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)
Scleroderma23.03.02.005; 15.06.01.002; 10.04.07.0010.001809%Not Available
Sensory loss17.02.07.007--Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.0020.000904%Not Available
Sialoadenitis11.01.04.002; 07.06.04.002--
Sinus bradycardia02.03.03.0090.002110%
Sinusitis22.07.03.007; 11.01.13.0050.000603%
Skin discomfort23.03.03.006--Not Available
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.0010.000603%Not Available
Small intestinal obstruction07.13.06.0010.001809%
Somnolence19.02.05.003; 17.02.04.0060.002110%
Stress19.06.02.004--Not Available
Suicidal ideation19.12.01.0030.001206%
Swelling08.01.03.015--Not Available
Swelling face23.04.01.018; 10.01.05.0180.001206%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.002713%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.003618%
Tachycardia02.03.02.007--Not Available
Tenderness08.01.08.005--Not Available
Tendon injury15.07.01.010; 12.01.07.0120.000603%Not Available
Tension19.06.02.005--Not Available
Throat irritation07.05.03.004; 22.02.05.0130.000904%Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.0020.000603%
Tongue disorder07.14.01.0020.000904%Not Available
Toxic epidermal necrolysis23.03.01.008; 11.07.01.006; 12.03.01.015; 10.01.01.006--
Tracheobronchitis22.07.03.010; 11.01.13.008--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
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