Intelence Side Effects

Generic name: etravirine

Medically reviewed by Drugs.com. Last updated on Jan 7, 2025.

Note: This document provides detailed information about Intelence.

Applies to etravirine: oral tablet Side Effects associated with etravirine. Some dosage forms listed on this page may not apply specifically to the brand name Intelence.

Applies to etravirine: oral tablet.

Precautions

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe skin rash, or fever or chills while using this medicine.

Check with your doctor right away if you or your child have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.

Your immune system may get stronger when you start taking 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 will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

Do not take any other medicines without checking first with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements. To do so may increase the chance of side effects from etravirine (the active ingredient contained in Intelence)

Serious side effects of Intelence

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:

Other side effects of Intelence

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:

For healthcare professionals

Applies to etravirine: oral tablet.

General adverse events

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]

See also:

Further information

Intelence 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