Ozanimod
Ozanimod is a once-daily capsule medicine (a sphingosine 1-phosphate receptor modulator) used in adults for relapsing forms of multiple sclerosis and for moderately to severely active ulcerative colitis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ozanimod (Zeposia) is a once-daily capsule for adults with relapsing multiple sclerosis or moderately to severely active ulcerative colitis, a newer oral option (on the U.S. market since about 2020) that keeps white blood cells (lymphocytes) in the lymph nodes so fewer reach the brain and gut. It is generally well tolerated, with colds, headache and dizziness on standing among the effects people notice. Infection is the main thing to watch, so report a fever or feeling very unwell promptly, even in the three months after stopping. Expect an ECG (heart tracing) first and ongoing blood, liver, eye and skin checks, and report vision changes or liver symptoms promptly.
Clinical pearls
- If you miss a dose in the first two weeks, the 7-day step-up schedule has to start over.
- Never combine with MAO inhibitors (selegiline, phenelzine, linezolid); wait at least 14 days after stopping Zeposia before starting one.
- Without chickenpox immunity, expect testing and vaccination first; skip live vaccines during treatment and for three months after.
- Do not stop on your own; the label warns MS disability can worsen severely after stopping.
Patient information guide A plain-language walkthrough of Ozanimod, written from its FDA label.
What Ozanimod is used for
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Ozanimod is used in adults for these conditions:
- Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease (Zeposia).
- Moderately to severely active ulcerative colitis (UC) (Zeposia).
How Ozanimod works
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Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator. It binds to S1P receptors 1 and 5 and keeps lymphocytes (a type of white blood cell) from leaving the lymph nodes. This lowers the number of lymphocytes in your blood.
The exact way this helps MS and UC is unknown. It may involve fewer lymphocytes moving into the central nervous system and the intestine.
Ozanimod dosage
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Zeposia is a capsule swallowed whole once a day, with or without food. Treatment begins with a 7-day step-up schedule. This helps limit drops in heart rate.
- People with mild or moderate liver impairment take it every other day after the step-up.
- Missed a dose in the first 2 weeks? Restart the step-up schedule.
- Missed a dose after 2 weeks? Continue as planned.
Before starting, you will need an ECG, blood count, liver tests, an eye exam, and a skin exam. Follow your prescriber's directions.
Dosing details from the FDA-approved label
From the Ozanimod prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Multiple sclerosis and ulcerative colitis (initiation titration)
- Days 1-4: 0.23 mg once daily
- Days 5-7: 0.46 mg once daily
- Day 8 and thereafter: 0.92 mg once daily
- Swallow capsules whole, with or without food
- Multiple sclerosis and ulcerative colitis (maintenance)
- 0.92 mg taken orally once daily starting on Day 8
- Swallow capsules whole, with or without food
- Patients with mild or moderate hepatic impairment (Child-Pugh class A or B)
- Initiate with the 7-day titration as in Table 1
- After titration, 0.92 mg taken orally once every other day, starting on Day 8
- Hepatic impairment adjustment
- Reinitiation after missed dose during the first 2 weeks of treatment
- Reinitiate treatment using the titration regimen
- Missed dose after the first 2 weeks of treatment
- Continue with the treatment as planned
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Assessments are required prior to initiating ZEPOSIA. ( 2.1 ) Titration is required for treatment initiation. ( 2.2 ) The recommended maintenance dosage is 0.92 mg orally once daily. ( 2.2 ) The recommended maintenance dosage in patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) is 0.92 mg once every other day. ( 2.3 ) If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned. ( 2.4 ) 2.1 Assessments Prior to First Dose of ZEPOSIA Before initiation of treatment with ZEPOSIA, assess the following: Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.3) ]. Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1) ]. Liver Function Tests Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.4) ]. Ophthalmic Assessment Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with ZEPOSIA [see Warnings and Precautions (5.8) ]. Skin Examination Obtain a baseline skin examination prior to or shortly after initiation of ZEPOSIA. If a suspicious skin lesion is observed, it should be promptly evaluated [see Warnings and Precautions (5.9) ]. Current or Prior Medications If patients are taking anti-neoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7) ] . Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction [see Warnings and Precautions (5.3) and Drug Interactions (7) ].
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ozanimod side effects
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The most common side effects seen in studies were:
Common side effects
- Upper respiratory infections (colds, sore throat, sinus infections)
- Raised liver blood tests
- Headache
- Urinary tract infection
- Back pain
- High blood pressure
- Orthostatic hypotension (dizziness when standing up)
When to get medical help
- Signs of a serious infection, such as fever or feeling very unwell. Infections can be life-threatening.
