Gentamicin Sulfate (Gentocin, Vetro-Gen Veterinary): adverse event reports that FDA received
Active ingredient
Also sold as: Gentocin, Vetro-Gen Veterinary, Garacin, Garasol, Legacy, Gentaglyde, and 7 more brand names.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Read this first. FDA says this about the data:
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .
This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.
Contacting a veterinarianHow to report to FDAFrom January 1987 to June 2026, FDA received 358 adverse event reports that name a drug with gentamicin sulfate as its active ingredient. Of the 358 reports, 181 (50.6%) are about dogs. 78 reports are about horses (21.8%).
In January to March 2026, FDA received 3 reports that name this drug. The signs that appear in the largest number of the 358 reports are "Lethargy", "Death" and "Vomiting". A report is not proof that a drug caused a sign.
Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change. Reports about dogs are 50.6% of the reports that name this drug, and 72.6% of all reports.
Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.
Since the last update of the FDA data
The latest update of the FDA data, recorded on , changed no count of this page.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 3 reports that name gentamicin sulfate: 3 dog, 0 cat, 0 horse, 0 other or not given.
Signs that the reports list
A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 358 reports that list the sign. One report can list more than one sign.
The sign that is in the largest number of the reports comes first.
- Lethargy[unusually tired or inactive]9.8%35 reports
- Death9.5%34 reports
- Vomiting9.2%33 reports
- Anorexia[not eating]6.1%22 reports
- Emesis[vomiting]6.1%22 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]5.9%21 reports
- Ataxia[unsteady, uncoordinated movement]5.6%20 reports
- Lack of efficacy - NOS[the product did not have the expected effect]5.6%20 reports
- Diarrhoea[diarrhea]5%18 reports
- Abdominal pain4.7%17 reports
- Depression[dull, quiet or withdrawn]4.2%15 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.2%15 reports
- Elevated creatinine[a kidney value above the normal range]4.2%15 reports
- Death by euthanasia[the animal was euthanized]3.9%14 reports
Show the next 16 signs
- Weight loss3.9%14 reports
- Administration device NOS, malfunction3.6%13 reports
- Corneal ulcer3.6%13 reports
- Behavioural disorder NOS[behaviour change, type not specified]3.4%12 reports
- Colic3.1%11 reports
- Shaking3.1%11 reports
- Decreased appetite2.8%10 reports
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]2.8%10 reports
- Fever2.8%10 reports
- Loose stool2.8%10 reports
- Solution, Abnormal[a product quality report, not a sign in an animal]2.8%10 reports
- Tachycardia[fast heart rate]2.8%10 reports
- Anaemia NOS[low red blood cell count]2.5%9 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.5%9 reports
- Increased sweating2.5%9 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2.5%9 reports
The list shows 30 of 556 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)
Reports by species
