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Micardis

Last reviewed on RxList: 8/11/2020
Micardis Side Effects Center

What Is Micardis?

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.

What Are Side Effects of Micardis?

Common side effects of Micardis include:

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 for Micardis

Dosage of Micardis is individualized. The usual starting dose is 40 mg once a day.

What Drugs, Substances, or Supplements Interact with Micardis?

Micardis may interact with diuretics (water pills), or digoxin. Tell your doctor all medications you are taking.

Micardis During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

Salt and sodium are the same. See Answer
Micardis Consumer Information

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Get emergency medical help if you have 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, or dark colored urine.

Also call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • swelling, rapid weight gain; or
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

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)

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow
Micardis Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in labeling:

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction 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.

MICARDIS HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.

Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies].

Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo*

  Telmisartan/ Hydrochlorothiazide
(n = 414)
Placebo
(n = 74)
Telmisartan
(n = 209)
Hydrochlorothiazide
(n = 121)
Body as a whole        
  Fatigue 3% 1% 3% 3%
  Influenza-like symptoms 2% 1% 2% 3%
Central/Peripheral nervous system        
  Dizziness 5% 1% 4% 6%
Gastrointestinal system        
  Diarrhea 3% 0% 5% 2%
  Nausea 2% 0% 1% 2%
Respiratory system disorder        
  Sinusitis 4% 3% 3% 6%
  Upper respiratory tract infection 8% 7% 7% 10%
* includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof

Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis.

Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.

Telmisartan

Other adverse events that have been reported with telmisartan are listed below:

Autonomic Nervous System: impotence, increased sweating, flushing

Body as a Whole: allergy, fever, leg pain, chest pain

Cardiovascular: palpitation, angina pectoris, abnormal ECG, hypertension, peripheral edema

Central Nervous System: insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoesthesia

Gastrointestinal: flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache

Hepato-biliary: elevations of liver enzymes or serum bilirubin

Metabolic: gout, hypercholesterolemia, diabetes mellitus

Musculoskeletal: arthritis, arthralgia, leg cramps, myalgia

Psychiatric: anxiety, depression, nervousness

Resistance Mechanism: infection, abscess, otitis media

Respiratory: asthma, rhinitis, dyspnea, epistaxis

Skin: dermatitis, eczema, pruritus

Urinary: micturition frequency, cystitis

Vascular: cerebrovascular disorder

Special Senses: abnormal vision, conjunctivitis, tinnitus, earache

Hydrochlorothiazide

Other adverse events that have been reported with hydrochlorothiazide are listed below:

Body as a Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Metabolic: hyperglycemia, glycosuria

Musculoskeletal: muscle spasm

Nervous System/Psychiatric: restlessness

Renal: interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: transient blurred vision, xanthopsia

Clinical Laboratory Findings

Creatinine, Blood Urea Nitrogen (BUN)

Increases in BUN (≥11.2 mg/dL) and serum creatinine (≥0.5 mg/dL) were observed in 2.8% and 1.4%, respectively, of patients with essential hypertension treated with MICARDIS HCT tablets in controlled trials. No patient discontinued treatment with MICARDIS HCT tablets because of an increase in BUN or creatinine [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MICARDIS HCT. 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.

Blood and Lymphatic System Disorders: eosinophilia

Cardiac Disorders: atrial fibrillation, congestive heart failure, myocardial infarction, tachycardia, bradycardia

Ear and Labyrinth Disorders: vertigo

General Disorders and Administration Site Conditions: asthenia, edema

Hepato-biliary: Abnormal hepatic function/liver disorder

Immune System Disorders: anaphylactic reaction

Infections and Infestations: urinary tract infection

Investigations: increased CPK

Metabolism and Nutrition Disorders: hypoglycemia (in diabetic patients)

Musculoskeletal and Connective Tissue Disorders: tendon pain (including tendonitis, tenosynovitis), rhabdomyolysis

Nervous System Disorders: syncope, headache

Renal and Urinary Disorders: renal failure, renal impairment including acute renal failure

Reproductive System and Breast Disorders: erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders: coughing

Skin and Subcutaneous Tissue Disorders: drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), angioedema (with fatal outcome)

Vascular Disorder: orthostatic hypotension

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.

QUESTION

Salt and sodium are the same. See Answer

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