Micardis Side Effects

Generic Name: telmisartan

Note: This page contains information about the side effects of telmisartan. Some of the dosage forms included on this document may not apply to the brand name Micardis.

Not all side effects for Micardis may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to telmisartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by telmisartan (the active ingredient contained in Micardis). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking telmisartan:

Rare
  • Changes in vision
  • dizziness, lightheadedness, or fainting
  • fast heartbeat
  • large hives
  • painful urination or changes in urinary frequency
  • swelling in the hands, lower legs, and feet
Incidence not known
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • dark-colored urine
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • flushing
  • hives or welts
  • hoarseness
  • irregular breathing
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramps or stiffness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • pounding in the ears
  • rash
  • redness of the skin
  • slow, fast, or irregular heartbeat
  • sweating
  • swelling of the eyelids, face, or lips
  • tightness in the chest
  • trouble breathing or swallowing
  • trouble with speaking or walking
  • trouble with thinking
  • unusual tiredness or weakness
  • unusually warm skin
  • weakness or heaviness of the legs
  • weakness, numbness, or tingling in the arms or legs
  • weight gain

Some of the side effects that can occur with telmisartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Abdominal or stomach pain
  • back pain
  • bloating or gas
  • changes in appetite
  • coughing
  • diarrhea
  • dry mouth
  • ear pain or hearing problems
  • fever
  • general tiredness or weakness
  • headache
  • heartburn
  • increased sweating
  • muscle pain or spasm
  • nausea
  • nervousness
  • runny or stuffy nose
  • sneezing
  • sore throat
Incidence not known
  • Acid or sour stomach
  • belching
  • decreased interest in sexual intercourse
  • difficulty with moving
  • inability to have or keep an erection
  • indigestion
  • joint pain
  • lack or loss of strength
  • leg cramps
  • loss in sexual ability, desire, drive, or performance
  • muscle aching
  • stomach discomfort or upset
  • swelling
  • weakness

For Healthcare Professionals

Applies to telmisartan: oral tablet

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 (the active ingredient contained in Micardis) 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 (the active ingredient contained in Micardis) 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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