PROGRAF for Transplant: Side Effects & Safety Data
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There are 10 adverse event reports in the FDA FAERS database where PROGRAF was used for Transplant.
Most Reported Side Effects for PROGRAF
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 143 | 13.9% | 20 | 24 |
| Off label use | 140 | 13.6% | 13 | 41 |
| Acute graft versus host disease | 64 | 6.2% | 3 | 2 |
| Death | 44 | 4.3% | 44 | 5 |
| Chronic graft versus host disease | 43 | 4.2% | 4 | 4 |
| Renal failure | 31 | 3.0% | 5 | 12 |
| Diarrhoea | 30 | 2.9% | 2 | 18 |
| Pneumonia | 30 | 2.9% | 7 | 22 |
| Kidney transplant rejection | 29 | 2.8% | 7 | 16 |
| Malaise | 27 | 2.6% | 1 | 5 |
| Transplant rejection | 23 | 2.2% | 7 | 11 |
| Diabetes mellitus | 21 | 2.0% | 3 | 5 |
| Anaemia | 20 | 2.0% | 4 | 13 |
| Hospitalisation | 20 | 2.0% | 2 | 20 |
| Asthenia | 19 | 1.9% | 1 | 8 |
Other Indications for PROGRAF
Renal transplant (350)
Liver transplant (192)
Prophylaxis against graft versus host disease (101)
Product used for unknown indication (89)
Heart transplant (52)
Lung transplant (33)
Pancreas transplant (28)
Rheumatoid arthritis (23)
Prophylaxis against transplant rejection (20)
Immunosuppressant drug therapy (16)
Other Drugs Used for Transplant
TACROLIMUS (840)
CYCLOSPORINE (486)
MYCOPHENOLATE MOFETIL (391)
SIROLIMUS (265)
TACROLIMUS\TACROLIMUS ANHYDROUS (235)
MYCOPHENOLATE (209)
MYCOPHENOLIC ACID (178)
MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL (155)
EVEROLIMUS (153)
DACLIZUMAB (143)