Tacrolimus vs Cyclosporine: side effects in FDA adverse event reports
At a glance
| Tacrolimus | Cyclosporine | |
|---|---|---|
| Drug class | – | Calcineurin Inhibitor Immunosuppressant |
| Brand names | – | Cyclosporine Modified |
| FAERS reports | 155,699 | 110,597 |
| Serious | 90% | 68% |
| Death outcome | 25,744 | 14,502 |
| Boxed warning | Yes MALIGNANCIES AND SERIOUS INFECTIONS • Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lea | Yes Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, USP MODIFIED. |
Signals both drugs share
| Reaction | Tacrolimus | Cyclosporine | Label screen (A / B) |
|---|---|---|---|
| Bk virus infection | 1,551 · PRR 116.6 | 828 · PRR 62.2 | Labeled adverse reaction / Labeled adverse reaction |
| Transplant dysfunction | 1,248 · PRR 335.9 | 588 · PRR 95.1 | Labeled (related wording) / Labeled (related wording) |
| Heart transplant rejection | 619 · PRR 197.7 | 182 · PRR 39.8 | Likely indication confounding / Likely indication confounding |
| Chronic allograft nephropathy | 540 · PRR 299.2 | 167 · PRR 50.9 | Not in label — unassessed / Not in label — unassessed |
| Epstein-barr viraemia | 491 · PRR 111.3 | 215 · PRR 46.6 | Not in label — unassessed / Not in label — unassessed |
| Smooth muscle cell neoplasm | 330 · PRR 550.9 | 105 · PRR 64.3 | 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)
- Polyomavirus-associated nephropathy — n=1,817, PRR 501.3 Labeled adverse reaction
- 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
- Human polyomavirus infection — n=295, PRR 178.5 Labeled (related wording)
- Renal graft infection — n=195, PRR 756.4 Labeled (related wording)
Labeled signals distinctive to Cyclosporine
- Graft versus host disease — n=1,726, PRR 59.3 Labeled (related wording)
- Acute graft versus host disease — n=1,290, PRR 73.5 Labeled (related wording)
- Chronic graft versus host disease — n=1,203, PRR 93.7 Labeled (related wording)
- Cytomegalovirus infection reactivation — n=1,074, PRR 63.7 Labeled (related wording)
- Acute graft versus host disease in skin — n=1,017, PRR 110.9 Labeled (related wording)
- Graft versus host disease in gastrointestinal tract — n=619, PRR 77.7 Labeled (related wording)
- Graft versus host disease in skin — n=575, PRR 67.0 Labeled (related wording)
- Epstein-barr virus associated lymphoproliferative disorder — n=384, PRR 52.3 Labeled (related wording)
Common questions
Which has more reported side effects, Tacrolimus or Cyclosporine?
Tacrolimus has 155,699 FAERS reports and Cyclosporine 110,597. 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 68%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tacrolimus and Cyclosporine share?
Both drugs carry disproportionality signals for bk virus infection, transplant dysfunction, heart transplant rejection, chronic allograft nephropathy, epstein-barr viraemia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tacrolimus or Cyclosporine 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.