Drug · FAERS side-effect profile with label screen
Diroximel side effects: what 11,791 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Diroximel Fumarate (Vumerity)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
11,791 reports · 39% serious · 354 with death outcome · 79% female
openFDA FAERS counts, all years, deduplication not applied
Used for
VUMERITY 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. VUMERITY 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.
FDA label, Indications and Usage
What it is
VUMERITY contains diroximel fumarate.
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 4Labeled (related wording) 1Likely indication confounding 6Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 23
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. 952 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 |
|---|---|---|---|---|---|---|
| Hemihypoaesthesia | 19 | 106.6 67.1–169.4ROR 106.8 · χ² 1,776 / p <1e-300 | 91.6 EB05 62.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Multiple sclerosis pseudo relapse | 17 | 96.0 59.0–156.4ROR 96.2 · χ² 1,427 / p <1e-300 | 82.9 EB05 54.8 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 | no trial data cached |
| Neurogenic bowel | 10 | 76.9 40.8–144.8ROR 77.0 · χ² 647 / p 6e-143 | 65.0 EB05 37.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Joint space narrowing | 10 | 61.5 32.7–115.4ROR 61.5 · χ² 518 / p 7e-115 | 53.7 EB05 31.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Immunisation reaction | 20 | 50.9 32.6–79.4ROR 51.0 · χ² 903 / p 1e-198 | 47.4 EB05 32.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=8 · 100% consumer | no trial data cached |
| Multiple sclerosis | 1,099 | 41.4 39.1–43.8ROR 45.5 · χ² 42,379 / p <1e-300 | 40.4 EB05 38.5 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 25.1 · 92% consumer | no trial data cached |
| Primary progressive multiple sclerosis | 11 | 41.1 22.6–74.7ROR 41.2 · χ² 382 / p 2e-85 | 37.8 EB05 22.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious n=5 | no trial data cached |
| Magnetic resonance imaging abnormal | 26 | 40.0 27.1–58.9ROR 40.0 · χ² 928 / p 5e-204 | 38.1 EB05 27.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=6 · 77% consumer | no trial data cached |
| Vaccination complication | 18 | 39.3 24.6–62.6ROR 39.3 · χ² 620 / p 4e-137 | 37.1 EB05 24.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Agraphia | 13 | 39.1 22.6–67.8ROR 39.2 · χ² 436 / p 4e-97 | 36.4 EB05 22.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Band sensation | 26 | 36.7 24.9–54.2ROR 36.8 · χ² 851 / p 2e-187 | 35.2 EB05 25.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=6 · 92% consumer | no trial data cached |
| Product dose omission in error | 509 | 34.2 31.4–37.2ROR 35.7 · χ² 16,066 / p <1e-300 | 33.5 EB05 31.1 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 26.7 · 97% consumer | no trial data cached |
| Flushing | 1,611 | 28.4 27.1–29.7ROR 32.7 · χ² 42,016 / p <1e-300 | 27.9 EB05 26.8 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.6 · 90% consumer | no trial data cached |
| Lymphocyte count decreased | 253 | 25.7 22.7–29.0ROR 26.2 · χ² 5,893 / p <1e-300 | 25.3 EB05 22.8 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 · 87% consumer | no trial data cached |
| Multiple sclerosis relapse | 973 | 25.3 23.8–26.8ROR 27.4 · χ² 22,394 / p <1e-300 | 24.9 EB05 23.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 26.1 · 88% consumer | no trial data cached |
| Loss of control of legs | 50 | 23.4 17.7–31.0ROR 23.5 · χ² 1,038 / p 5e-228 | 23.0 EB05 18.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=25 · 96% consumer | no trial data cached |
| Secondary progressive multiple sclerosis | 22 | 20.8 13.6–31.6ROR 20.8 · χ² 390 / p 5e-87 | 20.2 EB05 13.9 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious n=10 · 82% consumer | no trial data cached |
| Progressive multiple sclerosis | 13 | 19.9 11.5–34.3ROR 19.9 · χ² 212 / p 3e-48 | 18.9 EB05 11.2 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious n=4 | no trial data cached |
| Clumsiness | 28 | 18.2 12.6–26.4ROR 18.3 · χ² 434 / p 1e-96 | 17.8 EB05 12.8 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=9 · 89% consumer | no trial data cached |
| Central nervous system lesion | 107 | 13.8 11.4–16.7ROR 13.9 · χ² 1,248 / p 1e-273 | 13.6 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 89% consumer | no trial data cached |
| Motor dysfunction | 76 | 13.4 10.7–16.8ROR 13.5 · χ² 853 / p 9e-188 | 13.2 EB05 10.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 93% consumer | no trial data cached |
| Infection susceptibility increased | 16 | 13.0 8.0–21.3ROR 13.1 · χ² 165 / p 5e-38 | 11.9 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Electric shock sensation | 18 | 11.9 7.5–18.9ROR 11.9 · χ² 168 / p 9e-39 | 10.8 EB05 6.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Reading disorder | 15 | 11.7 7.0–19.4ROR 11.7 · χ² 135 / p 2e-31 | 10.3 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Loss of therapeutic response | 19 | 11.2 7.1–17.6ROR 11.2 · χ² 165 / p 4e-38 | 10.1 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Hot flush (hot flashes) | 472 | 11.1 10.2–12.2ROR 11.6 · χ² 4,337 / p <1e-300 | 11.1 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 95% consumer | no trial data cached |
| Trigeminal neuralgia | 25 | 11.1 7.5–16.4ROR 11.1 · χ² 217 / p 2e-49 | 10.2 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 · 92% consumer | no trial data cached |
| Full blood count decreased | 118 | 10.4 8.7–12.5ROR 10.5 · χ² 990 / p 2e-217 | 10.2 EB05 8.7 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 21.9 · 95% consumer | no trial data cached |
