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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.

Incidence > 1% Incidence ≤ 1%
Body as a Whole
  Headache* Back pain
  Weakness Chest pain
  Fatigability Neck/shoulder ache
Pain, extremities
Cardiovascular
  None Angina pectoris
Orthostatic hypotension
Arrhythmia
Palpitation
Digestive
  Nausea/anorexia* Jaundice
  Diarrhea* GI bleeding
  Vomiting* Abdominal fullness
  Abdominal pain GI disturbance
  Gas pain Thirst
  Appetite changes Heartburn
  Constipation Flatulence
Dyspepsia
Metabolic
   Elevated serum potassium levels ( > 5.5 mEq per liter)** None
Skin
  None Skin rash
Itching
Dryness of mouth
Pruritus
Alopecia
Musculoskeletal
  Muscle cramps Joint pain
Leg ache
Nervous
  Dizziness Paresthesia
  Encephalopathy Tremors
Vertigo
Psychiatric
  None Nervousness
Mental confusion
Insomnia
Decreased libido
Depression
Somnolence
Respiratory
  Cough Shortness of breath
  Dyspnea  
Special Senses
  None Visual disturbances
Nasal congestion
Tinnitus
Increased intraocular pressure
Urogenital
  Impotence Polyuria
Dysuria
Urinary frequency
Bladder spasms
Gynecomastia
*Reactions occurring in 3% to 8% of patients treated with amiloride HCl. (Those reactions occurring in less than 3% of the patients are unmarked.)
**See WARNINGS.

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