Adalimumab-Adaz vs Adalimumab-Aaty: side effects in FDA adverse event reports
At a glance
| Adalimumab-Adaz | Adalimumab-Aaty | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | – |
| Brand names | Adalimumab | Adalimumab |
| FAERS reports | 52,421 | 47,048 |
| Serious | 93% | 94% |
| Death outcome | 8,010 | 6,925 |
| 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 WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5 |
Signals both drugs share
| Reaction | Adalimumab-Adaz | Adalimumab-Aaty | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 2,968 · PRR 273.0 | 2,657 · PRR 254.0 | Labeled (related wording) / Labeled (related wording) |
| Muscle injury | 2,233 · PRR 149.7 | 1,962 · PRR 140.2 | Labeled (related wording) / Labeled (related wording) |
| Peripheral venous disease | 1,260 · PRR 184.8 | 1,097 · PRR 169.2 | Labeled (related wording) / Labeled (related wording) |
| Hepatic enzyme | 90 · PRR 737.7 | 68 · PRR 426.2 | Labeled (related wording) / Labeled (related wording) |
| Pemphigus | 3,946 · PRR 186.5 | 3,547 · PRR 178.4 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 3,773 · PRR 162.4 | 3,385 · PRR 155.9 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 2,985 · PRR 165.9 | 2,690 · PRR 160.1 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 2,836 · PRR 151.6 | 2,512 · PRR 143.5 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,392 · PRR 490.1 | 2,133 · PRR 429.5 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,757 · PRR 510.1 | 1,478 · PRR 396.9 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,171 · PRR 602.2 | 1,063 · PRR 534.3 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 956 · PRR 363.7 | 868 · PRR 339.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 944 · PRR 296.6 | 822 · PRR 262.5 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 866 · PRR 129.5 | 797 · PRR 129.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 865 · PRR 1,097.8 | 795 · PRR 918.0 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 778 · PRR 351.8 | 668 · PRR 299.1 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 314 · PRR 155.6 | 297 · PRR 160.7 | Likely indication confounding / Likely indication confounding |
| Subcutaneous drug absorption impaired | 227 · PRR 287.2 | 194 · PRR 247.4 | Not in label — unassessed / Not in label — unassessed |
| Steroid dependence | 206 · PRR 128.0 | 206 · PRR 142.8 | Not in label — unassessed / Not in label — unassessed |
| Paradoxical psoriasis | 172 · PRR 277.3 | 177 · PRR 324.9 | 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-Aaty
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Adalimumab-Adaz or Adalimumab-Aaty?
Adalimumab-Adaz has 52,421 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 (93% vs 94%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab-Adaz and Adalimumab-Aaty 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-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.