What the label lists and what reports show
Emtricitabine and rilpivirine and tenofovir disoproxil side effects
Emtricitabine and rilpivirine and tenofovir disoproxil's FDA label: “Most common adverse reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2–4) are depressive disorders, insomnia, and headache.” FAERS holds 6,723 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 bone density decreased (3,553 reports).
- Generic listed
- Boxed warning
Check it at the source: the emtricitabine and rilpivirine and tenofovir disoproxil FDA label on DailyMed (effective July 16, 2025, Gilead Sciences, Inc.); 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 COMPLERA?COMPLERA can cause serious side effects, including: See " What is the most important information I should know about COMPLERA? " Severe skin rash and allergic reactions. Skin rash is a common side effect of COMPLERA. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital. If you get a rash with any of the following symptoms, stop taking COMPLERA and call your healthcare provider or get medical help right away: fever skin blisters mouth sores redness or swelling of the eyes (conjunctivitis) swelling of the face, lips, mouth, tongue or throat trouble breathing or swallowing pain on the right side of the stomach (abdominal) area dark or "tea colored" urine Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. […]
Source: FDA drug label, Gilead Sciences, Inc., effective July 16, 2025 (SPL set d637cfab-f1e8-4eb3-a1b3-f85ca3bec612), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2–4) are depressive disorders, insomnia, and headache.
Table 1 Selected Adverse Reactions Frequencies of adverse reactions are based on all Grades 2–4 treatment-emergent adverse events assessed to be related to study drug. (Grades 2–4) Reported in ≥2% of Adult Subjects…
| Preferred Term | RPV + FTC/TDF N=550 | EFV + FTC/TDF N=546 |
|---|---|---|
| Depressive disorders Includes adverse reactions reported as depressed mood, depression,… | 2% | 2% |
| Headache | 2% | 2% |
| Insomnia | 2% | 2% |
| Abnormal dreams | 1% | 3% |
| Dizziness | 1% | 7% |
| Nausea | 1% | 2% |
| Rash | 1% | 5% |
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 in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ]. Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ]. Hepatotoxicity [see Warnings and Precautions (5.3) ]. Depressive Disorders [see Warnings and Precautions (5.4) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.5) ]. Bone Loss and Mineralization Defects [see Warnings and Precautions (5.6) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.8) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.9) ]. Most common adverse reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2–4) are depressive disorders, insomnia, and headache. ( 6.1 ) Most common adverse reactions to emtricitabine and tenofovir disoproxil fumarate (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. …
Source: FDA drug label, Gilead Sciences, Inc., effective July 16, 2025 (SPL set d637cfab-f1e8-4eb3-a1b3-f85ca3bec612), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,723 reports list emtricitabine and rilpivirine and tenofovir disoproxil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 85 are coded as a death and 405 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 2020 (3,139, against a median of 199 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 25 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?
- Emtricitabine and rilpivirine and tenofovir disoproxil: 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