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Micardis HCT

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Micardis HCT

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 unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have a side effect such as:

  • feeling like you might pass out;
  • eye pain, vision problems;
  • swelling, rapid weight gain;
  • fast or pounding heartbeats;
  • urinating less than usual or not at all;
  • jaundice (yellowing of the skin or eyes);
  • low sodium (slurred speech, hallucinations, vomiting, severe weakness, loss of coordination, feeling unsteady, seizure (convulsions), shallow breathing); or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, limp feeling).

Other common side effects may include:

  • tired feeling;
  • flu symptoms;
  • nausea, diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 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

SIDE EFFECTS: Dizziness and lightheadedness may occur as your body adjusts to the medication. Tiredness and diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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
(Adverse Reactions)

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*

  Telm/HCTZ
(N=414)
(%)
Placebo
(N=74)
(%)
Telm
(N=209)
(%)
HCTZ
(N=121)
(%)
Body as a whole
  Fatisue 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 (20-160 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.

Telmisartan

Other adverse experiences that have been reported with telmisartan, without regard to causality, are listed below:

Autonomic Nervous System : impotence, increased sweating, flushing

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

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

CNS : insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoaesthesia

Gastrointestinal : flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders

Metabolic : gout, hypercholesterolemia, diabetes mellitus

Musculoskeletal : arthritis, arthralgia, leg cramps, myalgia

Psychiatric : anxiety, depression, nervousness

Resistance Mechanism : infection, fungal 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

A single case of angioedema was reported (among a total of 3781 patients treated with telmisartan).

Hydrochlorothiazide

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, 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, hyperuricemia

Musculoskeletal : muscle spasm

Nervous System/Psychiatric : restlessness

Renal : renal failure, renal dysfunction, interstitial nephritis

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

Special Senses : transient blurred vision, xanthopsia

Post-Marketing Experience

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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Micardis HCT - User Reviews

Micardis HCT User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Micardis HCT sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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