All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic)	1481	138402-11-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: irbesartan aprovel irbesartan hydrochloride karvea ifirmasta irbesartan HCl	A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease. Molecular weight: 428.54 Formula: C25H28N6O CLOGP: 4.69 LIPINSKI: 1 HAC: 7 HDO: 1 TPSA: 87.13 ALOGS: -4.70 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.15	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.08 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	10 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.94 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.10 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	14 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 26, 1997	EMA	SANOFI WINTHROP INDUSTRIE
Sept. 30, 1997	FDA	SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Acute kidney injury	523.41	10.47	889	56550	262526	63169057
Neurologic neglect syndrome	352.87	10.47	121	57318	2600	63428983
Carotid artery thrombosis	349.73	10.47	121	57318	2673	63428910
Personality disorder	321.62	10.47	139	57300	5672	63425911
Adjustment disorder	308.51	10.47	114	57325	3064	63428519
Hyponatraemia	291.20	10.47	428	57011	111472	63320111
Hemiplegia	284.61	10.47	148	57291	9175	63422408
Affect lability	243.75	10.47	142	57297	11009	63420574
Sensory loss	212.28	10.47	126	57313	10112	63421471
Motor dysfunction	201.37	10.47	124	57315	10637	63420946
Hyperkalaemia	188.90	10.47	239	57200	53964	63377619
Coordination abnormal	180.42	10.47	127	57312	13646	63417937
Hemiparesis	165.67	10.47	150	57289	23132	63408451
Aphasia	162.75	10.47	174	57265	32826	63398757
Eating disorder	162.51	10.47	136	57303	18880	63412703
Muscle spasticity	156.23	10.47	141	57298	21653	63409930
Fall	151.11	10.47	728	56711	391606	63039977
Systemic lupus erythematosus	144.20	10.47	12	57427	208906	63222677
Blood pressure increased	136.72	10.47	388	57051	161674	63269909
Glossodynia	129.98	10.47	8	57431	178868	63252715
Maternal exposure during pregnancy	128.91	10.47	22	57417	220040	63211543
Lactic acidosis	124.23	10.47	163	57276	38124	63393459
Drug ineffective	122.84	10.47	509	56930	1044256	62387327
Hand deformity	122.62	10.47	5	57434	159452	63272131
Cerebrovascular accident	116.99	10.47	284	57155	107740	63323843
Treatment failure	114.17	10.47	21	57418	199022	63232561
Therapeutic product effect decreased	113.83	10.47	19	57420	193168	63238415
Dysarthria	113.30	10.47	165	57274	42546	63389037
Blood pressure systolic increased	95.00	10.47	161	57278	47236	63384347
Drug interaction	94.43	10.47	434	57005	228697	63202886
Contraindicated product administered	84.22	10.47	46	57393	217602	63213981
Synovitis	84.00	10.47	32	57407	186886	63244697
Pain	81.72	10.47	369	57070	740259	62691324
Alopecia	76.44	10.47	117	57322	337419	63094164
Hepatic cytolysis	75.52	10.47	81	57358	15326	63416257
Renal failure	75.30	10.47	256	57183	117396	63314187
Pericarditis	75.17	10.47	14	57425	131565	63300018
Hypotension	73.77	10.47	460	56979	272144	63159439
Ischaemic stroke	73.61	10.47	86	57353	17871	63413712
Dysphagia	72.58	10.47	210	57229	88375	63343208
Swelling	71.90	10.47	86	57353	275292	63156291
Product use issue	68.80	10.47	59	57380	220461	63211122
Hypoglycaemia	66.14	10.47	159	57280	59906	63371677
Bradycardia	65.28	10.47	179	57260	73048	63358535
Pemphigoid	63.72	10.47	53	57386	7291	63424292
Sinus bradycardia	61.84	10.47	71	57368	14480	63417103
Skin haemorrhage	60.23	10.47	59	57380	10035	63421548
Abdominal discomfort	60.22	10.47	125	57314	320760	63110823
Duodenal ulcer perforation	60.15	10.47	5	57434	87204	63344379
Sinus congestion	60.08	10.47	78	57361	18045	63413538
Exposure during pregnancy	59.97	10.47	33	57406	155514	63276069
Wound	59.59	10.47	37	57402	163226	63268357
Muscular weakness	58.13	10.47	242	57197	122111	63309472
Off label use	57.64	10.47	366	57073	674096	62757487
Drug intolerance	57.27	10.47	121	57318	308540	63123043
Asthenia	55.87	10.47	561	56878	383043	63048540
Drug hypersensitivity	51.81	10.47	129	57310	310558	63121025
Arthropathy	50.63	10.47	84	57355	234708	63196875
Atrial fibrillation	48.76	10.47	222	57217	116414	63315169
Infection	48.48	10.47	83	57356	229090	63202493
Discomfort	48.37	10.47	48	57391	167326	63264257
Pulmonary pain	47.61	10.47	33	57406	3457	63428126
Angioedema	46.53	10.47	121	57318	47844	63383739
Psoriatic arthropathy	45.77	10.47	13	57426	91507	63340076
Sneezing	44.88	10.47	68	57371	18150	63413433
Therapeutic product effect incomplete	43.38	10.47	30	57409	125026	63306557
Hepatocellular injury	43.38	10.47	84	57355	27297	63404286
Heart rate decreased	43.24	10.47	114	57325	45446	63386137
Helicobacter infection	43.15	10.47	15	57424	92770	63338813
Confusional state	43.12	10.47	363	57076	236017	63195566
Joint swelling	43.09	10.47	152	57287	327514	63104069
Completed suicide	42.99	10.47	41	57398	145632	63285951
Dehydration	42.21	10.47	285	57154	173069	63258514
Cholestasis	41.48	10.47	86	57353	29348	63402235
Vulvovaginal burning sensation	41.23	10.47	25	57414	2084	63429499
Paranasal sinus discomfort	40.94	10.47	33	57406	4343	63427240
Respiratory tract congestion	40.35	10.47	64	57375	17768	63413815
Intra-abdominal haematoma	39.47	10.47	23	57416	1782	63429801
Amyloid arthropathy	39.21	10.47	16	57423	564	63431019
Blood pressure diastolic decreased	38.87	10.47	72	57367	22634	63408949
Lichen planopilaris	38.51	10.47	9	57430	42	63431541
Arteriovenous fistula occlusion	38.28	10.47	14	57425	365	63431218
Vulvovaginal pruritus	38.10	10.47	28	57411	3215	63428368
Fear of eating	37.82	10.47	14	57425	378	63431205
Rhabdomyolysis	37.74	10.47	106	57333	43845	63387738
Blue toe syndrome	37.30	10.47	14	57425	393	63431190
Irritable bowel syndrome	37.18	10.47	14	57425	82398	63349185
Inappropriate antidiuretic hormone secretion	37.08	10.47	57	57382	15405	63416178
Hepatic enzyme increased	36.92	10.47	80	57359	202248	63229335
Blood pressure diastolic abnormal	36.85	10.47	55	57384	14487	63417096
Product use in unapproved indication	36.83	10.47	66	57373	179014	63252569
Rhinalgia	36.63	10.47	21	57418	1578	63430005
Blood pressure systolic abnormal	35.90	10.47	52	57387	13334	63418249
Arterial occlusive disease	35.87	10.47	35	57404	5923	63425660
Tubulointerstitial nephritis	35.19	10.47	64	57375	19839	63411744
Hypersensitivity	35.07	10.47	141	57298	292544	63139039
Shock haemorrhagic	35.02	10.47	44	57395	9851	63421732
Rash	34.86	10.47	332	57107	560539	62871044
Hypertensive crisis	34.77	10.47	55	57384	15231	63416352
Cystitis	33.70	10.47	118	57321	54873	63376710
Blood pressure fluctuation	33.39	10.47	105	57334	46212	63385371
Blood pressure inadequately controlled	33.31	10.47	31	57408	4947	63426636
Anuria	32.56	10.47	48	57391	12503	63419080
Syncope	31.62	10.47	198	57241	117187	63314396
Anxiety	31.52	10.47	318	57121	217223	63214360
Angina pectoris	31.37	10.47	78	57361	30000	63401583
Sebaceous gland infection	31.18	10.47	10	57429	173	63431410
Keratitis	30.32	10.47	25	57414	3397	63428186
Torsade de pointes	30.32	10.47	48	57391	13303	63418280
Atrioventricular block first degree	30.08	10.47	35	57404	7238	63424345
Death	29.93	10.47	207	57232	374174	63057409
Renal impairment	29.65	10.47	158	57281	88197	63343386
Vertigo	29.64	10.47	120	57319	59767	63371816
Rheumatoid arthritis	29.32	10.47	124	57315	253695	63177888
Incision site haemorrhage	29.15	10.47	13	57426	572	63431011
Sinus disorder	28.10	10.47	66	57373	24487	63407096
Neurofibrosarcoma	28.10	10.47	9	57430	155	63431428
Adverse drug reaction	27.80	10.47	19	57420	79695	63351888
Oxygen saturation decreased	27.43	10.47	155	57284	88430	63343153
Blister	26.54	10.47	48	57391	129766	63301817
Fibromyalgia	25.69	10.47	21	57418	80399	63351184
Hypokalaemia	25.45	10.47	171	57268	103633	63327950
Myocardial infarction	24.75	10.47	165	57274	99728	63331855
Sedation	24.74	10.47	3	57436	38806	63392777
Intestinal angioedema	24.69	10.47	12	57427	643	63430940
Mobility decreased	24.59	10.47	45	57394	121114	63310469
Parotid gland enlargement	24.42	10.47	13	57426	845	63430738
Blood potassium increased	24.06	10.47	52	57387	18257	63413326
Rhinorrhoea	23.89	10.47	120	57319	65457	63366126
Prothrombin time ratio decreased	23.79	10.47	11	57428	527	63431056
Infusion related reaction	23.65	10.47	128	57311	245393	63186190
Sinus node dysfunction	23.61	10.47	25	57414	4660	63426923
Atrioventricular block complete	23.52	10.47	33	57406	8218	63423365
Skin exfoliation	23.46	10.47	89	57350	43013	63388570
Mixed liver injury	23.39	10.47	25	57414	4710	63426873
Coronary artery disease	22.97	10.47	73	57366	32304	63399279
Diabetic metabolic decompensation	22.93	10.47	16	57423	1694	63429889
Gangrene	22.91	10.47	28	57411	6095	63425488
Fibrous histiocytoma	22.87	10.47	11	57428	576	63431007
Vascular purpura	22.60	10.47	15	57424	1463	63430120
Hepatitis	22.36	10.47	83	57356	39705	63391878
Acidosis	22.29	10.47	38	57401	11195	63420388
Gastrointestinal procedural complication	22.23	10.47	8	57431	199	63431384
Muscle tension dysphonia	21.97	10.47	8	57431	206	63431377
Electrolyte imbalance	21.93	10.47	53	57386	20023	63411560
Dizziness	21.89	10.47	526	56913	429399	63002184
Erysipelas	21.62	10.47	31	57408	7874	63423709
Palpitations	21.50	10.47	175	57264	112595	63318988
Oedema peripheral	21.48	10.47	264	57175	189247	63242336
Impaired work ability	21.13	10.47	48	57391	17427	63414156
Oliguria	21.05	10.47	33	57406	9068	63422515
Hypergammaglobulinaemia	21.02	10.47	10	57429	511	63431072
Botryomycosis	20.95	10.47	5	57434	26	63431557
Impaired healing	20.88	10.47	38	57401	102504	63329079
Anal polyp	20.65	10.47	6	57433	73	63431510
Eosinophilia	20.64	10.47	56	57383	22700	63408883
Type 2 diabetes mellitus	20.00	10.47	17	57422	63851	63367732
Blood creatinine increased	19.93	10.47	142	57297	87702	63343881
International normalised ratio increased	19.85	10.47	89	57350	46336	63385247
Stomatitis	19.82	10.47	62	57377	138663	63292920
Malaise	19.70	10.47	504	56935	415450	63016133
Milk-alkali syndrome	19.31	10.47	11	57428	817	63430766
Toxicity to various agents	19.10	10.47	138	57301	247112	63184471
Intentional product use issue	19.10	10.47	56	57383	127836	63303747
Liver injury	19.08	10.47	16	57423	60504	63371079
Fatigue	19.04	10.47	636	56803	887392	62544191
Condition aggravated	19.04	10.47	253	57186	401964	63029619
Weight abnormal	19.02	10.47	13	57426	1331	63430252
Injection site extravasation	19	10.47	31	57408	8810	63422773
Product dose omission issue	18.97	10.47	129	57310	234184	63197399
Meningorrhagia	18.91	10.47	7	57432	189	63431394
Histoplasmosis	18.73	10.47	15	57424	1956	63429627
Chest discomfort	18.51	10.47	166	57273	109803	63321780
Hip arthroplasty	18.51	10.47	10	57429	47636	63383947
Cataract	18.44	10.47	101	57338	56952	63374631
Blood sodium decreased	18.42	10.47	56	57383	24196	63407387
Product substitution issue	18.31	10.47	43	57396	15953	63415630
Haematoma	18.21	10.47	71	57368	34749	63396834
Haemodialysis	17.40	10.47	30	57409	8917	63422666
Cardiac failure	17.35	10.47	139	57300	89003	63342580
Dermatitis bullous	17.17	10.47	29	57410	8479	63423104
Brucellosis	17.05	10.47	5	57434	63	63431520
Weaning failure	16.92	10.47	8	57431	403	63431180
Ill-defined disorder	16.91	10.47	30	57409	81725	63349858
Cardiac failure congestive	16.84	10.47	142	57297	92291	63339292
Injection site erythema	16.77	10.47	31	57408	83143	63348440
Drug ineffective for unapproved indication	16.73	10.47	5	57434	34058	63397525
Injection site reaction	16.65	10.47	17	57422	58507	63373076
Cardiac ventricular thrombosis	16.55	10.47	9	57430	610	63430973
Electrocardiogram QT prolonged	16.38	10.47	101	57338	59429	63372154
Bone swelling	16.30	10.47	13	57426	1685	63429898
Influenza	16.24	10.47	160	57279	108562	63323021
Malignant neoplasm progression	16.22	10.47	31	57408	82090	63349493
Enterococcal sepsis	16.11	10.47	12	57427	1406	63430177
Disease progression	16.07	10.47	57	57382	122701	63308882
Skin sensitisation	16.01	10.47	10	57429	879	63430704
Hyperlactacidaemia	15.79	10.47	16	57423	2833	63428750
Premature delivery	15.70	10.47	4	57435	30277	63401306
Body temperature decreased	15.51	10.47	47	57392	20272	63411311
Febrile neutropenia	15.50	10.47	55	57384	118394	63313189
Electrocardiogram PR prolongation	15.24	10.47	9	57430	715	63430868
Talipes	15.23	10.47	12	57427	1528	63430055
Foetal exposure during pregnancy	15.15	10.47	5	57434	31957	63399626
Prescribed overdose	15.07	10.47	6	57433	34147	63397436
Depression	15.01	10.47	110	57329	196382	63235201
Shock	14.94	10.47	51	57388	23412	63408171
Cutaneous vasculitis	14.91	10.47	21	57418	5248	63426335
Migraine	14.89	10.47	46	57393	103300	63328283
Vascular access site pain	14.77	10.47	5	57434	103	63431480
Metabolic acidosis	14.71	10.47	80	57359	44989	63386594
Contraindicated product prescribed	14.58	10.47	11	57428	1314	63430269
Upper respiratory tract infection	14.49	10.47	33	57406	82014	63349569
Retching	14.25	10.47	37	57402	14608	63416975
Aortic valve incompetence	14.25	10.47	22	57417	5966	63425617
Cough	14.22	10.47	356	57083	292387	63139196
Respiratory gas exchange disorder	14.13	10.47	7	57432	391	63431192
Intentional self-injury	14.10	10.47	3	57436	25684	63405899
Bronchial hyperreactivity	14.10	10.47	12	57427	1703	63429880
Renal pain	13.99	10.47	23	57416	6576	63425007
Jaundice	13.98	10.47	58	57381	29193	63402390
Subacute kidney injury	13.88	10.47	3	57436	9	63431574
Incorrect route of product administration	13.54	10.47	4	57435	27448	63404135
Inflammatory marker increased	13.39	10.47	23	57416	6816	63424767
Anaphylactic reaction	13.37	10.47	104	57335	65996	63365587
Arthropod bite	13.28	10.47	25	57414	7953	63423630
Oropharyngeal swelling	13.25	10.47	9	57430	912	63430671
Physical assault	13.23	10.47	9	57430	914	63430669
Ureteric obstruction	13.20	10.47	12	57427	1858	63429725
Localised oedema	13.14	10.47	20	57419	5358	63426225
Bronchopulmonary aspergillosis allergic	13.10	10.47	13	57426	2245	63429338
Abortion spontaneous	13.09	10.47	14	57425	47181	63384402
Myocardial ischaemia	13.04	10.47	33	57406	12826	63418757
Respiratory tract infection	13.04	10.47	11	57428	41472	63390111
Cockroach allergy	12.94	10.47	4	57435	61	63431522
Hypochromic anaemia	12.81	10.47	12	57427	1930	63429653
Sinus arrest	12.78	10.47	12	57427	1937	63429646
Tendon injury	12.77	10.47	12	57427	1938	63429645
Hepatotoxicity	12.69	10.47	9	57430	37032	63394551
Psoriasis	12.51	10.47	127	57312	86830	63344753
Tympanic membrane perforation	12.51	10.47	12	57427	1989	63429594
Fundoscopy abnormal	12.50	10.47	3	57436	16	63431567
Hypochloraemia	12.47	10.47	12	57427	1997	63429586
Sense of oppression	12.45	10.47	9	57430	1007	63430576
Device dislocation	12.22	10.47	4	57435	25701	63405882
Ear pain	12.08	10.47	9	57430	36109	63395474
Adverse event	12.07	10.47	27	57412	67532	63364051
Musculoskeletal stiffness	11.97	10.47	108	57331	184510	63247073
Drug resistance	11.95	10.47	3	57436	22930	63408653
Night sweats	11.93	10.47	16	57423	48798	63382785
Necrotising myositis	11.92	10.47	7	57432	550	63431033
Loss of consciousness	11.88	10.47	161	57278	117960	63313623
Injection site pruritus	11.84	10.47	14	57425	45102	63386481
Insulinoma	11.79	10.47	4	57435	83	63431500
Gastrointestinal disorder	11.77	10.47	70	57369	131169	63300414
Multiple sclerosis relapse	11.73	10.47	16	57423	48462	63383121
Overdose	11.63	10.47	157	57282	114921	63316662
Bundle branch block left	11.60	10.47	22	57417	7037	63424546
Hospitalisation	11.47	10.47	39	57400	85042	63346541
Optic nerve infarction	11.46	10.47	3	57436	24	63431559
C-reactive protein abnormal	11.37	10.47	15	57424	46081	63385502
Aphthous ulcer	11.36	10.47	33	57406	13905	63417678
Acute coronary syndrome	11.35	10.47	27	57412	10099	63421484
Reversible cerebral vasoconstriction syndrome	11.34	10.47	13	57426	2645	63428938
White blood cell analysis abnormal	11.14	10.47	3	57436	27	63431556
Nasal dryness	11.14	10.47	17	57422	4564	63427019
Immunisation reaction	11.13	10.47	7	57432	623	63430960
Dysmorphism	11.13	10.47	12	57427	2284	63429299
Injection site bruising	11.01	10.47	13	57426	41897	63389686
Ventricular asystole	10.80	10.47	4	57435	108	63431475
Device issue	10.79	10.47	4	57435	23777	63407806
Lipase increased	10.67	10.47	26	57413	9874	63421709
Oral lichen planus	10.58	10.47	7	57432	679	63430904
Infected bite	10.47	10.47	11	57428	2031	63429552

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Acute kidney injury	273.51	11.54	849	37955	304139	34613988
Hyperkalaemia	142.40	11.54	267	38537	69122	34849005
Lactic acidosis	114.96	11.54	166	38638	34606	34883521
Death	101.10	11.54	180	38624	397869	34520258
Hyponatraemia	73.31	11.54	230	38574	82461	34835666
Anorectal discomfort	64.35	11.54	35	38769	1929	34916198
Oesophageal pain	61.20	11.54	26	38778	823	34917304
Hypotension	57.11	11.54	431	38373	221218	34696909
Syncope	52.63	11.54	221	38583	91230	34826897
Failure to suspend medication	47.50	11.54	18	38786	420	34917707
Completed suicide	47.26	11.54	25	38779	98143	34819984
Fractured coccyx	46.40	11.54	14	38790	157	34917970
Off label use	45.78	11.54	276	38528	419248	34498879
Bradycardia	42.40	11.54	181	38623	75237	34842890
Hypoglycaemia	42.12	11.54	145	38659	54495	34863632
Pneumonia	41.42	11.54	235	38569	362392	34555735
Febrile neutropenia	41.15	11.54	55	38749	136794	34781333
Seronegative arthritis	41.10	11.54	21	38783	1018	34917109
Radiation inflammation	40.83	11.54	20	38784	885	34917242
Disease progression	40.73	11.54	36	38768	108041	34810086
Drug abuse	39.82	11.54	31	38773	99065	34819062
Drug ineffective	39.74	11.54	321	38483	456430	34461697
N-terminal prohormone brain natriuretic peptide abnormal	39.57	11.54	13	38791	196	34917931
Fall	39.17	11.54	370	38434	202515	34715612
Lung diffusion test decreased	38.18	11.54	17	38787	604	34917523
Tachyarrhythmia	36.45	11.54	31	38773	3577	34914550
Drug interaction	36.41	11.54	397	38407	225549	34692578
Lipoma	36.08	11.54	23	38781	1703	34916424
Blood pressure increased	35.43	11.54	192	38612	87910	34830217
Pulmonary pain	35.15	11.54	20	38784	1204	34916923
Pulmonary arterial pressure abnormal	35.14	11.54	12	38792	205	34917922
Eosinophilia	34.17	11.54	84	38720	26138	34891989
Mycobacterium test positive	34.03	11.54	14	38790	408	34917719
Rhabdomyolysis	32.62	11.54	156	38648	68007	34850120
Presyncope	32.58	11.54	68	38736	18991	34899136
Brain natriuretic peptide abnormal	32.33	11.54	13	38791	357	34917770
Electrocardiogram QRS complex abnormal	32.26	11.54	13	38791	359	34917768
Blood thyroid stimulating hormone abnormal	31.66	11.54	13	38791	377	34917750
Blood pressure systolic increased	31.49	11.54	75	38729	22877	34895250
Oxygen saturation increased	31.47	11.54	12	38792	285	34917842
Wrong patient received product	31.41	11.54	25	38779	2629	34915498
Myocardial infarction	31.40	11.54	236	38568	120849	34797278
Treatment failure	30.85	11.54	7	38797	46690	34871437
Hypovolaemia	30.37	11.54	44	38760	9190	34908937
Congenital diaphragmatic anomaly	29.40	11.54	7	38797	28	34918099
Atrial fibrillation	29.21	11.54	234	38570	122159	34795968
Tongue abscess	29.02	11.54	5	38799	0	34918127
Nail bed bleeding	28.51	11.54	12	38792	371	34917756
Gastrointestinal motility disorder	27.75	11.54	23	38781	2561	34915566
Agranulocytosis	26.59	11.54	72	38732	23749	34894378
Cerebrovascular accident	26.49	11.54	173	38631	84638	34833489
Blood creatinine increased	26.26	11.54	188	38616	94788	34823339
Arrhythmia	25.84	11.54	93	38711	35715	34882412
Inflammation	25.30	11.54	79	38725	28216	34889911
Carotid arteriosclerosis	25.26	11.54	19	38785	1839	34916288
Eczema	25.02	11.54	60	38744	18376	34899751
Left atrial dilatation	24.05	11.54	19	38785	1977	34916150
Vestibular neuronitis	23.79	11.54	9	38795	209	34917918
Antiphospholipid antibodies positive	23.73	11.54	10	38794	310	34917817
Dysgeusia	23.71	11.54	74	38730	26423	34891704
Mucosal dryness	23.60	11.54	16	38788	1315	34916812
Left ventricular dilatation	23.29	11.54	13	38791	754	34917373
Ear discomfort	23.28	11.54	21	38783	2621	34915506
Hypoparathyroidism	23.27	11.54	12	38792	593	34917534
Pancreatitis acute	22.84	11.54	76	38728	28065	34890062
Nephrectomy	22.81	11.54	13	38791	785	34917342
Preternatural anus	21.78	11.54	7	38797	98	34918029
Anuria	21.30	11.54	40	38764	10345	34907782
Ischaemic stroke	21.22	11.54	56	38748	18194	34899933
Cholestasis	21.18	11.54	72	38732	26876	34891251
Product use in unapproved indication	20.92	11.54	64	38740	117435	34800692
Asthma	20.67	11.54	98	38706	42558	34875569
Lymphoma	20.65	11.54	44	38760	12463	34905664
Malignant neoplasm progression	20.30	11.54	42	38762	88004	34830123
Goitre	20.28	11.54	16	38788	1662	34916465
Shock	20.24	11.54	66	38738	24113	34894014
SARS-CoV-2 sepsis	20.21	11.54	7	38797	125	34918002
Lung disorder	20.04	11.54	84	38720	34612	34883515
Renal haemorrhage	20.03	11.54	15	38789	1442	34916685
Supraventricular extrasystoles	19.99	11.54	22	38782	3486	34914641
Procedural failure	19.91	11.54	6	38798	67	34918060
Cerebral haematoma	19.76	11.54	25	38779	4590	34913537
Toxicity to various agents	19.61	11.54	136	38668	200226	34717901
Myopathy	19.48	11.54	41	38763	11513	34906614
Sepsis	19.45	11.54	107	38697	166454	34751673
Muscle strain	19.39	11.54	23	38781	3953	34914174
Sprue-like enteropathy	19.23	11.54	10	38794	503	34917624
Hyperlactacidaemia	19.10	11.54	20	38784	2996	34915131
Morganella infection	19.06	11.54	10	38794	512	34917615
Conduction disorder	19.04	11.54	17	38787	2093	34916034
Haematocrit increased	19.02	11.54	17	38787	2096	34916031
Musculoskeletal discomfort	19.00	11.54	33	38771	8035	34910092
Accidental death	18.70	11.54	18	38786	2438	34915689
Lividity	18.69	11.54	7	38797	158	34917969
Subarachnoid haematoma	18.66	11.54	8	38796	259	34917868
Product use issue	18.38	11.54	26	38778	63190	34854937
Metabolic acidosis	18.09	11.54	96	38708	43584	34874543
Neutrophil count decreased	18.09	11.54	18	38786	51086	34867041
Dyspnoea exertional	17.84	11.54	95	38709	43184	34874943
Dysmetria	17.57	11.54	10	38794	602	34917525
Dizziness	17.50	11.54	340	38464	218181	34699946
Distributive shock	17.44	11.54	13	38791	1241	34916886
Platelet count decreased	17.44	11.54	71	38733	119646	34798481
Enterocutaneous fistula	17.30	11.54	12	38792	1023	34917104
Acute pulmonary oedema	17.25	11.54	30	38774	7313	34910814
Leukopenia	17.16	11.54	27	38777	62829	34855298
Dyslipidaemia	16.82	11.54	30	38774	7458	34910669
Haemochromatosis	16.76	11.54	12	38792	1076	34917051
Blood lactic acid	16.68	11.54	8	38796	338	34917789
Periorbital haematoma	16.59	11.54	8	38796	342	34917785
Rash maculo-papular	16.53	11.54	69	38735	28382	34889745
Diabetes mellitus inadequate control	16.35	11.54	42	38762	13422	34904705
Rhinorrhoea	16.30	11.54	64	38740	25604	34892523
Bronchial haemorrhage	16.21	11.54	10	38794	699	34917428
Acute coronary syndrome	16.19	11.54	42	38762	13503	34904624
Granuloma	16.17	11.54	19	38785	3232	34914895
Bundle branch block left	16.14	11.54	26	38778	5953	34912174
Renal failure	16.00	11.54	218	38586	130339	34787788
Coronary artery disease	15.97	11.54	100	38704	48205	34869922
Pseudoporphyria	15.92	11.54	8	38796	374	34917753
Enterochromaffin cell hyperplasia	15.91	11.54	4	38800	21	34918106
Loss of control of legs	15.90	11.54	10	38794	723	34917404
Sneezing	15.83	11.54	24	38780	5218	34912909
Medication error	15.64	11.54	63	38741	25502	34892625
Therapeutic product effect incomplete	15.49	11.54	20	38784	50521	34867606
Haemoglobin increased	15.45	11.54	19	38785	3390	34914737
Toxic skin eruption	15.39	11.54	37	38767	11348	34906779
Tenoplasty	15.34	11.54	3	38801	3	34918124
Mental status changes	15.18	11.54	12	38792	38071	34880056
Drug resistance	15.04	11.54	5	38799	25922	34892205
Renal cyst	15.02	11.54	32	38772	9061	34909066
Appetite disorder	14.96	11.54	16	38788	2455	34915672
Gastrointestinal pain	14.87	11.54	19	38785	3523	34914604
Hypoxia	14.73	11.54	24	38780	55071	34863056
Atrial thrombosis	14.59	11.54	15	38789	2199	34915928
Haemorrhagic stroke	14.44	11.54	26	38778	6513	34911614
Intentional product use issue	14.24	11.54	28	38776	59788	34858339
Vomiting projectile	14.23	11.54	9	38795	657	34917470
Sedation	14.17	11.54	3	38801	21003	34897124
Dermatitis exfoliative	14.15	11.54	26	38778	6613	34911514
Thrombocytosis	14.12	11.54	20	38784	4092	34914035
Hospitalisation	14.10	11.54	26	38778	56876	34861251
Blood pressure inadequately controlled	14.09	11.54	16	38788	2624	34915503
Clang associations	13.95	11.54	4	38800	37	34918090
Respiratory failure	13.64	11.54	68	38736	108504	34809623
Neutropenia	13.62	11.54	110	38694	156668	34761459
Pancytopenia	13.50	11.54	57	38747	95100	34823027
Spinal epidural haemorrhage	13.50	11.54	4	38800	42	34918085
Product dose omission issue	13.37	11.54	78	38726	119633	34798494
Bronchiolitis	13.27	11.54	17	38787	3159	34914968
Sleep disorder due to a general medical condition	13.15	11.54	22	38782	5199	34912928
Pyrexia	13.13	11.54	276	38528	332737	34585390
Blood creatine phosphokinase increased	13.09	11.54	90	38714	44767	34873360
Bradyarrhythmia	12.94	11.54	14	38790	2177	34915950
Product substitution issue	12.79	11.54	32	38772	10063	34908064
Pemphigoid	12.63	11.54	29	38775	8637	34909490
Atrial flutter	12.58	11.54	42	38762	15532	34902595
Hepatic cytolysis	12.52	11.54	40	38764	14456	34903671
Hypertensive crisis	12.44	11.54	29	38775	8722	34909405
Histamine level increased	12.38	11.54	4	38800	57	34918070
Cardiac ablation	12.35	11.54	10	38794	1078	34917049
Loss of consciousness	12.24	11.54	143	38661	82524	34835603
Chronic kidney disease	12.21	11.54	83	38721	41127	34877000
Orthostatic hypotension	12.15	11.54	59	38745	25860	34892267
Angioedema	12.12	11.54	77	38727	37297	34880830
Thyroiditis	12.08	11.54	14	38790	2348	34915779
Drug dependence	11.89	11.54	6	38798	24211	34893916
Myalgia	11.79	11.54	144	38660	83966	34834161
Grip strength decreased	11.76	11.54	16	38788	3153	34914974
Superficial spreading melanoma stage I	11.74	11.54	3	38801	17	34918110
Renal impairment	11.64	11.54	158	38646	94355	34823772
Foreign body in respiratory tract	11.57	11.54	5	38799	165	34917962

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Acute kidney injury	708.47	10.14	1641	82916	517763	79142068
Hyponatraemia	336.75	10.14	644	83913	177204	79482627
Neurologic neglect syndrome	322.58	10.14	120	84437	2787	79657044
Hyperkalaemia	321.83	10.14	494	84063	113904	79545927
Carotid artery thrombosis	316.85	10.14	120	84437	2933	79656898
Personality disorder	283.82	10.14	136	84421	6010	79653821
Adjustment disorder	262.23	10.14	113	84444	3887	79655944
Hemiplegia	228.30	10.14	161	84396	14778	79645053
Lactic acidosis	226.78	10.14	324	84233	70035	79589796
