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U.S. Department of Health and Human Services

Safety

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Halaven (Eribulin Mesylate) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse drug reaction has been identified during post-approval of HALAVEN. 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. Gastrointestinal Disorders: Pancreatitis