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
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	412.23	10.52	764	47872	227294	50329194
Neurologic neglect syndrome	269.53	10.52	86	48550	1372	50555116
Carotid artery thrombosis	267.19	10.52	86	48550	1413	50555075
Hyponatraemia	253.44	10.52	382	48254	95757	50460731
Personality disorder	235.13	10.52	104	48532	4220	50552268
Adjustment disorder	227.00	10.52	82	48554	1937	50554551
Hemiplegia	207.01	10.52	113	48523	7268	50549220
Affect lability	168.40	10.52	106	48530	8892	50547596
Sensory loss	144.41	10.52	91	48545	7647	50548841
Hyperkalaemia	143.88	10.52	203	48433	47886	50508602
Motor dysfunction	136.39	10.52	89	48547	7942	50548546
Drug ineffective	122.94	10.52	393	48243	818940	49737548
Eating disorder	115.56	10.52	105	48531	15304	50541184
Lactic acidosis	115.22	10.52	151	48485	33204	50523284
Coordination abnormal	113.84	10.52	92	48544	11442	50545046
Aphasia	111.08	10.52	137	48499	28357	50528131
Muscle spasticity	107.67	10.52	106	48530	17078	50539410
Hemiparesis	106.25	10.52	113	48523	19935	50536553
Fall	103.98	10.52	612	48024	334320	50222168
Systemic lupus erythematosus	94.25	10.52	12	48624	140610	50415878
Treatment failure	91.63	10.52	12	48624	137625	50418863
Maternal exposure during pregnancy	90.96	10.52	21	48615	159757	50396731
Glossodynia	84.83	10.52	7	48629	115562	50440926
Cerebrovascular accident	83.98	10.52	240	48396	94440	50462048
Pain	82.17	10.52	284	48352	578619	49977869
Blood pressure increased	80.50	10.52	296	48340	132836	50423652
Therapeutic product effect decreased	79.21	10.52	17	48619	136033	50420455
Hand deformity	76.60	10.52	5	48631	100194	50456294
Contraindicated product administered	76.45	10.52	24	48612	148934	50407554
Synovitis	73.09	10.52	15	48621	123850	50432638
Hypoglycaemia	67.40	10.52	155	48481	53426	50503062
Dysarthria	66.81	10.52	125	48511	37278	50519210
Drug interaction	64.53	10.52	369	48267	199252	50357236
Sinus bradycardia	62.35	10.52	70	48566	13113	50543375
Bradycardia	61.72	10.52	168	48468	64258	50492230
Renal failure	60.21	10.52	232	48404	106401	50450087
Blood pressure systolic increased	59.04	10.52	115	48521	35334	50521154
Drug hypersensitivity	57.00	10.52	96	48540	250914	50305574
Ischaemic stroke	56.30	10.52	73	48563	15875	50540613
Hypotension	56.18	10.52	403	48233	235066	50321422
Off label use	54.96	10.52	252	48384	474174	50082314
Swelling	54.26	10.52	68	48568	200804	50355684
Pemphigoid	53.85	10.52	45	48591	5862	50550626
Alopecia	49.19	10.52	101	48535	244946	50311542
Hepatic cytolysis	48.93	10.52	49	48587	8054	50548434
Atrial fibrillation	47.66	10.52	209	48427	101536	50454952
Arthropathy	46.35	10.52	50	48586	157856	50398632
Asthenia	44.34	10.52	485	48151	318557	50237931
Muscular weakness	42.86	10.52	193	48443	94820	50461668
Exposure during pregnancy	41.81	10.52	33	48603	120982	50435506
Hepatocellular injury	41.78	10.52	83	48553	25864	50530624
Dysphagia	41.58	10.52	166	48470	77352	50479136
Pericarditis	41.58	10.52	12	48624	78677	50477811
Angioedema	40.93	10.52	103	48533	37573	50518915
Completed suicide	40.70	10.52	40	48596	131849	50424639
Rheumatoid arthritis	39.36	10.52	85	48551	202465	50354023
Fear of eating	38.93	10.52	14	48622	326	50556162
Product use issue	38.90	10.52	52	48584	149423	50407065
Joint swelling	38.35	10.52	115	48521	245171	50311317
Drug intolerance	37.75	10.52	98	48538	219006	50337482
Dehydration	37.52	10.52	263	48373	152186	50404302
Confusional state	37.46	10.52	306	48330	185622	50370866
Arteriovenous fistula occlusion	37.45	10.52	14	48622	365	50556123
Abdominal discomfort	37.37	10.52	107	48529	231534	50324954
Shock haemorrhagic	37.24	10.52	43	48593	8301	50548187
Blue toe syndrome	36.51	10.52	14	48622	392	50556096
Infection	34.92	10.52	71	48565	172883	50383605
Rhabdomyolysis	33.67	10.52	98	48538	38929	50517559
Vertigo	33.62	10.52	118	48518	51714	50504774
Death	33.48	10.52	180	48456	325199	50231289
Intra-abdominal haematoma	33.35	10.52	20	48616	1537	50554951
Atrioventricular block first degree	32.93	10.52	35	48601	6166	50550322
Inappropriate antidiuretic hormone secretion	32.82	10.52	51	48585	13092	50543396
Therapeutic product effect incomplete	31.55	10.52	25	48611	91490	50464998
Cholestasis	31.40	10.52	73	48563	25328	50531160
Renal impairment	31.39	10.52	150	48486	75511	50480977
Syncope	30.38	10.52	186	48450	102816	50453672
Neurofibrosarcoma	28.00	10.52	9	48627	147	50556341
Duodenal ulcer perforation	28.00	10.52	5	48631	45606	50510882
Discomfort	27.89	10.52	38	48598	108342	50448146
Blood pressure inadequately controlled	27.39	10.52	27	48609	4353	50552135
Hypertensive crisis	27.37	10.52	47	48589	13107	50543381
Wound	27.32	10.52	37	48599	105757	50450731
Torsade de pointes	26.91	10.52	44	48592	11791	50544697
Oedema peripheral	26.61	10.52	250	48386	157711	50398777
Prothrombin time ratio decreased	25.86	10.52	11	48625	405	50556083
Blood potassium increased	25.85	10.52	52	48584	16346	50540142
Product dose omission issue	25.38	10.52	91	48545	183747	50372741
Intestinal angioedema	24.52	10.52	12	48624	614	50555874
Dizziness	24.51	10.52	468	48168	345901	50210587
Vascular purpura	24.48	10.52	15	48621	1199	50555289
Hypersensitivity	24.40	10.52	115	48521	215046	50341442
Diabetic metabolic decompensation	24.15	10.52	16	48620	1464	50555024
Hypokalaemia	23.53	10.52	155	48481	87837	50468651
Coronary artery disease	23.14	10.52	72	48564	29654	50526834
Anal polyp	22.78	10.52	6	48630	46	50556442
Myocardial infarction	22.71	10.52	155	48481	88872	50467616
Tubulointerstitial nephritis	22.52	10.52	47	48589	15164	50541324
Meningorrhagia	22.39	10.52	7	48629	104	50556384
Atrioventricular block complete	22.23	10.52	31	48605	7224	50549264
Rash	22.17	10.52	292	48344	437179	50119309
Hypergammaglobulinaemia	21.95	10.52	10	48626	435	50556053
Acidosis	21.88	10.52	37	48599	10190	50546298
Blood pressure diastolic decreased	21.59	10.52	49	48587	16732	50539756
Toxicity to various agents	21.03	10.52	119	48517	212380	50344108
Botryomycosis	20.65	10.52	5	48631	26	50556462
Milk-alkali syndrome	20.64	10.52	11	48625	674	50555814
International normalised ratio increased	20.46	10.52	89	48547	43063	50513425
Skin haemorrhage	20.37	10.52	29	48607	6889	50549599
Blood creatinine increased	20.26	10.52	134	48502	76026	50480462
Eosinophilia	20.26	10.52	51	48585	18601	50537887
Psoriatic arthropathy	20.13	10.52	10	48626	47022	50509466
Blood sodium decreased	20.09	10.52	55	48581	21092	50535396
Pulmonary pain	19.80	10.52	17	48619	2298	50554190
Electrolyte imbalance	19.77	10.52	48	48588	17121	50539367
Bronchopulmonary aspergillosis allergic	19.73	10.52	13	48623	1178	50555310
Sedation	19.58	10.52	3	48633	30607	50525881
Dermatitis bullous	19.56	10.52	29	48607	7144	50549344
Histoplasmosis	19.44	10.52	15	48621	1744	50554744
Heart rate decreased	19.43	10.52	78	48558	36419	50520069
Haematoma	19.39	10.52	69	48567	30441	50526047
Irritable bowel syndrome	19.09	10.52	13	48623	51428	50505060
Contraindicated product prescribed	19.08	10.52	11	48625	786	50555702
Malaise	19.04	10.52	439	48197	335093	50221395
Brucellosis	18.69	10.52	5	48631	41	50556447
Blood pressure fluctuation	18.63	10.52	76	48560	35747	50520741
Infusion related reaction	18.41	10.52	92	48544	169465	50387023
Febrile neutropenia	18.12	10.52	42	48594	97625	50458863
Cardiac ventricular thrombosis	18.09	10.52	9	48627	477	50556011
Sebaceous gland infection	17.98	10.52	6	48630	111	50556377
Incision site haemorrhage	17.94	10.52	9	48627	486	50556002
Anxiety	17.72	10.52	254	48382	177352	50379136
Injection site erythema	17.59	10.52	28	48608	74908	50481580
Haemodialysis	17.56	10.52	30	48606	8332	50548156
Electrocardiogram QT prolonged	17.43	10.52	97	48539	51789	50504699
Cutaneous vasculitis	17.03	10.52	21	48615	4341	50552147
Shock	16.99	10.52	51	48585	20599	50535889
Product substitution issue	16.94	10.52	40	48596	14017	50542471
Fatigue	16.93	10.52	535	48101	707066	49849422
Injection site reaction	16.82	10.52	14	48622	50018	50506470
Anaphylactic reaction	16.81	10.52	99	48537	53956	50502532
Injection site pain	16.65	10.52	53	48583	110971	50445517
Enterococcal sepsis	16.61	10.52	12	48624	1263	50555225
Impaired healing	16.45	10.52	26	48610	69760	50486728
Product use in unapproved indication	16.19	10.52	57	48579	115762	50440726
Sneezing	15.89	10.52	39	48597	14005	50542483
Renal pain	15.73	10.52	23	48613	5596	50550892
Adverse drug reaction	15.62	10.52	18	48618	55204	50501284
Impaired work ability	15.56	10.52	38	48598	13602	50542886
Electrocardiogram PR prolongation	15.47	10.52	9	48627	654	50555834
Helicobacter infection	15.40	10.52	15	48621	49687	50506801
Oliguria	15.34	10.52	28	48608	8188	50548300
Hyperlactacidaemia	15.22	10.52	15	48621	2418	50554070
Retching	14.85	10.52	36	48600	12826	50543662
Hepatic enzyme increased	14.65	10.52	75	48561	137305	50419183
Parotid gland enlargement	14.39	10.52	9	48627	746	50555742
Skin sensitisation	14.30	10.52	9	48627	754	50555734
Necrotising myositis	14.04	10.52	7	48629	373	50556115
Oropharyngeal swelling	13.85	10.52	9	48627	797	50555691
Sinus node dysfunction	13.80	10.52	18	48618	3937	50552551
Tendon injury	13.77	10.52	12	48624	1655	50554833
Blood immunoglobulin E increased	13.76	10.52	14	48622	2345	50554143
Localised oedema	13.74	10.52	20	48616	4847	50551641
Subacute kidney injury	13.70	10.52	3	48633	9	50556479
Hypochromic anaemia	13.59	10.52	12	48624	1684	50554804
Cockroach allergy	13.58	10.52	4	48632	48	50556440
Sinus arrest	13.58	10.52	12	48624	1686	50554802
Sinusitis	13.57	10.52	102	48534	170456	50386032
Aortic valve incompetence	13.33	10.52	21	48615	5455	50551033
Intentional self-injury	13.21	10.52	3	48633	23109	50533379
Reversible cerebral vasoconstriction syndrome	13.14	10.52	13	48623	2106	50554382
