FDA — authorised 2 May 1957
- Application: NDA010929
- Marketing authorisation holder: BRACCO
- Local brand name: IODOTOPE
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 SODIUM IODIDE I 131 in United States
FDA authorised SODIUM IODIDE I 131 on 2 May 1957 · 1,367 US adverse-event reports
Marketing authorisations
FDA — authorised 18 August 1971
- Application: NDA016515
- Marketing authorisation holder: CURIUM
- Local brand name: SODIUM IODIDE I 131
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 August 1971
- Application: NDA016517
- Marketing authorisation holder: CURIUM
- Local brand name: SODIUM IODIDE I 131
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 1976
- Application: NDA017316
- Marketing authorisation holder: CIS
- Local brand name: SODIUM IODIDE I 131
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 November 1976
- Application: NDA017315
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: SODIUM IODIDE I 131
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 January 2003
- Application: NDA021305
- Marketing authorisation holder: JUBILANT
- Status: supplemented
FDA — authorised 5 February 2020
- Application: ANDA209166
- Marketing authorisation holder: INTL ISOTOPES
- Local brand name: SODIUM IODIDE I 131
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 12 June 2025
- Application: ANDA213615
- Marketing authorisation holder: CARDINAL HLTH 414
- Local brand name: SODIUM IODIDE I 131
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,367
Most-reported reactions
- Hypothyroidism — 1,086 reports (79.44%)
- Endocrine Ophthalmopathy — 50 reports (3.66%)
- Treatment Failure — 46 reports (3.37%)
- Parathyroid Tumour Benign — 33 reports (2.41%)
- Hyperthyroidism — 31 reports (2.27%)
- Abortion Spontaneous — 26 reports (1.9%)
- Dacryostenosis Acquired — 25 reports (1.83%)
- Acute Myeloid Leukaemia — 24 reports (1.76%)
- Maternal Exposure Before Pregnancy — 24 reports (1.76%)
- Nausea — 22 reports (1.61%)
SODIUM IODIDE I 131 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SODIUM IODIDE I 131 approved in United States?
Yes. FDA authorised it on 2 May 1957; FDA authorised it on 18 August 1971; FDA authorised it on 20 August 1971.
Who is the marketing authorisation holder for SODIUM IODIDE I 131 in United States?
BRACCO holds the US marketing authorisation.