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)
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Wheezing22.03.01.0090.000126%
Xanthopsia06.02.05.002--Not Available
Tubulointerstitial nephritis20.05.02.0020.000126%Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.013--Not Available
Peripheral swelling02.05.04.015; 08.01.03.053--Not Available
Localised oedema14.05.06.009; 08.01.07.011; 02.05.04.006--
General physical health deterioration08.01.03.0180.000467%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000820%Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.000126%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000126%
Blood pressure inadequately controlled24.06.01.0070.000681%Not Available
Exercise tolerance decreased08.01.03.0360.000378%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Respiratory tract congestion22.02.07.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Protein urine present13.13.02.006--Not Available
Epigastric discomfort07.01.02.004--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Colitis microscopic07.08.01.0110.000568%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000126%
Toxic skin eruption23.03.05.003; 12.03.01.073; 10.01.01.0080.000378%Not Available
Ocular icterus09.01.01.007; 06.08.03.009; 01.06.04.0070.000252%Not Available
Angiopathy24.03.02.007--Not Available
Protein-losing gastroenteropathy14.03.02.015; 07.11.01.0130.000252%Not Available
Hot flush21.02.02.001; 24.03.01.005; 08.01.03.0270.000404%
Prostate cancer21.04.02.002; 16.25.01.001--Not Available
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