Affect lability	216.70	10.14	140	84417	11119	79648712
Fall	170.79	10.14	989	83568	486640	79173191
Sensory loss	166.74	10.14	126	84431	12865	79646966
Motor dysfunction	152.73	10.14	126	84431	14607	79645224
Coordination abnormal	148.82	10.14	133	84424	17179	79642652
Muscle spasticity	144.44	10.14	144	84413	21331	79638500
Blood pressure increased	133.12	10.14	509	84048	210851	79448980
Eating disorder	132.27	10.14	135	84422	20562	79639269
Aphasia	127.35	10.14	199	84358	46533	79613298
Hemiparesis	124.67	10.14	166	84391	33567	79626264
Drug ineffective	124.41	10.14	658	83899	1080255	78579576
Cerebrovascular accident	122.70	10.14	403	84154	154889	79504942
Hypotension	118.11	10.14	835	83722	439482	79220349
Blood pressure systolic increased	111.43	10.14	230	84327	66756	79593075
Drug interaction	109.38	10.14	784	83773	414399	79245432
Treatment failure	108.46	10.14	24	84533	170462	79489369
Completed suicide	104.18	10.14	66	84491	245701	79414130
Hypoglycaemia	102.15	10.14	287	84270	101307	79558524
Off label use	98.86	10.14	562	83995	906653	78753178
Bradycardia	97.56	10.14	341	84216	135216	79524615
Maternal exposure during pregnancy	95.87	10.14	15	84542	136523	79523308
Death	95.05	10.14	297	84260	566217	79093614
Therapeutic product effect decreased	92.96	10.14	29	84528	163834	79495997
Hand deformity	89.79	10.14	5	84552	103914	79555917
Pemphigus	88.56	10.14	4	84553	99578	79560253
Ischaemic stroke	86.00	10.14	138	84419	32993	79626838
Systemic lupus erythematosus	85.76	10.14	13	84544	121136	79538695
Renal failure	79.69	10.14	422	84135	200546	79459285
Pulmonary pain	79.68	10.14	53	84504	4420	79655411
Synovitis	74.87	10.14	33	84524	150701	79509130
Atrial fibrillation	72.71	10.14	407	84150	197479	79462352
Glossodynia	71.09	10.14	12	84545	103325	79556506
Hepatic cytolysis	68.98	10.14	112	84445	27039	79632792
Syncope	64.54	10.14	367	84190	179082	79480749
Sneezing	63.90	10.14	91	84466	19592	79640239
Pemphigoid	62.24	10.14	79	84478	15236	79644595
Dysarthria	59.30	10.14	182	84375	67440	79592391
Pain	58.96	10.14	471	84086	703331	78956500
Rhabdomyolysis	57.32	10.14	239	84318	102892	79556939
Cholestasis	57.13	10.14	152	84405	51957	79607874
Alopecia	55.70	10.14	100	84457	231255	79428576
Febrile neutropenia	55.48	10.14	100	84457	230899	79428932
Anorectal discomfort	55.35	10.14	39	84518	3572	79656259
Anuria	55.34	10.14	88	84469	20875	79638956
Product use issue	53.91	10.14	87	84470	209735	79450096
Therapeutic product effect incomplete	52.24	10.14	44	84513	141601	79518230
Exposure during pregnancy	52.04	10.14	21	84536	101111	79558720
Eosinophilia	51.47	10.14	134	84423	45211	79614620
Rheumatoid factor positive	51.32	10.14	3	84554	59836	79599995
Drug hypersensitivity	51.23	10.14	155	84402	298761	79361070
Swelling	50.11	10.14	96	84461	216615	79443216
Duodenal ulcer perforation	49.47	10.14	6	84551	66205	79593626
Asthenia	47.87	10.14	785	83772	510904	79148927
Sinus bradycardia	47.14	10.14	91	84466	25156	79634675
Contraindicated product administered	46.71	10.14	59	84498	157479	79502352
Muscular weakness	46.61	10.14	311	84246	160418	79499413
Infection	46.11	10.14	119	84438	241593	79418238
Skin haemorrhage	45.86	10.14	60	84497	11921	79647910
Sinus congestion	45.11	10.14	78	84479	19818	79640013
Disease progression	44.99	10.14	79	84478	184283	79475548
Product use in unapproved indication	44.94	10.14	127	84430	250232	79409599
Rhinorrhoea	44.40	10.14	179	84378	75895	79583936
Toxicity to various agents	44.17	10.14	264	84293	421276	79238555
Fear of eating	43.40	10.14	17	84540	456	79659375
Failure to suspend medication	43.36	10.14	17	84540	457	79659374
Drug intolerance	42.41	10.14	141	84416	263978	79395853
Radiation inflammation	41.70	10.14	20	84537	885	79658946
Pericarditis	41.44	10.14	30	84527	104206	79555625
Vulvovaginal burning sensation	41.05	10.14	24	84533	1593	79658238
Angioedema	39.76	10.14	173	84384	75862	79583969
Vulvovaginal pruritus	39.35	10.14	28	84529	2605	79657226
Hepatocellular injury	38.88	10.14	125	84432	47468	79612363
Blood pressure inadequately controlled	37.14	10.14	39	84518	6138	79653693
Lichen planopilaris	37.09	10.14	9	84548	42	79659789
Wrong patient received product	36.79	10.14	34	84523	4584	79655247
Amyloid arthropathy	36.76	10.14	16	84541	564	79659267
Hyperlactacidaemia	36.67	10.14	37	84520	5558	79654273
N-terminal prohormone brain natriuretic peptide abnormal	36.66	10.14	13	84544	262	79659569
Hypertensive crisis	36.52	10.14	73	84484	20697	79639134
Pneumonia	36.24	10.14	488	84069	659758	79000073
Paranasal sinus discomfort	35.87	10.14	33	84524	4423	79655408
Shock haemorrhagic	35.87	10.14	71	84486	19989	79639842
Sedation	35.75	10.14	6	84551	51889	79607942
Renal impairment	34.73	10.14	286	84271	157497	79502334
Blood creatinine increased	34.64	10.14	282	84275	154775	79505056
Drug abuse	33.45	10.14	77	84480	162614	79497217
Tubulointerstitial nephritis	32.67	10.14	102	84455	38133	79621698
Myocardial infarction	32.46	10.14	318	84239	183811	79476020
Electrocardiogram QRS complex abnormal	32.25	10.14	15	84542	619	79659212
Lung diffusion test decreased	32.09	10.14	19	84538	1291	79658540
Dysphagia	31.67	10.14	230	84327	121906	79537925
Psoriatic arthropathy	31.60	10.14	22	84535	77977	79581854
Metabolic acidosis	31.11	10.14	171	84386	82358	79577473
Arteriovenous fistula occlusion	31.03	10.14	14	84543	538	79659293
Hypersensitivity	30.84	10.14	158	84399	262081	79397750
Shock	30.82	10.14	109	84448	43439	79616392
Mycobacterium test positive	30.47	10.14	13	84544	436	79659395
Dehydration	30.33	10.14	399	84158	247788	79412043
Blue toe syndrome	30.12	10.14	14	84543	577	79659254
Confusional state	30.10	10.14	489	84068	317508	79342323
Coronary artery disease	29.79	10.14	143	84414	65331	79594500
Sebaceous gland infection	29.67	10.14	10	84547	172	79659659
Oesophageal pain	29.34	10.14	29	84528	4250	79655581
Lipoma	29.30	10.14	25	84532	3034	79656797
Respiratory tract congestion	29.12	10.14	65	84492	19889	79639942
Helicobacter infection	29.12	10.14	19	84538	69685	79590146
Malignant neoplasm progression	29.07	10.14	63	84494	135927	79523904
Agranulocytosis	28.74	10.14	109	84448	44921	79614910
Blood pressure diastolic abnormal	28.53	10.14	63	84494	19139	79640692
Hepatitis	28.53	10.14	126	84431	55601	79604230
Dizziness	28.46	10.14	745	83812	525696	79134135
Hepatic enzyme increased	28.27	10.14	99	84458	182511	79477320
Rhinalgia	28.27	10.14	22	84535	2345	79657486
Intentional product use issue	28.15	10.14	76	84481	152036	79507795
Angina pectoris	28.04	10.14	119	84438	51613	79608218
Muscle strain	27.86	10.14	42	84515	9513	79650318
Neurofibrosarcoma	27.64	10.14	10	84547	214	79659617
