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Emtricitabine / tenofovir Side Effects

For the Consumer

Applies to emtricitabine / tenofovir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by emtricitabine / tenofovir. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking emtricitabine / tenofovir:

Less common:
  • Blisters under the skin
  • rash with flat lesions or small raised lesions on the skin
  • redness of the skin
  • skin rash, itching skin, hives or welts
  • spots on your skin resembling a blister or pimple
Rare:
  • Blindness or vision changes
  • burning of the face or mouth
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
  • chest pain
  • clumsiness or unsteadiness
  • sensation of pins and needles
  • sneezing
  • sore throat
  • stabbing pain
  • weakness in the hands or feet
Incidence not known:
  • Abdominal or stomach discomfort
  • agitation
  • bloating
  • bloody or cloudy urine
  • bone pain
  • chills
  • coma
  • confusion
  • constipation
  • convulsions or seizures
  • cough
  • darkened urine
  • decreased appetite
  • decreased frequency or amount of urine
  • depression
  • diarrhea
  • difficult or labored breathing
  • difficult or painful urination
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort
  • headache
  • hostility
  • increase in the amount of urine
  • increased blood pressure
  • increased thirst
  • indigestion
  • irritability
  • lethargy
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramping
  • muscle twitching
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • sleepiness
  • stupor
  • sudden decrease in the amount of urine
  • swelling of the face, fingers, hands, lower legs, or ankles
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • yellow eyes or skin

Severity: Minor

Some of the side effects that can occur with emtricitabine / tenofovir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:
  • Lack or loss of strength
  • passing of gas
  • weight loss
Rare:
  • Acid or sour stomach
  • back pain
  • belching
  • difficulty with moving
  • discouragement
  • feeling sad or empty
  • heartburn
  • increased cough
  • joint pain
  • loss of interest or pleasure
  • muscle aching or cramping
  • muscle pain or stiffness
  • pain
  • runny nose
  • stomach upset
  • stuffy nose
  • sweating
  • swollen joints
  • tiredness
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to emtricitabine / tenofovir: oral kit, oral tablet

General

Side effects have been reported for emtricitabine and/or tenofovir disoproxil fumarate (DF) when taken in combination with other antiretroviral agents. The most common side effects reported in HIV-1-infected patients during a clinical study of efavirenz, emtricitabine, and tenofovir DF included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. In this trial, emtricitabine-tenofovir DF (with efavirenz) was used from weeks 96 to 144, replacing emtricitabine plus tenofovir DF (with efavirenz).

In HIV-1-uninfected individuals in preexposure prophylaxis trials, the most common side effects reported with emtricitabine-tenofovir DF were headache, abdominal pain, and decreased weight.[Ref]

Metabolic

Emtricitabine-tenofovir DF:
-Very common (10% or more): Increased fasting cholesterol (up to 22%)
-Common (1% to 10%): Decreased phosphorus, increased fasting triglycerides, altered serum glucose, weight loss, hyperglycemia, increased alkaline phosphatase

Emtricitabine and tenofovir alafenamide:
-Frequency not reported: Increased total cholesterol, increased low-density lipoprotein (LDL) cholesterol, increased high-density lipoprotein (HDL) cholesterol, increased triglycerides

Emtricitabine:
-Common (1% to 10%): Hyperglycemia, hypertriglyceridemia, increased or decreased serum glucose
-Frequency not reported: Lactic acidosis

Tenofovir DF:
-Very common (10% or more): Hypophosphatemia, increased triglycerides
-Common (1% to 10%): Anorexia, weight loss, increased serum glucose
-Uncommon (0.1% to 1%): Hypokalemia
-Rare (less than 0.1%): Lactic acidosis

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 blood lipid levels, increased glucose levels[Ref]

Increased fasting cholesterol (greater than 240 mg/dL: up to 22%), decreased phosphorus (2.5 to less than the lower limit of normal: up to 7%; less than 2 mg/dL: up to 10%), increased fasting triglycerides (greater than 750 mg/dL: up to 5%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL: up to 3%), hyperglycemia (greater than 250 mg/dL: up to 2%), and increased alkaline phosphatase (greater than 550 units/L: 1%) have been reported with emtricitabine-tenofovir DF.

