Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in labeling: Radiation-induced Thyroiditis [see Warnings and Precautions (5.1) ] .
Radiation-induced Toxicities [see Warnings and Precautions (5.2) ].
Hypersensitivity Reactions [see Warnings and Precautions (5.3) ].
Embryo-Fetal Toxicity[see Warnings and Precautions (5.4) , Use in Specific Population (8.1) ].
Increased Radiation Exposure to Breast Tissue with Lactation [see Warnings and Precautions (5.5) , Use in Specific Populations (8.2) ].
Transient Infertility [see Warnings and Precautions (5.6) , Use in Specific Population (8.3) ].
Radiation Exposure to Other Individuals [see Warnings and Precautions (5.7) ].
Risk of Decreased Effectiveness of Therapy [see Warnings and Precautions (5.8) ].
Common adverse reactions reported with therapeutic doses of sodium iodide I-131 include local swelling, radiation sickness, sialadenitis, salivary gland dysfunction, bone marrow depression, lacrimal gland dysfunction, hypothyroidism, hyperthyroidism, thyrotoxic crisis.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact International Isotopes Inc.
at 1-800-699-3108 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Radiation-induced thyroiditis may cause or worsen hyperthyroidism.
Consider pre-treatment with anti-thyroid medications.
( 5.1 ) Multiple non-thyroid radiation toxicities, including hematopoietic suppression: Individualize dose and monitor for toxicity.
( 5.2 ) Fetal toxicity: May cause severe and irreversible hypothyroidism in the neonate.
Verify absence of pregnancy before administering the product.
Like all medications, Sodium Iodide I-131 can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: