What the label lists and what reports show
Vedolizumab side effects
Vedolizumab's FDA label: “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 …” FAERS holds 85,644 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is colitis ulcerative (15,612 reports).
- No generic listed
Check it at the source: the vedolizumab FDA label on DailyMed (effective April 29, 2026, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ENTYVIO?ENTYVIO may cause serious side effects, see " What is the most important information I should know about ENTYVIO? " The most common side effects of ENTYVIO include: common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, pain in extremities, and with injections under the skin: pain, swelling, itching, hives, bruising, rash, or redness at the injection site. These are not all of the possible side effects of ENTYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost 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.
Table 2. Adverse Reactions in ≥3% of Intravenous ENTYVIO-Treated Adult Patients and ≥1% Higher than in Placebo (UC Trials I and II Data from patients receiving open-label intravenous ENTYVIO treatment at Weeks 0 and 2…
| Adverse Reaction | ENTYVIO IV Patients who received ENTYVIO for up to 52 weeks. (N=1434) | Placebo Patients who received placebo for up to 52 weeks. (N=297) |
|---|---|---|
| Nasopharyngitis | 13% | 7% |
| Headache | 12% | 11% |
| Arthralgia | 12% | 10% |
| Nausea | 9% | 8% |
| Pyrexia | 9% | 7% |
| Upper respiratory tract infection | 7% | 6% |
| Fatigue | 6% | 3% |
| Cough | 5% | 3% |
| Bronchitis | 4% | 3% |
| Influenza | 4% | 2% |
| Back pain | 4% | 3% |
| Rash | 3% | 2% |
| Pruritus | 3% | 1% |
| Sinusitis | 3% | 1% |
| Oropharyngeal pain | 3% | 1% |
| Pain in extremities | 3% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, 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?
85,644 reports list vedolizumab among the medicines taken, 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. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vedolizumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions