Janus Kinase Inhibitor side effects compared: 4 drugs, 94,682 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Upadacitinib (Rinvoq) | 81,026 | 68% | 3,016 | boxed | Ileostomy; Eczema herpeticum; Small intestinal resection | Knee arthroplasty; Colectomy |
| Baricitinib (Olumiant) | 9,584 | 69% | 877 | boxed | Covid-19 pneumonia; Thrombocytosis; Diverticulitis intestinal perforated | Haemophagocytic lymphohistiocytosis; Bronchopulmonary aspergillosis |
| Abrocitinib (Cibinqo) | 3,839 | 34% | 65 | boxed | Acne; Dry skin; Herpes zoster | Pruritus; Eczema |
| Delgocitinib (Anzupgo) | 233 | 33% | 2 | – | – | Dermatitis atopic; Dermatitis |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Eczema herpeticum | 2/4 | 61.0 | 96 | 2/2 members' labels |
| Dermatitis | 2/4 | 45.7 | 37 | 0/2 members' labels |
| Dermatitis atopic | 2/4 | 31.9 | 196 | 0/2 members' labels |
| Arthrodesis | 2/4 | 20.3 | 73 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Ostomy bag placement | Upadacitinib | 130 | 112.5 | Not in label — unassessed |
| Semen discolouration | Upadacitinib | 81 | 94.9 | Not in label — unassessed |
| Subcutaneous drug absorption impaired | Upadacitinib | 105 | 61.7 | Not in label — unassessed |
| Stoma creation | Upadacitinib | 125 | 59.0 | Not in label — unassessed |
| Intestinal anastomosis | Upadacitinib | 81 | 38.2 | Not in label — unassessed |
| Ileostomy | Upadacitinib | 288 | 33.2 | Labeled adverse reaction |
| Medical device implantation | Upadacitinib | 150 | 28.3 | Not in label — unassessed |
| Colectomy total | Upadacitinib | 54 | 27.6 | Not in label — unassessed |
| Shoulder arthroplasty | Upadacitinib | 251 | 27.0 | Not in label — unassessed |
| Neck surgery | Upadacitinib | 171 | 20.7 | Not in label — unassessed |
| Haemophagocytic lymphohistiocytosis | Baricitinib | 62 | 18.9 | Not in label — unassessed |
| Colectomy | Upadacitinib | 383 | 18.9 | Not in label — unassessed |
| Wrist surgery | Upadacitinib | 63 | 18.9 | Not in label — unassessed |
| Knee arthroplasty | Upadacitinib | 1,409 | 18.7 | Not in label — unassessed |
| Covid-19 pneumonia | Baricitinib | 96 | 17.8 | Labeled adverse reaction |
| Joint arthroplasty | Upadacitinib | 114 | 17.5 | Not in label — unassessed |
| Hip surgery | Upadacitinib | 314 | 16.2 | Not in label — unassessed |
| Small intestinal resection | Upadacitinib | 66 | 15.6 | Labeled (related wording) |
| Bronchopulmonary aspergillosis | Baricitinib | 54 | 15.4 | Not in label — unassessed |
| Spinal fusion surgery | Upadacitinib | 224 | 15.2 | Not in label — unassessed |
| Oral surgery | Upadacitinib | 127 | 14.9 | Not in label — unassessed |
| Eczema | Abrocitinib | 91 | 9.9 | Not in label — unassessed |
| Acne | Abrocitinib | 88 | 6.3 | Labeled adverse reaction |
| Herpes zoster | Abrocitinib | 53 | 5.0 | Labeled — boxed warning |
| Sleep disorder | Abrocitinib | 55 | 4.3 | Not in label — unassessed |
Common questions
Which janus kinase inhibitor has the most FDA adverse event reports?
Upadacitinib has the most FAERS co-reports in this class (81,026), followed by Baricitinib (9,584). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across janus kinase inhibitor drugs?
Reaction terms flagged in at least half of the 4 members include eczema herpeticum, dermatitis, dermatitis atopic, arthrodesis. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.