What the label lists and what reports show
Etravirine side effects
Etravirine's FDA label: “The most common adverse drug reactions of moderate to severe intensity (at least 2%) which occurred at a higher rate than placebo in adults are rash and peripheral neuropathy.” FAERS holds 4,420 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (286 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the etravirine FDA label on DailyMed (effective August 15, 2023, Janssen Products LP); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INTELENCE?INTELENCE can cause serious side effects including: Severe skin rash and allergic reactions. Skin rash is a common side effect of INTELENCE. The risk of getting a skin rash is higher in females. Rarely, rash can be severe and may lead to death. Severe skin rash with blisters or peeling skin, including the area around the mouth or eyes, may happen more frequently in children less than 18 years of age who take INTELENCE in combination with other HIV-1 medicine than in adults. Call your healthcare provider right away if a rash develops; severe cases may need to be treated in a hospital. […]
Source: FDA drug label, Janssen Products LP, effective August 15, 2023 (SPL set 6a9cbc29-9f15-4b24-8d86-206b82887f3d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse drug reactions of moderate to severe intensity (at least 2%) which occurred at a higher rate than placebo in adults are rash and peripheral neuropathy.
Table 3: Selected Grade 2 to 4 Laboratory Abnormalities Observed in Treatment-Experienced Subjects (Pooled TMC125-C206 and TMC125-C216 Trials)
| DAIDS Toxicity Range | INTELENCE + BR N=599 % | Placebo + BR N=604 % |
|---|---|---|
| > 1.5–2 × ULN | 7% | 8% |
| > 2–5 × ULN | 7% | 8% |
| > 5 × ULN | 2% | 1% |
| > 1.5–3 × ULN | 4% | 6% |
| > 3–5 × ULN | 2% | 2% |
| > 5 × ULN | 1% | < 1% |
| > 1.4–1.8 × ULN | 6% | 5% |
| > 1.9–3.4 × ULN | 2% | 1% |
| > 3.4 × ULN | 0% | < 1% |
| 90–99 g/L | 2% | 4% |
| 70–89 g/L | < 1% | < 1% |
| < 70 g/L | < 1% | < 1% |
| 1,500–1,999/mm 3 | 2% | 3% |
| 1,000–1,499/mm 3 | 1% | 4% |
| < 1,000/mm 3 | 1% | < 1% |
| 750–999/mm 3 | 5% | 6% |
| 500–749/mm 3 | 4% | 4% |
| < 500/mm 3 | 2% | 3% |
| 50,000–99,999/mm 3 | 3% | 5% |
| 25,000–49,999/mm 3 | 1% | 1% |
| < 25,000/mm 3 | < 1% | < 1% |
| > 6.20–7.77 mmol/L 240–300 mg/dL | 20% | 17% |
| > 7.77 mmol/L > 300 mg/dL | 8% | 5% |
| 4.13–4.9 mmol/L 160–190 mg/dL | 13% | 12% |
| > 4.9 mmol/L > 190 mg/dL | 7% | 7% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in greater detail in other sections: Severe skin and hypersensitivity reactions [see Warnings and Precautions (5.1) ]. Immune reconstitution syndrome [see Warnings and Precautions (5.3) ]. The most common adverse drug reactions of moderate to severe intensity (at least 2%) which occurred at a higher rate than placebo in adults are rash and peripheral neuropathy. ( 6.1 ) The most common adverse drug reactions in at least 2% of pediatric patients are rash and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults The safety assessment is based on all data from 1203 subjects in the Phase 3 placebo-controlled trials, TMC125-C206 and TMC125-C216, conducted in antiretroviral treatment-experienced HIV-1-infected adult subjects, 599 of whom received INTELENCE (200 mg twice daily). …
Source: FDA drug label, Janssen Products LP, effective August 15, 2023 (SPL set 6a9cbc29-9f15-4b24-8d86-206b82887f3d), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,420 reports list etravirine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 474 are coded as a death and 1,277 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Etravirine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions