What the label lists and what reports show
Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil side effects
Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil's FDA label: “Most common adverse drug reactions to STRIBILD (incidence greater than or equal to 10%, all grades) are nausea and diarrhea.” FAERS holds 8,951 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 (4,593 reports).
- No generic listed
- Boxed warning
Check it at the source: the cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil FDA label on DailyMed (effective February 4, 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 STRIBILD?STRIBILD may cause the following serious side effects, including: See " What is the most important information I should know about STRIBILD? " 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 you are taking STRIBILD. Your healthcare provider may tell you to stop taking STRIBILD 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. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. Severe liver problems. […]
Source: FDA drug label, Gilead Sciences, Inc., effective February 4, 2025 (SPL set 74ae2a93-b267-444c-8f0f-a2a6522260ee), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse drug reactions to STRIBILD (incidence greater than or equal to 10%, all grades) are nausea and diarrhea.
Table 1 Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events attributed to study drugs. (All Grades) Reported in ≥5% of Adult Subjects in Any Treatment Arm in Studies 102…
| Reaction | STRIBILD N=701 | ATRIPLA N=352 | ATV+RTV+TRUVADA N=355 |
|---|---|---|---|
| Ocular icterus | <1% | 0% | 13% |
| Diarrhea | 12% | 11% | 17% |
| Flatulence | 2% | <1% | 8% |
| Nausea | 16% | 9% | 14% |
| Fatigue | 4% | 8% | 6% |
| Jaundice | 0% | <1% | 9% |
| Somnolence | 1% | 7% | 1% |
| Headache | 7% | 4% | 6% |
| Dizziness | 3% | 21% | 5% |
| Insomnia | 3% | 9% | 1% |
| Abnormal dreams | 9% | 27% | 4% |
| Rash Rash event includes dermatitis, drug eruption, eczema, pruritus, pruritus… | 4% | 15% | 6% |
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 Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.2) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.3) ]. Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.6) ]. Most common adverse drug reactions to STRIBILD (incidence greater than or equal to 10%, all grades) are nausea and 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 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 February 4, 2025 (SPL set 74ae2a93-b267-444c-8f0f-a2a6522260ee), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,951 reports list cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 143 are coded as a death and 756 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 (3,889, against a median of 297 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, 5 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 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