Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Irbesartan
Drug ID BADD_D01194
Description Irbesartan is an angiotensin receptor blocker (ARB) indicated to treat hypertension or diabetic nephropathy.[L7456,L7459] It can also be used as part of a combination product with [hydrochlorothiazide] for patients not well controlled or not expected to be well controlled on monotherapy.[L7459] Unlike angiotensin converting enzyme inhibitors, ARBs are not associated with a dry cough.[L7456,L7459] Irbesartan was granted FDA approval on 30 September 1997.[L7456,L7459]
Indications and Usage For the treatment of hypertension, as well as diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. Irbesartan is also used as a second line agent in the treatment of congestive heart failure.
Marketing Status Prescription; Discontinued
ATC Code C09CA04
DrugBank ID DB01029
KEGG ID D00523
MeSH ID D000077405
PubChem ID 3749
TTD Drug ID D00JAU
NDC Product Code 65162-284; 42658-122; 12666-0011; 0024-5851; 71205-452; 50090-4519; 63187-757; 59746-449; 70518-2245; 50090-3244; 33342-049; 29300-212; 31722-161; 68382-300; 33342-048; 70771-1160; 0024-5852; 53747-029; 62332-043; 68554-0005; 46708-440; 71205-082; 50090-3431; 66639-006; 65372-1118; 71335-1826; 53360-1305; 63629-8259; 68180-410; 70771-1161; 0955-1040; 50228-161; 50228-162; 65862-639; 0955-1042; 70518-2211; 42658-121; 71335-0423; 50090-5055; 59746-448; 65162-286; 42419-011; 65862-530; 31722-160; 62332-041; 29300-214; 63187-737; 71335-0071; 0955-1041; 65862-637; 62332-042; 65862-638; 71335-1263; 72189-270; 65162-285; 70518-2685; 68180-411; 46708-872; 50228-160; 43547-375; 70518-2205; 69766-101; 64220-130; 82231-110; 42658-123; 33342-047; 50090-2017; 68382-299; 53360-1303; 59746-447; 31722-729; 62331-054; 31722-162; 65841-156; 55111-082; 71205-404; 63629-5241; 50090-3269; 43547-374; 68382-301; 50090-2978; 71335-1547; 53360-1307; 29300-213; 68180-412; 46708-441; 72189-201; 0024-5850; 61919-793; 31722-731; 46708-439; 72189-205; 70771-1159; 70518-2246; 71335-1244; 43547-376; 15894-0008; 31722-730; 70518-1328; 71205-379
Synonyms Irbesartan | Avapro | Karvea | 2-N-Butyl-3-((2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1,3-diazaspiro(4,4)non-1-en-4-one | Aprovel | SR 47436 | SR-47436 | SR47436 | BMS 186295 | BMS-186295
Chemical Information
Molecular Formula C25H28N6O
CAS Registry Number 138402-11-6
SMILES CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Gastric cancer16.13.03.001; 07.21.02.0010.000603%Not Available
Gastritis07.08.02.0010.000603%
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis07.19.03.001; 11.01.07.004--Not Available
Gastrointestinal disorder07.11.01.0010.003618%Not Available
Gastrointestinal pain07.01.05.005--
Glycosuria20.02.01.005--
Gout15.01.06.001; 14.09.01.001--Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000603%Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemolytic anaemia01.06.03.002--Not Available
Hair disorder23.02.06.003--Not Available
Hallucination19.10.02.002--
Headache17.14.01.0010.005426%
Heart rate decreased13.14.04.0010.000603%Not Available
Heart rate increased13.14.04.0020.000603%Not Available
Hepatic function abnormal09.01.02.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.0080.003316%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000603%Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.001206%
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.0030.002110%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis08.01.03.028; 23.02.03.0040.002713%
Hyperkalaemia14.05.03.0010.005125%
Hypersensitivity10.01.03.0030.002110%
Hypersensitivity vasculitis24.05.02.012; 23.06.02.005; 10.02.02.017; 01.01.04.008--Not Available
Hypertension24.08.02.0010.004823%
Hypertensive crisis24.08.01.0010.005125%Not Available
Hyperuricaemia14.09.01.003--
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