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Spironolactone and Hydrochlorothiazide (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 Spironolactone and Hydrochlorothiazide 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 (16)
Death (2)

Reports by Reaction Type

Renal Failure Acute (7)Hypotension (7)Myocardial Infarction (6)Cerebrovascular Accident (6)Loss of Employment (3)Confusional State (1)Personality Change (1)Breast Enlargement (1)Gynaecomastia (1)Suicidal Ideation (1)Depression (1)Breast Hyperplasia (1)

Possible Spironolactone and Hydrochlorothiazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Cerebrovascular Accident, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Protonix
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lipitor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Plavix
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Isosorbide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone and Hydrochlorothiazide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Liraglutide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Temazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Metformin Hydrochloride
    Dosage: unk



Possible Spironolactone and Hydrochlorothiazide side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-05

Patient: 52 year old female

Reactions: Loss of Employment, Cerebrovascular Accident, Myocardial Infarction

Drug(s) suspected as cause:
Isosorbide Dinitrate
    Indication: Product Used FOR Unknown Indication

Victoza
    Indication: Product Used FOR Unknown Indication

Lipitor
    Indication: Product Used FOR Unknown Indication

Spironolactone and Hydrochlorothiazide
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Indication: Product Used FOR Unknown Indication

Protonix
    Dosage: 80 mg (40 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Temazepam
    Indication: Product Used FOR Unknown Indication

Plavix
    Indication: Product Used FOR Unknown Indication



Possible Spironolactone and Hydrochlorothiazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: female

Reactions: Myocardial Infarction, Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Plavix
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone and Hydrochlorothiazide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lipitor
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Temazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Isosorbide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Protonix
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Liraglutide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Spironolactone and Hydrochlorothiazide side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: 52 year old female

Reactions: Myocardial Infarction, Cerebrovascular Accident

Drug(s) suspected as cause:
Victoza
    Indication: Product Used FOR Unknown Indication

Plavix
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Spironolactone and Hydrochlorothiazide
    Indication: Product Used FOR Unknown Indication

Temazepam
    Indication: Product Used FOR Unknown Indication

Isosorbide Dinitrate
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Indication: Product Used FOR Unknown Indication

Protonix
    Dosage: 80 mg (40 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin Hydrochloride
    Indication: Product Used FOR Unknown Indication

Lipitor
    Indication: Product Used FOR Unknown Indication



Possible Spironolactone and Hydrochlorothiazide side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 52 year old female

Reactions: Loss of Employment, Cerebrovascular Accident, Myocardial Infarction

Drug(s) suspected as cause:
Lisinopril
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Indication: Product Used FOR Unknown Indication

Spironolactone and Hydrochlorothiazide
    Indication: Product Used FOR Unknown Indication

Temazepam
    Indication: Product Used FOR Unknown Indication

Plavix
    Indication: Product Used FOR Unknown Indication

Liraglutide (Liraglutide)
    Indication: Product Used FOR Unknown Indication

Protonix
    Dosage: 80 mg (40 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Isosorbide Dinitrate
    Indication: Product Used FOR Unknown Indication

Lipitor
    Indication: Product Used FOR Unknown Indication



Possible Spironolactone and Hydrochlorothiazide side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 52 year old female

Reactions: Loss of Employment, Cerebrovascular Accident, Myocardial Infarction

Drug(s) suspected as cause:
Isosorbide Dinitrate
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Temazepam
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Lipitor
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Spironolactone and Hydrochlorothiazide
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Protonix
    Dosage: 80 mg (40 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Plavix
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Liraglutide (Liraglutide)
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication



Possible Spironolactone and Hydrochlorothiazide side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: 62 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Insulin Glargine
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Insulin Glargine
    Start date: 2011-11-21
    End date: 2012-05-15

Placebo
    Indication: Type 2 Diabetes Mellitus

Lisinopril

Aspirin

Blinded Study Medication
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20
    End date: 2011-11-14

Insulin Glargine
    Start date: 2012-05-16

Insulin Aspart
    Start date: 2011-03-11
    End date: 2011-06-02

Furosemide

Blinded Study Medication
    Start date: 2011-12-05

Insulin Aspart
    Start date: 2011-06-03

Isosorbide Mononitrate

Nifedipine

Spironolactone and Hydrochlorothiazide

Insulin Aspart
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-10

Atenolol

Other drugs received by patient: Niacin



Possible Spironolactone and Hydrochlorothiazide side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: 62 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Spironolactone and Hydrochlorothiazide

Lisinopril

Atenolol

Isosorbide Mononitrate

Insulin Aspart
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-10

Insulin Aspart
    Start date: 2011-03-11
    End date: 2011-06-02

Insulin Aspart
    Start date: 2011-06-03

Nifedipine

Placebo
    Indication: Type 2 Diabetes Mellitus

Lantus
    Start date: 2011-11-21
    End date: 2012-05-15

Lantus
    Start date: 2012-05-16

Blinded Study Medication
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20
    End date: 2011-11-14

Blinded Study Medication
    Start date: 2011-12-05

Aspirin

Furosemide

Other drugs received by patient: Niacin



Possible Spironolactone and Hydrochlorothiazide side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: 62 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atenolol

Blinded Study Medication
    Start date: 2011-12-05

Spironolactone and Hydrochlorothiazide

Lantus
    Start date: 2012-05-16

Lisinopril

Insulin Aspart
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-10

Furosemide

Insulin Aspart
    Start date: 2011-03-11
    End date: 2011-06-02

Insulin Aspart
    Start date: 2011-06-03

Aspirin

Nifedipine

Blinded Study Medication
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20
    End date: 2011-11-14

Lantus
    Start date: 2011-11-21
    End date: 2012-05-15

Placebo
    Indication: Type 2 Diabetes Mellitus

Isosorbide Mononitrate

Lantus
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Other drugs received by patient: Niacin



Possible Spironolactone and Hydrochlorothiazide side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: 62 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Study Medication
    Start date: 2011-12-05

Insulin Aspart
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-10

Insulin Aspart
    Start date: 2011-06-03

Spironolactone and Hydrochlorothiazide

Blinded Study Medication
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20
    End date: 2011-11-14

Lisinopril

Aspirin

Insulin Glargine
    Start date: 2012-05-16

Atenolol

Insulin Glargine
    Start date: 2011-11-21
    End date: 2012-05-15

Placebo
    Indication: Type 2 Diabetes Mellitus

Insulin Aspart
    Start date: 2011-03-11
    End date: 2011-06-02

Insulin Glargine
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Isosorbide Mononitrate

Furosemide

Nifedipine

Other drugs received by patient: Niacin



Possible Spironolactone and Hydrochlorothiazide side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: 62 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Study Medication
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20
    End date: 2011-11-14

Insulin Aspart
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-10

Insulin Glargine
    Start date: 2011-11-21
    End date: 2012-05-15

Insulin Glargine
    Start date: 2012-05-16

Nifedipine

Spironolactone and Hydrochlorothiazide

Blinded Study Medication
    Start date: 2011-12-05

Placebo
    Indication: Type 2 Diabetes Mellitus

Lisinopril

Atenolol

Insulin Aspart
    Start date: 2011-06-03

Isosorbide Mononitrate

Insulin Aspart
    Start date: 2011-03-11
    End date: 2011-06-02

Insulin Glargine
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Aspirin

Furosemide

Other drugs received by patient: Niacin



Possible Spironolactone and Hydrochlorothiazide side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: 62 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Insulin Glargine
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Blinded Study Medication
    Start date: 2011-12-05

Insulin Aspart
    Start date: 2011-06-03

Insulin Glargine
    Start date: 2012-05-16

Nifedipine

Spironolactone and Hydrochlorothiazide

Insulin Aspart
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-03-10

Atenolol

Blinded Study Medication
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20
    End date: 2011-11-14

Placebo
    Indication: Type 2 Diabetes Mellitus

Insulin Glargine
    Start date: 2011-11-21
    End date: 2012-05-15

Lisinopril

Isosorbide Mononitrate

Aspirin

Insulin Aspart
    Start date: 2011-03-11
    End date: 2011-06-02

Furosemide

Other drugs received by patient: Niacin



Possible Spironolactone and Hydrochlorothiazide side effects in male

Reported by a physician from United States on 2012-06-07

Patient: male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Spironolactone and Hydrochlorothiazide

Furosemide

Lisinopril

Isosorbide Mononitrate

Insulin Aspart
    Dosage: 126 u
    Start date: 2011-03-11
    End date: 2011-06-02

Insulin Glargine
    Dosage: 128 u
    Start date: 2011-05-16

Atenolol

Acetylsalicylic Acid SRT

Insulin Aspart
    Dosage: 120 u
    Indication: Type 2 Diabetes Mellitus

Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20

Insulin Glargine
    Dosage: 128 u
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-11
    End date: 2011-11-20

Insulin Glargine
    Dosage: 140 u
    Start date: 2011-11-21
    End date: 2012-05-15

Saxagliptin
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-20

Insulin Aspart
    Dosage: 150 u
    Start date: 2012-06-03

Nifedipine

Other drugs received by patient: Niacin; Insulin; Insulin



Possible Spironolactone and Hydrochlorothiazide side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-21

Patient: female, weighing 99.8 kg (219.5 pounds)

Reactions: Personality Change, Confusional State, Paranoia, Mood Swings, Depression, Suicidal Ideation

Drug(s) suspected as cause:
Spironolactone and Hydrochlorothiazide

Other drugs received by patient: Metformin HCL



Possible Spironolactone and Hydrochlorothiazide side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-01-30

Patient: 67 year old male, weighing 71.2 kg (156.7 pounds)

Reactions: Breast Hyperplasia, Gynaecomastia

Drug(s) suspected as cause:
Spironolactone and Hydrochlorothiazide



Possible Spironolactone and Hydrochlorothiazide side effects in male

Reported by a individual with unspecified qualification from United States on 2011-11-09

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Breast Pain, Breast Enlargement, Breast Mass

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Spironolactone and Hydrochlorothiazide

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