Emtricitabine Side Effects

Medically reviewed by Drugs.com. Last updated on May 18, 2024.

Applies to emtricitabine: oral capsule, oral solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also taking lamivudine, Atripla®, Combivir®, Complera®, Epivir®, Epivir-HBV®, Epzicom®, Odefsey®, Stribild®, Triumeq®, Trizivir®, or Truvada®. Tell your doctor right away if you or your child are using any of these medicines. Do not start using emtricitabine until your doctor tells you to.

Two rare but serious reactions to this medicine are lactic acidosis (build up of acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have abdominal or stomach discomfort or cramping, dark urine, a decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Do not change your dose or stop using this medicine, even for a short time, without talking to your doctor.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Serious side effects of emtricitabine

Along with its needed effects, emtricitabine 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:

Other side effects of emtricitabine

Some side effects of emtricitabine 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:

For healthcare professionals

Applies to emtricitabine: oral capsule, oral solution.

General adverse events

The most common side effects reported during clinical trials in adults were headache, diarrhea, elevated creatine kinase, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. The most common side effects reported during clinical trials in children were anemia and skin discoloration/hyperpigmentation.^[Ref]

Dermatologic

• Very common (10% or more): Rash event (included rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash, allergic reaction; up to 30%)
• Common (1% to 10%): Vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discoloration (hyperpigmentation)
• Postmarketing reports: Angioedema

Combination antiretroviral therapy:

• Frequency not reported: Lipodystrophy/redistribution of body fat^[Ref]

Grades 2 to 4 rash event and rash were reported in 7% and 5% of patients, respectively.

Skin discoloration (manifested by hyperpigmentation primarily on the palms and/or soles) was generally mild and asymptomatic. Clinical significance and mechanism are unknown; according to some authorities, skin discoloration was of little clinical significance.

Skin discoloration (hyperpigmentation) was very common in pediatric patients.^[Ref]

Nervous system

• Very common (10% or more): Dizziness (up to 25%), headache (up to 22%)
• Common (1% to 10%): Paresthesia, neuropathy/peripheral neuritis
• Frequency not reported: Somnolence^[Ref]

Grades 2 to 4 dizziness and headache were reported in 8% and 6% of patients, respectively.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 23%), nausea (up to 18%), abdominal pain (up to 14%)
• Common (1% to 10%): Elevated amylase (including elevated pancreatic amylase), elevated serum lipase, vomiting, dyspepsia
• Frequency not reported: Gastroenteritis^[Ref]

Grades 2 to 4 diarrhea, nausea, and vomiting were reported in 9%, 9%, and 2% of patients, respectively.

Elevated serum amylase (greater than 2 times the upper limit of normal [2 x ULN), pancreatic amylase (greater than 2 x ULN), and serum lipase (greater than 2 x ULN) have been reported in up to 5%, up to 2%, and up to 1% of patients, respectively. Elevated serum amylase (greater than 175 units/L) was reported in 8% of patients.

Gastroenteritis was only reported in pediatric patients.^[Ref]

Metabolic

• Very common (10% or more): Elevated fasting cholesterol (22%)
• Common (1% to 10%): Hypertriglyceridemia, hyperglycemia, elevated triglycerides, increased/decreased serum glucose, elevated fasting triglycerides
• Frequency not reported: Lactic acidosis

Antiretroviral therapy:

• Frequency not reported: Increased blood lipid levels, increased glucose levels^[Ref]

Elevated fasting cholesterol (greater than 240 mg/dL) and fasting triglycerides (greater than 750 mg/dL) were reported in 22% and 4% of patients, respectively. Elevated triglycerides (greater than 750 mg/dL [greater than 8.47 mmol/L]) and increased/decreased serum glucose (less than 40 or greater than 250 mg/dL [less than 2.2 or greater than 13.9 mmol/L]) have been reported in up to 10% and up to 3% of patients, respectively. Elevated triglycerides (greater than 750 mg/dL) and hyperglycemia (greater than 250 mg/dL) were reported in 5% and 2% of patients, respectively.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.^[Ref]

Respiratory

• Very common (10% or more): Rhinitis (up to 18%), increased cough (up to 14%)
• Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis
• Frequency not reported: Pneumonia^[Ref]

Grades 2 to 4 sinusitis, upper respiratory tract infections, and nasopharyngitis were reported in 8%, 8%, and 5% of patients, respectively.

