Etrasimod side effects: what 1,633 FDA adverse event reports show

Etrasimod · Velsipity · 24 reaction terms · 659 drug–reaction co-reports · data 2026-09-14

Drug class

Sphingosine 1-phosphate receptor modulator

FDA label, Indications wording

Brand names

Velsipity

openFDA label

Who reports

1,633 reports · 39% serious · 5 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis in adults. ( 1 )

FDA label, Indications and Usage

What it is

VELSIPITY contains etrasimod, a sphingosine 1-phosphate (S1P) receptor modulator, supplied as etrasimod arginine. Etrasimod arginine is a white, off-white to light brown solid that is slightly soluble in water.

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 19 strongest signals

Labeled adverse reaction 1Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 8

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. 5 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
Type 2 diabetes mellitus	66	25.1 19.8–31.8ROR 26.2 · χ² 1,505 / p <1e-300	24.9 EB05 20.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 39.3 · 100% clinician	no trial data cached
Colitis ulcerative	87	25.1 20.5–30.8ROR 26.5 · χ² 1,989 / p <1e-300	24.9 EB05 20.8 · IC025 +4.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 38.7	no trial data cached
Colitis	47	16.0 12.1–21.3ROR 16.5 · χ² 648 / p 3e-143	15.9 EB05 12.3 · IC025 +3.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 25.7	no trial data cached
Lymphocyte count decreased	18	13.1 8.3–20.7ROR 13.2 · χ² 189 / p 3e-43	12.2 EB05 7.6 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 15.9	no trial data cached
Inflammatory bowel disease	10	13.1 7.0–24.2ROR 13.1 · χ² 100 / p 9e-24	11.1 EB05 5.6 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.9	no trial data cached
Rectal haemorrhage	43	12.8 9.5–17.2ROR 13.1 · χ² 457 / p 9e-102	12.5 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.4	no trial data cached
Haematochezia (blood in stool)	53	12.4 9.5–16.1ROR 12.7 · χ² 543 / p 2e-120	12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Heart rate decreased	24	8.7 5.9–13.0ROR 8.9 · χ² 157 / p 3e-36	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.1	no trial data cached
Haemorrhoids	13	8.5 5.0–14.7ROR 8.6 · χ² 79 / p 3e-19	7.0 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Iron deficiency anaemia	6	8.4 3.8–18.7ROR 8.4 · χ² 32 / p 8e-9	5.7 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Diarrhoea haemorrhagic	6	8.2 3.7–18.3ROR 8.3 · χ² 31 / p 1e-8	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Frequent bowel movements	17	8.1 5.1–13.0ROR 8.2 · χ² 99 / p 1e-23	7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Condition aggravated	179	7.6 6.6–8.7ROR 8.4 · χ² 1,036 / p 1e-227	7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.3	no trial data cached
Brain fog	8	7.0 3.5–14.1ROR 7.1 · χ² 36 / p 1e-9	5.3 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.5	no trial data cached
Therapeutic product effect incomplete	38	6.9 5.0–9.5ROR 7.0 · χ² 187 / p 9e-43	6.4 EB05 4.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Blood iron decreased	6	6.5 2.9–14.5ROR 6.6 · χ² 23 / p 9e-7	4.6 EB05 2.3 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 11.0	no trial data cached
Thyroid disorder	6	5.0 2.2–11.1ROR 5.0 · χ² 15 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious PRR 5.2	no trial data cached
Immune system disorder	5	4.9 2.0–11.7ROR 4.9 · χ² 12 / p 3e-4	3.6 EB05 1.7 · IC025 +0.3	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Abdominal pain lower	9	4.6 2.4–8.7ROR 4.6 · χ² 22 / p 2e-6	3.8 EB05 2.2 · IC025 +0.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.1	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
Condition aggravated	179	7.6 6.6–8.7ROR 8.4 · χ² 1,036 / p 1e-227	7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.3	no trial data cached
Colitis ulcerative	87	25.1 20.5–30.8ROR 26.5 · χ² 1,989 / p <1e-300	24.9 EB05 20.8 · IC025 +4.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 38.7	no trial data cached
Type 2 diabetes mellitus	66	25.1 19.8–31.8ROR 26.2 · χ² 1,505 / p <1e-300	24.9 EB05 20.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 39.3 · 100% clinician	no trial data cached
Haematochezia (blood in stool)	53	12.4 9.5–16.1ROR 12.7 · χ² 543 / p 2e-120	12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Colitis	47	16.0 12.1–21.3ROR 16.5 · χ² 648 / p 3e-143	15.9 EB05 12.3 · IC025 +3.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 25.7	no trial data cached
Rectal haemorrhage	43	12.8 9.5–17.2ROR 13.1 · χ² 457 / p 9e-102	12.5 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.4	no trial data cached
Therapeutic product effect incomplete	38	6.9 5.0–9.5ROR 7.0 · χ² 187 / p 9e-43	6.4 EB05 4.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Heart rate decreased	24	8.7 5.9–13.0ROR 8.9 · χ² 157 / p 3e-36	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.1	no trial data cached
Lymphocyte count decreased	18	13.1 8.3–20.7ROR 13.2 · χ² 189 / p 3e-43	12.2 EB05 7.6 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 15.9	no trial data cached
Frequent bowel movements	17	8.1 5.1–13.0ROR 8.2 · χ² 99 / p 1e-23	7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Haemorrhoids	13	8.5 5.0–14.7ROR 8.6 · χ² 79 / p 3e-19	7.0 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Inflammatory bowel disease	10	13.1 7.0–24.2ROR 13.1 · χ² 100 / p 9e-24	11.1 EB05 5.6 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.9	no trial data cached
Abdominal pain lower	9	4.6 2.4–8.7ROR 4.6 · χ² 22 / p 2e-6	3.8 EB05 2.2 · IC025 +0.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.1	no trial data cached
Brain fog	8	7.0 3.5–14.1ROR 7.1 · χ² 36 / p 1e-9	5.3 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.5	no trial data cached
Thyroid disorder	6	5.0 2.2–11.1ROR 5.0 · χ² 15 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious PRR 5.2	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.

Type 2 diabetes mellitus — n=66, PRR 25.1
Rectal haemorrhage — n=43, PRR 12.8
Haematochezia — n=53, PRR 12.4

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 Etrasimod?

In FDA FAERS, the most frequently co-reported reaction terms for Etrasimod are colitis ulcerative, type 2 diabetes mellitus, haematochezia, colitis, rectal haemorrhage, heart rate decreased. 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 Etrasimod have an FDA boxed warning?

No. The FDA label retrieved for Etrasimod has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Etrasimod 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 65171e4a-d136-4abc-b08c-c40c1b486ff6, effective 20250818; matched on openfda.generic_name.exact:"ETRASIMOD")
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, 24 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.