Adalimumab vs Adalimumab-Aaty: side effects in FDA adverse event reports
At a glance
| Adalimumab | Adalimumab-Aaty | |
|---|---|---|
| Drug class | – | – |
| Brand names | Humira | Adalimumab |
| FAERS reports | 703,389 | 47,048 |
| Serious | 51% | 94% |
| Death outcome | 30,045 | 6,925 |
| 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. SERIOUS INFECTIONS ( 5 |
Signals both drugs share
| Reaction | Adalimumab | Adalimumab-Aaty | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 2,657 · PRR 254.0 | Labeled (related wording) / Labeled (related wording) |
| Muscle injury | 3,785 · PRR 24.9 | 1,962 · PRR 140.2 | Labeled (related wording) / Labeled (related wording) |
| Pemphigus | 9,240 · PRR 86.7 | 3,547 · PRR 178.4 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 3,385 · PRR 155.9 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 2,690 · PRR 160.1 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 2,512 · PRR 143.5 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 2,133 · PRR 429.5 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,918 · PRR 45.6 | 1,478 · PRR 396.9 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 2,023 · PRR 39.0 | 797 · PRR 129.5 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,063 · PRR 534.3 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 822 · PRR 262.5 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 868 · PRR 339.4 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 795 · PRR 918.0 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 668 · PRR 299.1 | 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-Aaty
- Peripheral venous disease — n=1,097, PRR 169.2 Labeled (related wording)
- Hepatic enzyme — n=68, PRR 426.2 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Adalimumab-Aaty?
Adalimumab has 703,389 FAERS reports and Adalimumab-Aaty 47,048. 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 94%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Adalimumab-Aaty 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-Aaty 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.