Tenofovir Side Effects
Some side effects of tenofovir 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
Along with its needed effects, tenofovir 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
- fever or chills
- sore throat
- tightness in the chest
- troubled breathing
- Abdominal or stomach discomfort
- decreased appetite
- fast, shallow breathing
- general feeling of discomfort
- muscle pain or cramping
- unusual tiredness or weakness
- bloody or cloudy urine
- bone pain
- convulsions or seizures
- darkened urine
- decreased frequency or amount of urine
- difficult or painful urination
- fast heartbeat
- increased blood pressure
- increased thirst
- muscle twitching
- pains in the stomach, side, or abdomen, possibly radiating to the back
- swelling of the face, fingers, or lower legs
- 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
- Back pain
- hives or welts
- itching skin
- lack or loss of strength
- redness of the skin
- skin rash
- 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
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 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 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.
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 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 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 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 side effects (Grades 2 to 4) have included depression (up to 11%) and anxiety (6%). Abnormal dreams have been reported.
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, 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.
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 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 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 side effects (Grade 3/4) have included decreased neutrophils (up to 3%).
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 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 side effects have included allergic reaction (including angioedema) during postmarketing experience.
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