Is Aztreonam approved by the US FDA?

Drugs@FDA lists 8 application product lines for Aztreonam, including AZACTAM (Prescription); CAYSTON (Prescription); AZTREONAM (Prescription); AZTREONAM (Prescription); AZACTAM (Discontinued).

Is Aztreonam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Aztreonam: Cayston.

Are there safety signals or safety updates for Aztreonam?

US FDA: 3 entries (latest 2019-11-20).

Active substance

Aztreonam

US FDA 8
EMA 1
Health Canada 1
Safety 3

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
AZACTAM	1GM/VIAL; 2GM/VIAL	injectable · injection	LABS DELBERT	Prescription	31 Dec 1986
CAYSTON	75MG/VIAL	for solution · inhalation	GILEAD	Prescription	22 Feb 2010
AZTREONAM	500MG/VIAL; 1GM/VIAL; 2GM/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	18 Jun 2010
AZTREONAM	1GM/VIAL; 2GM/VIAL	injectable · injection	HOSPIRA	Prescription	8 Nov 2021
AZACTAM	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	LABS DELBERT	Discontinued	31 Dec 1986
AZACTAM IN PLASTIC CONTAINER	40MG/ML; 20MG/ML; 10MG/ML	injectable · injection	BRISTOL MYERS SQUIBB	Discontinued	24 May 1989
AZTREONAM	1GM/VIAL; 2GM/VIAL	injectable · injection	HIKMA PHARMS	Discontinued	23 Mar 2011
AZTREONAM	1GM/VIAL; 2GM/VIAL	injectable · injection	HIKMA PHARMS	Discontinued	5 Feb 2026

EMA European Union — centrally authorised medicines

Cayston Gilead Sciences Ireland UC · Authorised · authorised 21 Sep 2009 · ATC J01DF01

Therapeutic indication (EMA)

Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CAYSTON	02329840	75 MG / VIAL	POWDER FOR SOLUTION · INHALATION	GILEAD SCIENCES CANADA INC

Safety signals and safety-related labeling changes

US FDA 20 Nov 2019 CAYSTON — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2018 AZACTAM — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 18 Jun 2018 AZACTAM IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for aztreonam →

Combinations containing Aztreonam

Avibactam + aztreonam

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.