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Viread Side Effects

Generic Name: tenofovir

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

In Summary

Common side effects of Viread include: abdominal pain, depression, nausea, vomiting, and vesicobullous reaction. Other side effects include: pneumonia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tenofovir: oral powder, oral tablet

Along with its needed effects, tenofovir (the active ingredient contained in Viread) 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 tenofovir:

Less Common

  • Chest pain
  • chills
  • cough
  • fever
  • tightness in the chest
  • troubled breathing

Rare

  • Decreased appetite
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • stomach discomfort
  • unusual tiredness or weakness

Incidence Not Known

  • Agitation
  • bone pain
  • changes in urination
  • confusion
  • decreased awareness or responsiveness
  • depression
  • fast heartbeat
  • hives or welts, itching, skin rash
  • increased blood pressure
  • increased thirst
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • seizures
  • severe sleepiness
  • swelling of the face, fingers, or lower legs
  • vomiting
  • weight gain
  • yellow eyes or skin

Some side effects of tenofovir 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

Less Common

  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • heartburn
  • indigestion
  • joint pain or swelling
  • loss of appetite
  • muscle stiffness
  • passing of gas
  • weight loss

For Healthcare Professionals

Applies to tenofovir: oral powder, oral tablet

General

In clinical trials, the most common side effects reported with tenofovir (the active ingredient contained in Viread) alafenamide were headache, nausea, and fatigue.

During controlled clinical trials, the most common side effects reported with tenofovir disoproxil fumarate (DF) in HIV-1-infected patients included rash, diarrhea, headache, pain, depression, asthenia, and nausea. The most common side effects associated with this drug in combination with other antiretrovirals have included mild to moderate gastrointestinal events (e.g., nausea, diarrhea, vomiting, and flatulence) in therapy-experienced patients and mild to moderate gastrointestinal events and dizziness in therapy-naive patients. About 1% of patients in clinical trials discontinued therapy due to gastrointestinal side effects.

During controlled clinical trials, the most common side effects reported with tenofovir DF in patients with chronic hepatitis B virus (HBV) infection and compensated liver disease included nausea, abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash. In patients with chronic HBV and decompensated liver disease, the most common side effects reported during a controlled trial included abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia.[Ref]

Gastrointestinal

Abdominal pain (any severity: 22%), nausea (any severity: 20%), and vomiting (any severity: 13%) have been in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir (the active ingredient contained in Viread) DF.

Pancreatitis, abdominal pain, and elevated amylase have also been reported during postmarketing experience with tenofovir DF.[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Abdominal pain (included upper abdominal pain, abdominal pain, lower abdominal pain, abdominal tenderness), nausea, diarrhea, dyspepsia, elevated serum amylase, vomiting, flatulence, abdominal distension

-Frequency not reported: Elevated amylase levels with associated symptoms (e.g., nausea, low back pain; abdominal tenderness, pain, distension; biliary pancreatitis, pancreatitis), elevated lipase

Tenofovir DF:

-Very common (10% or more): Abdominal pain (up to 22%), nausea (up to 20%), diarrhea (up to 16%), vomiting (up to 13%)

-Common (1% to 10%): Elevated serum amylase, flatulence, dyspepsia, abdominal distension, upper abdominal pain

-Uncommon (0.1% to 1%): Pancreatitis, elevated serum lipase[Ref]

Other

In studies in chronic hepatitis B patients using tenofovir (the active ingredient contained in Viread) alafenamide, median serum phosphorus decreased by 0.1 mg/dL.

Pyrexia (any severity: 11%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF. Serum phosphorus less than 2 mg/dL was reported in a patient with chronic HBV and decompensated liver disease using tenofovir DF.

Asthenia has also been reported during postmarketing experience with tenofovir DF.[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Fatigue, increased fasted low-density lipoprotein (LDL) cholesterol

-Frequency not reported: Decreased serum phosphorus, decreased fasted total cholesterol, decreased fasted high-density lipoprotein (HDL) cholesterol, increased fasted triglycerides

Tenofovir DF:

-Very common (10% or more): Elevated fasting cholesterol (up to 22%), pain (up to 13%), pyrexia/fever (up to 11%), asthenia (up to 11%), elevated triglycerides (up to 11%)

-Common (1% to 10%): Fatigue, weight loss, chest pain, procedural pain, elevated fasting triglycerides, elevated alkaline phosphatase

-Frequency not reported: Serum phosphorus less than 2 mg/dL, decreased fasted total cholesterol, decreased fasted HDL cholesterol, decreased fasted LDL cholesterol, decreased fasted triglycerides

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipid levels[Ref]

Dermatologic

Pruritus (any severity: 16%) has been reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir (the active ingredient contained in Viread) DF.

Rash has also been reported during postmarketing experience with tenofovir DF.[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Rash, pruritus

-Postmarketing reports: Angioedema, urticaria

Tenofovir DF:

-Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash; up to 18%), pruritus (up to 16%)

-Common (1% to 10%): Sweating

-Uncommon (0.1% to 1%): Lipodystrophy

-Rare (0.01% to 0.1%): Angioedema

-Frequency not reported: Lichenoid drug eruption with eosinophilia[Ref]

Psychiatric

Tenofovir (the active ingredient contained in Viread) DF:

-Very common (10% or more): Insomnia (up to 18%), depression (up to 11%)

-Common (1% to 10%): Anxiety, abnormal dreams

Insomnia (any severity: 18%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.

Nervous system

Tenofovir (the active ingredient contained in Viread) alafenamide:

-Very common (10% or more): Headache (up to 12%)

-Common (1% to 10%): Dizziness

Tenofovir DF:

-Very common (10% or more): Headache (up to 14%), dizziness (up to 13%)

-Common (1% to 10%): Peripheral neuropathy (including peripheral neuritis and neuropathy)

-Frequency not reported: Somnolence, paresthesia[Ref]

Dizziness (any severity: 13%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.[Ref]

Musculoskeletal

Tenofovir (the active ingredient contained in Viread) alafenamide:

-Common (1% to 10%): Back pain, arthralgia, elevated creatine kinase

-Frequency not reported: Decreased bone mineral density

Tenofovir DF:

-Very common (10% or more): Elevated creatine kinase (up to 12%)

-Common (1% to 10%): Arthralgia, myalgia, back pain

-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness

-Rare (less than 0.1%): Myopathy

-Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C telopeptide, urinary N telopeptide), clinically relevant fractures (excluding fingers and toes), bone abnormalities (infrequently contributing to fractures), osteonecrosis

-Postmarketing reports: Osteomalacia (manifested as bone pain and which may contribute to fractures)[Ref]

Rhabdomyolysis, muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir DF.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.[Ref]

Metabolic

Tenofovir (the active ingredient contained in Viread) DF:

-Very common (10% or more): Hypophosphatemia

-Common (1% to 10%): Anorexia, elevated serum glucose/hyperglycemia

-Uncommon (0.1% to 1%): Hypokalemia

-Rare (0.01% to 0.1%): Lactic acidosis

-Frequency not reported: Higher 1,25 vitamin D levels

Antiretroviral therapy:

-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased glucose levels[Ref]

Lactic acidosis, hypokalemia, and hypophosphatemia have also been reported during postmarketing experience with tenofovir DF.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.[Ref]

Hepatic

Death due to progression of liver disease has been reported in 4% of patients with chronic HBV and decompensated liver disease (n=45) using tenofovir (the active ingredient contained in Viread) DF.

On-treatment ALT or hepatic flares have been reported in patients with chronic HBV using tenofovir DF. In general, ALT flares occurred within the first 4 to 8 weeks of therapy, accompanied by decreases in HBV-DNA levels, and resolved within 4 to 8 weeks without changes to therapy.

Hepatic steatosis and hepatitis have also been reported during postmarketing experience with tenofovir DF.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of this drug.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]

Tenofovir alafenamide:

-Common (1% to 10%): Elevated ALT, elevated AST

-Uncommon (0.1% to 1%): Treatment ALT flares

Tenofovir DF:

-Common (1% to 10%): Elevated transaminases, elevated ALT, elevated AST, death due to progression of liver disease

-Uncommon (0.1% to 1%): Treatment ALT flares

-Rare (0.01% to 0.1%): Hepatic steatosis, hepatitis

-Frequency not reported: On-treatment ALT or hepatic flares, severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis

-Postmarketing reports: Elevated liver enzymes (primarily AST, ALT, GGT)[Ref]

Renal

In studies in chronic hepatitis B patients using tenofovir (the active ingredient contained in Viread) alafenamide, mean serum creatinine increased by less than 0.1 mg/dL.

A confirmed increase in serum creatinine of 0.5 mg/dL was reported in 9% of patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF; however, since tenofovir DF and decompensated liver disease may have an impact on renal function, the contribution of tenofovir DF to renal impairment in these patients was difficult to ascertain.

