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About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Prograf

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Fujisawa Healthcare
Approval Status: Approved April 1997
Treatment for: kidney transplant rejection

General Information

Prograf has been approved for use as an immunosuppressive for the prevention of organ rejection in kidney transplant recipients. It is manufactured in capsule and injection form. Previously, Prograf has been used since 1994 for the prophylaxis of rejection in liver transplants.

Side Effects

Adverse effects associated with Prograf include tremor, hypertension, hypophosphatemia, infection, creatinine increase, headache, and diarrhea. New onset post-transplant diabetes mellitus (PTDM) was seen in 20% of Prograf-treated kidney transplant patients. The percentage of PTDM patients that remained insulin dependent at the two year post-transplant mark declined to 11%.


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Drug listing last updated on June 20, 2008

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