No black box warning on record for Spironolactone

As of the latest FDA labeling reviewed, Spironolactone (spironolactone) does not carry a black box warning. Standard warnings and precautions still apply — see the full Spironolactone medicine page for the complete safety profile.

Other warnings & precautions

Hyperkalemia: The most dangerous adverse effect of spironolactone. Concurrent use with ACE inhibitors, ARBs, potassium supplements, or NSAIDs and renal impairment dramatically increases hyperkalemia risk. In the RALES trial, 2% of patients had serious hyperkalemia. Post-marketing data showed higher rates in clinical practice. Monitor potassium at baseline, 1 week, 1 month, and regularly thereafter. Contraindicated if K+ >5.0 mEq/L or Cr >2.0 mg/dL.
Tumor Risk: Spironolactone has been shown to be tumorigenic in chronic toxicity studies in rats. The significance of these findings for humans is unclear, but the medicine should be used at the lowest effective dose for the shortest duration consistent with therapeutic goals.
Gynecomastia: Dose-dependent gynecomastia (breast development/tenderness in men) occurs due to anti-androgen and mild estrogenic effects. Can be distressing for male patients. Eplerenone (a more selective aldosterone antagonist) has less anti-androgen activity and causes less gynecomastia if this is problematic.
Pregnancy: Although Category C overall, spironolactone has anti-androgen properties and may cause feminization of male fetuses. Avoid in pregnancy when alternatives exist. Discontinue immediately if pregnancy is detected.

No black box warning on record for Spironolactone

Other warnings & precautions

Hyperkalemia: The most dangerous adverse effect of spironolactone. Concurrent use with ACE inhibitors, ARBs, potassium supplements, or NSAIDs and renal impairment dramatically increases hyperkalemia risk. In the RALES trial, 2% of patients had serious hyperkalemia. Post-marketing data showed higher rates in clinical practice. Monitor potassium at baseline, 1 week, 1 month, and regularly thereafter. Contraindicated if K+ >5.0 mEq/L or Cr >2.0 mg/dL.
Tumor Risk: Spironolactone has been shown to be tumorigenic in chronic toxicity studies in rats. The significance of these findings for humans is unclear, but the medicine should be used at the lowest effective dose for the shortest duration consistent with therapeutic goals.
Gynecomastia: Dose-dependent gynecomastia (breast development/tenderness in men) occurs due to anti-androgen and mild estrogenic effects. Can be distressing for male patients. Eplerenone (a more selective aldosterone antagonist) has less anti-androgen activity and causes less gynecomastia if this is problematic.
Pregnancy: Although Category C overall, spironolactone has anti-androgen properties and may cause feminization of male fetuses. Avoid in pregnancy when alternatives exist. Discontinue immediately if pregnancy is detected.

Spironolactone Black Box Warning

No black box warning on record for Spironolactone

Other warnings & precautions

Spironolactone Black Box Warning

No black box warning on record for Spironolactone

Other warnings & precautions