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Amiloride Side Effects

Brand Names: Midamor

Please note - some side effects for Amiloride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Amiloride - for the Consumer

Amiloride

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 Amiloride:

Diarrhea; headache; loss of appetite; nausea; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Amiloride:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Amiloride/Hydrochlorothiazide

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 Amiloride/Hydrochlorothiazide:

Changes in blood sugar; constipation; dizziness; fatigue; headache; inflammation of a salivary gland; loss of appetite; nausea; sensitivity to sunlight; stomach pain; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Amiloride/Hydrochlorothiazide:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dry mouth; excessive thirst; impotence; leg or muscle cramps; mental confusion; rapid, weak, or irregular heartbeat; stomach pain; urination problems; vomiting; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Amiloride Side Effects - for the Professional

Amiloride

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.

(Those reactions occurring in less than 3% of the patients are unmarked.)

**See WARNINGS.

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

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

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Side Effects by Body System - for Healthcare Professionals

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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