Emtriva Side Effects

Generic name: emtricitabine

Note: This document contains side effect information about emtricitabine. Some of the dosage forms listed on this page may not apply to the brand name Emtriva.

Some side effects of Emtriva 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: oral capsule, oral solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking emtricitabine (the active ingredient contained in Emtriva) hives; difficult 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;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, nausea with vomiting; or

• fast or uneven heart rate.

Stop using emtricitabine and call your doctor at once if you have a serious side effect such as:

• signs of a new infection such as fever, chills, sore throat, flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;

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

• increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

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

• swelling in your neck or throat (enlarged thyroid);

• weakness or prickly feeling in your fingers or toes;

• problems with walking, breathing, speech, swallowing, or eye movement; or

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

Less serious side effects of emtricitabine may include:

• headache, dizziness;

• mild diarrhea, mild nausea, upset stomach;

• darkened patches of skin on your palms and/or soles;

• strange dreams;

• cough, runny nose;

• mild skin rash; or

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

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: oral capsule, oral solution

General

The most common side effects reported during any of 3 large controlled clinical trials were headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.

During 2 clinical trials, the most common side effects associated with emtricitabine (the active ingredient contained in Emtriva) in combination with other antiretrovirals were headache, diarrhea, nausea, and rash. Most were of mild to moderate severity. Treatment was discontinued due to these adverse effects in approximately 1% of patients.

Side effects have been reported for emtricitabine when taken in combination with other antiretroviral agents.

Dermatologic

Dermatological side effects have included rash event (any Grade: up to 30%; Grades 2 to 4: 7%). "Rash event" included rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash, and allergic reaction. Skin discoloration (palmar-plantar hyperpigmentation) has been reported.

Nervous system

Nervous system side effects have included dizziness (any Grade: up to 25%; Grades 2 to 4: 8%), headache (any Grade: up to 22%; Grades 2 to 4: 6%), insomnia (any Grade: up to 16%; Grades 2 to 4: 5%), paresthesia (any Grade: up to 6%), neuropathy/peripheral neuritis (any Grade: 4%), and somnolence.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (any Grade: 23%; Grades 2 to 4: 9%), nausea (any Grade: up to 18%; Grades 2 to 4: 9%), vomiting (any Grade: 9%; Grades 2 to 4: 2%), and dyspepsia (any Grade: up to 8%).

Metabolic

Metabolic side effects have included blood glucose changes (less than 40 or greater than 250 mg/dL; up to 3%), hyperglycemia (greater than 250 mg/dL; 2%), and increased fasting cholesterol (greater than 240 mg/dL; 22%), triglycerides (greater than 750 mg/dL; up to 10%), serum amylase (greater than 2 times ULN: up to 5%; greater than 175 units/L: 8%), fasting triglycerides (greater than 750 mg/dL; 4%), pancreatic amylase (greater than 2 times ULN; up to 2%), serum lipase (greater than 2 times ULN; up to 1%), and alkaline phosphatase (greater than 550 units/L; 1%). 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 receiving antiretroviral therapy.

Respiratory

Respiratory side effects have included rhinitis (any Grade: up to 18%), increased cough (any Grade: 14%), sinusitis (Grades 2 to 4: 8%), upper respiratory tract infections (Grades 2 to 4: 8%), and nasopharyngitis (Grades 2 to 4: 5%).

Other

Other side effects have included asthenia (any Grade: up to 16%), abdominal pain (any Grade: up to 14%), and fatigue (Grades 2 to 4: 9%).

Musculoskeletal

Increased creatine kinase (greater than 990 units/L in males and 845 units/L in females) has been reported in 9% of patients.

Musculoskeletal side effects have included elevated creatine kinase (greater than 4 times ULN; up to 12%), myalgia (any Grade: up to 6%), and arthralgia (any Grade: up to 5%).

Psychiatric

Psychiatric side effects have included abnormal dreams (any Grade: up to 11%), depressive disorders (any Grade: up to 9%), and depression (Grades 2 to 4: 9%).

Hepatic

Increased AST (greater than 180 units/L in males and 170 units/L in females) has been reported in 3% of patients. Increased ALT (greater than 215 units/L in males and 170 units/L in females) has been reported in 2% of patients.

Hepatic side effects have included elevated AST (greater than 5 times ULN; up to 6%), ALT (greater than 5 times ULN; up to 5%), and bilirubin (greater than 2.5 times ULN; up to 1%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of emtricitabine and other nucleoside analogs alone or in combination with other antiretroviral agents. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and hepatitis B after discontinuation of emtricitabine and were associated with liver failure and liver decompensation in some patients.

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.

Hematologic

Hematologic side effects have included decreased neutrophils (less than 750/mm3; up to 5%).

Genitourinary

Genitourinary side effects have included hematuria (greater than 75 RBC/HPF; 3%) and glycosuria (3 plus; less than 1%).

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