Emtricitabine Side Effects

Brand Names: Emtriva

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.

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 dreams; change in color of skin on palms or soles of feet; cough; diarrhea; dizziness; headache; indigestion or stomach upset; joint or muscle pain; mild stomach pain; nausea; runny nose; sleeplessness; tiredness; vomiting; weakness or lack of energy.

Seek medical attention right away if any of these SEVERE side effects occur when using Emtricitabine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; depression; fast or difficult breathing; fast, slow, or irregular heartbeat; feeling unusually cold; fever, chills, or sore throat; general feeling of being unwell; muscle pain or tenderness; severe or persistent cough; severe or persistent nausea or vomiting; severe or persistent stomach discomfort, pain, or tenderness; sluggishness; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the eyes or skin); unusual drowsiness, dizziness, or light-headedness; unusual muscle pain or tenderness; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; joint pain; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; sweating; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Emtricitabine/Tenofovir:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; chest pain; fever; mental or mood changes (eg, depression); muscle pain or weakness; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Emtricitabine/Rilpivirine/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/Rilpivirine/Tenofovir:

Back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; joint pain; loss of appetite; mild stomach pain or discomfort; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Emtricitabine/Rilpivirine/Tenofovir:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; chest pain; fever; irregular heartbeat; mental or mood changes (eg, depression, unusual negative thoughts, anxiety, restlessness); muscle pain or weakness; numbness, burning, pain, or tingling; severe or persistent dizziness; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; suicidal thoughts or behaviors; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 dreams; change in color of skin on palms or soles of feet; cough; diarrhea; dizziness; headache; indigestion or stomach upset; joint or muscle pain; mild stomach pain; nausea; runny nose; sleeplessness; tiredness; vomiting; weakness or lack of energy.

Seek medical attention right away if any of these SEVERE side effects occur when using Emtricitabine Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; depression; fast or difficult breathing; fast, slow, or irregular heartbeat; feeling unusually cold; fever, chills, or sore throat; general feeling of being unwell; muscle pain or tenderness; severe or persistent cough; severe or persistent nausea or vomiting; severe or persistent stomach discomfort, pain, or tenderness; sluggishness; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the eyes or skin); unusual drowsiness, dizziness, or light-headedness; unusual muscle pain or tenderness; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Side Effects by Body System - for Healthcare Professionals

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 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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