Safety

Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution

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

October 2015

Summary View

ADVERSE REACTIONS

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

  • Nervous System Disorders: *Cerebral Edema Injury, poisoning and procedural complications: **Radiation pneumonitis, **Pulmonary fibrosis


*In patients with iodine-avid brain metastases
**In patients with iodine-avid lung metastases

 

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.

 

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