Ozanimod Side Effects
Applies to ozanimod: oral capsule.
Serious side effects of Ozanimod
Along with its needed effects, ozanimod 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
- change in size, shape, or color of existing mole
- changes in vision
- chest pain, tightness, or discomfort
- clear or bloody discharge from nipple
- difficulty in moving
- dimpling of breast skin
- drowsiness
- hives, itching, or skin rash
- inverted nipple
- irritation
- joint pain, stiffness, or swelling
- lump in the breast or under the arm
- mole that leaks fluid or bleeds
- muscle pain or stiffness
- nausea
- new mole
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- persistent crusting or scaling of nipple
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- redness of the skin
- redness or swelling of the breast
- seizures
- severe headache
- shiny bump
- sore on the skin of the breast that does not heal
- stiff neck or back
- stomach pain, continuing
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- trouble swallowing
- vomiting
- white, yellow or waxy scar-like area
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
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More about ozanimod
- Check interactions
- Compare alternatives
- Reviews (6)
- Dosage information
- Patient tips
- During pregnancy
- Drug class: selective immunosuppressants
- Breastfeeding
- En español
Patient resources
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Professional resources
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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.
