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Ozanimod

Precautions

Before taking ozanimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, bronchitis, emphysema, sleep apnea), current/recent/returning infection (including hepatitis and tuberculosis), diabetes, certain eye problems (macular edema, uveitis), heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG), high blood pressure, liver problems, smoking, stroke/mini-stroke.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ozanimod can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. If a live vaccine is needed, it should be given at least one month before starting this medication. Tell your health care professional that you are using ozanimod before having any immunizations/vaccinations. Avoid getting a live vaccine while using this medication and for 3 months after the last dose of this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ozanimod. Ozanimod may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

Back pain, dizziness, and lightheadedness may occur. Slow heartbeat may also occur, especially when you first start this medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), shortness of breath, unusual tiredness.

This medication can weaken your immune system/increase the risk of infection while you are taking it and for 3 months after your last dose. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, herpes). Tell your doctor right away if you develop any signs of an infection such as sore throat/cough that doesn't go away, difficulty breathing, fever/chills, cold/flu symptoms, sores, or blisters. Do not start ozanimod if you already have an infection.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Symptoms of PML can seem like a worsening MS attack. Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure.

Get medical help right away if you have any very serious side effects, including: very slow heartbeat, fast/irregular heartbeat, severe dizziness, fainting, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes), sudden/severe headache.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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RxAnswers™ is a copyrighted combined product from TraceGains and First DataBank, Inc.

Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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Information expires December 2025.