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Endocrine & metabolic: Diabetes mellitus (new onset).
Gastrointestinal: Constipation, nausea.
Genitourinary: Cystitis (interstitial).
Hepatic: Increased serum ALT (>3 x ULN).
Neuromuscular & skeletal: Arthralgia, increased creatine phosphokinase, myalgia, weakness.
Rare but important or life-threatening: Abnormal thyroid function test, cognitive dysfunction (reversible; including amnesia, confusion, memory impairment), depression, elevated glycosylated hemoglobin (HbA1c), gynecomastia, hematuria (microscopic), hepatic failure, hepatitis, hypersensitivity reaction (including angioedema, pruritus, rash, urticaria), immune-mediated necrotizing myopathy, increased gamma-glutamyltransferase, increased serum alkaline phosphatase, increased serum bilirubin, increased serum glucose, increased serum transaminases, interstitial pulmonary disease, jaundice, myoglobinuria, myopathy, myositis, pancreatitis, peripheral neuropathy, proteinuria (dose related), renal failure, rhabdomyolysis, sleep disorder (including insomnia and nightmares), thrombocytopenia.
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