What the label lists and what reports show
Ozanimod side effects
Ozanimod's FDA label: “Most common adverse reactions (incidence ≥4%) are: Multiple Sclerosis: upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.” FAERS holds 8,256 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (762 reports).
- No generic listed
Check it at the source: the ozanimod FDA label on DailyMed (effective April 16, 2026, Celgene Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZEPOSIA?ZEPOSIA may cause serious side effects, including: See "What is the most important information I should know about ZEPOSIA?" liver problems. ZEPOSIA may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA and periodically during treatment. Call your healthcare provider right away if you have any of the following symptoms: unexplained nausea vomiting stomach area (abdominal) pain tiredness loss of appetite yellowing of the whites of your eyes or skin dark colored urine increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. See " How should I take ZEPOSIA? " section for more information. breathing problems. Some people who take ZEPOSIA have shortness of breath. […]
Source: FDA drug label, NDA209899 (Bristol), as published by Celgene Corporation, effective April 16, 2026 (SPL set 93ce2fab-edfb-4804-8074-963071de51e4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥4%) are: Multiple Sclerosis: upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
Table 2: Adverse Reactions with an Incidence of at Least 2% in ZEPOSIA-Treated Patients and at Least 1% Greater than IFN beta-1a in Patients with Multiple Sclerosis (Pooled MS Study 1 and Study 2) a
| Reaction | Adverse Reactions ZEPOSIA 0.92 mg Once Daily e (n=882) % | MS Studies 1 and 2 IFN beta-1a 30 mcg Intramuscularly Once Weekly (n=885) % |
|---|---|---|
| Upper respiratory infection b | 26 | 23 |
| Hepatic transaminase elevation c | 10 | 5 |
| Orthostatic hypotension | 4 | 3 |
| Urinary tract infection | 4 | 3 |
| Back pain | 4 | 3 |
| Hypertension d | 4 | 2 |
| Upper abdominal pain | 2 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.2) ] Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] Fetal Risk [see Warnings and Precautions (5.5) ] Increased Blood Pressure [see Warnings and Precautions (5.6) ] Respiratory Effects [see Warnings and Precautions (5.7) ] Macular Edema [see Warnings and Precautions (5.8) ] Cutaneous Malignancies [see Warnings and Precautions (5.9) ] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.10) ] Unintended Additive Immunosuppressive Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs [see Warnings and Precautions (5.11) ] Severe Increase in Multiple Sclerosis Disability after Stopping ZEPOSIA [see Warnings and Precautions (5.12) ] Immune System Effects after Stopping ZEPOSIA [see Warnings and Precautions (5.13) ] Most common adverse reactions (incidence ≥4%) are: Multiple Sclerosis: upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. ( 6.1 ) Ulcerative Colitis: liver test increased, upper respiratory infection, and headache.
Source: FDA drug label, NDA209899 (Bristol), as published by Celgene Corporation, effective April 16, 2026 (SPL set 93ce2fab-edfb-4804-8074-963071de51e4), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,256 reports list ozanimod among the medicines taken, each a report of something that happened, not proof the medicine caused it; 87 are coded as a death and 604 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (1,903, against a median of 243 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ozanimod: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions