>10%:

• Dermatologic: Rash (children 21%; adults 3% to 10%)
• Endocrine & metabolic: Hypertriglyceridemia (>400 mg/dL: 61%), hypercholesterolemia (>300 mg/dL: 22%)
• Gastrointestinal: Diarrhea (15%)
• Hepatic: Transaminases increased (>2.5 x ULN: 26% to 32%; grade 3/4: 10% to 20%)
• Neuromuscular & skeletal: CPK increased (grade 3/4: children 11%)

2% to 10%:

• Central nervous system: Fever (6% to 8%), fatigue (6%), headache (5%)
• Endocrine & metabolic: Dehydration (2%)
• Gastrointestinal: Nausea (5% to 9%), amylase increased (grade 3: 6% to 8%), vomiting (6%), abdominal pain (4%), diarrhea (children 4%), weight loss (3%)
• Hematologic: Bleeding (children 8%), WBC decreased (grades 3: 5%), anemia (3%), neutropenia (2%)
• Hepatic: ALT increased (2%, grades 3/4: 10%), AST increased (grades 3/4: 6%), GGT increased (2%)
• Neuromuscular & skeletal: Myalgia (2%)
• Respiratory: Cough (children 6%), dyspnea (2%), epistaxis (children 4%)

<2%: Abdominal distension, anorexia, appetite decreased, diabetes mellitus, dizziness, dyspepsia, exanthem, facial wasting, flatulence, flu-like syndrome, gastroesophageal reflux, hepatic failure, hepatic steatosis, hepatitis, hyperbilirubinemia, hyperglycemia, hypersensitivity, immune reconstitution syndrome, insomnia, intracranial hemorrhage, lipase increased, lipoatrophy, lipodystrophy (acquired), lipohypertrophy, malaise, mitochondrial toxicity, muscle cramp, neuropathy (peripheral), pancreatitis, pruritus, renal insufficiency, sleep disorder, somnolence, thrombocytopenia