- New weakness on one side of the body, clumsy limbs, vision changes, or confusion or personality changes. These can be signs of PML, a rare brain infection.
- Vision changes, which can be a sign of macular edema (swelling in the back of the eye).
- Signs of liver injury. This can happen as early as 10 days after the first dose.
- Slow heartbeat or heart rhythm problems, especially when starting treatment.
- Worsening breathing, since lung function can decline.
- A suspicious new skin spot or lesion.
- Symptoms of cryptococcal meningitis, a serious fungal infection of the brain's lining.
Call your doctor about signs of serious infection, vision changes, liver problems, a very slow heartbeat, or symptoms of PML such as weakness on one side, clumsiness, or confusion.
Ozanimod warnings and precautions
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- Infections: Ozanimod lowers lymphocytes, and serious or life-threatening infections have occurred. Monitoring continues for 3 months after stopping.
- PML: a rare brain infection, with risk rising with longer use.
- Heart rate: a temporary slowing can happen when starting.
- Liver injury: serious cases, including liver failure needing transplant, have been reported.
- Other risks: higher blood pressure, lung function decline, macular edema, and skin cancers.
- Pregnancy: possible serious risk to a baby.
- After stopping: the label lists a severe increase in MS disability and immune effects.
Ozanimod interactions
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Several medicines and vaccines can clash with ozanimod:
- MAO inhibitors: contraindicated because of uncertain effects on drug levels.
- Strong CYP2C8 inhibitors such as gemfibrozil: raise active drug levels, so not recommended.
- Strong CYP2C8 inducers such as rifampin: may lower effectiveness, so avoid.
- Heart-rate-lowering or QT-prolonging drugs and antiarrhythmics: additive heart effects.
- A beta blocker with a calcium channel blocker: generally avoid starting Zeposia.
- Immunosuppressing drugs: added immune effects.
- Live vaccines: avoid during treatment and for 3 months after.
Interactions listed in the FDA-approved label
From the Ozanimod prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies: ZEPOSIA has not been studied in combination with these therapies except cyclosporine, which had no pharmacokinetic interaction; there is a risk of additive immune effects. Use caution during concomitant administration and in the weeks following; when switching from drugs with prolonged immune effects, consider half-life and mode of action. Initiating ZEPOSIA after alemtuzumab is not recommended. ZEPOSIA can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
- Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs: These drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought.
- QT prolonging drugs with known arrhythmogenic properties: ZEPOSIA has not been studied in patients taking QT prolonging drugs; there are potential additive effects on heart rate. Treatment with ZEPOSIA should generally not be initiated; if considered, advice from a cardiologist should be sought.
- Combination of beta blocker and heart rate lowering calcium channel blocker (e.g., verapamil, diltiazem): Co-administration has not been studied, but there is a potential of additive effects on heart rate. Treatment with ZEPOSIA should generally not be initiated in patients on both; if considered, advice from a cardiologist should be sought.
- Live attenuated vaccines (vaccination): During and for up to three months after discontinuation, vaccinations may be less effective; live attenuated vaccines may carry the risk of infection. Avoid live attenuated vaccines during ZEPOSIA treatment and for up to 3 months after discontinuation.
- Monoamine oxidase (MAO) inhibitors (e.g., selegiline, phenelzine, linezolid): Effect of MAO inhibition on ozanimod and/or its metabolites has not been studied; potential effects on efficacy or safety cannot be ruled out. Co-administration is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of MAO inhibitors.
- Strong CYP2C8 inhibitors (e.g., gemfibrozil): Increases exposure of the active metabolites of ozanimod, which may increase the risk of adverse reactions. Co-administration is not recommended.
- Strong CYP2C8 inducers (e.g., rifampin): Reduces exposure of the major active metabolites of ozanimod, which may decrease efficacy. Co-administration should be avoided.
Read the label’s full interactions text
7 DRUG INTERACTIONS Tables 5 and 6 include drugs with clinically important drug and vaccine interactions when administered concomitantly with ZEPOSIA and instructions for preventing or managing them. Table 5: Clinically Relevant Interactions Affecting Drugs and Vaccines Co-administered with ZEPOSIA 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 Clinical Pharmacology (12.3) ] . Prevention or Management: Caution should be used during concomitant administration because of the risk of additive immune effects during such therapy and in the weeks following administration [see Warnings and Precautions (5.1) ] . When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects [see Warnings and Precautions (5.11) ] . Alemtuzumab : Initiating treatment with ZEPOSIA after alemtuzumab is not recommended 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. Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs That May Decrease Heart Rate 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. Prevention or Management: If treatment with ZEPOSIA is considered in patients on Class Ia or Class III anti-arrhythmic drugs, advice from a cardiologist should be sought [see Warnings and Precautions (5.3) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ozanimod
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- Not for people with recent heart attack, stroke, TIA, unstable angina, or serious heart failure (last 6 months).
- Not for certain heart blocks or sick sinus syndrome without a pacemaker, severe untreated sleep apnea, or MAO inhibitor use.
- Delay if you have an active infection.
- Check chickenpox immunity before starting.
- Use effective birth control during treatment and for 3 months after.
- Discuss breastfeeding with your doctor.
- Not established for children.
- Older adults should be monitored for heart and liver effects.
- Severe liver impairment: not recommended. Mild or moderate: every-other-day dosing.
What Ozanimod does in the body
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In trials, average lymphocyte counts fell to about 45% of baseline at 3 months and stayed low during treatment. After stopping, counts returned to the normal range in a median of about 30 days. Zeposia can cause a temporary drop in heart rate at the start, which the step-up schedule lessens. Lung function measures showed dose-related reductions.
How your body processes Ozanimod
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Ozanimod reaches its peak level about 6 to 8 hours after a dose, and food does not meaningfully change this. It is broken down by several enzymes into active metabolites that account for most of the drug's activity. Ozanimod's half-life is about 21 hours, while the main active metabolite lasts about 11 days. Elimination is mostly through urine and feces as inactive metabolites. Levels are higher in people with mild or moderate liver impairment.
How to store Ozanimod
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Ozanimod
159 supplements and herbal products have documented interactions with Ozanimod in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 20
- Moderate · 127
- Minor · 12
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Ozanimod: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ozanimod — the kind of thing our pharmacy team would talk through with you at the counter.
What is Zeposia used for?
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How do I take it?
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What side effects should I expect?
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Do I need any tests?
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Can I take it with my other medicines or vaccines?
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What about pregnancy?
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Is Ozanimod available over the counter?
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When was Ozanimod first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ozanimod on HelloPharmacist
Ozanimod forms and strengths (how it comes)
Ozanimod is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Zeposia is used in adults for relapsing forms of multiple sclerosis.
- Zeposia is used in adults for moderately to severely active ulcerative colitis.
- Zeposia capsules are swallowed whole, with or without food.
- Zeposia starts with a 7-day step-up schedule, then continues once daily.
- Zeposia is taken every other day after the step-up in people with mild or moderate liver impairment.
- If a Zeposia dose is missed in the first 2 weeks, treatment is restarted with the step-up schedule.
Ozanimod on the U.S. market: products, makers and brands
How Ozanimod appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Ozanimod product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2020. Brand names on the directory include Zeposia, ZEPOSIA 7-Day Starter Pack, ZEPOSIA Starter Kit; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (8) · Kit (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Ozanimod is used (Medicaid data)
A general measure of how commonly Ozanimod is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ozanimod is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ozanimod prescribed? Of the 1,601 medications we measure, Ozanimod ranks #1,039 by Medicaid prescriptions — more than 35% of them.
Utilization by Ozanimod product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ozanimod 0.92 MG Oral Capsule
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2288406
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ozanimod, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 6 listed Ozanimod NDCs with Medicaid activity.
Compare Ozanimod products
A representative set of FDA-listed product records for Ozanimod — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 0.92 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 💊Kits | ||||
| — | — | Celgene Corporation × 2 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Ozanimod NDCs →
Ozanimod side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ozanimod — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ozanimod in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ozanimod FDA approval history
How Ozanimod went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ozanimod recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Ozanimod recalls since July 2021.
✅No Ozanimod recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2288236 1 dose form · 3 strengths
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Dose form (SCDF) Oral Capsule RxCUI 2288405In current FDA listings
Look up RxCUI 2288236 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Ozanimod supply and shortage status
Whether Ozanimod is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Ozanimod brand names
Ozanimod is sold under 3 brand names in the FDA directory — Zeposia, ZEPOSIA 7-Day Starter Pack, ZEPOSIA Starter Kit. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ozanimod: manufacturers and labelers
One company lists Ozanimod products with the FDA. By number of product records, the largest are Celgene Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ozanimod drug class (RxNorm)
Ozanimod belongs to the Sphingosine 1-phosphate Receptor Modulator class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Ozanimod page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Celgene Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →