Drug · FAERS side-effect profile with label screen
Ozanimod side effects: what 8,228 FDA adverse event reports show
Drug class
Sphingosine 1-phosphate receptor modulator
FDA label, Indications wording of the closest related product
Label matched
Ozanimod Hydrochloride (Zeposia)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
8,228 reports · 27% serious · 87 with death outcome · 71% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. moderately to severely active ulcerative colitis (UC) in adults.
FDA label, Indications and Usage
What it is
ZEPOSIA contains ozanimod, a sphingosine 1-phosphate receptor modulator and is supplied as ozanimod hydrochloride (HCl).
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 4Lab value / disease marker 4Not in label — unassessed 25
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 601 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Magnetic resonance imaging head abnormal | 10 | 40.0 21.4–74.6ROR 40.0 · χ² 337 / p 2e-75 | 36.8 EB05 21.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Lymphocyte count abnormal | 10 | 22.7 12.2–42.2ROR 22.7 · χ² 184 / p 3e-42 | 21.3 EB05 11.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=2 | no trial data cached |
| Multiple sclerosis relapse | 585 | 21.7 20.0–23.4ROR 23.2 · χ² 11,452 / p <1e-300 | 21.5 EB05 20.1 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.7 | no trial data cached |
| Lymphocyte count decreased | 117 | 16.9 14.1–20.3ROR 17.1 · χ² 1,725 / p <1e-300 | 16.8 EB05 14.3 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 9.4 | no trial data cached |
| Lymphopenia | 88 | 16.0 13.0–19.7ROR 16.1 · χ² 1,214 / p 3e-266 | 15.8 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · 92% clinician | no trial data cached |
| Colitis ulcerative | 257 | 14.7 13.0–16.6ROR 15.2 · χ² 3,259 / p <1e-300 | 14.6 EB05 13.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.1 · ♀ 47% (drug 71%) | no trial data cached |
| Macular oedema | 29 | 13.2 9.2–19.0ROR 13.3 · χ² 314 / p 2e-70 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=29 | no trial data cached |
| Multiple sclerosis | 176 | 9.3 8.1–10.8ROR 9.5 · χ² 1,299 / p 1e-284 | 9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.7 | no trial data cached |
| Loss of therapeutic response | 11 | 9.3 5.1–16.8ROR 9.3 · χ² 73 / p 7e-18 | 7.4 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Feeling of despair | 14 | 7.7 4.5–12.9ROR 7.7 · χ² 74 / p 3e-18 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Bladder disorder | 29 | 7.4 5.2–10.7ROR 7.4 · χ² 154 / p 1e-35 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Product distribution issue | 23 | 6.6 4.4–9.9ROR 6.6 · χ² 104 / p 1e-24 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=3 · 74% consumer | no trial data cached |
| Optic neuritis | 23 | 6.4 4.3–9.7ROR 6.4 · χ² 100 / p 9e-24 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · ♀ 91% (drug 71%) | no trial data cached |
| Insurance issue | 37 | 6.3 4.6–8.7ROR 6.4 · χ² 161 / p 4e-37 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Heart rate decreased | 87 | 6.3 5.1–7.7ROR 6.3 · χ² 380 / p 6e-85 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Defaecation urgency | 17 | 6.2 3.9–10.0ROR 6.2 · χ² 69 / p 5e-17 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Decreased interest | 14 | 6.0 3.6–10.2ROR 6.0 · χ² 54 / p 1e-13 | 5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Bowel movement irregularity | 18 | 6.0 3.8–9.5ROR 6.0 · χ² 70 / p 3e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cardiac flutter | 14 | 5.5 3.3–9.3ROR 5.5 · χ² 47 / p 3e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Peroneal nerve palsy | 12 | 5.4 3.0–9.5ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| General physical condition abnormal | 14 | 5.2 3.1–8.9ROR 5.3 · χ² 44 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious n=2 | no trial data cached |
| Adverse event | 189 | 5.2 4.5–6.0ROR 5.3 · χ² 642 / p 7e-142 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | no trial data cached |
| Hepatic enzyme abnormal | 10 | 5.1 2.7–9.5ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Central nervous system lesion | 26 | 4.8 3.3–7.0ROR 4.8 · χ² 74 / p 4e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Brain fog | 26 | 4.5 3.1–6.7ROR 4.5 · χ² 68 / p 8e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Concussion | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Disturbance in attention | 88 | 4.1 3.4–5.1ROR 4.2 · χ² 206 / p 4e-47 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 92% clinician | no trial data cached |
