Note: This document contains side effect information about adefovir. Some dosage forms listed on this page may not apply to the brand name Hepsera.

Applies to adefovir: oral tablet.

Serious side effects of Hepsera

Along with its needed effects, adefovir (the active ingredient contained in Hepsera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking adefovir:

More common

• Dark urine
• general tiredness and weakness
• light-colored stools
• nausea and vomiting
• upper right abdomen or stomach pain
• yellow eyes and skin

Less common

• Blood in the urine
• change in frequency of urination or amount of urine
• difficult breathing
• drowsiness
• increased thirst
• loss of appetite
• swelling of the feet or lower legs
• weakness

Rare

• Fast, shallow breathing
• general feeling of discomfort
• muscle pain or cramping
• shortness of breath
• sleepiness
• unusual tiredness or weakness

Incidence not known

• Bloating
• bone fractures, especially of the thigh bone
• bone pain
• chills
• cloudy urine
• constipation
• convulsions
• darkened urine
• decreased frequency or amount of urine
• fast heartbeat
• fever
• increase in the amount of urine
• increased blood pressure
• indigestion
• lower back or side pain
• muscular pain, tenderness, wasting, or weakness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• swelling of the face, fingers, or lower legs
• weight gain

Other side effects of Hepsera

Some side effects of adefovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• headache
• lack or loss of strength

Less common

• Acid or sour stomach
• belching
• bloated or full feeling
• diarrhea
• excess air or gas in the stomach or intestines
• heartburn
• passing gas
• stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to adefovir: oral tablet.

General

In patients with compensated liver disease, the most commonly reported side effects were asthenia, headache, abdominal pain, and nausea during 48 weeks of therapy. In patients with decompensated liver disease, the most commonly reported side effects were increased creatinine and asthenia during up to 203 weeks of therapy.^[Ref]

Renal

Very common (10% or more): Increased serum creatinine

Common (1% to 10%): Renal failure, abnormal renal function

Frequency not reported: Renal toxicity, changes in renal function, renal events, renal insufficiency, renal calculus, renal pain, nephrotoxicity, Fanconi-like syndrome, overall renal function deterioration

Postmarketing reports: Proximal renal tubulopathy, Fanconi syndrome^[Ref]

In 125 hepatitis B e antigen (HBeAg)-negative patients with extended therapy (up to 240 weeks), serum creatinine increases of at least 0.5 mg/dL from baseline were confirmed in 4 patients; 1 patient discontinued therapy due to elevated serum creatinine level. In 65 HBeAg-positive patients with extended therapy (up to 234 weeks), serum creatinine increases of at least 0.5 mg/dL from baseline were confirmed in 6 patients; 2 patients discontinued therapy due to elevated serum creatinine level.

Pre- and post-liver transplantation patients (n=226 and 241, respectively) with chronic hepatitis B and lamivudine-resistant hepatitis B were treated for up to 203 weeks; changes in renal function were reported in those with risk factors for renal dysfunction. Serum creatinine increases of at least 0.3 mg/dL from baseline were seen in 37% and 53% of pre-liver transplantation patients by 48 and 96 weeks, respectively; serum creatinine increases of at least 0.5 mg/dL from baseline occurred in 18%, 35%, and 35% of pre-liver transplantation patients by 48, 96, and 144 week, respectively. Serum creatinine increases of at least 0.3 mg/dL from baseline were seen in 32% and 51% of post-liver transplantation patients by 48 and 96 weeks, respectively; serum creatinine increases of at least 0.5 mg/dL from baseline occurred in 12%, 28%, and 30% of post-liver transplantation patients by 48, 96, and 144 weeks, respectively. Serum creatinine elevations at least 0.5 mg/dL from baseline resolved (up to 0.3 mg/dL increase from baseline) in 8 of 39 pre-liver transplantation patients and in 14 of 43 post-liver transplantation patients by last study visit. Serum phosphorus values less than 2 mg/dL were seen in 1.3% and 2.5% of pre- and post-liver transplantation patients, respectively, by last study visit. This drug was discontinued due to renal events in 4% of pre- and post-liver transplant patients. Causality could not be definitely determined because of the presence of multiple risk factors for renal dysfunction.

Fanconi-like syndrome and overall renal function deterioration have been reported at high doses.

Renal failure has also been reported during postmarketing experience.^[Ref]

Hepatic

Elevated ALT (greater than 5 times the upper limit of normal [5 x ULN]) and AST (greater than 5 x ULN) were reported in 20% and 8% of patients, respectively, during the first 48 weeks of therapy.

Severe acute exacerbations of hepatitis have been reported in patients who have discontinued this drug. Although most cases appeared self-limited or resolved by restarting therapy, severe hepatitis exacerbations (including fatalities) have been reported.

Clinical and laboratory evidence of exacerbations of hepatitis have been reported after treatment with this drug was discontinued.

Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) have been reported with the use of nucleoside analogs alone or in combination with antiretrovirals.^[Ref]

Very common (10% or more): Elevated ALT (20%)

Common (1% to 10%): Elevated AST

Frequency not reported: Hepatic failure, severe acute exacerbations of hepatitis

Postmarketing reports: Clinical and laboratory evidence of exacerbations of hepatitis

Nucleoside analogs:

-Frequency not reported: Severe hepatomegaly with steatosis^[Ref]

Other

Very common (10% or more): Asthenia (up to 13%), decreased serum phosphorus

Common (1% to 10%): Decreased carnitine levels

Frequency not reported: Fever, weight loss, influenza-like syndrome, infection, pain, accidental injury^[Ref]

Genitourinary

Hematuria (at least 3+) and glycosuria (at least 3+) were reported in 11% and 1% of patients, respectively, during the first 48 weeks of therapy.

Very common (10% or more): Hematuria (11%)

Common (1% to 10%): Glycosuria

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, flatulence, diarrhea, dyspepsia, vomiting, increased amylase

Postmarketing reports: Pancreatitis^[Ref]

Increased amylase (greater than 2 x ULN) was reported in 4% of patients during the first 48 weeks of therapy.^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Dizziness^[Ref]

Musculoskeletal

Common (1% to 10%): Increased creatine kinase

Frequency not reported: Arthralgia, back pain, hypophosphatemic osteomalacia (in the context of Fanconi syndrome)

Postmarketing reports: Myopathy, osteomalacia (manifested as bone pain and infrequently contributing to fractures)^[Ref]

Increased creatine kinase (greater than 4 x ULN) was reported in 7% of patients during the first 48 weeks of therapy.

Osteomalacia and myopathy, both associated with proximal renal tubulopathy, have been reported.^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash^[Ref]

Metabolic

Hypophosphatemia has also been reported during postmarketing experience.

Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) have been reported with the use of nucleoside analogs alone or in combination with antiretrovirals.^[Ref]

Common (1% to 10%): Hypophosphatemia

Frequency not reported: Anorexia

Nucleoside analogs:

-Frequency not reported: Lactic acidosis^[Ref]

Psychiatric

Frequency not reported: Insomnia

Respiratory

Frequency not reported: Increased cough, pharyngitis, sinusitis, bronchitis, rhinitis^[Ref]

Cardiovascular

Frequency not reported: Myocardial infarction^[Ref]

Myocardial infarction has been reported at high doses.^[Ref]

Ocular

Frequency not reported: Amblyopia^[Ref]

Amblyopia has been reported at high doses.^[Ref]