Moduretic Side Effects

Generic name: amiloride / hydrochlorothiazide

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

Some side effects of Moduretic 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 amiloride / hydrochlorothiazide: oral tablet

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• eye pain, vision problems;

• numbness or tingly feeling;

• muscle pain or weakness;

• slow, fast, or uneven heartbeat;

• feeling drowsy, restless, or light-headed;

• urinating less than usual or not at all;

• dry mouth, increased thirst, tiredness, nausea, vomiting;

• shallow breathing;

• tremors, confusion; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of amiloride / hydrochlorothiazide may include:

• mild nausea or vomiting;

• gas, stomach pain; or

• skin rash.

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 amiloride / hydrochlorothiazide: oral tablet

Metabolic

Cases of severe hyperkalemia associated with paralysis, cardiac arrhythmias, and even death have been reported.

Patients who are at particular risk for thiazide-induced hyponatremia include the elderly, frail women, and those with hypovolemia or who are in the postoperative state. In the latter two cases, antidiuretic hormone levels tend to be elevated, which may contribute to the development of hyponatremia.

Hyperkalemia is more likely in patients with underlying renal dysfunction.

Metabolic side effects are common. Hyperkalemia occurs in 1% to 2% of patients. Hyperkalemia is more likely in women, patients with diabetes (even without signs of diabetic nephropathy), and patients with renal insufficiency. Hyponatremia may occur in up to 20% of patients.

Increases in serum uric acid, total cholesterol, and total triglycerides have been associated with the use of HCTZ. This may be important in some patients at risk for or who have a history of gout or coronary artery disease.

Hypersensitivity

A 50-year-old woman with a history of congestive heart failure developed acute noncardiogenic pulmonary edema within 10 minutes after ingesting HCTZ-amiloride. Inadvertent rechallenge resulted in a recurrence. Subsequent selective skin patch testing revealed an allergy to HCTZ and not to amiloride.

Hypersensitivity reactions to HCTZ-amiloride are rare. A case of allergic pneumonitis and noncardiogenic pulmonary edema has been associated with the use of this drug. Acute pulmonary edema, interstitial cystitis, interstitial nephritis, and anaphylaxis have been associated with the use of HCTZ.

Genitourinary

Genitourinary problems include rare complaints of impotence among male patients. Polyuria and urinary frequency have been reported in less than 1% of patients.

Gastrointestinal

Gastrointestinal side effects are unusual. Diarrhea, nausea, constipation, anorexia, and general abdominal pain occur in less than 5% of patients.

Rare instances of pancreatitis and acute cholecystitis have been associated with the use of HCTZ.

Nervous system

Nervous system side effects occur in less than 3% of patients. They include headache, weakness, and fatigue.

Cardiovascular

Cardiovascular side effects are mainly limited to the increased risk of hyperkalemia-induced arrhythmias in patients at risk for arrhythmias. Angina pectoris, arrhythmias, and orthostatic hypotension have been reported in less than 1% of patients.

Dermatologic

Dermatologic side effects associated with hydrochlorothiazide (HCTZ) include isolated cases of subacute cutaneous lupus, erythema annular centrifugum, and acute eczematous dermatitis. Thiazides may induce phototoxic dermatitis.

Renal

A 74-year-old woman developed acute renal failure and granulomatous interstitial nephritis during amiloride-HCTZ therapy. Her renal function slightly improved after stopping the drug and after 20 months of oral steroid therapy.

New or worsened renal insufficiency has rarely been associated with each component of this drug. Granulomatous interstitial nephritis has been associated with amiloride-HCTZ.

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