Emtricitabine Side Effects

Please note - some side effects for Emtricitabine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Emtricitabine - for the Consumer

Emtricitabine

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Emtricitabine:

Abnormal skin sensation; change in color of skin on palms or soles of feet; changes in body fat; cough; depression; diarrhea; dizziness; headache; indigestion; joint or muscle pain; nausea; runny nose; sleeplessness; stomach pain; vomiting; weakness or lack of energy.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fast or difficult breathing; feeling unusually cold; fever, chills, or sore throat; mental or mood changes; muscle pain or tenderness; severe or persistent cough; severe or persistent stomach discomfort, pain, or tenderness; slow or irregular heartbeat; unusual tiredness or weakness; yellowing of the eyes or skin.

Emtricitabine/Tenofovir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Emtricitabine/Tenofovir:

Abnormal skin sensations; back pain; changes in body fat (eg, increased fat in the upper back and stomach areas, decreased fat in the face, arms, and legs); cough; diarrhea; dizziness; gas; headache; indigestion; lightening of the skin color on the palms of hands or soles of feet; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); sleeplessness; strange dreams; sweating; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain; chills; dark urine; decreased urination or difficulty urinating; dizziness; extreme weakness or tiredness; fast or irregular heartbeat; feeling cold, especially in the arms and legs; fever; increased thirst; increased urination; light-colored bowel movements (stools); lightheadedness; mental or mood changes (eg, depression); not feeling like eating for several days; numbness, burning, pain, or tingling in the hands or feet; shortness of breath; severe or persistent dizziness; sore throat; stomach pain with nausea and vomiting; unusual muscle pain; unusual tiredness; yellowing of the skin or eyes.

Emtricitabine Solution

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Emtricitabine Solution:

Abnormal skin sensation; change in color of skin on palms or soles of feet; changes in body fat; cough; depression; diarrhea; dizziness; headache; indigestion; joint or muscle pain; nausea; runny nose; sleeplessness; stomach pain; vomiting; weakness or lack of energy.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fast or difficult breathing; feeling unusually cold; fever, chills, or sore throat; mental or mood changes; muscle pain or tenderness; severe or persistent cough; severe or persistent stomach discomfort, pain, or tenderness; slow or irregular heartbeat; unusual tiredness or weakness; yellowing of the eyes or skin.

Side Effects by Body System

General

The most common side effects associated with emtricitabine in combination with other antiretrovirals have included headache, diarrhea, nausea, and rash. Most were of mild to moderate severity. Treatment was discontinued due to adverse effects in approximately 1% of patients in clinical trials. Side effects have been reported for emtricitabine when taken in combination with other antiretroviral agents.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, dyspepsia, nausea, vomiting, increased pancreatic amylase greater than 2 times upper limit of normal (ULN), increased serum amylase greater than 2 times ULN, and increased serum lipase greater than 2 times ULN.

Dermatologic

Dermatological side effects have included rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash, allergic reaction, and hyperpigmentation of the palms and/or soles.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, and elevated creatine kinase greater than 4 times ULN.

Nervous system

Nervous system side effects have included abnormal dreams, depressive disorders, dizziness, insomnia, neuropathy, peripheral neuritis, paresthesia, somnolence, and depression.

Respiratory

Respiratory side effects have included increased cough, rhinitis, and upper respiratory tract infections.

Other

Other side effects have included headache, abdominal pain, asthenia, fatigue, sinusitis, nasopharyngitis, and increased alkaline phosphatase (greater than 550 U/L).

Hematologic

Hematologic side effects have included decreases in neutrophils (less than 750/mm3) and hemoglobin (less than 8.0 mg/dL).

Hepatic

Hepatic side effects have included elevations in alanine transaminase (ALT) greater than 5 times ULN, aspartate transaminase (AST) greater than 5 times ULN, bilirubin greater than 2.5 times ULN, and fasting cholesterol greater than 240 mg/dL. 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.

Posttreatment exacerbations of hepatitis have occurred after discontinuation of emtricitabine. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.

Metabolic

Metabolic side effects have included blood glucose changes (less than 40 or over 250 mg/dL) and increased triglycerides greater than 750 mg/dL.

Genitourinary

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

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