The share is of all 358 reports that name gentamicin sulfate. The other reports give a different species or no species.
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
No chart: no month has 5 or more reports.
No chart: no month has 5 or more reports.
No chart: no month has 5 or more reports.
The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
Reports by year
- Dog
- Cat
- Horse
- Other or not given
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 7 | 0 | 0 | 1 | 8 |
| 2025 | 10 | 2 | 0 | 4 | 16 |
| 2024 | 5 | 2 | 2 | 13 | 22 |
| 2023 | 7 | 0 | 3 | 11 | 21 |
| 2022 | 3 | 1 | 2 | 6 | 12 |
| 2021 | 3 | 0 | 5 | 0 | 8 |
| 2020 | 5 | 1 | 1 | 1 | 8 |
| 2019 | 5 | 0 | 1 | 0 | 6 |
| 2018 | 7 | 3 | 1 | 0 | 11 |
| 2017 | 9 | 2 | 9 | 0 | 20 |
| 2016 | 17 | 1 | 9 | 2 | 29 |
| 2015 | 8 | 1 | 0 | 2 | 11 |
| 2014 | 7 | 0 | 0 | 2 | 9 |
| 2013 | 16 | 1 | 2 | 2 | 21 |
| 2012 | 27 | 1 | 1 | 0 | 29 |
| 2011 | 8 | 0 | 1 | 0 | 9 |
| 2010 | 0 | 0 | 0 | 1 | 1 |
| 2009 | 0 | 0 | 0 | 2 | 2 |
| 2008 | 0 | 0 | 0 | 1 | 1 |
| 2007 | 1 | 1 | 6 | 1 | 9 |
| 2006 | 0 | 0 | 12 | 2 | 14 |
| 2005 | 2 | 0 | 1 | 0 | 3 |
| 2003 | 2 | 0 | 0 | 9 | 11 |
| 2002 | 1 | 1 | 2 | 2 | 6 |
| 2001 | 4 | 3 | 5 | 1 | 13 |
| 2000 | 4 | 1 | 0 | 1 | 6 |
| 1999 | 5 | 1 | 9 | 0 | 15 |
| 1998 | 3 | 1 | 2 | 0 | 6 |
| 1997 | 5 | 2 | 2 | 0 | 9 |
| 1996 | 2 | 1 | 0 | 0 | 3 |
| 1995 | 0 | 0 | 0 | 1 | 1 |
| 1994 | 0 | 0 | 1 | 0 | 1 |
| 1993 | 0 | 0 | 1 | 3 | 4 |
| 1992 | 3 | 1 | 0 | 0 | 4 |
| 1991 | 0 | 1 | 0 | 0 | 1 |
| 1990 | 0 | 0 | 0 | 2 | 2 |
| 1989 | 1 | 0 | 0 | 0 | 1 |
| 1988 | 1 | 0 | 0 | 1 | 2 |
| 1987 | 3 | 0 | 0 | 0 | 3 |
2026 has the reports that FDA received through Jun 2026. Download the years (CSV)
What the reports record
Outcome at the time of the report
- Recovered/Normal21.5%77
- Recovered with Sequela[recovered, with a lasting effect]1.4%5
- Ongoing12%43
- Died12%43
- Euthanized2.5%9
- Outcome Unknown13.7%49
An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 358 reports that name gentamicin sulfate.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue74.3%266
- Lack of expected effectiveness3.4%12
- Both safety and lack of expected effectiveness3.4%12
- Manufacturing or product defect17%61
- Other2%7
196 reports say if the event was serious. 40.8% of them have the serious flag. The person who sends the report sets the flag.
Show age, weight, breed and route
Age of the animal
- Under 1 year8.1%29
- 1 to 3 years15.4%55
- 4 to 7 years17%61
- 8 to 11 years15.9%57
- 12 years and over11.7%42
- Age not given31.8%114
Weight of the animal
- Under 5 kg (11 lb)12%43
- 5 to 9.9 kg (11 to 22 lb)13.4%48
- 10 to 24.9 kg (22 to 55 lb)10.6%38
- 25 to 44.9 kg (55 to 99 lb)12%43
- 45 kg and over (99 lb and over)19.3%69
- Weight not given32.7%117
Breed, where the report gives one breed
- Labrador Retriever4.2%15
- Quarter Horse3.6%13
- Domestic Shorthair2.8%10
- Thoroughbred2.5%9
- Bulldog2.2%8
- Golden Retriever2.2%8
- Shih Tzu2%7
- Standardbred1.7%6
A breed with many animals has many reports.
Route in the report
- Intravenous16.5%59
- Topical14.2%51
- Auricular (Otic)8.1%29
- Intramuscular5.3%19
- Ophthalmic4.5%16
- Subcutaneous3.9%14
Each bar is on a scale of 0 to 100%.
