Adalimumab-Adaz vs Adalimumab-Fkjp: side effects in FDA adverse event reports
At a glance
| Adalimumab-Adaz | Adalimumab-Fkjp | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | – |
| Brand names | Adalimumab | Adalimumab |
| FAERS reports | 52,421 | 46,046 |
| Serious | 93% | 95% |
| Death outcome | 8,010 | 6,734 |
| Boxed warning | Yes SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing | 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-Adaz | Adalimumab-Fkjp | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 2,968 · PRR 273.0 | 2,658 · PRR 259.7 | Labeled (related wording) / Labeled (related wording) |
| Muscle injury | 2,233 · PRR 149.7 | 1,963 · PRR 143.4 | Labeled (related wording) / Labeled (related wording) |
| Peripheral venous disease | 1,260 · PRR 184.8 | 1,097 · PRR 172.9 | Labeled (related wording) / Labeled (related wording) |
| Hepatic enzyme | 90 · PRR 737.7 | 68 · PRR 435.5 | Labeled (related wording) / Labeled (related wording) |
| Pemphigus | 3,946 · PRR 186.5 | 3,550 · PRR 182.5 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 3,773 · PRR 162.4 | 3,387 · PRR 159.4 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,985 · PRR 165.9 | 2,690 · PRR 163.6 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,836 · PRR 151.6 | 2,512 · PRR 146.6 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,392 · PRR 490.1 | 2,134 · PRR 439.3 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,757 · PRR 510.1 | 1,478 · PRR 405.5 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,171 · PRR 602.2 | 1,063 · PRR 545.9 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 956 · PRR 363.7 | 869 · PRR 347.6 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 944 · PRR 296.6 | 822 · PRR 268.2 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 866 · PRR 129.5 | 799 · PRR 132.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 865 · PRR 1,097.8 | 795 · PRR 938.0 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 778 · PRR 351.8 | 668 · PRR 305.6 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 314 · PRR 155.6 | 294 · PRR 161.9 | Likely indication confounding / Likely indication confounding |
| Subcutaneous drug absorption impaired | 227 · PRR 287.2 | 194 · PRR 252.8 | Not in label — unassessed / Not in label — unassessed |
| Steroid dependence | 206 · PRR 128.0 | 206 · PRR 145.9 | Not in label — unassessed / Not in label — unassessed |
| Paradoxical psoriasis | 172 · PRR 277.3 | 169 · PRR 306.8 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Adalimumab-Adaz
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Adalimumab-Fkjp
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Adalimumab-Adaz or Adalimumab-Fkjp?
Adalimumab-Adaz has 52,421 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 (93% vs 95%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab-Adaz and Adalimumab-Fkjp share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, muscle injury, peripheral venous disease, hepatic enzyme, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab-Adaz 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.