SIROLIMUS for Renal transplant: Side Effects & Safety Data
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There are 830 adverse event reports in the FDA FAERS database where SIROLIMUS was used for Renal transplant.
Most Reported Side Effects for SIROLIMUS
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 1,960 | 17.2% | 251 | 523 |
| Drug ineffective | 1,005 | 8.8% | 148 | 261 |
| Product use in unapproved indication | 984 | 8.7% | 171 | 268 |
| Transplant rejection | 698 | 6.1% | 49 | 117 |
| Pneumonia | 599 | 5.3% | 128 | 267 |
| Product use issue | 506 | 4.5% | 44 | 150 |
| Alopecia | 491 | 4.3% | 2 | 11 |
| Acne | 482 | 4.2% | 1 | 12 |
| Transplant dysfunction | 468 | 4.1% | 2 | 9 |
| Condition aggravated | 433 | 3.8% | 58 | 112 |
| Ovarian cyst | 420 | 3.7% | 0 | 10 |
| Death | 386 | 3.4% | 383 | 45 |
| Diarrhoea | 371 | 3.3% | 40 | 205 |
| Pyrexia | 370 | 3.3% | 43 | 244 |
| Acute kidney injury | 320 | 2.8% | 71 | 202 |
Other Indications for SIROLIMUS
Immunosuppressant drug therapy (1,687)
Product used for unknown indication (944)
Immunosuppression (884)
Prophylaxis against transplant rejection (777)
Prophylaxis against graft versus host disease (710)
Liver transplant (486)
Heart transplant (367)
Graft versus host disease (289)
Transplant (265)
Chronic graft versus host disease (189)
Other Drugs Used for Renal transplant
TACROLIMUS (14,171)
MYCOPHENOLATE MOFETIL (5,874)
CYCLOSPORINE (2,768)
MYCOPHENOLIC ACID (2,668)
PREDNISONE (2,500)
PREDNISOLONE (2,476)
MYCOPHENOLATE (1,905)
EVEROLIMUS (1,604)
BASILIXIMAB (1,435)
TACROLIMUS\TACROLIMUS ANHYDROUS (1,368)