Tacrolimus vs Everolimus: side effects in FDA adverse event reports
At a glance
| Tacrolimus | Everolimus | |
|---|---|---|
| Drug class | – | Kinase Inhibitor, mTOR Inhibitor Immunosuppressant |
| Brand names | – | – |
| FAERS reports | 155,699 | 49,204 |
| Serious | 90% | 77% |
| Death outcome | 25,744 | 10,666 |
| 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
| Reaction | Tacrolimus | Everolimus | Label screen (A / B) |
|---|---|---|---|
| Polyomavirus-associated nephropathy | 1,817 · PRR 501.3 | 302 · PRR 61.8 | Labeled adverse reaction / Not in label — unassessed |
| Bk virus infection | 1,551 · PRR 116.6 | 304 · PRR 41.3 | Labeled adverse reaction / Labeled (related wording) |
| Parvovirus b19 infection | 531 · PRR 206.6 | 55 · PRR 27.5 | Labeled adverse reaction / Not in label — unassessed |
| Human polyomavirus infection | 295 · PRR 178.5 | 43 · PRR 37.3 | Labeled (related wording) / Not in label — unassessed |
| Polyomavirus viraemia | 689 · PRR 304.9 | 180 · PRR 91.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Tacrolimus
- Post transplant lymphoproliferative disorder — n=3,045, PRR 210.3 Labeled (related wording)
- Transplant dysfunction — n=1,248, PRR 335.9 Labeled (related wording)
- Renal transplant failure — n=600, PRR 210.5 Labeled (related wording)
- Lung transplant rejection — n=366, PRR 165.9 Labeled (related wording)
- Graft loss — n=357, PRR 128.3 Labeled adverse reaction
- Renal graft infection — n=195, PRR 756.4 Labeled (related wording)
- New onset diabetes after transplantation — n=163, PRR 5,374.4 Labeled adverse reaction
- Pancreas transplant rejection — n=149, PRR 377.9 Labeled (related wording)
Labeled signals distinctive to Everolimus
- Pancreatic neuroendocrine tumour — n=175, PRR 155.9 Labeled adverse reaction
- Insulinoma — n=26, PRR 70.7 Labeled adverse reaction
Common questions
Which has more reported side effects, Tacrolimus or Everolimus?
Tacrolimus has 155,699 FAERS reports and Everolimus 49,204. 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 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tacrolimus and Everolimus share?
Both drugs carry disproportionality signals for polyomavirus-associated nephropathy, bk virus infection, parvovirus b19 infection, human polyomavirus infection, polyomavirus viraemia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tacrolimus or Everolimus 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.