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AccessPak for HIV PEP Basic Side Effects

Generic Name: emtricitabine / tenofovir

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

Some side effects of AccessPak for HIV PEP Basic 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 emtricitabine / tenofovir: oral tablet

Along with its needed effects, emtricitabine / 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 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 side effects of emtricitabine / 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:

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 (10% or more; any severity) 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 (greater than 2%) reported were headache, abdominal pain, and decreased weight.

Gastrointestinal

Common (1% to 10%): Diarrhea (Grades 2 to 4: up to 9%; all Grades: up to 7%), nausea (Grades 2 to 4: up to 9%), abdominal pain (all Grades: up to 4%), vomiting (Grades 2 to 4: up to 2%)
Frequency not reported: Flatulence

Emtricitabine or tenofovir:
Common (1% to 10%): Dyspepsia (at least 5%)

Tenofovir:
Postmarketing reports: Pancreatitis, abdominal pain, increased amylase

Metabolic

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Very common (10% or more): Increased fasting cholesterol (greater than 240 mg/dL: up to 22%)
Common (1% to 10%): Decreased phosphorus (2.5 to less than lower limit of normal: up to 7%; less than 2 mg/dL: up to 10%), increased creatine kinase (greater than 990 units/L in males and 845 units/L in females: up to 9%), increased serum amylase (greater than 175 units/L: up to 8%), increased fasting triglycerides (greater than 750 mg/dL: 4%), increased pancreatic amylase (greater than 2 times upper limit of normal [ULN]: up to 3%), increased serum lipase (greater than 2 times ULN: up to 3%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL: up to 3%), weight loss (up to 3%), hyperglycemia (greater than 250 mg/dL: up to 2%), increased alkaline phosphatase (greater than 550 units/L: 1%)
Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Tenofovir:
Postmarketing reports: Hypokalemia, lactic acidosis, hypophosphatemia

Hepatic

Very common (10% or more): Elevated AST (1.25 to less than 2.5 times ULN: up to 14%), elevated ALT (1.25 to less than 2.5 times ULN: up to 14%)
Common (1% to 10%): Elevated AST (greater than 180 units/L in males and 170 units/L in females: 3%; greater than 2.6 times ULN: up to 5%), elevated ALT (greater than 215 units/L in males and 170 units/L in females: 2%; greater than 2.6 times ULN: up to 7%), bilirubin (greater than 2.5 times ULN: up to 3%)
Frequency not reported: Severe acute exacerbations of hepatitis B

Emtricitabine:
Frequency not reported: Liver failure, liver decompensation

Tenofovir:
Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
Postmarketing reports: Hepatic steatosis, hepatitis, increased liver enzymes (primarily AST, ALT, gamma glutamyltransferase)

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of emtricitabine-tenofovir 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, including tenofovir, in combination with other antiretroviral agents.

Hematologic

Very common (10% or more): Decreased neutrophils (1000 to 1300/mm3: up to 13%)
Common (1% to 10%): Decreased neutrophils (less than 750/mm3: up to 5%), hemoglobin (8.5 to 10 mg/dL: 4%; less than 9.4 mg/dL: up to 2%)

Respiratory

Very common (10% or more): Pharyngitis (all Grades: up to 13%)
Common (1% to 10%): Sinusitis (Grades 2 to 4: up to 8%), upper respiratory tract infections (Grades 2 to 4: up to 8%), nasopharyngitis (Grades 2 to 4: up to 5%)

Emtricitabine or tenofovir:
Common (1% to 10%): Increased cough (at least 5%), pneumonia (at least 5%), rhinitis (at least 5%)

Tenofovir:
Postmarketing reports: Dyspnea

Psychiatric

Common (1% to 10%): Depression (Grades 2 to 4: up to 9%; all Grades: up to 6%), insomnia (Grades 2 to 4: up to 5%), anxiety (all Grades: up to 3%)
Frequency not reported: Abnormal dreams

Emtricitabine or tenofovir:
Common (1% to 10%): Anxiety (at least 5%)

Nervous system

Common (1% to 10%): Dizziness (Grades 2 to 4: 8%), headache (Grades 2 to 4: up to 6%; all Grades: up to 7%)
Frequency not reported: Somnolence

Emtricitabine or tenofovir:
Common (1% to 10%): Peripheral neuropathy (including neuropathy and peripheral neuritis; at least 5%), paresthesia (at least 5%)

Other

Common (1% to 10%): Fatigue (Grades 2 to 4: up to 9%)

Emtricitabine or tenofovir:
Common (1% to 10%): Asthenia (at least 5%), pain (at least 5%), abdominal pain (at least 5%), back pain (at least 5%), fever (at least 5%)

Tenofovir:
Frequency not reported: Higher 1,25 vitamin D levels
Postmarketing reports: Asthenia

Dermatologic

Common (1% to 10%): Rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash; Grades 2 to 4: up to 7%)

Emtricitabine:
Frequency not reported: Skin discoloration (palmar-plantar hyperpigmentation)

Tenofovir:
Frequency not reported: Sweating
Postmarketing reports: Rash

Musculoskeletal

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.

Common (1% to 10%): Bone fractures (1.7%)
Frequency not reported: Decreased bone mineral density

Emtricitabine or tenofovir:
Common (1% to 10%): Myalgia (at least 5%), arthralgia (at least 5%), back pain (all Grades: up to 5%)

Tenofovir:
Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism
Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Renal

Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Common (1% to 10%): Increased creatinine (1.1 to 1.3 times ULN: up to 2%)
Uncommon (0.1% to 1%): Increased creatinine (greater than 1.4 times ULN: less than 1%)

Tenofovir:
Frequency not reported: New onset or worsening renal impairment
Postmarketing reports: Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, interstitial nephritis (including acute cases)

Genitourinary

Common (1% to 10%): Proteinuria (Grade 1: up to 6%), syphilis (all Grades: up to 6%), secondary syphilis (all Grades: up to 6%), urethritis (all Grades: up to 5%), urinary tract infection (all Grades: up to 5%), hematuria (greater than 75 RBC/HPF: up to 3%), genital ulceration (all Grades: 2%), anogenital warts (all Grades: up to 2%)
Uncommon (0.1% to 1%): Proteinuria (Grade 2 to 3: less than 1%), glycosuria (3 plus or greater: less than 1%)

Tenofovir:
Postmarketing reports: Proteinuria, polyuria

Immunologic

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

Hypersensitivity

Tenofovir:
Postmarketing reports: Allergic reaction (including angioedema)

Endocrine

Tenofovir:
Frequency not reported: Higher serum parathyroid hormone levels

More about AccessPak for HIV PEP Basic (emtricitabine / tenofovir)

Consumer resources

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