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U.S. Department of Health and Human Services

Safety

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Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution

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

 

March 2014

Summary View

CONTRAINDICATIONS

  • breastfeeding

ADVERSE REACTIONS

The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of benign disease, such as hyperthyroidism:

  • sialadenitis, iododerma, hypothyroidism, hyperthyroidism, thyrotoxic crisis, hypoparathyroidism, and local

The following adverse reactions have been reported with doses of sodium iodide I-131 used in the treatment of malignant disease:

  • solid cancers, nausea, vomiting, and congenital hypothyroidism 

 

February 2012

Summary View

ADVERSE REACTIONS

  • Published reports have described salivary and lacrimal gland dysfunction.