In clinical trials, the following mean increases were reported in antiretroviral therapy-naive patients after using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat for 48 weeks: total cholesterol increased by 30 mg/dL, LDL cholesterol by 15 mg/dL, HDL cholesterol by 7 mg/dL, and triglycerides by 29 mg/dL.

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.

Hypokalemia, lactic acidosis, and hypophosphatemia have also been reported during postmarketing experience with tenofovir DF.[Ref]

Hepatic

Increased AST (1.25 to less than 2.5 times the upper limit of normal [1.25 to less than 2.5 x ULN]: up to 14%; greater than 2.6 x ULN: up to 5%), ALT (1.25 to less than 2.5 x ULN: up to 14%; greater than 2.6 x ULN: up to 7%), and bilirubin (greater than 2.5 x ULN: up to 3%) have been reported with emtricitabine-tenofovir DF.

Increased AST (greater than 180 units/L) and ALT (greater than 215 units/L) have been reported in 3% and 2% of males using emtricitabine-tenofovir DF, respectively. Increased AST (greater than 170 units/L) and ALT (greater than 170 units/L) have been reported in 3% and 2% of females using emtricitabine-tenofovir DF, respectively.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of this drug and were associated with liver failure and liver decompensation in some emtricitabine-treated patients.

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 with tenofovir DF.[Ref]

Emtricitabine-tenofovir DF:
-Very common (10% or more): Increased AST (up to 14%), increased ALT (up to 14%)
-Common (1% to 10%): Increased bilirubin
-Frequency not reported: Severe acute exacerbations of hepatitis B

Emtricitabine:
-Common (1% to 10%): Increased serum AST and/or increased serum ALT, hyperbilirubinemia
-Frequency not reported: Liver failure, liver decompensation

Tenofovir DF:
-Common (1% to 10%): Increased transaminases (AST and/or ALT)
-Rare (less than 0.1%): Hepatic steatosis, hepatitis
-Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
-Postmarketing reports: Increased liver enzymes (primarily AST, ALT, GGT)[Ref]

Hematologic

Decreased neutrophils (1000 to 1300/mm3: up to 13%; less than 750/mm3: up to 5%) and hemoglobin (8.5 to 10 mg/dL: 4%; less than 9.4 mg/dL: up to 2%) have been reported with emtricitabine-tenofovir DF.[Ref]

Emtricitabine-tenofovir DF:
-Very common (10% or more): Decreased neutrophils (up to 13%)
-Common (1% to 10%): Decreased hemoglobin

Emtricitabine:
-Common (1% to 10%): Neutropenia
-Uncommon (0.1% to 1%): Anemia

Tenofovir DF:
-Common (1% to 10%): Decreased neutrophils[Ref]

Respiratory

Emtricitabine-tenofovir DF:
-Very common (10% or more): Pharyngitis (up to 13%)
-Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Increased cough, pneumonia, rhinitis

Emtricitabine:
-Very common (10% or more): Rhinitis, increased cough

Tenofovir DF:
-Common (1% to 10%): Pneumonia
-Postmarketing reports: Dyspnea[Ref]

Gastrointestinal

Increased serum amylase (greater than 175 units/L: up to 8%), pancreatic amylase (greater than 2 x ULN: up to 3%), and serum lipase (greater than 2 x ULN: up to 3%) have been reported with emtricitabine-tenofovir DF.

In clinical trials, nausea was the most common side effect reported in antiretroviral therapy-naive HIV-1-infected patients using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat.