Limb injury	13.04	10.52	46	48590	20204	50536284
Foetal exposure during pregnancy	13.00	10.52	5	48631	27354	50529134
Physical assault	12.87	10.52	9	48627	899	50555589
Malignant neoplasm progression	12.87	10.52	29	48607	68095	50488393
Fundoscopy abnormal	12.84	10.52	3	48633	13	50556475
Fibrous histiocytoma	12.79	10.52	7	48629	452	50556036
Injection site pruritus	12.75	10.52	12	48624	40399	50516089
Paranasal sinus discomfort	12.68	10.52	15	48621	2971	50553517
Condition aggravated	12.66	10.52	205	48431	296853	50259635
Cardiac failure	12.61	10.52	120	48516	75920	50480568
Upper respiratory tract infection	12.49	10.52	28	48608	65870	50490618
Anuria	12.48	10.52	31	48605	11213	50545275
Haematoma muscle	12.19	10.52	8	48628	720	50555768
Body temperature decreased	12.11	10.52	39	48597	16356	50540132
Weight abnormal	12.09	10.52	9	48627	991	50555497
Vulvovaginal burning sensation	12.09	10.52	11	48625	1604	50554884
Cardiac failure congestive	12.00	10.52	129	48507	84253	50472235
Insulinoma	11.93	10.52	4	48632	75	50556413
Myocardial ischaemia	11.83	10.52	31	48605	11582	50544906
Premature delivery	11.79	10.52	4	48632	23659	50532829
Oral lichen planus	11.76	10.52	7	48629	531	50555957
Respiratory gas exchange disorder	11.69	10.52	6	48630	340	50556148
Angina pectoris	11.65	10.52	53	48583	26135	50530353
Optic nerve infarction	11.63	10.52	3	48633	21	50556467
Injection site swelling	11.41	10.52	14	48622	41759	50514729
Abortion spontaneous	11.41	10.52	14	48622	41758	50514730
Jaundice	11.39	10.52	53	48583	26376	50530112
Hepatitis	11.37	10.52	60	48576	31393	50525095
Hospitalisation	11.21	10.52	31	48605	67906	50488582
Multiple sclerosis relapse	11.11	10.52	15	48621	42949	50513539
Loss of consciousness	11.11	10.52	151	48485	104202	50452286
Arthralgia	11.10	10.52	329	48307	438373	50118115
Sinus congestion	11.02	10.52	34	48602	13937	50542551
Disease progression	10.99	10.52	51	48585	95815	50460673
Stomatitis	10.99	10.52	55	48581	101289	50455199
White blood cell analysis abnormal	10.96	10.52	3	48633	27	50556461
Musculoskeletal stiffness	10.62	10.52	76	48560	128405	50428083
Bone swelling	10.58	10.52	9	48627	1201	50555287
Adult failure to thrive	10.57	10.52	4	48632	108	50556380
Acute coronary syndrome	10.57	10.52	26	48610	9348	50547140
Migraine	10.55	10.52	37	48599	75243	50481245
Ill-defined disorder	10.54	10.52	23	48613	54631	50501857
Pneumonia respiratory syncytial viral	10.54	10.52	7	48629	643	50555845
Arthropod bite	10.54	10.52	20	48616	6025	50550463

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	210.91	11.41	722	33030	264545	29276230
Hyperkalaemia	100.98	11.41	219	33533	61173	29479602
Death	89.38	11.41	159	33593	341925	29198850
Lactic acidosis	86.52	11.41	137	33615	30110	29510665
Hyponatraemia	76.63	11.41	209	33543	67424	29473351
Anorectal discomfort	66.89	11.41	34	33718	1585	29539190
Oesophageal pain	63.35	11.41	26	33726	732	29540043
Hypotension	61.15	11.41	405	33347	193949	29346826
Drug abuse	52.94	11.41	13	33739	79870	29460905
Off label use	50.12	11.41	176	33576	300624	29240151
Hypoglycaemia	47.52	11.41	142	33610	48204	29492571
Fractured coccyx	46.60	11.41	14	33738	150	29540625
Syncope	45.70	11.41	199	33553	81172	29459603
Failure to suspend medication	45.29	11.41	17	33735	375	29540400
Seronegative arthritis	42.88	11.41	21	33731	903	29539872
Bradycardia	42.74	11.41	168	33584	65461	29475314
Completed suicide	42.69	11.41	25	33727	90221	29450554
N-terminal prohormone brain natriuretic peptide abnormal	39.84	11.41	13	33739	186	29540589
Blood pressure increased	37.32	11.41	175	33577	73628	29467147
Lipoma	36.85	11.41	22	33730	1409	29539366
Presyncope	36.84	11.41	66	33686	16023	29524752
Pneumonia	36.18	11.41	216	33536	319956	29220819
Blood thyroid stimulating hormone abnormal	36.15	11.41	13	33739	253	29540522
Blood pressure systolic increased	35.91	11.41	67	33685	16778	29523997
Lung diffusion test decreased	35.44	11.41	16	33736	571	29540204
Pulmonary arterial pressure abnormal	35.43	11.41	12	33740	194	29540581
Electrocardiogram QRS complex abnormal	34.29	11.41	13	33739	295	29540480
Brain natriuretic peptide abnormal	33.73	11.41	13	33739	309	29540466
Fall	32.14	11.41	326	33426	176852	29363923
Febrile neutropenia	32.10	11.41	49	33703	112191	29428584
Wrong patient received product	31.91	11.41	24	33728	2258	29538517
Eosinophilia	31.86	11.41	75	33677	22086	29518689
Oxygen saturation increased	31.58	11.41	12	33740	274	29540501
Mycobacterium test positive	31.35	11.41	13	33739	376	29540399
Drug ineffective	31.28	11.41	265	33487	362905	29177870
Hypovolaemia	31.06	11.41	42	33710	8003	29532772
Gastrointestinal motility disorder	30.72	11.41	23	33729	2149	29538626
Congenital diaphragmatic anomaly	29.20	11.41	7	33745	28	29540747
Cerebrovascular accident	28.93	11.41	168	33584	76743	29464032
Arrhythmia	28.91	11.41	90	33662	31223	29509552
Tongue abscess	28.88	11.41	5	33747	0	29540775
Treatment failure	28.76	11.41	4	33748	36935	29503840
Rhabdomyolysis	27.72	11.41	140	33612	60668	29480107
Blood creatinine increased	27.67	11.41	179	33573	84923	29455852
Dysgeusia	27.59	11.41	72	33680	22602	29518173
Carotid arteriosclerosis	26.76	11.41	18	33734	1420	29539355
Agranulocytosis	26.21	11.41	66	33686	20274	29520501
Hypoparathyroidism	25.74	11.41	12	33740	462	29540313
Vestibular neuronitis	25.52	11.41	9	33743	165	29540610
Disease progression	25.15	11.41	34	33718	81882	29458893
Left ventricular dilatation	24.60	11.41	13	33739	657	29540118
Antiphospholipid antibodies positive	24.42	11.41	10	33742	280	29540495
Mucosal dryness	24.39	11.41	15	33737	1014	29539761
Left atrial dilatation	24.11	11.41	18	33734	1675	29539100
Ear discomfort	23.73	11.41	20	33732	2217	29538558
Eczema	23.46	11.41	50	33702	13776	29526999
Supraventricular extrasystoles	22.73	11.41	22	33730	2919	29537856
Goitre	21.79	11.41	16	33736	1451	29539324
Anuria	21.66	11.41	39	33713	9502	29531273
Lung disorder	21.62	11.41	80	33672	30282	29510493
Preternatural anus	21.59	11.41	7	33745	98	29540677
Renal haemorrhage	21.44	11.41	15	33737	1261	29539514
Myopathy	21.34	11.41	41	33711	10492	29530283
Dizziness	21.31	11.41	319	33433	189365	29351410
Cholestasis	21.25	11.41	67	33685	23395	29517380
Muscle strain	21.09	11.41	23	33729	3510	29537265
Dyslipidaemia	20.94	11.41	30	33722	6031	29534744
Nephrectomy	20.88	11.41	12	33740	716	29540059
Hyperlactacidaemia	20.63	11.41	20	33732	2658	29538117
Pancreatitis acute	20.61	11.41	68	33684	24317	29516458
Shock	20.20	11.41	62	33690	21342	29519433
SARS-CoV-2 sepsis	20.13	11.41	7	33745	123	29540652
Drug interaction	19.91	11.41	326	33426	197059	29343716
Morganella infection	19.77	11.41	10	33742	461	29540314
Procedural failure	19.75	11.41	6	33746	67	29540708
Haematocrit increased	19.63	11.41	16	33736	1692	29539083
Lividity	19.19	11.41	7	33745	142	29540633
Sepsis	18.96	11.41	91	33661	142591	29398184
Product use in unapproved indication	18.64	11.41	45	33707	86830	29453945
Conduction disorder	18.59	11.41	16	33736	1824	29538951
Accidental death	18.58	11.41	17	33735	2101	29538674
Myocardial infarction	18.56	11.41	200	33552	110096	29430679
Sneezing	18.51	11.41	24	33728	4390	29536385
Atrial fibrillation	18.45	11.41	193	33559	105453	29435322
Granuloma	18.23	11.41	18	33734	2446	29538329
Rash maculo-papular	18.14	11.41	65	33687	24224	29516551
Bundle branch block left	18.06	11.41	26	33726	5251	29535524
Enterocutaneous fistula	17.47	11.41	11	33741	775	29540000
Haemochromatosis	17.13	11.41	12	33740	1011	29539764
Acute pulmonary oedema	17.06	11.41	29	33723	6750	29534025
Pseudoporphyria	16.99	11.41	8	33744	315	29540460
Appetite disorder	16.96	11.41	16	33736	2056	29538719
Toxicity to various agents	16.60	11.41	123	33629	173538	29367237
Periorbital haematoma	16.58	11.41	8	33744	333	29540442
Blood lactic acid	16.47	11.41	8	33744	338	29540437
Renal failure	16.37	11.41	207	33545	118392	29422383
Bronchial haemorrhage	16.30	11.41	10	33742	673	29540102
Renal cyst	16.29	11.41	31	33721	7876	29532899
Product dose omission issue	16.24	11.41	56	33696	96327	29444448
Blood creatine phosphokinase increased	16.07	11.41	90	33662	40554	29500221
Malignant neoplasm progression	16.05	11.41	38	33714	73821	29466954
Haemoglobin increased	15.87	11.41	18	33734	2868	29537907
Leukopenia	15.86	11.41	24	33728	55179	29485596
Cardiac ablation	15.85	11.41	10	33742	707	29540068
Enterochromaffin cell hyperplasia	15.80	11.41	4	33748	21	29540754
Coronary artery disease	15.62	11.41	95	33657	44095	29496680
Neutrophil count decreased	15.60	11.41	16	33736	43551	29497224
Atrial thrombosis	15.57	11.41	15	33737	1978	29538797
Tenoplasty	15.25	11.41	3	33749	3	29540772
Diabetes mellitus inadequate control	15.24	11.41	39	33713	12095	29528680
Product use issue	15.14	11.41	22	33730	51422	29489353
Vomiting projectile	14.87	11.41	9	33743	591	29540184
Mental status changes	14.71	11.41	11	33741	34916	29505859
Pruritus	14.48	11.41	200	33552	116649	29424126
Cerebral haematoma	14.46	11.41	21	33731	4275	29536500
Dermatitis exfoliative	14.25	11.41	26	33726	6399	29534376
Product substitution issue	14.23	11.41	32	33720	9140	29531635
Hospitalisation	14.20	11.41	19	33733	45969	29494806
Thyroiditis	14.11	11.41	14	33738	1914	29538861
Respiratory failure	14.06	11.41	60	33692	97071	29443704
Chronic kidney disease	13.97	11.41	80	33672	36336	29504439
Metabolic acidosis	13.97	11.41	82	33670	37580	29503195
Inflammatory marker increased	13.93	11.41	19	33733	3648	29537127
Myalgia	13.76	11.41	137	33615	73882	29466893
Platelet count decreased	13.75	11.41	67	33685	104605	29436170
White blood cell count decreased	13.66	11.41	49	33703	83313	29457462
Angioedema	13.51	11.41	72	33680	31843	29508932
Therapeutic product effect incomplete	13.44	11.41	15	33737	39290	29501485
Spinal epidural haemorrhage	13.39	11.41	4	33748	42	29540733
