Adalimumab vs Adalimumab-Fkjp: side effects in FDA adverse event reports
At a glance
| Adalimumab | Adalimumab-Fkjp | |
|---|---|---|
| Drug class | – | – |
| Brand names | Humira | Adalimumab |
| FAERS reports | 703,389 | 46,046 |
| Serious | 51% | 95% |
| Death outcome | 30,045 | 6,734 |
| 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 SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-fkjp are at increased risk for developing se |
Signals both drugs share
| Reaction | Adalimumab | Adalimumab-Fkjp | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 2,658 · PRR 259.7 | Labeled (related wording) / Labeled (related wording) |
| Muscle injury | 3,785 · PRR 24.9 | 1,963 · PRR 143.4 | Labeled (related wording) / Labeled (related wording) |
| Pemphigus | 9,240 · PRR 86.7 | 3,550 · PRR 182.5 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 3,387 · PRR 159.4 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 2,690 · PRR 163.6 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 2,512 · PRR 146.6 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 2,134 · PRR 439.3 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,918 · PRR 45.6 | 1,478 · PRR 405.5 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 2,023 · PRR 39.0 | 799 · PRR 132.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,063 · PRR 545.9 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 822 · PRR 268.2 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 869 · PRR 347.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 795 · PRR 938.0 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 668 · PRR 305.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Adalimumab
- Synovitis — n=11,430, PRR 50.9 Labeled adverse reaction
- 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)
- Granuloma skin — n=539, PRR 54.9 Labeled (related wording)
Labeled signals distinctive to Adalimumab-Fkjp
- Peripheral venous disease — n=1,097, PRR 172.9 Labeled (related wording)
- Hepatic enzyme — n=68, PRR 435.5 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Adalimumab-Fkjp?
Adalimumab has 703,389 FAERS reports and Adalimumab-Fkjp 46,046. 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 95%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Adalimumab-Fkjp share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, muscle injury, pemphigus, hand deformity, helicobacter infection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab or Adalimumab-Fkjp 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.