Is Cysteamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Cysteamine, including CYSTAGON (50 mg, Capsule, hard, SAR 434.75); CYSTAGON (150 mg, Capsule, hard, SAR 1216.00).

Is Cysteamine approved by the US FDA?

Drugs@FDA lists 5 application product lines for Cysteamine, including CYSTAGON (Prescription); CYSTARAN (Prescription); PROCYSBI (Prescription); PROCYSBI (Prescription); CYSTADROPS (Prescription).

Are there safety signals or safety updates for Cysteamine?

US FDA: 3 entries (latest 2022-02-11).

Active substance

Cysteamine

SFDA 2
US FDA 5
Health Canada 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CYSTAGON	50 mg	Capsule, hard · Oral use	100 Bottle	SAR 434.75	NCE · Prescription	Recordati Rare Diseases	Valid
CYSTAGON	150 mg	Capsule, hard · Oral use	100 Bottle	SAR 1216.00	NCE · Prescription	Recordati Rare Diseases	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CYSTAGON	EQ 50MG BASE; EQ 150MG BASE	capsule · oral	MYLAN	Prescription	15 Aug 1994
CYSTARAN	EQ 0.44% BASE	solution/drops · ophthalmic	LEADIANT BIOSCI INC	Prescription	2 Oct 2012
PROCYSBI	EQ 25MG BASE; EQ 75MG BASE	capsule, delayed release · oral	HORIZON	Prescription	30 Apr 2013
PROCYSBI	EQ 75MG BASE/PACKET; EQ 300MG BASE/PACKET	granule, delayed release · oral	HORIZON	Prescription	14 Feb 2020
CYSTADROPS	EQ 0.37% BASE	solution/drops · ophthalmic	RECORDATI RARE	Prescription	19 Aug 2020

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CYSTADROPS	02485605	0.37 % / W/W	SOLUTION · OPHTHALMIC	RECORDATI RARE DISEASES CANADA INC
PROCYSBI	02464705	25 MG	CAPSULE (DELAYED-RELEASE) · ORAL	AMGEN CANADA INC
PROCYSBI	02464713	75 MG	CAPSULE (DELAYED-RELEASE) · ORAL	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 11 Feb 2022 PROCYSBI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Feb 2022 PROCYSBI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Apr 2020 CYSTARAN — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for cysteamine →

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.