Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S.
LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Irbesartan and Hydrochlorothiazide AVALIDE tablets have been evaluated for safety in 1694 patients treated for essential hypertension in 6 clinical trials.
In Studies I through IV with AVALIDE, no adverse events peculiar to this combination drug product have been observed.
Adverse events have been limited to those that were reported previously with irbesartan or hydrochlorothiazide (HCTZ).
The overall incidence of adverse events was similar with the combination and placebo.
In general, treatment with AVALIDE was well tolerated.
5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to administration.
( 5.2 ) Impaired renal function.
( 5.7 ) Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus.
( 5.4 ) Acute angle-closure glaucoma, acute myopia, and choroidal effusion.
( 5.8 ) 5.1 Fetal Toxicity AVALIDE can cause fetal harm when administered to a pregnant woman.
Like all medications, Avalide can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: