Tofacitinib vs Apremilast: side effects in FDA adverse event reports
At a glance
| Tofacitinib | Apremilast | |
|---|---|---|
| Drug class | – | Phosphodiesterase 4 Inhibitor |
| Brand names | – | Otezla |
| FAERS reports | 183,399 | 145,474 |
| Serious | 48% | 24% |
| Death outcome | 9,244 | 5,952 |
| Boxed warning | Yes SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are | No |
Signals both drugs share
| Reaction | Tofacitinib | Apremilast | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,332 · PRR 166.2 | 2,155 · PRR 59.8 | Labeled (related wording) / Not in label — unassessed |
| Folliculitis | 3,673 · PRR 63.0 | 2,075 · PRR 36.1 | Not in label — unassessed / Labeled adverse reaction |
| Peripheral venous disease | 1,297 · PRR 54.8 | 1,015 · PRR 49.0 | Labeled (related wording) / Not in label — unassessed |
| Swollen joint count | 128 · PRR 124.5 | 115 · PRR 126.9 | Not in label — unassessed / Labeled adverse reaction |
| Hepatic enzyme | 81 · PRR 158.9 | 75 · PRR 168.1 | Labeled (related wording) / Not in label — unassessed |
| Synovitis | 9,435 · PRR 125.9 | 2,981 · PRR 28.4 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,050 · PRR 134.5 | 2,406 · PRR 32.3 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 6,427 · PRR 123.0 | 2,213 · PRR 31.1 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,568 · PRR 93.0 | 2,129 · PRR 37.9 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,897 · PRR 228.9 | 2,152 · PRR 140.7 | Likely indication confounding / Not in label — unassessed |
| Muscle injury | 3,301 · PRR 76.9 | 1,586 · PRR 34.4 | Not in label — unassessed / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 2,554 · PRR 75.1 | 1,166 · PRR 31.7 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,570 · PRR 113.9 | 1,377 · PRR 112.1 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,294 · PRR 65.7 | 854 · PRR 45.6 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,125 · PRR 155.1 | 975 · PRR 143.3 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 941 · PRR 83.8 | 767 · PRR 75.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 879 · PRR 88.5 | 765 · PRR 88.2 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 731 · PRR 184.1 | 602 · PRR 148.4 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 604 · PRR 64.7 | 603 · PRR 81.5 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 368 · PRR 55.6 | 283 · PRR 48.4 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Tofacitinib
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Apremilast
- Tender joint count — n=19, PRR 41.3 Labeled (related wording)
Common questions
Which has more reported side effects, Tofacitinib or Apremilast?
Tofacitinib has 183,399 FAERS reports and Apremilast 145,474. 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 (48% vs 24%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tofacitinib and Apremilast share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, folliculitis, peripheral venous disease, swollen joint count, hepatic enzyme. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tofacitinib or Apremilast 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.