Telmisartan Side Effects
Some side effects of telmisartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to telmisartan: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking telmisartan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.
Call your doctor at once if you have any other serious side effects, such as:
feeling like you might pass out;
painful or difficult urination;
feeling short of breath, even with mild exertion;
swelling in your hands or feet; or
high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).
Less serious side effects of telmisartan may include:
stuffy nose, sinus pain, cough;
stomach pain, diarrhea;
mild skin rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to telmisartan: oral tablet
Cardiovascular side effects associated with the use of angiotensin II receptor inhibitors have included dizziness (related to orthostatic hypotension). Palpitations, chest pain, and angioedema have been reported rarely. A single case of angioedema has been reported during initial clinical studies; however, additional cases of angioedema and urticaria have been reported in postmarketing experience. Hypertension, chest pain, peripheral edema, palpitations, tachycardia, and abnormal ECG findings have been reported in 1% or less in patients and at rates similar to placebo. Stroke has been reported rarely. A case of myocardial infarction has been reported. Dependent edema, angina, abnormal ECG findings, hypertension, cerebrovascular disorder, and peripheral edema have been reported. Atrial fibrillation, bradycardia, congestive heart failure, myocardial infarction, increased blood pressure, aggravated hypertension, and hypotension (including postural hypotension) have been reported during postmarketing experience.
One patient in a clinical trial died of a presumed myocardial infarction, however, causality was not established.
The risk of orthostatic hypotension has been greater among patients with intravascular salt or volume depletion.
Respiratory side effects including upper respiratory infections, sinusitis, and pharyngitis have been reported in 1% to 7% of patients and at rates similar to placebo. Asthma, rhinitis, dyspnea, and epistaxis have also been reported. Cough has been reported during postmarketing experience. Acute sinusitis and bronchitis have been reported.
Musculoskeletal side effects including back pain has been reported in 3% of patients and at rates similar to placebo. Arthritis, arthralgias, myalgias, and leg pain have been reported in less than 1% of patients and at rates similar to placebo. Rhabdomyolysis has been reported during postmarketing experience in patients receiving angiotensin II receptor blockers including telmisartan. Muscle cramps (including leg cramps), and tendon pain (including tendonitis, tenosynovitis), myalgia, peripheral ischemia, and elevated creatine phosphokinase (CPK) have also been reported during postmarketing experience.
Gastrointestinal side effects including diarrhea has been reported in 3% of patients. Flatulence, abdominal pain, nausea, constipation, gastritis, vomiting, dry mouth, dyspepsia, hemorrhoids, gastroenteritis, enteritis, and gastroesophageal reflux has been reported in less than 1% of patients and at rates similar to placebo. A case of pancreatitis has been reported. Cholecystitis and cholelithiasis have been reported.
Nervous system side effects have included headache in 1% of patients and at a rate similar to placebo. Dizziness, pain, fatigue, insomnia, somnolence, migraine, vertigo, tinnitus, earaches, paresthesias, involuntary muscle contractions, and hypoesthesia have been reported in less than 1% of patients and at rates similar to placebo. Asthenia, weakness, and syncope have been reported during postmarketing experience.
Genitourinary side effects have been reported rarely. Impotence, urinary frequency, and cystitis have been reported at rates similar to placebo. Endometriosis has been reported. Urinary tract infection and erectile dysfunction have been reported during postmarketing experience.
Metabolic side effects including gout, hypercholesterolemia, and hyperglycemia have been reported in less than 1% of patients. Causal relationships have not been shown, and these side effects were also noted among placebo patients. Hyperkalemia and increased uric acid have been reported during postmarketing experience.
Psychiatric side effects have rarely included anxiety, depression, and nervousness.
Dermatologic side effects have been reported rarely. Pruritus, rash, eczema, and general dermatitis have been reported at rates similar to placebo.
Ocular side effects have rarely included abnormal vision and conjunctivitis.
Hematologic side effects have included anemia and granuloma. Eosinophilia and thrombocytopenia have been reported in postmarketing studies.
Renal side effects have rarely included oliguria, azotemia, and acute renal failure.
Hepatic side effects have rarely included elevations of serum hepatic enzymes at rates slightly greater than placebo. Abnormal hepatic function and liver disorder have been reported in postmarketing studies.
Hypersensitivity side effects have been reported rarely. A case of angioedema has also been reported. Edema (including face, lower limb, and angioneurotic edema), hypersensitivity, erythema, angioedema, and urticaria have been reported during postmarketing experience.
Other side effects including increased sweating, flushing, fever, malaise, infection, abscess, otitis media, tinnitus, earache, and toothache have been reported. Influenza-like symptoms have been reported.
In general, telmisartan has been well tolerated in premarketing clinical trials. This drug has been evaluated for safety in more than 3,700 patients, including 1,900 treated for more than 6 months and more than 1,300 for more than 1 year. Adverse drug events associated with the use of telmisartan have generally been mild and transient and have only infrequently required discontinuation of therapy. In placebo-controlled trials involving 1,041 patients treated with daily doses ranging from 20 to 160 mg (monotherapy) for up to 12 weeks, the overall incidence of adverse events was similar to placebo.
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