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 The most common adverse reaction in adults was diarrhea (2%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 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.
A total of 4814 patients were evaluated for safety when treated with azilsartan medoxomil tablets at doses of 20, 40 or 80 mg in clinical trials.
This includes 1704 patients treated for at least six months;
of these, 588 were treated for at least one year.
Treatment with azilsartan medoxomil tablets was well-tolerated with an overall incidence of adverse reactions similar to placebo.
The rate of withdrawals due to adverse events in placebo-controlled monotherapy and combination therapy trials was 2.4% (19/801) for placebo, 2.2% (24/1072) for azilsartan medoxomil tablets 40 mg and 2.7% (29/1074) for azilsartan medoxomil tablets 80 mg.
The most common adverse event leading to discontinuation, hypotension/orthostatic hypotension, was reported by 0.4% (8/2146) patients randomized to azilsartan medoxomil tablets 40 mg or 80 mg compared to 0% (0/801) patients randomized to placebo.
5 WARNINGS AND PRECAUTIONS Correct volume or salt depletion prior to administration of azilsartan medoxomil tablets.
( 5.2 ) Monitor for worsening renal function in patients with renal impairment.
( 5.3 ) 5.1 Fetal Toxicity Azilsartan medoxomil tablets can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Like all medications, Azilsartan Medoxomil 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: