Drug · FAERS side-effect profile with label screen
Atazanavir Sulfate side effects: what 2,956 FDA adverse event reports show
Drug class
Protease inhibitor
FDA label, Indications wording
Brand names
Reyataz
openFDA label
Who reports
2,956 reports · 95% serious · 319 with death outcome · 39% female
openFDA FAERS counts, all years, deduplication not applied
Used for
REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus .
FDA label, Indications and Usage
What it is
The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 5Reporting / coding artifact 9Lab value / disease marker 1Not in label — unassessed 21
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 28 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Abortion induced | 81 | 61.5 49.5–76.3ROR 63.2 · χ² 4,719 / p <1e-300 | 60.1 EB05 49.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 38.5 · ♀ 99% (drug 39%) | no trial data cached |
| Eyelid ptosis | 70 | 49.2 39.0–62.0ROR 50.3 · χ² 3,233 / p <1e-300 | 48.2 EB05 39.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 3% (drug 39%) | no trial data cached |
| Paranoia | 109 | 44.9 37.3–54.0ROR 46.6 · χ² 4,611 / p <1e-300 | 44.3 EB05 37.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 34.0 · ♀ 1% (drug 39%) · 96% clinician | no trial data cached |
| Drug interaction | 946 | 42.5 40.4–44.8ROR 62.1 · χ² 38,394 / p <1e-300 | 42.3 EB05 40.0 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 27.8 · ♀ 5% (drug 39%) | no trial data cached |
| Caesarean section | 63 | 38.2 29.9–48.8ROR 39.0 · χ² 2,234 / p <1e-300 | 37.6 EB05 30.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.9 · ♀ 98% (drug 39%) | no trial data cached |
| Premature delivery | 84 | 37.4 30.3–46.2ROR 38.5 · χ² 2,929 / p <1e-300 | 37.0 EB05 30.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 · ♀ 100% (drug 39%) | no trial data cached |
| Abortion spontaneous | 192 | 34.0 29.7–39.0ROR 36.3 · χ² 6,101 / p <1e-300 | 33.7 EB05 29.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 · ♀ 100% (drug 39%) | no trial data cached |
| Loss of personal independence in daily activities | 226 | 33.9 29.9–38.4ROR 36.6 · χ² 7,158 / p <1e-300 | 33.6 EB05 30.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · ♀ 0% (drug 39%) · 91% clinician | no trial data cached |
| Maternal exposure during pregnancy | 419 | 33.9 31.0–37.0ROR 39.3 · χ² 13,319 / p <1e-300 | 33.7 EB05 31.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 22.7 · ♀ 100% (drug 39%) | no trial data cached |
| Premature baby | 132 | 31.1 26.4–36.8ROR 32.6 · χ² 3,810 / p <1e-300 | 30.9 EB05 26.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · ♀ 61% (drug 39%) | no trial data cached |
| Hyperbilirubinaemia | 44 | 30.4 22.7–40.8ROR 30.9 · χ² 1,218 / p 4e-267 | 29.9 EB05 23.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Foetal exposure during pregnancy | 326 | 28.6 25.8–31.7ROR 32.0 · χ² 8,646 / p <1e-300 | 28.4 EB05 25.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 17.2 | no trial data cached |
| Psychotic disorder | 115 | 27.7 23.2–33.2ROR 28.8 · χ² 2,928 / p <1e-300 | 27.5 EB05 23.5 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.2 · ♀ 2% (drug 39%) · 96% clinician | no trial data cached |
| Depression | 787 | 24.5 23.1–26.0ROR 33.0 · χ² 17,858 / p <1e-300 | 24.4 EB05 23.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.7 · ♀ 1% (drug 39%) | no trial data cached |
| Prescribed overdose | 56 | 20.6 15.9–26.7ROR 21.0 · χ² 1,022 / p 2e-224 | 20.4 EB05 16.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · ♀ 2% (drug 39%) · 96% clinician | no trial data cached |
| Drug resistance | 64 | 17.7 13.9–22.6ROR 18.1 · χ² 992 / p 6e-218 | 17.6 EB05 14.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 · ♀ 59% (drug 39%) · 93% clinician | no trial data cached |
| Blood bilirubin increased | 63 | 16.5 12.9–21.1ROR 16.9 · χ² 903 / p 1e-198 | 16.4 EB05 13.2 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 11.1 · 93% clinician | no trial data cached |
| Diplopia (double vision) | 60 | 16.4 12.8–21.1ROR 16.7 · χ² 853 / p 1e-187 | 16.3 EB05 13.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 0% (drug 39%) | no trial data cached |
| Incorrect route of product administration | 35 | 14.8 10.6–20.6ROR 15.0 · χ² 436 / p 4e-97 | 14.5 EB05 10.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 17.9 · ♀ 0% (drug 39%) · 91% clinician | no trial data cached |
| Pregnancy | 42 | 14.8 10.9–19.9ROR 15.0 · χ² 524 / p 2e-116 | 14.5 EB05 11.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · ♀ 98% (drug 39%) | no trial data cached |
| Drug exposure during pregnancy | 55 | 11.3 8.7–14.7ROR 11.5 · χ² 508 / p 1e-112 | 11.0 EB05 8.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 76% (drug 39%) | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 119 | 9.2 7.7–11.0ROR 9.6 · χ² 867 / p 9e-191 | 9.0 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 2% (drug 39%) · 94% clinician | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 28 | 7.4 5.1–10.7ROR 7.4 · χ² 148 / p 3e-34 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · ♀ 14% (drug 39%) | no trial data cached |
| Haematuria (blood in urine) | 35 | 7.2 5.2–10.1ROR 7.3 · χ² 182 / p 8e-42 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 97% clinician | no trial data cached |
| Nephropathy toxic | 10 | 6.4 3.4–11.8ROR 6.4 · χ² 40 / p 1e-10 | 5.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Renal failure acute | 37 | 6.1 4.4–8.4ROR 6.2 · χ² 153 / p 2e-35 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 17% (drug 39%) | no trial data cached |
| Splenomegaly | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 37 / p 5e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Drug level increased | 14 | 6.0 3.6–10.1ROR 6.0 · χ² 53 / p 1e-13 | 5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Alanine aminotransferase increased | 49 | 5.7 4.3–7.5ROR 5.7 · χ² 184 / p 4e-42 | 5.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · ♀ 12% (drug 39%) · 98% clinician | no trial data cached |
| Nephrolithiasis (kidney stones) | 36 | 5.6 4.0–7.7ROR 5.6 · χ² 131 / p 1e-30 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 97% clinician | no trial data cached |
| Intentional product use issue | 65 | 5.2 4.1–6.7ROR 5.3 · χ² 220 / p 5e-50 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 4% (drug 39%) · 95% clinician | no trial data cached |
| Aspartate aminotransferase increased | 39 | 5.2 3.8–7.1ROR 5.3 · χ² 129 / p 4e-30 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 94% clinician | no trial data cached |
| Dysphagia (difficulty swallowing) | 63 | 4.7 3.7–6.0ROR 4.8 · χ² 182 / p 9e-42 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 2% (drug 39%) | no trial data cached |
| Blood triglycerides increased | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Ventricular tachycardia | 10 | 4.3 2.3–8.0ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Proteinuria | 11 | 4.1 2.3–7.5ROR 4.2 · χ² 23 / p 7e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Oral herpes | 11 | 4.0 2.2–7.2ROR 4.0 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Hepatitis (liver inflammation) | 14 | 3.9 2.3–6.5ROR 3.9 · χ² 27 / p 9e-8 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Exposure during pregnancy | 29 | 3.3 2.3–4.8ROR 3.3 · χ² 45 / p 1e-11 | 3.2 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · ♀ 96% (drug 39%) | no trial data cached |
| Febrile neutropenia | 28 | 3.0 2.1–4.3ROR 3.0 · χ² 35 / p 1e-9 | 2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 · 100% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug interaction | 946 | 42.5 40.4–44.8ROR 62.1 · χ² 38,394 / p <1e-300 | 42.3 EB05 40.0 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 27.8 · ♀ 5% (drug 39%) | no trial data cached |
| Depression | 787 | 24.5 23.1–26.0ROR 33.0 · χ² 17,858 / p <1e-300 | 24.4 EB05 23.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.7 · ♀ 1% (drug 39%) | no trial data cached |
| Maternal exposure during pregnancy | 419 | 33.9 31.0–37.0ROR 39.3 · χ² 13,319 / p <1e-300 | 33.7 EB05 31.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 22.7 · ♀ 100% (drug 39%) | no trial data cached |
| Foetal exposure during pregnancy | 326 | 28.6 25.8–31.7ROR 32.0 · χ² 8,646 / p <1e-300 | 28.4 EB05 25.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 17.2 | no trial data cached |
| Loss of personal independence in daily activities | 226 | 33.9 29.9–38.4ROR 36.6 · χ² 7,158 / p <1e-300 | 33.6 EB05 30.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · ♀ 0% (drug 39%) · 91% clinician | no trial data cached |
| Abortion spontaneous | 192 | 34.0 29.7–39.0ROR 36.3 · χ² 6,101 / p <1e-300 | 33.7 EB05 29.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 · ♀ 100% (drug 39%) | no trial data cached |
| Premature baby | 132 | 31.1 26.4–36.8ROR 32.6 · χ² 3,810 / p <1e-300 | 30.9 EB05 26.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · ♀ 61% (drug 39%) | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 119 | 9.2 7.7–11.0ROR 9.6 · χ² 867 / p 9e-191 | 9.0 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 2% (drug 39%) · 94% clinician | no trial data cached |
| Psychotic disorder | 115 | 27.7 23.2–33.2ROR 28.8 · χ² 2,928 / p <1e-300 | 27.5 EB05 23.5 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.2 · ♀ 2% (drug 39%) · 96% clinician | no trial data cached |
| Paranoia | 109 | 44.9 37.3–54.0ROR 46.6 · χ² 4,611 / p <1e-300 | 44.3 EB05 37.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 34.0 · ♀ 1% (drug 39%) · 96% clinician | no trial data cached |
| Premature delivery | 84 | 37.4 30.3–46.2ROR 38.5 · χ² 2,929 / p <1e-300 | 37.0 EB05 30.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 · ♀ 100% (drug 39%) | no trial data cached |
| Abortion induced | 81 | 61.5 49.5–76.3ROR 63.2 · χ² 4,719 / p <1e-300 | 60.1 EB05 49.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 38.5 · ♀ 99% (drug 39%) | no trial data cached |
| Eyelid ptosis | 70 | 49.2 39.0–62.0ROR 50.3 · χ² 3,233 / p <1e-300 | 48.2 EB05 39.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 3% (drug 39%) | no trial data cached |
| Intentional product use issue | 65 | 5.2 4.1–6.7ROR 5.3 · χ² 220 / p 5e-50 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 4% (drug 39%) · 95% clinician | no trial data cached |
| Drug resistance | 64 | 17.7 13.9–22.6ROR 18.1 · χ² 992 / p 6e-218 | 17.6 EB05 14.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 · ♀ 59% (drug 39%) · 93% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Abortion induced — n=81, PRR 61.5
- Eyelid ptosis — n=70, PRR 49.2
- Paranoia — n=109, PRR 44.9
- Caesarean section — n=63, PRR 38.2
- Premature delivery — n=84, PRR 37.4
- Abortion spontaneous — n=192, PRR 34.0
- Loss of personal independence in daily activities — n=226, PRR 33.9
- Premature baby — n=132, PRR 31.1
- Hyperbilirubinaemia — n=44, PRR 30.4
- Prescribed overdose — n=56, PRR 20.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Atazanavir?
In FDA FAERS, the most frequently co-reported reaction terms for Atazanavir are depression, loss of personal independence in daily activities, abortion spontaneous, premature baby, suicidal ideation, psychotic disorder. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Atazanavir have an FDA boxed warning?
No. The FDA label retrieved for Atazanavir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atazanavir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 165cff62-b284-4a27-a65d-9ec8a5bfcdd8, effective 20241205; matched on
openfda.generic_name.exact:"ATAZANAVIR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 68 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.