Gentamicin adverse event reports that FDA received

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

Name type: Generic name
Class: Aminoglycoside antibacterial
Also reported as: Gentamicin Injection Usp, Gentamicin Cream, Gentamicin /00047102/

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 5,591 adverse event reports that name Gentamicin. In these reports the drug is a suspect or interacting product.

In the same period, 7,598 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 285 reports in the 12 months to June 2026 and 317 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, 285 (under 0.1%) name Gentamicin. Reports from consumers or other non-health professionals were 8.2% of the reports that name Gentamicin 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 Gentamicin 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 79 reports that name Gentamicin.
In January to March 2026, FDA received 54.
In April to June 2025, FDA received 67.

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 571 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 5,573 of the 5,591 reports (99.7%).

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 571 terms.

Reaction terms in the reports that name Gentamicin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,591 reports
Drug ineffectivethe medicine did not work as expected	717	12.8%
Acute kidney injurysudden loss of kidney function	622	11.1%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	301	5.4%
Premature babya baby born early	296	5.3%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	291	5.2%
Pyrexiafever	272	4.9%
Premature delivery	240	4.3%
Condition aggravatedthe condition being treated got worse	238	4.3%
Product use in unapproved indicationused for a purpose not on the label	232	4.1%
Off label useused for a purpose or in a way not on the label	231	4.1%
Renal failure acute	220	3.9%
Drug interactionan interaction between medicines	171	3.1%
Renal failurekidney failure	167	3%
Renal tubular necrosis	165	3%
Septic shockshock arising from infection	145	2.6%
Rashskin rash	139	2.5%
Hypotensionlow blood pressure	138	2.5%
Nephropathy toxic	131	2.3%
Renal impairmentreduced kidney function	130	2.3%
Sepsisa severe body-wide response to infection	126	2.3%
Blood creatinine increasedraised creatinine, a kidney test	123	2.2%
Anaphylactic reactiona severe, sudden allergic reaction	122	2.2%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	118	2.1%
Pathogen resistance	118	2.1%
Drug resistance	109	1.9%
Delivery	103	1.8%
Diarrhoealoose or frequent stools	100	1.8%
Thrombocytopenialow platelets	99	1.8%
Dizzinesslight-headedness or unsteadiness	96	1.7%
Normal labour	96	1.7%
Dyspnoeashortness of breath	93	1.7%
Toxic epidermal necrolysisa severe skin reaction with peeling	93	1.7%
Balance disorderproblems with balance	90	1.6%
Exposure during pregnancythe medicine was taken during pregnancy	90	1.6%
Multiple organ dysfunction syndromeseveral organs failing	89	1.6%
Pneumonialung infection	89	1.6%
Vomitingbeing sick	87	1.6%
Ototoxicity	86	1.5%
Nauseafeeling sick	84	1.5%
Treatment failurethe treatment did not work	83	1.5%
Anaemialow red blood cells	81	1.4%
Eosinophilia	81	1.4%
Candida infectionthrush, a yeast infection	76	1.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	76	1.4%
Vestibular disorder	72	1.3%
Clostridium difficile infection	71	1.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	66	1.2%
Pruritusitching	66	1.2%
Metabolic acidosistoo much acid in the body fluids	62	1.1%
Neutropenialow neutrophils, a type of white blood cell	60	1.1%

Download all 571 terms of Gentamicin (CSV)

The counts add to more than 5,591 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 (this page)	Generic name	5,591
Gentamicin sulfate	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, 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	91	81	4	10	41	27	1	30	10
2005	128	122	14	11	58	22	0	53	6
2006	92	79	14	12	41	6	0	25	13
2007	99	91	14	16	37	3	0	47	8
2008	82	75	18	9	52	4	0	19	7
2009	133	107	28	7	51	9	1	47	26
2010	122	115	16	11	67	13	1	44	7
2011	129	125	16	15	81	8	0	50	4
2012	115	109	29	11	57	6	0	39	6
2013	160	149	25	13	77	12	3	71	11
2014	220	215	24	22	91	23	1	118	5
2015	222	213	38	22	100	2	2	109	9
2016	199	186	29	21	69	6	1	106	13
2017	261	245	36	33	86	4	1	180	16
2018	368	355	56	36	171	11	1	222	13
2019	338	334	52	47	174	18	0	213	4
2020	382	370	50	61	214	13	1	253	12
2021	348	327	47	38	155	23	1	232	21
2022	553	526	94	69	243	19	2	378	27
2023	608	565	82	74	215	13	0	450	43
2024	400	390	64	81	203	5	3	287	10
2025	378	359	76	35	151	3	1	299	19
2026	163	157	27	36	81	4	0	124	6

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, 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, by the year in which FDA received them
Year	Reports
2004	85
2005	129
2006	94
2007	93
2008	93
2009	134
2010	113
2011	146
2012	134
2013	169
2014	213
2015	228
2016	204
2017	279
2018	409
2019	353
2020	415
2021	358
2022	528
2023	635
2024	370
2025	276
2026	133

Reports that name Gentamicin, 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
Age	Reports	Share
Under 2	255	4.6%
2 to 11	211	3.8%
12 to 17	130	2.3%
18 to 44	825	14.8%
45 to 64	1,129	20.2%
65 to 74	787	14.1%
75 and over	698	12.5%
Age not given	1,556	27.8%

Sex of the patient in the reports that name Gentamicin
Sex	Reports	Share
Female	2,268	40.6%
Male	2,489	44.5%
Unknown or not given	834	14.9%

Type of reporter in the reports that name Gentamicin
Reporter	Reports	Share
Physician	1,584	28.3%
Pharmacist	473	8.5%
Other health professional	2,798	50%
Lawyer	10	0.2%
Consumer or non-health professional	460	8.2%
Not given	266	4.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 22.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gentamicin record
Indication as recorded (MedDRA)	Reports	Share
Antibiotic therapy	282	5%
Endocarditis	270	4.8%
Antibiotic prophylaxis	173	3.1%
Infection	118	2.1%
Foetal exposure during pregnancy	114	2%
Ureaplasma infection	111	2%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,591 reports.

Drugs in the same reports

Other drugs that the reports of Gentamicin name, in any role, in order of name
Drug	Reports that name the two
Amoxicillin	318
Ampicillin	969
Azithromycin	450
Betamethasone	352
Ceftriaxone	506
Ciprofloxacin	438
Clindamycin	315
Meropenem	585
Metronidazole	511
Vancomycin	1,243

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 sulfate same ingredient
Bethkis same class
Bacitracin same class
Kitabis Pak same class
Arikayce same class
Neomycin same class
Genoxal next in the A to Z list
Genotropin Mq next in the A to Z list
Gentamicine next in the A to Z list
Genotropin next in the A to Z list
Gentamycin next in the A to Z list
Genosyl 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 GentamicinThe 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.

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Reported Reactions. Gentamicin: adverse event reports that FDA received. https://reportedreactions.com/drug/gentamicin/ 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 Gentamicin as a suspect or interacting product. The 7,598 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 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?

No. It is a count of what people reported to FDA: 5,591 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 (50%), physician (28.3%) and pharmacist (8.5%). 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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