Hyzaar Side Effects

Generic name: hydrochlorothiazide / losartan

Note: This document contains side effect information about hydrochlorothiazide / losartan. Some of the dosage forms listed on this page may not apply to the brand name Hyzaar.

Some side effects of Hyzaar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to hydrochlorothiazide / losartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking hydrochlorothiazide / losartan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and losartan 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:

• eye pain, vision problems;

• a light-headed feeling, like you might pass out;

• swelling, rapid weight gain, little or no urinating;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• fast or pounding heartbeats;

• pale skin, easy bruising or bleeding;

• jaundice (yellowing of the skin or eyes); or

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

• stomach pain;

• back pain;

• dizziness, tired feeling;

• skin rash;

• runny or stuffy nose, sore throat; or

• dry cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to hydrochlorothiazide / losartan: oral tablet

General

Hydrochlorothiazide-losartan is generally well-tolerated. The overall incidence of adverse experiences reported with losartan monotherapy appears to be similar to placebo. For the most part, side effects associated with the combination drug are transient and mild. In controlled clinical trials, discontinuation of therapy due to adverse drug events has been reported in 2.5% and 2.3% of patients treated with the combination and placebo, respectively.

General side effects reported postmarketing have included malaise thought to be related to the losartan component.

Metabolic

Since HCTZ may increase total serum cholesterol by 11%, LDL lipoprotein cholesterol by 12%, and VLDL lipoprotein cholesterol levels by 50%, and since it may reduce insulin secretion, it should be used with caution in patients with hypercholesterolemia and/or diabetes.

HCTZ-induced hyperuricemia may be an important consideration in patients with a history of gout. Hypophosphatemia and low serum magnesium concentrations may occur, but are usually clinically insignificant except in malnourished patients.

Metabolic side effects associated with HCTZ are more commonly associated with daily HCTZ doses of 50 mg or more, which are not recommended with the combination product. These side effects may occur at lower doses, however, and include mild hypokalemia (decrease of 0.5 mEq/L), metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, hypercholesterolemia and elevated serum uric acid levels.

Hypersensitivity

Hypersensitivity reactions typically present as nausea, vomiting, diarrhea, and rash, and are probably due to the HCTZ component. Hypersensitivity is reported in less than 1% of patients. Cases of acute pulmonary edema, interstitial cystitis or nephritis, and anaphylaxis have also been associated with HCTZ.

Cardiovascular

Cardiovascular side effects associated with losartan include dizziness in 5.7% (vs. 2.9% in placebo-treated subjects) and orthostatic hypotension. Rarely, HCTZ-induced hypokalemia or hyponatremia have been associated with significant cardiac arrhythmias including ventricular ectopy and complete AV heart block. Hypokalemia is much less likely with the combination drug, however, since losartan inhibits aldosterone secretion. Fingernail clubbing has also been associated with the use of losartan. In addition, angioneurotic edema has been reported during losartan therapy.

Nervous system

Nervous system side effects associated with losartan include headache in up to 14%, asthenia/fatigue in 4%, insomnia in 1% of patients, and rare cases of ageusia (altered tasted) and migraine headache. Rare cases of cerebrovascular insufficiency have been associated with HCTZ induced plasma volume contraction. Dysgeusia has been reported with losartan in postmarketing experience.

Dermatologic

A 67-year-old white 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.

Dermatologic reactions associated with HCTZ include erythema annular centrifugum, acute eczematous dermatitis, and morbilliform or leukocytoclastic vasculitis. 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 associated with HCTZ. Erythroderma has been reported with losartan in postmarketing experience.

Renal

The increase in plasma renin activity associated with losartan is relatively small compared with those increases associated with ACE inhibitors. These blunted increases do not appear to affect the antihypertensive response to the antagonist.

In one study of patients with significant proteinuria and moderate renal insufficiency (average creatinine clearance > 60 mL/min), losartan 50 to 100 mg/day was associated with significantly increased renal plasma flow and significantly decreased urinary excretion of total protein, albumin, and immunoglobulin.

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

Renal side effects including new or worsened renal insufficiency may occur due to HCTZ-induced intravascular volume depletion. Rare cases of interstitial nephritis have been associated with HCTZ. Decreased renal function or hyperkalemia has only rarely been associated with losartan, although experience with this drug is limited compared with the related compounds, the ACE inhibitors. The effects of losartan and ACE inhibitors on renal hemodynamics and kidney function are similar. In addition, acute renal failure associated with losartan therapy has been reported in at least one patient with bilateral renal artery stenosis.

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 were reported in the 1960's, although these patients were on a combination HCTZ-potassium product.

Gastrointestinal complaints have been reported in less than 2% of patients, and have included loose bowel movements, dyspepsia, epigastric discomfort, and nausea. Rare cases of pancreatitis and acute cholecystitis have been associated with HCTZ. Dysgeusia, ageusia, and oral ulcers associated with losartan therapy have been rarely reported. Acute pancreatitis has also been associated with losartan use.

Respiratory

Respiratory system side effects are rare. Cough has been reported in 3.4% of treated patients and 3.3% of patients taking placebo. One comparative study has shown that losartan reduces coughing in patients who have a history of cough associated with ACE inhibitors. However, cases of cough, including rechallenge, have been associated with losartan use in postmarketing research. Nasal congestion has been reported in 1% to 2% of patients. Approximately 30 cases of acute noncardiogenic pulmonary edema have been associated with thiazide diuretics. These cases have been thought to be due to idiosyncrasy or a hypersensitivity mechanism.

Musculoskeletal

Musculoskeletal side effects including back or leg pain have been reported in approximately 1% of patients, compared to 0% with placebo. In addition, rare reports of rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Immunologic

Immunologic side effects are rare, and include cases of allergic vasculitis and hemolytic anemia associated with HCTZ. A case of Henoch-Schonlein purpura with a high titer of x-specific antineutrophil cytoplasmic antibodies (xANCA) has been associated with losartan therapy.

Hematologic

Hematologic side effects are rare. Cases of immune-complex hemolytic anemia, aplastic anemia, and thrombocytopenia have been associated with HCTZ. Hematologic side effects associated with losartan have included reports of small decreases in hemoglobin and hematocrit in which no patients were discontinued due to anemia. In addition, anemia has been reported in renal transplant recipients (not having posttransplant erythrocytosis) treated with losartan. Losartan has also been implicated in a case of immune thrombocytopenia. Thrombocytopenia has also been noted in postmarketing experience with losartan.

Endocrine

A prospective study of 34 patients who received oral thiazide diuretics for 14 years without interruption revealed an increased mean fasting blood glucose level after treatment. Withdrawal of thiazide therapy for 7 months in 10 of the patients resulted in mean reductions of 10% in the average fasting blood glucose value and 25% in the average 2-hour glucose tolerance test value. A control group was not reported.

Endocrinologic problems associated with thiazide diuretics include glucose intolerance and a potentially deleterious effect on the lipid profile. This may be important in some patients with or who are at risk for diabetes or coronary artery disease.

Hepatic

Hepatic side effects including increases in hepatic enzymes and serum bilirubin have been reported only occasionally with losartan. Less than 0.1% of patients from large-scale controlled trials discontinued losartan therapy due to increased liver function tests. Hepatitis has been reported rarely with losartan therapy.

Ocular

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

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