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MIDAMOR (AMILORIDE HCL): ADVERSE REACTIONS

Amiloride Hydrochloride (Midamor) is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq per liter, 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: incidence greater than one percent; and incidence one percent or less. The incidence for the first group was determined from clinical studies conducted in the United States (837 patients treated with Midamor). The adverse effects listed in the second group include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between Midamor (Amiloride) and these adverse reactions, some of which have been reported only rarely.

Body as a Whole: headache, weakness, fatigability, back pain, chest pain, neck / shoulder ache, pain extremities

Cardiovascular: orthostatic hypotension, angina pectoris, arrhythmia, palpitation

Digestive: diarrhea, nausea / anorexia, vomiting, gas pain, abdominal pain, appetite changes, jaundice, constipation, GI bleeding, abdominal fullness, thirst, GI disturbance, heartburn, dyspepsia, flatulence

Metabolic: elevated serum, potassium levels, ( > 5.5 mEq per liter)

Skin: itching, skin rash, dryness of mouth, alopecia, pruritus

Musculoskeletal: joint pain, muscle cramps, leg ache

Nervous: dizziness, paresthesia, encephalopathy, tremors, vertigo

Psychiatric: mental confusion, nervousness, insomnia, depression, decreased libido, somnolence

Respiratory: dyspnea, cough, shortness of breath

Special Senses: nasal congestion, visual disturbances, tinnitus, increased intraocular pressure

Urogenital: dysuria, impotence polyuria, urinary frequency, gynecomastia, bladder spasms

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



Midamor (Amiloride HCl) related pharmaceutical drugs and medications

Trade name of the drug Pharmaceutical forms and doses Companies
Spironolactone Actavis - Spironolactone
  • Tablets, Film-Coated; Oral; Spironolactone 25 mg
  • Tablets, Film-Coated; Oral; Spironolactone 50 mg
  • Tablets, Film-Coated; Oral; Spironolactone 75 mg
  • Tablets, Film-Coated; Oral; Spironolactone 100 mg
  • Tablets; Oral; Spironolactone 25 mg
  • Actavis
  • Zuellig Pharma
  • Demadex adverse reactions - Torsemide Sodium
  • Injectable; Injection; Torsemide Sodium 10 mg / ml
  • Roche


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