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U.S. Department of Health and Human Services

Safety

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Prograf (tacrolimus) Capsules, Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011

 

Summary View

5 WARNINGS AND PRECAUTIONS

5.16 Pure Red Cell Aplasia
  • Cases of pure red cell aplasia (PRCA) have......

6 ADVERSE REACTIONS

6.2 Post Market Reactions
  • hemic/lymphatic......pure red cell aplasia added