Prescription medicine
Vedolizumab Brand names: Entyvio
Vedolizumab (Entyvio) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vedolizumab FDA label on DailyMed (effective April 29, 2026, Takeda Pharmaceuticals America, Inc.); the BLA 125476 record on Drugs@FDA; every vedolizumab label on DailyMed.
Highlights of the record
FDA label of April 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC).
Forms and strengths
- 108 mg/.68ml
- 300 mg/5ml
Injection (solution); injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- May 20, 2014 Entyvio, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
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
- 85,644 through July 30, 2026
What is vedolizumab used for?
From the label: indications and usageENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD).
FDA pharmacologic class: Integrin Receptor Antagonist.
Source: FDA drug label (ENTYVIO), Takeda Pharmaceuticals America, Inc., effective April 29, 2026 (SPL set 6e94621c-1a95-4af9-98d1-52b9e6f1949c), via openFDA; the full label on DailyMed
What does the patient leaflet for vedolizumab 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 ENTYVIO?ENTYVIO may cause serious side effects, including: Infusion-related and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing). Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. If your healthcare provider feels that you are at risk for tuberculosis (TB), you may be treated with medicine for TB before you begin treatment with ENTYVIO. Progressive Multifocal Leukoencephalopathy (PML). People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. Liver Problems. […]
From the patient leaflet: How should I store ENTYVIO?Store ENTYVIO in a refrigerator between 36°F to 46°F (2°C to 8°C). If needed, the prefilled syringe or prefilled pen can be left out of the refrigerator in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling). Do not use the prefilled syringe or prefilled pen if left out of the refrigerator for more than 7 days or left in direct sunlight. Do not freeze ENTYVIO. Do not use ENTYVIO if it has been frozen. Keep ENTYVIO in the original package to protect from light until the time of use. ENTYVIO prefilled syringe or prefilled pen is not made with natural rubber latex. Keep ENTYVIO and all medicines out of the reach of children.
Source: FDA drug label (ENTYVIO), Takeda Pharmaceuticals America, Inc., effective April 29, 2026 (SPL set 6e94621c-1a95-4af9-98d1-52b9e6f1949c), via openFDA; the full label on DailyMed
Is there a generic for vedolizumab (Entyvio)?
No generic vedolizumab is approved (Drugs@FDA, October 8, 2026).
- 2014 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vedolizumab label say about other medicines?
The vedolizumab label names 1 other medicine 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 |
|---|---|---|
| Natalizumab | drug interactions | DRUG INTERACTIONS 7.1 Natalizumab Products Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products. |
Source: FDA drug label (ENTYVIO), Takeda Pharmaceuticals America, Inc., effective April 29, 2026 (SPL set 6e94621c-1a95-4af9-98d1-52b9e6f1949c), via openFDA; the full label on DailyMed
What do FAERS reports show for vedolizumab?
The FDA Adverse Event Reporting System holds 85,644 reports that list vedolizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,219 are coded as a death and 25,056 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 next?
- Other integrin receptor antagonists
- the pharmacologic class, with prices and generics
- Vedolizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other