 661 34750698
Blood bilirubin increased 17.74 10.93 142 205430 38154 34713205
Haemorrhage intracranial 17.70 10.93 157 205415 15789 34735570
Gastric cancer 17.57 10.93 8 205564 6461 34744898
Lymphoma 17.57 10.93 29 205543 12478 34738881
Stridor 17.47 10.93 43 205529 2491 34748868
Renal artery stenosis 17.35 10.93 40 205532 2221 34749138
Acquired acrodermatitis enteropathica 17.27 10.93 5 205567 5 34751354
Neutrophil count increased 17.21 10.93 48 205524 17098 34734261
Blood alkaline phosphatase increased 17.16 10.93 110 205462 31065 34720294
Hepatitis cholestatic 17.10 10.93 13 205559 7934 34743425
Myelodysplastic syndrome 16.98 10.93 57 205515 19151 34732208
Hepatic failure 16.95 10.93 126 205446 34405 34716954
Blood pressure fluctuation 16.64 10.93 84 205488 25165 34726194
Sleep disorder due to a general medical condition 16.63 10.93 5 205567 5216 34746143
Neutropenic sepsis 16.61 10.93 35 205537 13732 34737627
Spur cell anaemia 16.60 10.93 8 205564 58 34751301
Systemic infection 16.59 10.93 5 205567 5207 34746152
Arteriosclerosis coronary artery 16.57 10.93 128 205444 12357 34739002
Cholangitis 16.52 10.93 16 205556 8673 34742686
Dizziness postural 16.52 10.93 76 205496 6088 34745271
Eye swelling 16.49 10.93 108 205464 9887 34741472
Carcinoid tumour of the gastrointestinal tract 16.37 10.93 8 205564 60 34751299
Circulatory collapse 16.26 10.93 66 205506 20972 34730387
Essential hypertension 16.23 10.93 47 205525 3001 34748358
Hypogammaglobulinaemia 16.23 10.93 13 205559 7727 34743632
Stent placement 16.21 10.93 66 205506 5012 34746347
Pemphigus 16.15 10.93 32 205540 1599 34749760
Oedema mouth 16.14 10.93 28 205544 1263 34750096
Generalised tonic-clonic seizure 16.00 10.93 67 205505 21107 34730252
Inflammation 16.00 10.93 99 205473 28196 34723163
Psychomotor hyperactivity 15.79 10.93 20 205552 9602 34741757
Respiratory tract infection 15.76 10.93 61 205511 19651 34731708
Hepatitis acute 15.65 10.93 13 205559 7588 34743771
Respiratory tract oedema 15.60 10.93 15 205557 371 34750988
Benign gastrointestinal neoplasm 15.47 10.93 10 205562 135 34751224
Complications of transplanted kidney 15.45 10.93 4 205568 4605 34746754
Device related infection 15.34 10.93 51 205521 17186 34734173
Speech disorder 15.33 10.93 224 205348 25462 34725897
Colitis ulcerative 15.31 10.93 48 205524 16472 34734887
Delirium 15.31 10.93 175 205397 43816 34707543
Overdose 15.26 10.93 413 205159 90646 34660713
Rash 15.08 10.93 1513 204059 221239 34530120
Encephalopathy 14.99 10.93 134 205438 35185 34716174
Urine oxalate increased 14.96 10.93 5 205567 11 34751348
Peripheral vascular disorder 14.94 10.93 64 205508 4972 34746387
Diabetic foot infection 14.63 10.93 19 205553 660 34750699
Tympanic membrane disorder 14.61 10.93 7 205565 50 34751309
Extrapyramidal disorder 14.51 10.93 34 205538 12846 34738513
Lymphomatoid papulosis 14.48 10.93 11 205561 195 34751164
Cognitive disorder 14.42 10.93 104 205468 28589 34722770
Pulmonary tuberculosis 14.35 10.93 5 205567 4749 34746610
Diabetic autonomic neuropathy 14.35 10.93 4 205568 3 34751356
Hypotonia 14.32 10.93 15 205557 7838 34743521
Poisoning deliberate 14.28 10.93 15 205557 7829 34743530
Chronic graft versus host disease 14.27 10.93 4 205568 4369 34746990
BK virus infection 14.23 10.93 8 205564 5730 34745629
Dyspnoea 14.22 10.93 2470 203102 374312 34377047
Uveitis 14.18 10.93 14 205558 7521 34743838
Anal fistula 14.17 10.93 7 205565 5392 34745967
Carcinoid tumour of the stomach 14.16 10.93 7 205565 54 34751305
Penile swelling 14.14 10.93 21 205551 829 34750530
Kidney transplant rejection 14.03 10.93 14 205558 7483 34743876
Inflammatory marker increased 14 10.93 6 205566 5022 34746337
Gout 14 10.93 174 205398 19079 34732280
Pneumatosis intestinalis 13.95 10.93 3 205569 3920 34747439
Erectile dysfunction 13.95 10.93 184 205388 20453 34730906
Cachexia 13.94 10.93 13 205559 7173 34744186
Drug ineffective for unapproved indication 13.92 10.93 82 205490 23633 34727726
Musculoskeletal chest pain 13.91 10.93 103 205469 9815 34741544
Intestinal obstruction 13.89 10.93 78 205494 22744 34728615
Endometriosis male 13.87 10.93 5 205567 15 34751344
Psychomotor skills impaired 13.86 10.93 3 205569 3903 34747456
Non-cardiac chest pain 13.83 10.93 56 205516 4241 34747118
Liver abscess 13.81 10.93 3 205569 3892 34747467
Postural orthostatic tachycardia syndrome 13.70 10.93 8 205564 89 34751270
Gastrointestinal haemorrhage 13.70 10.93 644 204928 87833 34663526
Acute myeloid leukaemia 13.69 10.93 58 205514 18212 34733147
Alcoholic ketoacidosis 13.63 10.93 5 205567 16 34751343
Renal tubular acidosis 13.57 10.93 37 205535 2282 34749077
Infective pulmonary exacerbation of cystic fibrosis 13.55 10.93 12 205560 6789 34744570
Toe amputation 13.52 10.93 39 205533 2485 34748874
Adenovirus infection 13.52 10.93 7 205565 5250 34746109
Jaundice 13.51 10.93 121 205451 31761 34719598
Tenosynovitis 13.47 10.93 5 205567 4565 34746794
Behaviour disorder 13.45 10.93 6 205566 4904 34746455
Body temperature decreased 13.45 10.93 36 205536 12998 34738361
Vomiting projectile 13.37 10.93 18 205554 648 34750711
Cardiovascular disorder 13.29 10.93 103 205469 9953 34741406
Haematochezia 13.28 10.93 193 205379 46341 34705018
Blood sodium decreased 13.20 10.93 150 205422 16101 34735258
Erythema multiforme 13.16 10.93 19 205553 8630 34742729
Pollakiuria 13.12 10.93 175 205397 19499 34731860
Myxoedema coma 13.12 10.93 12 205560 278 34751081
Cataract nuclear 13.10 10.93 16 205556 522 34750837
Ascites 13.00 10.93 194 205378 46377 34704982
Epiglottic oedema 12.99 10.93 10 205562 181 34751178
Hyperammonaemia 12.97 10.93 11 205561 6356 34745003
Weaning failure 12.96 10.93 11 205561 230 34751129
Enlarged uvula 12.92 10.93 11 205561 231 34751128
Meningitis aseptic 12.86 10.93 45 205527 3179 34748180
Arteriosclerosis 12.85 10.93 117 205455 11851 34739508
Diverticulum 12.83 10.93 79 205493 7080 34744279
Aggression 12.79 10.93 157 205415 38807 34712552
Inappropriate schedule of product administration 12.78 10.93 274 205298 62022 34689337
Death 12.76 10.93 2102 203470 395947 34355412
Klebsiella infection 12.72 10.93 19 205553 8512 34742847
Sleep attacks 12.68 10.93 9 205563 143 34751216
Oesophageal carcinoma 12.67 10.93 22 205550 9282 34742077
Drug level increased 12.66 10.93 77 205495 22019 34729340
Glossodynia 12.59 10.93 49 205523 3644 34747715
Organising pneumonia 12.59 10.93 10 205562 5969 34745390
Shock 12.57 10.93 206 205366 23973 34727386
Fistula 12.54 10.93 13 205559 6827 34744532
Pulmonary arterial hypertension 12.52 10.93 20 205552 8719 34742640
Pallor 12.49 10.93 93 205479 25387 34725972
Adenocarcinoma pancreas 12.47 10.93 26 205546 1348 34750011
Dilatation atrial 12.44 10.93 33 205539 2002 34749357
Lipoedema 12.43 10.93 3 205569 0 34751359
Alanine aminotransferase abnormal 12.42 10.93 6 205566 4682 34746677
Faeces discoloured 12.39 10.93 138 205434 14740 34736619
White blood cell count decreased 12.32 10.93 448 205124 94997 34656362
Hypoglycaemic unconsciousness 12.26 10.93 19 205553 779 34750580
Dermatitis atopic 12.23 10.93 63 205509 5284 34746075
Cerebral infarction 12.17 10.93 103 205469 27352 34724007
Terminal state 12.12 10.93 4 205568 3930 34747429
Haemolysis 12.10 10.93 18 205554 8076 34743283
Osteonecrosis of jaw 12.08 10.93 59 205513 17830 34733529
Oral candidiasis 12.08 10.93 34 205538 12076 34739283
Hepatic encephalopathy 12.03 10.93 45 205527 14640 34736719
Albumin urine present 12.01 10.93 13 205559 371 34750988
Therapy non-responder 12.01 10.93 160 205412 38986 34712373
Loss of personal independence in daily activities 11.94 10.93 131 205441 33048 34718311
Dystonia 11.93 10.93 29 205543 10816 34740543
Acute coronary syndrome 11.90 10.93 127 205445 13418 34737941
Acute cutaneous lupus erythematosus 11.90 10.93 7 205565 79 34751280
Endotracheal intubation complication 11.88 10.93 13 205559 376 34750983
Musculoskeletal stiffness 11.83 10.93 198 205374 46482 34704877
Throat tightness 11.83 10.93 87 205485 8271 34743088
Lip oedema 11.77 10.93 38 205534 2575 34748784
Application site infection 11.74 10.93 6 205566 50 34751309
Virologic failure 11.71 10.93 3 205569 3477 34747882
Diabetic retinopathy 11.66 10.93 30 205542 1787 34749572
Candida infection 11.64 10.93 59 205513 17656 34733703
Psychotic disorder 11.63 10.93 90 205482 24362 34726997
Osteoporosis 11.61 10.93 37 205535 12631 34738728
Drug eruption 11.58 10.93 69 205503 19829 34731530
Somnolence 11.48 10.93 535 205037 110581 34640778
Atrial septal defect 11.48 10.93 16 205556 7376 34743983
Pain in extremity 11.45 10.93 878 204694 125635 34625724
Pneumopericardium 11.44 10.93 8 205564 124 34751235
Pneumonia fungal 11.40 10.93 15 205557 7085 34744274
Hypoventilation 11.38 10.93 3 205569 3411 34747948
Anaesthesia 11.35 10.93 6 205566 54 34751305
Malignant transformation 11.35 10.93 19 205553 832 34750527
Rash pruritic 11.33 10.93 222 205350 26719 34724640
Colorectal cancer 11.30 10.93 7 205565 4754 34746605
Skin tightness 11.29 10.93 34 205538 2219 34749140
Macroglossia 11.29 10.93 13 205559 398 34750961
Meniere's disease 11.26 10.93 6 205566 55 34751304
Suicide attempt 11.24 10.93 162 205410 38954 34712405
Finger amputation 11.23 10.93 9 205563 173 34751186
Contrast media reaction 11.16 10.93 20 205552 926 34750433
Diabetic ketoacidosis 11.05 10.93 158 205414 17874 34733485
Raynaud's phenomenon 11.05 10.93 11 205561 284 34751075
Product monitoring error 11.02 10.93 6 205566 4375 34746984
Neoplasm progression 10.97 10.93 86 205486 23214 34728145
Electrocardiogram QT prolonged 10.95 10.93 172 205400 40780 34710579
Enterococcal infection 10.95 10.93 24 205548 9282 34742077
Hepatocellular carcinoma 10.93 10.93 17 205555 7492 34743867

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Angioedema 12191.35 9.70 6243 357827 69792 79310526
Myocardial infarction 1331.23 9.70 2730 361340 181399 79198919
Cardiac failure congestive 1286.64 9.70 2321 361749 140081 79240237
Hyperkalaemia 798.76 9.70 1673 362397 112725 79267593
Swollen tongue 773.33 9.70 963 363107 41607 79338711
Intestinal angioedema 736.71 9.70 238 363832 645 79379673
Acute kidney injury 706.30 9.70 4415 359655 514989 78865329
Coronary artery disease 706.12 9.70 1155 362915 64319 79315999
Completed suicide 658.39 9.70 2538 361532 243229 79137089
Cerebrovascular accident 628.41 9.70 1843 362227 153449 79226869
Off label use 581.07 9.70 2160 361910 905055 78475263
Lip swelling 570.09 9.70 813 363257 40098 79340220
Drug abuse 388.46 9.70 129 363941 162562 79217756
Acute myocardial infarction 382.69 9.70 986 363084 76050 79304268
Drug ineffective 368.42 9.70 3165 360905 1077748 78302570
Febrile neutropenia 346.61 9.70 326 363744 230673 79149645
Pyrexia 335.97 9.70 1777 362293 676932 78703386
Neutropenia 257.70 9.70 583 363487 287127 79093191
Swelling face 245.77 9.70 800 363270 70412 79309906
Hypotension 243.41 9.70 3074 360996 437243 78943075
C-reactive protein increased 204.34 9.70 173 363897 128854 79251464
Coronary arterial stent insertion 204.22 9.70 190 363880 5854 79374464
Coronary artery bypass 186.62 9.70 181 363889 5881 79374437
Lactic acidosis 181.76 9.70 719 363351 69640 79310678
Interstitial lung disease 180.73 9.70 149 363921 112451 79267867
Dehydration 180.04 9.70 1828 362242 246359 79133959
Suspected suicide 166.53 9.70 223 363847 10353 79369965
Hepatic function abnormal 154.53 9.70 70 364000 73037 79307281
Renal failure 153.84 9.70 1497 362573 199471 79180847
Pancreatitis 148.46 9.70 664 363406 67911 79312407
Dizziness 144.08 9.70 3279 360791 523162 78857156
Hypotensive transfusion reaction 143.53 9.70 39 364031 41 79380277
Injury 130.92 9.70 699 363371 76797 79303521
Hypovolaemia 124.78 9.70 260 363810 17431 79362887
General physical health deterioration 121.44 9.70 747 363323 274491 79105827
Myelosuppression 119.63 9.70 20 364050 40276 79340042
Thrombocytopenia 119.08 9.70 716 363354 264543 79115775
Infusion related reaction 118.40 9.70 594 363476 229643 79150675
Drug intolerance 117.47 9.70 715 363355 263404 79116914
Mental status changes 116.56 9.70 609 363461 66350 79313968
Cytomegalovirus infection 116.38 9.70 26 364044 42618 79337700