Sinus disorder	27.16	10.14	68	84489	22396	79637435
Tongue abscess	26.90	10.14	5	84552	3	79659828
Stomatitis	26.65	10.14	74	84483	146683	79513148
Platelet count decreased	26.61	10.14	111	84446	194553	79465278
Retro-orbital neoplasm	26.45	10.14	7	84550	49	79659782
Atrioventricular block complete	26.40	10.14	56	84501	16554	79643277
Blood thyroid stimulating hormone abnormal	26.37	10.14	15	84542	945	79658886
Fibromyalgia	26.26	10.14	18	84539	64322	79595509
Brain natriuretic peptide abnormal	26.15	10.14	14	84543	783	79659048
Blood pressure systolic abnormal	26.10	10.14	57	84500	17190	79642641
Vertigo	25.94	10.14	143	84414	68939	79590892
Injection site reaction	25.64	10.14	13	84544	54772	79605059
Inflammatory marker increased	25.53	10.14	43	84514	10697	79649134
Sepsis	25.49	10.14	174	84383	269254	79390577
Condition aggravated	25.47	10.14	376	84181	500748	79159083
Product dose omission issue	25.38	10.14	156	84401	247381	79412450
Tachyarrhythmia	25.31	10.14	34	84523	6928	79652903
Hypovolaemia	25.12	10.14	57	84500	17634	79642197
Presyncope	25.07	10.14	98	84459	40956	79618875
Vascular purpura	25.05	10.14	23	84534	3075	79656756
Drug resistance	24.78	10.14	7	84550	42206	79617625
Irritable bowel syndrome	24.63	10.14	18	84539	62223	79597608
Oxygen saturation increased	24.53	10.14	12	84545	555	79659276
Arrhythmia	24.47	10.14	129	84428	61143	79598688
Intra-abdominal haematoma	24.43	10.14	22	84535	2869	79656962
Anxiety	24.19	10.14	384	84173	248128	79411703
Heart rate decreased	24.07	10.14	142	84415	70174	79589657
Keratitis	23.72	10.14	26	84531	4296	79655535
Abdominal discomfort	23.67	10.14	162	84395	250565	79409266
Fractured coccyx	22.91	10.14	14	84543	1008	79658823
Subacute kidney injury	22.59	10.14	5	84552	14	79659817
Acute coronary syndrome	22.51	10.14	61	84496	21072	79638759
Nail bed bleeding	22.37	10.14	12	84545	674	79659157
Discomfort	22.32	10.14	64	84493	125553	79534278
Inappropriate antidiuretic hormone secretion	22.30	10.14	70	84487	26243	79633588
Preternatural anus	22.10	10.14	7	84550	98	79659733
Mental status changes	22.09	10.14	23	84534	66936	79592895
Cardiac failure congestive	21.79	10.14	239	84318	142163	79517668
Loss of consciousness	21.77	10.14	273	84284	167670	79492161
Blood pressure diastolic decreased	21.70	10.14	76	84481	30140	79629691
Arterial occlusive disease	21.64	10.14	35	84522	8421	79651410
Pancreatitis acute	21.60	10.14	107	84450	49497	79610334
Acute pulmonary oedema	21.50	10.14	47	84510	14183	79645648
Pulmonary arterial pressure abnormal	21.48	10.14	12	84545	730	79659101
Drug ineffective for unapproved indication	21.36	10.14	14	84543	51224	79608607
Bradyarrhythmia	21.13	10.14	24	84533	4122	79655709
Infusion related reaction	21.12	10.14	150	84407	230087	79429744
Product substitution issue	21.10	10.14	58	84499	20198	79639633
Cystitis	21.05	10.14	111	84446	52621	79607210
Left atrial dilatation	20.93	10.14	21	84536	3132	79656699
Gastrointestinal motility disorder	20.90	10.14	29	84528	6093	79653738
Hospitalisation	20.69	10.14	43	84514	94193	79565638
Parotid gland enlargement	20.67	10.14	13	84544	985	79658846
Gastrointestinal procedural complication	20.55	10.14	8	84549	211	79659620
Neutrophil count decreased	20.52	10.14	43	84514	93916	79565915
SARS-CoV-2 sepsis	20.32	10.14	7	84550	129	79659702
Blood pressure fluctuation	20.10	10.14	131	84426	67014	79592817
Wound	20.05	10.14	60	84497	116119	79543712
Psoriasis	20.03	10.14	163	84394	89424	79570407
Chest discomfort	19.90	10.14	229	84328	137815	79522016
Body temperature decreased	19.85	10.14	77	84480	32068	79627763
Intentional self-injury	19.74	10.14	5	84552	32414	79627417
Myelosuppression	19.72	10.14	9	84548	40287	79619544
Bundle branch block left	19.69	10.14	40	84517	11473	79648358
Intestinal angioedema	19.55	10.14	12	84545	871	79658960
Left ventricular dilatation	19.50	10.14	13	84544	1088	79658743
Hypokalaemia	19.47	10.14	236	84321	143804	79516027
Joint swelling	19.37	10.14	204	84353	288442	79371389
Cytokine release syndrome	19.30	10.14	7	84550	35991	79623840
Rash	19.15	10.14	467	84090	577891	79081940
Fibrous histiocytoma	19.12	10.14	11	84546	708	79659123
Respiratory failure	19.06	10.14	113	84444	180798	79479033
Procedural failure	18.94	10.14	6	84551	84	79659747
Anal polyp	18.69	10.14	6	84551	88	79659743
Influenza	18.68	10.14	215	84342	129391	79530440
Atrioventricular block first degree	18.58	10.14	41	84516	12450	79647381
Oedema peripheral	18.57	10.14	373	84184	251915	79407916
Heart valve incompetence	18.41	10.14	20	84537	3271	79656560
Mobility decreased	18.39	10.14	67	84490	122108	79537723
Injection site pruritus	18.39	10.14	11	84546	42272	79617559
Oliguria	18.30	10.14	48	84509	16261	79643570
Subarachnoid haematoma	18.25	10.14	8	84549	287	79659544
Carotid arteriosclerosis	18.21	10.14	18	84539	2638	79657193
Dyspnoea exertional	18.18	10.14	156	84401	86917	79572914
Depression	18.10	10.14	145	84412	216645	79443186
Extrasystoles	18.03	10.14	30	84527	7389	79652442
Device dislocation	17.89	10.14	3	84554	25967	79633864
Torsade de pointes	17.89	10.14	53	84504	19259	79640572
Rash morbilliform	17.89	10.14	27	84530	6123	79653708
Necrotising myositis	17.84	10.14	13	84544	1255	79658576
Cerebral haemorrhage	17.55	10.14	113	84444	57560	79602271
Adverse drug reaction	17.54	10.14	27	84530	66365	79593466
Incision site haemorrhage	17.28	10.14	12	84545	1074	79658757
Upper respiratory tract infection	17.28	10.14	45	84512	91123	79568708
Lymphoma	17.21	10.14	49	84508	17411	79642420
Ill-defined disorder	17.20	10.14	27	84530	65848	79593983
Haemochromatosis	17.11	10.14	13	84544	1337	79658494
Dyslipidaemia	17.09	10.14	38	84519	11595	79648236
Angina unstable	16.90	10.14	47	84510	16480	79643351
Renal pain	16.85	10.14	31	84526	8265	79651566
Sinus arrest	16.84	10.14	20	84537	3602	79656229
Leukopenia	16.82	10.14	65	84492	116448	79543383
Incorrect route of product administration	16.78	10.14	8	84549	34921	79624910
Prothrombin time ratio decreased	16.57	10.14	11	84546	914	79658917
Botryomycosis	16.57	10.14	5	84552	59	79659772
Diabetes mellitus inadequate control	16.54	10.14	60	84497	24204	79635627
Cerebral haematoma	16.54	10.14	30	84527	7912	79651919
Intraventricular haemorrhage	16.46	10.14	23	84534	4864	79654967
Psychotic disorder	16.34	10.14	12	84545	41390	79618441
Conduction disorder	16.28	10.14	19	84538	3360	79656471
Renal cyst	16.17	10.14	43	84514	14689	79645142
Hypergammaglobulinaemia	16.15	10.14	10	84547	737	79659094
Rectal haemorrhage	16.08	10.14	137	84420	76163	79583668
Injection site pain	15.95	10.14	77	84480	129761	79530070
Orthostatic hypotension	15.86	10.14	108	84449	56056	79603775
Dysgeusia	15.58	10.14	109	84448	57068	79602763
Escherichia peritonitis	15.47	10.14	3	84554	3	79659828
Sprue-like enteropathy	15.20	10.14	12	84545	1306	79658525
Blood creatine phosphokinase increased	15.18	10.14	121	84436	65969	79593862
Muscle tension dysphonia	15.08	10.14	6	84551	168	79659663
Myopathy	15.01	10.14	52	84505	20511	79639320
Mixed liver injury	14.99	10.14	28	84529	7550	79652281
Diabetic metabolic decompensation	14.84	10.14	18	84539	3314	79656517
Blood lactic acid	14.82	10.14	8	84549	455	79659376
Enterochromaffin cell hyperplasia	14.78	10.14	5	84552	87	79659744
Enterocutaneous fistula	14.78	10.14	14	84543	1947	79657884
Sinus node dysfunction	14.67	10.14	28	84529	7673	79652158
Respiratory tract infection	14.67	10.14	18	84539	48671	79611160
Morganella infection	14.61	10.14	11	84546	1116	79658715
Impaired work ability	14.56	10.14	50	84507	19631	79640200
Rheumatoid arthritis	14.53	10.14	146	84411	208324	79451507
Meningorrhagia	14.38	10.14	7	84550	320	79659511
Ureteric obstruction	14.32	10.14	16	84541	2700	79657131
Tympanic membrane perforation	14.29	10.14	13	84544	1717	79658114
International normalised ratio increased	14.27	10.14	145	84412	84576	79575255
Goitre	14.27	10.14	23	84534	5516	79654315
Seronegative arthritis	14.22	10.14	21	84536	4671	79655160
Clang associations	14.13	10.14	4	84553	37	79659794
Weaning failure	14.03	10.14	9	84548	706	79659125
Blister	14.02	10.14	72	84485	119404	79540427
Renal tubular necrosis	13.88	10.14	58	84499	24981	79634850
Haemoglobin increased	13.85	10.14	24	84533	6108	79653723
Injection site erythema	13.77	10.14	40	84517	78157	79581674
Vestibular neuronitis	13.71	10.14	9	84548	734	79659097
Lymphocyte count decreased	13.71	10.14	18	84539	47271	79612560
Cytomegalovirus infection	13.67	10.14	15	84542	42629	79617202
Arthropathy	13.64	10.14	121	84436	176990	79482841
Wrong technique in product usage process	13.59	10.14	37	84520	73838	79585993
Premature delivery	13.57	10.14	4	84553	23463	79636368
Skin sensitisation	13.55	10.14	10	84547	985	79658846
Atrial thrombosis	13.52	10.14	18	84539	3638	79656193
Chronic gastritis	13.49	10.14	19	84538	4049	79655782
White blood cell count decreased	13.48	10.14	131	84426	188157	79471674
Device related infection	13.46	10.14	10	84547	34284	79625547
Antiphospholipid antibodies positive	13.44	10.14	9	84548	759	79659072
Mitral valve incompetence	13.43	10.14	63	84494	28502	79631329
Lower limb fracture	13.35	10.14	4	84553	23211	79636620
Dermatitis exfoliative	13.32	10.14	33	84524	10796	79649035
Cutaneous vasculitis	13.32	10.14	28	84529	8224	79651607
Flatulence	13.18	10.14	84	84473	42640	79617191
Renal haemorrhage	13.13	10.14	14	84543	2242	79657589
Malaise	13.11	10.14	640	83917	489229	79170602
Rash maculo-papular	13.06	10.14	103	84454	55975	79603856
Electrolyte imbalance	13.01	10.14	66	84491	30815	79629016
Neuropathy peripheral	12.98	10.14	92	84465	141213	79518618
Vascular access site pain	12.91	10.14	5	84552	130	79659701
Progressive multifocal leukoencephalopathy	12.89	10.14	3	84554	20597	79639234
Brucellosis	12.73	10.14	5	84552	135	79659696
Hypoparathyroidism	12.67	10.14	10	84547	1088	79658743
Renal artery stenosis	12.65	10.14	17	84540	3465	79656366
Blood potassium increased	12.64	10.14	63	84494	29212	79630619
Impaired healing	12.59	10.14	49	84508	87606	79572225
Histoplasmosis	12.58	10.14	14	84543	2351	79657480
Pseudoporphyria	12.56	10.14	8	84549	620	79659211
Bundle branch block right	12.51	10.14	33	84524	11218	79648613
Bone swelling	12.47	10.14	12	84545	1702	79658129
Injection site extravasation	12.47	10.14	30	84527	9639	79650192
Staphylococcal infection	12.46	10.14	27	84530	58268	79601563
Haemodialysis	12.45	10.14	45	84512	18123	79641708
Milk-alkali syndrome	12.38	10.14	11	84546	1409	79658422
Lividity	12.24	10.14	7	84550	446	79659385
Multiple sclerosis relapse	12.22	10.14	19	84538	46514	79613317
Increased appetite	12.18	10.14	34	84523	11944	79647887
Fatigue	12.15	10.14	836	83721	928891	78730940
Nephrectomy	12.09	10.14	13	84544	2102	79657729
Muscle mass	12.08	10.14	7	84550	457	79659374
Hypochloraemia	11.88	10.14	14	84543	2501	79657330
Myocardial ischaemia	11.79	10.14	56	84501	25463	79634368
Gangrene	11.76	10.14	28	84529	8936	79650895
Localised oedema	11.71	10.14	26	84531	7926	79651905
Palpitations	11.69	10.14	194	84363	126416	79533415
Muscular dystrophy	11.68	10.14	5	84552	169	79659662
Injection site swelling	11.67	10.14	20	84537	47112	79612719
Skin exfoliation	11.65	10.14	99	84458	55001	79604830
Periorbital haematoma	11.52	10.14	9	84548	965	79658866
Haematoma muscle	11.44	10.14	14	84543	2601	79657230
Weight abnormal	11.34	10.14	11	84546	1575	79658256
Transient ischaemic attack	11.31	10.14	95	84462	52600	79607231
Gastric ulcer	11.30	10.14	68	84489	33837	79625994
Blood sodium decreased	11.27	10.14	67	84490	33188	79626643
Migraine	11.27	10.14	51	84506	87442	79572389
Seizure	11.26	10.14	137	84420	188697	79471134
Alanine aminotransferase increased	11.26	10.14	114	84443	162456	79497375
Intentional overdose	11.26	10.14	66	84491	105894	79553937
Erysipelas	11.24	10.14	31	84526	10819	79649012
Neoplasm prostate	11.23	10.14	5	84552	186	79659645
Bursitis	11.06	10.14	13	84544	35831	79624000
Bronchial haemorrhage	11.06	10.14	10	84547	1310	79658521
Chronic kidney disease	11.04	10.14	113	84444	66041	79593790
Blood osmolarity decreased	10.99	10.14	10	84547	1321	79658510
Mucosal dryness	10.89	10.14	16	84541	3543	79656288
Hypochromic anaemia	10.88	10.14	14	84543	2737	79657094
Pyrexia	10.82	10.14	599	83958	678110	78981721
Cataract	10.79	10.14	107	84450	62013	79597818
Haematocrit increased	10.74	10.14	17	84540	4017	79655814
Tumour lysis syndrome	10.73	10.14	6	84551	23933	79635898
Neutropenia	10.71	10.14	228	84329	287482	79372349
White blood cell analysis abnormal	10.67	10.14	3	84554	27	79659804
Aortic valve incompetence	10.64	10.14	28	84529	9502	79650329
Contraindicated product prescribed	10.59	10.14	11	84546	1710	79658121
Hepatocellular carcinoma	10.59	10.14	27	84530	8994	79650837
Superficial spreading melanoma stage I	10.57	10.14	3	84554	28	79659803
Antipsychotic drug level above therapeutic	10.53	10.14	12	84545	2068	79657763
Haemophagocytic lymphohistiocytosis	10.49	10.14	5	84552	21832	79637999
Nasal dryness	10.49	10.14	18	84539	4545	79655286
Histamine level increased	10.48	10.14	4	84553	100	79659731
Coronavirus infection	10.47	10.14	24	84533	7473	79652358
Ascites	10.37	10.14	43	84514	75519	79584312
Drug dependence	10.37	10.14	17	84540	40752	79619079
Toxic skin eruption	10.36	10.14	49	84508	22244	79637587
Respiratory gas exchange disorder	10.36	10.14	8	84549	843	79658988
Coronavirus test positive	10.35	10.14	9	84548	1120	79658711
