warnings
WARNINGS Sodium iodide I 131 is not usually used for the treatment of hyperthyroidism in patients under 30 years of age unless circumstances preclude other methods of treatment.
FDA label 5a221b83-b3ad-45a8-be87-632cd8c5b3b3
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- e7e62765-1872-4690-bb32-c2d3d831e951
- SPL ID
- 5a221b83-b3ad-45a8-be87-632cd8c5b3b3
- Version
- 3
- Effective date
- 2013-01-03
- Source export date
- 2026-10-12
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:33:54
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 5a221b83-b3ad-45a8-be87-632cd8c5b3b3 | id | |
| spl set id | e7e62765-1872-4690-bb32-c2d3d831e951 | set_id |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS The immediate adverse reactions following sodium iodide I 131 treatment of hyperthyroidism are usually mild. Following the larger doses used in treating thyroid carcinoma, adverse reactions may be much more severe and present special problems. Untoward effects which may be associated with the use of sodium iodide I 131 include depression of the hematopoietic system when large doses are employed, radiation sickness (some degree of nausea and vomiting), increase in clinical symptoms, bone marrow depression, severe sialoadenitis, acute leukemia, anemia, chromosomal abnormalities, acute thyroid crises, blood dyscrasia, leukopenia, or thrombocytopenia. Tenderness and swelling of the neck, pain on swallowing, sore throat, and cough may occur around the third day after treatment and are usually amenable to analgesics. Temporary thinning of the hair may occur two to three months after treatment. Allergic type reactions have been reported infrequently following the administration of iodine-containing radiopharmaceuticals.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.