Oxbrytavoxelotor
According to the FDA label: OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
22,291 adverse event reports submitted to the FDA (2019–2026)
Top Reported Adverse Events
The most frequently reported events in association with Oxbryta in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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- Sickle Cell Anaemia With Crisis 11,216 reports
Product Dose Omission Issue 5,172 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Diarrhoea 3,187 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 2,416 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Nausea 2,016 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Headache 1,691 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain Upper 1,171 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Pain 1,082 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Therapy Cessation 1,040 reports
Fatigue 1,007 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Abdominal Discomfort 969 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →- Therapy Interrupted 900 reports
Vomiting 833 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Haemoglobin Decreased 752 reports
A blood test result showing a low level of haemoglobin, the protein in red blood cells that carries oxygen. This is closely related to anaemia. Also spelled hemoglobin in American English.
Full definition in the glossary →Abdominal Pain 627 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 13,113 |
| Male | 8,702 |
| Unknown | 1 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,157 |
| 18-34 | 4,959 |
| 35-49 | 3,790 |
| 50-64 | 2,222 |
| 65-74 | 396 |
| 75+ | 53 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Oxbryta. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 12,682 |
| Hospitalization | 7,855 |
| Other Serious | 2,413 |
| Death | 414 |
| Life-Threatening | 78 |
| Disability | 29 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Oxbryta. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2019 | 3 |
| 2020 | 3,384 |
| 2021 | 3,536 |
| 2022 | 9,276 |
| 2023 | 4,504 |
| 2024 | 1,436 |
| 2025 | 141 |
| 2026 (partial) | 11 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Oxbryta
In FDA adverse event reports that mention Oxbryta, these medications appeared most often in the same report.
- Hydroxyurea (2,013 reports)
- Folic Acid (1,355 reports)
- Ergocalciferol (454 reports)
- Deferasirox (424 reports)
- Oxycodone (405 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026