AccessPak for HIV PEP Basic Side Effects

Generic Name: emtricitabine / tenofovir

Note: This page contains information about the side effects of emtricitabine / tenofovir. Some of the dosage forms included on this document may not apply to the brand name AccessPak for HIV PEP Basic.

Not all side effects for AccessPak for HIV PEP Basic may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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.

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

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 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 included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

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

Metabolic

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

Tenofovir:
-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

Combination antiretroviral therapy:
-Frequency not reported: Metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia), redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")[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.

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.[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.

Increased AST (greater than 180 units/L) and ALT (greater than 215 units/L) have been reported in 3% and 2% of males, respectively. Increased AST (greater than 170 units/L) and ALT (greater than 170 units/L) have been reported in 3% and 2% of females, 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.[Ref]

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 and tenofovir:
-Frequency not reported: Severe hepatomegaly with steatosis

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

Tenofovir:
-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.[Ref]

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

Respiratory

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

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

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

Tenofovir:
-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.

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

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

Emtricitabine or tenofovir:
-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:
-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

Common (1% to 10%): Depression, insomnia, abnormal dreams, anxiety

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

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

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

Nervous system

Common (1% to 10%): Dizziness, headache
Frequency not reported: Somnolence

Emtricitabine or tenofovir:
-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:
-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.[Ref]

Common (1% to 10%): Fatigue, syphilis, secondary syphilis

Emtricitabine or tenofovir:
-Common (1% to 10%): Asthenia, pain, fever

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

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

Dermatologic

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:
-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.[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.

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.[Ref]

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

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

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

Tenofovir:
-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 bone mineral density, 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.

Rhabdomyolysis, osteomalacia, 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.[Ref]

Common (1% to 10%): Increased creatinine

Tenofovir:
-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)[Ref]

Genitourinary

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

Tenofovir:
-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.

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

Immunologic

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

Endocrine

Tenofovir:
-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. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults adolescents. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." ([2014 May]):

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

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

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

7. 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

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

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