Is Ferric carboxymaltose registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Ferric carboxymaltose, including FERINJECT (50 mg/ml, Solution for injection/infusion, SAR 356.35); JECTIRON (50 mg/ml, Solution for injection/infusion, SAR 338.55).

Is Ferric carboxymaltose approved by the US FDA?

Drugs@FDA lists 4 application product lines for Ferric carboxymaltose, including INJECTAFER (Prescription); FERRIC CARBOXYMALTOSE (Prescription); FERRIC CARBOXYMALTOSE (Prescription); FERRIC CARBOXYMALTOSE (Prescription).

Are there safety signals or safety updates for Ferric carboxymaltose?

EMA PRAC: 2 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2026-08-13).

Active substance

Ferric carboxymaltose

SFDA 3
US FDA 4
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FERINJECT	50 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 356.35	NCE · Prescription	VIFOR INTERNATIONAL	Valid
FERINJECT	50 mg/ml	Solution for injection/infusion · Intravenous use	5 Vial	SAR 1781.85	NCE · Prescription	VIFOR INTERNATIONAL	Valid
JECTIRON	50 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 338.55	NCE · Prescription	SPIMACO	Valid

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE ASSOCIATED ANEMIA; MATERNAL AND CHILD HEALTHCARE- SUPPLEMENTATION FOR MOTHER AND CHILD

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

Product	Strength	Form · route	Applicant	Status	First approved
INJECTAFER	750MG IRON/15ML (50MG IRON/ML); 500MG IRON/10ML (50MG IRON/ML); 1GM IRON/20ML (50MG IRON/ML); 100MG IRON/2ML (50MG IRON/ML)	solution · intravenous	AM REGENT	Prescription	25 Jul 2013
FERRIC CARBOXYMALTOSE	750MG IRON/15ML (50MG IRON/ML)	solution · intravenous	MYLAN LABS LTD	Prescription	25 Jun 2026
FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	solution · intravenous	MYLAN	Prescription	25 Jun 2026
FERRIC CARBOXYMALTOSE	100MG IRON/2ML (50MG IRON/ML)	solution · intravenous	MYLAN	Prescription	25 Jun 2026

Safety signals and safety-related labeling changes

US FDA 13 Aug 2026 INJECTAFER — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 16 Nov 2020 Ferric carboxymaltose (Ferinject▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures
Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltose treatment in patients with persistent hypophosphataemia.
EMA PRAC 31 Oct 2019 PRAC signal: Arteriospasm coronary
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Arteriospasm coronary
Action for MAH: update of the product information: No

All safety entries for ferric carboxymaltose →

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.