BRASH syndrome 111.18 9.70 65 364005 952 79379366
Blood glucose increased 109.27 9.70 898 363172 114077 79266241
Leukopenia 107.55 9.70 232 363838 116281 79264037
Product dose omission issue 105.32 9.70 1651 362419 245886 79134432
Sopor 103.46 9.70 14 364056 32996 79347322
Chest pain 100.44 9.70 1829 362241 280475 79099843
Synovitis 98.34 9.70 355 363715 150379 79229939
Angina unstable 93.06 9.70 222 363848 16305 79364013
Syncope 92.61 9.70 1238 362832 178211 79202107
Agranulocytosis 92.26 9.70 45 364025 44985 79335333
Septic shock 90.58 9.70 274 363796 122527 79257791
Pharyngeal oedema 89.93 9.70 217 363853 16055 79364263
Drug resistance 89.86 9.70 40 364030 42173 79338145
Renal injury 89.57 9.70 222 363848 16705 79363613
Blood pressure fluctuation 88.04 9.70 106 363964 67039 79313279
Drug hypersensitivity 87.95 9.70 1882 362188 297034 79083284
Therapeutic product effect incomplete 86.94 9.70 342 363728 141303 79239015
Maternal exposure during pregnancy 85.51 9.70 327 363743 136211 79244107
Altered state of consciousness 85.02 9.70 47 364023 43775 79336543
Blood potassium increased 84.51 9.70 310 363760 28965 79351353
Gastrointestinal haemorrhage 84.19 9.70 1038 363032 146681 79233637
Asthenia 82.37 9.70 2981 361089 508708 78871610
Infection 80.63 9.70 710 363360 241002 79139316
Dysphagia 79.27 9.70 880 363190 121256 79259062
Bronchopulmonary aspergillosis 78.81 9.70 6 364064 22288 79358030
Neutrophil count decreased 77.96 9.70 198 363872 93761 79286557
Cardiac disorder 76.73 9.70 539 363531 65218 79315100
Cholestasis 76.36 9.70 75 363995 52034 79328284
Myocardial ischaemia 76.01 9.70 273 363797 25246 79355072
Type 2 diabetes mellitus 75.53 9.70 483 363587 56639 79323679
Mucosal inflammation 75.27 9.70 144 363926 75436 79304882
Product use in unapproved indication 75.12 9.70 755 363315 249604 79130714
Exposure during pregnancy 75.05 9.70 225 363845 100907 79279411
Nasopharyngitis 74.78 9.70 769 363301 253112 79127206
International normalised ratio increased 74.29 9.70 650 363420 84071 79296247
Malignant neoplasm progression 73.26 9.70 345 363725 135645 79244673
Tongue oedema 73.24 9.70 123 363947 6994 79373324
Lower respiratory tract infection 73.08 9.70 322 363748 128898 79251420
Contraindicated product administered 72.89 9.70 421 363649 157117 79223201
Condition aggravated 72.53 9.70 1738 362332 499386 78880932
Hypophagia 72.42 9.70 403 363667 44964 79335354
Pancreatitis acute 71.60 9.70 429 363641 49175 79331143
Product quality issue 71.47 9.70 326 363744 33614 79346704
Coma 69.03 9.70 232 363838 100417 79279901
Ischaemic cardiomyopathy 68.80 9.70 125 363945 7570 79372748
Oxygen saturation decreased 67.98 9.70 330 363740 128717 79251601
Blood urea increased 67.91 9.70 418 363652 48372 79331946
Blood creatinine increased 67.72 9.70 1039 363031 154018 79226300
Intentional self-injury 67.02 9.70 32 364038 32387 79347931
Bone marrow failure 66.66 9.70 81 363989 51026 79329292
Psoriasis 65.87 9.70 662 363408 88925 79291393
Hepatocellular injury 65.79 9.70 72 363998 47521 79332797
Hepatic cytolysis 65.69 9.70 21 364049 27130 79353188
Blood cholesterol increased 65.64 9.70 627 363443 83093 79297225
Blood pressure inadequately controlled 65.23 9.70 108 363962 6069 79374249
Abortion spontaneous 64.33 9.70 27 364043 29480 79350838
Electrocardiogram T wave peaked 63.56 9.70 45 364025 930 79379388
Arthralgia 63.05 9.70 2060 362010 569743 78810575
Premature delivery 62.66 9.70 15 364055 23452 79356866
Pancytopenia 62.03 9.70 472 363598 165273 79215045
Transient ischaemic attack 61.51 9.70 432 363638 52263 79328055
Labile blood pressure 61.47 9.70 63 364007 2190 79378128
Erythema 59.10 9.70 693 363377 222597 79157721
Depressed level of consciousness 57.63 9.70 236 363834 96416 79283902
Pneumocystis jirovecii pneumonia 57.31 9.70 39 364031 32469 79347849
Cytokine release syndrome 57.29 9.70 48 364022 35950 79344368
Epilepsy 56.27 9.70 62 364008 40798 79339520
Renal tubular necrosis 56.10 9.70 245 363825 24794 79355524
Aspergillus infection 55.80 9.70 10 364060 19151 79361167
Hepatotoxicity 55.48 9.70 93 363977 51259 79329059
Joint swelling 54.82 9.70 957 363113 287689 79092629
Hepatitis 54.77 9.70 107 363963 55620 79324698
Toxic skin eruption 54.37 9.70 17 364053 22276 79358042
Sedation 54.23 9.70 96 363974 51799 79328519
Atrial fibrillation 54.05 9.70 1233 362837 196653 79183665
Blood pressure diastolic abnormal 53.84 9.70 11 364059 19191 79361127
Lymphopenia 53.42 9.70 37 364033 30520 79349798
Therapy cessation 53.02 9.70 323 363747 37239 79343079
Anhedonia 52.85 9.70 169 363901 14729 79365589
Tenosynovitis 52.75 9.70 5 364065 15549 79364769
Bradycardia 52.33 9.70 890 363180 134667 79245651
Thrombotic microangiopathy 51.72 9.70 14 364056 20155 79360163
Hyperlipidaemia 51.53 9.70 246 363824 25847 79354471
Disseminated intravascular coagulation 50.90 9.70 53 364017 35789 79344529
Lymphocyte count decreased 50.76 9.70 86 363984 47203 79333115
Vascular graft 50.42 9.70 54 364016 1977 79378341
Glycosylated haemoglobin increased 49.86 9.70 197 363873 19063 79361255
Bronchiectasis 49.59 9.70 20 364050 22366 79357952
Pneumonia 49.27 9.70 2488 361582 657758 78722560
Alanine aminotransferase increased 49.25 9.70 489 363581 162081 79218237
Shock 49.08 9.70 354 363716 43194 79337124
Hypertensive emergency 48.95 9.70 62 364008 2723 79377595
Fear 48.40 9.70 214 363856 21772 79358546
Drug reaction with eosinophilia and systemic symptoms 48.33 9.70 142 363928 64102 79316216
Chronic kidney disease 48.22 9.70 488 363582 65666 79314652
Haematotoxicity 47.65 9.70 7 364063 15512 79364806
Febrile bone marrow aplasia 47.49 9.70 3 364067 13017 79367301
Gamma-glutamyltransferase increased 47.10 9.70 113 363957 54567 79325751
Muscle spasms 46.86 9.70 1086 362984 173644 79206674
Rheumatoid nodule 46.85 9.70 11 364059 17427 79362891
Therapy partial responder 46.69 9.70 11 364059 17386 79362932
Sedation complication 46.02 9.70 8 364062 15661 79364657
Status epilepticus 45.55 9.70 29 364041 25012 79355306
Immune reconstitution inflammatory syndrome 45.51 9.70 5 364065 13836 79366482
