Micardis HCT Side Effects

Generic Name: hydrochlorothiazide / telmisartan

Note: This page contains information about the side effects of hydrochlorothiazide / telmisartan. Some of the dosage forms included on this document may not apply to the brand name Micardis HCT.

Not all side effects for Micardis HCT may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to hydrochlorothiazide / telmisartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by hydrochlorothiazide / telmisartan. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking hydrochlorothiazide / telmisartan:

Less common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • confusion
  • convulsions
  • decreased urine
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • sudden sweating
  • unusual tiredness or weakness
Less common or rare
  • Chills
  • cold sweats
Rare
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some of the side effects that can occur with hydrochlorothiazide / telmisartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Body aches or pain
  • cough
  • difficulty breathing
  • dizziness
  • ear congestion
  • fever
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
Less common
  • Abdominal or stomach pain
  • acid or sour stomach
  • back pain
  • belching
  • cough producing mucus
  • diarrhea
  • heartburn
  • hoarseness
  • indigestion
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • pain or tenderness around the eyes and cheekbones
  • rash
  • shivering
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble sleeping
  • trouble swallowing
  • voice changes

For Healthcare Professionals

Applies to hydrochlorothiazide / telmisartan: oral tablet

General

In general, prior to approval by the FDA, hydrochlorothiazide-telmisartan was evaluated for safety in more than 1,700 patients, including over 700 treated for over 6 months, and 420 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse experiences associated with the use of hydrochlorothiazide-telmisartan was comparable to placebo or to monotherapy with telmisartan or hydrochlorothiazide. The overall frequency of adverse experiences was not related to gender, age, or race.

Cardiovascular

Cardiovascular side effects associated with hydrochlorothiazide-telmisartan including tachycardia and orthostatic hypotension have been reported in less than 2% of patients. Cardiac arrhythmias, ventricular ectopy, and complete AV heart block that are associated with hypokalemia and hyponatremia have been reported with the use of HCTZ. Hypotension has been reported in association with HCTZ-induced pulmonary edema.

Cardiovascular side effects associated with the use of angiotensin II receptor inhibitors have included dizziness (related to orthostatic hypotension), palpitations, and chest pain. Cardiovascular side effects for telmisartan in relation to comparator therapy have included peripheral edema (1.0% vs. 0.0%). Chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, increased blood pressure, aggravated hypertension, hypotension, and postural hypotension have been reported with the use of telmisartan in postmarketing experience.

In controlled clinical trials, discontinuation of therapy due to orthostatic hypotension occurred in 0.2% of treated patients.

Orthostatic hypotension may occur and may rarely be associated with syncope, particularly in the elderly.

Dermatologic

Dermatologic side effects associated with HCTZ have included case reports of erythema annulare centrifugum and acute eczematous dermatitis. Thiazides may induce phototoxic dermatitis. In addition, a rare, distinct entity with clinical and laboratory features indistinguishable from those of subacute cutaneous lupus erythematosus has been reported with the use of HCTZ. Rash has been reported in less than 1% of patients.

Dermatologic side effects associated with telmisartan including pruritus, rash, eczema, and general dermatitis have been reported rarely and at rates similar to placebo.

A 67-year-old woman with hypothyroidism, hypercalcemia, depression, and hypertension developed facial erythema, headaches, tremors, confusion and personality changes associated with a new positive ANA and anti-nRNP, and a skin biopsy consistent with lupus erythematosus while taking HCTZ, levothyroxine, and amitriptyline. The eruption resolved upon discontinuation of HCTZ, but she later developed a higher ANA titer associated with symptomatic diffuse interstitial pulmonary infiltrates. She was successfully treated with corticosteroids.

Endocrine

Endocrinologic side effects associated with thiazide diuretics have been reported rarely. A single case of recurrent parathyroid adenoma is reported, although the association is probably coincidental.

