Enrofloxacin (Baytril, Enroflox): adverse event reports that FDA received
Active ingredient
Also sold as: Baytril, Enroflox, Zobuxa, EnroPro, EnroMed 100, Tenotryl.
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 December 1989 to June 2026, FDA received 8,078 adverse event reports that name a drug with enrofloxacin as its active ingredient. Of the 8,078 reports, 3,584 (44.4%) are about dogs. 1,557 reports are about cats (19.3%).
In January to March 2026, FDA received 71 reports that name this drug. The signs that appear in the largest number of the 8,078 reports are "Solution, Abnormal", "Vomiting" and "Lethargy". A report is not proof that a drug caused a sign.
Reports that name this drug fell by 34.7% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 44.4% of the reports that name this drug, and 72.6% of all reports.
Since the last update of the FDA data
The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:
- All species: from 63 to 71.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 71 reports that name enrofloxacin: 53 dog, 7 cat, 1 horse, 10 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 8,078 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.
- Solution, Abnormal[a product quality report, not a sign in an animal]11.7%948 reports
- Vomiting11.3%911 reports
- Lethargy[unusually tired or inactive]9.7%787 reports
- Death7.9%638 reports
- Death by euthanasia[the animal was euthanized]7.5%606 reports
- Anorexia[not eating]7.2%583 reports
- Blindness6.1%490 reports
- Mydriasis[dilated pupils]6%488 reports
- Uncoded sign[a sign with no matching dictionary term]5.9%479 reports
- Solution/Suspension, crystals[a product quality report, not a sign in an animal]5.4%436 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]5%400 reports
- Diarrhoea[diarrhea]4.6%370 reports
- Ataxia[unsteady, uncoordinated movement]4.6%369 reports
- Seizure NOS[seizure, type not specified]3.9%312 reports
Show the next 16 signs
- Fever3.7%296 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.6%289 reports
- Lack of efficacy - NOS[the product did not have the expected effect]3.6%289 reports
- Behavioural disorder NOS[behaviour change, type not specified]3.5%284 reports
- Retinal disorder NOS[NOS: not otherwise specified]3.3%267 reports
- Accidental exposure[exposure that was not intended]3.3%264 reports
- Weight loss3.1%250 reports
- Leucocytosis NOS[high white blood cell count]3.1%249 reports
- Not eating2.9%232 reports
- Anaemia NOS[low red blood cell count]2.8%223 reports
- Depression[dull, quiet or withdrawn]2.7%221 reports
- Decreased appetite2.7%219 reports
- Abnormal radiograph finding2.7%215 reports
- Convulsion[seizure]2.5%204 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]2.4%197 reports
- Dehydration2.3%187 reports
