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IRBESARTAN
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Post-Marketing Experience
- The following adverse reactions have been identified during post-approval use of Irbesartan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Irbesartan.
- The following have been reported: urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); increased liver function tests; jaundice; hepatitis; hyperkalemia, and thrombocytopenia.
- Impaired renal function, including cases of renal failure, has been reported.
- Cases of increased CPK and rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
59
42853
Other ADRs
6062
14111217
Odds Ratio = 3.205
Drug Property Information
ATC Code(s):
- C09DB05 - irbesartan
- C09DB - Angiotensin II antagonists and calcium channel blockers
- C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
- C09DA04 - irbesartan
- C09DA - Angiotensin II antagonists and diuretics
- C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
- C09CA04 - irbesartan
- C09CA - "Angiotensin II antagonists, plain"
- C09C - "ANGIOTENSIN II ANTAGONISTS, PLAIN"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
Active Ingredient:irbesartan
Active Ingredient UNII:J0E2756Z7N
Drugbank ID:DB01029
PubChem Compound:3749
CAS Number:138402-11-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 150.0 mg/day C09CA04
Chemical Structure: 
SMILE Code:
CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5
CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: Rhabdomyolysis associated with phentermine.
[Steidl Kelly E,Darko William,Probst Luke A,Noviasky John A,Nasser Samer]Am J Health Syst Pharm.2010 Nov 15;67(22):1929-32. doi: 10.2146/ajhp090395. PMID: 21048209
2: Hypokalemia induced myopathy as first manifestation of primary hyperaldosteronism - an elderly patient with unilateral adrenal hyperplasia: a case report.
[Kotsaftis Panagiotis,Savopoulos Christos,Agapakis Dimitrios,Ntaios George,Tzioufa Valentini,Papadopoulos Vasilios,Fahantidis Epaminondas,Hatzitolios Apostolos]Cases J.2009 Jul 16;2:6813. doi: 10.4076/1757-1626-2-6813. PMID: 19829865
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