Drug · FAERS side-effect profile with label screen
Fingolimod side effects: what 4,418 FDA adverse event reports show
Drug class
Sphingosine 1-phosphate receptor modulator
FDA label, Indications wording
Who reports
4,418 reports · 84% serious · 131 with death outcome · 72% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Fingolimod capsules are 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 patients 10 years of age and older. Fi.
FDA label, Indications and Usage
What it is
Fingolimod is a sphingosine 1-phosphate receptor modulator.
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 8Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 21
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. 97 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 |
|---|---|---|---|---|---|---|
| Lymphopenia | 449 | 156.5 143.1–171.1ROR 174.1 · χ² 67,018 / p <1e-300 | 150.5 EB05 139.2 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 81.0 · 96% clinician | no trial data cached |
| Lymphocyte count decreased | 150 | 40.6 34.7–47.5ROR 42.0 · χ² 5,708 / p <1e-300 | 40.1 EB05 35.0 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 25.5 | no trial data cached |
| Rebound effect | 96 | 40.5 33.2–49.4ROR 41.4 · χ² 3,631 / p <1e-300 | 39.9 EB05 33.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 43.4 · 98% clinician | no trial data cached |
| Multiple sclerosis relapse | 495 | 34.2 31.5–37.2ROR 38.4 · χ² 15,870 / p <1e-300 | 33.9 EB05 31.5 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.6 | no trial data cached |
| Multiple sclerosis | 275 | 27.3 24.3–30.6ROR 29.1 · χ² 6,918 / p <1e-300 | 27.1 EB05 24.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 27.2 | no trial data cached |
| Central nervous system lesion | 77 | 26.6 21.3–33.2ROR 27.0 · χ² 1,860 / p <1e-300 | 26.3 EB05 21.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 | no trial data cached |
| Basal cell carcinoma | 60 | 18.3 14.2–23.5ROR 18.5 · χ² 961 / p 3e-211 | 18.1 EB05 14.6 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Decreased immune responsiveness | 37 | 18.0 13.1–24.9ROR 18.2 · χ² 576 / p 1e-127 | 17.8 EB05 13.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · 92% clinician | no trial data cached |
| Hemiparesis | 62 | 17.3 13.5–22.2ROR 17.6 · χ² 935 / p 1e-205 | 17.2 EB05 13.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 97% clinician | no trial data cached |
| Ataxia | 43 | 17.2 12.8–23.1ROR 17.3 · χ² 637 / p 6e-141 | 17.0 EB05 13.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Malignant melanoma | 37 | 13.1 9.5–18.1ROR 13.2 · χ² 401 / p 1e-89 | 12.8 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Gamma-glutamyltransferase increased | 51 | 10.9 8.3–14.4ROR 11.1 · χ² 450 / p 4e-100 | 10.6 EB05 8.2 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.3 | no trial data cached |
| Squamous cell carcinoma | 21 | 10.6 6.9–16.2ROR 10.6 · χ² 173 / p 9e-40 | 9.6 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 100% clinician | no trial data cached |
| Covid-19 pneumonia | 26 | 10.4 7.1–15.3ROR 10.5 · χ² 211 / p 4e-48 | 9.6 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 50% (drug 72%) | no trial data cached |
| Micturition urgency | 24 | 10.1 6.8–15.0ROR 10.1 · χ² 187 / p 8e-43 | 9.2 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · 92% clinician | no trial data cached |
| Immunodeficiency | 29 | 9.4 6.5–13.5ROR 9.4 · χ² 208 / p 2e-47 | 8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 97% clinician | no trial data cached |
| Sensory disturbance | 30 | 8.8 6.2–12.6ROR 8.9 · χ² 201 / p 7e-46 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Motor dysfunction | 17 | 8.0 5.0–12.8ROR 8.0 · χ² 97 / p 4e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Paralysis | 23 | 7.6 5.1–11.4ROR 7.6 · χ² 125 / p 2e-29 | 6.8 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Coordination abnormal | 22 | 7.4 4.9–11.3ROR 7.5 · χ² 116 / p 2e-27 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Muscle spasticity | 17 | 6.5 4.1–10.5ROR 6.5 · χ² 74 / p 4e-18 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Skin cancer | 28 | 6.2 4.3–8.9ROR 6.2 · χ² 116 / p 2e-27 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Aphasia (loss of speech) | 39 | 6.1 4.5–8.4ROR 6.2 · χ² 162 / p 2e-37 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Disease recurrence | 60 | 6.0 4.6–7.7ROR 6.0 · χ² 244 / p 3e-55 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · 90% clinician | no trial data cached |
| Skin lesion | 33 | 5.8 4.1–8.1ROR 5.8 · χ² 125 / p 2e-29 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Ovarian cancer | 11 | 5.6 3.1–10.2ROR 5.7 · χ² 37 / p 5e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Hyperbilirubinaemia | 12 | 5.5 3.1–9.7ROR 5.5 · χ² 40 / p 1e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Leukopenia (low white blood cells) | 56 | 5.3 4.1–6.9ROR 5.4 · χ² 193 / p 3e-44 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 95% clinician | no trial data cached |
