Infliximab vs Vedolizumab: side effects in FDA adverse event reports
At a glance
| Infliximab | Vedolizumab | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | Integrin Receptor Antagonist |
| Brand names | Renflexis | Entyvio, Entyvio Pen |
| FAERS reports | 217,056 | 85,584 |
| Serious | 89% | 87% |
| Death outcome | 13,761 | 4,219 |
| Boxed warning | Yes SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of seri | No |
Signals both drugs share
| Reaction | Infliximab | Vedolizumab | Label screen (A / B) |
|---|---|---|---|
| Dislocation of vertebra | 1,023 · PRR 82.3 | 402 · PRR 53.9 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 964 · PRR 88.6 | 406 · PRR 61.7 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 713 · PRR 145.6 | 169 · PRR 40.4 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 219 · PRR 64.8 | 176 · PRR 117.0 | Not in label — unassessed / Not in label — unassessed |
| Vaginal flatulence | 159 · PRR 104.9 | 190 · PRR 408.2 | Not in label — unassessed / Not in label — unassessed |
| Ileocaecal resection | 139 · PRR 69.4 | 106 · PRR 114.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Infliximab
- Lupus-like syndrome — n=3,336, PRR 56.5 Labeled adverse reaction
- Rheumatic fever — n=3,038, PRR 224.9 Labeled (related wording)
- Hepatosplenic t-cell lymphoma — n=184, PRR 94.3 Labeled — boxed warning
- Swollen joint count — n=135, PRR 117.9 Labeled (related wording)
Labeled signals distinctive to Vedolizumab
- Colon dysplasia — n=52, PRR 54.6 Labeled (related wording)
Common questions
Which has more reported side effects, Infliximab or Vedolizumab?
Infliximab has 217,056 FAERS reports and Vedolizumab 85,584. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (89% vs 87%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Infliximab and Vedolizumab share?
Both drugs carry disproportionality signals for dislocation of vertebra, adjustment disorder with depressed mood, lupus vulgaris, subcutaneous drug absorption impaired, vaginal flatulence. Shared signals often reflect a shared drug class or the condition both are used for.
Is Infliximab or Vedolizumab safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.