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)
Asthma22.03.01.002; 10.01.03.0100.000126%Not Available
Atrioventricular block complete02.03.01.0030.000126%
Atrioventricular block first degree02.03.01.0040.000505%
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.000378%Not Available
Back pain15.03.04.005--
Blindness06.02.10.003; 17.17.01.003--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine13.13.01.020--Not Available
Blood creatinine increased13.13.01.004--
Blood pressure fluctuation24.06.01.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood urea increased13.13.01.006--Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.001--
Bradycardia02.03.02.0020.000631%Not Available
Breast feeding26.05.01.001--Not Available
Burning sensation17.02.06.001; 08.01.09.0290.000618%Not Available
Bursitis12.04.03.010; 15.04.01.001--Not Available
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.0020.000252%Not Available
Cardiac murmur13.14.01.001--Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Cardiogenic shock24.06.02.006; 02.05.01.0030.000126%Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Change of bowel habit07.02.03.002--Not Available
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.000404%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.000681%Not Available
Chills08.01.09.001; 15.05.03.016--
Choking22.12.03.0030.000126%Not Available
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