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Ozanimod Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 19, 2022.

Applies to ozanimod: oral capsules.

Side effects include:

MS trials (≥4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension.

UC trials (≥ 4%): Liver enzyme elevations, upper respiratory infection, headache.

For Healthcare Professionals

Applies to ozanimod: oral capsule.

Hypersensitivity

Frequency not reported: Hypersensitivity[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]

General

Common (1% to 10%): Pyrexia[Ref]

Frequently asked questions

References

1. "Product Information. Zeposia (ozanimod)." Celgene Corporation (2020):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.