Is Sodium iodide i 131 approved by the US FDA?

Drugs@FDA lists 13 application product lines for Sodium iodide i 131, including SODIUM IODIDE I 131 (Prescription); HICON (Prescription); SODIUM IODIDE I 131 (Prescription); IODOTOPE (Discontinued); IODOTOPE (Discontinued).

Are there safety signals or safety updates for Sodium iodide i 131?

US FDA: 3 entries (latest 2021-06-11).

Active substance

Sodium iodide i 131

US FDA 13
Safety 3

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SODIUM IODIDE I 131	0.009-0.1mCi	capsule · oral	JUBILANT	Prescription	24 Jan 2003
HICON	250-1000mCi	solution · oral	JUBILANT	Prescription	24 Jan 2003
SODIUM IODIDE I 131	250-1000mCi	solution · oral	INTL ISOTOPES	Prescription	5 Feb 2020
IODOTOPE	1-130mCi; 1-150mCi	capsule · oral	BRACCO	Discontinued	2 May 1957
IODOTOPE	7-106mCi/BOT	solution · oral	BRACCO	Discontinued	2 May 1957
SODIUM IODIDE I 131	3.5-150mCi/VIAL	solution · oral	CURIUM	Discontinued	18 Aug 1971
SODIUM IODIDE I 131	0.8-100mCi	capsule · oral	CURIUM	Discontinued	18 Aug 1971
SODIUM IODIDE I 131	0.8-100mCi; 15-100uCi	capsule · oral	CURIUM	Discontinued	20 Aug 1971
SODIUM IODIDE I 131	50uCi; 100uCi	capsule · oral	CIS	Discontinued	9 Nov 1976
SODIUM IODIDE I 131	50mCi/ML	solution · oral	SUN PHARM INDS INC	Discontinued	16 Nov 1976
HICON	1-250mCi/0.25ML; 1-500mCi/0.5ML; 1-1000mCi/ML	solution · oral	JUBILANT	Discontinued	24 Jan 2003
SODIUM IODIDE I 131	2-200mCi	capsule · oral	JUBILANT	Discontinued	24 Jan 2003
SODIUM IODIDE I 131	250-1000mCi	solution · oral	CARDINAL HLTH 414	Discontinued	12 Jun 2025

Safety signals and safety-related labeling changes

US FDA 11 Jun 2021 HICON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Feb 2018 SODIUM IODIDE I 131 — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 6 Feb 2018 SODIUM IODIDE I 131 — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for sodium iodide i 131 →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.