Ustekinumab vs Vedolizumab: side effects in FDA adverse event reports
At a glance
| Ustekinumab | Vedolizumab | |
|---|---|---|
| Drug class | Interleukin-12 Antagonist, Interleukin-23 Antagonist | Integrin Receptor Antagonist |
| Brand names | – | Entyvio, Entyvio Pen |
| FAERS reports | 101,629 | 85,584 |
| Serious | 59% | 87% |
| Death outcome | 5,950 | 4,219 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Ustekinumab | Vedolizumab | Label screen (A / B) |
|---|---|---|---|
| Adjustment disorder with depressed mood | 846 · PRR 149.7 | 406 · PRR 61.7 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 798 · PRR 115.5 | 402 · PRR 53.9 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 661 · PRR 260.2 | 169 · PRR 40.4 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 215 · PRR 134.7 | 176 · PRR 117.0 | Not in label — unassessed / Not in label — unassessed |
| Ileocaecal resection | 121 · PRR 118.3 | 106 · PRR 114.9 | Not in label — unassessed / Not in label — unassessed |
| Ileectomy | 72 · PRR 55.6 | 53 · PRR 45.4 | Not in label — unassessed / Not in label — unassessed |
| Proctocolectomy | 54 · PRR 44.6 | 62 · PRR 62.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Ustekinumab
- Peripheral venous disease — n=1,058, PRR 74.2 Labeled (related wording)
- Contraindication to vaccination — n=42, PRR 57.8 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, Ustekinumab or Vedolizumab?
Ustekinumab has 101,629 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 (59% vs 87%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Ustekinumab and Vedolizumab share?
Both drugs carry disproportionality signals for adjustment disorder with depressed mood, dislocation of vertebra, lupus vulgaris, subcutaneous drug absorption impaired, ileocaecal resection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Ustekinumab 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.