Cardiomyopathy 44.20 9.70 253 363817 28521 79351797
Arteriosclerosis 43.66 9.70 182 363888 18045 79362273
Treatment failure 43.61 9.70 533 363537 169953 79210365
Eosinophilia 42.91 9.70 89 363981 45256 79335062
Product use issue 41.98 9.70 689 363381 209133 79171185
Productive cough 41.95 9.70 234 363836 88097 79292221
Nodular rash 41.79 9.70 23 364047 298 79380020
Anaphylactic reaction 41.63 9.70 574 363496 83169 79297149
Coronary artery occlusion 41.56 9.70 159 363911 15156 79365162
Oedema mouth 41.55 9.70 60 364010 2991 79377327
Rheumatic fever 41.35 9.70 247 363823 28278 79352040
Cognitive disorder 40.90 9.70 172 363898 69754 79310564
Haemophagocytic lymphohistiocytosis 40.12 9.70 25 364045 21812 79358506
Body temperature decreased 39.79 9.70 53 364017 32092 79348226
Gastrointestinal disorder 39.38 9.70 362 363708 121843 79258475
Product complaint 39.07 9.70 142 363928 13207 79367111
Haemorrhage intracranial 38.74 9.70 228 363842 25965 79354353
Wheezing 38.70 9.70 748 363322 115916 79264402
Blood lactate dehydrogenase increased 38.67 9.70 75 363995 39095 79341223
Progressive multifocal leukoencephalopathy 38.66 9.70 23 364047 20577 79359741
Pneumonitis 38.58 9.70 145 363925 60715 79319603
Device interaction 38.54 9.70 30 364040 720 79379598
Blood sodium decreased 38.44 9.70 272 363798 32983 79347335
Sleep disorder due to general medical condition, insomnia type 38.32 9.70 89 363981 43467 79336851
Tuberculosis 38.13 9.70 11 364059 15187 79365131
Spinal stenosis 38.08 9.70 158 363912 15633 79364685
Blood urea abnormal 37.83 9.70 38 364032 1289 79379029
Osteoporosis 37.60 9.70 124 363946 53988 79326330
Blood glucose decreased 37.29 9.70 226 363844 26008 79354310
Blood pressure systolic abnormal 37.25 9.70 16 364054 17231 79363087
Lymphomatoid papulosis 37.12 9.70 22 364048 331 79379987
Blood electrolytes abnormal 37.12 9.70 45 364025 1889 79378429
Panniculitis 37.03 9.70 6 364064 12365 79367953
Drooling 37.02 9.70 83 363987 5851 79374467
Gout 36.97 9.70 216 363854 24533 79355785
Prescribed overdose 36.57 9.70 297 363773 37586 79342732
Liver disorder 36.52 9.70 188 363882 72229 79308089
Facet joint syndrome 36.33 9.70 124 363946 11178 79369140
Blood pressure systolic increased 36.02 9.70 170 363900 66816 79313502
Neurotoxicity 35.96 9.70 58 364012 32460 79347858
Peripheral venous disease 35.90 9.70 156 363914 15753 79364565
Dizziness postural 35.63 9.70 125 363945 11424 79368894
Neuroleptic malignant syndrome 35.60 9.70 44 364026 27515 79352803
Mydriasis 35.58 9.70 18 364052 17625 79362693
Hyperthermia 35.49 9.70 19 364051 18018 79362300
Lip dry 35.41 9.70 152 363918 15266 79365052
Diarrhoea 35.30 9.70 4561 359509 875928 78504390
Stomatitis 35.23 9.70 465 363605 146292 79234026
Aplastic anaemia 35.03 9.70 19 364051 17886 79362432
Red blood cell sedimentation rate increased 34.95 9.70 101 363969 45841 79334477
Adjustment disorder with depressed mood 34.94 9.70 106 363964 8980 79371338
Colitis ulcerative 34.76 9.70 66 364004 34676 79345642
Transplant rejection 34.69 9.70 23 364047 19414 79360904
Emotional distress 34.69 9.70 306 363764 39663 79340655
Product substitution issue 34.39 9.70 183 363887 20073 79360245
Arthropathy 33.98 9.70 586 363484 176525 79203793
Inappropriate schedule of product administration 33.70 9.70 419 363651 133209 79247109
Inflammation 33.66 9.70 270 363800 93483 79286835
Liver injury 33.61 9.70 401 363669 56213 79324105
Post transplant lymphoproliferative disorder 33.35 9.70 6 364064 11458 79368860
Pathogen resistance 33.12 9.70 12 364058 14330 79365988
Hyperbilirubinaemia 32.89 9.70 38 364032 24480 79355838
Angina pectoris 32.75 9.70 371 363699 51361 79328957
Laryngeal oedema 32.36 9.70 96 363974 8033 79372285
Swollen joint count increased 32.26 9.70 197 363873 22730 79357588
Product coating issue 32.18 9.70 13 364057 78 79380240
Grip strength decreased 32.11 9.70 190 363880 21679 79358639
Orbital myositis 32.07 9.70 16 364054 167 79380151
Arterial occlusive disease 31.90 9.70 98 363972 8358 79371960
Epstein-Barr virus infection 31.74 9.70 13 364057 14403 79365915
Oral allergy syndrome 31.51 9.70 13 364057 83 79380235
Sleep disorder due to a general medical condition 31.23 9.70 13 364057 14264 79366054
Somatic delusion 31.12 9.70 26 364044 692 79379626
Multiple organ dysfunction syndrome 31.10 9.70 375 363695 119871 79260447
Cystitis haemorrhagic 30.97 9.70 3 364067 9169 79371149
Systemic infection 30.89 9.70 4 364066 9748 79370570
Vision blurred 30.84 9.70 666 363404 105232 79275086
Graft versus host disease 30.80 9.70 15 364055 15011 79365307
Body temperature increased 30.71 9.70 102 363968 44318 79336000
Overdose 30.54 9.70 625 363445 183581 79196737
Venoocclusive liver disease 30.51 9.70 8 364062 11763 79368555
Stridor 30.43 9.70 73 363997 5380 79374938
Rotator cuff repair 30.32 9.70 40 364030 1830 79378488
Suicide attempt 30.15 9.70 238 363832 82694 79297624
Aphthous ulcer 30.12 9.70 20 364050 16869 79363449
Poisoning deliberate 30.09 9.70 25 364045 18803 79361515
Drug dependence 30.02 9.70 91 363979 40678 79339640
Hypoaesthesia 30.01 9.70 1050 363020 178302 79202016
Pharyngeal swelling 29.63 9.70 90 363980 7629 79372689
Blood parathyroid hormone decreased 29.62 9.70 6 364064 10530 79369788
Accelerated hypertension 29.56 9.70 25 364045 677 79379641
Pelvic mass 29.54 9.70 32 364038 1187 79379131
Extrapyramidal disorder 29.52 9.70 36 364034 22643 79357675
Diabetic ketoacidosis 29.49 9.70 261 363809 33861 79346457
Cardiac failure 29.48 9.70 513 363557 154329 79225989
Neutropenic sepsis 29.25 9.70 49 364021 27015 79353303
Dilatation atrial 29.17 9.70 57 364013 3647 79376671
Polyneuropathy 28.71 9.70 41 364029 24110 79356208
Hypoglycaemia 28.65 9.70 636 363434 100958 79279360
Gangrene 28.51 9.70 98 363972 8866 79371452
Full blood count decreased 28.50 9.70 215 363855 26604 79353714
Second primary malignancy 28.41 9.70 15 364055 14335 79365983
Unresponsive to stimuli 28.38 9.70 384 363686 55404 79324914
Chronic sinusitis 28.27 9.70 12 364058 13014 79367304
Arteriosclerosis coronary artery 28.26 9.70 158 363912 17658 79362660
Weight increased 28.23 9.70 1009 363061 276377 79103941
Prostate cancer recurrent 28.19 9.70 26 364044 792 79379526
Drug eruption 27.63 9.70 105 363965 43830 79336488
Haemodialysis 27.42 9.70 159 363911 18009 79362309
Erectile dysfunction 27.34 9.70 136 363934 14528 79365790
Diabetic neuropathy 27.25 9.70 76 363994 6140 79374178
Pancreatitis necrotising 27.05 9.70 57 364013 3851 79376467
Nausea 27.04 9.70 4862 359208 952334 78427984
Ventricular hypertrophy 26.73 9.70 81 363989 6857 79373461
Hepatic enzyme increased 26.70 9.70 632 363438 181978 79198340
Mouth swelling 26.54 9.70 74 363996 5977 79374341
Lip oedema 26.49 9.70 76 363994 6240 79374078
Caesarean section 26.49 9.70 12 364058 12523 79367795
Oedema 26.36 9.70 724 363346 118856 79261462
Generalised tonic-clonic seizure 26.30 9.70 107 363963 43803 79336515
Platelet count decreased 26.22 9.70 682 363388 193982 79186336
Foetal death 26.21 9.70 3 364067 8041 79372277
Enterocolitis 26.13 9.70 17 364053 14495 79365823
Herpes zoster 26.13 9.70 285 363785 92798 79287520
Uveitis 26.10 9.70 23 364047 16807 79363511
Memory impairment 25.91 9.70 681 363389 111053 79269265
Pneumonia aspiration 25.85 9.70 189 363881 66778 79313540
Rash maculo-papular 25.84 9.70 150 363920 55928 79324390
Rhabdomyolysis 25.81 9.70 635 363435 102496 79277822
Similar reaction on previous exposure to drug 25.78 9.70 12 364058 106 79380212
Transaminases increased 25.71 9.70 135 363935 51608 79328710
COVID-19 25.53 9.70 537 363533 157137 79223181
Aplasia 25.27 9.70 3 364067 7817 79372501
Aspartate aminotransferase increased 25.23 9.70 463 363607 138178 79242140
Intentional dose omission 25.14 9.70 93 363977 8724 79371594
Therapeutic product effect decreased 25.11 9.70 563 363507 163300 79217018
Fibromyalgia 25.02 9.70 423 363647 63917 79316401
Ill-defined disorder 24.91 9.70 187 363883 65688 79314630
Atrioventricular block first degree 24.84 9.70 118 363952 12373 79367945
Unintentional medical device removal 24.82 9.70 3 364067 7709 79372609
Diabetic foot infection 24.66 9.70 24 364046 783 79379535
Cytomegalovirus viraemia 24.51 9.70 14 364056 12807 79367511
Potassium wasting nephropathy 24.42 9.70 13 364057 157 79380161
Gastric cancer 24.40 9.70 8 364062 10171 79370147
Blood loss anaemia 24.28 9.70 137 363933 15361 79364957
Oral herpes 24.23 9.70 56 364014 27398 79352920
Ulnar nerve palsy 24.20 9.70 7 364063 11 79380307
Depression 24.16 9.70 1216 362854 215574 79164744
Cardiac arrest 24.12 9.70 988 363082 171108 79209210
Fall 24.01 9.70 2560 361510 485069 78895249
Blood pressure increased 23.85 9.70 1187 362883 210173 79170145
Factor VII deficiency 23.69 9.70 8 364062 26 79380292
Upper gastrointestinal haemorrhage 23.65 9.70 291 363779 41089 79339229
Essential hypertension 23.63 9.70 71 363999 5982 79374336
Dysphonia 23.63 9.70 378 363692 56494 79323824
Dry mouth 23.56 9.70 547 363523 87472 79292846
Hypogammaglobulinaemia 23.56 9.70 15 364055 12936 79367382
Myelodysplastic syndrome 23.50 9.70 66 364004 30235 79350083
Drug-induced liver injury 23.46 9.70 191 363879 65926 79314392
Acute myeloid leukaemia 23.42 9.70 68 364002 30817 79349501
Mouth ulceration 23.35 9.70 93 363977 38301 79342017
Atrioventricular block second degree 23.31 9.70 80 363990 7232 79373086
Peripheral vascular disorder 23.14 9.70 85 363985 7945 79372373
Hepatic ischaemia 23.14 9.70 27 364043 1088 79379230
Pulmonary tuberculosis 23.13 9.70 4 364066 7861 79372457
Immunodeficiency 22.98 9.70 40 364030 21728 79358590
Unevaluable event 22.93 9.70 369 363701 55216 79325102
Dermatitis exfoliative generalised 22.86 9.70 3 364067 7238 79373080
Metabolic acidosis 22.75 9.70 515 363555 82014 79298304
Non-cardiac chest pain 22.73 9.70 95 363975 9429 79370889
Azotaemia 22.52 9.70 86 363984 8190 79372128
Osteonecrosis of jaw 22.48 9.70 111 363959 43115 79337203
Mitral valve incompetence 22.41 9.70 214 363856 28351 79351967
Dislocation of vertebra 22.37 9.70 83 363987 7797 79372521
Toxic epidermal necrolysis 22.32 9.70 116 363954 44465 79335853
Stent placement 22.26 9.70 73 363997 6447 79373871
Asthma 22.20 9.70 459 363611 134636 79245682
Alopecia 22.09 9.70 848 363222 230507 79149811
Myalgia 22.09 9.70 1048 363022 184593 79195725
Anaemia 21.98 9.70 1741 362329 443274 78937044
Dystonia 21.98 9.70 40 364030 21359 79358959
Encephalitis 21.91 9.70 21 364049 14739 79365579
Electrocardiogram T wave abnormal 21.90 9.70 51 364019 3687 79376631
Oropharyngeal pain 21.88 9.70 359 363711 108994 79271324
Amnesia 21.83 9.70 407 363663 62650 79317668
No reaction on previous exposure to drug 21.78 9.70 14 364056 245 79380073
Torsade de pointes 21.76 9.70 157 363913 19155 79361163
Enthesopathy 21.73 9.70 13 364057 11595 79368723
Acute coronary syndrome 21.66 9.70 168 363902 20965 79359353
Systemic lupus erythematosus 21.60 9.70 406 363664 120743 79259575
Ageusia 21.59 9.70 140 363930 16492 79363826
Hypertension 21.58 9.70 1773 362297 329219 79051099
Device related infection 21.54 9.70 82 363988 34212 79346106
Pulmonary renal syndrome 21.39 9.70 20 364050 620 79379698
Raynaud's phenomenon 21.32 9.70 25 364045 1013 79379305
Anal abscess 21.31 9.70 8 364062 9347 79370971
Oral candidiasis 21.20 9.70 67 364003 29561 79350757
Dysgeusia 21.18 9.70 373 363697 56804 79323514
Eczema 21.13 9.70 105 363965 40713 79339605
Muscle relaxant therapy 21.12 9.70 12 364058 166 79380152
Intentional product use issue 20.72 9.70 532 363538 151580 79228738
Sight disability 20.72 9.70 11 364059 132 79380186
Penile swelling 20.72 9.70 20 364050 646 79379672
Conjunctivitis 20.70 9.70 55 364015 25660 79354658
Suspected suicide attempt 20.66 9.70 15 364055 323 79379995
Pseudomonas infection 20.66 9.70 40 364030 20863 79359455
Schizophrenia 20.64 9.70 24 364046 15416 79364902
Infective pulmonary exacerbation of cystic fibrosis 20.62 9.70 17 364053 12834 79367484
Speech disorder 20.47 9.70 356 363714 54089 79326229
Pregnancy 20.45 9.70 59 364011 26792 79353526
Concomitant disease aggravated 20.41 9.70 18 364052 13149 79367169
Oedema genital 20.38 9.70 19 364051 587 79379731
Eosinophil count increased 20.37 9.70 29 364041 17076 79363242
Appendicitis 20.37 9.70 40 364030 20754 79359564
Candida infection 19.95 9.70 98 363972 38116 79342202
Acne 19.80 9.70 61 364009 27129 79353189
Blood pressure diastolic decreased 19.80 9.70 71 363999 30145 79350173
Product monitoring error 19.66 9.70 8 364062 8898 79371420
Miosis 19.57 9.70 26 364044 15763 79364555
Device expulsion 19.57 9.70 57 364013 25804 79354514
Alanine aminotransferase abnormal 19.51 9.70 8 364062 8859 79371459
Respiratory tract infection 19.48 9.70 136 363934 48553 79331765
Thermohypoaesthesia 19.44 9.70 10 364060 112 79380206
Feeling abnormal 19.42 9.70 901 363169 158298 79222020
Premature labour 19.41 9.70 7 364063 8383 79371935
Substance abuse 19.41 9.70 12 364058 10514 79369804
Tachycardia 19.38 9.70 641 363429 177127 79203191
Rheumatoid arthritis 19.27 9.70 767 363303 207703 79172615
Graft versus host disease in gastrointestinal tract 19.21 9.70 3 364067 6353 79373965
Dialysis 19.05 9.70 147 363923 18315 79362003
Withdrawal hypertension 18.95 9.70 15 364055 369 79379949
Hypoaldosteronism 18.88 9.70 15 364055 371 79379947
Carcinoid tumour of the gastrointestinal tract 18.82 9.70 9 364061 85 79380233
Electrocardiogram change 18.80 9.70 26 364044 1245 79379073
Ovarian cyst 18.79 9.70 18 364052 12637 79367681
Chronic graft versus host disease 18.77 9.70 4 364066 6777 79373541
Chronic obstructive pulmonary disease 18.77 9.70 517 363553 84902 79295416
Drug use disorder 18.72 9.70 8 364062 8643 79371675
Anti-cyclic citrullinated peptide antibody 18.63 9.70 64 364006 5788 79374530
Hand deformity 18.61 9.70 348 363722 103571 79276747
Colitis ischaemic 18.56 9.70 127 363943 15232 79365086
Ankylosing spondylitis 18.54 9.70 17 364053 12188 79368130
Fistula 18.53 9.70 19 364051 12921 79367397
Acquired acrodermatitis enteropathica 18.53 9.70 5 364065 5 79380313
Posterior reversible encephalopathy syndrome 18.41 9.70 60 364010 26221 79354097
Pulseless electrical activity 18.26 9.70 119 363951 14041 79366277
Eye swelling 18.22 9.70 193 363877 26275 79354043
Hepatitis B reactivation 18.20 9.70 3 364067 6105 79374213
Sepsis 18.19 9.70 1025 363045 268403 79111915
Joint range of motion decreased 18.14 9.70 232 363838 33050 79347268
Hyponatraemia 18.08 9.70 989 363081 176859 79203459
Pallor 18.04 9.70 144 363926 49918 79330400
Adenovirus infection 17.98 9.70 8 364062 8439 79371879
Treatment noncompliance 17.97 9.70 337 363733 51931 79328387
Gait inability 17.94 9.70 373 363697 58544 79321774
Diverticulum 17.90 9.70 123 363947 14773 79365545
Oropharyngeal swelling 17.74 9.70 26 364044 1314 79379004
BK virus infection 17.73 9.70 9 364061 8795 79371523
Device dislocation 17.70 9.70 60 364010 25910 79354408
Cytopenia 17.65 9.70 42 364028 20341 79359977
Blood glucose abnormal 17.63 9.70 95 363975 10471 79369847
Carotid artery stenosis 17.61 9.70 83 363987 8675 79371643
Urethral prolapse 17.58 9.70 4 364066 0 79380318
Benign gastrointestinal neoplasm 17.56 9.70 10 364060 139 79380179
C-reactive protein abnormal 17.49 9.70 139 363931 48228 79332090
Hyperammonaemia 17.40 9.70 15 364055 11078 79369240
Pulmonary toxicity 17.34 9.70 20 364050 12894 79367424
Disease progression 17.32 9.70 677 363393 183685 79196633
Lethargy 17.30 9.70 490 363580 80802 79299516
Blood immunoglobulin E increased 17.28 9.70 3 364067 5879 79374439
Myxoedema coma 17.26 9.70 19 364051 718 79379600
Nodule 17.16 9.70 51 364019 22943 79357375
Haemolysis 17.03 9.70 20 364050 12792 79367526
Cough 16.98 9.70 1918 362152 364871 79015447
Hepatitis acute 16.92 9.70 28 364042 15514 79364804
Lid lag 16.87 9.70 8 364062 74 79380244
Labelled drug-drug interaction medication error 16.80 9.70 67 364003 27583 79352735
Gastrointestinal toxicity 16.77 9.70 8 364062 8101 79372217
Glomerulonephritis membranous 16.72 9.70 28 364042 1588 79378730
Acute respiratory distress syndrome 16.71 9.70 125 363945 43942 79336376
Renal artery stenosis 16.69 9.70 44 364026 3438 79376880
Spur cell anaemia 16.67 9.70 9 364061 112 79380206
Abnormal dreams 16.66 9.70 99 363971 11313 79369005
Peripheral sensory neuropathy 16.63 9.70 21 364049 13012 79367306
Paradoxical drug reaction 16.61 9.70 6 364064 7179 79373139
End stage renal disease 16.56 9.70 104 363966 12116 79368202
Breast cancer stage I 16.53 9.70 5 364065 6695 79373623
Joint effusion 16.50 9.70 36 364034 17978 79362340
Refusal of treatment by patient 16.49 9.70 83 363987 8908 79371410
Haematochezia 16.48 9.70 291 363779 87354 79292964
Fatigue 16.41 9.70 4621 359449 925106 78455212
Respiratory distress 16.37 9.70 365 363705 57974 79322344
Abortion induced 16.33 9.70 6 364064 7103 79373215
Body height decreased 16.30 9.70 80 363990 8500 79371818
Deep vein thrombosis postoperative 16.16 9.70 94 363976 10658 79369660
Neutrophil count increased 16.16 9.70 74 363996 29322 79350996
Adverse drug reaction 16.08 9.70 407 363663 65985 79314333
Pre-eclampsia 16.08 9.70 6 364064 7035 79373283
Poor venous access 16.03 9.70 37 364033 18112 79362206
Skin toxicity 16.01 9.70 9 364061 8305 79372013
Nephrogenic systemic fibrosis 15.94 9.70 63 364007 6097 79374221
Dysarthria 15.92 9.70 413 363657 67209 79313109
Faecal calprotectin increased 15.90 9.70 3 364067 5538 79374780
Skin necrosis 15.88 9.70 37 364033 18050 79362268
Facial nerve disorder 15.85 9.70 18 364052 704 79379614
Drug tolerance 15.84 9.70 10 364060 8665 79371653
Blood bilirubin increased 15.83 9.70 210 363860 66022 79314296
Macroglossia 15.76 9.70 23 364047 1158 79379160
Colorectal cancer 15.75 9.70 10 364060 8637 79371681
Renal tubular acidosis 15.66 9.70 44 364026 3570 79376748
Charles Bonnet syndrome 15.62 9.70 5 364065 13 79380305
Female genital tract fistula 15.60 9.70 4 364066 5971 79374347
Loss of personal independence in daily activities 15.55 9.70 353 363717 102227 79278091
Adrenal insufficiency 15.49 9.70 72 363998 28415 79351903
Tumour lysis syndrome 15.19 9.70 57 364013 23882 79356436
Hypertensive heart disease 15.18 9.70 48 364022 4158 79376160
