Tacrolimus vs Hydrocortisone: side effects in FDA adverse event reports
At a glance
| Tacrolimus | Hydrocortisone | |
|---|---|---|
| Drug class | – | Corticosteroid |
| Brand names | – | – |
| FAERS reports | 155,699 | 88,710 |
| Serious | 90% | 82% |
| Death outcome | 25,744 | 11,614 |
| 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
No strong shared signal after removing coding and lab terms.
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
- Bk virus infection — n=1,551, PRR 116.6 Labeled adverse reaction
- Transplant dysfunction — n=1,248, PRR 335.9 Labeled (related wording)
- 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
Labeled signals distinctive to Hydrocortisone
- Duodenal ulcer perforation — n=2,466, PRR 119.8 Labeled (related wording)
- Steroid withdrawal syndrome — n=250, PRR 76.9 Labeled (related wording)
- Secondary immunodeficiency — n=223, PRR 54.2 Labeled (related wording)
- Adrenal suppression — n=148, PRR 50.2 Labeled (related wording)
- Topical steroid withdrawal reaction — n=146, PRR 145.5 Labeled (related wording)
Common questions
Which has more reported side effects, Tacrolimus or Hydrocortisone?
Tacrolimus has 155,699 FAERS reports and Hydrocortisone 88,710. 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 82%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tacrolimus and Hydrocortisone share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Tacrolimus or Hydrocortisone 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.