Drug · FAERS side-effect profile with label screen
Fingolimod Hydrochloride side effects: what 4,929 FDA adverse event reports show
Drug class
Sphingosine 1-phosphate receptor modulator
FDA label, Indications wording
Who reports
4,929 reports · 85% serious · 146 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) 4Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 22
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. 145 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 | 475 | 148.7 136.3–162.2ROR 164.4 · χ² 67,190 / p <1e-300 | 142.8 EB05 132.3 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 77.2 · 96% clinician | no trial data cached |
| Lymphocyte count decreased | 195 | 47.4 41.3–54.5ROR 49.3 · χ² 8,723 / p <1e-300 | 46.7 EB05 41.5 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 31.4 | no trial data cached |
| Multiple sclerosis relapse | 597 | 37.1 34.4–40.0ROR 42.0 · χ² 20,793 / p <1e-300 | 36.7 EB05 34.3 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.8 | no trial data cached |
| Rebound effect | 97 | 36.7 30.1–44.7ROR 37.4 · χ² 3,305 / p <1e-300 | 36.1 EB05 30.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 38.7 · 98% clinician | no trial data cached |
| Multiple sclerosis | 330 | 29.4 26.5–32.6ROR 31.4 · χ² 8,983 / p <1e-300 | 29.2 EB05 26.6 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 28.8 | no trial data cached |
| Central nervous system lesion | 94 | 29.1 23.8–35.6ROR 29.7 · χ² 2,507 / p <1e-300 | 28.8 EB05 24.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 26.4 | no trial data cached |
| Ataxia | 55 | 19.7 15.2–25.7ROR 19.9 · χ² 955 / p 6e-210 | 19.5 EB05 15.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Decreased immune responsiveness | 42 | 18.4 13.6–24.8ROR 18.5 · χ² 669 / p 6e-148 | 18.1 EB05 13.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Hemiparesis | 71 | 17.8 14.1–22.4ROR 18.0 · χ² 1,104 / p 2e-242 | 17.6 EB05 14.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 94% clinician | no trial data cached |
| Basal cell carcinoma | 62 | 17.0 13.2–21.7ROR 17.2 · χ² 912 / p 1e-200 | 16.8 EB05 13.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Gamma-glutamyltransferase increased | 63 | 12.1 9.5–15.5ROR 12.3 · χ² 630 / p 2e-139 | 11.9 EB05 9.5 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 | no trial data cached |
| Malignant melanoma | 37 | 11.8 8.5–16.2ROR 11.8 · χ² 353 / p 5e-79 | 11.3 EB05 8.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Sensory disturbance | 42 | 11.1 8.2–15.0ROR 11.2 · χ² 375 / p 6e-84 | 10.7 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Immunodeficiency | 38 | 11.0 8.0–15.1ROR 11.1 · χ² 335 / p 4e-75 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Covid-19 pneumonia | 28 | 10.0 6.9–14.5ROR 10.1 · χ² 219 / p 9e-50 | 9.3 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 48% (drug 72%) | no trial data cached |
| Squamous cell carcinoma | 22 | 10.0 6.6–15.1ROR 10.0 · χ² 168 / p 1e-38 | 9.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 95% clinician | no trial data cached |
| Coordination abnormal | 32 | 9.7 6.9–13.7ROR 9.8 · χ² 241 / p 1e-54 | 9.0 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Micturition urgency | 25 | 9.4 6.4–13.9ROR 9.4 · χ² 179 / p 4e-41 | 8.5 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 92% clinician | no trial data cached |
| Muscle spasticity | 24 | 8.2 5.5–12.3ROR 8.3 · χ² 145 / p 9e-34 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Paralysis | 27 | 8.0 5.5–11.7ROR 8.0 · χ² 158 / p 1e-36 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Motor dysfunction | 18 | 7.6 4.8–12.0ROR 7.6 · χ² 96 / p 5e-23 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Ligament sprain | 16 | 6.9 4.2–11.3ROR 6.9 · χ² 75 / p 2e-18 | 5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Aphasia (loss of speech) | 47 | 6.6 5.0–8.8ROR 6.7 · χ² 218 / p 1e-49 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Skin cancer | 32 | 6.3 4.5–8.9ROR 6.4 · χ² 138 / p 3e-32 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Skin lesion | 37 | 5.8 4.2–8.0ROR 5.8 · χ² 142 / p 5e-33 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Disease recurrence | 61 | 5.4 4.2–7.0ROR 5.5 · χ² 217 / p 2e-49 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Leukopenia (low white blood cells) | 63 | 5.4 4.2–6.9ROR 5.4 · χ² 220 / p 4e-50 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 92% clinician | no trial data cached |
| Hyperbilirubinaemia | 13 | 5.4 3.1–9.3ROR 5.4 · χ² 42 / p 5e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Status epilepticus | 14 | 5.3 3.1–8.9ROR 5.3 · χ² 44 / p 1e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Lymphoma | 19 | 5.2 3.3–8.2ROR 5.2 · χ² 61 / p 3e-15 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Gastrointestinal carcinoma | 11 | 5.1 2.8–9.2ROR 5.1 · χ² 32 / p 7e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Urosepsis | 11 | 5.1 2.8–9.2ROR 5.1 · χ² 32 / p 7e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Ovarian cancer | 11 | 5.1 2.8–9.1ROR 5.1 · χ² 32 / p 8e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Neutrophil count increased | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 34 / p 3e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.2 | no trial data cached |
| Glomerular filtration rate decreased | 14 | 4.9 2.9–8.3ROR 4.9 · χ² 40 / p 1e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 | no trial data cached |
| Bladder disorder | 11 | 4.7 2.6–8.5ROR 4.7 · χ² 28 / p 5e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Diarrhoea haemorrhagic | 10 | 4.5 2.4–8.4ROR 4.6 · χ² 24 / p 4e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Hypoaesthesia (numbness) | 157 | 4.5 3.8–5.2ROR 4.6 · χ² 421 / p 9e-94 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Incontinence | 11 | 4.4 2.4–8.0ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Vasculitis | 12 | 4.4 2.5–7.7ROR 4.4 · χ² 28 / p 6e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | 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 | 597 | 37.1 34.4–40.0ROR 42.0 · χ² 20,793 / p <1e-300 | 36.7 EB05 34.3 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.8 | no trial data cached |
| Lymphopenia | 475 | 148.7 136.3–162.2ROR 164.4 · χ² 67,190 / p <1e-300 | 142.8 EB05 132.3 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 77.2 · 96% clinician | no trial data cached |
| Multiple sclerosis | 330 | 29.4 26.5–32.6ROR 31.4 · χ² 8,983 / p <1e-300 | 29.2 EB05 26.6 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 28.8 | no trial data cached |
| Lymphocyte count decreased | 195 | 47.4 41.3–54.5ROR 49.3 · χ² 8,723 / p <1e-300 | 46.7 EB05 41.5 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 31.4 | no trial data cached |
| Covid-19 | 172 | 4.1 3.6–4.8ROR 4.3 · χ² 409 / p 3e-91 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Gait disturbance | 161 | 3.6 3.1–4.2ROR 3.7 · χ² 298 / p 5e-67 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Hypoaesthesia (numbness) | 157 | 4.5 3.8–5.2ROR 4.6 · χ² 421 / p 9e-94 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Paraesthesia (tingling/numbness) | 117 | 3.2 2.6–3.8ROR 3.2 · χ² 172 / p 2e-39 | 3.1 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Urinary tract infection (bladder infection) | 97 | 2.4 2.0–3.0ROR 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 1.8 | no trial data cached |
| Rebound effect | 97 | 36.7 30.1–44.7ROR 37.4 · χ² 3,305 / p <1e-300 | 36.1 EB05 30.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 38.7 · 98% clinician | no trial data cached |
| Muscular weakness | 94 | 3.5 2.9–4.3ROR 3.6 · χ² 168 / p 1e-38 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Central nervous system lesion | 94 | 29.1 23.8–35.6ROR 29.7 · χ² 2,507 / p <1e-300 | 28.8 EB05 24.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 26.4 | no trial data cached |
| Visual impairment | 84 | 2.9 2.4–3.6ROR 2.9 · χ² 104 / p 1e-24 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Disease progression | 84 | 3.0 2.5–3.7ROR 3.1 · χ² 113 / p 1e-26 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · ♀ 49% (drug 72%) · 92% clinician | no trial data cached |
| Breast cancer | 77 | 3.5 2.8–4.3ROR 3.5 · χ² 134 / p 2e-31 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 · ♀ 100% (drug 72%) · 95% 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=97, PRR 36.7
- Central nervous system lesion — n=94, PRR 29.1
- Ataxia — n=55, PRR 19.7
- Decreased immune responsiveness — n=42, PRR 18.4
- Hemiparesis — n=71, PRR 17.8
- Sensory disturbance — n=42, PRR 11.1
- Immunodeficiency — n=38, PRR 11.0
- Covid-19 pneumonia — n=28, PRR 10.0
- Coordination abnormal — n=32, PRR 9.7
- Micturition urgency — n=25, PRR 9.4
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 Fingolimod?
In FDA FAERS, the most frequently co-reported reaction terms for Fingolimod are multiple sclerosis relapse, lymphopenia, multiple sclerosis, lymphocyte count decreased, covid-19, gait disturbance. 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, 185 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.