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 Irbesartan is indicated to treat hypertension and diabetic nephropathy in hypertensive patients with type 2 diabetes, elevated serum creatinine, and proteinuria.[L7456] A combination product with hydrochlorothiazide is indicated for hypertension in patients with uncontrolled hypertension with monotherapy or first line in patients not expected to be well controlled with monotherapy.[L7459]
Marketing Status approved; investigational
ATC Code C09CA04
DrugBank ID DB01029
KEGG ID D00523
MeSH ID D000077405
PubChem ID 3749
TTD Drug ID D00JAU
NDC Product Code 12666-0011; 65841-156; 65862-637; 66639-006; 31722-162; 46708-439; 46708-440; 50090-2017; 59746-448; 68382-299; 64220-130; 29300-213; 63187-757; 65162-286; 65862-639; 68382-300; 70518-3632; 71205-404; 71335-0071; 71335-1244; 71335-1826; 65372-1118; 29300-214; 31722-729; 31722-730; 33342-047; 43547-376; 68180-412; 70518-1690; 71205-082; 71335-1263; 0024-5850; 68382-301; 71205-379; 33342-048; 63629-8259; 65162-285; 68180-411; 15894-0008; 65862-530; 31722-161; 46708-441; 70771-1161; 0955-1041; 68554-0005; 69766-101; 31722-731; 42658-123; 62332-041; 62332-043; 63629-5241; 68180-410; 70518-2246; 70771-1159; 70771-1160; 42419-011; 53360-1303; 55111-082; 82231-110; 59746-447; 59746-449; 63187-737; 70518-2685; 71335-0423; 0955-1040; 53360-1307; 53747-029; 65862-638; 31722-160; 42658-121; 43547-374; 50228-160; 0024-5852; 62332-042; 71205-452; 72189-201; 72189-205; 0955-1042; 53360-1305; 62331-054; 43547-375; 50228-161; 0024-5851; 61919-793; 65162-284; 70518-2245; 71335-1547; 71335-2168; 72189-270; 29300-212; 33342-049; 42658-122; 50228-162
UNII J0E2756Z7N
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Feeling jittery08.01.09.016--Not Available
Flatulence07.01.04.002--
Flushing23.06.05.003; 08.01.03.025; 24.03.01.0020.000404%
Food interaction08.06.03.0020.000126%Not Available
Frequent bowel movements07.02.04.002--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.000807%
Gastric cancer16.13.03.001; 07.21.02.0010.000126%Not Available
Gastritis07.08.02.0010.000530%
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis07.19.03.001; 11.01.07.004--Not Available
Gastrointestinal disorder07.11.01.0010.001564%Not Available
Gastrointestinal pain07.01.05.005--
Glaucoma06.03.01.0020.000126%
Glossodynia07.14.02.001--Not Available
Glycosuria20.02.01.005--
Gout14.09.01.001; 15.01.06.001--Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000189%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000126%
Haemoglobin decreased13.01.05.003--Not Available
Haemolytic anaemia01.06.03.002--Not Available
Haemorrhoids24.10.02.002; 07.15.03.001--
Hair disorder23.02.06.003--Not Available
Head discomfort17.02.05.027--Not Available
Headache17.14.01.0010.001905%
Hepatic function abnormal09.01.02.001--Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000126%Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.0080.001009%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000126%Not Available
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