Tacrolimus vs Ruxolitinib: side effects in FDA adverse event reports
At a glance
| Tacrolimus | Ruxolitinib | |
|---|---|---|
| Drug class | – | Kinase Inhibitor, Janus Kinase Inhibitor |
| Brand names | – | Jakafi, Jakafi Xr |
| FAERS reports | 155,699 | 71,064 |
| Serious | 90% | 49% |
| Death outcome | 25,744 | 9,813 |
| Boxed warning | Yes MALIGNANCIES AND SERIOUS INFECTIONS • Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lea | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Tacrolimus
- Post transplant lymphoproliferative disorder — n=3,045, PRR 210.3 Labeled (related wording)
- Polyomavirus-associated nephropathy — n=1,817, PRR 501.3 Labeled adverse reaction
- Bk virus infection — n=1,551, PRR 116.6 Labeled adverse reaction
- Transplant dysfunction — n=1,248, PRR 335.9 Labeled (related wording)
- Renal transplant failure — n=600, PRR 210.5 Labeled (related wording)
- Parvovirus b19 infection — n=531, PRR 206.6 Labeled adverse reaction
- Lung transplant rejection — n=366, PRR 165.9 Labeled (related wording)
- Graft loss — n=357, PRR 128.3 Labeled adverse reaction
Labeled signals distinctive to Ruxolitinib
- Graft versus host disease in gastrointestinal tract — n=223, PRR 34.4 Labeled (related wording)
- Graft versus host disease in skin — n=202, PRR 29.7 Labeled (related wording)
- Myeloproliferative neoplasm — n=112, PRR 60.7 Labeled adverse reaction
- Chronic graft versus host disease in skin — n=91, PRR 32.6 Labeled (related wording)
- Disease risk factor — n=37, PRR 30.5 Labeled (related wording)
Common questions
Which has more reported side effects, Tacrolimus or Ruxolitinib?
Tacrolimus has 155,699 FAERS reports and Ruxolitinib 71,064. 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 (90% vs 49%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tacrolimus and Ruxolitinib share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Tacrolimus or Ruxolitinib 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.