Amiloride/Hydrochlorothiazide Side Effects

Please note - some side effects for Amiloride/Hydrochlorothiazide 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 Amiloride/Hydrochlorothiazide - for the Consumer

Amiloride/Hydrochlorothiazide

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 Amiloride/Hydrochlorothiazide:

Changes in blood sugar; constipation; dizziness; fatigue; headache; inflammation of a salivary gland; loss of appetite; nausea; sensitivity to sunlight; stomach pain; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dry mouth; excessive thirst; impotence; leg or muscle cramps; mental confusion; rapid, weak, or irregular heartbeat; stomach pain; urination problems; vomiting; yellowing of 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.

Side Effects by Body System - for Healthcare Professionals

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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