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

General

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

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.[Ref]

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 (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.[Ref]

Nervous system

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

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.[Ref]

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 (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.[Ref]

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.[Ref]

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.[Ref]

Cardiovascular

Cardiovascular side effects have included myocardial infarction at high doses.[Ref]

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.[Ref]

Metabolic

Metabolic side effects have included hypophosphatemia during postmarketing experience.[Ref]

Ocular

Ocular side effects have included amblyopia at high doses.[Ref]

References

1. "Product Information. Hepsera (adefovir dipivoxil)." Gilead Sciences, Foster City, CA.

2. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. "Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B." N Engl J Med 352 (2005): 2673-81

3. Fontaine H, Vallet-Pichard A, Chaix ML, et al. "Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency." Transplantation 80 (2005): 1086-92

4. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. "Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B." N Engl J Med 348 (2003): 800-7

5. Han SH "Natural course, therapeutic options and economic evaluation of therapies for chronic hepatitis B." Drugs 66 (2006): 1831-51

6. Marcellin P, Chang TT, Lim SG, et al. "Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B." N Engl J Med 348 (2003): 808-16

7. Sun DQ, Wang HS, Ni MY, Wang BJ, Guo RC "Pharmacokinetics, safety and tolerance of single- and multiple-dose adefovir dipivoxil in healthy Chinese subjects." Br J Clin Pharmacol 63 (2007): 15-23

8. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. "Long-Term Therapy With Adefovir Dipivoxil for HBeAg-Negative Chronic Hepatitis B for up to 5 Years." Gastroenterology (2006):

9. Gish RG "Clinical trial results of new therapies for HBV: implications for treatment guidelines." Semin Liver Dis 25 Suppl 1 (2005): 29-39

10. Wong T, Girgis CM, Ngu MC, et al. "Hypophosphatemic osteomalacia after low-dose adefovir dipivoxil therapy for hepatitis B." J Clin Endocrinol Metab 95 (2010): 479-80

11. Perazella MA "Drug-induced renal failure: update on new medications and unique mechanisms of nephrotoxicity." Am J Med Sci 325 (2003): 349-62

12. de Silva HJ, Dassanayake AS, Manamperi A, de Silva AP "Treatment of Lamivudine-resistant hepatitis B infection in post-renal transplant patients with adefovir dipivoxil: premiminary results." Transplant Proc 38 (2006): 3118-20

13. Izzedine H, Kheder-Elfekih R, Housset P, Sarkozy C, Brocheriou I, Deray G "Adefovir dipivoxil-induced acute tubular necrosis and Fanconi syndrome in a renal transplant patient." AIDS 23 (2009): 544-5

14. Rivkina A, Rybalov S "Chronic hepatitis B: current and future treatment options." Pharmacotherapy 22 (2002): 721-37

15. Lok AS "The maze of treatments for hepatitis B." N Engl J Med 352 (2005): 2743-6

16. Tanji N, Tanji K, Kambham N, Markowitz GS, Bell A, D'agati VD "Adefovir nephrotoxicity: possible role of mitochondrial DNA depletion." Hum Pathol 32 (2001): 734-40

17. Roling J, Schmid H, Fischereder M, Draenert R, Goebel FD "HIV-Associated Renal Diseases and Highly Active Antiretroviral Therapy-Induced Nephropathy." Clin Infect Dis 42 (2006): 1488-95

18. Garcia A, Mazuecos A, Gonzalez P, et al. "Treatment with adefovir dipivoxil in a renal transplant patient with renal insufficiency and Lamivudine-resistant hepatitis B infection." Transplant Proc 37 (2005): 1462-3

19. Izzedine H, Launay-Vacher V, Deray G "Antiviral drug-induced nephrotoxicity." Am J Kidney Dis 45 (2005): 804-17

20. Delaney WE 4th "Progress in the treatment of chronic hepatitis B: long-term experience with adefovir dipivoxil." J Antimicrob Chemother (2007):

21. Muller C "Chronic Hepatitis B and C--current treatment and future therapeutic prospects." Wien Med Wochenschr 156(13-14) (2006): 391-6

22. Sims KA, Woodland AM "Entecavir: a new nucleoside analog for the treatment of chronic hepatitis B infection." Pharmacotherapy 26 (2006): 1745-57

23. Izzedine H, Launay-Vacher V, Deray G "Renal tubular transporters and antiviral drugs: an update." AIDS 19 (2005): 455-62

24. Robinson DM, Scott LJ, Plosker GL "Entecavir: a review of its use in chronic hepatitis B." Drugs 66 (2006): 1605-22

25. Bendele RA, Richardson FC "Adefovir nephrotoxicity and mitochondrial DNA depletion." Hum Pathol 33 (2002): 574

26. Szczech LA "Hypertension and medication-related renal dysfunction in the HIV-infected patient." Semin Nephrol 21 (2001): 386-93

27. Falloon J "Salvage antiretroviral therapy." Aids 14 (2000): s209-17

28. Izzedine H, Hulot JS, Launay-Vacher V, et al. "Renal safety of adefovir dipivoxil in patients with chronic hepatitis B: Two double-blind, randomized, placebo-controlled studies." Kidney Int 66 (2004): 1153-8

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