Spironolactone and Hydrochlorothiazide (Spironolactone / Hydrochlorothiazide) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

Hydrochlorothiazide

Body as a whole: Weakness.

Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialoadenitis, cramping, constipation, gastric irritation, nausea, anorexia.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic: Electrolyte imbalance (see Precautions ), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal: Muscle spasm.

Nervous system/psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis (see Warnings ).

Skin: Erythema multiforme, pruritus.

Special senses: Transient blurred vision, xanthopsia.

Spironolactone

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Endocrine: Gynecomastia (see Precautions ), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.

Hematologic: Agranulocytosis.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Nervous system/psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.

Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal: Renal dysfunction (including renal failure).

REPORTS OF SUSPECTED SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE SIDE EFFECTS / ADVERSE REACTIONS

Possible Spironolactone and Hydrochlorothiazide side effects / adverse reactions 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

Suspect drug(s):
Spironolactone and Hydrochlorothiazide

Possible Spironolactone and Hydrochlorothiazide side effects / adverse reactions 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

Suspect drug(s):
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 / adverse reactions 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

Suspect drug(s):
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