Ozanimod Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 9, 2024.

Applies to ozanimod: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®), or after receiving alemtuzumab (Campath®, Lemtrada®) within the past 14 days. Using these medicines together may cause serious unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Ozanimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

Herpes zoster and other serious infections may occur while taking this medicine. Symptoms include painful blisters on the trunk of your body, itching skin, rash, or trouble breathing. These symptoms should be treated first before taking this medicine.

While you are being treated with ozanimod, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should be given at least 3 months after your last dose of this medicine.

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision or any other change in vision occurs during treatment with this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of ozanimod

Along with its needed effects, ozanimod may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ozanimod:

For healthcare professionals

Applies to ozanimod: oral capsule.

General adverse events

• Common (1% to 10%): Pyrexia^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Herpes zoster
• Frequency not reported: Cryptococcal meningitis (CM)^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, arthralgia^[Ref]

Ocular

• Uncommon (0.1% to 1%): Macular edema^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

• Very common (10% or more): Aminotransferase elevations (e.g., alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, transaminases increased) (10%)^[Ref]

Oncologic

• Frequency not reported: Malignancies (e.g., melanoma, basal cell carcinoma, breast cancer, seminoma, cutaneous malignancies)^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (e.g., nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, laryngitis) (26%)
• Common (1% to 10%): Dose-dependent reductions in absolute FEV1 and FVC^[Ref]

Other

• Frequency not reported: Severe exacerbation of disease (e.g., disease rebound)^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Rare (0.01% to 0.1%): Progressive multifocal leukoencephalopathy (PML)^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension (e.g., hypertension, essential hypertension, orthostatic hypertension), peripheral edema
• Uncommon (0.1% to 1%): Bradycardia
• Frequency not reported: Atrioventricular conduction delays^[Ref]

Dermatologic

• Frequency not reported: Rash, urticaria^[Ref]

Gastrointestinal

• Common (1% to 10%): Upper abdominal pain, nausea^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity^[Ref]

See also:

Frequently asked questions

• Is Zeposia (ozanimod) a biologic? How does it work?
• How long does it take Zeposia (ozanimod) to work?
• Why does Zeposia (ozanimod) slow down your heart rate?
• What are the new drugs used for multiple sclerosis (MS)?

Further information

Ozanimod side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer