What the label lists and what reports show
Emtricitabine and tenofovir alafenamide side effects
Emtricitabine and tenofovir alafenamide's FDA label: “In participants with HIV-1, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea.” FAERS holds 11,272 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 (4,845 reports).
- No generic listed
- Boxed warning
Check it at the source: the emtricitabine and tenofovir alafenamide FDA label on DailyMed (effective July 7, 2026, 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 DESCOVY?DESCOVY may cause serious side effects, including: See “ What is the most important information I should know about DESCOVY? ” Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking medicines to treat HIV-1. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you have any new symptoms of infection after starting your HIV-1 medicine. New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while taking DESCOVY. Your healthcare provider may tell you to stop taking DESCOVY if you develop new or worse kidney problems. Too much lactic acid in your blood (lactic acidosis). […]
Source: FDA drug label, Gilead Sciences, Inc., effective July 7, 2026 (SPL set 06f66e98-e6ee-4538-9506-6c1282cc14c1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn participants with HIV-1, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea.
Table 3 Adverse Reactions (All Grades) Reported in ≥2% in Either Arm in the DISCOVER Trial of Participants without HIV-1
| Reaction | DESCOVY (N=2,694) | TRUVADA (N=2,693) |
|---|---|---|
| Diarrhea | 5% | 6% |
| Nausea | 4% | 5% |
| Headache | 2% | 2% |
| Fatigue | 2% | 3% |
| Abdominal pain Includes the following terms: abdominal pain, abdominal pain upper,… | 2% | 3% |
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) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.3) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.4) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.5) ]. In participants with HIV-1, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea. ( 6.1 ) In adults without HIV-1 in a PrEP trial, the most common adverse reaction (incidence greater than or equal to 5%, all grades) was diarrhea. ( 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 July 7, 2026 (SPL set 06f66e98-e6ee-4538-9506-6c1282cc14c1), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,272 reports list emtricitabine and tenofovir alafenamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 364 are coded as a death and 1,206 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 (4,101, against a median of 743 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 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