Prescription medicine

Aztreonam Brand names: Azactam, Cayston

Aztreonam (Azactam) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 2 generic labelers.

Generic listed

Check it at the source: the aztreonam FDA label on DailyMed (effective June 3, 2024, Hospira, Inc.); the NDA 50580 record on Drugs@FDA; every aztreonam label on DailyMed.

Highlights of the record

FDA label of June 3, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Forms and strengths

Injection (powder) (lyophilized) for solution; injection (powder) for solution; kit.

On the market

Earliest approval on file: December 31, 1986 Azactam, Labs Delbert; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 4 first June 18, 2010; 2 with a marketed status in Drugs@FDA
Labelers listed (NDC): 5 of which 2 under generic applications, 3 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 7,147 through July 30, 2026

What is aztreonam used for?

From the label: indications and usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. […]

Conditions named in the indications of aztreonam's FDA labels, with every medicine labeled for each:

Bacterial infections

From other aztreonam labels
Bacterial infections: Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and …

FDA pharmacologic class: Monobactam Antibacterial.

Source: FDA drug label (Aztreonam), Hospira, Inc., effective June 3, 2024 (SPL set d4500795-3b07-4a7d-b432-73cafbb3dbc6), via openFDA; the full label on DailyMed

Is there a generic for aztreonam (Azactam)?

The FDA approved the first generic aztreonam on June 18, 2010. 4 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists aztreonam from 2 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1986 earliest approval on file
2010 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the aztreonam label say about other medicines?

The aztreonam label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name aztreonam. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Epinephrine	warnings	Serious hypersensitivity reactions may require epinephrine and other emergency measures (see ADVERSE REACTIONS ).

Check aztreonam against other medicines

Source: FDA drug label (Aztreonam), Hospira, Inc., effective June 3, 2024 (SPL set d4500795-3b07-4a7d-b432-73cafbb3dbc6), via openFDA; the full label on DailyMed

What do FAERS reports show for aztreonam?

The FDA Adverse Event Reporting System holds 7,147 reports that list aztreonam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 978 are coded as a death and 3,574 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2019 (1,221, against a median of 397 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

Infective Pulmonary Exacerbation Of Cystic Fibrosis849
Dyspnoea (named in the label)440
Hospitalisation (an outcome recorded in the report)390
Off Label Use (a use or a product term, not a reaction)374
Cough (named in the label)359
Death (an outcome recorded in the report)302
Pneumonia297
Pyrexia (named in the label)294

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other monobactam antibacterials: the pharmacologic class, with prices and generics
Aztreonam side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other