What the label lists and what reports show
Atazanavir and cobicistat side effects
Atazanavir and cobicistat's FDA label: “Most common adverse reactions seen with atazanavir coadministered with cobicistat (greater than 5%, Grades 2-4) are jaundice and rash.” FAERS holds 245 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 pain (43 reports).
- No generic listed
- A presentation discontinued
Check it at the source: the atazanavir and cobicistat FDA label on DailyMed (effective May 12, 2025, E.R. Squibb & Sons, L.L.C.); 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 EVOTAZ?EVOTAZ can cause serious side effects, including: • A change in the way your heart beats (heart rhythm change). If you have certain heart rhythm problems, your healthcare provider may check your heart rhythm with a test called an electrocardiogram (ECG). Tell your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem. • Severe skin reactions. Skin rash is common with EVOTAZ but can sometimes be severe. Skin rash usually goes away within 2 weeks without any change in treatment. Severe rash may develop with other symptoms which could be serious. […]
Source: FDA drug label, NDA206353 (Bristol), as published by E.R. Squibb & Sons, L.L.C., effective May 12, 2025 (SPL set 83db29d7-5d85-49d6-8cb6-740473365cf8), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions seen with atazanavir coadministered with cobicistat (greater than 5%, Grades 2-4) are jaundice and rash.
Table 2: Selected Adverse Reactions a (Grades 2-4) Reported in ≥2% of Treatment-Naive Adults with HIV-1 in the Atazanavir Coadministered with Cobicistat Group in Study GS-US-216-0114 (Week 144 analysis)
| Reaction | Atazanavir coadministered with cobicistat and emtricitabine/tenofovir DF (n=344) | Atazanavir coadministered with ritonavir and emtricitabine/tenofovir DF (n=348) |
|---|---|---|
| Jaundice | 6% | 3% |
| Rash b | 5% | 4% |
| Ocular icterus | 4% | 2% |
| Nausea | 2% | 2% |
| Diarrhea | 2% | 1% |
| Headache | 2% | 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, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: • cardiac conduction abnormalities [see Warnings and Precautions (5.1) ] • rash [see Warnings and Precautions (5.2) ] • effects on serum creatinine [see Warnings and Precautions (5.3) ] • new onset or worsening renal impairment when used with tenofovir DF [see Warnings and Precautions (5.4) ] • chronic kidney disease [see Warnings and Precautions (5.5) ] • nephrolithiasis and cholelithiasis [see Warnings and Precautions (5.6) ] • hepatotoxicity [see Warnings and Precautions (5.7) ] • hyperbilirubinemia [see Warnings and Precautions (5.10) ] For additional safety information about atazanavir and cobicistat, consult the full prescribing information for these individual products. Most common adverse reactions seen with atazanavir coadministered with cobicistat (greater than 5%, Grades 2-4) are jaundice and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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, NDA206353 (Bristol), as published by E.R. Squibb & Sons, L.L.C., effective May 12, 2025 (SPL set 83db29d7-5d85-49d6-8cb6-740473365cf8), via openFDA; the full label on DailyMed
What do FAERS reports show?
245 reports list atazanavir and cobicistat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 23 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 20 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.
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?
- Atazanavir and cobicistat: 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