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 af074197-6f46-494d-8804-ff072bf39511
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
- 2cc82f8b-8e3f-7af1-6525-e7f324e8c02b
- SPL ID
- af074197-6f46-494d-8804-ff072bf39511
- Version
- 2
- Effective date
- 2012-02-01
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:42:48
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 | af074197-6f46-494d-8804-ff072bf39511 | id | |
| spl set id | 2cc82f8b-8e3f-7af1-6525-e7f324e8c02b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse events associated with the class of Sodium Iodide I-131 drug product include hypersensitivity reactions, radiation toxicities, and metabolic events. Immediate adverse reactions typically are related to hypersensitivity; e.g., anaphylaxis, rash, hives, bronchospasm, and other allergic events. Radiation adverse events related to the dose include the following: Bone marrow depression, leukopenia, thrombocytopenia, acute leukemia, anemia, blood dyscrasia, chromosomal abnormalities, radiation sickness, and death. Delayed radiation toxicity includes radiation thyroiditis, gastritis and sialadentis. Metabolic adverse events include hypothyroidism and exaggerated hyperthyroidism due to radiation thyroiditis. Tenderness and swelling of the neck, pain on swallowing, sore throat and cough may occur about the 3 rd day after treatment.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.