Adalimumab vs Infliximab: side effects in FDA adverse event reports
At a glance
| Adalimumab | Infliximab | |
|---|---|---|
| Drug class | – | Tumor Necrosis Factor Blocker |
| Brand names | Humira | Renflexis |
| FAERS reports | 703,389 | 217,056 |
| Serious | 51% | 89% |
| Death outcome | 30,045 | 13,761 |
| 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 | Yes SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of seri |
Signals both drugs share
| Reaction | Adalimumab | Infliximab | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 11,430 · PRR 50.9 | 9,005 · PRR 96.4 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 4,679 · PRR 171.9 | Labeled (related wording) / Not in label — unassessed |
| Muscle injury | 3,785 · PRR 24.9 | 3,385 · PRR 67.7 | Labeled (related wording) / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 3,038 · PRR 224.9 | Likely indication confounding / Labeled (related wording) |
| Granuloma skin | 539 · PRR 54.9 | 530 · PRR 173.6 | Labeled (related wording) / Not in label — unassessed |
| Pemphigus | 9,240 · PRR 86.7 | 8,799 · PRR 239.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 7,477 · PRR 129.7 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 4,856 · PRR 88.0 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 4,112 · PRR 63.8 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,918 · PRR 45.6 | 1,773 · PRR 124.9 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 2,023 · PRR 39.0 | 1,235 · PRR 51.5 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,228 · PRR 163.6 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 1,023 · PRR 82.3 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 964 · PRR 88.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 713 · PRR 145.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 660 · PRR 63.0 | 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 Infliximab
- Lupus-like syndrome — n=3,336, PRR 56.5 Labeled adverse reaction
- Hepatosplenic t-cell lymphoma — n=184, PRR 94.3 Labeled — boxed warning
- Swollen joint count — n=135, PRR 117.9 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Infliximab?
Adalimumab has 703,389 FAERS reports and Infliximab 217,056. 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 89%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Infliximab share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, rheumatic fever, granuloma skin. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab or Infliximab 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.