Quick answers
- What is Vedolizumab used for?
- The FDA-approved label (Entyvio, Takeda Pharmaceuticals America, Inc., April 29, 2026) says: “ENTYVIO 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). moderately to severely active Crohn's disease (CD).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vedolizumab have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Vedolizumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Vedolizumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Vedolizumab?
- 1 company lists prescription products of Vedolizumab in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc..
What Vedolizumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ENTYVIO 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). moderately to severely active Crohn's disease (CD).
— FDA label: Entyvio, Takeda Pharmaceuticals America, Inc., effective April 29, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Entyvio, Entyvio Pen |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Takeda Pharmaceuticals America, Inc.3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125476 ENTYVIO | Takeda Pharms USA | May 20, 2014 | 15, latest February 25, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
| BLA761133 ENTYVIO | Takeda Pharms USA | September 27, 2023 | 5, latest February 25, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Entyvio, Takeda Pharmaceuticals America, Inc., effective April 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →