PROGRAF for Immunosuppression: Side Effects & Safety Data
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There are 16 adverse event reports in the FDA FAERS database where PROGRAF was used for Immunosuppression.
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 Immunosuppression
TACROLIMUS (9,959)
MYCOPHENOLATE MOFETIL (6,355)
PREDNISONE (5,733)
CYCLOSPORINE (2,989)
MYCOPHENOLIC ACID (2,778)
PREDNISOLONE (2,577)
METHYLPREDNISOLONE (2,041)
AZATHIOPRINE (1,324)
BASILIXIMAB (1,083)
SIROLIMUS (884)