Note: This document contains side effect information about ozanimod. Some dosage forms listed on this page may not apply to the brand name Zeposia.
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]