| Lymphoma | 17 | 5.2 3.2–8.4ROR 5.2 · χ² 54 / p 1e-13 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Gastrointestinal carcinoma | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 30 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Urosepsis | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 29 / p 3e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Diarrhoea haemorrhagic | 10 | 5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Status epilepticus | 12 | 5.0 2.9–8.9ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Vasculitis | 12 | 4.9 2.8–8.6ROR 4.9 · χ² 33 / p 4e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Covid-19 | 159 | 4.3 3.7–5.0ROR 4.4 · χ² 398 / p 9e-89 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Alanine aminotransferase increased | 54 | 4.2 3.2–5.4ROR 4.2 · χ² 127 / p 7e-30 | 4.0 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 · 94% clinician | no trial data cached |
| Cognitive disorder | 40 | 4.1 3.0–5.6ROR 4.1 · χ² 90 / p 1e-21 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Exposure during pregnancy | 53 | 4.0 3.1–5.3ROR 4.1 · χ² 119 / p 6e-28 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · ♀ 100% (drug 72%) · 98% clinician | no trial data cached |
| Osteomyelitis | 15 | 3.9 2.4–6.5ROR 3.9 · χ² 30 / p 2e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Foetal exposure during pregnancy | 66 | 3.9 3.0–4.9ROR 3.9 · χ² 137 / p 5e-32 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Multiple sclerosis relapse | 495 | 34.2 31.5–37.2ROR 38.4 · χ² 15,870 / p <1e-300 | 33.9 EB05 31.5 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.6 | no trial data cached |
| Lymphopenia | 449 | 156.5 143.1–171.1ROR 174.1 · χ² 67,018 / p <1e-300 | 150.5 EB05 139.2 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 81.0 · 96% clinician | no trial data cached |
| Multiple sclerosis | 275 | 27.3 24.3–30.6ROR 29.1 · χ² 6,918 / p <1e-300 | 27.1 EB05 24.5 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 27.2 | no trial data cached |
| Covid-19 | 159 | 4.3 3.7–5.0ROR 4.4 · χ² 398 / p 9e-89 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Lymphocyte count decreased | 150 | 40.6 34.7–47.5ROR 42.0 · χ² 5,708 / p <1e-300 | 40.1 EB05 35.0 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 25.5 | no trial data cached |
| Hypoaesthesia (numbness) | 107 | 3.4 2.8–4.1ROR 3.4 · χ² 179 / p 4e-41 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Gait disturbance | 98 | 2.4 2.0–2.9ROR 2.5 · χ² 81 / p 1e-19 | 2.4 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Rebound effect | 96 | 40.5 33.2–49.4ROR 41.4 · χ² 3,631 / p <1e-300 | 39.9 EB05 33.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 43.4 · 98% clinician | no trial data cached |
| Paraesthesia (tingling/numbness) | 83 | 2.5 2.0–3.1ROR 2.5 · χ² 74 / p 5e-18 | 2.5 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Disease progression | 81 | 3.3 2.6–4.0ROR 3.3 · χ² 125 / p 2e-29 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · ♀ 49% (drug 72%) · 91% clinician | no trial data cached |
| Central nervous system lesion | 77 | 26.6 21.3–33.2ROR 27.0 · χ² 1,860 / p <1e-300 | 26.3 EB05 21.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 | no trial data cached |
| Breast cancer | 72 | 3.6 2.9–4.6ROR 3.7 · χ² 135 / p 1e-31 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · ♀ 100% (drug 72%) · 94% clinician | no trial data cached |
| Foetal exposure during pregnancy | 66 | 3.9 3.0–4.9ROR 3.9 · χ² 137 / p 5e-32 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 95% clinician | no trial data cached |
| Hemiparesis | 62 | 17.3 13.5–22.2ROR 17.6 · χ² 935 / p 1e-205 | 17.2 EB05 13.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 97% clinician | no trial data cached |
| Disease recurrence | 60 | 6.0 4.6–7.7ROR 6.0 · χ² 244 / p 3e-55 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · 90% clinician | 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.
- Rebound effect — n=96, PRR 40.5
- Central nervous system lesion — n=77, PRR 26.6
- Decreased immune responsiveness — n=37, PRR 18.0
- Hemiparesis — n=62, PRR 17.3
- Ataxia — n=43, PRR 17.2
- Covid-19 pneumonia — n=26, PRR 10.4
- Micturition urgency — n=24, PRR 10.1
- Immunodeficiency — n=29, PRR 9.4
- Sensory disturbance — n=30, PRR 8.8
- Paralysis — n=23, PRR 7.6
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 Fingolimod?
In FDA FAERS, the most frequently co-reported reaction terms for Fingolimod are multiple sclerosis relapse, lymphopenia, multiple sclerosis, covid-19, lymphocyte count decreased, hypoaesthesia. 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 Fingolimod have an FDA boxed warning?
No. The FDA label retrieved for Fingolimod has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fingolimod 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 5434bd4a-2610-0e17-4f14-513ff1cbb822, effective 20260610; matched on
openfda.generic_name.exact:"FINGOLIMOD") - 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, 137 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.