What the label lists and what reports show
Rilpivirine side effects
Rilpivirine's FDA label: “The most common adverse reactions to EDURANT or EDURANT PED (incidence >2%) of at least moderate to severe intensity (≥ Grade 2) were depressive disorders, headache, insomnia and rash.” FAERS holds 8,599 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 injection site pain (691 reports).
- Generic approved
Check it at the source: the rilpivirine FDA label on DailyMed (effective August 28, 2025, 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 EDURANT and EDURANT PED?EDURANT and EDURANT PED can cause serious side effects including: Severe skin rash and allergic reactions. Call your healthcare provider right away if you develop a rash with EDURANT or EDURANT PED. In some cases, rash and allergic reaction may need to be treated in a hospital. Stop taking EDURANT or EDURANT PED and get medical help right away if you develop a rash with any of the following signs or symptoms: fever tiredness difficulty breathing or swallowing skin blisters swelling of the face, lips, mouth, tongue, or throat generally ill feeling muscle or joint aches blisters or mouth sores redness or swelling of the eyes (conjunctivitis) Liver problems. […]
Source: FDA drug label, Janssen Products, LP, effective August 28, 2025 (SPL set 03880372-2c68-45c6-a53a-f420c49541d6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions to EDURANT or EDURANT PED (incidence >2%) of at least moderate to severe intensity (≥ Grade 2) were depressive disorders, headache, insomnia and rash.
Table 3: Selected Adverse Reactions of at Least Moderate Intensity Intensities are defined as follows: Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating with inability to…
| Reaction | System Organ Class, Preferred Term, % EDURANT + BR N=686 | Pooled Data from the Phase 3 TMC278-C209 and TMC278-C215 Trials Efavirenz + BR N=682 |
|---|---|---|
| Abdominal pain | 2% | 2% |
| Nausea | 1% | 3% |
| Vomiting | 1% | 2% |
| Fatigue | 2% | 2% |
| Headache | 3% | 4% |
| Dizziness | 1% | 7% |
| Depressive disorders Includes adverse reactions reported as depressed mood, depression,… | 5% | 4% |
| Insomnia | 3% | 4% |
| Abnormal dreams | 2% | 4% |
| Rash | 3% | 11% |
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 discussed below and in other sections of the labeling: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Depressive Disorders [see Warnings and Precautions (5.3) ] The most common adverse reactions to EDURANT or EDURANT PED (incidence >2%) of at least moderate to severe intensity (≥ Grade 2) were depressive disorders, headache, insomnia and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 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 clinical practice. Clinical Trials Experience in Adults The safety assessment is based on the Week 96 pooled data from 1368 patients in the Phase 3 controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE) in antiretroviral treatment-naïve HIV-1 infected adult patients, 686 of whom received EDURANT (25 mg once daily) [see Clinical Studies (14.1) ]. The median duration of exposure for patients in the EDURANT arm and efavirenz arm was 104.3 and 104.1 weeks, respectively. …
Source: FDA drug label, Janssen Products, LP, effective August 28, 2025 (SPL set 03880372-2c68-45c6-a53a-f420c49541d6), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,599 reports list rilpivirine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 289 are coded as a death and 919 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. Reports rose sharply in 2023 (1,785, against a median of 288 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 17 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?
- Rilpivirine: 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