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Etrasimod Arginine: uses, dosing, side effects & brands

Etrasimod Arginine is a sphingosine 1-phosphate receptor modulator sold in the U.S. under one brand, for ulcerative colitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Sphingosine 1-Phosphate Receptor Modulator
Treats
Ulcerative Colitis
Available as
Tablet
Sold as
Velsipity
Prescription?
Prescription only
Generic available?
Not in our catalog

How etrasimod arginine is dosed

From the FDA label for Velsipity (application NDA216956). Other etrasimod arginine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Assessments are required prior to initiating VELSIPITY. ( 2.1 ) • The recommended dosage is 2 mg orally once daily. ( 2.2 ) 2.1 Assessments, Medications, and Vaccinations Prior to First Dose of VELSIPITY Before initiation of treatment with VELSIPITY, assess the following: Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior UC therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1) ]. Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.2) ] . Liver Function Tests Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.3) ]. Ophthalmic Assessment Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with VELSIPITY [see Warnings and Precautions (5.4) ]. Skin Examination Obtain a skin examination prior to or shortly after initiation of VELSIPITY. If a suspicious skin lesion is observed, it should be promptly evaluated [see Warnings and Precautions (5.7) ] . Current or Prior Medications • Determine if patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see…

Etrasimod Arginine side effects

The 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect…

Who shouldn’t take etrasimod arginine

VELSIPITY is contraindicated in patients who: • In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2) ] . • Have a history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker [see Warnings and Precautions (5.2) ] . • In the last 6 months, experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure. ( 4 , 5.2 ) • History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker. ( 4 , 5.2 )

Etrasimod Arginine drug interactions

Etrasimod is primarily metabolized by CYP2C8, CYP2C9, and CYP3A4. Table 3 includes drugs with clinically important drug interactions when administered concomitantly with VELSIPITY and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information. The effect of concomitant use of VELSIPITY with a combination of separate drugs that are moderate to strong inhibitors or inducers of either CYP2C8, CYP2C9, or CYP3A4 is unknown. However, based on the information below, a similar clinically significant change in exposure cannot be ruled out when two or more metabolic pathways are affected. Table 3: Drugs That Affect VELSIPITY CYP-Mediated Metabolic Pathways Anti-Arrhythmic Drugs and QT Prolonging Drugs Clinical Impact A transient decrease in heart rate and AV conduction delays may occur when initiating VELSIPITY [see Warnings and Precautions (5.2) ] . Because of the potential additive effect on heart rate, VELSIPITY may increase the risk of QT prolongation and Torsades de Pointes with concomitant use of Class Ia and Class III anti-arrhythmic drugs and QT prolonging drugs. 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. Beta-Blockers or Calcium Channel Blockers Clinical Impact A transient decrease in heart rate and AV conduction delays may occur when initiating VELSIPITY [see Warnings and Precautions (5.2) ] . Concomitant use of VELSIPITY in patients receiving stable beta blocker treatment did not result in additive effects on heart rate reduction [see Clinical Pharmacology (12.2) ] . However, the risk of additive heart rate reduction following initiation of beta blocker therapy with stable VELSIPITY treatment or concomitant use with other drugs that may decrease heart rate is unknown. Prevention or Management VELSIPITY can be initiated in patients receiving stable doses of beta blocker treatment. Seek the advice of a cardiologist before initiating a beta blocker in a patient receiving stable VELSIPITY treatment or concomitant use with other drugs that may decrease heart rate (e.g., calcium channel blockers). Anti-Neoplastic, Immune-Modulating, or Non-Corticosteroid Immunosuppressive Therapies Clinical Impact Risk of additive immune system effects with VELSIPITY VELSIPITY has not been studied in combination with anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies. Prevention or Management Avoid concomitant administration during and in the weeks following administration of VELSIPITY. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects [see Warnings and Precautions (5.10) ] . Moderate to Strong Inhibitors of CYP2C9 and CYP3A4 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 Clinical Pharmacology (12.3) ] . Prevention or Management Concomitant use with a drug that is a moderate to strong inhibitor of CYP2C9 and a moderate to strong inhibitor of CYP3A4 is not recommended. CYP2C9 Poor Metabolizers Using Moderate to Strong Inhibitors of CYP2C8 or CYP3A4 Clinical Impact Increased exposure of etrasimod in patients who are CYP2C9 poor metabolizers is expected with concomitant use of moderate to strong inhibitors of CYP2C8 or CYP3A4 [see Clinical Pharmacology (12.3 , 12.5) ] . Prevention or Management Concomitant use not recommended. Rifampin 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 Clinical Pharmacology (12.3) ] . Prevention or Management Concomitant use not recommended. See full prescribing information for a list of clinically important drug interactions. ( 7 )

Every etrasimod arginine product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Velsipity.

What people report to the FDA about etrasimod arginine

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4 reports naming etrasimod arginine, and the FDA flagged 75% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • acne3 reports
  • anaemia3 reports
  • c-reactive protein increased3 reports
  • colitis ulcerative3 reports
  • concomitant disease aggravated3 reports
  • dizziness3 reports
  • labelled drug-drug interaction issue3 reports
  • nausea3 reports

Read these as a signal, not a rate. A report does not mean etrasimod arginine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is etrasimod arginine?

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.

What kind of drug is etrasimod arginine?

The FDA classifies etrasimod arginine as a sphingosine 1-phosphate receptor modulator. These drugs mimic the natural lipid signal S1P and bind its receptors on immune cells called lymphocytes. This traps the lymphocytes inside the lymph nodes so fewer circulate in the blood, reducing the inflammatory attack on the nervous system or gut in diseases like multiple sclerosis. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take etrasimod arginine with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run etrasimod arginine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does etrasimod arginine come in?

Across the brands we track, etrasimod arginine is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic etrasimod arginine?

We do not currently list a generic-labelled etrasimod arginine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Etrasimod Arginine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/etrasimod-arginine
MLA
“Etrasimod Arginine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/etrasimod-arginine.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for etrasimod arginine on DailyMed (NIH) ↗.