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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