Musculoskeletal side effects also included arthralgia(关节痛) and myalgia(肌病).
Metabolic side effects have included elevated lipase (greater than or equal to 2.1 times ULN; 7%), fasting hyperglycemia (greater than 250 mg/dL; up to 3%), elevated alkaline phosphatase, and elevated amylase. Decreased blood bicarbonate has been reported in 2% of entecavir-treated patients with hepatic decompensation. Lactic acidosis has been reported during postmarketing experience.
GenitourinaryGenitourinary side effects have included hematuria (Grade 3 to 4; 9%), glycosuria (Grade 3 to 4; 4%), and dysuria.
RenalRenal side effects have included confirmed creatinine increases of 0.5 mg/dL or more (up to 2%). A confirmed increase in serum creatinine of 0.5 mg/dL (11%) and renal failure (less than 1%) have been reported in entecavir-treated patients with hepatic decompensation.
RespiratoryRespiratory side effects have included upper respiratory tract infection, cough, nasopharyngitis, and rhinitis. Upper respiratory infection has been reported in 10% of entecavir-treated patients with hepatic decompensation.
GastrointestinalGastrointestinal side effects of moderate to severe intensity (Grade 2 to 4) have included diarrhea (up to 1%), dyspepsia (up to 1%), nausea (less than 1%), and vomiting (less than 1%). Abdominal pain (unspecified) and upper abdominal pain have also been reported. Deaths due to gastrointestinal hemorrhage were reported in entecavir-treated patients with hepatic decompensation.
OncologicOncologic side effects have included malignant neoplasms occurring at a rate of 8.4 per 1000 patient-years. Hepatocellular carcinoma has been reported in 6% of entecavir-treated patients with hepatic decompensation.
Nervous systemNervous system side effects of moderate to severe intensity (Grade 2 to 4) have included headache (up to 4%), dizziness (less than 1%), and somnolence (less than 1%).
HematologicHematologic side effects have included decreased albumin (less than 2.5 g/dL) and platelets (less than 50,000/mm3) in less than 1% of patients.
ImmunologicImmunologic side effects have included anaphylactoid reaction during postmarketing experience.
PsychiatricPsychiatric side effects of moderate to severe intensity (Grade 2 to 4) have included insomnia (less than 1%).
DermatologicDermatologic side effects have included erythema. Rash and alopecia have been reported during postmarketing experience.
HypersensitivityHypersensitivity side effects have included photosensitivity with lethargy in at least one patient, which resolved after stopping entecavir.
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