Endometriosis male 15.11 9.70 5 364065 15 79380303
Ileus paralytic 15.10 9.70 13 364057 9607 79370711
Expired product administered 15.04 9.70 68 364002 6983 79373335
Skin exfoliation 14.92 9.70 343 363727 54757 79325561
Encephalomalacia 14.89 9.70 23 364047 1218 79379100
Electrocardiogram QT prolonged 14.87 9.70 307 363763 90079 79290239
Tonsillitis 14.87 9.70 6 364064 6708 79373610
Alcoholic ketoacidosis 14.87 9.70 5 364065 16 79380302
Asphyxia 14.84 9.70 19 364051 11701 79368617
Hereditary angioedema with normal C1 esterase inhibitor 14.82 9.70 4 364066 4 79380314
Anti-neutrophil cytoplasmic antibody positive vasculitis 14.81 9.70 44 364026 3685 79376633
Pollakiuria 14.75 9.70 246 363824 37071 79343247
Gait disturbance 14.73 9.70 1119 362951 206387 79173931
Device difficult to use 14.68 9.70 24 364046 13361 79366957
Psoriatic arthropathy 14.66 9.70 463 363607 77536 79302782
Shock haemorrhagic 14.61 9.70 45 364025 20015 79360303
Acute generalised exanthematous pustulosis 14.59 9.70 36 364034 17218 79363100
Bone density decreased 14.58 9.70 24 364046 13323 79366995
Neutropenic colitis 14.56 9.70 4 364066 5703 79374615
Cardiomegaly 14.49 9.70 184 363886 26168 79354150
Hypertransaminasaemia 14.41 9.70 20 364050 11904 79368414
Occult blood positive 14.40 9.70 66 364004 6817 79373501
Product prescribing error 14.32 9.70 133 363937 44680 79335638
Osteoarthritis 14.31 9.70 510 363560 86799 79293519
Pemphigoid 14.20 9.70 119 363951 15196 79365122
Graft versus host disease in skin 14.16 9.70 5 364065 6068 79374250
Hypertensive urgency 14.14 9.70 15 364055 543 79379775
Penile contusion 14.12 9.70 8 364062 110 79380208
Infusion site pain 14.12 9.70 27 364043 14149 79366169
Liver abscess 14.09 9.70 5 364065 6049 79374269
Gastric ulcer helicobacter 14.01 9.70 5 364065 20 79380298
Blood glucose fluctuation 13.93 9.70 64 364006 6618 79373700
Immune-mediated myositis 13.85 9.70 41 364029 3426 79376892
Laryngotracheal oedema 13.84 9.70 6 364064 44 79380274
Osmolar gap increased 13.81 9.70 8 364062 115 79380203
Autoimmune disorder 13.81 9.70 126 363944 16486 79363832
Sinus bradycardia 13.76 9.70 176 363894 25071 79355247
Bone erosion 13.75 9.70 39 364031 17808 79362510
Tricuspid valve incompetence 13.69 9.70 144 363926 19568 79360750
Disturbance in social behaviour 13.62 9.70 3 364067 4967 79375351
Frequent bowel movements 13.62 9.70 79 363991 29460 79350858
Intestinal obstruction 13.61 9.70 128 363942 42892 79337426
Creatinine renal clearance decreased 13.58 9.70 43 364027 18959 79361359
Migraine 13.57 9.70 300 363770 87193 79293125
Apathy 13.56 9.70 24 364046 12953 79367365
Toe amputation 13.54 9.70 44 364026 3867 79376451
Anxiety 13.54 9.70 1314 362756 247198 79133120
Red cell distribution width increased 13.52 9.70 31 364039 15211 79365107
Therapeutic response unexpected 13.52 9.70 145 363925 19801 79360517
Mixed liver injury 13.48 9.70 9 364061 7569 79372749
Rhinovirus infection 13.42 9.70 10 364060 7943 79372375
Cerebral thrombosis 13.37 9.70 32 364038 2355 79377963
Enlarged uvula 13.29 9.70 13 364057 427 79379891
Pseudomembranous colitis 13.28 9.70 4 364066 5370 79374948
Retching 13.28 9.70 130 363940 17337 79362981
Diabetic autonomic neuropathy 13.18 9.70 3 364067 0 79380318
Sleep attacks 13.14 9.70 9 364061 176 79380142
Fracture 13.14 9.70 53 364017 21748 79358570
Fear of injection 13.13 9.70 9 364061 7465 79372853
Drug specific antibody present 13.10 9.70 7 364063 6645 79373673
Cholelithiasis 13.09 9.70 324 363746 52340 79327978
Neoplasm progression 13.04 9.70 162 363908 51520 79328798
Sputum discoloured 13.01 9.70 53 364017 21690 79358628
Oesophageal carcinoma 12.99 9.70 19 364051 11065 79369253
Colitis 12.96 9.70 246 363824 73061 79307257
Foetal disorder 12.96 9.70 8 364062 130 79380188
Hypoglycaemic unconsciousness 12.92 9.70 21 364049 1162 79379156
Pseudomonal sepsis 12.91 9.70 6 364064 6168 79374150
Uvulitis 12.90 9.70 4 364066 9 79380309
Diverticulum intestinal haemorrhagic 12.89 9.70 44 364026 3967 79376351
Paraesthesia 12.87 9.70 953 363117 175370 79204948
Drug dispensed to wrong patient 12.86 9.70 16 364054 690 79379628
Lymphoma 12.84 9.70 39 364031 17421 79362897
Rectal haemorrhage 12.83 9.70 447 363623 75853 79304465
Neurological decompensation 12.82 9.70 4 364066 5249 79375069
Psychomotor skills impaired 12.76 9.70 4 364066 5233 79375085
Prostate examination abnormal 12.75 9.70 9 364061 185 79380133
Confusional state 12.75 9.70 1648 362422 316349 79063969
Therapeutic response shortened 12.72 9.70 34 364036 15829 79364489
Coronary artery surgery 12.71 9.70 9 364061 186 79380132
Sinus node dysfunction 12.68 9.70 69 364001 7632 79372686
Dermatitis atopic 12.66 9.70 84 363986 9972 79370346
Product physical issue 12.66 9.70 45 364025 4140 79376178
Vitreous floaters 12.62 9.70 66 364004 7190 79373128
Hypercholesterolaemia 12.59 9.70 161 363909 22934 79357384
Therapeutic response decreased 12.55 9.70 222 363848 66631 79313687
Cytomegalovirus colitis 12.50 9.70 3 364067 4682 79375636
Fear of eating 12.50 9.70 13 364057 460 79379858
Pharyngitis 12.49 9.70 56 364014 22319 79357999
Pulse absent 12.48 9.70 84 363986 10019 79370299
Lymphoproliferative disorder 12.46 9.70 5 364065 5610 79374708
Fungal infection 12.46 9.70 126 363944 41622 79338696
Nodal rhythm 12.46 9.70 37 364033 3098 79377220
Seizure 12.44 9.70 720 363350 188114 79192204
Bicytopenia 12.44 9.70 3 364067 4667 79375651
Endotracheal intubation complication 12.44 9.70 17 364053 805 79379513
Lacunar infarction 12.38 9.70 57 364013 5900 79374418
Clonus 12.33 9.70 8 364062 6832 79373486
Herpes simplex 12.32 9.70 23 364047 12164 79368154
Musculoskeletal stiffness 12.32 9.70 663 363407 174345 79205973
Skin odour abnormal 12.31 9.70 29 364041 2112 79378206
Anaphylactic shock 12.31 9.70 105 363965 35891 79344427
Pancreatitis haemorrhagic 12.31 9.70 17 364053 813 79379505
Heart rate increased 12.29 9.70 439 363631 120285 79260033
Exercise tolerance increased 12.24 9.70 5 364065 31 79380287
Fluid intake reduced 12.21 9.70 59 364011 6229 79374089
Granuloma 12.09 9.70 12 364058 8285 79372033
