Prescription medicine
Ozanimod Brand names: Zeposia
Ozanimod (Zeposia) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ozanimod FDA label on DailyMed (effective April 16, 2026, Celgene Corporation); the NDA 209899 record on Drugs@FDA; every ozanimod label on DailyMed.
Highlights of the record
FDA label of April 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Forms and strengths
- 0.92 mg
Kit; capsule.
On the market
- Earliest approval on file
- March 25, 2020 Zeposia, Bristol; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- September 30, 2038 Zeposia capsules; 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
- 8,256 through July 30, 2026
What is ozanimod used for?
From the label: indications and usageZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. moderately to severely active ulcerative colitis (UC) in adults. ZEPOSIA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ) Moderately to severely active ulcerative colitis (UC) in adults.
FDA pharmacologic class: Sphingosine 1-phosphate Receptor Modulator.
Source: FDA drug label (ZEPOSIA 7-Day Starter Pack), NDA209899 (Bristol), as published by Celgene Corporation, effective April 16, 2026 (SPL set 93ce2fab-edfb-4804-8074-963071de51e4), via openFDA; the full label on DailyMed
What does the patient leaflet for ozanimod say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZEPOSIA?ZEPOSIA may cause serious side effects, including: Infections. ZEPOSIA can increase your risk of serious infections that can be life-threatening and cause death. ZEPOSIA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 months of stopping treatment. Your healthcare provider may do a blood test of your white blood cells before you start taking ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA: fever feeling very tired flu-like symptoms cough painful and frequent urination (signs of a urinary tract infection) rash headache with fever, neck stiffness, sensitivity to light, nausea or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine) Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection. Progressive multifocal leukoencephalopathy (PML). ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on 1 side of your body loss of coordination in your arms or legs decreased strength problems with balance changes in your vision changes in your thinking or memory confusion changes in your personality Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. […]
From the patient leaflet: How should I store ZEPOSIA?Store ZEPOSIA at room temperature between 68°F to 77°F (20°C to 25°C). Keep ZEPOSIA and all medicines out of the reach of children.
Source: FDA drug label (ZEPOSIA 7-Day Starter Pack), NDA209899 (Bristol), as published by Celgene Corporation, effective April 16, 2026 (SPL set 93ce2fab-edfb-4804-8074-963071de51e4), via openFDA; the full label on DailyMed
Is there a generic for ozanimod (Zeposia)?
No generic ozanimod is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 5 patents for Zeposia capsules: the compound patent runs to September 30, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ozanimod label say about other medicines?
The ozanimod label names 14 other medicines 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 |
|---|---|---|
| Alemtuzumab | drug interactions | … of these drugs must be considered in order to avoid unintended additive immunosuppressive effects [see ]. Alemtuzumab: Initiating treatment with ZEPOSIA after alemtuzumab is not recommended because of the characteristics and duration of alemtuzumab immune suppressive effects. … |
| Amiodarone | drug interactions | Clinical Impact: ZEPOSIA has not been studied in patients taking QT prolonging drugs. Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. … |
| Cyclosporine | drug interactions | Anti-Neoplastic, Immune-Modulating, or Non-Corticosteroid Immunosuppressive Therapies Clinical Impact: ZEPOSIA has not been studied in combination with anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies with the exception of cyclosporine, which had no pharmacokinetic interaction [see … |
| Diltiazem | drug interactions | … patients who are concurrently treated with both a heart rate lowering calcium channel blocker (e.g., verapamil, diltiazem) and beta blocker [see Warnings and Precautions (5.3) ]. If treatment initiation with ZEPOSIA is considered in patients on both a heart rate lowering calcium channel blocker and beta blocker … |
| Gemfibrozil | drug interactions | … adverse reactions. Prevention or Management: Co-administration of ZEPOSIA with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. |
| Glatiramer | drug interactions | … because of the characteristics and duration of alemtuzumab immune suppressive effects. Beta interferon or glatiramer acetate: ZEPOSIA can generally be started immediately after discontinuation of beta interferon or glatiramer acetate. |
| Linezolid | drug interactions | … Prevention or Management: Co-administration of ZEPOSIA with MAO inhibitors (e.g., selegiline, phenelzine, linezolid) is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of treatment with MAO inhibitors. |
| Phenelzine | drug interactions | … be ruled out. Prevention or Management: Co-administration of ZEPOSIA with MAO inhibitors (e.g., selegiline, phenelzine, linezolid) is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of treatment with MAO inhibitors. |
| Procainamide | drug interactions | Clinical Impact: ZEPOSIA has not been studied in patients taking QT prolonging drugs. Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. … |
| Quinidine | drug interactions | Clinical Impact: ZEPOSIA has not been studied in patients taking QT prolonging drugs. Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. … |
| Rifampin | drug interactions | Strong CYP2C8 Inducers Clinical Impact: Co-administration of ZEPOSIA with strong CYP2C8 inducers (e.g., rifampin) reduces the exposure of the major active metabolites of ozanimod [see ], which may decrease the efficacy of ZEPOSIA. … |
| Selegiline | drug interactions | … metabolites cannot be ruled out. Prevention or Management: Co-administration of ZEPOSIA with MAO inhibitors (e.g., selegiline, phenelzine, linezolid) is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of treatment with MAO inhibitors. |
| Sotalol | drug interactions | Clinical Impact: ZEPOSIA has not been studied in patients taking QT prolonging drugs. Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. … |
| Verapamil | drug interactions | … initiated in patients who are concurrently treated with both a heart rate lowering calcium channel blocker (e.g., verapamil, diltiazem) and beta blocker [see Warnings and Precautions (5.3) ]. If treatment initiation with ZEPOSIA is considered in patients on both a heart rate lowering calcium channel blocker and beta … |
Source: FDA drug label (ZEPOSIA 7-Day Starter Pack), NDA209899 (Bristol), as published by Celgene Corporation, effective April 16, 2026 (SPL set 93ce2fab-edfb-4804-8074-963071de51e4), via openFDA; the full label on DailyMed
What do FAERS reports show for ozanimod?
The FDA Adverse Event Reporting System holds 8,256 reports that list ozanimod among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 87 are coded as a death and 604 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 2021 (1,903, against a median of 243 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other sphingosine 1-phosphate receptor modulators
- the pharmacologic class, with prices and generics
- Ozanimod side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other