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)
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Eyelid disorder23.03.03.028; 06.08.03.010--Not Available
Foetal disorder18.03.02.0010.000126%Not Available
Inflammation10.02.01.089; 08.01.05.0070.000404%Not Available
Libido disorder21.03.02.006; 19.08.03.004--Not Available
Limb discomfort15.03.04.0140.000126%Not Available
Intra-abdominal haemorrhage12.01.17.011; 24.07.02.035; 07.12.02.0080.000126%
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Disease recurrence08.01.03.0500.000429%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Renal impairment20.01.03.0100.000946%Not Available
Sinus disorder22.04.06.002--
Dysaesthesia pharynx22.04.05.012; 17.02.06.017--
Chronic kidney disease20.01.03.0170.000126%
Intestinal congestion07.01.06.019--Not Available
Oral disorder07.05.01.005--Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.008--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Acute kidney injury20.01.03.0160.004226%
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000441%Not Available
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.000126%Not Available
Administration site discomfort12.07.04.010; 08.02.04.010--Not Available
Intestinal angioedema23.04.01.019; 10.01.05.019; 07.08.03.0120.000378%Not Available
Liver function test increased13.03.04.031--Not Available
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