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Aldactazide (Spironolactone / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aldactazide 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 (14)
Death (2)

Reports by Reaction Type

Cardiac Disorder (6)Implantable Defibrillator Insertion (3)Impaired Work Ability (3)Fatigue (3)Myocardial Infarction (3)Dyspnoea (3)Vascular Purpura (2)Renal Injury (1)Creatinine Renal Clearance Decreased (1)Hyperkalaemia (1)Pain (1)Headache (1)

Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Implantable Defibrillator Insertion, Dyspnoea, Fatigue, Impaired Work Ability, Myocardial Infarction, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amiodarone HCL
    Dosage: 200 mg, 2x/day

Aldactazide
    Dosage: 25 mg, 1/2 daily



Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female

Reactions: Implantable Defibrillator Insertion, Dyspnoea, Fatigue, Impaired Work Ability, Myocardial Infarction, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amiodarone HCL
    Dosage: 200 mg, 2x/day

Aldactazide
    Dosage: 25 mg, 1/2 daily



Possible Aldactazide side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: male

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Calan
    Dosage: unk

Aldactazide
    Dosage: unk

Calan SR
    Dosage: unk



Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Headache

Drug(s) suspected as cause:
Nitrostat
    Dosage: unk

Aldactazide
    Dosage: unk

Norvasc
    Dosage: unk



Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Lipitor
    Dosage: unk

Protonix
    Dosage: unk

Aldactazide
    Dosage: unk



Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Lipitor
    Dosage: unk

Protonix
    Dosage: unk

Aldactazide
    Dosage: unk



Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: female

Reactions: Implantable Defibrillator Insertion, Dyspnoea, Fatigue, Impaired Work Ability, Myocardial Infarction, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aldactazide
    Dosage: 25 mg, 1/2 daily

Amiodarone HCL
    Dosage: 200 mg, 2x/day



Possible Aldactazide side effects in 64 year old male

Reported by a individual with unspecified qualification from France on 2012-04-30

Patient: 64 year old male

Reactions: Renal Impairment, Vascular Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Influvac (Influenza Virus Vaccine Polyvalet) (Influenza Virus Surface
    Dosage: 0.0027 df (1 df, 1 in 1 in 1 y), intramuscular
    Indication: Influenza Immunisation
    Start date: 2011-11-01

Renitec (Enalapril) (20 MG, Oral Lyophilisate) (Enalapril)
    Dosage: 1 df (1 df, 1 in 1 d), oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Diamicron (Gliclazide) (30 MG, Modified-Release Tablet) (Gliclazide)
    Dosage: 4 df (4 df, morning), oral
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-10-01

Sinrom (Acenociymarol) (4 MG, Tablet) (Acenocoumarol)
    Dosage: 1.25 df and 1df alternately, oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2008-10-01

Glucophage
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-01

Allopurinol
    Dosage: 1 df (1 df, 1 in 1 d), oral
    Administration route: Oral
    Indication: Gout
    Start date: 2008-10-01
    End date: 2012-03-23

Lercan (Lercanidioube Hydrochloride) (10 MG, Film-Coated Talbet) (Lerc
    Dosage: 1 df (1 df, 1 in 1 d), oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Aldactazide
    Dosage: 1 df (1 df, 1 in 1 d),oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Omeprazole
    Dosage: 1 df (1 df, 1 in 1d), oral
    Administration route: Oral
    Indication: Gastritis
    Start date: 2008-10-01

Trandate
    Dosage: 3 df (1 df, 3 in 1 d), oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Levothyroxine Sodium
    Dosage: 1 df (1 df, 1 in 1d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-01

Furosemide
    Dosage: from 1 df to several df depending on respiratory conditions, oral
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-10-01

Digoxin
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-01



Possible Aldactazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-25

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Aldactazide



Possible Aldactazide side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-24

Patient: male

Reactions: Renal Injury, Leukocytoclastic Vasculitis, Creatinine Renal Clearance Decreased, Vascular Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Gout
    Start date: 2008-10-01
    End date: 2012-03-23

Trandate
    Dosage: 1 df, tid
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Enalapril Maleate
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Lercanidipine
    Dosage: 1 df, daily
    Indication: Hypertension
    Start date: 2008-10-01

Lasix
    Dosage: 1 df, prn
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2008-10-01
    End date: 2010-10-01

Aldactazide
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-01

Sintrom
    Dosage: 1.25df and 1df taken alternatively per day
    Administration route: Oral
    Start date: 2008-10-01

Omeprazole
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Gastritis
    Start date: 2008-10-01

Influvac
    Dosage: 1 df, per year
    Start date: 2011-11-01

Levothyroxine Sodium
    Dosage: 1 df, daily
    Administration route: Oral
    Start date: 2008-10-01

Diamicron
    Dosage: 4 df, daily in the morning
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-10-01

Digoxin
    Administration route: Oral
    Start date: 2008-10-01

Glucophage
    Administration route: Oral
    Start date: 2008-10-01



Possible Aldactazide side effects in 87 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-22

Patient: 87 year old female

Reactions: Agranulocytosis, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diltiazem HCL
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    End date: 2011-05-04

Pantoprazole
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    End date: 2011-05-04

Bactrim
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-20
    End date: 2011-04-25

Molsidomine (Molsidomine)
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    End date: 2011-05-04

Flagyl
    Dosage: df, 5 times per month, oral
    Administration route: Oral
    Indication: Infection Prophylaxis
    Start date: 2010-08-01
    End date: 2011-04-05

Aldactazide
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    End date: 2011-05-04



Possible Aldactazide side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: female

Reactions: Cardiac Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Aldactazide
    Dosage: unk

Protonix
    Dosage: unk



Possible Aldactazide side effects in 78 year old female

Reported by a pharmacist from United States on 2011-10-06

Patient: 78 year old female, weighing 47.6 kg (104.8 pounds)

Reactions: Hyperkalaemia, Pain, Muscular Weakness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enalapril Maleate
    Dosage: 20mg bid po chronic
    Administration route: Oral
    Indication: Hypertension

Aldactazide
    Dosage: 25/25 x 2 bid po chronic
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Metoprolol Tartrate; Lipitor; Sotalol HCL; Glyburide; Coumadin; Aspirin



Possible Aldactazide side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Protonix
    Dosage: unk

Aldactazide

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