This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aldactone (Spironolactone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (572)
Death (63)
Life Threatening Events (79)
Disability (16)
Reports by Reaction Type
Hyperkalaemia (124),
Renal Failure Acute (124),
Drug Interaction (62),
Dehydration (37),
Hyponatraemia (32),
Hypotension (31),
Renal Failure (30),
Lactic Acidosis (28),
Bradycardia (25),
Hepatic Encephalopathy (24),
Diarrhoea (22),
Fall (21)
Below are a few examples of reports where side effects / adverse reactions may be related to Aldactone (Spironolactone). For a complete list or a specific selection of reports, please use the links above.
Possible Aldactone side effects in
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient:
Reactions: Migraine, Nerve Injury, Pain in Extremity
Drug(s) suspected as cause:
Aldactone
Lyrica
Spiriva
Possible Aldactone side effects in 60 year old female
Reported by a pharmacist from Japan on 2012-08-27
Patient: 60 year old female
Reactions: Drug Eruption
Drug(s) suspected as cause:
Aldactone
Possible Aldactone side effects in 87 year old female
Reported by a physician from France on 2012-08-27
Patient: 87 year old female
Reactions: Renal Failure, Hyponatraemia, General Physical Health Deterioration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Administration route: Oral
End date: 2011-12-02
Lasix
Administration route: Oral
End date: 2011-12-02
Nexium
Administration route: Oral
End date: 2011-12-05
Other drugs received by patient: Bricanyl; Atrovent; Atacand; Previscan
Possible Aldactone side effects in 65 year old female
Reported by a physician from Switzerland on 2012-08-24
Patient: 65 year old female, weighing 38.0 kg (83.6 pounds)
Reactions: Hyperkalaemia, Adrenal Insufficiency, Hyponatraemia, Convulsion
Drug(s) suspected as cause:
Aldactone
Dosage: 25 mg, 1x/day
Administration route: Oral
End date: 2012-07-31
Prednisone
Dosage: 5 mg, 1x/day
Administration route: Oral
Start date: 2012-07-27
Prednisone
Dosage: 30 mg, 1x/day
Administration route: Oral
Start date: 2012-07-18
End date: 2012-07-26
Prednisone
Dosage: 5 mg, 1x/day
Administration route: Oral
End date: 2012-07-17
Vfend
Dosage: 200 mg, 2x/day
Administration route: Oral
Indication: Bronchopulmonary Aspergillosis
Start date: 2012-07-26
Other drugs received by patient: Prograf; Zithromax; Aspirin; Prograf; Myfortic; Liquaemin INJ
Possible Aldactone side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24
Patient: 73 year old female
Reactions: Dermo-Hypodermitis, Fungal Oesophagitis, Shock Haemorrhagic, Cytolytic Hepatitis, Cholestasis, Necrotising Fasciitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: 50 mg, 1x/day
Administration route: Oral
End date: 2012-06-26
Anafranil
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Depression
Start date: 2012-05-01
End date: 2012-06-26
Levofloxacin
Dosage: 500 mg, 2x/day
Administration route: Oral
Start date: 2012-05-25
End date: 2012-06-26
Orbenin CAP
Dosage: 3 g, 3x/day
Start date: 2012-05-25
End date: 2012-06-26
Other drugs received by patient: Humalog; Lyrica; Lasix; Oxycodone Hydrochloride; Ketoprofen; Penicillin G Sodium; Clindamycin HCL; Nexium; Prednisone TAB; Oxycontin; Glucophage
Possible Aldactone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: Migraine, Pain in Extremity, Peripheral Nerve Injury
Drug(s) suspected as cause:
Aldactone
Dosage: unk
Lyrica
Dosage: unk
Spiriva
Dosage: unk
Possible Aldactone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: Arthritis
Drug(s) suspected as cause:
Aldactone
Dosage: unk
Lipitor
Dosage: unk
Possible Aldactone side effects in
Reported by a physician from Japan on 2012-08-23
Patient:
Reactions: Malaise, Skin Disorder, Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Aldactone
Administration route: Oral
Amlodipine Besylate
Administration route: Oral
Lasix
Administration route: Oral
Ledolper
Dosage: 1 tablet per day , as needed
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-02-07
Lickle
Administration route: Oral
Peginterferon Alfa-2B
Dosage: 1.5 microgram per kilogram, qw
Indication: Hepatitis C
Start date: 2012-02-07
End date: 2012-04-17
Rebetol
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2012-03-14
End date: 2012-03-27
Rebetol
Dosage: 600 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-07
End date: 2012-03-13
Rebetol
Dosage: 200 mg, qd
Administration route: Oral
Start date: 2012-03-28
End date: 2012-04-19
Telavic
Dosage: 2250 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-07
End date: 2012-04-17
Telavic
Dosage: 1500 mg, qd
Administration route: Oral
Start date: 2012-04-18
End date: 2012-04-19
Other drugs received by patient: Acetaminophen; Motilium; Rabeprazole Sodium; Gasmotin
Possible Aldactone side effects in 77 year old female
Reported by a physician from Switzerland on 2012-08-23
Patient: 77 year old female, weighing 88.0 kg (193.6 pounds)
Reactions: Renal Impairment, Diarrhoea, Ataxia, Bradycardia, Accidental Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: unk
End date: 2012-04-01
Amlodipine Besylate
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Atenolol
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Coversum Combi
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Lithium Carbonate
Dosage: 225 mg, 1x/day
Administration route: Oral
End date: 2012-04-01
Venlafaxine
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Possible Aldactone side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 56 year old female
Reactions: Road Traffic Accident, Neck Injury, Headache, Back Disorder
Drug(s) suspected as cause:
Aldactone
Dosage: 25 mg, 2x/day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1997-01-01
Estring
Dosage: as directed
Indication: Product Used FOR Unknown Indication
Premarin
Dosage: 1.25 mg, 2x/day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Levothyroxine; Fluticasone Propionate
Possible Aldactone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Therapeutic Response Unexpected, Fluid Retention
Drug(s) suspected as cause:
Aldactone
Possible Aldactone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Therapeutic Response Unexpected, Fluid Retention
Drug(s) suspected as cause:
Aldactone
Possible Aldactone side effects in 78 year old male
Reported by a consumer/non-health professional from Turkey on 2012-08-16
Patient: 78 year old male
Reactions: Renal Failure Chronic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: unk
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-15
Desal
Dosage: 80 mg, unk
Start date: 2011-03-15
Desal
Dosage: 20 mg, daily
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-14
Ramipril
Dosage: 2.5 mg, daily
Administration route: Oral
Start date: 2011-03-15
Other drugs received by patient: Aspirin; Lipitor; Famotidine; Ceftriaxone; Plavix; Bisoprolol Fumarate; Glyceryl Trinitrate; Insulin; Heparin
Possible Aldactone side effects in 97 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-15
Patient: 97 year old female
Reactions: Death, Pneumonia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: 1 df (1 tablet), 1x/day
Administration route: Oral
Indication: Hypertension
Latanoprost
Dosage: 1.5 ug (one drop), 1x/day
Indication: Intraocular Pressure Test Abnormal
Start date: 2011-01-01
Other drugs received by patient: Omeprazole; Levothyroxine Sodium; Furosemide; Isosorbide Mononitrate; Clonazepam; Citrol; Diovan
Possible Aldactone side effects in 60 year old female
Reported by a consumer/non-health professional from Japan on 2012-08-14
Patient: 60 year old female
Reactions: Drug Eruption
Drug(s) suspected as cause:
Aldactone
Possible Aldactone side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 56 year old female
Reactions: Road Traffic Accident, Neck Injury, Headache, Back Disorder
Drug(s) suspected as cause:
Aldactone
Dosage: 25 mg, 2x/day
Administration route: Oral
Start date: 1997-01-01
Estring
Dosage: unk, as directed
Premarin
Dosage: 1.25 mg, 2x/day
Administration route: Oral
Other drugs received by patient: Levothyroxine; Fluticasone Propionate
Possible Aldactone side effects in 82 year old male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-10
Patient: 82 year old male
Reactions: Metabolic Acidosis, Hyperkalaemia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: 25 mg, daily
Administration route: Oral
Indication: Hypertension
Start date: 2011-01-01
End date: 2012-07-04
Lasix
Dosage: 75 mg, daily
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
End date: 2012-07-07
Ramipril
Dosage: 2.5 mg, daily
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
End date: 2012-07-07
Other drugs received by patient: Esomeprazole; Monoket; Ivabradine; Aspirin; Humalog; Lantus
Possible Aldactone side effects in 93 year old male
Reported by a pharmacist from Japan on 2012-08-07
Patient: 93 year old male
Reactions: Hypoglycaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Aldactone
Other drugs received by patient: Lansoprazole; Urso 250; Tamsulosin HCL; Hokunalin; Gramalil; Ubretid; Ferrous Citrate; Furosemide
Possible Aldactone side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-06
Patient: 47 year old male
Reactions: Eosinophilic Myocarditis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen and Tramadol HCL
Administration route: Oral
Indication: Pain
End date: 2012-07-01
Aldactone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-01
Bisoprolol Fumarate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-01
Corotrope
Indication: Ejection Fraction Decreased
Start date: 2012-06-06
End date: 2012-07-01
Dobutamine HCL
Indication: Ejection Fraction Decreased
Start date: 2012-06-06
Imovane
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-01
Lasix
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-01
Procoralan
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-01
Possible Aldactone side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-06
Patient: 63 year old male
Reactions: Drug Interaction, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Other drugs received by patient possibly interacting with the suspect drug:
Candesartan Cilexetil and Hydrochlorothiazide
Dosage: 1 df, 1x/day
Administration route: Oral
End date: 2012-07-18
Other drugs received by patient: Amlodipine Besylate; Baraclude; Propranolol; Aspirin
Possible Aldactone side effects in 78 year old male
Reported by a consumer/non-health professional from Australia on 2012-08-02
Patient: 78 year old male
Reactions: Accident, Polyp Colorectal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Possible Aldactone side effects in 87 year old female
Reported by a physician from Japan on 2012-08-02
Patient: 87 year old female
Reactions: Drug Eruption
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Aldactone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Amoban
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Galantamine Hydrobromide
Administration route: Oral
Indication: Dementia
Other drugs received by patient: Lasix
Possible Aldactone side effects in female
Reported by a physician from United States on 2012-08-01
Patient: female
Reactions: Blood Potassium Increased
Drug(s) suspected as cause:
Aldactone
Possible Aldactone side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Anxiety, Abdominal Pain, Nausea, Drug Hypersensitivity, Musculoskeletal Pain, Depression, Gastrooesophageal Reflux Disease, Muscle Spasms
Drug(s) suspected as cause:
Aldactone
Dosage: 25 mg, qd
Administration route: Oral
Buspar
Dosage: 15 mg, qd
Buspar
Naprosyn
Dosage: 500 mg, bid
Nexium
Dosage: 40 mg, qd
Zocor
Dosage: 20 mg, qd
Administration route: Oral
Possible Aldactone side effects in 46 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-30
Patient: 46 year old male
Reactions: Eosinophilic Myocarditis, Cardiogenic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen and Tramadol HCL
Dosage: unk
Administration route: Oral
Indication: Pain
End date: 2012-07-01
Aldactone
Dosage: 50 mg, daily
Administration route: Oral
End date: 2012-07-01
Bisoprolol Fumarate
Dosage: 2.5 mg, daily
Administration route: Oral
End date: 2012-07-01
Corotrope
Dosage: unk
Indication: Ejection Fraction Decreased
Start date: 2012-06-06
End date: 2012-07-01
Dobutamine
Dosage: unk
Indication: Ejection Fraction Decreased
Start date: 2012-06-06
Imovane
Dosage: unk
Administration route: Oral
End date: 2012-07-01
Lasix
Dosage: 40 mg, daily
Administration route: Oral
End date: 2012-07-01
Procoralan
Dosage: 7.5 mg, 2x/day
Administration route: Oral
End date: 2012-07-01
Possible Aldactone side effects in 77 year old female
Reported by a physician from Switzerland on 2012-07-27
Patient: 77 year old female, weighing 88.0 kg (193.6 pounds)
Reactions: Renal Impairment, Diarrhoea, Ataxia, Bradycardia, Accidental Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: unk
End date: 2012-04-01
Amlodipine Besylate
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Atenolol
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Coversum Combi
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Lithium Carbonate
Dosage: 225 mg, 1x/day
Administration route: Oral
End date: 2012-04-01
Venlafaxine
Dosage: unk
Administration route: Oral
End date: 2012-04-01
Possible Aldactone side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-27
Patient: male
Reactions: Hyperkalaemia, Bundle Branch Block Left, Electrocardiogram Repolarisation Abnormality
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: 1 df, daily
Administration route: Oral
Indication: Hypertension
Start date: 2012-01-01
End date: 2012-06-25
Potassium Chloride
Dosage: 2 df, daily
Administration route: Oral
Indication: Hypokalaemia
Start date: 2012-05-01
End date: 2012-06-25
Valsartan
Dosage: 1 df, daily (80 mg)
Indication: Hypertension
Start date: 2012-05-01
End date: 2012-06-25
Other drugs received by patient: Difix; Crestor; Spiriva; Aspirin; Magnesium Hydroxide TAB; Bisoprolol Fumarate; Humalog; Ramipril; Cordarone; Ranexa; Levothyroxine Sodium; Lasix; Aranesp; Lantus; Nexium; Plavix; Minitran; Symbicort
Possible Aldactone side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27
Patient: 73 year old female
Reactions: Dermo-Hypodermitis, Cytolytic Hepatitis, Cholestasis, Necrotising Fasciitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: 50 mg, 1x/day
Administration route: Oral
End date: 2012-06-26
Anafranil
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Depression
Start date: 2012-05-01
End date: 2012-06-26
Levofloxacin
Dosage: 500 mg, 2x/day
Administration route: Oral
Start date: 2012-05-25
End date: 2012-06-26
Orbenin CAP
Dosage: 3 g, 3x/day
Start date: 2012-05-25
End date: 2012-06-26
Other drugs received by patient: Humalog; Ketoprofen; Oxycodone HCL; Penicillin G Sodium; Nexium; Lyrica; Clindamycin HCL; Glucophage; Prednisone TAB; Oxycontin; Lasix
Possible Aldactone side effects in male
Reported by a physician from United States on 2012-07-27
Patient: male
Reactions: Syncope, Hyperkalaemia, Infective Exacerbation of Chronic Obstructive Airways Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Blinded Therapy
Humalog
Dosage: 500 iu, unk
Indication: Type 2 Diabetes Mellitus
Insulin Aspart
Dosage: 100 iu, unk
Indication: Type 2 Diabetes Mellitus
Insulin Glargine
Dosage: 100 iu, unk
Indication: Type 2 Diabetes Mellitus
Novolin R
Dosage: 100 iu, unk
Indication: Type 2 Diabetes Mellitus
Terazosin Hydrochloride
Dosage: unk
Start date: 2012-03-30
End date: 2012-04-06
Valsartan
Other drugs received by patient: Nicotinic Acid; Acetylsalicylic Acid
Possible Aldactone side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26
Patient: 47 year old male
Reactions: Eosinophilic Myocarditis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen and Tramadol HCL
Administration route: Oral
Indication: Pain
End date: 2012-07-01
Aldactone
Administration route: Oral
End date: 2012-07-01
Bisoprolol Fumarate
Administration route: Oral
End date: 2012-07-01
Corotrope
Indication: Ejection Fraction Decreased
Start date: 2012-06-06
End date: 2012-07-01
Dobutamine HCL
Administration route: Oral
Indication: Ejection Fraction Decreased
Start date: 2012-06-06
Imovane
Administration route: Oral
End date: 2012-07-01
Lasix
Administration route: Oral
End date: 2012-07-01
Procoralan
Administration route: Oral
End date: 2012-07-01
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