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 the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy with telmisartan and amlodipine tablets were peripheral edema, dizziness, and hypotension, each leading to discontinuation of ≤0.5% of telmisartan and amlodipine tablets-treated patients.
Adverse reactions that occurred at a ≥2% higher incidence on telmisartan and amlodipine tablets than placebo were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), and back pain (2.2% vs 0%).
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact 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.
Telmisartan and amlodipine tablets The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension;
approximately 1900 of these patients were exposed for at least 6 months and over 160 of these patients were exposed for at least one year.
Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
In the placebo-controlled factorial design study, the population treated with a telmisartan and amlodipine combination had a mean age of 53 years and included approximately 50% males, 79% were Caucasian, 17% Blacks, and 4% Asians.
Patients received doses ranging from 20/2.5 mg to 80/10 mg orally, once daily.
The frequency of adverse reactions was not related to gender, age, or race.
5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure (5.1) Hypotension: Correct any volume or salt depletion before initiating therapy.
Observe for signs and symptoms of hypotension.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis (5.2) Titrate slowly in patients with hepatic (5.4) or severe renal impairment (5.5) Heart failure: Monitor for worsening (5.8) Avoid concomitant use with an ACE inhibitor (5.6) Myocardial infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of telmisartan and amlodipine tablets, particularly in patients with severe obstructive coronary artery disease (5.7).
5.1 Fetal Toxicity Pregnancy Category D Telmisartan 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, Telmisartan And Amlodipine 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: