Viread Side Effects

Please note - some side effects for Viread may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Viread - for the Consumer

Viread

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Viread:

Abnormal skin sensations; back pain; changes in body fat; diarrhea; dizziness; gas; headache; indigestion; loss of appetite; nausea; sleeplessness; sweating; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; bone pain; chest pain; dark urine; decreased urination or difficulty urinating; extreme weakness or tiredness; fast or irregular heartbeat; feeling cold, especially in the arms and legs; fever, chills, or sore throat; light-colored bowel movements (stools); lightheadedness; mental or mood changes (eg, depression); muscle or joint aches; not feeling like eating for several days; numbness, burning, pain, or tingling in the hands or feet; pneumonia; rapid breathing; severe or persistent nausea or vomiting; shortness of breath; stomach pain; unusual muscle pain; unusual stomach discomfort; unusual tiredness; yellowing of the skin or eyes.

Viread Side Effects - for the Professional

Viread

In HIV-infected patients: Most common adverse reactions (incidence ≥10%, Grades 2 – 4) are rash, diarrhea, headache, pain, depression, asthenia, and nausea. (6)

In HBV-infected patients: Most common adverse reaction (all grades) was nausea (9%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

General

The most common side effects associated with tenofovir in combination with other antiretrovirals have included mild to moderate gastrointestinal intolerance in treatment-experienced patients and mild to moderate gastrointestinal intolerance and dizziness in treatment-naive patients. Less than 1% of patients in clinical trials discontinued treatment due to gastrointestinal side effects.

Gastrointestinal

Gastrointestinal side effects are common and have included nausea, diarrhea, vomiting, flatulence, dyspepsia, anorexia, and abdominal pain. Pancreatitis and elevated serum amylase have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included elevations in aspartate transaminase (AST) and alanine transaminase (ALT). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs, including tenofovir, 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.

Metabolic

Metabolic side effects have included weight loss, lipodystrophy, and elevations in serum glucose, urine glucose, fasting cholesterol, alkaline phosphatase, and fasting triglycerides. Lactic acidosis, hypokalemia, and hypophosphatemia have been reported during postmarketing experience.

Renal

Renal side effects have included new onset or worsening renal impairment, nephritis, and decreased urine volume. 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 have included arthralgia, myalgia, and elevated creatine kinase levels. 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.

Dermatologic

Dermatologic side effects 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) in up to 18% of study subjects and sweating in up to 3%. At least one case of lichenoid drug eruption with eosinophilia has been reported.

Nervous system

Nervous system side effects have included somnolence, headache, abnormal dreams, depression, dizziness, insomnia, paresthesia, and peripheral neuropathy (including peripheral neuritis and neuropathy).

Other

Other side effects have included asthenia, pain, headache, abdominal pain, back pain, chest pain, fever, and fatigue.

Respiratory

Respiratory side effects have included pneumonia, nasal congestion, sinusitis, upper respiratory tract infection, and nasopharyngitis. Dyspnea has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreased neutrophils.

Genitourinary

Genitourinary side effects have included hematuria and glycosuria. Proteinuria and polyuria have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction during postmarketing experience.

Other

Body fat redistribution and/or accumulation have been observed in patients taking antiretroviral agents. A causal relationship to the administration of tenofovir has not been established. The mechanism and long-term effects of these complications have not been determined.

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