Approved animal drugs with this active ingredient (FDA Green Book)
This section is reference data. It has no report count.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Brand names
- Gentocin
- Vetro-Gen Veterinary
- Garacin
- Garasol
- Legacy
- Gentaglyde
- Gentamex 100
- GentaMax 100
- Genta-Ject
- GentaPoult
- GEN-GARD
- GentaMed-P
The Green Book has 1 more brand name with this active ingredient. Brand names A to Z
What the Green Book records give
- Applications with an approval in force
- 26
- Approved species
- Equids, Swine, Dogs, Cats, Turkeys, Chickens, Cattle
- Dose forms
- Liquid (Solution), Soluble Powder, Injection, Ointment, Ophthalmic Solution, Oral Concentrate Solution, Spray
- Routes
- Intrauterine, Oral, Subcutaneous, Intramuscular, Ophthalmic, Immersion, Intrasynovial, Topical
- Sale
- RX (prescription), OTC (over the counter)
- Earliest approval date in the records
The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Gentocin Solution | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 038-292 |
| Gentocin Solution | Gentamicin Sulfate | Intervet, Inc. | Horses | NADA 046-724 |
| Garacin | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 091-191 |
| Garasol Solution | Gentamicin Sulfate | Intervet, Inc. | Turkeys | NADA 092-523 |
| Gentocin Ophthalmic Ointment | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 098-989 |
| Gentocin Ophthalmic Solution | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 099-008 |
| Garasol | Gentamicin Sulfate | Intervet, Inc. | Chickens, Turkeys | NADA 101-862 |
| Garacin Piglet Injection | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 103-037 |
| Garacin Pig Pump Oral Solution | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 130-464 |
| Gentocin Pink Eye Spray | Gentamicin Sulfate | Intervet, Inc. | Cattle | NADA 130-952 |
| Garacin Soluble Powder | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 133-836 |
| Gentamicin Sulfate Inj. Sol. | Gentamicin Sulfate | Cronus Pharma Specialities India Private Ltd. | Dogs | NADA 137-310 |
| Gentamicin Sulfate Solution 100 mg/ml | Gentamicin Sulfate | Cronus Pharma Specialities India Private Ltd. | Horses | ANADA 200-023 |
| Gentamicin Sulfate Solution; Legacy Sterile Solution | Gentamicin Sulfate | Huvepharma EOOD | Horses | ANADA 200-037 |
| Gentaglyde Solution | Gentamicin Sulfate | Zoetis Inc. | Horses | ANADA 200-102 |
| Gentamex 100 | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Horses | ANADA 200-115 |
| GentaMax 100 | Gentamicin Sulfate | Elanco US Inc. | Horses | ANADA 200-137 |
| Genta-Ject; GentaPoult | Gentamicin Sulfate | Huvepharma EOOD | Chickens, Turkeys | ANADA 200-147 |
| Gentamicin Sulfate Pig Pump Oral Solution | Gentamicin Sulfate | Huvepharma EOOD | Swine | ANADA 200-174 |
| GEN-GARD | Gentamicin Sulfate | Huvepharma EOOD | Swine | ANADA 200-185 |
| Vetro-Gen Veterinary Ophthalmic Ointment | Gentamicin Sulfate | Dechra Veterinary Products LLC | Dogs, Cats | ANADA 200-273 |
| Gentamicin Piglet Injection | Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Swine | ANADA 200-394 |
| Gentamicin Sulfate Solution | Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Horses | ANADA 200-395 |
| GentaMed-P | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Chickens, Turkeys | ANADA 200-468 |
| GentaMed | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Swine | ANADA 200-494 |
| Gentamicin Sulfate Ophthalmic Solution | Gentamicin Sulfate | Domes Pharma S.A. | Dogs, Cats | ANADA 200-576 |
| Garasol Injectionapproval withdrawn | Gentamicin Sulfate | Intervet, Inc. | Turkeys | NADA 047-486 |
| Gentoralapproval withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Swine | ANADA 200-190 |
| Gentasolapproval withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Turkeys | ANADA 200-191 |
Other pages with this ingredient
A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.
- Gentamicin Sulfate, all combinations
- Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate
- Betamethasone Valerate + Gentamicin Sulfate
- Clotrimazole + Gentamicin Sulfate
- Clotrimazole + Gentamicin Sulfate + Mometasone furoate
- Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate
- Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate
Next in the A to Z list
FDA pages for this drug
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
- Green Book record of NADA 038-292The FDA record of the application for Gentocin Solution.
- Green Book record of NADA 098-989The FDA record of the application for Gentocin Ophthalmic Ointment.
- Green Book record of NADA 099-008The FDA record of the application for Gentocin Ophthalmic Solution.
- Green Book record of NADA 137-310The FDA record of the application for Gentamicin Sulfate Inj. Sol..
- Green Book record of ANADA 200-273The FDA record of the application for Vetro-Gen Veterinary Ophthalmic Ointment.
- Green Book record of ANADA 200-576The FDA record of the application for Gentamicin Sulfate Ophthalmic Solution.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
The site checked these addresses on . The links open in a new tab.
Cite this page
Pet Drug Reports. Gentamicin Sulfate: adverse event reports that FDA received. https://petdrugreports.com/drug/gentamicin-sulfate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .
Where the data come from
The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.
The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.
Questions about these reports
- Which brand are these reports about?
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.
- Do the reports show that the drug caused the signs?
No. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
- How many reports did FDA receive in the latest 12 months?
FDA received 19 reports in the 12 months to June 2026. It received 14 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
- What kinds of report are in the count?
Of the 358 reports received from January 1987 to June 2026, 74.3% are about a safety issue only. 6.7% are about a lack of expected effectiveness, alone or with a safety issue. 17% are about a defect of the product or its package.