Cyclosporine vs Mycophenolate Mofetil: side effects in FDA adverse event reports
At a glance
| Cyclosporine | Mycophenolate Mofetil | |
|---|---|---|
| Drug class | Calcineurin Inhibitor Immunosuppressant | – |
| Brand names | Cyclosporine Modified | – |
| FAERS reports | 110,597 | 32,904 |
| Serious | 68% | 84% |
| Death outcome | 14,502 | 4,489 |
| Boxed warning | Yes Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, USP MODIFIED. | Yes EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenit |
Signals both drugs share
| Reaction | Cyclosporine | Mycophenolate Mofetil | Label screen (A / B) |
|---|---|---|---|
| Bk virus infection | 828 · PRR 62.2 | 1,455 · PRR 119.5 | Labeled adverse reaction / Labeled adverse reaction |
| Acute graft versus host disease in skin | 1,017 · PRR 110.9 | 1,046 · PRR 94.7 | Labeled (related wording) / Not in label — unassessed |
| Transplant dysfunction | 588 · PRR 95.1 | 1,031 · PRR 221.6 | Labeled (related wording) / Likely indication confounding |
| Chronic graft versus host disease in skin | 249 · PRR 71.3 | 372 · PRR 107.3 | Labeled (related wording) / Not in label — unassessed |
| Chronic allograft nephropathy | 167 · PRR 50.9 | 435 · PRR 192.7 | Not in label — unassessed / Labeled (related wording) |
| Acute graft versus host disease in liver | 265 · PRR 110.3 | 273 · PRR 94.5 | Labeled (related wording) / Not in label — unassessed |
| Graft dysfunction | 99 · PRR 98.5 | 114 · PRR 100.7 | Labeled (related wording) / Not in label — unassessed |
| Acute graft versus host disease in intestine | 508 · PRR 107.8 | 536 · PRR 95.9 | Not in label — unassessed / Not in label — unassessed |
| Heart transplant rejection | 182 · PRR 39.8 | 557 · PRR 178.2 | Likely indication confounding / Likely indication confounding |
| Smooth muscle cell neoplasm | 105 · PRR 64.3 | 290 · PRR 370.4 | Not in label — unassessed / Not in label — unassessed |
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)
- 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)
- Graft versus host disease in liver — n=200, PRR 74.0 Labeled (related wording)
Labeled signals distinctive to Mycophenolate Mofetil
- Post transplant lymphoproliferative disorder — n=2,254, PRR 126.8 Labeled (related wording)
- Polyomavirus-associated nephropathy — n=1,473, PRR 272.3 Labeled adverse reaction
- Renal transplant failure — n=425, PRR 117.2 Labeled (related wording)
- Graft loss — n=296, PRR 105.1 Labeled adverse reaction
- Lung transplant rejection — n=251, PRR 94.0 Labeled (related wording)
- Human polyomavirus infection — n=227, PRR 120.6 Labeled (related wording)
- Renal graft infection — n=144, PRR 257.5 Labeled (related wording)
- Cytomegalovirus gastrointestinal infection — n=113, PRR 93.8 Labeled (related wording)
Common questions
Which has more reported side effects, Cyclosporine or Mycophenolate Mofetil?
Cyclosporine has 110,597 FAERS reports and Mycophenolate Mofetil 32,904. 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 (68% vs 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Cyclosporine and Mycophenolate Mofetil share?
Both drugs carry disproportionality signals for bk virus infection, acute graft versus host disease in skin, transplant dysfunction, chronic graft versus host disease in skin, chronic allograft nephropathy. Shared signals often reflect a shared drug class or the condition both are used for.
Is Cyclosporine or Mycophenolate Mofetil 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.