Hepsera Side Effects

Please note - some side effects for Hepsera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Hepsera - for the Consumer

Hepsera

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Hepsera:

Diarrhea; fever; gas; headache; increased cough; indigestion; nausea; sore throat; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine you produce; cold arms and legs; dark urine; dizziness; fast or irregular heartbeat; light-colored bowel movements; loss of appetite; muscle pain; severe or persistent stomach pain, nausea, or vomiting; unusual drowsiness; unusual weakness or fatigue; or yellowing of the skin or eyes.

Hepsera Side Effects - for the Professional

Hepsera

Most common adverse reaction (>10%) in compensated disease patients is asthenia and in pre- and post-transplantation lamivudine-resistant liver disease patients is increased creatinine. (6)

Side Effects by Body System

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.

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. Myopathy and osteomalacia, both associated with proximal renal tubulopathy, have been reported during postmarketing experience.

Ocular

Ocular side effects have included amblyopia at high doses.

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