Tenofovir alafenamide Side Effects
Commonly reported side effects of tenofovir alafenamide include: abdominal pain, depression, nausea, vomiting, and vesicobullous reaction. Other side effects include: pneumonia, and decreased bone mineral density. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to tenofovir alafenamide: oral tablet
Along with its needed effects, tenofovir alafenamide 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 alafenamide:
Incidence Not Known
- Abdominal or stomach discomfort
- bloody urine
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- fast, shallow breathing
- general feeling of discomfort
- increased blood pressure
- increased thirst
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle pain or cramping
- nausea and vomiting
- right upper abdominal or stomach pain and fullness
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual tiredness or weakness
- weight gain
- yellow eyes and skin
Some side effects of tenofovir alafenamide 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:
For Healthcare Professionals
Applies to tenofovir alafenamide: oral powder, oral tablet
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]
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).
Very common (10% or more): Abdominal pain (up to 22%), nausea (up to 20%), diarrhea (up to 16%), vomiting (up to 13%)
Uncommon (0.1% to 1%): Pancreatitis, elevated serum lipase[Ref]
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
-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]
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
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]
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
Very common (10% or more): Headache (up to 14%), dizziness (up to 13%)
Frequency not reported: Somnolence, paresthesia[Ref]
Dizziness (any severity: 13%) was reported in patients with chronic HBV and decompensated liver disease (n=45).[Ref]
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
-Frequency not reported: Increased weight[Ref]
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
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]
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
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 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]
Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis, pneumonia, pharyngolaryngeal pain
Frequency not reported: Nasal congestion
Common (1% to 10%): Decreased neutrophils[Ref]
Common (1% to 10%): Hematuria, glycosuria
Frequency not reported: Decreased urine volume
Postmarketing reports: Proteinuria, polyuria[Ref]
Postmarketing reports: Allergic reaction (including angioedema)[Ref]
Frequency not reported: Higher serum parathyroid hormone levels
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Some side effects may not be reported. You may report them to the FDA.
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- Drug class: nucleoside reverse transcriptase inhibitors (NRTIs)
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