AGAMREE’s safety profile includes endocrine, psychiatric, and metabolic adverse reactions.

Reported Adverse Reactions and Risks

Common adverse reactions (>10% incidence) include cushingoid features (29% at 6 mg/kg), psychiatric disorders (21%), vomiting (14%), weight gain (11%), and vitamin D deficiency (11%). Serious risks include immunosuppression-related infections, adrenal insufficiency, gastrointestinal perforation, and avascular necrosis. Psychiatric symptoms (e.g., aggression, mood swings) are dose-dependent and reversible upon dose reduction. Long-term use may cause growth retardation, cataracts, and osteoporosis. Rare events include Kaposi’s sarcoma and thromboembolism. Anaphylaxis is noted in corticosteroid class warnings but not explicitly reported with AGAMREE in trials.