Is Flucytosine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Flucytosine.

Is Flucytosine approved by the US FDA?

Drugs@FDA lists 8 application product lines for Flucytosine, including ANCOBON (Prescription); FLUCYTOSINE (Prescription); FLUCYTOSINE (Prescription); FLUCYTOSINE (Prescription); FLUCYTOSINE (Prescription).

Is Flucytosine on the WHO Model List of Essential Medicines?

Yes — 6.3. Antifungal medicines (core list): Cryptococcosis.

Are there safety signals or safety updates for Flucytosine?

US FDA: 1 entry; MHRA: 1 entry (latest 2022-02-15).

Active substance

Flucytosine

SFDA 1
US FDA 8
WHO EML 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
ANCOTIL TAB 500MG	500 mg	Tablet · Oral use	100 Blister	SAR 411.45	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ANCOBON	250MG; 500MG	capsule · oral	BAUSCH	Prescription	26 Nov 1971
FLUCYTOSINE	250MG; 500MG	capsule · oral	SIGMAPHARM LABS LLC	Prescription	28 Jun 2011
FLUCYTOSINE	250MG; 500MG	capsule · oral	NOVEL LABS INC	Prescription	7 Jul 2017
FLUCYTOSINE	250MG; 500MG	capsule · oral	STRIDES PHARMA	Prescription	17 Apr 2020
FLUCYTOSINE	250MG; 500MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	1 May 2020
FLUCYTOSINE	250MG; 500MG	capsule · oral	PHARMOBEDIENT	Prescription	23 Jul 2025
FLUCYTOSINE	250MG; 500MG	capsule · oral	HIKMA PHARMS	Discontinued	17 Oct 2017
FLUCYTOSINE	250MG; 500MG	capsule · oral	STRIDES PHARMA	Discontinued	18 Jun 2018

WHO WHO Model List of Essential Medicines (2025)

6.3. Antifungal medicines · core
Cryptococcosis
Parenteral > General injections > IV: 2.5 g per 250 mL infusion | Oral > Solid: 250 mg capsule

Safety signals and safety-related labeling changes

US FDA 15 Feb 2022 ANCOBON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
MHRA 22 Oct 2020 Flucytosine (Ancotil): new contraindication in patients with DPD deficiency
Flucytosine is a prodrug of 5-fluorouracil used to treat systemic yeast and fungal infections and can cause life-threatening and severe toxicity in patients with complete and partial dihydropyrimidine dehydrogenase (DPD) deficiency. Although pre-testing of DPD status before flucytosine treatment is not required, a new contraindication for patients with complete DPD deficiency has been introduced.

All safety entries for flucytosine →

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.