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]