The list shows 30 of 1,805 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 8,078 reports that name enrofloxacin. The other reports give a different species or no species.
Reports for each month, Jul 2021 to Jun 2026
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 | 104 | 10 | 8 | 19 | 141 |
| 2025 | 247 | 55 | 3 | 68 | 373 |
| 2024 | 260 | 39 | 1 | 70 | 370 |
| 2023 | 174 | 33 | 5 | 66 | 278 |
| 2022 | 116 | 21 | 1 | 18 | 156 |
| 2021 | 116 | 15 | 1 | 82 | 214 |
| 2020 | 131 | 22 | 6 | 80 | 239 |
| 2019 | 149 | 23 | 2 | 125 | 299 |
| 2018 | 176 | 33 | 4 | 104 | 317 |
| 2017 | 197 | 46 | 1 | 94 | 338 |
| 2016 | 243 | 46 | 4 | 131 | 424 |
| 2015 | 155 | 37 | 5 | 167 | 364 |
| 2014 | 199 | 55 | 3 | 207 | 464 |
| 2013 | 223 | 66 | 7 | 284 | 580 |
| 2012 | 232 | 66 | 1 | 156 | 455 |
| 2011 | 108 | 55 | 4 | 167 | 334 |
| 2010 | 116 | 55 | 4 | 106 | 281 |
| 2009 | 75 | 49 | 3 | 74 | 201 |
| 2008 | 50 | 43 | 4 | 54 | 151 |
| 2007 | 40 | 68 | 3 | 52 | 163 |
| 2006 | 48 | 46 | 3 | 132 | 229 |
| 2005 | 36 | 55 | 0 | 64 | 155 |
| 2004 | 53 | 63 | 0 | 37 | 153 |
| 2003 | 37 | 78 | 3 | 53 | 171 |
| 2002 | 42 | 100 | 2 | 126 | 270 |
| 2001 | 55 | 142 | 0 | 82 | 279 |
| 2000 | 43 | 129 | 1 | 128 | 301 |
| 1999 | 45 | 52 | 0 | 71 | 168 |
| 1998 | 42 | 27 | 1 | 15 | 85 |
| 1997 | 29 | 7 | 0 | 11 | 47 |
| 1996 | 12 | 5 | 0 | 6 | 23 |
| 1995 | 16 | 6 | 0 | 6 | 28 |
| 1994 | 3 | 0 | 1 | 0 | 4 |
| 1993 | 7 | 3 | 0 | 0 | 10 |
| 1992 | 1 | 3 | 0 | 1 | 5 |
| 1991 | 1 | 4 | 0 | 0 | 5 |
| 1990 | 2 | 0 | 0 | 0 | 2 |
| 1989 | 1 | 0 | 0 | 0 | 1 |
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/Normal14.1%1,142
- Recovered with Sequela[recovered, with a lasting effect]1%79
- Ongoing9.4%757
- Died9.6%775
- Euthanized6.5%522
- Outcome Unknown14.4%1,167
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 8,078 reports that name enrofloxacin.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue68%5,497
- Lack of expected effectiveness1.6%128
- Both safety and lack of expected effectiveness3.1%254
- Manufacturing or product defect27.2%2,196
- Otherunder 0.1%3
3,993 reports say if the event was serious. 75.7% 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 year7.2%581
- 1 to 3 years10.6%857
- 4 to 7 years16.2%1,305
- 8 to 11 years16.6%1,343
- 12 years and over16.2%1,311
- Age not given33.2%2,681
Weight of the animal
- Under 5 kg (11 lb)15.5%1,254
- 5 to 9.9 kg (11 to 22 lb)17.1%1,383
- 10 to 24.9 kg (22 to 55 lb)12.3%992
- 25 to 44.9 kg (55 to 99 lb)12.4%1,004
- 45 kg and over (99 lb and over)5.6%455
- Weight not given37%2,990
Breed, where the report gives one breed
- Domestic9.2%741
- Domestic Shorthair5.1%415
- Labrador Retriever3.1%251
- Shih Tzu1.4%110
- German Shepherd Dog1.3%101
- Chihuahua1.2%100
- Golden Retriever1.2%96
- Yorkshire Terrier0.8%68
A breed with many animals has many reports.
Route in the report
- Oral35.2%2,845
- Subcutaneous8.1%658
- Intramuscular5.2%420
- Intravenous5.1%416
- Other1.3%109
- Parenteral1.3%103
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
- Baytril
- Enroflox
- Zobuxa
- EnroPro
- EnroMed 100
- Tenotryl
What the Green Book records give
- Applications with an approval in force
- 22
- Approved species
- Dogs, Cats, Cattle, Swine
- Dose forms
- Injectable Solution, Tablet, Flavored Tablets, Chewable Tablets, Flavored antibacterial tablets, Liquid (Solution), Solution
- Routes
- Intramuscular, Oral, Subcutaneous, Injection
- Sale
- RX (prescription)
- 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 |
|---|---|---|---|---|
| Baytril Antibacterial Tablets; Baytril Taste Tabs Antibacterial Tablets | Enrofloxacin | Elanco US Inc. | Dogs, Cats | NADA 140-441 |
| Baytril Antibacterial Injectable Solution | Enrofloxacin | Elanco US Inc. | Dogs | NADA 140-913 |
| Baytril 100 | Enrofloxacin | Elanco US Inc. | Cattle, Swine | NADA 141-068 |
| Enroflox 100 | Enrofloxacin | Norbrook Laboratories, Ltd. | Cattle, Swine | ANADA 200-495 |
| Enroflox Injection for Dogs 2.27% | Enrofloxacin | Norbrook Laboratories, Ltd. | Dogs | ANADA 200-513 |
| Zobuxa | Enrofloxacin | Elanco US Inc. | Dogs, Cats | ANADA 200-517 |
| Enrofloxacin Antibacterial Injectable Solution | Enrofloxacin | Dechra Veterinary Products LLC | Dogs | ANADA 200-527 |
| Enrofloxacin Flavored Tablets | Enrofloxacin | Dechra Veterinary Products LLC | Dogs, Cats | ANADA 200-551 |
| EnroMed 100 | Enrofloxacin | Bimeda Animal Health Ltd. | Cattle, Swine | ANADA 200-598 |
| Baytril Soft Chewable Tablets | Enrofloxacin | Elanco US Inc. | Dogs, Cats | ANADA 200-608 |
| Enrofloxacin 100 | Enrofloxacin | Sparhawk Laboratories, Inc. | Cattle, Swine | ANADA 200-628 |
| Enrofloxacin Flavored Tablets | Enrofloxacin | Felix Pharmaceuticals Pvt. Ltd. | Dogs, Cats | ANADA 200-680 |
| Tenotryl | Enrofloxacin | Virbac AH, Inc. | Cattle, Swine | ANADA 200-688 |
| Enrofloxacin | Enrofloxacin | Accord Healthcare, Inc. | Dogs | ANADA 200-697 |
| Enrofloxacin | Enrofloxacin | Felix Pharmaceuticals Pvt. Ltd. | Dogs | ANADA 200-708 |
| Enroflox Chewable Tablets | Enrofloxacin | Norbrook Laboratories, Ltd. | Dogs, Cats | ANADA 200-720 |
| Enrofloxacin | Enrofloxacin | ZyVet Animal Health, Inc. | Dogs, Cats | ANADA 200-737 |
| Enrofloxacin | Enrofloxacin | Felix Pharmaceuticals Pvt. Ltd. | Cattle, Swine | ANADA 200-758 |
| EnroPro 22.7 | Enrofloxacin | Cronus Pharma Specialities India Private Ltd. | Dogs | ANADA 200-764 |
| EnroPro 100 | Enrofloxacin | Cronus Pharma Specialities India Private Ltd. | Cattle, Swine | ANADA 200-765 |
| Enrofloxacin Flavored Tablets | Enrofloxacin | Hikma Pharmaceuticals USA, Inc. | Dogs, Cats | ANADA 200-810 |
| EnroPro | Enrofloxacin | Cronus Pharma Specialities India Private Ltd. | Dogs, Cats | ANADA 200-835 |
| Baytril 100-CA1approval withdrawn | Enrofloxacin | Elanco US Inc. | Cattle | NADA 141-527 |
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.
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 140-441The FDA record of the application for Baytril Antibacterial Tablets, Baytril Taste Tabs Antibacterial Tablets.
- Green Book record of NADA 140-913The FDA record of the application for Baytril Antibacterial Injectable Solution.
- Green Book record of ANADA 200-513The FDA record of the application for Enroflox Injection for Dogs 2.27%.
- Green Book record of ANADA 200-517The FDA record of the application for Zobuxa.
- Green Book record of ANADA 200-527The FDA record of the application for Enrofloxacin Antibacterial Injectable Solution.
- Green Book record of ANADA 200-551The FDA record of the application for Enrofloxacin Flavored Tablets.
- 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. Enrofloxacin: adverse event reports that FDA received. https://petdrugreports.com/drug/enrofloxacin/ 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 279 reports in the 12 months to June 2026. It received 427 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 8,078 reports received from December 1989 to June 2026, 68% are about a safety issue only. 4.7% are about a lack of expected effectiveness, alone or with a safety issue. 27.2% are about a defect of the product or its package.