Is Cefepime registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Cefepime, including CEFAFOUR 1gm IV/IM Vial (1 g, powder for solution for injection, SAR 33.65); CEFAFOUR 2 gm IV/IM Vial (2 g, powder for solution for injection, SAR 57.80); Cefepime Amarox (1000 mg, Powder for solution for injection/infusion, SAR 29.00); DELTACEF 1 gm Vial (1 g, powder for solution for injection, SAR 30.30); DELTACEF 2 gm Vial (2 g, powder for solution for injection, SAR 52.00).

Is Cefepime approved by the US FDA?

Drugs@FDA lists 12 application product lines for Cefepime, including CEFEPIME HYDROCHLORIDE (Prescription); CEFEPIME IN PLASTIC CONTAINER (Prescription); CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (Prescription); CEFEPIME HYDROCHLORIDE (Prescription); CEFEPIME HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Cefepime?

EMA PRAC: 5 entries; US FDA: 3 entries (latest 2026-06-25).

Active substance

Cefepime

SFDA 9
US FDA 12
Health Canada 3
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CEFAFOUR 1gm IV/IM Vial	1 g	powder for solution for injection · Intravenous use	1 Vial	SAR 33.65	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CEFAFOUR 2 gm IV/IM Vial	2 g	powder for solution for injection · Intravenous use	1 Vial	SAR 57.80	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Cefepime Amarox	1000 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 29.00	Generic · Prescription	Saudi Amarox	Valid
DELTACEF 1 gm Vial	1 g	powder for solution for injection · Intramuscular and intravenous use	1 Vial	SAR 30.30	Generic · Prescription	MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY	Valid
DELTACEF 2 gm Vial	2 g	powder for solution for injection · Intramuscular and intravenous use	1 Vial	SAR 52.00	Generic · Prescription	MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY	Valid
PROTEC 1 GM Injection	1 g	Powder for injection · Intramuscular use	1 Vial	SAR 40.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
PROTEC 2 GM Injection*	2 g	Powder for injection · Intravenous use	1 Vial	SAR 63.75	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MAXIPIME 1 G VIAL	1 g	Injection · Parenteral use	1 Vial	SAR 46.00	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
MAXIPIME 2 G VIAL	2 g	Injection · Parenteral use	1 Vial	SAR 72.50	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PYELONEPHRITIS; ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); COMMUNITY ACQUIRED PNEUMONEA; DENTAL ABSCESS; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; OSTEOMYELITIS; PERITONITIS; Pyogenic Arthritis; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	ACS DOBFAR	Prescription	20 Mar 2008
CEFEPIME IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML); EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	injectable · injection	BAXTER HLTHCARE	Prescription	5 Aug 2008
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	B BRAUN	Prescription	6 May 2010
CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	QILU ANTIBIOTICS	Prescription	1 Feb 2016
CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	SAGENT PHARMS INC	Prescription	4 Jan 2017
CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 100GM BASE	powder · intravenous	SAMSON MEDCL	Prescription	21 Aug 2018
CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	HIKMA	Prescription	22 May 2024
MAXIPIME	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	HOSPIRA INC	Discontinued	18 Jan 1996
CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	HOSPIRA INC	Discontinued	18 Jun 2007
CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	CHARTWELL RX	Discontinued	21 Dec 2010
CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	HOSPIRA INC	Discontinued	30 Jul 2012
CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	ASTRAL	Discontinued	21 Jul 2020

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-CEFEPIME	02467496	1 G / VIAL	POWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUS	APOTEX INC
APO-CEFEPIME	02467518	2 G / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	APOTEX INC
CEFEPIME FOR INJECTION USP	02499096	2 G / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED

Safety signals and safety-related labeling changes

US FDA 25 Jun 2026 CEFEPIME IN PLASTIC CONTAINER — 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 7 Apr 2026 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER — 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 11 Aug 2021 MAXIPIME — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Oct 2020 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2020 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 11 Sep 2014 PRAC signal: Convulsions
Action for MAH: update of the product information: No
EMA PRAC 6 Mar 2014 PRAC signal: Convulsions
Action for MAH: update of the product information: No
EMA PRAC 6 Mar 2014 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No

All safety entries for cefepime →

Combinations containing Cefepime

Cefepime + enmetazobactam

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.