Is Diatrizoate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Diatrizoate, including GASTROGRAFIN 76-ORAL AQUEOUS SOLN. (597.3 mg, Gastroenteral solution, SAR 58.20).

Is Diatrizoate approved by the US FDA?

Drugs@FDA lists 38 application product lines for Diatrizoate, including CYSTOGRAFIN (Prescription); CYSTOGRAFIN DILUTE (Prescription); GASTROGRAFIN (Prescription); MD-GASTROVIEW (Prescription); DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (Prescription).

Are there safety signals or safety updates for Diatrizoate?

US FDA: 2 entries (latest 2017-04-05).

Active substance

Diatrizoate

SFDA 1
US FDA 38
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GASTROGRAFIN 76-ORAL AQUEOUS SOLN.	597.3 mg	Gastroenteral solution · Oral use	1 Bottle	SAR 58.20	Generic · Prescription	BAYER AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CYSTOGRAFIN	30%	solution · urethral	BRACCO	Prescription	2 Aug 1955
CYSTOGRAFIN DILUTE	18%	solution · urethral	BRACCO	Prescription	2 Aug 1955
GASTROGRAFIN	66%;10%	solution · oral, rectal	BRACCO	Prescription	17 Jan 1958
MD-GASTROVIEW	66%;10%	solution · oral, rectal	LIEBEL-FLARSHEIM	Prescription	2 Sep 1981
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	66%;10%	solution · oral, rectal	ADAPTIS	Prescription	27 Jun 2022
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	66%;10%	solution · oral, rectal	ANNORA PHARMA	Prescription	17 Nov 2023
HYPAQUE	50%; 25%	injectable · injection	GE HEALTHCARE	Discontinued	26 Nov 1954
HYPAQUE SODIUM 20%	20%	solution · ureteral	GE HEALTHCARE	Discontinued	26 Nov 1954
RENOGRAFIN-76	66%;10%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
RENOGRAFIN-60	52%;8%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
RENO-DIP	30%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
RENO-60	60%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
DIATRIZOATE MEGLUMINE	76%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
RENOVIST II	28.5%;29.1%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
RENOVIST	34.3%;35%	injectable · injection	BRACCO	Discontinued	2 Aug 1955
RENO-30	30%	solution · ureteral	BRACCO	Discontinued	2 Aug 1955
HYPAQUE-M,90%	60%;30%	injectable · injection	GE HEALTHCARE	Discontinued	9 Nov 1955
HYPAQUE-M,75%	50%;25%	injectable · injection	GE HEALTHCARE	Discontinued	9 Nov 1955
HYPAQUE	100%	for solution · oral, rectal	GE HEALTHCARE	Discontinued	26 Mar 1956
HYPAQUE	40%	solution · oral, rectal	GE HEALTHCARE	Discontinued	26 Mar 1956
CARDIOGRAFIN	85%	injectable · injection	BRACCO	Discontinued	3 Dec 1958
HYPAQUE	60%; 30%	injectable · injection	GE HEALTHCARE	Discontinued	21 Aug 1969
HYPAQUE-CYSTO	30%	solution · urethral	GE HEALTHCARE	Discontinued	21 Aug 1969
HYPAQUE-76	66%;10%	injectable · injection	GE HEALTHCARE	Discontinued	2 Jul 1980
ANGIOVIST 370	66%;10%	injectable · injection	BAYER HLTHCARE	Discontinued	23 Sep 1982

13 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GASTROGRAFIN	02228564	10 %; 66 %	SOLUTION · ORAL; RECTAL	BRACCO IMAGING CANADA

Safety signals and safety-related labeling changes

US FDA 5 Apr 2017 MD-76R — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Apr 2017 MD-76R — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for diatrizoate →

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.