Prescription medicine

Voxelotor Brand names: Oxbryta

Voxelotor (Oxbryta) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the voxelotor FDA label on DailyMed (effective December 26, 2023, Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.); the NDA 213137 record on Drugs@FDA; every voxelotor label on DailyMed.

Highlights of the record

FDA label of December 26, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older.

Forms and strengths

300 mg
500 mg

Film-coated tablet; tablet for suspension.

On the market

Earliest approval on file: November 25, 2019 Oxbryta, Global Blood Theraps; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 12, 2037 Oxbryta tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 22,300 through July 30, 2026

What is voxelotor used for?

From the label: indications and usage
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). OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb). […]

FDA pharmacologic class: Hemoglobin S Polymerization Inhibitor.

Source: FDA drug label (OXBRYTA), Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc., effective December 26, 2023 (SPL set 3c557fac-29ec-483f-b691-8a935d4decc3), via openFDA; the full label on DailyMed

What does the patient leaflet for voxelotor say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while taking OXBRYTA?
Do not take St. John's wort during treatment with OXBRYTA.

From the patient leaflet: How should I store OXBRYTA?
Store OXBRYTA between 68°F to 86°F (20°C to 30°C). • The OXBRYTA bottle comes with a child-resistant closure. • The OXBRYTA bottle may contain a desiccant canister to help keep your medicine dry (protect it from moisture) and a polyester coil. Do not eat the desiccant or polyester coil. Keep OXBRYTA and all medicines out of the reach of children.

Is there a generic for voxelotor (Oxbryta)?

No generic voxelotor is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 11 patents for Oxbryta tablets: the compound patent runs to February 6, 2035, and the last listed entry to October 12, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2019 earliest approval on file
2037 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the voxelotor label say about other medicines?

The voxelotor label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Midazolam	drug interactions	Voxelotor on Other Drugs Voxelotor increased the systemic exposure of midazolam (a sensitive CYP3A4 substrate) [see Clinical Pharmacology (12.3) ].

Check voxelotor against other medicines

What do FAERS reports show for voxelotor?

The FDA Adverse Event Reporting System holds 22,300 reports that list voxelotor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 416 are coded as a death and 7,858 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. Reports rose sharply in 2022 (9,276, against a median of 141 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

Sickle Cell Anaemia With Crisis11,218
Product Dose Omission Issue (a use or a product term, not a reaction)5,172
Diarrhoea (named in the label)3,187
Off Label Use (a use or a product term, not a reaction)2,417
Nausea (named in the label)2,016
Headache (named in the label)1,691
Abdominal Pain Upper1,171
Pain1,085

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Voxelotor side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other