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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.001507%Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.004522%
Abdominal pain upper07.01.05.003--
Abnormal faeces07.01.03.001--Not Available
Acoustic stimulation tests abnormal13.07.01.004--Not Available
Acute hepatic failure09.01.03.0010.000393%Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.0010.001206%Not Available
Acute pulmonary oedema02.05.02.004; 22.01.03.0050.001507%Not Available
Ageusia07.14.03.003; 17.02.07.0010.001507%Not Available
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.0010.000904%Not Available
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.0060.002713%
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Angina pectoris02.02.02.002; 24.04.04.0020.000904%
Angioedema10.01.05.009; 23.04.01.0010.006934%Not Available
Anorectal disorder07.03.01.001--Not Available
Anosmia17.04.04.001; 22.04.03.0060.001507%
Anxiety19.06.02.002--
Apathy19.04.04.0020.000603%Not Available
Aplastic anaemia01.03.03.002--Not Available
Arrhythmia02.03.02.0010.001206%Not Available
Arrhythmia supraventricular02.03.03.001--Not Available
Arteriosclerosis24.04.02.0010.000157%Not Available
Arthralgia15.01.02.0010.003015%
Arthritis15.01.01.001--
Asthenia08.01.01.0010.005426%Not Available
Asthma10.01.03.010; 22.03.01.0020.000603%Not Available
Atrioventricular block complete02.03.01.0030.000603%
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