What the label lists and what reports show
Emtricitabine and tenofovir disoproxil side effects
Emtricitabine and tenofovir disoproxil's FDA label: “In HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.” FAERS holds 45,341 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 (16,608 reports).
- Generic listed
- Boxed warning
Check it at the source: the emtricitabine 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 TRUVADA?TRUVADA may cause serious side effects, including: See " What is the most important information I should know about TRUVADA? " 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 during treatment with TRUVADA. Your healthcare provider may tell you to take TRUVADA less often, or to stop taking TRUVADA if you get new or worse kidney problems. Changes in your immune system (Immune Reconstitution Syndrome) can happen when taking medicines to treat HIV-1 infection. 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 your HIV-1 medicine. Bone problems can happen in some people who take TRUVADA. […]
Source: FDA drug label, Gilead Sciences, Inc, effective July 16, 2025 (SPL set 54e82b13-a037-49ed-b4b3-030b37c0ecdd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
Table 3 Selected Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. (Grades 2–4) Reported in ≥5% in Any Treatment Group in…
| Reaction | FTC+TDF+EFV From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz… N=257 | AZT/3TC+EFV N=254 |
|---|---|---|
| Fatigue | 9% | 8% |
| Depression | 9% | 7% |
| Nausea | 9% | 7% |
| Diarrhea | 9% | 5% |
| Dizziness | 8% | 7% |
| Upper respiratory tract infections | 8% | 5% |
| Sinusitis | 8% | 4% |
| Rash event Rash event includes rash, exfoliative rash, rash generalized, rash macular,… | 7% | 9% |
| Headache | 6% | 5% |
| Insomnia | 5% | 7% |
| Nasopharyngitis | 5% | 3% |
| Vomiting | 2% | 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 with HBV Infection [see Warnings and Precautions (5.1) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.4) ]. Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6) ]. In HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. ( 6.1 ) In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-445-3235 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.
Source: FDA drug label, Gilead Sciences, Inc, effective July 16, 2025 (SPL set 54e82b13-a037-49ed-b4b3-030b37c0ecdd), via openFDA; the full label on DailyMed
What do FAERS reports show?
45,341 reports list emtricitabine and tenofovir disoproxil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,830 are coded as a death and 7,631 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 (14,654, against a median of 1,589 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 24 reactions below, 4 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 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