Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Amiloride HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq 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 amiloride HCl 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 amiloride HCl).
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 amiloride HCl and these adverse reactions, some of which have been reported only rarely.
*Reactions occurring in 3% to 8% of patients treated with amiloride HCl.
WARNINGS Hyperkalemia Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal.
Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic.
This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly.
When amiloride is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2%.
It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function.
Like all medications, Amiloride Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: