Vemlidy Side Effects
Generic name: tenofovir alafenamide
Medically reviewed by Drugs.com. Last updated on Dec 28, 2023.
Note: This document provides detailed information about Vemlidy Side Effects associated with tenofovir alafenamide. Some dosage forms listed on this page may not apply specifically to the brand name Vemlidy.
Applies to tenofovir alafenamide: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Post Treatment Severe Acute Exacerbation of Hepatitis BDiscontinuation of anti-hepatitis B therapy, including tenofovir alafenamide, may result in severe acute exacerbations of hepatitis B.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir alafenamide.
If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Common side effects of Vemlidy
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:
More common
- acid or sour stomach
- belching
- cough
- difficulty in moving
- heartburn
- indigestion
- joint pain
- muscle stiffness
Less common
- back pain
Serious side effects of Vemlidy
Along with its needed effects, tenofovir alafenamide (the active ingredient contained in Vemlidy) 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
- agitation
- bloody urine
- coma
- confusion
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- diarrhea
- dizziness
- fast, shallow breathing
- general feeling of discomfort
- headache
- hostility
- irritability
- lethargy
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle pain, cramping, or twitching
- nausea and vomiting
- right upper abdominal or stomach pain and fullness
- seizures
- sleepiness
- stomach discomfort
- stupor
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- yellow eyes and skin
For healthcare professionals
Applies to tenofovir alafenamide: oral powder, oral tablet.
General
In clinical trials, the most common side effects reported with tenofovir alafenamide (the active ingredient contained in Vemlidy) were headache, nausea, and fatigue.
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]
Gastrointestinal
- Common (1% to 10%): Abdominal pain (included upper abdominal pain, abdominal pain, lower abdominal pain, abdominal tenderness), nausea, diarrhea, dyspepsia, elevated serum amylase, vomiting, flatulence, abdominal distension
- Frequency not reported: Elevated amylase levels with associated symptoms (e.g., nausea, low back pain; abdominal tenderness, pain, distension; biliary pancreatitis, pancreatitis), elevated lipase
Tenofovir DF:
- 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]
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) using tenofovir DF.
Pancreatitis, abdominal pain, and elevated amylase have also been reported during postmarketing experience with tenofovir DF.[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Other
- Common (1% to 10%): Fatigue, increased fasted low-density lipoprotein (LDL) cholesterol
- Frequency not reported: Decreased serum phosphorus, decreased fasted total cholesterol, decreased fasted high-density lipoprotein (HDL) cholesterol, increased fasted triglycerides
Tenofovir DF:
- Very common (10% or more): Elevated fasting cholesterol (up to 22%), pain (up to 13%), pyrexia/fever (up to 11%), asthenia (up to 11%), elevated triglycerides (up to 11%)
- Common (1% to 10%): Fatigue, weight loss, chest pain, procedural pain, elevated fasting triglycerides, elevated alkaline phosphatase
- Frequency not reported: Serum phosphorus less than 2 mg/dL, decreased fasted total cholesterol, decreased fasted HDL cholesterol, decreased fasted LDL cholesterol, decreased fasted triglycerides
Antiretroviral therapy:
- Frequency not reported: Increased weight, increased blood lipid levels[Ref]
In studies in chronic hepatitis B patients using tenofovir alafenamide, median serum phosphorus decreased by 0.1 mg/dL.
Pyrexia (any severity: 11%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF. Serum phosphorus less than 2 mg/dL was reported in a patient with chronic HBV and decompensated liver disease using tenofovir DF.
Asthenia has also been reported during postmarketing experience with tenofovir DF.[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Dermatologic
- Common (1% to 10%): Rash, pruritus
- Postmarketing reports: Angioedema, urticaria
Tenofovir DF:
- 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) using tenofovir DF.
Rash has also been reported during postmarketing experience with tenofovir DF.[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Psychiatric
Tenofovir DF:
- Very common (10% or more): Insomnia (up to 18%), depression (up to 11%)
- Common (1% to 10%): Anxiety, abnormal dreams
Insomnia (any severity: 18%) was reported in patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.
Nervous system
- Very common (10% or more): Headache (up to 12%)
- Common (1% to 10%): Dizziness
Tenofovir DF:
- 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) using tenofovir DF.[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Musculoskeletal
- Common (1% to 10%): Back pain, arthralgia, elevated creatine kinase
- Frequency not reported: Decreased bone mineral density
Tenofovir DF:
- 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, muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir DF.
Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Metabolic
Tenofovir DF:
- Very common (10% or more): Hypophosphatemia
- Common (1% to 10%): Anorexia, elevated serum glucose/hyperglycemia
- Uncommon (0.1% to 1%): Hypokalemia
- Rare (0.01% to 0.1%): Lactic acidosis
- Frequency not reported: 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 glucose levels[Ref]
Lactic acidosis, hypokalemia, and hypophosphatemia have also been reported during postmarketing experience with tenofovir DF.
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.[Ref]
Hepatic
Tenofovir alafenamide:
- Common (1% to 10%): Elevated ALT, elevated AST
- Uncommon (0.1% to 1%): Treatment ALT flares
Tenofovir DF:
- Common (1% to 10%): Elevated transaminases, elevated ALT, elevated AST, death due to progression of liver disease
- Uncommon (0.1% to 1%): Treatment ALT flares
- Rare (0.01% to 0.1%): Hepatic steatosis, hepatitis
- Frequency not reported: On-treatment ALT or hepatic flares, severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis
- Postmarketing reports: Elevated liver enzymes (primarily AST, ALT, GGT)[Ref]
Death due to progression of liver disease has been reported in 4% of patients with chronic HBV and decompensated liver disease (n=45) using tenofovir DF.
On-treatment ALT or hepatic flares have been reported in patients with chronic HBV using tenofovir DF. 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.
Hepatic steatosis and hepatitis have also been reported during postmarketing experience with tenofovir DF.
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.[Ref]
Renal
Tenofovir alafenamide:
- Frequency not reported: Increased serum creatinine
Tenofovir DF:
- 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]
In studies in chronic hepatitis B patients using tenofovir alafenamide (the active ingredient contained in Vemlidy) mean serum creatinine increased by less than 0.1 mg/dL.
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) using tenofovir DF; however, since tenofovir DF and decompensated liver disease may have an impact on renal function, the contribution of tenofovir DF to renal impairment in these patients was 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 with tenofovir DF.[Ref]
Respiratory
- Common (1% to 10%): Cough
Tenofovir DF:
- Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis, pneumonia, pharyngolaryngeal pain
- Frequency not reported: Nasal congestion
- Postmarketing reports: Dyspnea[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Hematologic
Tenofovir DF:
- Common (1% to 10%): Decreased neutrophils[Ref]
Genitourinary
- Common (1% to 10%): Glycosuria (at least 3+)
Tenofovir DF:
- Common (1% to 10%): Hematuria, glycosuria
- Frequency not reported: Decreased urine volume
- Postmarketing reports: Proteinuria, polyuria[Ref]
Tenofovir alafenamide (the active ingredient contained in Vemlidy)
Hypersensitivity
Tenofovir DF:
- Postmarketing reports: Allergic reaction (including angioedema)[Ref]
Immunologic
Tenofovir DF:
- Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)
Endocrine
Tenofovir DF:
- Frequency not reported: Higher serum parathyroid hormone levels
References
1. (2001) "Product Information. Viread (tenofovir)." Gilead Sciences
2. Paxton LA, Hope T, Jaffe HW (2007) "Pre-exposure prophylaxis for HIV infection: what if it works?" Lancet, 370, p. 89-93
