Etravirine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 13, 2024.

Applies to etravirine: oral tablet.

Serious side effects of etravirine

Along with its needed effects, etravirine 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 etravirine:

More common

• rash

Less common

• blurred vision
• burning, numbness, tingling, or painful sensations
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Rare

• blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• fever
• hives, itching
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• muscle pain
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble with breathing or swallowing
• unusual tiredness or weakness

Incidence not known

• dark urine
• general feeling of tiredness or weakness
• headache
• light-colored stools
• stomach pain, continuing
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• vomiting
• yellow eyes or skin

Other side effects of etravirine

Some side effects of etravirine 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:

Less common

• stomach pain

For healthcare professionals

Applies to etravirine: oral tablet.

General

The safety report of this drug is based on 599 HIV-1-infected, therapy-experienced patients receiving 200 mg twice daily in combination with background regimen; the median exposure was 52.3 weeks. The most commonly reported side effects (of all intensities) were rash, diarrhea, nausea, and headache. Discontinuation due to side effects occurred in 5.2% of patients using this drug; a total of 2.2% of HIV-1-infected patients in phase 3 trials discontinued this drug due to rash.^[Ref]

Hepatic

• Very common (10% or more): Worsening from baseline of AST (up to 27.8%), worsening from baseline of ALT (up to 25%)
• Common (1% to 10%): Worsening from baseline of total bilirubin, elevated ALT, elevated AST
• Uncommon (0.1% to 1%): Hepatomegaly, cytolytic hepatitis, hepatic steatosis, hepatitis
• Frequency not reported: Hepatic failure^[Ref]

Grade 2 or higher abnormalities representing a worsening from baseline of AST, ALT, and total bilirubin have been reported in 27.8%, 25%, and 7.1%, respectively, in patients coinfected with hepatitis B and/or C virus as compared to 6.7%, 7.5%, and 1.8% reported in non-coinfected patients.

Grades 2, 3, and 4 elevated ALT have been reported in 6%, 3%, and 1% of patients, respectively. Grades 2, 3, and 4 elevated AST have been reported in 6%, 3%, and less than 1% of patients, respectively.^[Ref]

Other

• Very common (10% or more): Elevated total cholesterol (up to 20%), elevated low-density lipoprotein (up to 13%)
• Common (1% to 10%): Elevated triglycerides, fatigue
• Uncommon (0.1% to 1%): Sluggishness
• Frequency not reported: Pyrexia

Antiretroviral therapy:

• Frequency not reported: Increased weight^[Ref]

Grades 2 and 3 elevated total cholesterol have been reported in 20% and 8% of patients, respectively. Grades 2 and 3 elevated low-density lipoprotein have been reported in 13% and 7% of patients, respectively. Grades 2, 3, and 4 elevated triglycerides have been reported in 9%, 6%, and 4% of patients, respectively.^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 19.2%)
• Common (1% to 10%): Night sweats, lipohypertrophy, prurigo, dry skin
• Uncommon (0.1% to 1%): Hyperhidrosis, face swelling, angioneurotic edema, erythema multiforme, acquired lipodystrophy
• Rare (0.01% to 0.1%): Stevens-Johnson syndrome
• Very rare (less than 0.01%): Toxic epidermal necrolysis
• Frequency not reported: Contact dermatitis, erythema, pruritus
• Postmarketing reports: Toxic epidermal necrolysis (fatal cases), Stevens-Johnson syndrome (fatal cases), drug rash with eosinophilia and systemic symptoms (DRESS)^[Ref]

During clinical trials, rash generally was mild to moderate, occurred chiefly in the second week of therapy, and was infrequent after the fourth week. Rash usually resolved within 1 to 2 weeks on continued use of the drug. The incidence of rash was higher in women taking this drug (at least grade 2 rash: 15%) compared to men (at least grade 2 rash: 9.5%). Discontinuation due to rash occurred in 5% of women compared to 1.9% of men. Patients with a history of nonnucleoside reverse transcriptase inhibitor-related rash did not appear to be at increased risk.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 18%), nausea (up to 14.9%)
• Common (1% to 10%): Elevated pancreatic amylase, elevated lipase, abdominal pain, vomiting, gastroesophageal reflux disease, flatulence, gastritis, abdominal distension, constipation, dry mouth, stomatitis, elevated blood amylase
• Uncommon (0.1% to 1%): Pancreatitis, hematemesis, retching^[Ref]

Grades 2, 3, and 4 elevated pancreatic amylase have been reported in 7%, 7%, and 2% of patients, respectively. Grades 2, 3, and 4 elevated lipase have been reported in 4%, 2%, and 1% of patients, respectively.^[Ref]

Metabolic

• Very common (10% or more): Elevated glucose levels (up to 15%)
• Common (1% to 10%): Hypertriglyceridemia, hypercholesterolemia, hyperlipidemia, hyperglycemia, diabetes mellitus, anorexia, dyslipidemia

Antiretroviral therapy:

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

Grades 2 and 3 elevated glucose levels have been reported in 15% and 4% of patients, respectively.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 10.9%)
• Common (1% to 10%): Peripheral neuropathy, somnolence, paresthesia, hypoesthesia, amnesia
• Uncommon (0.1% to 1%): Convulsion, syncope, disturbance in attention, hypersomnia, tremor, vertigo, hemorrhagic stroke^[Ref]

Renal

• Common (1% to 10%): Elevated creatinine, renal failure^[Ref]

Grades 2 and 3 elevated creatinine have been reported in 6% and 2% of patients, respectively.^[Ref]

Hematologic

• Common (1% to 10%): Decreased neutrophils, decreased platelet count, decreased hemoglobin, decreased WBC count, anemia, thrombocytopenia
• Frequency not reported: Hemolytic anemia^[Ref]

Grades 2, 3, and 4 decreased neutrophils have been reported in 5%, 4%, and 2% of patients, respectively. Grades 2, 3, and 4 decreased platelet count have been reported in 3%, 1%, and less than 1% of patients, respectively. Grades 2, 3, and 4 decreased hemoglobin have been reported in 2%, less than 1%, and less than 1% of patients, respectively. Grades 2, 3, and 4 decreased WBC count have been reported in 2%, 1%, and 1% of patients, respectively.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, myocardial infarction
• Uncommon (0.1% to 1%): Angina pectoris, atrial fibrillation
• Frequency not reported: Mild atrioventricular block^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, anxiety, sleep disorders
• Uncommon (0.1% to 1%): Abnormal dreams, confusional state, disorientation, nervousness, nightmares^[Ref]

Ocular

• Common (1% to 10%): Blurred vision^[Ref]

Respiratory

• Common (1% to 10%): Exertional dyspnea
• Uncommon (0.1% to 1%): Bronchospasm^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Drug hypersensitivity
• Postmarketing reports: Severe hypersensitivity reactions (including DRESS and cases of hepatic failure)^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Immune reconstitution syndrome
• Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Gynecomastia^[Ref]

Musculoskeletal

• Frequency not reported: Severe myopathy (including articular pain, muscular pain, weakness, stiffness, increased creatine kinase)
• Postmarketing reports: Rhabdomyolysis

Combination antiretroviral therapy:

• Frequency not reported: Osteonecrosis^[Ref]

Further information

Etravirine 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.

Some side effects may not be reported. You may report them to the FDA.

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