Pancreatitis, abdominal pain, and increased amylase have also been reported during postmarketing experience with tenofovir DF.[Ref]

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Diarrhea, nausea, increased serum amylase, abdominal pain, increased pancreatic amylase, increased serum lipase, vomiting
-Frequency not reported: Flatulence

Emtricitabine and tenofovir alafenamide:
-Common (1% to 10%): Nausea

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Dyspepsia, abdominal pain

Emtricitabine:
-Very common (10% or more): Diarrhea, nausea, abdominal pain
-Common (1% to 10%): Increased amylase (including increased pancreatic amylase), increased serum lipase, vomiting, dyspepsia

Tenofovir DF:
-Very common (10% or more): Diarrhea, vomiting, nausea
-Common (1% to 10%): Abdominal pain, abdominal distension, flatulence, dyspepsia, increased serum amylase
-Uncommon (0.1% to 1%): Pancreatitis[Ref]

Psychiatric

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Depression, insomnia, abnormal dreams, anxiety

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Anxiety

Emtricitabine:
-Very common (10% or more): Insomnia, abnormal dreams
-Common (1% to 10%): Depressive disorders

Tenofovir DF:
-Very common (10% or more): Depression
-Common (1% to 10%): Insomnia, anxiety[Ref]

Nervous system

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Dizziness, headache
-Frequency not reported: Somnolence

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Peripheral neuropathy (including neuropathy, peripheral neuritis), paresthesia

Emtricitabine:
-Very common (10% or more): Dizziness, headache
-Common (1% to 10%): Neuropathy/peripheral neuritis, paresthesia

Tenofovir DF:
-Very common (10% or more): Dizziness, headache
-Common (1% to 10%): Peripheral neuropathy (including neuropathy, peripheral neuritis)[Ref]

Other

Asthenia has also been reported during postmarketing experience with tenofovir DF.[Ref]

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Fatigue, syphilis, secondary syphilis

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Pain, fever

Emtricitabine:
-Very common (10% or more): Asthenia
-Common (1% to 10%): Pain

Tenofovir DF:
-Very common (10% or more): Pain, asthenia
-Common (1% to 10%): Chest pain, fever
-Frequency not reported: Higher 1,25 vitamin D levels

Antiretroviral therapy:
-Frequency not reported: Increased weight[Ref]

Dermatologic

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash)

Emtricitabine:
-Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, allergic reaction)
-Common (1% to 10%): Skin discoloration (palmar-plantar hyperpigmentation)
-Frequency not reported: Lipodystrophy
-Postmarketing reports: Angioedema

Tenofovir DF:
-Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash)
-Common (1% to 10%): Sweating
-Uncommon (0.1% to 1%): Lipodystrophy
-Rare (less than 0.1%): Angioedema[Ref]

Rash has also been reported during postmarketing experience with tenofovir DF.[Ref]

Musculoskeletal

Increased creatine kinase (males: greater than 990 units/L; females: greater than 845 units/L) has been reported in up to 9% of patients using emtricitabine-tenofovir DF.

In clinical trials, a significant decline in BMD was seen in 15% of therapy-naive HIV-1-infected patients using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat. In virologically-suppressed tenofovir DF-treated patients who switched to emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean BMD increased between baseline and week 48; decreased BMD was also reported.

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 with tenofovir DF.[Ref]

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Increased creatine kinase, bone fractures
-Frequency not reported: Decreased bone mineral density (BMD)

Emtricitabine and tenofovir alafenamide:
-Very common (10% or more): Decreased BMD
-Uncommon (0.1% to 1%): Fractures (excluding fingers and toes)
-Frequency not reported: Increased biochemical markers of bone metabolism, increased BMD

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Myalgia, arthralgia, back pain

Emtricitabine:
-Very common (10% or more): Increased creatine kinase
-Common (1% to 10%): Myalgia, arthralgia

Tenofovir DF:
-Very common (10% or more): Increased creatine kinase
-Common (1% to 10%): Myalgia, arthralgia, back pain
-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness
-Rare (less than 0.1%): Myopathy
-Frequency not reported: Decreased BMD, increased biochemical markers of bone metabolism
-Postmarketing reports: Osteomalacia (manifested as bone pain and which may contribute to fractures)

Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis[Ref]

Renal

Increased creatinine (1.1 to 1.3 x ULN: up to 2%; greater than 1.4 x ULN: less than 1%) has been reported with emtricitabine-tenofovir DF.

