What the label lists and what reports show
Etrasimod arginine side effects
Etrasimod arginine's FDA label: “Most common adverse reactions (incidence ≥5%) are: headache, elevated liver tests, and dizziness.” FAERS holds 1,633 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (96 reports).
- No generic listed
Check it at the source: the etrasimod arginine FDA label on DailyMed (effective August 18, 2025, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VELSIPITY?VELSIPITY can cause serious side effects, including: • See " What is the most important information I should know about VELSIPITY? " • Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms: • unexplained nausea • vomiting • stomach area (abdominal pain) • tiredness • loss of appetite • yellowing of the whites of your eyes or skin • dark colored urine If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY. • Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed. • A problem with your vision called macular edema. […]
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective August 18, 2025 (SPL set 65171e4a-d136-4abc-b08c-c40c1b486ff6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5%) are: headache, elevated liver tests, and dizziness.
Table 1: Adverse Reactions Reported in at least 2% of subjects and at a higher rate than placebo. in Subjects with Ulcerative Colitis in a Placebo-Controlled 52-Week Study (UC-1)
| Adverse Reaction | VELSIPITY 2 mg Once Daily N = 289 % | Placebo N = 144 % |
|---|---|---|
| Headache Headache includes related terms headache, migraine, and tension headache. | 9 | 5 |
| Elevated liver tests Elevated liver tests includes related terms ALT increased, AST… | 6 | 5 |
| Dizziness Dizziness includes related terms dizziness, dizziness exertional, and dizziness… | 5 | 2 |
| Arthralgia | 4 | 2 |
| Hypertension Hypertension includes related terms hypertension, and blood pressure… | 3 | 1 |
| Urinary tract infection Urinary tract infection includes related terms urinary tract… | 3 | 2 |
| Nausea | 3 | 1 |
| Hypercholesterolemia Hypercholesterolemia includes related terms hypercholesterolemia and… | 3 | 0 |
| Herpes viral infection Herpes viral infection includes related terms herpes zoster, oral… | 2 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: • Infections [see Warnings and Precautions (5.1) ] • Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2) ] • Liver Injury [see Warnings and Precautions (5.3) ] • Macular Edema [see Warnings and Precautions (5.4) ] • Increased Blood Pressure [see Warnings and Precautions (5.5) ] • Fetal Risk [see Warnings and Precautions (5.6) ] • Cutaneous Malignancies [see Warnings and Precautions (5.7) ] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8) ] • Respiratory Effects [see Warnings and Precautions (5.9) ] • Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs [see Warnings and Precautions (5.10) ] • Immune System Effects After Stopping VELSIPITY [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence ≥5%) are: headache, elevated liver tests, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective August 18, 2025 (SPL set 65171e4a-d136-4abc-b08c-c40c1b486ff6), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,633 reports list etrasimod arginine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 139 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Etrasimod arginine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions