No black box warning on record for Prednisone

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

Other warnings & precautions

Adrenal Suppression and Tapering: Prednisone suppresses the hypothalamic-pituitary-adrenal (HPA) axis. Abrupt discontinuation after prolonged use can cause acute adrenal insufficiency (adrenal crisis): severe hypotension, nausea, vomiting, altered consciousness, potentially fatal. ANY patient who has received prednisone >5mg/day for >3 weeks must be tapered slowly.
Infection Risk: Corticosteroids suppress all arms of immune response. Patients are at risk for infections from bacteria, viruses, fungi, and parasites, and may not mount a normal febrile response. Screen for latent TB (LTBI) before long-term therapy. Consider prophylaxis for Pneumocystis pneumonia in high-dose patients.
Bone Protection: Long-term corticosteroid use is the leading cause of medicine-induced osteoporosis. ALL patients starting long-term (>3 months) prednisone should be prescribed calcium + vitamin D supplementation, and bisphosphonate therapy should be considered based on fracture risk assessment.
Diabetes and Glucose Monitoring: Corticosteroids cause steroid-induced hyperglycemia in up to 50% of patients without diabetes, and can worsen control in known diabetics. Blood glucose should be monitored, and antidiabetic therapy adjusted accordingly.
Ophthalmic Effects: Long-term use can cause posterior subcapsular cataracts and elevated intraocular pressure. Annual ophthalmologic examination is recommended for patients on chronic corticosteroids.

Other warnings & precautions

Adrenal Suppression and Tapering: Prednisone suppresses the hypothalamic-pituitary-adrenal (HPA) axis. Abrupt discontinuation after prolonged use can cause acute adrenal insufficiency (adrenal crisis): severe hypotension, nausea, vomiting, altered consciousness, potentially fatal. ANY patient who has received prednisone >5mg/day for >3 weeks must be tapered slowly.

Infection Risk: Corticosteroids suppress all arms of immune response. Patients are at risk for infections from bacteria, viruses, fungi, and parasites, and may not mount a normal febrile response. Screen for latent TB (LTBI) before long-term therapy. Consider prophylaxis for Pneumocystis pneumonia in high-dose patients.

Bone Protection: Long-term corticosteroid use is the leading cause of medicine-induced osteoporosis. ALL patients starting long-term (>3 months) prednisone should be prescribed calcium + vitamin D supplementation, and bisphosphonate therapy should be considered based on fracture risk assessment.

Diabetes and Glucose Monitoring: Corticosteroids cause steroid-induced hyperglycemia in up to 50% of patients without diabetes, and can worsen control in known diabetics. Blood glucose should be monitored, and antidiabetic therapy adjusted accordingly.

Ophthalmic Effects: Long-term use can cause posterior subcapsular cataracts and elevated intraocular pressure. Annual ophthalmologic examination is recommended for patients on chronic corticosteroids.

Prednisone Black Box Warning

No black box warning on record for Prednisone

Other warnings & precautions

Prednisone Black Box Warning

No black box warning on record for Prednisone

Other warnings & precautions