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Micardis

Last reviewed on RxList: 3/1/2018
Micardis Side Effects Center

Last reviewed on RxList 3/1/2018

Micardis (telmisartan) is an angiotensin II receptor antagonist used to treat high blood pressure (hypertension). Micardis is sometimes given together with other blood pressure medications. Micardis is also used to reduce the risk of stroke, heart attack, or death from heart problems in people who are at least 55 years old with risk factors for serious heart disorders. Common side effects of Micardis include:

  • dizziness,
  • lightheadedness,
  • blurred vision, or
  • back pain as your body adjusts to the medication.
  • Other side effects of Micardis include stuffy nose,
  • sinus pain,
  • cough,
  • stomach pain,
  • diarrhea,
  • headache,
  • tired feeling,
  • weakness, or
  • skin rash.

Tell your doctor if you have serious side effects of Micardis including:

  • fainting,
  • unusual change in the amount of urine, or
  • symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

Dosage of Micardis is individualized. The usual starting dose is 40 mg once a day. Micardis may interact with diuretics (water pills), or digoxin. Tell your doctor all medications you are taking. Micardis is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Micardis (telmisartan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Micardis Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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 unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urinating;
  • swelling, rapid weight gain; or
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

  • stuffy nose, sinus pain;
  • back pain; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Micardis (Telmisartan)

Micardis Professional Information

SIDE EFFECTS

The following adverse reaction is described elsewhere in labeling:

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.

Hypertension

MICARDIS has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of MICARDIS (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with MICARDIS and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with MICARDIS and at a Greater Rate Than Patients Treated with Placebo

  Telmisartan
n=1455
%
Placebo
n=380
%
Upper respiratory tract infection 7 6
Back pain 3 1
Sinusitis 3 2
Diarrhea 3 2
Pharyngitis 1 0

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with MICARDIS tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.

The incidence of cough occurring with telmisartan in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with MICARDIS monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to MICARDIS tablets:

Autonomic Nervous System: impotence, increased sweating, flushing;

Body as a Whole: allergy, fever, leg pain, malaise;

Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG;

CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia;

Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, nonspecific gastrointestinal disorders;

Metabolic: gout, hypercholesterolemia, diabetes mellitus;

Musculoskeletal: arthritis, arthralgia, leg cramps;

Psychiatric: anxiety, depression, nervousness;

Resistance Mechanism: infection, fungal infection, abscess, otitis media;

Respiratory: asthma, bronchitis, rhinitis, dyspnea, epistaxis;

Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis;

Vascular: cerebrovascular disorder;

Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of MICARDIS tablets.

Hemoglobin

A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% telmisartan patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine

A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients compared with 0.3% placebo patients. One telmisartan-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

Liver Enzymes

Occasional elevations of liver chemistries occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of telmisartan in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of telmisartan for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on telmisartan and 7.6% on placebo. The only serious adverse events at least 1% more common on telmisartan than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MICARDIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to MICARDIS.

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including MICARDIS.

Read the entire FDA prescribing information for Micardis (Telmisartan)

Related Resources for Micardis

Read the Micardis User Reviews »

© Micardis Patient Information is supplied by Cerner Multum, Inc. and Micardis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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