Summary

More frequently reported side effects include: increased serum alanine aminotransferase, increased serum amylase, increased serum aspartate aminotransferase, and neutropenia. Continue reading for a comprehensive list of adverse effects.

Applies to emtricitabine: oral capsule, oral solution.

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:

More common

• Body aches or pain
• chest pain or tightness
• chills
• cough
• diarrhea
• difficulty in breathing
• ear congestion
• earache
• fever
• headache
• hoarseness
• loss of appetite
• loss of voice
• lower back or side pain
• nasal congestion
• nausea
• painful or difficult urination
• pale skin
• redness or swelling in the ear
• runny nose
• sneezing
• sore throat
• stomach pain
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Bloody urine
• blurred vision
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• sweating
• unexplained weight loss
• vomiting

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:

More common

• Abnormal dreams
• belching
• darkening of the skin
• difficulty in moving
• discouragement
• feeling sad or empty
• heartburn
• indigestion
• irritability
• joint pain or swelling
• lack or loss of strength
• loss of interest or pleasure
• muscle pain, cramps, or stiffness
• skin rash
• stomach discomfort or upset
• trouble concentrating
• trouble sleeping

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dizziness
• stabbing pain

For Healthcare Professionals

Applies to emtricitabine: oral capsule, oral solution.

General

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

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]

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]

Nervous system

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

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]

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

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]

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]

Psychiatric

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

Very common (10% or more): Insomnia (up to 16%), abnormal dreams (up to 11%)

Common (1% to 10%): Depressive disorders, depression^[Ref]

Other

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]

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]

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

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]

Common (1% to 10%): Neutropenia, decreased neutrophils

Uncommon (0.1% to 1%): Anemia

Frequency not reported: Decreased hemoglobin^[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]