What the label lists and what reports show
Emtricitabine side effects
Emtricitabine's FDA label: “Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.” FAERS holds 7,176 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 drug resistance (437 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the emtricitabine 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 EMTRIVA?EMTRIVA may cause serious side effects, including: See " What is the most important information I should know about EMTRIVA? " Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-infected person starts taking antiretroviral medicines. 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 start having any new symptoms after starting EMTRIVA. Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. […]
Source: FDA drug label, Gilead Sciences, Inc., effective December 2, 2025 (SPL set d6599395-3944-44f9-97f2-e0424c6b6a1f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.
Table 2 Selected Treatment-Emergent Adverse Reactions (All Grades, Regardless of Causality) Reported in ≥3% of EMTRIVA-Treated Subjects in Either Trial 301A or 303 (0–48 Weeks)
| Reaction | EMTRIVA + AZT/d4T + NNRTI/PI (N=294) | 3TC + AZT/d4T + NNRTI/PI (N=146) | EMTRIVA + didanosine + EFV (N=286) | d4T + didanosine + EFV (N=285) |
|---|---|---|---|---|
| Asthenia | 16% | 10% | 12% | 17% |
| Headache | 13% | 6% | 22% | 25% |
| Abdominal pain | 8% | 11% | 14% | 17% |
| Diarrhea | 23% | 18% | 23% | 32% |
| Nausea | 18% | 12% | 13% | 23% |
| Vomiting | 9% | 7% | 9% | 12% |
| Dyspepsia | 4% | 5% | 8% | 12% |
| Myalgia | 4% | 4% | 6% | 3% |
| Arthralgia | 3% | 4% | 5% | 6% |
| Insomnia | 7% | 3% | 16% | 21% |
| Depressive disorders | 6% | 10% | 9% | 13% |
| Paresthesia | 5% | 7% | 6% | 12% |
| Dizziness | 4% | 5% | 25% | 26% |
| Neuropathy/peripheral neuritis | 4% | 3% | 4% | 13% |
| Abnormal dreams | 2% | <1% | 11% | 19% |
| Rhinitis | 18% | 12% | 12% | 10% |
| Increased cough | 14% | 11% | 14% | 8% |
| Rash event Rash event includes rash, pruritus, maculopapular rash, urticaria,… | 17% | 14% | 30% | 33% |
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 Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.2) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.3) ]. Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Skin hyperpigmentation was very common (≥10%) in pediatric patients. ( 6 ) 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials Experience in Adults More than 2,000 adult subjects with HIV-1 infection have been treated with EMTRIVA alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials.
Source: FDA drug label, Gilead Sciences, Inc., effective December 2, 2025 (SPL set d6599395-3944-44f9-97f2-e0424c6b6a1f), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,176 reports list emtricitabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 889 are coded as a death and 2,157 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 18 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: 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