Pet Drug Reports

Drugs by active ingredient

Drug · single active ingredient

Enrofloxacin: adverse event reports

All products with this active ingredient · 23 FDA-approved applications in the Green Book

7,996reports naming this ingredient, 1989–20260.6% of all reports · about 220 a year
302reports, 12 months to March 2026407 in the 12 months before
75.6%classed serious, as reportedof 3,920 reports stating it
15.7%record death or euthanasia, as reported1,256 reports
44.1%of reports concern dogs0.4% of all dog reports

Between December 1989 and March 2026 FDA received 7,996 adverse event reports listing a drug with enrofloxacin as the recorded active ingredient. The Green Book lists 23 FDA-approved applications with this single active ingredient.

openFDA masks the brand and manufacturer in every report, so these figures describe the ingredient across all products and cannot be attributed to a brand.

In the 12 months to March 2026, 302 reports named it, down 26% from 407 in the 12 months before. Recent months are provisional: fDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Over its whole reporting history that is about 220 reports a year and 0.6% of all 1,357,245 reports (0.4% of all dog reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.

Reporters most often listed solution, Abnormal (11.8%), vomiting (11.2%) and lethargy (9.6%). A report can list several signs, so shares add to more than 100%; 1,789 different terms appear across these reports.

44.1% of reports concern dogs. Not every report describes illness: 27.4% as product or packaging defects. Of reports that state seriousness, 75.6% were classed as serious, and 15.7% of all reports record a death or euthanasia as an outcome, as reported. FDA has not necessarily determined whether any drug played a part.

Monthly reports by species, five years

Dog926 · peak 40
Apr 2021: 9May 2021: 9Jun 2021: 3Jul 2021: 12Aug 2021: 15Sep 2021: 13Oct 2021: 8Nov 2021: 6Dec 2021: 7Jan 2022: 13Feb 2022: 10Mar 2022: 8Apr 2022: 12May 2022: 9Jun 2022: 3Jul 2022: 9Aug 2022: 14Sep 2022: 14Oct 2022: 10Nov 2022: 9Dec 2022: 5Jan 2023: 12Feb 2023: 16Mar 2023: 8Apr 2023: 16May 2023: 17Jun 2023: 16Jul 2023: 19Aug 2023: 10Sep 2023: 12Oct 2023: 17Nov 2023: 15Dec 2023: 16Jan 2024: 18Feb 2024: 21Mar 2024: 21Apr 2024: 15May 2024: 15Jun 2024: 29Jul 2024: 18Aug 2024: 40Sep 2024: 25Oct 2024: 15Nov 2024: 15Dec 2024: 28Jan 2025: 25Feb 2025: 40Mar 2025: 20Apr 2025: 13May 2025: 28Jun 2025: 24Jul 2025: 25Aug 2025: 12Sep 2025: 23Oct 2025: 11Nov 2025: 12Dec 2025: 12Jan 2026: 15Feb 2026: 21Mar 2026: 132022202320242025
Cat168 · peak 8
Apr 2021: 4May 2021: 1Jul 2021: 2Sep 2021: 1Nov 2021: 4Dec 2021: 2Mar 2022: 1Apr 2022: 2May 2022: 3Jun 2022: 1Jul 2022: 1Aug 2022: 6Sep 2022: 4Oct 2022: 1Nov 2022: 2Jan 2023: 3Feb 2023: 3Mar 2023: 3Apr 2023: 3May 2023: 1Jun 2023: 3Jul 2023: 2Aug 2023: 3Sep 2023: 6Oct 2023: 4Nov 2023: 2Feb 2024: 2Mar 2024: 6Apr 2024: 1May 2024: 1Jun 2024: 8Jul 2024: 3Aug 2024: 2Sep 2024: 7Oct 2024: 3Nov 2024: 4Dec 2024: 2Jan 2025: 5Feb 2025: 8Mar 2025: 6Apr 2025: 5May 2025: 7Jun 2025: 5Jul 2025: 2Aug 2025: 2Sep 2025: 6Oct 2025: 5Nov 2025: 3Dec 2025: 2Jan 2026: 2Feb 2026: 1Mar 2026: 22022202320242025
Horse12 · peak 2
Jun 2021: 1Jan 2022: 1Mar 2023: 1Apr 2023: 1Jul 2023: 1Aug 2023: 1Nov 2023: 1Aug 2024: 1May 2025: 1Jun 2025: 2Feb 2026: 12022202320242025
Other282 · peak 17
Apr 2021: 4May 2021: 5Jun 2021: 8Jul 2021: 17Aug 2021: 9Sep 2021: 2Oct 2021: 2Nov 2021: 1Dec 2021: 7Jan 2022: 1Feb 2022: 4Apr 2022: 2Jul 2022: 1Aug 2022: 3Sep 2022: 2Oct 2022: 1Nov 2022: 2Dec 2022: 2Jan 2023: 7Feb 2023: 8Mar 2023: 9Apr 2023: 5May 2023: 5Jun 2023: 3Jul 2023: 1Aug 2023: 5Sep 2023: 5Oct 2023: 8Nov 2023: 2Dec 2023: 8Jan 2024: 9Feb 2024: 13Mar 2024: 3Apr 2024: 6May 2024: 7Jun 2024: 3Jul 2024: 1Aug 2024: 12Sep 2024: 1Oct 2024: 4Nov 2024: 6Dec 2024: 5Jan 2025: 13Feb 2025: 7Mar 2025: 6Apr 2025: 6May 2025: 9Jun 2025: 2Jul 2025: 8Aug 2025: 3Sep 2025: 4Oct 2025: 2Nov 2025: 2Dec 2025: 3Jan 2026: 3Feb 2026: 2Mar 2026: 32022202320242025

