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Aldactone (Spironolactone) - Side Effect Reports to FDA

 
 



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 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

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 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 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

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 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 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 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 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 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 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 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 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 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 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 female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: female

Reactions: Blood Glucose Increased

Drug(s) suspected as cause:
Aldactone

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