Electrocardiogram T wave abnormal	10.29	10.14	16	84541	3722	79656109
Bronchiolitis	10.26	10.14	17	84540	4171	79655660
Pancreatic carcinoma metastatic	10.24	10.14	16	84541	3737	79656094
Multiple organ dysfunction syndrome	10.23	10.14	80	84477	120166	79539665

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C09CA04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN Angiotensin II receptor blockers (ARBs), plain
ATC	C09DA04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and diuretics
ATC	C09DB05	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC	C09DX07	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
FDA MoA	N0000000070	Angiotensin 2 Receptor Antagonists
FDA EPC	N0000175561	Angiotensin 2 Receptor Blocker
MeSH PA	D047228	Angiotensin II Type 1 Receptor Blockers
MeSH PA	D057911	Angiotensin Receptor Antagonists
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:61016	angiotensin receptor antagonists
CHEBI has role	CHEBI:78298	environmental contaminants

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

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Diabetic renal disease	indication	127013003
Chronic heart failure	off-label use	48447003
Atrial fibrillation	off-label use	49436004	DOID:0060224
Diastolic heart failure	off-label use	418304008	DOID:9775
Nondiabetic Proteinuric Nephropathy	off-label use
Anuria	contraindication	2472002	DOID:2983
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Secondary angle-closure glaucoma	contraindication	21571006
Hypovolemia	contraindication	28560003
Dehydration	contraindication	34095006
Hyperuricemia	contraindication	35885006	DOID:1920
Angioedema	contraindication	41291007	DOID:1558
Hypokalemia	contraindication	43339004
Low blood pressure	contraindication	45007003
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Sympathectomy	contraindication	57071006
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
Hyponatremia	contraindication	89627008
Gout	contraindication	90560007	DOID:13189
Disorder of muscle	contraindication	129565002	DOID:423
Hypomagnesemia	contraindication	190855004
Acute pancreatitis	contraindication	197456007	DOID:2913
Rhabdomyolysis	contraindication	240131006
Neonatal hyperbilirubinemia	contraindication	281610001
Pregnancy, function	contraindication	289908002
Renal artery stenosis	contraindication	302233006
Azotemia	contraindication	445009001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.37	acidic
pKa2	3.63	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Type-1 angiotensin II receptor	GPCR	P30556	AGTR1_HUMAN	ANTAGONIST	Ki	9.10		CHEMBL	CHEMBL
Endothelin-1 receptor	GPCR	P25101	EDNRA_HUMAN		Ki	5		CHEMBL
Sodium/bile acid cotransporter	Transporter	Q14973	NTCP_HUMAN	INHIBITOR	Ki	4.92		IUPHAR
Type-1B angiotensin II receptor	GPCR		AGTRB_RAT		Ki	9.10		CHEMBL
Angiotensin II receptor (AT-1) type-1	GPCR		AGTRA_RAT AGTRB_RAT		IC50	8.89		CHEMBL
Angiotensin II receptor	GPCR		AGTRA_RAT AGTRB_RAT AGTR2_RAT		IC50	8.89		CHEMBL

External reference:

ID	Source
4021071	VUID
N0000148533	NUI
D00523	KEGG_DRUG
329055-23-4	SECONDARY_CAS_RN
4021071	VANDF
C0288171	UMLSCUI
CHEBI:5959	CHEBI
CHEMBL1513	ChEMBL_ID
D000077405	MESH_DESCRIPTOR_UI
DB01029	DRUGBANK_ID
3749	PUBCHEM_CID
589	IUPHAR_LIGAND_ID
7229	INN_ID
J0E2756Z7N	UNII
83818	RXNORM
4917	MMSL
52343	MMSL
d04222	MMSL
006921	NDDF
108585000	SNOMEDCT_US
386877005	SNOMEDCT_US
734504000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Avapro	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5850	TABLET, FILM COATED	75 mg	ORAL	NDA	29 sections
Avapro	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5851	TABLET, FILM COATED	150 mg	ORAL	NDA	29 sections
Avapro	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5852	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
Avalide	HUMAN PRESCRIPTION DRUG LABEL	2	0024-5855	TABLET, FILM COATED	150 mg	ORAL	NDA	30 sections
Avalide	HUMAN PRESCRIPTION DRUG LABEL	2	0024-5855	TABLET, FILM COATED	150 mg	ORAL	NDA	30 sections
Avalide	HUMAN PRESCRIPTION DRUG LABEL	2	0024-5856	TABLET, FILM COATED	300 mg	ORAL	NDA	30 sections
Avalide	HUMAN PRESCRIPTION DRUG LABEL	2	0024-5856	TABLET, FILM COATED	300 mg	ORAL	NDA	30 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0254	TABLET	150 mg	ORAL	ANDA	28 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0255	TABLET	300 mg	ORAL	ANDA	28 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8232	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8238	TABLET, FILM COATED	150 mg	ORAL	ANDA	28 sections
Irbesartan	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1040	TABLET, FILM COATED	75 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
Irbesartan	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1041	TABLET, FILM COATED	150 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
Irbesartan	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1042	TABLET, FILM COATED	300 mg	ORAL	NDA AUTHORIZED GENERIC	27 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0955-1045	TABLET, FILM COATED	150 mg	ORAL	NDA AUTHORIZED GENERIC	29 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0955-1045	TABLET, FILM COATED	150 mg	ORAL	NDA AUTHORIZED GENERIC	29 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0955-1046	TABLET, FILM COATED	300 mg	ORAL	NDA AUTHORIZED GENERIC	29 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0955-1046	TABLET, FILM COATED	300 mg	ORAL	NDA AUTHORIZED GENERIC	29 sections
Irbesartan	HUMAN PRESCRIPTION DRUG LABEL	1	29300-212	TABLET	75 mg	ORAL	ANDA	23 sections
Irbesartan	HUMAN PRESCRIPTION DRUG LABEL	1	29300-213	TABLET	150 mg	ORAL	ANDA	23 sections
Irbesartan	HUMAN PRESCRIPTION DRUG LABEL	1	29300-214	TABLET	300 mg	ORAL	ANDA	23 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	29300-215	TABLET, FILM COATED	150 mg	ORAL	ANDA	26 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	29300-215	TABLET, FILM COATED	150 mg	ORAL	ANDA	26 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	29300-216	TABLET, FILM COATED	300 mg	ORAL	ANDA	26 sections
Irbesartan and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	29300-216	TABLET, FILM COATED	300 mg	ORAL	ANDA	26 sections
Irbesartan	Human Prescription Drug Label	1	31722-160	TABLET	75 mg	ORAL	ANDA	27 sections
Irbesartan	Human Prescription Drug Label	1	31722-161	TABLET	150 mg	ORAL	ANDA	27 sections
Irbesartan	Human Prescription Drug Label	1	31722-162	TABLET	300 mg	ORAL	ANDA	27 sections
Irbesartan	Human Prescription Drug Label	1	31722-729	TABLET	75 mg	ORAL	ANDA	27 sections
Irbesartan	Human Prescription Drug Label	1	31722-730	TABLET	150 mg	ORAL	ANDA	27 sections