Sinusitis 12.07 9.70 750 363320 194751 79185567
Hepatic encephalopathy 12.03 9.70 63 364007 24103 79356215
Metastases to lymph nodes 12.01 9.70 18 364052 10379 79369939
Lupus vulgaris 11.91 9.70 38 364032 3308 79377010
Oedema peripheral 11.90 9.70 1321 362749 250967 79129351
Erythema multiforme 11.88 9.70 41 364029 17610 79362708
Road traffic accident 11.88 9.70 272 363798 43392 79336926
Finger deformity 11.85 9.70 10 364060 7464 79372854
Depressed mood 11.85 9.70 153 363917 48327 79331991
Hypertensive crisis 11.84 9.70 146 363924 20624 79359694
COVID-19 pneumonia 11.83 9.70 80 363990 28769 79351549
Heart rate decreased 11.81 9.70 238 363832 70078 79310240
Multiple injuries 11.81 9.70 39 364031 3456 79376862
Monocyte count increased 11.80 9.70 19 364051 10642 79369676
Palatal swelling 11.74 9.70 8 364062 155 79380163
Walking aid user 11.73 9.70 83 363987 10065 79370253
Metastases to lung 11.69 9.70 43 364027 18120 79362198
Transient psychosis 11.68 9.70 6 364064 67 79380251
Product solubility abnormal 11.64 9.70 18 364052 954 79379364
Respiratory tract oedema 11.63 9.70 17 364053 857 79379461
Pulmonary fibrosis 11.62 9.70 137 363933 43975 79336343
Body temperature 11.61 9.70 5 364065 36 79380282
Pericarditis 11.56 9.70 375 363695 103861 79276457
Albumin urine present 11.54 9.70 15 364055 676 79379642
Pain in jaw 11.52 9.70 145 363925 46006 79334312
Bundle branch block left 11.51 9.70 91 363979 11422 79368896
Enterococcal infection 11.50 9.70 35 364035 15625 79364693
Skin induration 11.48 9.70 46 364024 4479 79375839
Somnolence 11.46 9.70 937 363133 238044 79142274
Nasal congestion 11.44 9.70 264 363806 76288 79304030
Hallucination, auditory 11.43 9.70 52 364018 20641 79359677
Atrioventricular block 11.42 9.70 106 363964 13935 79366383
Brain oedema 11.41 9.70 68 364002 25195 79355123
Nasal polyps 11.38 9.70 10 364060 7317 79373001
Transcription medication error 11.26 9.70 12 364058 437 79379881
Small intestinal ulcer haemorrhage 11.22 9.70 7 364063 116 79380202
Dyspnoea 11.22 9.70 4211 359859 852814 78527504
Erythema marginatum 11.21 9.70 4 364066 16 79380302
Hypoaesthesia oral 11.17 9.70 106 363964 14018 79366300
Angiotensin converting enzyme inhibitor foetopathy 11.17 9.70 5 364065 40 79380278
Lichen planus 11.15 9.70 33 364037 2758 79377560
Breast cancer stage III 11.14 9.70 80 363990 9746 79370572
Pulse volume decreased 11.12 9.70 3 364067 3 79380315
Hospice care 11.10 9.70 83 363987 10241 79370077
Subileus 11.06 9.70 6 364064 5648 79374670
Hypoventilation 11.05 9.70 10 364060 7214 79373104
Hepatocellular carcinoma 11.04 9.70 15 364055 9006 79371312
Obesity 10.90 9.70 223 363847 34902 79345416
Metastases to liver 10.88 9.70 80 363990 28234 79352084
Spinal pain 10.88 9.70 35 364035 15357 79364961
Complications of transplanted kidney 10.74 9.70 8 364062 6358 79373960
Cardiac murmur 10.71 9.70 115 363955 15709 79364609
Circumoral oedema 10.67 9.70 10 364060 311 79380007
Cytomegalovirus test positive 10.66 9.70 7 364063 5940 79374378
Cataract nuclear 10.66 9.70 18 364052 1028 79379290
Electrocardiogram ST-T change 10.60 9.70 23 364047 1586 79378732
Vasculitis 10.60 9.70 69 364001 25033 79355285
Diffuse large B-cell lymphoma 10.55 9.70 25 364045 12124 79368194
Vitritis infective 10.50 9.70 4 364066 20 79380298
Malaise 10.49 9.70 2024 362046 487845 78892473
Cerebellar syndrome 10.45 9.70 6 364064 5474 79374844
Respiratory disorder 10.44 9.70 143 363927 44713 79335605
Pain 10.42 9.70 2959 361111 700843 78679475
Dilatation ventricular 10.42 9.70 42 364028 4102 79376216
Metastases to bone 10.39 9.70 67 364003 24360 79355958
Blood calcium decreased 10.36 9.70 94 363976 31725 79348593
Retroperitoneal oedema 10.34 9.70 4 364066 21 79380297
Dysaesthesia 10.33 9.70 7 364063 5841 79374477
Carcinoid tumour of the stomach 10.31 9.70 8 364062 191 79380127
Pneumopericardium 10.28 9.70 8 364062 192 79380126
Drug level below therapeutic 10.27 9.70 18 364052 9752 79370566
Toxic shock syndrome staphylococcal 10.26 9.70 3 364067 5 79380313
Epiglottic oedema 10.23 9.70 10 364060 328 79379990
Bradykinesia 10.22 9.70 13 364057 8030 79372288
Eosinophilic pleural effusion 10.21 9.70 10 364060 329 79379989
Muscle injury 10.19 9.70 158 363912 48403 79331915
Muscular weakness 10.14 9.70 859 363211 159870 79220448
Dyspnoea at rest 10.14 9.70 11 364059 7291 79373027
Skin hypertrophy 10.12 9.70 47 364023 4881 79375437
Deep vein thrombosis 10.12 9.70 661 363409 120258 79260060
Gastrointestinal vascular malformation 10.12 9.70 5 364065 51 79380267
Peripheral artery stenosis 10.11 9.70 20 364050 1291 79379027
Urine sodium increased 10.10 9.70 8 364062 197 79380121
Eosinophilic oesophagitis 10.09 9.70 13 364057 581 79379737
Pulmonary arterial hypertension 10.03 9.70 82 363988 28284 79352034
Intracranial pressure increased 10.02 9.70 14 364056 8308 79372010
Brain abscess 10.01 9.70 5 364065 4931 79375387
Jaundice cholestatic 9.97 9.70 23 364047 11261 79369057
Cystitis 9.94 9.70 175 363895 52557 79327761
Ludwig angina 9.93 9.70 9 364061 268 79380050
Petit mal epilepsy 9.92 9.70 7 364063 5720 79374598
Peritoneal fibrosis 9.91 9.70 3 364067 6 79380312
Circulatory collapse 9.91 9.70 117 363953 37551 79342767
Malignant transformation 9.91 9.70 19 364051 1199 79379119
Pulmonary pain 9.90 9.70 4 364066 4469 79375849
Transplant dysfunction 9.89 9.70 11 364059 7210 79373108
Terminal state 9.84 9.70 5 364065 4884 79375434
Impaired healing 9.80 9.70 315 363755 87340 79292978
Prostatic specific antigen increased 9.79 9.70 81 363989 10305 79370013
Kidney transplant rejection 9.79 9.70 20 364050 10226 79370092
Cholangitis 9.78 9.70 28 364042 12748 79367570
Contrast media reaction 9.76 9.70 26 364044 2044 79378274
Meningitis 9.76 9.70 18 364052 9564 79370754
Foot deformity 9.75 9.70 67 364003 24007 79356311
Hepatic failure 9.75 9.70 209 363861 61003 79319315
Psychiatric decompensation 9.70 9.70 3 364067 3960 79376358
Conjunctival scar 9.70 9.70 8 364062 209 79380109

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

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