Hepsera Side Effects
Generic Name: adefovir
Note: This page contains information about the side effects of adefovir. Some of the dosage forms included on this document may not apply to the brand name Hepsera.
Not all side effects for Hepsera may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to adefovir: oral tablets
Side effects include:
Asthenia, headache, abdominal pain, nausea, flatulence, diarrhea, dyspepsia.
For Healthcare Professionals
Applies to adefovir: oral tablet
In patients with chronic hepatitis B, the incidence of side effects increased slightly with increased duration of treatment.
Other side effects have included asthenia (13%), abdominal pain (9%), fever (greater than or equal to 2%), weight loss, influenza-like syndrome, infection, back pain, pain, and accidental injury.
Renal side effects have included hematuria (greater than or equal to 3+, 11% ), increases in serum creatinine (greater than or equal to 0.3 mg/dL, 4% to 37%; greater than or equal to 0.5 mg/dL, 2% to 31%), decreases in serum phosphorus (4% to 6%), renal failure (greater than or equal to 2%), renal insufficiency (greater than or equal to 2%), glycosuria (greater than or equal to 3+, 1%), renal calculus, and renal pain. Adefovir was discontinued due to renal side effects in 1% of pre- and post-liver transplant patients. Causality could not be definitely determined because of the presence of multiple risk factors for renal dysfunction. A rare potential risk of adefovir (the active ingredient contained in Hepsera) includes nephrotoxicity. Fanconi-like syndrome and overall renal function deterioration have been reported at high doses. Renal failure, proximal renal tubulopathy, and Fanconi syndrome have been reported during postmarketing experience.
Nervous system side effects have included headache (9%), dizziness, and insomnia.
Gastrointestinal side effects have included abdominal pain (9%), nausea (5%), flatulence (4%), diarrhea (3%), dyspepsia (3%), vomiting (2%), and anorexia. Pancreatitis has been reported during postmarketing experience.
Hepatic side effects have included hepatic failure (greater than or equal to 2%), and laboratory abnormalities with increases in ALT (greater than 5 times ULN), AST (greater than 5 times ULN), creatine kinase (greater than 4 times ULN), and amylase (greater than 2 times ULN). Nucleoside analogs alone or in combination with antiretrovirals have been associated with lactic acidosis and severe hepatomegaly with steatosis.
Severe acute exacerbations of hepatitis have been reported in patients who have discontinued adefovir (the active ingredient contained in Hepsera) dipivoxil. Although most events appear to have been self-limited, fatalities have been reported. Patients who discontinue adefovir dipivoxil should have close monitoring of hepatic function at repeated intervals over a period of time. If appropriate, resumption of antihepatitis B therapy may be warranted.
Dermatologic side effects reported in pre- and post-liver transplantation patients have included pruritus and rash in greater than or equal to 2% of patients.
Respiratory side effects reported in pre- and post-liver transplantation patients have included increased cough, pharyngitis, and sinusitis in greater than or equal to 2% of patients. Bronchitis and rhinitis have also been reported.
Cardiovascular side effects have included myocardial infarction at high doses.
Musculoskeletal side effects have included arthralgia. Hypophosphatemic osteomalacia (in the context of Fanconi syndrome) has been reported. Myopathy and osteomalacia (manifested as bone pain and may contribute to fractures), both associated with proximal renal tubulopathy, have been reported during postmarketing experience.
Metabolic side effects have included hypophosphatemia during postmarketing experience.
Ocular side effects have included amblyopia at high doses.
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