Ozanimod Side Effects

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

Applies to ozanimod: oral capsule.

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:

More common side effects

• body aches or pain
• cough or hoarseness
• dark-colored urine
• difficulty in breathing
• ear congestion
• fever or chills
• general feeling of tiredness or weakness
• headache
• light-colored stools
• loss of voice
• lower back or side pain
• painful or difficult urination
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness
• yellow eyes or skin

Less common side effects

• bladder pain
• bloody or cloudy urine
• blurred vision
• cold sweats
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• frequent urge to urinate
• nervousness
• pounding in the ears
• slow or fast heartbeat

Rare side effects

• painful blisters on the trunk of the body

Incidence not known

• back pain
• burning or stinging of the skin
• change in size, shape, or color of existing mole
• changes in vision
• chest pain, tightness, or discomfort
• clear or bloody discharge from nipple
• difficulty in moving
• dimpling of breast skin
• drowsiness
• hives, itching, or skin rash
• inverted nipple
• irritation
• joint pain, stiffness, or swelling
• lump in the breast or under the arm
• mole that leaks fluid or bleeds
• muscle pain or stiffness
• nausea
• new mole
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• persistent crusting or scaling of nipple
• persistent non-healing sore
• pink growth
• reddish patch or irritated area
• redness of the skin
• redness or swelling of the breast
• seizures
• severe headache
• shiny bump
• sore on the skin of the breast that does not heal
• stiff neck or back
• stomach pain, continuing
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• trouble swallowing
• vomiting
• white, yellow or waxy scar-like area

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]

Frequently asked questions

• Is Zeposia (ozanimod) a biologic? How does it work?
• How long does it take Zeposia (ozanimod) to work?
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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