Vedolizumab: uses, dosing, side effects & brands
Vedolizumab is a medicine sold in the U.S. under one brand, for ulcerative colitis, crohn disease and enteritis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Ulcerative Colitis, Crohn Disease and Enteritis
- Available as
- Injectable
- Sold as
- Entyvio
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How vedolizumab is dosed
From the FDA label for Entyvio (application BLA761133). Other vedolizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Important Administration Information Before Initiating ENTYVIO Consider evaluating patients for tuberculosis (TB) infection. ( 2.1 , 5.2 ) Update immunizations according to current immunization guidelines. ( 2.1 , 5.5 ) Intravenous Administration : ENTYVIO should be administered intravenously by a healthcare provider. ( 2.1 ) Subcutaneous Injection : ENTYVIO prefilled syringe and ENTYVIO PEN are intended for subcutaneous use. A patient may self-inject or caregiver may inject after proper training on correct subcutaneous injection technique. ( 2.1 ) Recommended Dosage ( 2.2 ) Week 0 : 300 mg infused intravenously over approximately 30 minutes. Week 2 : 300 mg infused intravenously over approximately 30 minutes. Week 6 : Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2. Intravenous Infusion : 300 mg infused over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection : 108 mg subcutaneously once every two weeks. Discontinue ENTYVIO in patients who do not show evidence of therapeutic benefit by Week 14. Patients currently receiving and responding to ENTYVIO intravenous therapy after Week 6 may also be switched to subcutaneous injection. Administer the first subcutaneous dose in place of the next scheduled intravenous infusion and…
Vedolizumab side effects
The following topics are also discussed in detail in the Warnings and Precautions section: Infusion-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities. ( 6.1 ) Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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 the rates observed in practice. The data described below reflect exposure to intravenous ENTYVIO in 3,326…
Who shouldn’t take vedolizumab
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. ( 4 )
Vedolizumab 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. 7.2 TNF Blockers Because of the potential for increased risk of infections, avoid the concomitant use of ENTYVIO with TNF blockers. 7.3 CYP450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of certain cytokines (e.g., IL-6, IL-10, TNFα, IFN) during chronic inflammation. Therefore, use of ENTYVIO may normalize the formation of CYP450 enzymes by modulating the underlying disease. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed. See the prescribing information of specific CYP substrates.
Every vedolizumab 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: Entyvio.
Vedolizumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for vedolizumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMaternal vedolizumab injections produce low levels in breastmilk and do not appear to adversely affect the nursing infant. Because vedolizumab is a large protein molecule with a molecular weight of about 147,000 Da, it is likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Vedolizumab does not affect SIgA, SIgM levels in milk in women with inflammatory bowel disease. Waiting for at least 2 weeks postpartum to resume therapy suspended during pregnancy may minimize transfer to the infant. However, in infants of mothers who received vedolizumab during late pregnancy, continued use while breastfeeding did not prolong vedolizumab elimination by the infant. Most experts and guidelines consider vedolizumab to be probably acceptable during nursing.
National Institute of Child Health and Human Development, record revised June 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about vedolizumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 58,776 reports naming vedolizumab, and the FDA flagged 98% 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:
- colitis ulcerative13,032 reports
- crohn^s disease9,412 reports
- diarrhoea6,824 reports
- abdominal pain6,120 reports
- haematochezia5,199 reports
- fatigue4,293 reports
- frequent bowel movements4,263 reports
- inappropriate schedule of product administration3,450 reports
Read these as a signal, not a rate. A report does not mean vedolizumab 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 26, 2026.
Related calculators
Frequently asked questions
What is vedolizumab?
Entyvio (Vedolizumab) is a medication used to treat Ulcerative Colitis, Crohn Disease, Enteritis.
Can you take vedolizumab 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 vedolizumab 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 vedolizumab come in?
Across the brands we track, vedolizumab is currently marketed as injectable, 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 vedolizumab?
We do not currently list a generic-labelled vedolizumab 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). Vedolizumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/vedolizumab
- MLA
- “Vedolizumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/vedolizumab.
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 vedolizumab on DailyMed (NIH) ↗.