Gastrointestinal

Thiazide diuretics may increase serum cholesterol and triglycerides, resulting in increased risk of cholesterol gallstone formation. Reports of bowel strictures associated with thiazide ingestion have been reported, although these patients were on a combination HCTZ-potassium product.

Gastrointestinal side effects associated with HCTZ have been reported rarely. These have included case reports of pancreatitis and acute cholecystitis. Nausea, vomiting, and diarrhea have been reported in less than 1% of patients. Bowel strictures have been reported.

Gastrointestinal effects associated with telmisartan have including diarrhea (3%), flatulence, abdominal pain, nausea, constipation, gastritis, vomiting, dry mouth, dyspepsia, hemorrhoids, gastroenteritis, enteritis, and gastroesophageal reflux have been reported in less than 1% of patients and at rates similar to placebo. A case of acute pancreatitis has been reported. Cholecystitis and cholelithiasis have been reported.

Genitourinary

Genitourinary side effects associated with telmisartan have been reported extremely rarely and at rates similar to placebo. These have included impotence, urinary frequency, and cystitis. Interstitial cystitis has been reported rarely. Urinary tract infection and erectile dysfunction have been reported during postmarketing experience. Endometriosis has been reported.

Hematologic

Hematologic side effects associated with HCTZ have been reported rarely. Cases of immune-complex hemolytic anemia, aplastic anemia, and thrombocytopenia have been reported.

Hematologic side effects associated with telmisartan have been reported rarely. Decreased hemoglobin (greater than 2 g/dL) has been reported in 0.8% of patients compared to 0.3% in placebo. Granuloma has been reported.

Hepatic

Hepatic side effects associated with telmisartan including occasional elevations of serum hepatic enzymes have been reported rarely and in some studies at rates slightly greater than placebo.

Hypersensitivity

There have been approximately 34 known cases of thiazide-induced pulmonary edema, encompassing 52 episodes of pulmonary edema. In some cases, doses as small as 12.5 mg were associated with the development of pulmonary edema. The average time to onset of this adverse reaction is 44 minutes, women carry a relative risk of 9 to 1, and the average age is 56 years. The mortality rate is 6%. Some experts consider this side effect grossly underreported. These cases of acute noncardiogenic pulmonary edema are thought to be due to idiosyncrasy or a hypersensitivity mechanism.

Hypersensitivity side effects associated with HCTZ have been reported rarely. Cases of acute pulmonary edema and anaphylaxis have been reported. These have included approximately 30 case reports of acute noncardiogenic pulmonary edema. Morbilliform and leukocytoclastic vasculitis have been reported.

Hypersensitivity side effects associated with telmisartan including edema, face edema, lower limb edema, angioneurotic edema, hypersensitivity, erythema, angioedema, and urticaria have been reported during postmarketing experience. Angioedema has been reported with the use of angiotensin II receptor inhibitors.

Immunologic

Immunologic side effects associated with HCTZ have included numerous case reports of patients developing a rash histologically identical to subacute cutaneous lupus following HCTZ administration.

A 53-year-old man with hypertension developed nausea, vomiting, diarrhea, and progressive anorexia and weakness associated with scleral icterus, anemia with spherocytosis, dark red urine with proteinuria, bilirubinuria, hemoglobinuria, and elevated lactic dehydrogenase levels 18 months after beginning hydrochlorothiazide and methyldopa. Haptoglobin was less than 50 mg per dl. Direct and indirect Coombs tests were positive. The patient died suddenly; autopsy revealed no obvious cause of death, left ventricular hypertrophy, and mild coronary atherosclerosis.

Metabolic

Metabolic side effects associated with HCTZ have been reported frequently, especially when doses greater than 50 mg per day are used. These have included glucose intolerance (3%), metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, and elevated serum uric acid levels. Mild hypokalemia (decrease of 0.5 mEq/L) have been reported in up to 50% of patients, and may predispose patients to cardiac arrhythmias. Increased (by 11%) total serum cholesterol, increased (by 12%) LDL lipoprotein cholesterol, and increased (by 50%) VLDL lipoprotein cholesterol have been reported.

Metabolic side effects associated with the use of telmisartan including gout, hypercholesterolemia, and hyperglycemia have been reported in less than 1% of patients. Causal relationships have not been shown, and these abnormalities were also noted among placebo patients. Hyperkalemia has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects associated with hydrochlorothiazide have rarely included case reports of myalgias.

Musculoskeletal side effects associated with telmisartan including back pain has been reported in 3% of patients and at rates similar to placebo. Arthritis, arthralgias, myalgias, and leg pain have been reported in less than 1% of patients and at rates similar to placebo. Rhabdomyolysis has been reported during postmarketing experience in patients receiving angiotensin II receptor blockers including telmisartan. Muscle cramps (including leg cramps), and tendon pain (including tendonitis, tenosynovitis), myalgia, peripheral ischemia, and elevated creatine phosphokinase (CPK) have also been reported during postmarketing experience.

Nervous system

Although extremely rare cases of stroke have occurred during therapy with telmisartan, there is an expected incidence of stroke among all patients with hypertension.

Nervous system side effects including cerebrovascular insufficiency have been associated with HCTZ-induced plasma volume contraction.

Nervous system side effects associated with telmisartan including headache have been reported in 1% to 3.5% of patients.
Dizziness has been reported in up to 3.5% of patients. Pain, insomnia, somnolence, migraine, vertigo, tinnitus, paresthesias, involuntary muscle contractions, and hypoesthesias have been reported in less than 1% of patients and at rates similar to placebo. Stroke has been reported rarely. Asthenia, weakness, and syncope have been reported during postmarketing experience.

Ocular

Ocular side effects have included idiosyncratic reactions to the hydrochlorothiazide component resulting in acute transient myopia and acute angle-closure glaucoma.

Ocular side effects associated with telmisartan have rarely included abnormal vision and conjunctivitis.

Psychiatric

Psychiatric side effects associated with telmisartan have rarely included anxiety, depression, and nervousness.

Renal

Although hydrochlorothiazide has been used to treat nephrogenic diabetes insipidus, a case report in which the drug was believed to have caused this condition has been reported.

In some patients whose renal function is dependent upon the renin-angiotensin-aldosterone (RAA) system, such as patients with severe congestive heart failure, use of angiotensin II receptor inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death.

As with ACE inhibitors, use of angiotensin II receptor inhibitors can lead to increases in BUN and serum creatinine in patients with unilateral or bilateral renal artery stenosis.

Renal side effects including renal insufficiency manifesting as an increased serum creatinine and BUN have been reported due to HCTZ-induced intravascular volume depletion. Rare cases of interstitial nephritis have been reported and at a rate similar to placebo. A case of nephrogenic diabetes insipidus has been reported.

Renal side effects associated with telmisartan have been reported rarely. Increased (0.5 mg/dL or greater) serum creatinine (0.4% vs. 0.3% in placebo) and increased BUN has been reported. Oliguria and/or progressive azotemia have been reported with the use of angiotensin II receptor inhibitors. Rarely, acute renal failure and/or death have been reported.

Respiratory

Angiotensin II receptor blockade, unlike ACE inhibition, has no impact on the processing of peptides such as bradykinin and substance P, two peptides associated with the induction of cough.

Respiratory side effects associated with telmisartan including upper respiratory infections, sinusitis, and pharyngitis have been reported in 1% to 7% of patients and at rates similar to placebo. Bronchitis has been reported. Cough has been reported in 1.6% of patients at rates similar to placebo during postmarketing experience. Acute sinusitis has been reported.

Other

Other side effects associated with hydrochlorothiazide-telmisartan have included flu-like symptoms. Earaches and fatigue has been reported in less than 1% of patients and at rates similar to placebo. Chills have been reported rarely.

Other side effects for telmisartan in relation to comparator therapy have included fatigue (3.5% vs. 8.6%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)