Micardis
- Generic Name: telmisartan
- Brand Name: Micardis
Micardis (Telmisartan) side effects drug center
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:
- 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 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.
Micardis Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Also call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- little or no urination;
- swelling in your feet or ankles, rapid weight gain;
- unusual pain or tightness in your lower body;
- a skin ulcer; 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)
Micardis Professional Information
SIDE EFFECTS
The following adverse reactions are discussed elsewhere in labeling:
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Electrolytes and Metabolic Disorders [see WARNINGS AND PRECAUTIONS]
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)
&Copy; 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.