82/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
Vedolizumab Adverse Events Show High Seriousness and Gastrointestinal Reactions
224,197 FDA adverse event reports analyzed
Last updated: 2026-05-12
VEDOLIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 224,197 FDA adverse event reports, VEDOLIZUMAB has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for VEDOLIZUMAB include OFF LABEL USE, COLITIS ULCERATIVE, CROHN^S DISEASE, DRUG INEFFECTIVE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VEDOLIZUMAB.
Vedolizumab has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 224,197 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Off Label Use, Colitis Ulcerative, Crohn^S Disease. Of classified reports, 86.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal issues like diarrhea, abdominal pain, and nausea are common and often serious.
Serious adverse events account for 86.5% of all reports, indicating high concern. The most frequent reactions include gastrointestinal disorders and infections.
Patients taking Vedolizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Vedolizumab may interact with other immunosuppressants, and patients should be monitored for potential drug interactions and adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Vedolizumab received a safety concern score of 82/100 (high concern). This is based on a 86.5% serious event ratio across 80,135 classified reports. The score accounts for 224,197 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 41,646, Male: 32,614, Unknown: 22. The most frequently reported age groups are age 44 (1,071 reports), age 65 (928 reports), age 53 (921 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 80,135 classified reports for VEDOLIZUMAB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Vedolizumab may interact with other immunosuppressants, and patients should be monitored for potential drug interactions and adverse effects.
If you are taking Vedolizumab, here are important things to know. The most commonly reported side effects include off label use, colitis ulcerative, crohn^s disease, drug ineffective, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious infections and gastrointestinal issues, especially after the first dose. Follow prescribed dosing schedules to avoid therapeutic failure. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on monitoring serious infections and gastrointestinal issues.
The FDA has received approximately 224,197 adverse event reports associated with Vedolizumab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Vedolizumab include Off Label Use, Colitis Ulcerative, Crohn^S Disease, Drug Ineffective, Diarrhoea. By volume, the top reported reactions are: Off Label Use (21,828 reports), Colitis Ulcerative (14,515 reports), Crohn^S Disease (10,631 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Vedolizumab.
Out of 80,135 classified reports, 69,290 (86.5%) were classified as serious and 10,845 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Vedolizumab break down by patient sex as follows: Female: 41,646, Male: 32,614, Unknown: 22. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Vedolizumab adverse events are: age 44: 1,071 reports, age 65: 928 reports, age 53: 921 reports, age 62: 914 reports, age 64: 913 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Vedolizumab adverse event reports is Takeda Pharmaceuticals America, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Vedolizumab include: Abdominal Pain, Fatigue, Haematochezia, Frequent Bowel Movements, Arthralgia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Vedolizumab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Vedolizumab has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Gastrointestinal issues like diarrhea, abdominal pain, and nausea are common and often serious.
Key safety signals identified in Vedolizumab's adverse event data include: High incidence of serious gastrointestinal reactions.. Significant number of serious infections reported.. Common reactions include abdominal pain, diarrhea, and nausea.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Vedolizumab may interact with other immunosuppressants, and patients should be monitored for potential drug interactions and adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Vedolizumab.
Monitor for signs of serious infections and gastrointestinal issues, especially after the first dose. Follow prescribed dosing schedules to avoid therapeutic failure.
Vedolizumab has 224,197 adverse event reports on file with the FDA. Serious adverse events account for 86.5% of all reports, indicating high concern. The volume of reports for Vedolizumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious infections and gastrointestinal issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Takeda Pharmaceuticals America, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with VEDOLIZUMAB:
Drugs related to VEDOLIZUMAB based on therapeutic use, drug class, or shared indications: