Neomycin sulfate adverse event reports that FDA received

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

Name type: Generic name
Class: Aminoglycoside antibacterial
Also reported as: Neomycin Sulfate Tab

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 2010 to June 2026, FDA received 770 adverse event reports that name Neomycin sulfate. In these reports the drug is a suspect or interacting product.

In the same period, 438 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 57 reports in the 12 months to June 2026 and 115 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, 57 (under 0.1%) name Neomycin sulfate. Reports from other health professionals were 54.2% of the reports that name Neomycin sulfate and 19.7% 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 Neomycin sulfate 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 10 reports that name Neomycin sulfate.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 11.

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 234 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 757 of the 770 reports (98.3%).

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 234 terms.

Reaction terms in the reports that name Neomycin sulfate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 770 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	397	51.6%
Drug ineffectivethe medicine did not work as expected	337	43.8%
Off label useused for a purpose or in a way not on the label	218	28.3%
Painpain, site not specified	217	28.2%
Nauseafeeling sick	212	27.5%
Infusion related reactiona reaction during or soon after an infusion	209	27.1%
Therapeutic product effect incomplete	194	25.2%
Macular degenerationa disease of the central retina	176	22.9%
Rashskin rash	160	20.8%
Dyspnoeashortness of breath	155	20.1%
Type 2 diabetes mellitustype 2 diabetes	153	19.9%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	150	19.5%
Swelling	143	18.6%
Therapeutic product effect decreased	143	18.6%
Product use in unapproved indicationused for a purpose not on the label	137	17.8%
Systemic lupus erythematosuslupus, an autoimmune disease	134	17.4%
C-reactive protein increased	133	17.3%
Psoriatic arthropathy	133	17.3%
Treatment failurethe treatment did not work	129	16.8%
Malaisegeneral feeling of being unwell	127	16.5%
Contraindicated product administered	125	16.2%
Confusional stateconfusion	124	16.1%
Sleep disordera sleep problem	124	16.1%
Headachehead pain	123	16%
Product use issuea problem in how the product was used	123	16%
Synovitis	123	16%
Wound	123	16%
C-reactive protein abnormal	121	15.7%
Pemphigus	121	15.7%
Pericarditisinflammation of the sac around the heart	121	15.7%
Ill-defined disordera condition that was not clearly described	120	15.6%
Rheumatic fever	120	15.6%
Pyrexiafever	119	15.5%
Dyspepsiaindigestion	110	14.3%
Onychomycosis	110	14.3%
Weight decreasedweight loss	107	13.9%
Injection site reactiona reaction where the injection was given	103	13.4%
Onychomadesis	101	13.1%
Intentional product use issuedeliberate use not as intended	85	11%
Drug intolerancethe medicine was not tolerated	76	9.9%
Abdominal painstomach or belly pain	72	9.4%
Condition aggravatedthe condition being treated got worse	70	9.1%
Erythemaskin redness	69	9%
Rectal haemorrhage	69	9%
General physical health deteriorationgeneral decline in health	68	8.8%
Joint swellinga swollen joint	68	8.8%
Chronic sinusitis	67	8.7%
Female genital tract fistula	67	8.7%
Paraesthesia oral	67	8.7%
Haematocheziablood in the stool	66	8.6%

Download all 234 terms of Neomycin sulfate (CSV)

The counts add to more than 770 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.

Outcomes by year

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

Outcomes in the reports that name Neomycin sulfate, 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
2007	0	0	0	0	0	0	0	0	0
2008	0	0	0	0	0	0	0	0	0
2009	1	1	0	0	0	0	0	1	0
2011	10	1	0	0	0	0	0	1	9
2012	20	4	0	0	2	0	0	2	16
2013	14	3	0	0	0	0	0	3	11
2014	33	1	0	0	0	0	0	1	32
2015	29	1	0	0	0	0	0	1	28
2016	52	7	0	0	0	0	0	7	45
2017	28	2	0	0	0	0	0	2	26
2018	28	6	0	0	2	0	0	5	22
2019	80	14	0	0	1	0	0	13	66
2020	35	14	0	0	1	0	0	13	21
2021	48	22	0	0	1	1	0	22	26
2022	68	65	8	1	16	1	0	61	3
2023	47	43	17	9	28	9	2	40	4
2024	82	78	32	30	59	30	21	78	4
2025	141	141	81	81	109	80	67	141	0
2026	54	54	32	32	45	32	30	54	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 Neomycin sulfate, 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 Neomycin sulfate, by the year in which FDA received them
Year	Reports
2010	2
2011	8
2012	23
2013	16
2014	36
2015	30
2016	60
2017	35
2018	35
2019	70
2020	45
2021	71
2022	74
2023	55
2024	102
2025	93
2026	15

Reports that name Neomycin sulfate, 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 Neomycin sulfate
Age	Reports	Share
Under 2	2	0.3%
2 to 11	1	0.1%
12 to 17	3	0.4%
18 to 44	151	19.6%
45 to 64	76	9.9%
65 to 74	125	16.2%
75 and over	39	5.1%
Age not given	373	48.4%

Sex of the patient in the reports that name Neomycin sulfate
Sex	Reports	Share
Female	601	78.1%
Male	53	6.9%
Unknown or not given	116	15.1%

Type of reporter in the reports that name Neomycin sulfate
Reporter	Reports	Share
Physician	157	20.4%
Pharmacist	42	5.5%
Other health professional	417	54.2%
Lawyer	2	0.3%
Consumer or non-health professional	150	19.5%
Not given	2	0.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 43% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Neomycin sulfate record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	114	14.8%
Skin laceration	3	0.4%
Postoperative care	2	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 770 reports.

Pages near this one

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

Official pages

DailyMed labels for Neomycin sulfateThe 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. Neomycin sulfate: adverse event reports that FDA received. https://reportedreactions.com/drug/neomycin-sulfate/ 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 Neomycin sulfate as a suspect or interacting product. The 438 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 Neomycin sulfate 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 Neomycin sulfate?

No. It is a count of what people reported to FDA: 770 reports from January 2010 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 (54.2%), physician (20.4%) and consumer or non-health professional (19.5%). 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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