3. Cerner Multum, Inc. "Australian Product Information."
4. (2017) "Product Information. Vemlidy (tenofovir)." Gilead Sciences
5. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (2018) Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. https://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf
6. Panel on Antiretroviral Guidelines for Adults and Adolescents (2018) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf
7. Kearney BP, Yale K, Shah J, Zhong L, Flaherty JF (2006) "Pharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairment." Clin Pharmacokinet, 45, p. 1115-24
8. Blum MR, Chittick GE, Begley JA, Zong J (2007) "Steady-state pharmacokinetics of emtricitabine and tenofovir disoproxil fumarate administered alone and in combination in healthy volunteers." J Clin Pharmacol, 47, p. 751-9
9. Warnke D, Barreto J, Temesgen Z (2007) "Antiretroviral drugs." J Clin Pharmacol, 47, p. 1570-9
10. Baeten JM, Donnell D, Ndase P, et al. (2012) "Antiretroviral prophylaxis for HIV prevention in heterosexual men and women." N Engl J Med, 367, p. 399-410
11. Woolley IJ, Veitch AJ, Harangozo CS, Moyle M, Korman TM (2004) "Lichenoid drug eruption to tenofovir in an HIV/hepatitis B virus co-infected patient." AIDS, 18, p. 1857-8
12. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E (2008) "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother, 62, p. 879-88
13. Cerner Multum, Inc. "UK Summary of Product Characteristics."
14. Cirino CM, Kan VL (2006) "Hypokalemia in HIV patients on tenofovir." AIDS, 20, p. 1671-3
15. Shepp DH, Curtis S, Rooney JF (2007) "Causes and consequences of hypokalemia in patients on tenofovir disoproxil fumarate." AIDS, 21, p. 1479-81
16. Izzedine H, Launay-Vacher V, Deray G (2005) "Antiviral drug-induced nephrotoxicity." Am J Kidney Dis, 45, p. 804-17
17. Blaas S, Schneidewind A, Gluck T, Salzberger B (2006) "Acute renal failure in HIV patients with liver cirrhosis receiving tenofovir: a report of two cases." AIDS, 20, p. 1786-7
18. Fux CA, Christen A, Zgraggen S, Mohaupt MG, Furrer H (2007) "Effect of tenofovir on renal glomerular and tubular function." AIDS, 21, p. 1483-5
19. Callens S, De Schacht C, Huyst V, Colebunders R (2003) "Pancreatitis in an HIV-infected person on a tenofovir, didanosine and stavudine containing highly active antiretroviral treatment." J Infect, 47, p. 188-9
20. Perazella MA (2003) "Drug-induced renal failure: update on new medications and unique mechanisms of nephrotoxicity." Am J Med Sci, 325, p. 349-62
21. Anderson PL (2004) "Pharmacologic perspectives for once-daily antiretroviral therapy." Ann Pharmacother, 38, p. 1969-70
22. Izzedine H, Launay-Vacher V, Deray G (2005) "Renal tubular transporters and antiviral drugs: an update." AIDS, 19, p. 455-62
23. Roling J, Schmid H, Fischereder M, Draenert R, Goebel FD (2006) "HIV-Associated Renal Diseases and Highly Active Antiretroviral Therapy-Induced Nephropathy." Clin Infect Dis, 42, p. 1488-95
24. Hammer SM, Saag MS, Schechter M, et al. (2006) "Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel." JAMA, 296, p. 827-43
25. Izzedine H, Hulot JS, Villard E, et al. (2006) "Association between ABCC2 Gene Haplotypes and Tenofovir-Induced Proximal Tubulopathy." J Infect Dis, 194, p. 1481-91
26. Szczech LA (2008) "Tenofovir nephrotoxicity: focusing research questions and putting them into clinical context." J Infect Dis, 197, p. 7-9
27. Agarwala R, Mohan S, Herlitz LC, Cheng JT (2010) "The case: 41-year-old HIV patient with proteinuria and progressive renal dysfunction. Tenofovir toxicity." Kidney Int, 77, p. 475-6
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Further information
Vemlidy side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.