FDA — authorised 9 November 1979
- Application: NDA018307
- Marketing authorisation holder: MEDA PHARMS
- Local brand name: THYRO-BLOCK
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Potassium Iodide in United States
FDA authorised Potassium Iodide on 9 November 1979 · 2,776 US adverse-event reports
Marketing authorisations
FDA — authorised 13 September 2000
- Application: NDA018664
- Marketing authorisation holder: ANBEX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 September 2002
- Application: ANDA076350
- Marketing authorisation holder: BTG INTL
- Status: approved
FDA — authorised 24 March 2016
- Application: ANDA206211
- Marketing authorisation holder: MISSION PHARMACAL
- 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: 2,776
Most-reported reactions
- Diarrhoea — 308 reports (11.1%)
- Dyspnoea — 307 reports (11.06%)
- Fatigue — 298 reports (10.73%)
- Fall — 286 reports (10.3%)
- Headache — 274 reports (9.87%)
- Nausea — 272 reports (9.8%)
- Arthralgia — 266 reports (9.58%)
- Sepsis — 260 reports (9.37%)
- Dizziness — 254 reports (9.15%)
- Insomnia — 251 reports (9.04%)
Potassium Iodide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Potassium Iodide approved in United States?
Yes. FDA authorised it on 9 November 1979; FDA authorised it on 13 September 2000; FDA authorised it on 10 September 2002.
Who is the marketing authorisation holder for Potassium Iodide in United States?
MEDA PHARMS holds the US marketing authorisation.