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.

Some side effects of Viread may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tenofovir: oral powder, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tenofovir (the active ingredient contained in Viread) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have a serious side effect such as:

• liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems - increased thirst and urination, loss of appetite, constipation, urinating less than usual or not at all;

• signs of a new infection such as fever, chills, sore throat, flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;

• increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• problems with walking, breathing, speech, swallowing, or eye movement; or

• severe lower back pain, loss of bladder or bowel control.

Less serious side effects of tenofovir may include:

• mild nausea or diarrhea;

• depression, headache, dizziness, mild weakness;

• mild itching or rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tenofovir: oral powder, oral tablet

General

The most common side effects (greater than or equal to 10%; Grades 2 to 4) reported during controlled clinical trials in patients with HIV infection included rash, diarrhea, headache, pain, depression, asthenia, and nausea. The most common side effects associated with tenofovir (the active ingredient contained in Viread) in combination with other antiretrovirals have included mild to moderate gastrointestinal events (such as nausea, diarrhea, vomiting, and flatulence) in treatment-experienced patients and mild to moderate gastrointestinal events and dizziness in treatment-naive patients. Less than 1% of patients in clinical trials discontinued treatment due to gastrointestinal side effects.

The most common side effects (greater than 5%) reported during controlled clinical trials in patients with chronic hepatitis B and compensated liver disease included nausea, abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash. In patients with chronic hepatitis B and decompensated liver disease, the most common side effects reported during a controlled trial included abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia.

Gastrointestinal

Gastrointestinal side effects (Grades 2 to 4) have included diarrhea (up to 16%), nausea (up to 11%), vomiting (up to 7%), flatulence (up to 4%), dyspepsia (up to 4%), and anorexia (up to 4%). Abdominal pain (any severity; 22%), nausea (any severity; 20%), and vomiting (any severity; 13%) have been in patients with chronic hepatitis B and decompensated liver disease (n=45). Pancreatitis, abdominal pain, and elevated amylase have been reported during postmarketing experience.

Metabolic

Hypokalemia and hypophosphatemia may occur due to proximal renal tubulopathy.

Metabolic side effects (Grade 3/4) have included elevated fasting cholesterol (up to 22%), creatine kinase (up to 12%), triglycerides (up to 11%), serum amylase (up to 9%), fasting triglycerides (up to 4%), serum glucose (up to 3%), alkaline phosphatase (1%), and serum lipase (1%). Additional side effects (Grades 2 to 4) have included weight loss (up to 4%) and lipodystrophy (1%). Serum phosphorus less than 2 mg/dL was reported in a patient with chronic hepatitis B and decompensated liver disease. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance," have been observed in patients receiving antiretroviral therapy, including tenofovir; however, a causal relationship has not been established. Lactic acidosis, hypokalemia, and hypophosphatemia have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects (Grades 2 to 4) have included rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, and vesicular rash; up to 18%) and sweating (up to 3%). Pruritus (any severity; 16%) has been reported in patients with chronic hepatitis B and decompensated liver disease (n=45). At least one case of lichenoid drug eruption with eosinophilia has been reported. Rash has also been reported during postmarketing experience.

Nervous system

Nervous system side effects (Grades 2 to 4) have included headache (up to 14%), dizziness (up to 8%), insomnia (up to 5%), and peripheral neuropathy (including peripheral neuritis and neuropathy; up to 5%). Insomnia (any severity; 18%) and dizziness (any severity; 13%) were reported in patients with chronic hepatitis B and decompensated liver disease (n=45). Somnolence and paresthesia have been reported.

Other

Other side effects (Grades 2 to 4) have included pain (up to 13%), asthenia (up to 11%), fatigue (9%), back pain (up to 9%), fever (up to 8%), abdominal pain (up to 7%), and chest pain (up to 3%). Pyrexia (any severity; 11%) was reported in patients with chronic hepatitis B and decompensated liver disease (n=45).

Psychiatric

Psychiatric side effects (Grades 2 to 4) have included depression (up to 11%) and anxiety (6%). Abnormal dreams have been reported.

Hepatic

Hepatic side effects (Grade 3/4) have included elevated alanine transaminase (ALT; up to 10%) and aspartate transaminase (AST; up to 5%). On-treatment ALT or hepatic flares have been reported in patients with chronic hepatitis B. Death due to progression of liver disease has been reported in 4% of patients with chronic hepatitis B and decompensated liver disease (n=45). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs, including tenofovir (the active ingredient contained in Viread) in combination with other antiretroviral agents. Hepatic steatosis, hepatitis, and elevated liver enzymes (primarily AST, ALT, and gamma glutamyl transferase) have been reported during postmarketing experience. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of tenofovir.

Renal

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

Renal side effects have included new onset or worsening renal impairment, nephritis, and decreased urine volume. A confirmed increase in serum creatinine of 0.5 mg/dL was reported in 9% of patients with chronic hepatitis B and decompensated liver disease (n=45); however, since tenofovir 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. Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, and interstitial nephritis (including acute cases) have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects (Grades 2 to 4) have included arthralgia (5%) and myalgia (up to 4%). Decreased bone mineral density and increased biochemical markers of bone metabolism have been reported. Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, and myopathy have been reported during postmarketing experience.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur due to proximal renal tubulopathy.

Respiratory

Respiratory side effects (Grades 2 to 4) have included sinusitis (8%), upper respiratory tract infections (8%), nasopharyngitis (5%), and pneumonia (up to 5%). Nasal congestion has been reported. Dyspnea has been reported during postmarketing experience.

Hematologic

Hematologic side effects (Grade 3/4) have included decreased neutrophils (up to 3%).

Genitourinary

Genitourinary side effects (Grade 3/4) have included hematuria (up to 7%) and glycosuria (up to 3%). Proteinuria and polyuria have been reported during postmarketing experience.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (including angioedema) during postmarketing experience.

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