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Viread Side Effects

Generic Name: tenofovir

Note: This page contains side effects data for the generic drug tenofovir. It is possible that some of the dosage forms included below may not apply to the brand name Viread.

In Summary

Common side effects of Viread include: depression, nausea, vomiting, abdominal pain, 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

As well as its needed effects, tenofovir (the active ingredient contained in Viread) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking tenofovir, check with your doctor immediately:

Less common:
  • Chest pain
  • cough
  • fever or chills
  • tightness in the chest
  • troubled breathing
Rare
  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • unusual tiredness or weakness
Incidence not known:
  • Agitation
  • bone pain
  • changes in urination
  • confusion
  • convulsions or seizures
  • depression
  • fast heartbeat
  • increased blood pressure
  • increased thirst
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • stupor
  • swelling of the face, fingers, or lower legs
  • vomiting
  • weight gain
  • yellow eyes or skin

Minor Side Effects

Some tenofovir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Back pain
  • lack or loss of strength
  • pain
  • redness of the skin
  • skin rash, itching skin, hives or welts
Less common:
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • heartburn or indigestion
  • joint pain or swelling
  • muscle pains or stiffness
  • passing of gas
  • redistribution or accumulation of body fat
  • weight loss

For Healthcare Professionals

Applies to tenofovir: oral powder, oral tablet

General

During controlled clinical trials, the most common side effects reported with tenofovir (the active ingredient contained in Viread) 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).

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

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]

Metabolic

Serum phosphorus less than 2 mg/dL was reported in a patient with chronic HBV and decompensated liver disease.

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.

Lactic acidosis, hypokalemia, and hypophosphatemia have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Elevated fasting cholesterol (up to 22%), elevated triglycerides (up to 11%), hypophosphatemia
Common (1% to 10%): Elevated fasting triglycerides, anorexia, elevated serum glucose/hyperglycemia, elevated alkaline phosphatase
Uncommon (0.1% to 1%): Hypokalemia
Rare (0.01% to 0.1%): Lactic acidosis
Frequency not reported: Serum phosphorus less than 2 mg/dL, 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 blood lipid levels, increased glucose levels[Ref]

Dermatologic

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]

Pruritus (any severity: 16%) has been reported in patients with chronic HBV and decompensated liver disease (n=45).

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

Psychiatric

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

Very common (10% or more): Insomnia (up to 18%), depression (up to 11%)
Common (1% to 10%): Anxiety, abnormal dreams

Nervous system

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).[Ref]

Other

Pyrexia (any severity: 11%) was reported in patients with chronic HBV and decompensated liver disease (n=45).

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

Very common (10% or more): Pain (up to 13%), pyrexia/fever (up to 11%), asthenia (up to 11%)
Common (1% to 10%): Fatigue, weight loss, chest pain, procedural pain

Antiretroviral therapy:
-Frequency not reported: Increased weight[Ref]

Musculoskeletal

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

Rhabdomyolysis, muscular weakness, and myopathy have also been reported during postmarketing experience.[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).

On-treatment ALT or hepatic flares have been reported in patients with chronic HBV. 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.

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.

Hepatic steatosis and hepatitis have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Elevated transaminases, elevated ALT, elevated AST, death due to progression of liver disease
Rare (0.01% to 0.1%): Hepatic steatosis, hepatitis
Frequency not reported: On-treatment ALT or hepatic flares, lactic acidosis/severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis
Postmarketing reports: Elevated liver enzymes (primarily AST, ALT, gamma glutamyltransferase)[Ref]

Renal

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); however, since tenofovir (the active ingredient contained in Viread) and decompensated liver disease may have an impact on renal function, the contribution of tenofovir to renal impairment in these patients is 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.[Ref]

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

Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis, pneumonia, pharyngolaryngeal pain
Frequency not reported: Nasal congestion
Postmarketing reports: Dyspnea[Ref]

Hematologic

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

Genitourinary

Common (1% to 10%): Hematuria, glycosuria
Frequency not reported: Decreased urine volume
Postmarketing reports: Proteinuria, polyuria[Ref]

Hypersensitivity

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

Endocrine

Frequency not reported: Higher serum parathyroid hormone levels

Immunologic

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

References

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It is possible that some side effects of Viread may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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