Cefuroxime sodium adverse event reports that FDA received

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

Name type: Generic name
Class: Cephalosporin antibacterial

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 January 2004 to June 2026, FDA received 865 adverse event reports that name Cefuroxime sodium. In these reports the drug is a suspect or interacting product.

In the same period, 408 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 51 reports in the 12 months to June 2026 and 61 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, 51 (under 0.1%) name Cefuroxime sodium. Reports from consumers or other non-health professionals were 19.2% of the reports that name Cefuroxime sodium 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 Cefuroxime sodium 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 18 reports that name Cefuroxime sodium.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 6.

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 167 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 828 of the 865 reports (95.7%).

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 167 terms.

Reaction terms in the reports that name Cefuroxime sodium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 865 reports
Dyspnoeashortness of breath	124	14.3%
Condition aggravatedthe condition being treated got worse	87	10.1%
Pulmonary alveolar haemorrhage	82	9.5%
Pulmonary fibrosis	82	9.5%
Haemoptysiscoughing up blood	81	9.4%
Pulmonary vasculitis	81	9.4%
Therapeutic product effect incomplete	81	9.4%
Wheezing	80	9.2%
Asthma	79	9.1%
Lung disordera lung problem, type not specified	79	9.1%
Neuritis	79	9.1%
Neurological symptom	79	9.1%
Obstructive airways disorder	79	9.1%
Hypothyroidismunderactive thyroid	78	9%
Anxiety	77	8.9%
Eosinophilic granulomatosis with polyangiitis	77	8.9%
Vasculitisinflammation of blood vessels	77	8.9%
Respiratory symptom	76	8.8%
Full blood count abnormal	74	8.6%
Loss of personal independence in daily activities	73	8.4%
Pain in extremitypain in an arm or leg	72	8.3%
Sleep disorder due to a general medical condition	71	8.2%
Anaphylactic shocka severe allergic reaction with collapse	66	7.6%
Hypoxialow oxygen	61	7.1%
Forced expiratory volume decreased	59	6.8%
Productive cougha cough with phlegm	58	6.7%
Arteriosclerosis coronary artery	57	6.6%
Pulmonary embolisma blood clot in the lung	56	6.5%
Total lung capacity abnormal	56	6.5%
Visual impairmentreduced vision	55	6.4%
Arteriosclerosis	54	6.2%
Conjunctivitis allergic	54	6.2%
Normochromic normocytic anaemia	54	6.2%
Antineutrophil cytoplasmic antibody positive	53	6.1%
Dust allergy	53	6.1%
Mite allergy	53	6.1%
Thrombosis	53	6.1%
Mycotic allergy	52	6%
Nodule	52	6%
Spirometry abnormal	51	5.9%
Wrong technique in drug usage processthe medicine was used in the wrong way	50	5.8%
Hypersensitivityan allergic-type reaction	46	5.3%
Accidental overdosean accidental overdose	44	5.1%
Anaphylactic reactiona severe, sudden allergic reaction	44	5.1%
Hypotensionlow blood pressure	41	4.7%
Off label useused for a purpose or in a way not on the label	39	4.5%
Capillaritis	33	3.8%
Rashskin rash	28	3.2%
Sleep disordera sleep problem	27	3.1%
Deaththe patient died; cause not stated by this term	26	3%

Download all 167 terms of Cefuroxime sodium (CSV)

The counts add to more than 865 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 Cefuroxime with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Cefuroxime	Generic name	5,078
Cefuroxime sodium (this page)	Generic name	865

Sum of the separately reported names: 5,943. 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 Cefuroxime sodium, 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	13	13	0	6	5	0	0	5	0
2005	9	9	1	1	3	0	0	5	0
2006	15	15	0	5	4	0	0	10	0
2007	18	17	1	4	9	0	0	8	1
2008	8	8	0	0	6	0	0	2	0
2009	10	8	2	0	2	0	0	4	2
2010	10	8	3	0	3	0	0	3	2
2011	42	42	3	0	15	0	0	28	0
2012	40	36	4	10	15	0	1	17	4
2013	23	23	3	3	5	0	0	15	0
2014	81	81	1	3	11	46	0	22	0
2015	69	68	1	21	9	4	1	44	1
2016	33	31	2	15	16	0	4	16	2
2017	31	30	1	5	12	1	0	25	1
2018	64	64	8	9	23	0	0	58	0
2019	42	42	2	5	16	0	0	35	0
2020	31	29	1	10	10	1	0	21	2
2021	25	25	1	4	8	2	0	22	0
2022	54	52	7	19	29	5	1	41	2
2023	74	73	8	23	37	2	0	59	1
2024	63	58	9	32	31	0	0	52	5
2025	70	70	31	41	42	4	3	63	0
2026	40	40	13	21	26	3	0	34	0

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 Cefuroxime sodium, 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 Cefuroxime sodium, by the year in which FDA received them
Year	Reports
2004	13
2005	9
2006	15
2007	18
2008	8
2009	10
2010	9
2011	40
2012	46
2013	25
2014	78
2015	68
2016	33
2017	40
2018	58
2019	48
2020	34
2021	34
2022	61
2023	72
2024	68
2025	50
2026	28

Reports that name Cefuroxime sodium, 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 Cefuroxime sodium
Age	Reports	Share
Under 2	6	0.7%
2 to 11	25	2.9%
12 to 17	13	1.5%
18 to 44	131	15.1%
45 to 64	185	21.4%
65 to 74	188	21.7%
75 and over	141	16.3%
Age not given	176	20.3%

Sex of the patient in the reports that name Cefuroxime sodium
Sex	Reports	Share
Female	360	41.6%
Male	375	43.4%
Unknown or not given	130	15%

Type of reporter in the reports that name Cefuroxime sodium
Reporter	Reports	Share
Physician	241	27.9%
Pharmacist	78	9%
Other health professional	318	36.8%
Lawyer	1	0.1%
Consumer or non-health professional	166	19.2%
Not given	61	7.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cefuroxime sodium record
Indication as recorded (MedDRA)	Reports	Share
Antibiotic prophylaxis	127	14.7%
Prophylaxis	64	7.4%
Infection prophylaxis	28	3.2%
Cataract operation	20	2.3%
Surgery	19	2.2%
Infection	15	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 865 reports.

Pages near this one

Cefuroxime same ingredient
Cefuroxime axetil same class
Cephalexin same class
Claforan same class
Ceftriaxone sodium same class
Fetroja same class
Cefzil next in the A to Z list
Celebra next in the A to Z list
Cefuroxim next in the A to Z list
Celebrex next in the A to Z list
Celecox next in the A to Z list
Ceftriaxone next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Cefuroxime sodiumThe 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. Cefuroxime sodium: adverse event reports that FDA received. https://reportedreactions.com/drug/cefuroxime-sodium/ 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 Cefuroxime sodium as a suspect or interacting product. The 408 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 Cefuroxime sodium 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 Cefuroxime sodium?

No. It is a count of what people reported to FDA: 865 reports from January 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 (36.8%), physician (27.9%) and consumer or non-health professional (19.2%). 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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