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Ozanimod Side Effects

Medically reviewed by Drugs.com. Last updated on April 20, 2020.

For the Consumer

Applies to ozanimod: oral capsule

Warning

You should not use ozanimod if you have a serious heart condition such as "AV block" or sick sinus syndrome and no pacemaker, or if you've recently had heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke. You also should not use ozanimod if you have severe untreated sleep apnea.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod.

Ozanimod can slow your heart rate when you start taking it. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, rash, painful and frequent urination, confusion, neck stiffness, or increased sensitivity to light. Your risk of infection could last for 3 months after you stop taking this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats;

  • a light-headed feeling, like you might pass out;

  • cough, new or worsening shortness of breath;

  • sudden confusion, severe headache, or vision loss;

  • a seizure;

  • pounding in your neck or ears;

  • liver problems--nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

  • changes in vision--blurred vision, increased sensitivity to light, seeing an unusual color in your vision, or having a blind spot or shadows in the center of your vision; or

  • symptoms of infection--fever, tiredness, cough, rash, increased urination, pain or burning when you urinate, neck stiffness, increased sensitivity to light.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

Very common (10% or more): Common (1% to 10%): Back pain[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

Rare (0.01% to 0.1%): Progressive multifocal leukoencephalopathy (PML)[Ref]

Cardiovascular

Common (1% to 10%): Hypertension (e.g., hypertension, essential hypertension, orthostatic hypertension)

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%): Abdominal pain upper[Ref]

References

1. "Product Information. Zeposia (ozanimod)." Celgene Corporation, Summit, NJ.

Frequently asked questions

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.