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Micardis HCT Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Micardis HCT (telmisartan and hydrochlorothiazide) is used to treat high blood pressure (hypertension). Micardis HCT is a combination of telmisartan, which is in the drug class called angiotensin II receptor antagonists, and hydrochlorothiazide, a thiazide diuretic (water pill). Common side effects include dizziness, lightheadedness, and blurred vision as your body adjusts to the medication.
The dosage of Micardis HCT is based on your medical condition and response to treatment. Micardis HCT may interact with other blood pressure medications, digoxin, blood thinners, steroids, lithium, cholestyramine, colestipol, insulin or diabetes medications you take by mouth, barbiturates, other diuretics, aspirin, NSAIDs (non-steroidal anti-inflammatory drugs), muscle relaxers, or narcotics. Tell your doctor all medications you are taking. Micardis HCT is not recommended for use during pregnancy due to the risk for harm to the fetus. This medication passes into breast milk. Consult your doctor before breast-feeding.
Our Micardis HCT 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Micardis HCT in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, hydrochlorothiazide and 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 muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.
Stop using this medication and call your doctor at once if you have any other serious side effects, such as:
- eye pain, vision problems;
- feeling light-headed, fainting;
- swelling, rapid weight gain;
- fast or pounding heartbeats;
- urinating less than usual, or not at all;
- jaundice (yellowing of the skin or eyes); or
- dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).
Less serious side effects may include:
- stomach pain, diarrhea;
- back pain;
- headache, tired feeling, dizziness;
- skin rash;
- stuffy nose, sore throat; or
- dry cough.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Micardis HCT (Telmisartan, Hydrochlorothiazide) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Micardis HCT Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.
Tell your doctor right away if you have any serious side effects, including: fainting, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), toe/joint pain, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), decrease in vision, eye pain.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Micardis HCT (Telmisartan, Hydrochlorothiazide)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Micardis HCT FDA Prescribing Information: Side Effects
Micardis® HCT (telmisartan and hydrochlorothiazide) tablets has been evaluated for safety in over 1700 patients, including 716 treated for over six months and 420 for over one year. In clinical trials with MICARDIS HCT tablets, no unexpected adverse events have been observed. Adverse experiences have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide. The overall incidence of adverse experiences reported with the combination was comparable to placebo. Most adverse experiences were mild in intensity and transient in nature and did not require discontinuation of therapy.
Adverse events occurring at an incidence of 2% or more in patients treated with telmisartan/hydrochlorothiazide 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 in ≥ 2%
of Telmisartan/Hydrochlorothiazide (HCTZ) Patients*
|Body as a whole|
|Central/peripheral nervous system|
|Respiratory system disorder|
|Upper respiratory tract infection||8||7||7||10|
|* includes all doses of telmisartan (20-160 mg), hydrochlorothiazide (6.25-25 mg), and combinations thereof|
The following adverse events were reported at a rate less than 2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo: back pain, dyspepsia, vomiting, tachycardia, hypokalemia, bronchitis, pharyngitis, rash, hypotension postural, abdominal pain.
Finally, the following adverse events were reported at a rate of 2% or greater in patients treated with telmisartan/hydrochlorothiazide, but were as, or more common in the placebo group: pain, headache, cough, urinary tract infection.
Adverse events occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.
In controlled trials (n=1017), 0.3% of patients treated with Micardis® HCT (telmisartan and hydrochlorothiazide) tablets 40/12.5 mg, 80/12.5 mg or 80/25 mg discontinued due to orthostatic hypotension, and the incidence of dizziness was 4%, 7%, and 1%, respectively.
Other adverse experiences that have been reported with telmisartan, without regard to causality, are listed below:
Vascular : cerebrovascular disorder
A single case of angioedema was reported (among a total of 3781 patients treated with telmisartan).
Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body as a whole : weakness
Hypersensitivity : purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
Musculoskeletal : muscle spasm
Nervous System/Psychiatric : restlessness
Renal : renal failure, renal dysfunction, interstitial nephritis
The following adverse reactions have been identified during post-approval use of Micardis® (telmisartan) tablets. 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 tablets. The most frequently 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 tablets.
Clinical Laboratory Findings
In controlled trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Micardis® HCT (telmisartan and hydrochlorothiazide) tablets.
Hemoglobin and Hematocrit : Decreases in hemoglobin ( ≥ 2 g/dL) and hematocrit ( ≥ 9%) were observed in 1.2% and 0.6% of telmisartan/hydrochlorothiazide patients, respectively, in controlled trials. Changes in hemoglobin and hematocrit were not considered clinically significant and there were no discontinuations due to anemia.
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 due to an increase in BUN or creatinine.
Liver Function Tests : Occasional elevations of liver enzymes and/or serum bilirubin have occurred. No telmisartan/hydrochlorothiazide treated patients discontinued therapy due to abnormal hepatic function.
Serum Electrolytes : See PRECAUTIONS.
Read the entire FDA prescribing information for Micardis HCT (Telmisartan, Hydrochlorothiazide) »
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