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Micardis Side Effects

Generic Name: telmisartan

Please note - some side effects for Micardis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Micardis - for the Consumer

Micardis

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Micardis:

Back pain; diarrhea; dizziness; sinus pain or congestion; sore throat; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur when using Micardis:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced or painful urination; chest pain; difficulty swallowing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased or excessive sweating; muscle pain or cramps; severe or persistent vomiting or diarrhea; severe or persistent weakness; shortness of breath; swelling of the arms or legs; symptoms of low blood pressure (eg, fainting, lightheadedness, severe dizziness); tendon or joint pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Micardis HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Micardis HCT:

Diarrhea; dizziness; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Micardis HCT:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion; decrease in sexual ability; decreased, difficult, or painful urination; depression; drowsiness; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased or excessive sweating; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness or light-headedness; severe or persistent dry mouth, nausea, or stomach pain; shortness of breath; sluggishness; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, decreased vision clearness); vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

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

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

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

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

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

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

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

Psychiatric side effects have rarely included anxiety, depression, and nervousness.

Dermatologic

Dermatologic side effects have been reported rarely. Pruritus, rash, eczema, and general dermatitis have been reported at rates similar to placebo.

Ocular

Ocular side effects have rarely included abnormal vision and conjunctivitis.

Hematologic

Hematologic side effects have included anemia and granuloma. Eosinophilia and thrombocytopenia have been reported in postmarketing studies.

Renal

Renal side effects have rarely included oliguria, azotemia, and acute renal failure.

Hepatic

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

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

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.

General

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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