Ozanimod
Pronunciation: (oh-ZAN-ih-mod).
- Generic name
- Ozanimod
- Brand names
- Ozanim, Ozava, Zeposia
- Drug class
- Sphingosine 1-phosphate (S1P) receptor modulator
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Ozanimod is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Ozanimod works
Ozanimod is a selective sphingosine 1-phosphate (S1P) receptor modulator, primarily targeting S1P1 and S1P5 receptors. By binding to these receptors on lymphocytes, it prevents their egress from lymph nodes, reducing the number of circulating lymphocytes. This limits the migration of pathogenic immune cells into the central nervous system (in MS) or the colon (in ulcerative colitis), thereby decreasing inflammation and tissue damage. (1) (2)
What Ozanimod is used for
Relapsing forms of multiple sclerosis (RMS)
Relapsing forms of multiple sclerosis (RMS) (2)
Ulcerative colitis (UC)
Ulcerative colitis (UC) (2)
Before taking Ozanimod
Do not take / not appropriate for
- recent (within 6 months) myocardial infarction, stroke, unstable angina, decompensated heart failure, severe untreated sleep apnea, certain heart blocks without a pacemaker, and severe hepatic impairment. (Contraindication) (2)
- Baseline ECG, liver function tests, and ophthalmologic evaluation are recommended. (Contraindication) (2)
Tell your clinician about
(2)How to take Ozanimod
- General Instructions: Take Ozanimod exactly as prescribed, once daily, with or without food. Do not open, crush, or chew the capsules.. Adult Dosing: For multiple sclerosis and ulcerative colitis: Start with a 7-day titration schedule (beginning with a lower dose and gradually increasing to the full dose of 0.92 mg once daily).. Pediatric Dosing: Safety and efficacy in children under 18 years have not been established. Use in pediatric patients is not recommended.. Administration: Swallow the capsule whole with water at the same time each day. Follow the titration pack instructions for the first week.. When To Stop: Do not stop taking Ozanimod without consulting your healthcare provider. Stopping suddenly may increase the risk of disease flare or complications.. Storage: Store at room temperature (20°C to 25°C/68°F to 77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember on the same day. If it is the next day, skip the missed dose and resume your regular schedule. If you miss one or more days during the first 14 days of treatment, contact your healthcare provider as you may need to restart the titration schedule.
Overdose
If you take too much Ozanimod, seek emergency medical attention or call your local poison control center immediately. Symptoms of overdose may include slow heart rate, confusion, or severe dizziness. Supportive care and monitoring of vital signs, especially heart rate and rhythm, are recommended. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Hypertension
Incidence: Reported in the clinician-authored database; frequency not established
Bradycardia
Incidence: Reported in the clinician-authored database; frequency not established
Elevated liver enzymes
Incidence: Reported in the clinician-authored database; frequency not established
Infections
Incidence: Reported in the clinician-authored database; frequency not established
Macular edema
Incidence: Reported in the clinician-authored database; frequency not established
Progressive multifocal leukoencephalopathy (PML)
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
May increase risk of infections, including serious or life-threatening infections — serious
Symptoms: May increase risk of infections, including serious or life-threatening infections. Can cause slow heart rate, especially after the first dose. May increase liver enzymes; liver function should be monitored. Can cause macular edema (swelling in the back of the eye). May increase blood pressure; monitor regularly.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include recent (within 6 months) myocardial infarction, stroke, unstable angina, decompensated heart failure, severe untreated sleep apnea, certain heart blocks without a pacemaker, and severe hepatic impairment. Use caution in patients with a history of uveitis, macular edema, active infections, or immunosuppression. Baseline ECG, liver function tests, and ophthalmologic evaluation are recommended.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Ozanimod may interact with other immunosuppressants, certain heart medications (such as antiarrhythmics or beta-blockers), CYP2C8 inhibitors/inducers, and monoamine oxidase inhibitors. Always inform your healthcare provider about all medicines and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
The FDA label reports that animal studies found adverse effects on development with ozanimod, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, with fetal blood vessel malformations seen in rabbits. Women of childbearing potential should be counseled on the potential risk to the fetus and the need for effective contraception during treatment. Because ozanimod takes time to clear from the body, effective contraception should continue for about 3 months after stopping treatment. Do not become pregnant while taking ozanimod without first discussing this with your prescriber. (2)
Breastfeeding
The FDA label reports that ozanimod and/or its metabolites were detected in the milk of lactating rats at levels higher than in maternal plasma; it is not established whether this occurs in humans. The developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for ozanimod and any potential risk to the breastfed infant — discuss this with your prescriber. (2)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (2)
Renal_impairment
FDA label guidance: renal impairment (including end-stage renal disease) has no clinically important effect on ozanimod pharmacokinetics, so no dose adjustment is needed for renal impairment. For hepatic impairment: mild or moderate hepatic impairment (Child-Pugh Class A or B) requires a reduced maintenance dose of 0.92 mg once every other day (after the same 7-day starting titration); ozanimod has not been evaluated in severe hepatic impairment (Child-Pugh Class C), which the clinician database already records as a contraindication — severe hepatic impairment patients must not be treated with ozanimod. (2)
Hepatic_impairment
FDA label guidance: renal impairment (including end-stage renal disease) has no clinically important effect on ozanimod pharmacokinetics, so no dose adjustment is needed for renal impairment. For hepatic impairment: mild or moderate hepatic impairment (Child-Pugh Class A or B) requires a reduced maintenance dose of 0.92 mg once every other day (after the same 7-day starting titration); ozanimod has not been evaluated in severe hepatic impairment (Child-Pugh Class C), which the clinician database already records as a contraindication — severe hepatic impairment patients must not be treated with ozanimod. (2)
Monitoring
(2)Storage
Store ozanimod capsules at room temperature (20°C to 25°C/68°F to 77°F), away from moisture and heat, and out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Relapsing forms of multiple sclerosis (RMS)
Dose summary: Starting dose: 0.23 mg orally once daily for 7 days, followed by 0.46 mg orally once daily.
Renal context: FDA label: renal impairment, including end-stage renal disease, has no clinically important effect on ozanimod pharmacokinetics. No dose adjustment is needed for renal impairment. (1) (2)
Hepatic guidance
FDA label: mild or moderate hepatic impairment (Child-Pugh Class A or B) requires a reduced maintenance dose of 0.92 mg once every other day, after the standard 7-day titration. Ozanimod has not been evaluated in severe hepatic impairment (Child-Pugh Class C) and must not be used in that population — this is a contraindication.
Frequently asked questions
What conditions does Ozanimod treat?
Ozanimod is approved for the treatment of relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis in adults.
How does Ozanimod work?
Ozanimod works by blocking certain immune cells from leaving lymph nodes, reducing inflammation and damage in the central nervous system or colon.
What are the most common side effects?
Common side effects include headache, upper respiratory tract infections, elevated liver enzymes, back pain, and high blood pressure.
Can I receive vaccines while taking Ozanimod?
You should avoid live vaccines during and for at least 3 months after stopping Ozanimod. Inactivated vaccines may be less effective.
Is Ozanimod safe during pregnancy or breastfeeding?
Ozanimod is not recommended during pregnancy or breastfeeding. Discuss family planning and contraception with your healthcare provider before starting treatment.
What should I do if I miss a dose?
Take the missed dose as soon as possible on the same day. If you miss one or more days during the first 14 days, contact your healthcare provider as you may need to restart the titration schedule.
How long does it take for Ozanimod to start working?
Some patients may notice improvement within a few weeks, but it can take several months for full benefits. Continue taking Ozanimod as prescribed and attend all follow-up appointments.
What happens if I take too much Ozanimod?
Taking too much Ozanimod can lead to serious adverse effects, potentially including bradycardia, hypertension, or liver damage. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Do not attempt to self-treat or wait for symptoms to worsen, as prompt intervention is vital for patient safety.
Can I drink alcohol while taking Ozanimod?
It is generally advisable to limit or avoid alcohol consumption while taking Ozanimod. Both Ozanimod and alcohol can affect liver function, and combining them may increase the risk of liver enzyme elevations or liver damage. Always discuss alcohol intake with your healthcare provider to understand the specific risks and recommendations for your individual situation.
Is Ozanimod safe during pregnancy?
Ozanimod's safety during pregnancy has not been definitively established, and it is generally recommended to avoid its use. It falls under a pregnancy category that suggests potential risks. If you are pregnant, planning to become pregnant, or breastfeeding, it is imperative to consult your healthcare provider to discuss the potential risks and benefits and explore alternative treatment options.
What is the mechanism of action of Ozanimod?
Ozanimod is a selective sphingosine 1-phosphate (S1P) receptor modulator, primarily targeting S1P1 and S1P5 receptors. By binding to these receptors on lymphocytes, it prevents their egress from lymph nodes, reducing the number of circulating lymphocytes. This limits the migration of pathogenic immune cells into the central nervous system (in MS) or the colon (in ulcerative colitis), thereby decreasing inflammation and tissue damage. (1) (2)
What is the generic name of Ozanimod?
The generic name is Ozanimod. It is sold under brand names including Ozanim, Ozava, Zeposia.
What class of drug is Ozanimod?
Ozanimod is classed as: Sphingosine 1-phosphate (S1P) receptor modulator.
References
- Clinician-authored medicine record for Ozanimod (MedGuideGlobal medicines database)MedGuideGlobal clinician-authored medicine record · null · accessed 2026-08-06 · source 1
- DailyMed — ZEPOSIA (ozanimod) capsules, FDA-approved labelingU.S. Food and Drug Administration (via DailyMed) · United States · accessed 2026-08-07 · source 2
- ZEPOSIA (OZANIMOD HYDROCHLORIDE) CAPSULE ZEPOSIA 7-DAY STARTER PACK (OZANIMOD HYDROCHLORIDE) KIT ZEPOSIA STARTER KIT (OZANIMOD HYDROCHLORIDE) KIT [CELGENE CORPORATION] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- ZEPOSIA 7-Day Starter Pack — FDA approval record (Drugs@FDA NDA209899)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- Ozanimod — RxNorm normalized drug concept (RXCUI 2288235)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Ozanimod names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- ZEPOSIA.92 mg · celgene corporation