Blood pressure inadequately controlled	13.32	11.41	15	33737	2371	29538404
Bronchiolitis	13.18	11.41	16	33736	2739	29538036
Asthenia	13.17	11.41	330	33422	214920	29325855
Toxic skin eruption	12.92	11.41	32	33720	9725	29531050
Acute coronary syndrome	12.86	11.41	37	33715	12288	29528487
Gastrointestinal tract mucosal pigmentation	12.85	11.41	7	33745	376	29540399
Hepatic cytolysis	12.82	11.41	29	33723	8318	29532457
Medication error	12.75	11.41	53	33699	21158	29519617
Histamine level increased	12.41	11.41	4	33748	55	29540720
Obstruction	12.31	11.41	13	33739	1913	29538862
Hypoxia	12.30	11.41	22	33730	47357	29493418
Blood bicarbonate decreased	12.15	11.41	14	33738	2268	29538507
Ventricular hypokinesia	12.12	11.41	20	33732	4545	29536230
Renal impairment	12.10	11.41	144	33608	81189	29459586
Foreign body in respiratory tract	12.08	11.41	5	33747	144	29540631
Musculoskeletal discomfort	12.01	11.41	24	33728	6317	29534458
Atrial flutter	11.96	11.41	39	33713	13855	29526920
Oedema peripheral	11.93	11.41	175	33577	103382	29437393
Hypergastrinaemia	11.91	11.41	4	33748	63	29540712
Extrasystoles	11.72	11.41	17	33735	3457	29537318
Cardiac failure chronic	11.69	11.41	24	33728	6443	29534332
Superficial spreading melanoma stage I	11.66	11.41	3	33749	17	29540758
Pancytopenia	11.65	11.41	52	33700	83116	29457659
Drug resistance	11.63	11.41	5	33747	21535	29519240
Retinal disorder	11.56	11.41	9	33743	891	29539884
Wound decomposition	11.52	11.41	4	33748	70	29540705
Rash vesicular	11.50	11.41	14	33738	2404	29538371
Intercepted medication error	11.49	11.41	7	33745	465	29540310

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	538.65	10.31	1388	70086	447852	63979406
Hyponatraemia	310.57	10.31	575	70899	147764	64279494
Neurologic neglect syndrome	248.70	10.31	86	71388	1532	64425726
Carotid artery thrombosis	239.97	10.31	86	71388	1709	64425549
Hyperkalaemia	234.49	10.31	410	71064	100719	64326539
Personality disorder	206.47	10.31	102	71372	4609	64422649
Lactic acidosis	193.00	10.31	286	71188	61124	64366134
Adjustment disorder	191.21	10.31	82	71392	2663	64424595
Hemiplegia	165.95	10.31	127	71347	12641	64414617
Affect lability	152.32	10.31	105	71369	8885	64418373
Fall	119.30	10.31	830	70644	415996	64011262
Drug ineffective	119.05	10.31	504	70970	839743	63587515
Sensory loss	112.49	10.31	92	71382	10077	64417181
Hypoglycaemia	109.22	10.31	280	71194	89612	64337646
Hypotension	105.67	10.31	753	70721	380221	64047037
Motor dysfunction	103.53	10.31	92	71382	11281	64415977
Off label use	102.71	10.31	359	71115	632447	63794811
Muscle spasticity	99.48	10.31	107	71367	16562	64410696
Completed suicide	96.70	10.31	65	71409	224349	64202909
Cerebrovascular accident	96.11	10.31	353	71121	137230	64290028
Coordination abnormal	94.52	10.31	99	71375	14865	64412393
Eating disorder	93.56	10.31	104	71370	16701	64410557
Bradycardia	92.61	10.31	315	71159	117904	64309354
Aphasia	92.32	10.31	164	71310	40742	64386516
Death	90.80	10.31	256	71218	482449	63944809
Blood pressure increased	88.24	10.31	402	71072	172150	64255108
Treatment failure	86.67	10.31	13	71461	116803	64310455
Blood pressure systolic increased	83.09	10.31	175	71299	49278	64377980
Hemiparesis	81.15	10.31	130	71344	29697	64397561
Pain	69.78	10.31	346	71128	553165	63874093
Synovitis	69.13	10.31	13	71461	99077	64328181
Renal failure	66.81	10.31	386	71088	181302	64245956
Drug interaction	65.73	10.31	651	70823	361432	64065826
Maternal exposure during pregnancy	61.95	10.31	15	71459	95869	64331389
Drug hypersensitivity	59.36	10.31	108	71366	237707	64189551
Anorectal discomfort	59.27	10.31	38	71436	2847	64424411
Therapeutic product effect decreased	58.92	10.31	27	71447	115324	64311934
Syncope	57.35	10.31	334	71140	157301	64269957
Atrial fibrillation	56.20	10.31	353	71121	170736	64256522
Pemphigus	54.96	10.31	3	71471	60698	64366560
Ischaemic stroke	53.79	10.31	107	71367	28928	64398330
Drug abuse	52.24	10.31	42	71432	132332	64294926
Pemphigoid	52.01	10.31	68	71406	12918	64414340
Hand deformity	51.43	10.31	5	71469	62766	64364492
Hepatic cytolysis	50.82	10.31	70	71404	13979	64413279
Febrile neutropenia	50.69	10.31	81	71393	187576	64239682
Eosinophilia	48.71	10.31	121	71353	37955	64389303
Cholestasis	48.61	10.31	134	71340	44738	64382520
Systemic lupus erythematosus	48.48	10.31	13	71461	77599	64349659
Sinus bradycardia	48.10	10.31	89	71385	22804	64404454
Contraindicated product administered	48.09	10.31	30	71444	107799	64319459
Rhabdomyolysis	47.80	10.31	215	71259	91511	64335747
Asthenia	45.94	10.31	697	70777	427347	63999911
Fear of eating	44.83	10.31	17	71457	398	64426860
Toxicity to various agents	43.58	10.31	231	71243	363282	64063976
Failure to suspend medication	41.63	10.31	16	71458	389	64426869
Muscular weakness	40.72	10.31	261	71213	127077	64300181
Glossodynia	40.10	10.31	11	71463	64685	64362573
Pneumonia	39.14	10.31	414	71060	559162	63868096
Angioedema	38.49	10.31	153	71321	61668	64365590
Hepatocellular injury	38.48	10.31	124	71350	45111	64382147
Therapeutic product effect incomplete	38.18	10.31	35	71439	103447	64323811
Swelling	37.99	10.31	75	71399	160143	64267115
Hyperlactacidaemia	37.89	10.31	36	71438	4808	64422450
Renal impairment	37.35	10.31	267	71207	134750	64292508
N-terminal prohormone brain natriuretic peptide abnormal	37.11	10.31	13	71461	241	64427017
Sneezing	36.81	10.31	63	71411	15188	64412070
Product dose omission issue	36.71	10.31	103	71371	194644	64232614
Dizziness	35.72	10.31	672	70802	429491	63997767
Blood creatinine increased	35.55	10.31	265	71209	135517	64291741
Exposure during pregnancy	35.48	10.31	21	71453	77654	64349604
Wrong patient received product	35.37	10.31	31	71443	3731	64423527
Anuria	35.26	10.31	70	71404	18894	64408364
Oesophageal pain	35.00	10.31	29	71445	3234	64424024
Electrocardiogram QRS complex abnormal	33.56	10.31	15	71459	539	64426719
Alopecia	33.21	10.31	85	71389	165605	64261653
Shock	32.68	10.31	105	71369	38135	64389123
Product use issue	31.84	10.31	76	71398	151639	64275619
Infection	31.81	10.31	102	71372	184778	64242480
Dysarthria	31.51	10.31	140	71334	59266	64367992
Myocardial infarction	31.40	10.31	301	71173	165520	64261738
Vertigo	31.25	10.31	139	71335	58872	64368386
Blood pressure inadequately controlled	31.14	10.31	34	71440	5350	64421908
Arteriovenous fistula occlusion	30.51	10.31	14	71460	535	64426723
Dehydration	30.17	10.31	370	71104	216393	64210865
Shock haemorrhagic	30.05	10.31	61	71413	16730	64410528
Muscle strain	29.89	10.31	41	71433	8153	64419105
Blue toe syndrome	29.83	10.31	14	71460	564	64426694
Lipoma	29.77	10.31	24	71450	2575	64424683
Blood thyroid stimulating hormone abnormal	29.30	10.31	15	71459	731	64426527
Disease progression	28.92	10.31	72	71402	141608	64285650
Coronary artery disease	28.78	10.31	138	71336	60295	64366963
Confusional state	28.63	10.31	427	71047	260717	64166541
Rheumatoid factor positive	28.05	10.31	3	71471	34935	64392323
Vascular purpura	28.01	10.31	23	71451	2533	64424725
Sedation	27.74	10.31	6	71468	41456	64385802
Lung diffusion test decreased	27.70	10.31	17	71457	1179	64426079
Neurofibrosarcoma	27.70	10.31	10	71464	203	64427055
Hypertensive crisis	27.70	10.31	62	71412	18186	64409072
Mycobacterium test positive	27.63	10.31	12	71462	402	64426856
Drug intolerance	27.51	10.31	111	71363	187881	64239377
Brain natriuretic peptide abnormal	27.47	10.31	14	71460	676	64426582
Rheumatoid arthritis	27.32	10.31	92	71382	164202	64263056
Injection site reaction	26.99	10.31	9	71465	46655	64380603
Arrhythmia	26.75	10.31	123	71351	52821	64374437
Tongue abscess	26.68	10.31	5	71469	3	64427255
Hypovolaemia	26.23	10.31	55	71419	15431	64411827
Retro-orbital neoplasm	26.14	10.31	7	71467	49	64427209
Presyncope	26.14	10.31	92	71382	34997	64392261
Product use in unapproved indication	26.02	10.31	104	71370	176514	64250744
Oedema peripheral	25.89	10.31	351	71123	209966	64217292
Injection site pain	25.68	10.31	53	71421	111355	64315903
Tubulointerstitial nephritis	25.62	10.31	84	71390	30825	64396433
Oxygen saturation increased	25.39	10.31	12	71462	491	64426767
Agranulocytosis	24.92	10.31	96	71378	38133	64389125
Atrioventricular block complete	24.18	10.31	51	71423	14367	64412891
Sepsis	24.02	10.31	153	71321	230188	64197070
Platelet count decreased	23.31	10.31	101	71373	167610	64259648
Fractured coccyx	23.07	10.31	14	71460	952	64426306
Respiratory failure	23.06	10.31	96	71378	161087	64266171
Subacute kidney injury	22.64	10.31	5	71469	13	64427245
Seronegative arthritis	22.63	10.31	21	71453	2722	64424536
Malignant neoplasm progression	22.54	10.31	58	71416	112813	64314445
Gastrointestinal motility disorder	22.12	10.31	28	71446	5151	64422107
Pulmonary arterial pressure abnormal	22.12	10.31	12	71462	659	64426599
Dysgeusia	22.09	10.31	107	71367	46940	64380318
Product substitution issue	22.04	10.31	56	71418	17805	64409453
Preternatural anus	21.80	10.31	7	71467	98	64427160
Pulmonary pain	21.74	10.31	20	71454	2564	64424694
Atrioventricular block first degree	21.64	10.31	41	71433	10693	64416565
Necrotising myositis	21.46	10.31	13	71461	881	64426377
Duodenal ulcer perforation	21.24	10.31	6	71468	34619	64392639
Pancreatitis acute	21.23	10.31	99	71375	42756	64384502
Mental status changes	21.04	10.31	22	71452	61140	64366118
Left ventricular dilatation	20.96	10.31	13	71461	919	64426339
Dyslipidaemia	20.77	10.31	37	71437	9205	64418053
Rash morbilliform	20.71	10.31	27	71447	5114	64422144
Arthropathy	20.62	10.31	67	71407	120900	64306358
Left atrial dilatation	20.58	10.31	20	71454	2746	64424512
Intra-abdominal haematoma	20.49	10.31	19	71455	2460	64424798
SARS-CoV-2 sepsis	20.17	10.31	7	71467	126	64427132
Anal polyp	20.00	10.31	6	71468	66	64427192
Acute pulmonary oedema	19.98	10.31	44	71430	12765	64414493
Drug resistance	19.90	10.31	7	71467	35095	64392163
Bundle branch block left	19.82	10.31	38	71436	9996	64417262
Renal pain	19.79	10.31	31	71443	6943	64420315
Intestinal angioedema	19.72	10.31	12	71462	820	64426438
Hypersensitivity	19.71	10.31	132	71342	196320	64230938
Carotid arteriosclerosis	19.28	10.31	17	71457	2062	64425196
Condition aggravated	19.09	10.31	294	71180	372132	64055126
Injection site pruritus	19.08	10.31	9	71465	37817	64389441
Procedural failure	18.95	10.31	6	71468	80	64427178
Hospitalisation	18.87	10.31	34	71440	75173	64352085
Inappropriate antidiuretic hormone secretion	18.86	10.31	61	71413	22228	64405030
Sinus arrest	18.72	10.31	20	71454	3070	64424188
Blood creatine phosphokinase increased	18.69	10.31	120	71354	58438	64368820
Rash	18.42	10.31	378	71096	458171	63969087
Loss of consciousness	18.40	10.31	248	71226	148117	64279141
Neutrophil count decreased	18.40	10.31	36	71438	77160	64350098
Myopathy	18.36	10.31	52	71422	17628	64409630
Acute coronary syndrome	18.33	10.31	55	71419	19255	64408003
Joint swelling	18.14	10.31	152	71322	215230	64212028
Extrasystoles	18.08	10.31	29	71445	6629	64420629
Prothrombin time ratio decreased	17.94	10.31	11	71463	762	64426496
Intentional self-injury	17.88	10.31	5	71469	29039	64398219
Psychotic disorder	17.79	10.31	8	71466	34570	64392688
Infusion related reaction	17.78	10.31	108	71366	164359	64262899
Hypokalaemia	17.78	10.31	210	71264	121693	64305565
Hepatitis	17.48	10.31	98	71376	45484	64381774
Cardiac failure congestive	17.33	10.31	221	71253	130359	64296899
Haemochromatosis	17.27	10.31	13	71461	1261	64425997
Sebaceous gland infection	17.19	10.31	6	71468	110	64427148
Diabetic metabolic decompensation	17.14	10.31	18	71456	2710	64424548
Anxiety	16.91	10.31	317	71157	202332	64224926
Hypergammaglobulinaemia	16.90	10.31	10	71464	649	64426609
Body temperature decreased	16.81	10.31	65	71409	25863	64401395
Flatulence	16.66	10.31	81	71393	35585	64391673
Leukopenia	16.62	10.31	57	71417	101185	64326073
Angina unstable	16.56	10.31	46	71428	15421	64411837
Stomatitis	16.48	10.31	64	71410	109541	64317717
Botryomycosis	16.35	10.31	5	71469	59	64427199
Rhinorrhoea	16.23	10.31	118	71356	59851	64367407
Renal cyst	16.13	10.31	40	71434	12530	64414728
Conduction disorder	15.89	10.31	18	71456	2950	64424308
Cerebral haemorrhage	15.88	10.31	104	71370	50986	64376272
White blood cell count decreased	15.85	10.31	106	71368	157731	64269527
Mitral valve incompetence	15.73	10.31	63	71411	25475	64401783
Transient ischaemic attack	15.64	10.31	93	71381	44089	64383169
Atrial thrombosis	15.53	10.31	18	71456	3024	64424234
Rash maculo-papular	15.39	10.31	97	71377	46929	64380329
Goitre	15.38	10.31	23	71451	4950	64422308
Oliguria	15.26	10.31	43	71431	14533	64412725
Meningorrhagia	15.20	10.31	7	71467	270	64426988
Skin haemorrhage	15.14	10.31	31	71443	8554	64418704
Dysphagia	15.13	10.31	183	71291	106629	64320629
Torsade de pointes	15.13	10.31	48	71426	17315	64409943
International normalised ratio increased	15.11	10.31	144	71330	79023	64348235
Diabetes mellitus inadequate control	15.11	10.31	55	71419	21266	64405992
Orthostatic hypotension	15.05	10.31	96	71378	46642	64380616
Lung disorder	15.05	10.31	117	71357	60583	64366675
Pericarditis	15.04	10.31	29	71445	62487	64364771
Metabolic acidosis	15.03	10.31	132	71342	70826	64356432
Enterocutaneous fistula	14.98	10.31	13	71461	1544	64425714
Upper respiratory tract infection	14.84	10.31	37	71437	72748	64354510
Rectal haemorrhage	14.69	10.31	118	71356	61699	64365559
Haemoglobin increased	14.60	10.31	23	71451	5178	64422080
Enterochromaffin cell hyperplasia	14.57	10.31	5	71469	87	64427171
Irritable bowel syndrome	14.55	10.31	12	71462	37357	64389901
Blood lactic acid	14.49	10.31	8	71466	455	64426803
Malaise	14.44	10.31	556	70918	395691	64031567
Injection site erythema	14.42	10.31	36	71438	70764	64356494
Vestibular neuronitis	14.37	10.31	9	71465	647	64426611
Blood potassium increased	14.36	10.31	62	71412	25918	64401340
Device dislocation	14.30	10.31	3	71471	21175	64406083
Renal haemorrhage	14.29	10.31	14	71460	1941	64425317
Hypoparathyroidism	14.18	10.31	10	71464	877	64426381
Antiphospholipid antibodies positive	14.14	10.31	9	71465	666	64426592
Injection site swelling	14.08	10.31	15	71459	41338	64385920
Wrong technique in product usage process	14.06	10.31	32	71442	64942	64362316
Bradyarrhythmia	14.01	10.31	19	71455	3739	64423519
Cytokine release syndrome	13.96	10.31	3	71471	20826	64406432
Nephrectomy	13.94	10.31	12	71462	1410	64425848
Histoplasmosis	13.89	10.31	14	71460	2008	64425250
Contraindicated product prescribed	13.84	10.31	11	71463	1156	64426102
Brucellosis	13.69	10.31	5	71469	105	64427153
Pyrexia	13.69	10.31	494	70980	558150	63869108
Milk-alkali syndrome	13.63	10.31	11	71463	1182	64426076
Dyspnoea exertional	13.53	10.31	133	71341	73597	64353661
Bundle branch block right	13.52	10.31	33	71441	10236	64417022
Drug ineffective for unapproved indication	13.41	10.31	9	71465	31124	64396134
Cutaneous vasculitis	13.39	10.31	25	71449	6448	64420810
Fatigue	13.38	10.31	686	70788	748044	63679214
Pseudoporphyria	13.32	10.31	8	71466	534	64426724
Blood sodium decreased	13.09	10.31	66	71408	29416	64397842
Morganella infection	13.05	10.31	10	71464	996	64426262
Lividity	13.03	10.31	7	71467	377	64426881
Parotid gland enlargement	12.94	10.31	9	71465	772	64426486
Intentional product use issue	12.90	10.31	58	71416	95306	64331952
Neuropathy peripheral	12.79	10.31	77	71397	117448	64309810
Cerebral haematoma	12.73	10.31	26	71448	7159	64420099
Localised oedema	12.72	10.31	26	71448	7165	64420093
Anaphylactic reaction	12.66	10.31	124	71350	68540	64358718
Bronchopulmonary aspergillosis allergic	12.58	10.31	12	71462	1610	64425648
Muscle mass	12.55	10.31	7	71467	406	64426852
Neoplasm prostate	12.38	10.31	5	71469	139	64427119
Psoriatic arthropathy	12.33	10.31	18	71456	43263	64383995
Dermatitis exfoliative	12.30	10.31	32	71442	10320	64416938
Electrolyte imbalance	12.27	10.31	58	71416	25185	64402073
Coronavirus infection	12.25	10.31	22	71452	5508	64421750
Hypochromic anaemia	12.07	10.31	14	71460	2354	64424904
Haemodialysis	12.05	10.31	44	71430	17033	64410225
Periorbital haematoma	11.83	10.31	9	71465	887	64426371
Proctalgia	11.83	10.31	26	71448	7533	64419725
Blood pressure fluctuation	11.78	10.31	98	71376	51773	64375485
Congenital central nervous system anomaly	11.75	10.31	3	71471	17	64427241
Myocardial ischaemia	11.73	10.31	54	71420	23197	64404061
Device related infection	11.72	10.31	10	71464	30616	64396642
Vulvovaginal burning sensation	11.66	10.31	10	71464	1169	64426089
Neutropenia	11.65	10.31	191	71283	239433	64187825
Lymphocyte count decreased	11.52	10.31	17	71457	40682	64386576
Myelosuppression	11.52	10.31	6	71468	23824	64403434
Progressive multifocal leukoencephalopathy	11.48	10.31	3	71471	18229	64409029
Acute myocardial infarction	11.47	10.31	123	71351	69595	64357663
Eczema	11.46	10.31	64	71410	29656	64397602
Abdominal discomfort	11.46	10.31	138	71336	182184	64245074
Impaired work ability	11.41	10.31	40	71434	15179	64412079
Sinusitis	11.39	10.31	105	71369	145823	64281435
Prostatic specific antigen increased	11.37	10.31	28	71446	8732	64418526
Coronavirus test positive	11.36	10.31	9	71465	942	64426316
Bronchial haemorrhage	11.35	10.31	10	71464	1212	64426046
Hepatic enzyme increased	11.25	10.31	91	71383	129852	64297406
Haematocrit increased	11.11	10.31	16	71458	3329	64423929
Adenocarcinoma	11.09	10.31	16	71458	3335	64423923
Incorrect route of product administration	11.07	10.31	6	71468	23292	64403966
Vulvovaginal pruritus	11.06	10.31	12	71462	1874	64425384
Cytomegalovirus infection	11.06	10.31	15	71459	37184	64390074
Hepatocellular carcinoma	11.06	10.31	27	71447	8376	64418882
Renal artery stenosis	11.05	10.31	15	71459	2954	64424304
Ill-defined disorder	10.98	10.31	20	71454	44032	64383226
Staphylococcal infection	10.93	10.31	25	71449	50653	64376605
Mucosal dryness	10.92	10.31	15	71459	2986	64424272
Stupor	10.89	10.31	22	71452	6013	64421245
Peripheral artery thrombosis	10.87	10.31	15	71459	3000	64424258
Histamine level increased	10.87	10.31	4	71470	86	64427172
Multiple sclerosis relapse	10.86	10.31	18	71456	41117	64386141
Fibrous histiocytoma	10.83	10.31	7	71467	532	64426726
Angina pectoris	10.68	10.31	86	71388	44995	64382263
Blood pressure diastolic decreased	10.67	10.31	51	71423	22250	64405008
Pancreatic carcinoma metastatic	10.63	10.31	16	71458	3462	64423796
Reversible cerebral vasoconstriction syndrome	10.54	10.31	13	71461	2329	64424929
White blood cell analysis abnormal	10.54	10.31	3	71471	27	64427231
Insulinoma	10.50	10.31	4	71470	95	64427163
Skin sensitisation	10.49	10.31	8	71466	792	64426466
Superficial spreading melanoma stage I	10.44	10.31	3	71471	28	64427230
Sudden death	10.38	10.31	47	71427	20049	64407209
Paranasal sinus discomfort	10.34	10.31	15	71459	3140	64424118
Depression	10.31	10.31	142	71332	183149	64244109

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	0024-5856	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	0955-1046	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	29300-216	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
Irbesartan	Human Prescription Drug Label	1	31722-731	TABLET	300 mg	ORAL	ANDA	27 sections
Irbesartan	Human Prescription Drug Label	1	33342-047	TABLET	75 mg	ORAL	ANDA	26 sections
Irbesartan	Human Prescription Drug Label	1	33342-048	TABLET	150 mg	ORAL	ANDA	26 sections
Irbesartan	Human Prescription Drug Label	1	33342-049	TABLET	300 mg	ORAL	ANDA	26 sections
Irbesartan and Hydrochlorothiazide	Human Prescription Drug Label	2	33342-057	TABLET, FILM COATED	150 mg	ORAL	ANDA	23 sections
Irbesartan and Hydrochlorothiazide	Human Prescription Drug Label	2	33342-058	TABLET, FILM COATED	300 mg	ORAL	ANDA	23 sections