Vedolizumab

Common brands: Entyvio, Entyvio Pen, Prednisone, Prednisone Delayed Release, Prednisone Tablets, Usp, 10 Mg

Top reporter: Takeda Pharmaceuticals America, Inc.

Integrin Receptor Antagonist [EPC]Corticosteroid [EPC]Aminosalicylate [EPC]Tumor Necrosis Factor Blocker [EPC]Purine Antimetabolite [EPC]
83,516
Total Reports
56,123
Serious Reports
4,103
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.91%)

Patient Demographics

Male
33,922
Female
43,481

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Vedolizumab.

# Reaction Reports % of Total
1 OFF LABEL USE 22,124
14.5%
2 COLITIS ULCERATIVE 15,243
10.0%
3 CROHN^S DISEASE 11,111
7.3%
4 DRUG INEFFECTIVE 9,695
6.3%
5 DIARRHOEA 8,488
5.6%
6 ABDOMINAL PAIN 7,274
4.8%
7 FATIGUE 6,161
4.0%
8 HAEMATOCHEZIA 5,987
3.9%
9 FREQUENT BOWEL MOVEMENTS 5,132
3.4%
10 ARTHRALGIA 4,612
3.0%
11 MALAISE 4,228
2.8%
12 NAUSEA 4,053
2.7%
13 HEADACHE 4,024
2.6%
14 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 3,895
2.5%
15 PRODUCT DOSE OMISSION ISSUE 3,677
2.4%
16 WEIGHT DECREASED 3,105
2.0%
17 PYREXIA 2,930
1.9%
18 PNEUMONIA 2,731
1.8%
19 THERAPEUTIC REACTION TIME DECREASED 2,712
1.8%
20 PAIN 2,639
1.7%
21 VOMITING 2,639
1.7%
22 NO ADVERSE EVENT 2,607
1.7%
23 RECTAL HAEMORRHAGE 2,481
1.6%
24 NASOPHARYNGITIS 2,445
1.6%
25 ASTHENIA 2,289
1.5%
26 CONSTIPATION 2,180
1.4%
27 COVID-19 2,131
1.4%
28 DIZZINESS 2,124
1.4%
29 DEATH 2,084
1.4%
30 ABDOMINAL PAIN UPPER 2,056
1.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.