Adefovir Side Effects

Not all side effects for adefovir 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

General

In patients with chronic hepatitis B, the incidence of side effects increased slightly with increased duration of treatment.

Other

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

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 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

Nervous system side effects have included headache (9%), dizziness, and insomnia.

Gastrointestinal

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

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 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

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

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

Cardiovascular side effects have included myocardial infarction at high doses.

Musculoskeletal

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

Metabolic side effects have included hypophosphatemia during postmarketing experience.

Ocular

Ocular side effects have included amblyopia at high doses.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web3)