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 SUSPECTED ALDACTONE SIDE EFFECTS / ADVERSE REACTIONS

Possible Aldactone side effects / adverse reactions in 74 year old male

Reported by a pharmacist from Italy on 2011-10-03

Patient: 74 year old male

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Aldactone
    Administration route: Oral
    Start date: 2007-01-01
    End date: 2011-05-27

Lasix
    Administration route: Oral
    Start date: 2007-01-01
    End date: 2011-05-27

Ramipril
    Administration route: Oral
    Start date: 2007-01-01
    End date: 2011-05-27

Other drugs received by patient: Coumadin; Dronedarone HCL; Carvedilol

Possible Aldactone side effects / adverse reactions in 53 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-03

Patient: 53 year old male

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Aldactone
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2010-12-29
    End date: 2011-01-13

Nicardipine HCL
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-12-24
    End date: 2011-01-24

Xanax
    Dosage: 0.50 mg, 1x/day
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-12-01
    End date: 2011-01-13

Perindopril Erbumine
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-12-25
    End date: 2011-01-24

Vancomycin HCL
    Dosage: 2 g, 1x/day
    Indication: Infection
    Start date: 2010-12-17
    End date: 2011-01-16

Oxycodone HCL
    Dosage: unk
    Indication: Pain
    Start date: 2010-12-19
    End date: 2011-01-12

Fluconazole
    Dosage: 2 mg/ml, 2x/day
    Indication: Prophylaxis
    Start date: 2010-12-18
    End date: 2011-01-12

Other drugs received by patient: Heparin; Nexium; Corotrope; Zyrtec; Lyrica; Rifadin; Previscan; Lasix; Revatio; Lasix

Possible Aldactone side effects / adverse reactions in 83 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-10-04

Patient: 83 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Pantoprazole
    Dosage: 40 to 80 mg daily
    Administration route: Oral
    Start date: 2011-06-22
    End date: 2011-08-09

Novalgin
    Dosage: 30 drops once or 3 times daily
    Administration route: Oral
    Start date: 2011-07-24
    End date: 2011-08-05

Aldactone
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-06