What the label lists and what reports show
Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide side effects
Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide's FDA label: “Most common adverse reaction (incidence greater than or equal to 10%, all grades) is nausea.” FAERS holds 10,002 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 (4,533 reports).
- No generic listed
- Boxed warning
Check it at the source: the cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide FDA label on DailyMed (effective February 3, 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 GENVOYA?GENVOYA may cause serious side effects, including: See " What is the most important information I should know about GENVOYA? " Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicine. 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. New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys when starting and during treatment with GENVOYA. Your healthcare provider may tell you to stop taking GENVOYA if you develop new or worse kidney problems. 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 February 3, 2025 (SPL set 34784acf-15ed-4715-b504-eb30430518e9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (incidence greater than or equal to 10%, all grades) is nausea.
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 ≥ 5% of HIV-1 Infected Treatment-Naïve Adults Receiving…
| Reaction | GENVOYA N=866 | STRIBILD N=867 |
|---|---|---|
| Nausea | 11% | 13% |
| Diarrhea | 7% | 9% |
| Headache | 6% | 5% |
| Fatigue | 5% | 4% |
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 drug 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) ] Most common adverse reaction (incidence greater than or equal to 10%, all grades) is nausea. ( 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Treatment-Naïve Adults The primary safety assessment of GENVOYA was based on Week 144 pooled data from 1,733 subjects in two randomized, double-blind, active-controlled trials, Study 104 and Study 111, in antiretroviral treatment-naïve HIV-1 infected adult subjects. A total of 866 subjects received one tablet of GENVOYA once daily [see Clinical Studies (14.2) ]. …
Source: FDA drug label, Gilead Sciences, Inc., effective February 3, 2025 (SPL set 34784acf-15ed-4715-b504-eb30430518e9), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,002 reports list cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 199 are coded as a death and 1,140 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 (4,081, against a median of 524 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, 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?
- Cobicistat, elvitegravir, 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