Pneumonia was only reported in pediatric patients.^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (up to 16%), abnormal dreams (up to 11%)
• Common (1% to 10%): Depressive disorders, depression^[Ref]

Grades 2 to 4 depression, insomnia, and abnormal dreams were reported in 9%, 5%, and 4% of patients, respectively.^[Ref]

Other

• Very common (10% or more): Asthenia (up to 16%)
• Common (1% to 10%): Pain, fatigue, elevated alkaline phosphatase
• Frequency not reported: Infection, otitis media, fever

Antiretroviral therapy:

• Frequency not reported: Increased weight^[Ref]

Grades 2 to 4 fatigue was reported in 9% of patients.

Elevated alkaline phosphatase (greater than 550 units/L) was reported in 1% of patients.

Infection, otitis media, and fever were only reported in pediatric patients.^[Ref]

Musculoskeletal

• Very common (10% or more): Elevated creatine kinase (up to 12%)
• Common (1% to 10%): Myalgia, arthralgia
• Frequency not reported: Osteonecrosis^[Ref]

Elevated creatine kinase (greater than 4 x ULN) has been reported in up to 12% of patients. Elevated creatine kinase (greater than 990 units/L in males and 845 units/L in females) was reported in 9% of patients.^[Ref]

Hepatic

• Common (1% to 10%): Elevated serum AST, elevated serum ALT, hyperbilirubinemia
• Uncommon (0.1% to 1%): Elevated bilirubin
• Frequency not reported: Posttreatment exacerbation of hepatitis B, liver failure, liver decompensation, severe hepatomegaly with steatosis, elevated GGT^[Ref]

Elevated AST (greater than 5 x ULN), ALT (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) have been reported in up to 6%, up to 5%, and up to 1% of patients, respectively. Elevated AST (greater than 180 units/L in males and 170 units/L in females) and ALT (greater than 215 units/L in males and 170 units/L in females) were reported in 3% and 2% of patients, respectively.

Elevated AST and ALT was reported more often in patients coinfected with HIV and hepatitis B virus (HBV) than in those only infected with HIV.

Severe acute exacerbations of hepatitis B (including fatalities) have been reported in patients coinfected with HIV-1 and HBV after discontinuation of this drug and were associated with liver failure and liver decompensation in some patients.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Elevated GGT was only reported in a pediatric patient.^[Ref]

Hematologic

• Common (1% to 10%): Neutropenia, decreased neutrophils
• Uncommon (0.1% to 1%): Anemia
• Frequency not reported: Decreased hemoglobin^[Ref]

Decreased neutrophils (less than 750/mm3) have been reported in up to 5% of patients.

Anemia was common in pediatric patients. Decreased hemoglobin (less than 7 g/dL) was only reported in a pediatric patient.^[Ref]

Genitourinary

• Common (1% to 10%): Hematuria
• Frequency not reported: Glycosuria^[Ref]

Hematuria (greater than 75 RBC/high power field) and glycosuria (3 plus) were reported in 3% and less than 1% of patients, respectively.^[Ref]

Hypersensitivity

• Common (1% to 10%): Allergic reaction^[Ref]

Immunologic

• Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)^[Ref]

See also:

Frequently asked questions

• Descovy vs Truvada: How do they compare for HIV / PrEP?
• What drugs are contained in the HIV treatment Symtuza?
• What is the difference between HIV treatments Odefsey and Complera?
• Genvoya vs Stribild for HIV - How do they compare?

Further information

Emtricitabine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer