Label Changes for:
Aldactone (spironolactone) Tablets
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- ... or conditions known to cause hyperkalemia added
- Addison’s disease or other conditions associated with hyperkalemia, and with concomitant use of eplerenone.
Concomitant administration of Aldactone with the following drugs or potassium sources may lead to severe hyperkalemia:
- other potassium-sparing diuretics
- ACE inhibitors
- angiotensin II antagonists
- aldosterone blockers
- non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
- heparin and low molecular weight heparin
- other drugs known to cause hyperkalemia
- potassium supplements
- diet rich in potassium
- salt substitutes containing potassium
- Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
- Angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia: Concomitant administration may lead to severe hyperkalemia.
- Cholestyramine: Hyperkalemic metabolic acidosis has been reported in patients given Aldactone concurrently with cholestyramine.
- Reproductive: breast pain
- Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia
- Metabolism: electrolyte disturbances
- Musculoskeletal: Leg cramps.
- Nervous system /psychiatric: Lethargy, dizziness
- Skin: alopecia, pruritis