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 In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the amlodipine and valsartan-treated patients and 2.1% in the placebo-treated group.
The most common reasons for discontinuation of therapy with amlodipine and valsartan were peripheral edema and vertigo.
The adverse experiences that occurred in clinical trials (≥ 2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc.
at 1-877-244-9825 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.
Studies with Amlodipine and Valsartan: Amlodipine and valsartan has been evaluated for safety in over 2600 patients with hypertension;
over 1440 of these patients were treated for at least 6 months and over 540 of these patients were treated for at least 1 year.
Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to initiation (5.2) Increased angina and/or myocardial infarction (5.3) Monitor renal function and potassium in susceptible patients (5.4, 5.5) 5.1 Fetal Toxicity Amlodipine and Valsartan 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.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue amlodipine and valsartan as soon as possible [see Use in Specific Populations (8.1)].
Like all medications, Amlodipine And Valsartan 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: