Aztreonam adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Aztreonam
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Also reported as: Aztreonam For Injection

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 804 adverse event reports that name Aztreonam. In these reports the drug is a suspect or interacting product.

In the same period, 1,274 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 59 reports in the 12 months to June 2026 and 86 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 59 (under 0.1%) name Aztreonam. Reports from consumers or other non-health professionals were 7% of the reports that name Aztreonam and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Aztreonam is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 24 reports that name Aztreonam.
In January to March 2026, FDA received 6.
In April to June 2025, FDA received 12.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 116 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 748 of the 804 reports (93%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 116 terms.

Reaction terms in the reports that name Aztreonam, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 804 reports
Eosinophilia	106	13.2%
Off label useused for a purpose or in a way not on the label	90	11.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	70	8.7%
Condition aggravatedthe condition being treated got worse	58	7.2%
Drug ineffectivethe medicine did not work as expected	56	7%
Dyspnoeashortness of breath	50	6.2%
Drug intolerancethe medicine was not tolerated	48	6%
Therapeutic product effect incomplete	44	5.5%
Blood pressure increaseda raised blood pressure reading	43	5.3%
Thrombocytopenialow platelets	43	5.3%
Rash maculo-papulara rash of flat and raised spots	42	5.2%
Superinfection	42	5.2%
General physical health deteriorationgeneral decline in health	41	5.1%
Heart rate increaseda fast heart rate reading	40	5%
Asthma	39	4.9%
Bronchospasmtightening of the airways	39	4.9%
Pyrexiafever	39	4.9%
Atelectasis	38	4.7%
Atrial fibrillationan irregular heart rhythm	38	4.7%
Bacterial disease carrier	38	4.7%
Bronchial secretion retention	38	4.7%
Painpain, site not specified	38	4.7%
Palpitationsawareness of the heartbeat	38	4.7%
Sleep disorder due to a general medical condition	38	4.7%
Wheezing	38	4.7%
Drug resistance	37	4.6%
Hepatic cytolysis	37	4.6%
Anxiety	36	4.5%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	36	4.5%
Aggressionaggressive behaviour	34	4.2%
Leukocytosis	34	4.2%
Nonspecific reaction	34	4.2%
Falla fall	33	4.1%
Illness	33	4.1%
Myalgiamuscle pain	33	4.1%
Rib fracture	33	4.1%
Scoliosis	33	4.1%
Impaired quality of life	32	4%
Loss of personal independence in daily activities	32	4%
Rashskin rash	32	4%
Septic shockshock arising from infection	31	3.9%
Treatment noncompliancethe treatment was not taken as directed	31	3.9%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	29	3.6%
Deaththe patient died; cause not stated by this term	27	3.4%
Sinus operation	27	3.4%
Drug ineffective for unapproved indication	24	3%
Acute kidney injurysudden loss of kidney function	19	2.4%
Hospitalisationadmission to hospital	18	2.2%
Neutropenialow neutrophils, a type of white blood cell	16	2%
Renal impairmentreduced kidney function	16	2%

Download all 116 terms of Aztreonam (CSV)

The counts add to more than 804 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Aztreonam with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Aztreonam (this page)	Generic name	804
Azactam	Brand name	423
Cayston	Brand name	1,224

Sum of the separately reported names: 2,451. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Aztreonam, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	5	5	1	1	3	0	0	1	0
2005	5	2	0	1	1	0	0	0	3
2006	7	5	0	0	4	1	0	1	2
2007	7	5	1	1	4	0	0	0	2
2008	3	2	0	1	0	0	0	1	1
2009	7	7	1	2	6	1	0	2	0
2010	12	11	1	1	4	0	0	7	1
2011	9	9	0	0	5	0	0	5	0
2012	17	17	1	4	9	1	0	10	0
2013	6	4	0	1	4	0	0	0	2
2014	25	21	3	1	3	0	4	16	4
2015	28	27	6	3	11	1	0	17	1
2016	31	29	2	0	12	0	0	23	2
2017	37	30	6	1	15	0	1	17	7
2018	40	35	9	3	7	0	0	25	5
2019	65	56	12	6	27	3	0	36	9
2020	46	43	3	10	14	0	1	32	3
2021	97	93	23	5	41	1	0	65	4
2022	44	42	6	10	20	0	0	27	2
2023	54	50	11	2	31	1	0	35	4
2024	130	126	46	26	60	1	0	85	4
2025	82	80	37	9	35	0	0	64	2
2026	47	42	2	2	16	0	0	37	5

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Aztreonam, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Aztreonam, by the year in which FDA received them
Year	Reports
2004	5
2005	5
2006	7
2007	6
2008	4
2009	7
2010	11
2011	10
2012	17
2013	8
2014	26
2015	35
2016	36
2017	33
2018	46
2019	61
2020	53
2021	118
2022	54
2023	56
2024	112
2025	64
2026	30

Reports that name Aztreonam, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Aztreonam
Age	Reports	Share
Under 2	4	0.5%
2 to 11	13	1.6%
12 to 17	38	4.7%
18 to 44	146	18.2%
45 to 64	207	25.7%
65 to 74	93	11.6%
75 and over	115	14.3%
Age not given	188	23.4%

Sex of the patient in the reports that name Aztreonam
Sex	Reports	Share
Female	351	43.7%
Male	343	42.7%
Unknown or not given	110	13.7%

Type of reporter in the reports that name Aztreonam
Reporter	Reports	Share
Physician	303	37.7%
Pharmacist	88	10.9%
Other health professional	331	41.2%
Lawyer	1	0.1%
Consumer or non-health professional	56	7%
Not given	25	3.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 37.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Aztreonam record
Indication as recorded (MedDRA)	Reports	Share
Antibiotic therapy	33	4.1%
Pneumonia	29	3.6%
Pseudomonas infection	29	3.6%
Infection	18	2.2%
Bacterial infection	14	1.7%
Septic shock	13	1.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 804 reports.

Drugs in the same reports

Other drugs that the reports of Aztreonam name, in any role, in order of name
Drug	Reports that name the two
Amikacin	88
Ceftazidime	85
Ciprofloxacin	130
Imipenem	61
Levofloxacin	73
Linezolid	72
Meropenem	194
Metronidazole	111
Piperacillin sodium,tazobactam sodium	60
Vancomycin	173

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Azactam same ingredient
Cayston same ingredient
Azt next in the A to Z list
Aztreonam Lysine next in the A to Z list
Azstarys next in the A to Z list
Azulfidine next in the A to Z list
Azosemide next in the A to Z list
Azulfidine En-Tabs next in the A to Z list
Azor next in the A to Z list
Baby Aspirin next in the A to Z list
Azopt next in the A to Z list
Baby Teething next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for AztreonamThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Aztreonam: adverse event reports that FDA received. https://reportedreactions.com/drug/aztreonam/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Aztreonam as a suspect or interacting product. The 1,274 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Aztreonam was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Aztreonam?

No. It is a count of what people reported to FDA: 804 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (41.2%), physician (37.7%) and pharmacist (10.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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