| Diarrhoea haemorrhagic | 15 | 4.1 2.5–6.8ROR 4.1 · χ² 32 / p 9e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Urinary incontinence | 46 | 3.9 3.0–5.3ROR 4.0 · χ² 98 / p 2e-23 | 3.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Affective disorder | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 8e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Multiple allergies | 12 | 3.9 2.2–6.8ROR 3.9 · χ² 23 / p 8e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Haematochezia (blood in stool) | 81 | 3.7 3.0–4.6ROR 3.8 · χ² 160 / p 6e-37 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 44% (drug 71%) | no trial data cached |
| Neuralgia | 33 | 3.5 2.5–4.9ROR 3.5 · χ² 55 / p 5e-14 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Abnormal faeces | 11 | 3.4 1.9–6.2ROR 3.4 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious n=8 | no trial data cached |
| Balance disorder | 116 | 3.4 2.8–4.1ROR 3.4 · χ² 195 / p 1e-44 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Product dose omission in error | 35 | 3.3 2.4–4.6ROR 3.3 · χ² 54 / p 9e-14 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · ♀ 45% (drug 71%) · 82% consumer | no trial data cached |
| Muscle spasticity | 16 | 3.3 2.0–5.4ROR 3.3 · χ² 23 / p 8e-7 | 3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Product dose omission issue | 366 | 3.3 3.0–3.6ROR 3.4 · χ² 581 / p 1e-128 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Dizziness postural | 12 | 3.2 1.8–5.6ROR 3.2 · χ² 16 / p 4e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | – | no trial data cached |
| Hepatic enzyme increased | 84 | 3.1 2.5–3.9ROR 3.2 · χ² 121 / p 2e-28 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 762 | 2.5 2.3–2.7ROR 2.6 · χ² 705 / p 1e-155 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Multiple sclerosis relapse | 585 | 21.7 20.0–23.4ROR 23.2 · χ² 11,452 / p <1e-300 | 21.5 EB05 20.1 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.7 | no trial data cached |
| Drug ineffective (drug did not work) | 547 | 1.1 1.0–1.1ROR 1.1 · χ² 2 / p 0.101 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Headache | 515 | 2.1 1.9–2.3ROR 2.2 · χ² 300 / p 1e-67 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Product dose omission issue | 366 | 3.3 3.0–3.6ROR 3.4 · χ² 581 / p 1e-128 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Dizziness | 350 | 1.8 1.6–2.0ROR 1.8 · χ² 123 / p 6e-29 | 1.8 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Nausea | 285 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.073 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Diarrhoea (diarrhea) | 262 | 1.0 0.9–1.2ROR 1.0 · χ² 0 / p 0.299 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Colitis ulcerative | 257 | 14.7 13.0–16.6ROR 15.2 · χ² 3,259 / p <1e-300 | 14.6 EB05 13.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.1 · ♀ 47% (drug 71%) | no trial data cached |
| Pain | 254 | 1.0 0.9–1.2ROR 1.1 · χ² 1 / p 0.231 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Back pain | 215 | 2.4 2.1–2.7ROR 2.4 · χ² 167 / p 2e-38 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Adverse event | 189 | 5.2 4.5–6.0ROR 5.3 · χ² 642 / p 7e-142 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | no trial data cached |
| Fall | 183 | 1.4 1.2–1.6ROR 1.4 · χ² 21 / p 3e-6 | 1.4 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Multiple sclerosis | 176 | 9.3 8.1–10.8ROR 9.5 · χ² 1,299 / p 1e-284 | 9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 155 | 0.7 0.6–0.8ROR 0.7 · χ² 21 / p 2e-6 | 0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Lymphopenia — n=88, PRR 16.0
- Bladder disorder — n=29, PRR 7.4
- Optic neuritis — n=23, PRR 6.4
- Insurance issue — n=37, PRR 6.3
- Central nervous system lesion — n=26, PRR 4.8
- Disturbance in attention — n=88, PRR 4.1
- Urinary incontinence — n=46, PRR 3.9
- Haematochezia — n=81, PRR 3.7
- Neuralgia — n=33, PRR 3.5
- Balance disorder — n=116, PRR 3.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ozanimod?
In FDA FAERS, the most frequently co-reported reaction terms for Ozanimod are fatigue, multiple sclerosis relapse, headache, dizziness, nausea, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ozanimod have an FDA boxed warning?
No. The FDA label retrieved for Ozanimod has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ozanimod causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 93ce2fab-edfb-4804-8074-963071de51e4, effective 20260416; matched on
openfda.generic_name.exact:"OZANIMOD HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 641 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.