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U.S. Department of Health and Human Services

Safety

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Kineret (anakinra) for injection

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

 

October 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Kineret. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepato-biliary disorders:
  • elevations of transaminases
  • non-infectious hepatitis