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U.S. Department of Health and Human Services


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Lovaza (omega-3-acid ethyl esters) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Brand (Generic) Name

Sections Modified

Lovaza (omega-3-acid ethyl esters) Capsules


  • Postmarketing Experience
    • The following events have been reported: anaphylactic reaction, hemorrhagic diathesis