Gentamicin sulfate adverse event reports that FDA received

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

Name type: Generic name
Class: Aminoglycoside antibacterial
Also reported as: Gentamicin Sulfate Ophthalmic Solution

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.

Reports on file

From January 2004 to June 2026, FDA received 1,638 adverse event reports that name Gentamicin sulfate. In these reports the drug is a suspect or interacting product.

In the same period, 1,154 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 67 reports in the 12 months to June 2026 and 83 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Gentamicin 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 15 reports that name Gentamicin sulfate.
In January to March 2026, FDA received 24.
In April to June 2025, FDA received 20.

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 216 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 1,634 of the 1,638 reports (99.8%).

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 216 terms.

Reaction terms in the reports that name Gentamicin sulfate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,638 reports
Drug ineffectivethe medicine did not work as expected	148	9%
Acute kidney injurysudden loss of kidney function	138	8.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	128	7.8%
Off label useused for a purpose or in a way not on the label	124	7.6%
Renal failure acute	90	5.5%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	87	5.3%
Product use in unapproved indicationused for a purpose not on the label	74	4.5%
Pyrexiafever	71	4.3%
Rashskin rash	61	3.7%
Anaphylactic reactiona severe, sudden allergic reaction	60	3.7%
Renal failurekidney failure	57	3.5%
Premature babya baby born early	49	3%
Hypotensionlow blood pressure	48	2.9%
Premature delivery	48	2.9%
Condition aggravatedthe condition being treated got worse	43	2.6%
Hypersensitivityan allergic-type reaction	39	2.4%
Dyspnoeashortness of breath	37	2.3%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	37	2.3%
Nauseafeeling sick	36	2.2%
Diarrhoealoose or frequent stools	35	2.1%
Ototoxicity	35	2.1%
Normal labour	33	2%
Pneumonialung infection	33	2%
Arthralgiajoint pain	32	2%
Pruritusitching	31	1.9%
Delivery	29	1.8%
Sepsisa severe body-wide response to infection	29	1.8%
Malaisegeneral feeling of being unwell	28	1.7%
Renal impairmentreduced kidney function	27	1.6%
Renal tubular necrosis	27	1.6%
Toxic epidermal necrolysisa severe skin reaction with peeling	27	1.6%
Muscular weaknessmuscle weakness	26	1.6%
Septic shockshock arising from infection	26	1.6%
Tachycardiafast heart rate	25	1.5%
Pathogen resistance	23	1.4%
Urticariahives	23	1.4%
Drug interactionan interaction between medicines	22	1.3%
Nephropathy toxic	22	1.3%
Painpain, site not specified	22	1.3%
Product use issuea problem in how the product was used	22	1.3%
Seizurea fit or convulsion	22	1.3%
Fatiguetiredness	21	1.3%
Hypotonia	21	1.3%
Multiple organ dysfunction syndromeseveral organs failing	21	1.3%
Balance disorderproblems with balance	20	1.2%
Treatment failurethe treatment did not work	20	1.2%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	19	1.2%
Drug resistance	19	1.2%
Astheniaweakness or lack of energy	18	1.1%
Deaththe patient died; cause not stated by this term	18	1.1%

Download all 216 terms of Gentamicin sulfate (CSV)

The counts add to more than 1,638 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 Gentamicin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Gentamicin	Generic name	5,591
Gentamicin sulfate (this page)	Generic name	1,638

Sum of the separately reported names: 7,229. 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 Gentamicin 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
2004	20	20	3	3	11	1	0	7	0
2005	29	24	6	4	17	2	0	7	5
2006	20	17	1	2	8	0	0	7	3
2007	53	41	1	2	12	3	0	27	12
2008	13	13	1	3	7	2	0	5	0
2009	14	13	0	1	5	4	0	6	1
2010	26	23	6	1	13	3	1	9	3
2011	46	44	1	7	21	7	0	14	2
2012	42	36	3	8	13	2	0	16	6
2013	51	47	4	4	19	1	0	27	4
2014	62	58	8	5	24	4	0	32	4
2015	46	35	2	3	12	4	0	23	11
2016	103	72	10	12	27	5	0	40	31
2017	82	53	10	2	17	0	0	42	29
2018	136	108	25	20	47	3	1	66	28
2019	141	103	28	18	37	5	0	72	38
2020	146	132	35	27	56	8	0	85	14
2021	132	109	21	16	47	5	0	85	23
2022	83	71	17	12	41	3	0	61	12
2023	86	77	21	22	28	3	3	64	9
2024	175	157	16	10	36	4	7	140	18
2025	81	70	12	9	14	1	1	63	11
2026	51	44	19	12	15	2	1	32	7

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 Gentamicin 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 Gentamicin sulfate, by the year in which FDA received them
Year	Reports
2004	20
2005	28
2006	20
2007	54
2008	13
2009	15
2010	22
2011	49
2012	52
2013	53
2014	59
2015	54
2016	115
2017	91
2018	149
2019	145
2020	129
2021	129
2022	78
2023	123
2024	134
2025	67
2026	39

Reports that name Gentamicin 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 Gentamicin sulfate
Age	Reports	Share
Under 2	65	4%
2 to 11	77	4.7%
12 to 17	28	1.7%
18 to 44	231	14.1%
45 to 64	311	19%
65 to 74	232	14.2%
75 and over	213	13%
Age not given	481	29.4%

Sex of the patient in the reports that name Gentamicin sulfate
Sex	Reports	Share
Female	740	45.2%
Male	639	39%
Unknown or not given	259	15.8%

Type of reporter in the reports that name Gentamicin sulfate
Reporter	Reports	Share
Physician	475	29%
Pharmacist	119	7.3%
Other health professional	716	43.7%
Lawyer	3	0.2%
Consumer or non-health professional	248	15.1%
Not given	77	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 31.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gentamicin sulfate record
Indication as recorded (MedDRA)	Reports	Share
Antibiotic prophylaxis	60	3.7%
Endocarditis	53	3.2%
Antibiotic therapy	48	2.9%
Ureaplasma infection	40	2.4%
Sepsis	28	1.7%
Urinary tract infection	17	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,638 reports.

Drugs in the same reports

Other drugs that the reports of Gentamicin sulfate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	65
Ampicillin	167
Azithromycin	88
Betamethasone	91
Ciprofloxacin	75
Dextrose	90
Furosemide	75
Meropenem	113
Metronidazole	104
Vancomycin	157

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

Gentamicin same ingredient
Kitabis Pak same class
Bethkis same class
Neomycin same class
Bacitracin same class
Neomycin sulfate same class
Gentamicine next in the A to Z list
Genoxal next in the A to Z list
Gentamycin next in the A to Z list
Genotropin Mq next in the A to Z list
Genteal Mild next in the A to Z list
Genotropin 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 Gentamicin 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. Gentamicin sulfate: adverse event reports that FDA received. https://reportedreactions.com/drug/gentamicin-sulfate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Gentamicin sulfate as a suspect or interacting product. The 1,154 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 Gentamicin 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 Gentamicin sulfate?

No. It is a count of what people reported to FDA: 1,638 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 (43.7%), physician (29%) and consumer or non-health professional (15.1%). 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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