Adalimumab vs Ustekinumab: side effects in FDA adverse event reports
At a glance
| Adalimumab | Ustekinumab | |
|---|---|---|
| Drug class | – | Interleukin-12 Antagonist, Interleukin-23 Antagonist |
| Brand names | Humira | – |
| FAERS reports | 703,389 | 101,629 |
| Serious | 51% | 59% |
| Death outcome | 30,045 | 5,950 |
| Boxed warning | Yes WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead | No |
Signals both drugs share
| Reaction | Adalimumab | Ustekinumab | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 11,430 · PRR 50.9 | 4,564 · PRR 69.7 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 3,088 · PRR 150.3 | Labeled (related wording) / Not in label — unassessed |
| Muscle injury | 3,785 · PRR 24.9 | 2,157 · PRR 73.4 | Labeled (related wording) / Not in label — unassessed |
| Granuloma skin | 539 · PRR 54.9 | 143 · PRR 42.9 | Labeled (related wording) / Not in label — unassessed |
| Pemphigus | 9,240 · PRR 86.7 | 3,867 · PRR 93.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 3,970 · PRR 89.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 3,183 · PRR 93.6 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 2,544 · PRR 67.3 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 2,495 · PRR 277.9 | Likely indication confounding / Not in label — unassessed |
| Facet joint syndrome | 1,918 · PRR 45.6 | 1,380 · PRR 161.2 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 2,023 · PRR 39.0 | 767 · PRR 56.9 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,039 · PRR 234.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 798 · PRR 115.5 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 846 · PRR 149.7 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 661 · PRR 260.2 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 637 · PRR 127.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Adalimumab
- Injection site papule — n=3,181, PRR 70.5 Labeled (related wording)
- Rheumatoid nodule — n=1,249, PRR 23.7 Labeled (related wording)
- Injection site burning — n=562, PRR 73.3 Labeled (related wording)
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)
Common questions
Which has more reported side effects, Adalimumab or Ustekinumab?
Adalimumab has 703,389 FAERS reports and Ustekinumab 101,629. 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 (51% vs 59%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Ustekinumab share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, granuloma skin, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab or Ustekinumab 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.