Prednisone vs Cyclosporine: side effects in FDA adverse event reports
At a glance
| Prednisone | Cyclosporine | |
|---|---|---|
| Drug class | Corticosteroid | Calcineurin Inhibitor Immunosuppressant |
| Brand names | – | Cyclosporine Modified |
| FAERS reports | 499,794 | 110,597 |
| Serious | 79% | 68% |
| Death outcome | 52,153 | 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 | Prednisone | Cyclosporine | Label screen (A / B) |
|---|---|---|---|
| Granuloma skin | 482 · PRR 57.9 | 234 · PRR 74.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Prednisone
- Duodenal ulcer perforation — n=4,860, PRR 82.3 Labeled (related wording)
- Nocardiosis — n=888, PRR 21.9 Labeled (related wording)
- Steroid diabetes — n=492, PRR 21.0 Labeled (related wording)
- Secondary immunodeficiency — n=420, PRR 22.4 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)
- Bk virus infection — n=828, PRR 62.2 Labeled adverse reaction
- 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)
Common questions
Which has more reported side effects, Prednisone or Cyclosporine?
Prednisone has 499,794 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 (79% vs 68%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Prednisone and Cyclosporine share?
Both drugs carry disproportionality signals for granuloma skin. Shared signals often reflect a shared drug class or the condition both are used for.
Is Prednisone 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.