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U.S. Department of Health and Human Services

Safety

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Omniscan (Gadodiamide) Injection

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

November 2014

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Convulsions have been reported with intravenous use in patients with and without a history of convulsions or brain lesions. 

 

August 2013

Summary View

CONTRAINDICATIONS

  • prior hypersensitivity reaction to Omniscan
 

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reaction - Anaphylactoid and anaphylactic reactions, with cardiovascular, respiratory and/or cutaneous manifestations, resulting in death have occurred…