What the label lists and what reports show
Emtricitabine and rilpivirine and tenofovir alafenamide side effects
Emtricitabine and rilpivirine and tenofovir alafenamide's FDA label: “Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache and sleep disturbances.” FAERS holds 3,568 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 (1,601 reports).
- No generic listed
- Boxed warning
Check it at the source: the emtricitabine and rilpivirine and tenofovir alafenamide FDA label on DailyMed (effective December 2, 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 ODEFSEY?ODEFSEY may cause serious side effects, including: See " What is the most important information I should know about ODEFSEY? " Severe skin rash and allergic reactions. Skin rash is a common side effect of ODEFSEY. 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 ODEFSEY 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, or throat trouble breathing or swallowing pain on the right side of the stomach (abdominal) area dark "tea colored" urine Change in liver enzymes. […]
Source: FDA drug label, Gilead Sciences, Inc., effective December 2, 2025 (SPL set ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than or equal to 2%, all grades) are headache and sleep disturbances.
Table 1 Adverse Reactions Frequencies of adverse reactions are based on all adverse events attributed to study drugs by the investigator. (All Grades) Reported in ≥1% of Virologically-Suppressed Adults with HIV-1 in…
| Reaction | ODEFSEY (N=438) | EFV/FTC/TDF (N=437) Data from Trials 1160 and 1216 do not provide an adequate basis for… | ODEFSEY (N=316) | FTC/RPV/TDF (N=313) |
|---|---|---|---|---|
| Headache | 2% | 1% | 0 | 1% |
| Sleep Disturbances | 2% | 1% | 0 | <1% |
| Flatulence | 1% | <1% | <1% | 1% |
| Abnormal Dreams | 1% | 1% | 0 | 2% |
| Diarrhea | 1% | 3% | 1% | 2% |
| Nausea | 1% | 1% | 1% | 1% |
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 [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) ] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.7) ] Immune Reconstitution Syndrome [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence greater than or equal to 2%, all grades) are headache and sleep disturbances. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 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 (or a drug given in various combinations with other concomitant therapy) cannot be directly compared to rates in the clinical trials of another drug (or drug given in the same or different combination therapy) and may not reflect the rates observed in practice.
Source: FDA drug label, Gilead Sciences, Inc., effective December 2, 2025 (SPL set ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,568 reports list emtricitabine and rilpivirine and tenofovir alafenamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 385 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 (1,378, against a median of 183 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, 2 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 alafenamide: 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