Common adverse reactions include hyperglycemia, diarrhea, cutaneous reactions, and hematologic abnormalities, often requiring dose modifications.

Adverse Reaction Profile and Management

The most frequent adverse reactions (≥20%) include diarrhea (72%), cutaneous reactions (58%), hyperglycemia (57% random glucose elevation), lymphopenia (47%), anemia (45%), and nausea (35%). Grade ≥3 events: hyperglycemia (3.1%), diarrhea (9%), and cutaneous reactions (17%). Hyperglycemia management involves insulin/oral agents and dose holds for FG >250 mg/dL. Diarrhea necessitates antidiarrheals and fluid replacement; Grade 3/4 cases require temporary discontinuation. Cutaneous reactions (e.g., erythema multiforme) may resolve with topical/systemic steroids. Fatalities occurred due to sepsis (0.6%) and myocardial infarction (0.6%). Laboratory abnormalities (e.g., increased creatinine, triglycerides) warrant periodic monitoring. Permanent discontinuation rates reached 10%, primarily due to cutaneous toxicity.