Aldactone (Spironolactone) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Endocrine: Gynecomastia (see Precautions ), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.

Hematologic: Agranulocytosis.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Nervous system /psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.

Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal: Renal dysfunction (including renal failure).

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ALDACTONE

Possible Aldactone side effects / adverse reactions in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-16

Patient: 76 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Rash Erythematous, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldactone
    Dosage: daily dose:25mg
    Administration route: Oral
    Start date: 2006-08-31
    End date: 2006-09-13

Cordarone
    Administration route: Oral
    Start date: 2006-08-24
    End date: 2006-09-13

Diffu K
    Administration route: Oral
    Start date: 2006-08-31
    End date: 2006-09-16

Lasix
    Administration route: Oral
    Start date: 2006-07-20
    End date: 2006-09-16

Previscan
    Administration route: Oral

Triatec
    Administration route: Oral
    Start date: 2006-07-27
    End date: 2006-09-13

Possible Aldactone side effects / adverse reactions in 76 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-16

Patient: 76 year old male

Reactions: Hyperkalaemia, Drug Interaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldactone

Other drugs received by patient possibly interacting with the suspect drug:
Aldactone
    Indication: Hypertension

Diffu K
    Dosage: text:1 df-freq:daily
    Administration route: Oral
    Indication: Hypokalaemia

Kenzen
    Dosage: text:1 df-freq:daily
    Administration route: Oral
    Indication: Cardiomyopathy
    End date: 2006-08-02

Kenzen
    Indication: Hypertension

Lasix
    Administration route: Oral
    Indication: Cardiomyopathy

Lasix
    Indication: Hypertension

Other drugs received by patient: Hyperium; Hyperium; Allopurinol Sodium; Aspirin; Stablon; Zoxan LP; Omeprazole

Possible Aldactone side effects / adverse reactions in 79 year old male

Reported by a individual with unspecified qualification from Japan on 2007-01-29

Patient: 79 year old male

Reactions: Dehydration, Anorexia, Atrioventricular Block Complete, Depressed Level of Consciousness, Sinus Arrest, Arrhythmia

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Aldactone
    Dosage: 25 mg 1x per 1 day; oral
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2006-11-28

Ancaron (Amiodarone, Unspec)
    Dosage: 200 mg 1x per 1 day; oral; 100 mg 1x per 1 day; oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-12-07
    End date: 2006-12-12

Ancaron (Amiodarone, Unspec)
    Dosage: 200 mg 1x per 1 day; oral; 100 mg 1x per 1 day; oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-12-13

Lasix
    Dosage: 20 mg 1x per 1 day; oral
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2006-11-28

Lisinopril
    Dosage: 10 mg 1x per 1 day; oral
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2006-11-28

Other drugs received by patient: Bayaspirina (Acetylsalicylic Acid); Warfarin Potassium; Cibenol (Cibenzoline Succinate)