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 reasons for discontinuation of therapy with valsartan and hydrochlorothiazide were headache and dizziness.
The only adverse experience that occurred in ≥ 2% of patients treated with valsartan and hydrochlorothiazide and at a higher incidence than placebo was nasopharyngitis (2.4% vs.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies 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.
Hypertension Valsartan and hydrochlorothiazide has been evaluated for safety in more than 5,700 patients, including over 990 treated for over 6 months, and over 370 for over 1 year.
Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall incidence of adverse reactions with valsartan and hydrochlorothiazide was comparable to placebo.
The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race.
In controlled clinical trials, discontinuation of therapy due to side effects was required in 2.3% of valsartan and hydrochlorothiazide patients and 3.1% of placebo patients.
5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to initiation.
(5.2) Observe for signs of fluid or electrolyte imbalance.
(5.9) Monitor renal function and potassium in susceptible patients.
(5.3, 5.7) Exacerbation or activation of systemic lupus erythematosus.
(5.5) Acute angle-closure glaucoma.
Like all medications, Valsartan And Hydrochlorothiazide 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: