Cyclophosphamide vs Cyclosporine: side effects in FDA adverse event reports
At a glance
| Cyclophosphamide | Cyclosporine | |
|---|---|---|
| Drug class | Alkylating Drug | Calcineurin Inhibitor Immunosuppressant |
| Brand names | – | Cyclosporine Modified |
| FAERS reports | 175,993 | 110,597 |
| Serious | 96% | 68% |
| Death outcome | 35,641 | 14,502 |
| Boxed warning | No | 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 | Cyclophosphamide | Cyclosporine | Label screen (A / B) |
|---|---|---|---|
| Acute graft versus host disease | 1,426 · PRR 53.1 | 1,290 · PRR 73.5 | Not in label — unassessed / Labeled (related wording) |
| Cytomegalovirus infection reactivation | 1,352 · PRR 55.1 | 1,074 · PRR 63.7 | Labeled (related wording) / Labeled (related wording) |
| Chronic graft versus host disease | 1,056 · PRR 48.5 | 1,203 · PRR 93.7 | Not in label — unassessed / Labeled (related wording) |
| Acute graft versus host disease in skin | 871 · PRR 54.8 | 1,017 · PRR 110.9 | Not in label — unassessed / Labeled (related wording) |
| Bk virus infection | 810 · PRR 37.8 | 828 · PRR 62.2 | Not in label — unassessed / Labeled adverse reaction |
| Graft versus host disease in skin | 543 · PRR 38.8 | 575 · PRR 67.0 | Not in label — unassessed / Labeled (related wording) |
| Viral haemorrhagic cystitis | 284 · PRR 80.2 | 205 · PRR 77.5 | Labeled (related wording) / Not in label — unassessed |
| Chronic graft versus host disease in skin | 213 · PRR 36.2 | 249 · PRR 71.3 | Not in label — unassessed / Labeled (related wording) |
| Acute graft versus host disease in liver | 180 · PRR 39.4 | 265 · PRR 110.3 | Not in label — unassessed / Labeled (related wording) |
| Cystitis viral | 177 · PRR 103.7 | 116 · PRR 83.0 | Labeled (related wording) / Not in label — unassessed |
| Acute graft versus host disease in intestine | 348 · PRR 39.1 | 508 · PRR 107.8 | Not in label — unassessed / Not in label — unassessed |
| Encephalitis cytomegalovirus | 155 · PRR 66.4 | 125 · PRR 77.0 | Not in label — unassessed / Not in label — unassessed |
| Thymus hypoplasia | 140 · PRR 544.0 | 92 · PRR 219.5 | Not in label — unassessed / Not in label — unassessed |
| Lymphoid tissue hypoplasia | 139 · PRR 2,025.4 | 93 · PRR 320.5 | Likely indication confounding / Not in label — unassessed |
| Disseminated aspergillosis | 123 · PRR 42.2 | 90 · PRR 44.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Cyclophosphamide
- Cystitis haemorrhagic — n=1,125, PRR 46.1 Labeled (related wording)
- Hepatitis b reactivation — n=791, PRR 39.3 Labeled (related wording)
- Secondary immunodeficiency — n=283, PRR 36.8 Labeled (related wording)
- Ovarian failure — n=143, PRR 42.7 Labeled adverse reaction
- Cystitis bacterial — n=100, PRR 49.4 Labeled (related wording)
- Blood stem cell transplant failure — n=89, PRR 83.7 Labeled (related wording)
- Complications of bone marrow transplant — n=83, PRR 34.8 Labeled (related wording)
Labeled signals distinctive to Cyclosporine
- Graft versus host disease — n=1,726, PRR 59.3 Labeled (related wording)
- Graft versus host disease in gastrointestinal tract — n=619, PRR 77.7 Labeled (related wording)
- Transplant dysfunction — n=588, PRR 95.1 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)
- Chronic graft versus host disease in liver — n=111, PRR 84.6 Labeled (related wording)
- Graft dysfunction — n=99, PRR 98.5 Labeled (related wording)
- Chronic graft versus host disease oral — n=88, PRR 109.9 Labeled (related wording)
Common questions
Which has more reported side effects, Cyclophosphamide or Cyclosporine?
Cyclophosphamide has 175,993 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 (96% vs 68%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Cyclophosphamide and Cyclosporine share?
Both drugs carry disproportionality signals for acute graft versus host disease, cytomegalovirus infection reactivation, chronic graft versus host disease, acute graft versus host disease in skin, bk virus infection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Cyclophosphamide 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.