| Multiple allergies | 44 | 10.0 7.4–13.4ROR 10.0 · χ² 345 / p 3e-77 | 9.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=4 · 100% consumer | no trial data cached |
| Gastric disorder | 195 | 10.0 8.7–11.5ROR 10.1 · χ² 1,557 / p <1e-300 | 9.8 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 94% consumer | no trial data cached |
| Prescribed underdose | 111 | 9.9 8.2–11.9ROR 10.0 · χ² 875 / p 1e-192 | 9.7 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 97% consumer | no trial data cached |
| Musculoskeletal disorder | 106 | 9.9 8.1–11.9ROR 9.9 · χ² 830 / p 7e-183 | 9.6 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 92% consumer | no trial data cached |
| Akinesia | 11 | 9.5 5.2–17.1ROR 9.5 · χ² 75 / p 3e-18 | 7.6 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Cognitive disorder | 235 | 9.0 7.9–10.2ROR 9.1 · χ² 1,654 / p <1e-300 | 8.9 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 92% consumer | no trial data cached |
| Gastrointestinal disorder | 430 | 8.6 7.9–9.5ROR 8.9 · χ² 2,898 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 91% consumer | no trial data cached |
| Decreased immune responsiveness | 46 | 8.4 6.3–11.2ROR 8.4 · χ² 290 / p 3e-65 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 98% consumer | no trial data cached |
| Anal incontinence | 41 | 8.2 6.0–11.1ROR 8.2 · χ² 250 / p 1e-56 | 7.6 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 · 93% consumer | no trial data cached |
| Peroneal nerve palsy | 26 | 8.1 5.5–11.9ROR 8.1 · χ² 155 / p 8e-36 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 · 92% consumer | no trial data cached |
| Blood test abnormal | 64 | 8.1 6.3–10.3ROR 8.1 · χ² 390 / p 5e-87 | 7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 100% consumer | no trial data cached |
| Lymphopenia | 59 | 7.4 5.8–9.6ROR 7.5 · χ² 322 / p 3e-72 | 7.1 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | 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 |
|---|---|---|---|---|---|---|
| Flushing | 1,611 | 28.4 27.1–29.7ROR 32.7 · χ² 42,016 / p <1e-300 | 27.9 EB05 26.8 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.6 · 90% consumer | no trial data cached |
| Multiple sclerosis | 1,099 | 41.4 39.1–43.8ROR 45.5 · χ² 42,379 / p <1e-300 | 40.4 EB05 38.5 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 25.1 · 92% consumer | no trial data cached |
| Multiple sclerosis relapse | 973 | 25.3 23.8–26.8ROR 27.4 · χ² 22,394 / p <1e-300 | 24.9 EB05 23.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 26.1 · 88% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 873 | 2.4 2.3–2.6ROR 2.5 · χ² 736 / p 2e-162 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 · 92% consumer | no trial data cached |
| Product dose omission issue | 820 | 5.1 4.8–5.5ROR 5.4 · χ² 2,735 / p <1e-300 | 5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 95% consumer | no trial data cached |
| Fatigue (tiredness) | 781 | 1.8 1.7–1.9ROR 1.8 · χ² 276 / p 3e-62 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.1 · 92% consumer | no trial data cached |
| Nausea | 753 | 1.7 1.6–1.8ROR 1.7 · χ² 219 / p 6e-50 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.0 · 91% consumer | no trial data cached |
| Headache | 619 | 1.8 1.6–1.9ROR 1.8 · χ² 204 / p 1e-46 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.2 · 89% consumer | no trial data cached |
| Pruritus (itching) | 590 | 2.8 2.6–3.0ROR 2.9 · χ² 674 / p 5e-149 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 · 89% consumer | no trial data cached |
| Memory impairment | 566 | 7.3 6.7–7.9ROR 7.6 · χ² 3,083 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 95% consumer | no trial data cached |
| Fall | 558 | 3.0 2.7–3.2ROR 3.1 · χ² 740 / p 4e-163 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 93% consumer | no trial data cached |
| Abdominal discomfort | 526 | 5.6 5.1–6.1ROR 5.8 · χ² 1,984 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 · 91% consumer | no trial data cached |
| Product dose omission in error | 509 | 34.2 31.4–37.2ROR 35.7 · χ² 16,066 / p <1e-300 | 33.5 EB05 31.1 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 26.7 · 97% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 503 | 0.7 0.6–0.7ROR 0.7 · χ² 83 / p 4e-20 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.5 | no trial data cached |
| Hot flush (hot flashes) | 472 | 11.1 10.2–12.2ROR 11.6 · χ² 4,337 / p <1e-300 | 11.1 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 95% consumer | 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.
- Immunisation reaction — n=20, PRR 50.9
- Band sensation — n=26, PRR 36.7
- Loss of control of legs — n=50, PRR 23.4
- Central nervous system lesion — n=107, PRR 13.8
- Motor dysfunction — n=76, PRR 13.4
- Trigeminal neuralgia — n=25, PRR 11.1
- Multiple allergies — n=44, PRR 10.0
- Gastric disorder — n=195, PRR 10.0
- Prescribed underdose — n=111, PRR 9.9
- Musculoskeletal disorder — n=106, PRR 9.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Diroximel?
In FDA FAERS, the most frequently co-reported reaction terms for Diroximel are flushing, multiple sclerosis, multiple sclerosis relapse, diarrhoea, fatigue, nausea. 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 Diroximel have an FDA boxed warning?
No. The FDA label retrieved for Diroximel has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Diroximel 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 2d74414f-6b83-4ea2-9a95-3cecabbce774, effective 20250529; matched on
openfda.generic_name.exact:"DIROXIMEL FUMARATE") - 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, 992 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.