What the label lists and what reports show
Atazanavir side effects
Atazanavir's FDA label: “Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever.” FAERS holds 14,285 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 depression (1,317 reports).
- Generic listed
Check it at the source: the atazanavir FDA label on DailyMed (effective August 6, 2025, Aurobindo Pharma Limited); 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 atazanavir capsules?Atazanavir capsules can cause serious side effects, including: A change in the way your heart beats (heart rhythm change). Tell your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem. Skin rash. Skin rash is common with atazanavir capsules but can sometimes be severe. Severe rash may develop with other symptoms which could be serious. If you develop a severe rash or a rash with any of the following symptoms, stop taking atazanavir capsules and call your healthcare provider or go to the nearest hospital emergency room right away: general feeling of discomfort or “flu-like” symptoms blisters fever mouth sores muscle or joint aches swelling of your face red or inflamed eyes, like “pink eye” (conjunctivitis) painful, warm, or red lump under your skin Liver problems. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective August 6, 2025 (SPL set 7fbea274-d6b5-4faa-bbf0-05fefab42114), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever.
Table 8: Selected Adverse Reactions a of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Participants with HIV-1, b Studies AI424-034, AI424-007, and AI424-008
| Reaction | 64 weeks c atazanavir 400 mg (once daily) with lamivudine/ zidovudine e (n=404) | 64 weeks c efavirenz 600 mg (once daily) with lamivudine/ zidovudine e (n=401) | 120 weeks c,d atazanavir 400 mg (once daily) with stavudine and lamivudine or didanosine… | 73 weeks c,d nelfinavir 750 mg TID or 1250 mg BID with stavudine and lamivudine or… |
|---|---|---|---|---|
| Headache | 6% | 6% | 1% | 2% |
| Nausea | 14% | 12% | 6% | 4% |
| Jaundice/scleral icterus | 7% | * | 7% | * |
| Vomiting | 4% | 7% | 3% | 3% |
| Abdominal pain | 4% | 4% | 4% | 2% |
| Diarrhea | 1% | 2% | 3% | 16% |
| Insomnia | 3% | 3% | <1% | * |
| Dizziness | 2% | 7% | <1% | * |
| Peripheral neurologic symptoms | <1% | 1% | 4% | 3% |
| Rash | 7% | 10% | 5% | 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) ] hyperbilirubinemia [see Warnings and Precautions (5.8) ] chronic kidney disease [see Warnings and Precautions (5.5) ] nephrolithiasis and cholelithiasis [ see Warnings and Precautions (5.6) ] Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. Adverse Reactions in Treatment-Naive Adult Participants The safety profile of atazanavir in treatment-naive adults is based on 1625 participants with HIV-1 in clinical trials. 536 participants received atazanavir 300 mg with ritonavir 100 mg and 1089 participants received atazanavir 400 mg or higher (without ritonavir). …
Source: FDA drug label, Aurobindo Pharma Limited, effective August 6, 2025 (SPL set 7fbea274-d6b5-4faa-bbf0-05fefab42114), via openFDA; the full label on DailyMed
What do FAERS reports show?
14,285 reports list atazanavir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,065 are coded as a death and 4,204 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 21 reactions below, 7 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?
- Atazanavir: 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