Midamor Side Effects

Generic Name: amiloride

Please note - some side effects for Midamor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Midamor - for the Consumer

Midamor

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 Midamor:

Diarrhea; headache; loss of appetite; nausea; 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; slowed heart rate; unusual muscle weakness; unusual tiredness; vomiting.

Midamor Side Effects - for the Professional

Midamor

Midamor is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq per liter — see WARNINGS), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride are generally those known to be associated with diuresis, or with the underlying disease being treated.

The adverse reactions for Midamor listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with Midamor). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between Midamor and these adverse reactions, some of which have been reported only rarely.

Causal Relationship Unknown

Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

 

Activation of probable pre-existing peptic ulcer

 

Aplastic anemia

 

Neutropenia

 

Abnormal liver function

Side Effects by Body System

Metabolic

Cases of severe hyponatremia have been reported during hydrochlorothiazide-amiloride therapy. In 3 cases, the patients subsequently did well with hydrochlorothiazide and potassium supplementation, suggesting a significant role for amiloride in the development of their hyponatremia.

Significantly elevated serum uric acid, cholesterol, and triglyceride levels have been associated with combination hydrochlorothiazide-amiloride therapy. These metabolic abnormalities may not be due to amiloride since they are reported during hydrochlorothiazide monotherapy.

Amiloride is known to cause significant elevations in serum aldosterone, renin, and angiotensin II levels.

Metabolic side effects are the most common. Amiloride may cause hyperkalemia in up to 10% of patients, although the risk is decreased to about 1% to 2% when thiazide or loop diuretics are coadministered. Patients with diabetes or who are on other potassium-sparing therapy, ACE inhibitors, or potassium supplementation are predisposed to amiloride-induced hyperkalemia.

Renal

Renal side effects including renal insufficiency is unusual after amiloride monotherapy because it is only a weak diuretic.

Gastrointestinal

Gastrointestinal complaints of diarrhea, nausea, constipation, anorexia, and general abdominal pain occur less than 5% of patients.

Nervous system

Nervous system side effects occur in less than 3% of patients, and include headache, weakness, and fatigue. Encephalopathy may be induced by amiloride-associated metabolic changes in some patients with severe liver disease.

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 are reported in less than 1% of patients.

Genitourinary

Genitourinary problems include rare complaints of impotence. Polyuria and urinary frequency are reported in less than 1% of patients.

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