In 2 trials in antiretroviral therapy-naive HIV-1-infected patients (median estimated glomerular filtration rate [eGFR] 115 mL/min at baseline) using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine increased by 0.1 mg/dL from baseline to week 48; median UPCR was 44 mg/g at baseline and at week 48. In a trial in virologically-suppressed tenofovir DF-treated patients (mean eGFR 112 mL/min at baseline) who switched to emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine was similar to baseline; median UPCR was 61 mg/g at baseline and 46 mg/g at week 48. In a trial in renal dysfunction patients (baseline eGFR 30 to 69 mL/min) using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine was 1.5 mg/dL at baseline and week 24; median UPCR was 161 mg/g at baseline and 93 mg/g at week 24.

Proximal renal tubulopathy generally resolved or improved after tenofovir DF was stopped; however, decreased CrCl did not completely resolve in some patients after stopping the drug. 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]

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Increased creatinine

Emtricitabine and tenofovir alafenamide:
-Frequency not reported: Increased serum creatinine, decreased urine protein-to-creatinine ratio (UPCR), worsening renal function

Tenofovir DF:
-Uncommon (0.1% to 1%): Increased creatinine
-Rare (less than 0.1%): Renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy (including Fanconi syndrome), nephrogenic diabetes insipidus
-Frequency not reported: New onset or worsening renal impairment
-Postmarketing reports: Renal insufficiency, interstitial nephritis (including acute cases)

Tenofovir prodrugs:
-Frequency not reported: Renal impairment (including renal failure, Fanconi syndrome)[Ref]

Genitourinary

Emtricitabine-tenofovir DF:
-Common (1% to 10%): Proteinuria, urethritis, urinary tract infection, hematuria, genital ulceration, anogenital warts
-Uncommon (0.1% to 1%): Proteinuria, glycosuria

Tenofovir DF:
-Common (1% to 10%): Glycosuria, hematuria
-Uncommon (0.1% to 1%): Proteinuria
-Postmarketing reports: Polyuria[Ref]

Increased glycosuria (3+ or greater: less than 1%) and hematuria (greater than 75 red blood cells/high power field: up to 3%) have been reported with emtricitabine-tenofovir DF.

Proteinuria has also been reported during postmarketing experience with tenofovir DF.[Ref]

Immunologic

Emtricitabine-tenofovir DF:
-Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Hypersensitivity

Emtricitabine:
-Common (1% to 10%): Allergic reaction

Tenofovir DF:
-Postmarketing reports: Allergic reaction (including angioedema)[Ref]

Endocrine

Tenofovir DF:
-Frequency not reported: Higher serum parathyroid hormone levels[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." (4/8/2015):

4. "Product Information. Descovy (emtricitabine-tenofovir)." Gilead Sciences, Foster City, CA.

5. "Product Information. Truvada (emtricitabine-tenofovir)." Gilead Sciences, Foster City, CA.

6. Paxton LA, Hope T, Jaffe HW "Pre-exposure prophylaxis for HIV infection: what if it works?" Lancet 370 (2007): 89-93

7. Piacenti FJ "An update and review of antiretroviral therapy." Pharmacotherapy 26 (2006): 1111-33

8. Baeten JM, Donnell D, Ndase P, et al. "Antiretroviral prophylaxis for HIV prevention in heterosexual men and women." N Engl J Med 367 (2012): 399-410

9. de Perio MA, Gomez FJ, Frame PT, Fichtenbaum CJ "A truvada hypersensitivity reaction simulating abacavir hypersensitivity." AIDS 21 (2007): 2252-3

Not all side effects for emtricitabine / tenofovir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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