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Intelence Side Effects

Generic Name: etravirine

Note: This document contains side effect information about etravirine. Some of the dosage forms listed on this page may not apply to the brand name Intelence.

For the Consumer

Applies to etravirine: oral tablet

Along with its needed effects, etravirine (the active ingredient contained in Intelence) 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


  • 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

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


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]


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]

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]


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]


Very common (10% or more): Rash (up to 19.2%)

Common (1% to 10%): Night sweats, lipohypertrophy

Uncommon (0.1% to 1%): Prurigo, hyperhidrosis, dry skin, 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)[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]


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]

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

Uncommon (0.1% to 1%): Abdominal distension, pancreatitis, constipation, dry mouth, hematemesis, retching, stomatitis[Ref]


Very common (10% or more): Elevated glucose levels (up to 15%)

Common (1% to 10%): Hypertriglyceridemia, hypercholesterolemia, hyperlipidemia, hyperglycemia, diabetes mellitus

Uncommon (0.1% to 1%): 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

Uncommon (0.1% to 1%): Somnolence, paresthesia, convulsion, hypoesthesia, amnesia, syncope, disturbance in attention, hypersomnia, tremor, vertigo[Ref]


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]


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]

Common (1% to 10%): Decreased neutrophils, decreased platelet count, decreased hemoglobin, decreased WBC count, anemia, thrombocytopenia

Frequency not reported: Hemolytic anemia[Ref]


Common (1% to 10%): Hypertension, myocardial infarction

Uncommon (0.1% to 1%): Angina pectoris, atrial fibrillation, hemorrhagic stroke

Frequency not reported: Mild atrioventricular block[Ref]


Common (1% to 10%): Insomnia, anxiety

Uncommon (0.1% to 1%): Sleep disorders, abnormal dreams, confusional state, disorientation, nervousness, nightmares[Ref]


Uncommon (0.1% to 1%): Drug hypersensitivity

Postmarketing reports: Severe hypersensitivity reactions (including drug rash with eosinophilia and systemic symptoms [DRESS] and cases of hepatic failure)[Ref]


Uncommon (0.1% to 1%): Blurred vision[Ref]


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)[Ref]


Uncommon (0.1% to 1%): Exertional dyspnea, bronchospasm[Ref]


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


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]


1. "Etravirine: R165335, TMC 125, TMC-125, TMC125." Drugs R D 7 (2006): 367-73

2. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV Available from: URL:" ([2018, Mar 27]):

3. "Drugs for HIV infection." Treat Guidel Med Lett 7 (2009): 11-22

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. "Anti-HIV agents. Effectiveness of etravirine in treatment-experienced PHAs." TreatmentUpdate 19 (2007): 3-5

7. Johnson LB, Saravolatz LD "Etravirine, a Next-Generation Nonnucleoside Reverse-Transcriptase Inhbitor." Clin Infect Dis (2009):

8. "Etravirine(Intelence) for HIV infection." Med Lett Drugs Ther 50 (2008): 47-8

9. "Product Information. Intelence (etravirine)." Ortho Biotech Inc, Bridgewater, NJ.

10. Cohen CJ, Berger DS, Blick G, et al. "Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial." AIDS 23 (2009): 423-6

11. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother 62 (2008): 879-88

12. Peeters M, Janssen K, Kakuda TN, et al. "Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers (June)." Ann Pharmacother (2008):

13. Gruzdev B, Rakhmanova A, Doubovskaya E, et al. "A randomized, double-blind, placebo-controlled trial of TMC125 as 7-day monotherapy in antiretroviral naive, HIV-1 infected subjects." AIDS 17 (2003): 2487-94

14. "Anti-HIV agents. Brain side effects not common with etravirine." TreatmentUpdate 19 (2007): 6-7

15. Tommasi C, Tempestilli M, Fezza R, et al. "A rare case of severe myopathy associated with etravirine use." AIDS 24 (2010): 1088-90

Further information

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.