Proximal renal tubulopathy generally resolved or improved after this drug was stopped; however, decreased CrCl did not completely resolve in some patients after stopping tenofovir DF. Rhabdomyolysis, osteomalacia, bone abnormalities (infrequently contributing to fractures), hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, and acute tubular necrosis have also been reported during postmarketing experience with tenofovir DF.[Ref]

Tenofovir alafenamide:

-Frequency not reported: Increased serum creatinine

Tenofovir DF:

-Common (1% to 10%): Increased creatinine

-Uncommon (0.1% to 1%): Proximal renal tubulopathy (including Fanconi syndrome)

-Rare (0.01% to 0.1%): Acute renal failure, renal failure, acute tubular necrosis, nephrogenic diabetes insipidus

-Frequency not reported: New onset or worsening renal impairment, nephritis, decreased CrCl

-Postmarketing reports: Renal insufficiency, interstitial nephritis (including acute cases)[Ref]

Respiratory

Tenofovir (the active ingredient contained in Viread) alafenamide:

-Common (1% to 10%): Cough

Tenofovir DF:

-Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis, pneumonia, pharyngolaryngeal pain

-Frequency not reported: Nasal congestion

-Postmarketing reports: Dyspnea[Ref]

Hematologic

Tenofovir (the active ingredient contained in Viread) DF:

-Common (1% to 10%): Decreased neutrophils[Ref]

Genitourinary

Tenofovir (the active ingredient contained in Viread) alafenamide:

-Common (1% to 10%): Glycosuria (at least 3+)

Tenofovir DF:

-Common (1% to 10%): Hematuria, glycosuria

-Frequency not reported: Decreased urine volume

-Postmarketing reports: Proteinuria, polyuria[Ref]

Hypersensitivity

Tenofovir (the active ingredient contained in Viread) DF:

-Postmarketing reports: Allergic reaction (including angioedema)[Ref]

Immunologic

Tenofovir (the active ingredient contained in Viread) DF:

-Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)

Endocrine

Tenofovir (the active ingredient contained in Viread) DF:

-Frequency not reported: Higher serum parathyroid hormone levels

References

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2. "Product Information. Vemlidy (tenofovir)." Gilead Sciences, Foster City, CA.

3. Paxton LA, Hope T, Jaffe HW "Pre-exposure prophylaxis for HIV infection: what if it works?" Lancet 370 (2007): 89-93

4. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." ([2018, May 30]):

5. "Product Information. Viread (tenofovir)." Gilead Sciences, Foster City, CA.

6. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV "Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf." ([2018, May 22):

7. Kearney BP, Yale K, Shah J, Zhong L, Flaherty JF "Pharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairment." Clin Pharmacokinet 45 (2006): 1115-24

8. Blum MR, Chittick GE, Begley JA, Zong J "Steady-state pharmacokinetics of emtricitabine and tenofovir disoproxil fumarate administered alone and in combination in healthy volunteers." J Clin Pharmacol 47 (2007): 751-9

9. Baeten JM, Donnell D, Ndase P, et al. "Antiretroviral prophylaxis for HIV prevention in heterosexual men and women." N Engl J Med 367 (2012): 399-410

10. Warnke D, Barreto J, Temesgen Z "Antiretroviral drugs." J Clin Pharmacol 47 (2007): 1570-9

11. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother 62 (2008): 879-88

12. Woolley IJ, Veitch AJ, Harangozo CS, Moyle M, Korman TM "Lichenoid drug eruption to tenofovir in an HIV/hepatitis B virus co-infected patient." AIDS 18 (2004): 1857-8

13. Shepp DH, Curtis S, Rooney JF "Causes and consequences of hypokalemia in patients on tenofovir disoproxil fumarate." AIDS 21 (2007): 1479-81

14. Cirino CM, Kan VL "Hypokalemia in HIV patients on tenofovir." AIDS 20 (2006): 1671-3

15. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

16. Blaas S, Schneidewind A, Gluck T, Salzberger B "Acute renal failure in HIV patients with liver cirrhosis receiving tenofovir: a report of two cases." AIDS 20 (2006): 1786-7

17. Fux CA, Christen A, Zgraggen S, Mohaupt MG, Furrer H "Effect of tenofovir on renal glomerular and tubular function." AIDS 21 (2007): 1483-5

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

19. Callens S, De Schacht C, Huyst V, Colebunders R "Pancreatitis in an HIV-infected person on a tenofovir, didanosine and stavudine containing highly active antiretroviral treatment." J Infect 47 (2003): 188-9

20. Hammer SM, Saag MS, Schechter M, et al. "Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel." JAMA 296 (2006): 827-43

21. Agarwala R, Mohan S, Herlitz LC, Cheng JT "The case: 41-year-old HIV patient with proteinuria and progressive renal dysfunction. Tenofovir toxicity." Kidney Int 77 (2010): 475-6

22. 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

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

24. Izzedine H, Hulot JS, Villard E, et al. "Association between ABCC2 Gene Haplotypes and Tenofovir-Induced Proximal Tubulopathy." J Infect Dis 194 (2006): 1481-91

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

27. Szczech LA "Tenofovir nephrotoxicity: focusing research questions and putting them into clinical context." J Infect Dis 197 (2008): 7-9

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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