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Zeposia Side Effects

Generic name: ozanimod

Medically reviewed by Drugs.com. Last updated on Apr 17, 2021.

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

For the Consumer

Applies to ozanimod: oral capsule

Side effects requiring immediate medical attention

Along with its needed effects, ozanimod (the active ingredient contained in Zeposia) 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

  • 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

  • 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

  • Painful blisters on the trunk of the body

Incidence not known

  • Back pain
  • burning or stinging of the skin
  • changes in vision
  • chest pain, tightness, or discomfort
  • difficulty in moving
  • drowsiness
  • hives, itching, or skin rash
  • irritation
  • joint pain, stiffness, or swelling
  • muscle pain or stiffness
  • nausea
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • redness of the skin
  • seizures
  • severe headache
  • stiff neck or back
  • stomach pain, continuing
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • trouble swallowing
  • vomiting

Managing side effects (general information)

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, Summit, NJ.

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.

Medical Disclaimer