Micardis HCT Side Effects

Please note - some side effects for Micardis HCT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Micardis HCT - for the Consumer

Micardis HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Micardis HCT:

Diarrhea; dizziness; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Micardis HCT:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion; decrease in sexual ability; decreased, difficult, or painful urination; depression; drowsiness; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased or excessive sweating; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness or light-headedness; severe or persistent dry mouth, nausea, or stomach pain; shortness of breath; sluggishness; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, decreased vision clearness); vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Micardis HCT Side Effects - for the Professional

Micardis HCT

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	Placebo	Telm	HCTZ
	(N=414)	(N=74)	(N=209)	(N=121)
	(%)	(%)	(%)	(%)
* includes all doses of telmisartan (20-160 mg), hydrochlorothiazide (6.25-25 mg), and combinations thereof
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

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.

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Side Effects by Body System - for Healthcare Professionals

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%).

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