Abstract: Objective To probe into the general rules, characteristics and risk factors of the ADR induced by adefovir so as to provide references for clinical safe medication. Methods We retrospectively analyzed 160 ADR cases induced by adefovir which were collected by Shandong adverse drug reaction database, discussed the time distribution of the ADRs, and emphatically analyzed the ADRs of the skeletal muscle system lesions and hypophosphatemia. Results The ADRs induced by adefovir mainly involved in stomach intestinal system lesions and skin and local lesions. The serious ADRs by adefovir mainly involved in skeletal muscle system lesions and urinary system lesions, and usually appeared after a long-term administration. Stomach intestinal system lesions and skin and local lesions usually appeared within half a year, abnormal liver and renal function and hypophosphatemia usually appeared after half a year, skeletal muscle system lesions usually appeared after one year, osteomalacia usually appeared after four years. Conclusion The ADRs induced by adefovir were related to administration time, and would lead to nephrotoxicity, hypophosphatemic and osteomalacia after long-term administration of adefovir. The serious ADRs by adefovir were easy to appeare in the patients with liver cirrhosis or who were elderly. The regular monitoring of liver and renal function and serum phosphorus should be strengthened with correct diagnosis and timely treatment.

Key words: adefovir, adverse drug reaction(ADR), time-effect relationship, skeletal muscle system lesions