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 88 year old male

Reported by a pharmacist from Spain on 2007-01-09

Patient: 88 year old male

Reactions: Syncope, Hyperkalaemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldactone

Other drugs received by patient: Crinoren; Coropres; Idaptan; Tromalyt; Zocor; Nitradisc; Novomix

Possible Aldactone side effects / adverse reactions in 72 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2007-01-11

Patient: 72 year old female

Reactions: Nausea, Hyperkalaemia, Blood Pressure Inadequately Controlled, Bronchospasm, Nasal Congestion, Blood Creatinine Increased, Epistaxis

Suspect drug(s):
Atenolol
    Indication: Hypertension

Lisinopril
    Dosage: 10 mg

Aldactone
    Dosage: 12.5 mg, qd

Other drugs received by patient: Bendroflumethiazide (Bendroflumethiazide); Felodipine

Possible Aldactone side effects / adverse reactions in 78 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-11

Patient: 78 year old female

Reactions: Right Ventricular Failure, Dyspnoea, Hypotension, Oedema Peripheral, Dizziness

Adverse event resulted in: hospitalization

Suspect drug(s):
Atacand
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2006-08-01

Perindopril Erbumine
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2006-08-01

Aldactone
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2006-08-01

Other drugs received by patient: Omeprazole; Desloratadine; Previscan