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Avapro (IRBESARTAN)
Avapro (Irbesartan) is a small molecule Angiotensin 2 Receptor Blocker developed by Sanofi Aventis US, targeting the Type-1 angiotensin II receptor. It was FDA approved in 1997 for the treatment of diabetic renal disease and hypertensive disorder. As an off-patent medication, Avapro is available from multiple generic manufacturers. Key safety considerations include its potential to cause hyperkalemia and increased risk of kidney problems. Avapro's commercial status allows for generic competition, reducing its market exclusivity.
At a glance
| Generic name | IRBESARTAN |
|---|---|
| Sponsor | Sanofi |
| Drug class | Angiotensin 2 Receptor Blocker [EPC] |
| Target | Type-1 angiotensin II receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1997 |
Approved indications
- Diabetic renal disease
- Hypertensive disorder
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 ) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue irbesartan tablets as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 )
Common side effects
- Diarrhea
- Fatigue
- Dyspepsia/heartburn
- Dizziness
- Orthostatic hypotension
- Hyperkalemia
- Potassium >6.0 mEq/L
- Cough
- Urticaria
- Angioedema
- Anaphylactic reaction
- Anaphylactic shock
Drug interactions
- lithium
- spironolactone
- triamterene
Key clinical trials
- The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy (NA)
- A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia (PHASE3)
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU. (PHASE3)
- ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC) (PHASE2)
- Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy (NA)
- Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients (PHASE4)
- Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Avapro CI brief — competitive landscape report
- Avapro updates RSS · CI watch RSS
- Sanofi portfolio CI