Prescription medicine
Etrasimod arginine Brand names: Velsipity
Etrasimod arginine (Velsipity) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- 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 NDA 216956 record on Drugs@FDA; every etrasimod arginine label on DailyMed.
Highlights of the record
FDA label of August 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Forms and strengths
- 2 mg
Film-coated tablet.
On the market
- Earliest approval on file
- October 12, 2023 Velsipity, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 21, 2036 Velsipity tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,633 through July 30, 2026
What is etrasimod arginine used for?
From the label: indications and usageVELSIPITY 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.
Conditions named in the indications of etrasimod arginine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sphingosine 1-phosphate Receptor Modulator.
Source: FDA drug label (Velsipity), 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 patient leaflet for etrasimod arginine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VELSIPITY?VELSIPITY can cause serious side effects, including: 1. Infections. VELSIPITY can increase your risk of serious infections. These infections can be life-threatening and cause death. VELSIPITY lowers the number of white blood cells (lymphocytes) in your blood. This usually returns to normal within 4 to 5 weeks after you stop taking VELSIPITY. Your healthcare provider will test your blood before you start taking VELSIPITY. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with VELSIPITY, and for 5 weeks after you stop taking VELSIPITY: • fever or high temperature • tiredness • flu-like symptoms • pain when peeing or peeing more often than usual. These can be signs of a urinary tract infection. • headache with fever, neck stiffness, sensitivity to light, nausea, or confusion. These may be symptoms of meningitis, an infection of the lining around your brain and spine. Your healthcare provider may delay or stop your VELSIPITY treatment if you have an infection. 2. Slow heart rate (also known as bradyarrhythmia) when you start taking VELSIPITY. VELSIPITY may cause your heart rate to temporarily slow down especially after you take your first dose. You will have a test called an electrocardiogram (ECG) to check the electrical activity of your heart before you take your first dose of VELSIPITY. Call your healthcare provider if you experience these symptoms of slow heart rate: • feeling dizzy • feeling lightheaded • feeling like your heart is beating slowly or skipping beats • feeling short of breath • feeling confused • feeling tired • chest pain See " What are the possible side effects of VELSIPITY? " for more information about side effects.
From the patient leaflet: How should I store VELSIPITY?Store VELSIPITY at room temperature between 68°F to 77°F (20°C to 25°C). Keep VELSIPITY and all medicines out of the reach of children.
Source: FDA drug label (Velsipity), Pfizer Laboratories Div Pfizer Inc, effective August 18, 2025 (SPL set 65171e4a-d136-4abc-b08c-c40c1b486ff6), via openFDA; the full label on DailyMed
Is there a generic for etrasimod arginine (Velsipity)?
No generic etrasimod arginine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Velsipity tablets: the compound patent runs to June 21, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the etrasimod arginine label say about other medicines?
The etrasimod arginine label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Prevention or Management; Seek the advice of a cardiologist before initiating VELSIPITY treatment with Class Ia (e.g., quinidine, procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol), or other drugs that prolong the QT interval. |
| Fluconazole | drug interactions | Clinical Impact; Increased exposure of etrasimod was observed with concomitant use with a drug that is a moderate inhibitor of CYP2C9 and a moderate inhibitor of CYP3A4 (i.e., fluconazole) [see ]. |
| Procainamide | drug interactions | Prevention or Management; Seek the advice of a cardiologist before initiating VELSIPITY treatment with Class Ia (e.g., quinidine, procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol), or other drugs that prolong the QT interval. |
| Quinidine | drug interactions | Prevention or Management; Seek the advice of a cardiologist before initiating VELSIPITY treatment with Class Ia (e.g., quinidine, procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol), or other drugs that prolong the QT interval. |
| Rifampin | drug interactions | Clinical Impact; Concomitant use with a drug that is a combined CYP3A4 (strong), CYP2C8 (moderate) and CYP2C9 (moderate) inducer (i.e., rifampin) decreases exposure to etrasimod [see ]. |
| Sotalol | drug interactions | Prevention or Management; Seek the advice of a cardiologist before initiating VELSIPITY treatment with Class Ia (e.g., quinidine, procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol), or other drugs that prolong the QT interval. |
Source: FDA drug label (Velsipity), 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 for etrasimod arginine?
The FDA Adverse Event Reporting System holds 1,633 reports that list etrasimod arginine among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as etrasimod arginine?
4 other medicines are given the same way (oral) and in the same FDA class as etrasimod arginine or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mesalamine | Crohn's disease and ulcerative colitis | 27 labelers | $0.781 per tablet 1.2 g tablet | A presentation being discontinued |
| Sulfasalazine | Crohn's disease and ulcerative colitis | 5 labelers | $0.199 per tablet 500 mg tablet | No current entry |
| Balsalazide | Crohn's disease and ulcerative colitis | 9 labelers | $0.344 per capsule 750 mg capsule | No current entry |
| Olsalazine | Crohn's disease and ulcerative colitis | none listed | $15.70 per capsule 250 mg capsule | No current entry |
Every medicine labeled for the same conditions as etrasimod arginine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to etrasimod arginine
- 4 medicines for the same use
- Other sphingosine 1-phosphate receptor modulators
- the pharmacologic class, with prices and generics
- Etrasimod arginine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other