MODURETIC (amiloride and hydrochlorothiazide) is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with MODURETIC (amiloride and hydrochlorothiazide) is about 1-2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS). Minor adverse reactions to amiloride HCl have been 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 MODURETIC (amiloride and hydrochlorothiazide) are generally those known to be associated with diuresis, thiazide therapy, or with the underlying disease being treated. Clinical trials have not demonstrated that combining amiloride and hydrochlorothiazide increases the risk of adverse reactions over those seen with the individual components.
The adverse reactions for MODURETIC (amiloride and hydrochlorothiazide) 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 (607 patients treated with MODURETIC (amiloride and hydrochlorothiazide) ). 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 MODURETIC (amiloride and hydrochlorothiazide) and these adverse reactions, some of which have been reported only rarely.
|Incidence > 1%||Incidence ≤ 1%|
| Body as a Whole
Elevated serum potassium levels ( > 5.5 mEq per liter)***
Erythema multiforme including
Exfoliative dermatitis including toxic epidermal necrolysis
| Bad taste
|Impotence Nocturia Dysuria Incontinence
Renal dysfunction including renal failure Gynecomastia
| ** Reactions occurring in 3% to 8% of patients treated with MODURETIC (amiloride and hydrochlorothiazide) . (Those reactions occurring in less than 3% of the patients are unmarked.)
Other adverse reactions that have been reported with the individual components and within each category are listed in order of decreasing severity:
Body as a Whole: Painful extremities, neck/shoulder ache, fatigability; Cardiovascular: Palpitation; Digestive: Activation of probable pre-existing peptic ulcer, abnormal liver function, jaundice, dyspepsia, heartburn; Hematologic: Aplastic anemia, neutropenia; Integumentary: Alopecia, itching, dry mouth; Nervous System/Psychiatric: Encephalopathy, tremors, decreased libido; Respiratory: Shortness of breath, cough; Special Senses: Increased intraocular pressure, tinnitus; Urogenital: Bladder spasms, polyuria, urinary frequency.
Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation; Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis, cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, purpura; Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia; Nervous System/Psychiatric: Restlessness; Special Senses: Transient blurred vision, xanthopsia; Urogenital: Interstitial nephritis (see WARNINGS).