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)
Sinus disorder22.04.06.002--
Dysaesthesia pharynx22.04.05.012; 17.02.06.017--
Chronic kidney disease20.01.03.0170.000603%
Intestinal congestion07.01.06.019--Not Available
Oral disorder07.05.01.005--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.000157%
Microvillous inclusion disease07.11.04.003; 03.04.04.0010.000603%Not Available
Acute kidney injury20.01.03.0160.014772%
Drug-induced liver injury09.01.07.023; 12.03.01.0440.001809%Not Available
Immune thrombocytopenic purpura01.08.01.007; 10.04.01.0080.000603%Not Available
Administration site discomfort12.07.04.010; 08.02.04.010--Not Available
Intestinal angioedema07.08.03.012; 23.04.01.019; 10.01.05.0190.001809%Not Available
Liver function test increased13.03.01.044--Not Available
Ureterolithiasis20.04.02.0040.000603%Not Available
Blood immunoglobulin E increased13.06.05.0030.000904%Not Available
Nephritis allergic20.05.01.018; 10.01.03.0440.000157%Not Available
Oral lichen planus23.03.08.012; 07.05.01.0180.000603%Not Available
Renal dysplasia03.06.01.013; 20.01.06.0130.001206%Not Available
Paternal drugs affecting foetus18.03.02.018; 12.03.03.0070.000315%Not Available
Brain contusion24.07.06.020; 17.11.01.010; 12.01.10.0140.000603%Not Available
Sopor19.02.04.002; 17.02.04.0210.000603%Not Available
Tongue abscess11.01.04.020; 07.14.01.0120.001206%Not Available
Oral allergy syndrome10.01.01.0330.000904%Not Available
Portal hypertensive enteropathy24.08.06.005; 09.01.06.021; 07.12.03.0090.001809%Not Available
The 12th Page    First    Pre   12    Total 12 Pages