Prescription medicine
Sodium iodide i 131 Brand names: Hicon; first approved as Iodotope
Sodium iodide i 131 (Hicon) is a prescription medicine with an FDA approval on record since 1957. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the sodium iodide i 131 FDA label on DailyMed (effective January 21, 2025, Jubilant DraxImage Inc., dba Jubilant Radiopharma); the NDA 10929 record on Drugs@FDA; every sodium iodide i 131 label on DailyMed.
Highlights of the record
FDA label of January 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.
Forms and strengths
Kit; solution; capsule.
On the market
- Earliest approval on file
- May 2, 1957 Iodotope, Bracco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first February 5, 2020; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2016 0 Class I among all firms' recalls; latest February 19, 2026
- FAERS reports
- 1,122 through July 30, 2026
What is sodium iodide i 131 used for?
From the label: indications and usageHICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
FDA pharmacologic class: Radioactive Therapeutic Agent.
Source: FDA drug label (HICON), Jubilant DraxImage Inc., dba Jubilant Radiopharma, effective January 21, 2025 (SPL set 524a0dac-6e2b-2c0c-04b4-76d85dba63c5), via openFDA; the full label on DailyMed
Is there a generic for sodium iodide i 131 (Hicon)?
The FDA approved the first generic sodium iodide i 131 on February 5, 2020. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium iodide i 131 from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1957 earliest approval on file
- 2020 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has sodium iodide i 131 been recalled?
The FDA's Enforcement Report lists 3 recalls naming sodium iodide i 131 since 2016: 0 Class I (the most serious), 1 Class II, 2 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 19, 2026 | Class III | Radnostix | Failed Tablet/Capsule Specifications |
| January 26, 2026 | Class II | Radnostix | Presence of Particulate Matter: Due to production issues |
| March 11, 2016 | Class III | Jubilant Draximage Inc | Labeling: Label Error on Declared Strength |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sodium iodide i 131 label say about other medicines?
The sodium iodide i 131 label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Type of Medication: Amiodarone; Recommended time of withdrawal: 6 months |
| Ascorbic acid | warnings and precautions | Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands. |
| Methimazole | drug interactions | Type of Medication: Thionamide medications (e.g., propylthiouracil, methimazole, carbimazole); Recommended time of withdrawal: 3 days |
| Pilocarpine | warnings and precautions | Advise good hydration for one week following sodium iodide I 131 administration and stimulate salivary flow via a sialagogue (e.g. sugar-free candy or gum, pilocarpine, and ascorbic acid) to reduce radiation exposure to the salivary glands. |
| Potassium iodide | drug interactions | Type of Medication: Saturated solution of potassium iodide; Recommended time of withdrawal: 3 weeks |
| Propylthiouracil | drug interactions | Type of Medication: Thionamide medications (e.g., propylthiouracil, methimazole, carbimazole); Recommended time of withdrawal: 3 days |
| Sodium thiosulfate | warnings and precautions | Although iodide is not considered an allergen, hypersensitivity reactions may occur in relation with excipients or chemical component of the capsule, such as sodium thiosulfate. |
Source: FDA drug label (HICON), Jubilant DraxImage Inc., dba Jubilant Radiopharma, effective January 21, 2025 (SPL set 524a0dac-6e2b-2c0c-04b4-76d85dba63c5), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium iodide i 131?
The FDA Adverse Event Reporting System holds 1,122 reports that list sodium iodide i 131 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 59 are coded as a death and 95 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sodium iodide i 131 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other