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 kit, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking emtricitabine / tenofovir: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, vomiting, fast or uneven heart rate, or feeling very weak or tired.

Call your doctor at once if you have any of these other serious side effects:

• rapid heart rate, increased sweating, tremors, sleep problems (insomnia), feeling anxious or irritable;

• severe diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid), feeling short of breath;

• weakness or prickly feeling in your fingers or toes, joint pain;

• problems with balance or eye movement, trouble speaking or swallowing;

• severe lower back pain, loss of bladder or bowel control;

• signs of new infection such as fever, chills, skin lesions, or cough with yellow or green mucus; or

• signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of emtricitabine / tenofovir may include:

• mild diarrhea. mild nausea or stomach pain;

• headache, dizziness, depressed mood;

• strange dreams;

• mild itching or skin rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 (any severity; greater than or equal to 10%) 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

Gastrointestinal side effects have included 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%), and vomiting (Grades 2 to 4: up to 2%). Dyspepsia occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Flatulence has also been reported. Pancreatitis, abdominal pain, and increased amylase have been reported during postmarketing experience with tenofovir.

Metabolic

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

Metabolic side effects have included increased fasting cholesterol (greater than 240 mg/dL: up to 22%), creatine kinase (greater than 990 units/L in males and 845 units/L in females: up to 9%), serum amylase (greater than 175 units/L: up to 8%), fasting triglycerides (greater than 750 mg/dL: 4%), pancreatic amylase (greater than 2 times ULN: up to 3%), serum lipase (greater than 2 times ULN: up to 3%), and alkaline phosphatase (greater than 550 units/L: 1%). Decreased phosphorus (2.5 to less than LLN: up to 7%; less than 2 mg/dL: up to 10%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL: up to 3%), weight loss (up to 3%), and hyperglycemia (greater than 250 mg/dL: up to 2%) have been reported. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance," have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Hypokalemia, lactic acidosis, and hypophosphatemia have been reported during postmarketing experience with tenofovir.

Hepatic

Hepatic side effects have included elevated AST (greater than 180 units/L in males and 170 units/L in females: 3%; 1.25 to less than 2.5 times ULN: up to 14%; greater than 2.6 times ULN: up to 5%), ALT (greater than 215 units/L in males and 170 units/L in females: 2%; 1.25 to less than 2.5 times ULN: up to 14%; greater than 2.6 times ULN: up to 7%), and bilirubin (greater than 2.5 times ULN: up to 3%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs, including tenofovir, in combination with other antiretroviral agents. Hepatic steatosis, hepatitis, and increased liver enzymes (primarily AST, ALT, and gamma glutamyl transferase) have been reported during postmarketing experience with tenofovir. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of tenofovir.

Hematologic

Hematologic side effects have included 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%).

Respiratory

Respiratory side effects have included pharyngitis (all Grades: up to 13%), sinusitis (Grades 2 to 4: up to 8%), upper respiratory tract infections (Grades 2 to 4: up to 8%), and nasopharyngitis (Grades 2 to 4: up to 5%). Increased cough, pneumonia, and rhinitis occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Dyspnea has been reported during postmarketing experience with tenofovir.

Psychiatric

Psychiatric side effects have included depression (Grades 2 to 4: up to 9%; all Grades: up to 6%), insomnia (Grades 2 to 4: up to 5%), and anxiety (all Grades: up to 3%). Abnormal dreams have been reported during a clinical study of efavirenz, emtricitabine, and tenofovir. Anxiety occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs.

Nervous system

Nervous system side effects have included dizziness (Grades 2 to 4: 8%) and headache (Grades 2 to 4: up to 6%; all Grades: up to 7%). Somnolence has been reported. Peripheral neuropathy (including neuropathy and peripheral neuritis) and paresthesia occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs.

Other

Other side effects have included fatigue (Grades 2 to 4: up to 9%). Asthenia, pain, abdominal pain, back pain, and fever occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Asthenia has also been reported during postmarketing experience with tenofovir.

Dermatologic

Dermatologic side effects have included rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, and vesicular rash; Grades 2 to 4: up to 7%). Skin discoloration (palmar-plantar hyperpigmentation) has been reported with emtricitabine. Sweating has been reported with tenofovir. Rash has also been reported during postmarketing experience with tenofovir.

Musculoskeletal

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

Musculoskeletal side effects have included myalgia and arthralgia in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Back pain (all Grades: up to 5%) has been reported. Decreased bone mineral density and increased biochemical markers of bone metabolism have been reported with tenofovir. Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, and myopathy have been reported during postmarketing experience with tenofovir.

Renal

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

Renal side effects have included increased creatinine (1.1 to 1.3 times ULN: up to 2%; greater than 1.4 times ULN: less than 1%). New onset or worsening renal impairment has been reported with tenofovir. Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, and interstitial nephritis (including acute cases) have been reported during postmarketing experience with tenofovir.

Genitourinary

Genitourinary side effects have included proteinuria (Grade 1: up to 6%; Grade 2 to 3: less than 1%), 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%), and glycosuria (3 plus or greater: less than 1%). Proteinuria and polyuria have been reported during postmarketing experience with tenofovir.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (including angioedema) during postmarketing experience with tenofovir.

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