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)
Dysgeusia07.14.03.001; 17.02.07.0030.001206%
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.002713%
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.000157%
Dyspnoea22.02.01.004; 02.01.03.0020.008441%
Ear disorder04.03.01.001--Not Available
Ear infection11.01.05.001; 04.03.01.006--Not Available
Ear pain04.03.01.003--
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.001--Not Available
Electrolyte imbalance14.05.01.002--Not Available
Emotional disorder19.04.02.005--Not Available
Encephalopathy17.13.02.0010.000603%
Enteritis07.08.03.0020.001507%
Epistaxis24.07.01.005; 22.04.03.0010.000904%
Erythema23.03.06.0010.001507%Not Available
Essential hypertension24.08.02.008--Not Available
Eye irritation06.04.05.0030.000603%Not Available
Eye swelling06.08.03.0030.000603%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.000904%Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Facial paralysis17.04.03.0080.000603%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.001507%Not Available
Feeling cold08.01.09.008--Not Available
Feeling hot08.01.09.0090.000603%Not Available
Flatulence07.01.04.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.001206%
Food interaction08.06.03.0020.000603%Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.003015%
Gamma-glutamyltransferase increased13.03.01.0110.000603%
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