Fingolimod HCL side effects: what 85,986 FDA adverse event reports show

Fingolimod Hcl · 1,216 reaction terms · 281,312 drug–reaction co-reports · data 2026-09-14

Drug class

Sphingosine 1-phosphate receptor modulator

FDA label, Indications wording

Who reports

85,986 reports · 51% serious · 1,246 with death outcome · 78% 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 3Labeled (related wording) 7Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 11Not in label — unassessed 14

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,176 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Expanded disability status scale	45	347.9 220.2–549.7ROR 348.1 · calibrated p 2e-11 ✓	134.5 EB05 104.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=32	not reported in cached trials
Tumefactive multiple sclerosis	99	338.9 249.6–460.3ROR 339.3 · calibrated p 8e-12 ✓	137.3 EB05 116.1 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=98 · 100% clinician	not reported in cached trials
Expanded disability status scale score increased	672	289.1 258.5–323.4ROR 291.4 · calibrated p 1e-11 ✓	131.1 EB05 123.0 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious n=670	not reported in cached trials
Jc virus test positive	238	94.4 81.3–109.7ROR 94.7 · calibrated p 2e-7 ✓	67.7 EB05 60.8 · IC025 +5.7 3/3 methods agree	Lab value / disease marker	serious n=172	NCT00340834: 1/420 (0.2%) on Fingolimod (serious AE)
Jc polyomavirus test positive	276	74.7 65.2–85.4ROR 74.9 · calibrated p 1e-6 ✓	56.9 EB05 51.5 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	serious n=234	not reported in cached trials
Central nervous system lesion	2,900	64.7 62.1–67.3ROR 66.9 · calibrated p 2e-6 ✓	51.1 EB05 49.6 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 62.9	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Lymphocyte count decreased	3,552	61.2 59.0–63.5ROR 63.8 · calibrated p 3e-6 ✓	49.0 EB05 47.6 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	age-adj. PRR 53.4 · serious PRR 48.0	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Gait spastic	67	58.2 44.6–76.0ROR 58.2 · calibrated p 7e-6 ✓	46.4 EB05 37.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=60	not reported in cached trials
Cryptococcal cutaneous infection	32	56.0 38.1–82.2ROR 56.0 · calibrated p 1e-5 ✓	44.4 EB05 33.0 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=32 · 100% clinician	not reported in cached trials
Cd8 lymphocytes decreased	34	49.4 34.1–71.4ROR 49.4 · calibrated p 3e-5 ✓	40.3 EB05 30.1 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=27 · ♀ 100% (drug 78%) · 100% clinician	not reported in cached trials
Decreased vibratory sense	57	49.3 37.1–65.6ROR 49.3 · calibrated p 2e-5 ✓	40.6 EB05 32.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 54% (drug 78%)	not reported in cached trials
Relapsing-remitting multiple sclerosis	141	47.5 39.7–56.9ROR 47.6 · calibrated p 2e-5 ✓	39.6 EB05 34.4 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=135	not reported in cached trials
Macular oedema	863	44.4 41.3–47.7ROR 44.8 · calibrated p 3e-5 ✓	37.6 EB05 35.5 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=813	NCT00340834: 1/504 (0.2%) on Fingolimod (serious AE)
Secondary progressive multiple sclerosis	291	44.1 39.0–50.0ROR 44.3 · calibrated p 3e-5 ✓	37.3 EB05 33.9 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=283	NCT01201356: 2/4,083 (0.0%) on Fingolimod (serious AE)
Fibrous histiocytoma	54	43.6 32.6–58.2ROR 43.6 · calibrated p 4e-5 ✓	36.6 EB05 29.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=41 · 100% clinician	not reported in cached trials
Haemangioma of skin	64	41.7 32.0–54.3ROR 41.7 · calibrated p 5e-5 ✓	35.3 EB05 28.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=50 · 100% clinician	not reported in cached trials
Lentigo	71	40.4 31.4–52.0ROR 40.4 · calibrated p 6e-5 ✓	34.4 EB05 28.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=53 · 100% clinician	not reported in cached trials
Drug monitoring procedure not performed	238	37.5 32.8–43.0ROR 37.7 · calibrated p 8e-5 ✓	32.5 EB05 29.2 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious n=57 · 72% consumer	not reported in cached trials
Lymphopenia	1,652	32.4 30.8–34.1ROR 33.0 · calibrated p 2e-4 ✓	28.6 EB05 27.5 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 33.3 · serious PRR 28.4	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Multiple sclerosis relapse	7,732	30.6 29.9–31.3ROR 33.6 · calibrated p 1e-4 ✓	27.3 EB05 26.8 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 19.0 · serious PRR 39.4	NCT01201356: 34/4,083 (0.8%) on Fingolimod (serious AE)
Relapsing multiple sclerosis	34	30.4 21.3–43.4ROR 30.4 · calibrated p 4e-4 ✓	26.7 EB05 20.0 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=33	NCT00340834: 1/504 (0.2%) on Fingolimod (serious AE)
Basophil count decreased	29	29.6 20.1–43.5ROR 29.6 · calibrated p 5e-4 ✓	26.0 EB05 19.0 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=26 · ♀ 100% (drug 78%) · 100% clinician	not reported in cached trials
Lymphocyte count abnormal	114	27.3 22.5–33.1ROR 27.3 · calibrated p 5e-4 ✓	24.5 EB05 21.0 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=84	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Dysplastic naevus	36	27.1 19.2–38.3ROR 27.1 · calibrated p 6e-4 ✓	24.2 EB05 18.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=30 · 100% clinician	not reported in cached trials
Molluscum contagiosum	53	26.8 20.2–35.6ROR 26.8 · calibrated p 6e-4 ✓	24.0 EB05 19.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=38 · 100% clinician	not reported in cached trials
Seborrhoeic keratosis	141	25.9 21.7–30.8ROR 25.9 · calibrated p 6e-4 ✓	23.4 EB05 20.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=98 · 100% clinician	not reported in cached trials
Delivery	60	24.2 18.6–31.6ROR 24.2 · calibrated p 1e-3 ✓	21.9 EB05 17.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 100% (drug 78%)	not reported in cached trials
Lymphocyte percentage decreased	116	22.9 18.9–27.7ROR 22.9 · calibrated p 0.001 ✓	20.9 EB05 17.9 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=108	not reported in cached trials
Atrioventricular block first degree	364	22.1 19.9–24.7ROR 22.2 · calibrated p 0.001 ✓	20.3 EB05 18.6 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious n=209	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Optic neuritis	747	21.7 20.1–23.4ROR 21.9 · calibrated p 0.001 ✓	20.0 EB05 18.8 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.9	NCT01201356: 3/4,083 (0.1%) on Fingolimod (serious AE)
Paraparesis	144	21.3 18.0–25.3ROR 21.3 · calibrated p 0.002 ✓	19.6 EB05 17.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=144	NCT00340834: 1/420 (0.2%) on Fingolimod (serious AE)
Melanocytic naevus	351	21.2 19.0–23.6ROR 21.2 · calibrated p 0.002 ✓	19.5 EB05 17.8 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=234	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
T-lymphocyte count decreased	54	20.9 15.8–27.6ROR 20.9 · calibrated p 0.002 ✓	19.2 EB05 15.2 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=38	not reported in cached trials
Band sensation	101	20.9 17.0–25.6ROR 20.9 · calibrated p 0.002 ✓	19.2 EB05 16.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=70	not reported in cached trials
Atrioventricular block second degree	240	20.8 18.3–23.8ROR 20.9 · calibrated p 0.002 ✓	19.2 EB05 17.3 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=219	NCT00340834: 3/420 (0.7%) on Fingolimod (serious AE)
Progressive multiple sclerosis	90	20.2 16.3–25.1ROR 20.3 · calibrated p 0.002 ✓	18.7 EB05 15.6 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=86	NCT01201356: 2/4,083 (0.0%) on Fingolimod (serious AE)
Blood bilirubin decreased	47	19.9 14.8–26.8ROR 19.9 · calibrated p 0.002 ✓	18.3 EB05 14.3 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious n=37 · ♀ 100% (drug 78%) · 100% clinician	not reported in cached trials
Cd4 lymphocytes decreased	162	19.7 16.8–23.1ROR 19.8 · calibrated p 0.002 ✓	18.3 EB05 16.0 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=138	not reported in cached trials
Concomitant disease aggravated	463	19.7 17.9–21.7ROR 19.8 · calibrated p 0.002 ✓	18.3 EB05 16.9 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=323	not reported in cached trials
Heart rate decreased	2,635	19.6 18.9–20.4ROR 20.2 · calibrated p 0.002 ✓	18.2 EB05 17.6 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 26.7 · serious PRR 11.2 · 72% consumer	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Opportunistic infection	1,717	3.13.0–3.2	signal
Depression	3,191	2.82.7–2.9	signal
Liver injury	2,980	2.42.3–2.5	signal
Fall / fracture	3,556	2.32.2–2.4	signal
Seizure	1,278	1.61.5–1.7	raised
Malignancy	1,700	1.11.0–1.2	raised
Arrhythmia / qt	838	1.11.0–1.1	no difference
Serious infection	2,970	0.90.9–1.0	lower than other drugs
Tendon disorder	109	0.70.6–0.8	lower than other drugs
Extrapyramidal	265	0.60.5–0.7	lower than other drugs
Myocardial infarction	481	0.60.5–0.6	lower than other drugs
Stroke	545	0.50.5–0.6	lower than other drugs
Anaemia	648	0.50.5–0.6	lower than other drugs
Neutropenia / agranulocytosis	512	0.50.5–0.5	lower than other drugs
Thrombocytopenia	419	0.50.4–0.5	lower than other drugs
Hyperglycaemia / diabetes	598	0.40.4–0.5	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Fingolimod as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (15 of 40 signal terms matched).

NCT01201356 — Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis (N=4125, PHASE3; 407 AE terms posted; arms: Fingolimod 0.5 mg/Day)
NCT00340834 — Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extens (N=1292, PHASE3; 254 AE terms posted; arms: COR FTY720 1.25 mg; COR FTY720 0.5 mg; COR Interferon Beta-1a; EXT FTY720 1.25 mg)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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)	10,796	3.4 3.4–3.5ROR 3.8 · calibrated p 0.423	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.6 · serious PRR 3.1 · 73% consumer	NCT01201356: 5/4,083 (0.1%) on Fingolimod (serious AE)
Multiple sclerosis relapse	7,732	30.6 29.9–31.3ROR 33.6 · calibrated p 1e-4 ✓	27.3 EB05 26.8 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 19.0 · serious PRR 39.4	NCT01201356: 34/4,083 (0.8%) on Fingolimod (serious AE)
Headache	7,260	2.8 2.8–2.9ROR 3.0 · calibrated p 0.620	2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.8 · serious PRR 3.0	NCT01201356: 4/4,083 (0.1%) on Fingolimod (serious AE)
Dizziness	5,367	2.6 2.6–2.7ROR 2.8 · calibrated p 0.711	2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.3 · serious PRR 2.5 · 73% consumer	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
White blood cell count decreased	3,986	9.3 9.0–9.6ROR 9.7 · calibrated p 0.036 ✓	9.0 EB05 8.7 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 8.6 · serious PRR 7.6	not reported in cached trials
Gait disturbance	3,832	4.9 4.8–5.1ROR 5.1 · calibrated p 0.221	4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.8 · serious PRR 5.6	NCT01201356: 2/4,083 (0.0%) on Fingolimod (serious AE)
Hypoaesthesia (numbness)	3,764	6.3 6.1–6.5ROR 6.5 · calibrated p 0.121	6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 5.2 · serious PRR 7.1	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Lymphocyte count decreased	3,552	61.2 59.0–63.5ROR 63.8 · calibrated p 3e-6 ✓	49.0 EB05 47.6 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	age-adj. PRR 53.4 · serious PRR 48.0	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Fall	3,485	2.6 2.5–2.7ROR 2.6 · calibrated p 0.756	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.5 · serious PRR 2.3	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)
Nausea	3,424	1.1 1.0–1.1ROR 1.1 · calibrated p 0.347	1.1 EB05 1.0 · IC025 +0.0	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.2	NCT01201356: 2/4,083 (0.0%) on Fingolimod (serious AE)
Drug ineffective (drug did not work)	3,148	0.6 0.6–0.6ROR 0.6 · calibrated p 0.071	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.5 · serious PRR 0.9 · 71% consumer	not reported in cached trials
Malaise (feeling unwell)	3,129	1.7 1.7–1.8ROR 1.8 · calibrated p 0.811	1.7 EB05 1.7 · IC025 +0.7	Not in label — unassessed	age-adj. PRR 1.6 · serious PRR 1.8 · 72% consumer	not reported in cached trials
Memory impairment	2,967	5.4 5.2–5.6ROR 5.5 · calibrated p 0.186	5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 4.2 · serious PRR 4.9 · 79% consumer	not reported in cached trials
Pain	2,913	1.2 1.1–1.2ROR 1.2 · calibrated p 0.413	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.2 · 72% consumer	NCT01201356: 4/4,083 (0.1%) on Fingolimod (serious AE)
Central nervous system lesion	2,900	64.7 62.1–67.3ROR 66.9 · calibrated p 2e-6 ✓	51.1 EB05 49.6 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 62.9	NCT01201356: 1/4,083 (0.0%) on Fingolimod (serious AE)

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.

Expanded disability status scale — n=45, PRR 347.9
Central nervous system lesion — n=2,900, PRR 64.7 (also seen in trial arm)
Gait spastic — n=67, PRR 58.2
Decreased vibratory sense — n=57, PRR 49.3
Fibrous histiocytoma — n=54, PRR 43.6
Haemangioma of skin — n=64, PRR 41.7
Lentigo — n=71, PRR 40.4
Dysplastic naevus — n=36, PRR 27.1
Molluscum contagiosum — n=53, PRR 26.8
Seborrhoeic keratosis — n=141, PRR 25.9

✓ A hand-written Bradford Hill causality assessment exists for this drug: Fingolimod ↔ Bradycardia.

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 fatigue, multiple sclerosis relapse, headache, dizziness, white blood cell count decreased, 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, field patient.drug.openfda.generic_name.exact, 1,216 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
ClinicalTrials.gov API v2 (query FINGOLIMOD, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.