What the label lists and what reports show
Cobicistat, darunavir, emtricitabine and tenofovir alafenamide side effects
Cobicistat, darunavir, emtricitabine and tenofovir alafenamide's FDA label: “The most common adverse reactions (all grades, incidence greater than or equal to 2%) were diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, and flatulence.” FAERS holds 2,719 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 (1,056 reports).
- No generic listed
- Boxed warning
Check it at the source: the cobicistat, darunavir, emtricitabine and tenofovir alafenamide FDA label on DailyMed (effective April 17, 2026, Janssen Products LP); 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 SYMTUZA?SYMTUZA may cause serious side effects, including: See " What is the most important information I should know about SYMTUZA? " 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 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 before you start and while you are taking SYMTUZA. Your healthcare provider may tell you to stop taking SYMTUZA 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, Janssen Products LP, effective April 17, 2026 (SPL set 85a17d00-6b7c-41ea-a6b3-5ad924820dab), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (all grades, incidence greater than or equal to 2%) were diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, and flatulence.
Table 1: Adverse Reactions Reported in ≥2% of HIV-1 Infected Adults With No Prior Antiretroviral Treatment History in AMBER (Week 48 Analysis)
| Reaction | All Grades | At least Grade 2 | All Grades | At least Grade 2 |
|---|---|---|---|---|
| Diarrhea | 9% | 2% | 11% | 2% |
| Rash Includes pooled reported terms: dermatitis, dermatitis allergic, erythema,… | 8% | 4% | 7% | 5% |
| Nausea | 6% | 1% | 10% | 3% |
| Fatigue | 4% | 1% | 4% | 1% |
| Headache | 3% | 1% | 2% | 1% |
| Abdominal discomfort | 2% | - | 4% | <1% |
| Flatulence | 2% | <1% | 1% | - |
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, continuedADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe acute exacerbations of hepatitis B [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Severe skin reactions [see Warnings and Precautions (5.3) ] Immune reconstitution syndrome [see Warnings and Precautions (5.5) ] New onset or worsening renal impairment [see Warnings and Precautions (5.6) ] Lactic acidosis/severe hepatomegaly with steatosis [see Warnings and Precautions (5.8) ] The most common adverse reactions (all grades, incidence greater than or equal to 2%) were diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) 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, Janssen Products LP, effective April 17, 2026 (SPL set 85a17d00-6b7c-41ea-a6b3-5ad924820dab), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,719 reports list cobicistat, darunavir, emtricitabine and tenofovir alafenamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 109 are coded as a death and 303 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 24 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, darunavir, 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