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)
Chills15.05.03.016; 08.01.09.001--
Cholestasis09.01.01.0010.002110%Not Available
Chromaturia20.02.01.002--
Circulatory collapse24.06.02.0010.000157%Not Available
Colitis07.08.01.0010.001507%
Conduction disorder02.03.01.008--
Confusional state19.13.01.001; 17.02.03.005--
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.000603%Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Cough22.02.03.0010.003919%
Creatinine renal clearance increased13.13.01.0150.000603%Not Available
Cutaneous vasculitis24.05.02.004; 23.06.02.001; 10.02.02.003--Not Available
Death08.04.01.001--
Dehydration14.05.05.0010.001206%
Depressed mood19.15.02.0010.003015%Not Available
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.0010.000603%Not Available
Diarrhoea07.02.01.0010.008139%
Discomfort08.01.08.0030.000603%Not Available
Disorientation19.13.01.002; 17.02.05.0150.000603%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.000904%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.005426%
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.005--Not Available
Drug abuse19.07.02.0100.001494%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Drug interaction08.06.03.001--Not Available
Dry mouth07.06.01.002--
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