Reports by the month FDA received them. Each panel has its own scale; the peak month is printed at the top right. The newest months are incomplete because FDA posts reports with a delay of three to six months.

Reports by year received

02905801989: 119891990: 21991: 51992: 51993: 1019931994: 41995: 281996: 231997: 4719971998: 851999: 1682000: 3012001: 27920012002: 2702003: 1712004: 1532005: 15520052006: 2292007: 1632008: 1512009: 20120092010: 2812011: 3342012: 4552013: 58020132014: 4642015: 3642016: 4242017: 33820172018: 3172019: 2992020: 2392021: 21420212022: 1562023: 2782024: 3702025: 36920252026: 63

2026 covers reports received through March 2026 only.

Signs listed in reports

share of enrofloxacin reports listing the termall dog reports

  1. Solution, Abnormal[a product quality report, not a sign in an animal]11.8%947
  2. Vomiting11.2%899
  3. Lethargy[unusually tired or inactive]9.6%771
  4. Death7.8%625
  5. Death by euthanasia[the animal was euthanized]7.4%591
  6. Anorexia[not eating]7.2%577
  7. Blindness6.1%490
  8. Mydriasis[dilated pupils]6.1%488
  9. Uncoded sign[a sign with no matching dictionary term]6%479
  10. Solution/Suspension, crystals[a product quality report, not a sign in an animal]5.4%435
  11. Other abnormal test result NOS[abnormal laboratory result, type not specified]5%397
  12. Ataxia[unsteady, uncoordinated movement]4.6%368
  13. Diarrhoea[diarrhea]4.5%361
  14. Seizure NOS[seizure, type not specified]3.9%309
  15. Fever3.6%287
  16. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.5%282
  17. Behavioural disorder NOS[behaviour change, type not specified]3.5%280
  18. Lack of efficacy - NOS[the product did not have the expected effect]3.4%274
  19. Retinal disorder NOS[NOS: not otherwise specified]3.3%267
  20. Accidental exposure[exposure that was not intended]3.3%263
  21. Leucocytosis NOS[high white blood cell count]3.1%250
  22. Not eating2.8%222
  23. Depression[dull, quiet or withdrawn]2.8%221
  24. Anaemia NOS[low red blood cell count]2.7%215
  25. Convulsion[seizure]2.6%204
  26. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]2.4%194
  27. Vocalisation[crying out or unusual noise]2.3%180

Top 30 of 1,789 coded terms (VeDDRA, the veterinary reporting dictionary; plain-language gloss in brackets). One report can list several terms. The ticks show how often the same term appears in a wider pool of reports; they describe the reports, and FDA cautions that such figures cannot be used to estimate risk or to compare one product with another. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.

Outcomes and report types

Outcome recorded in the report

Recovered/Normal14.1%1,126
Recovered with Sequela1%78
Ongoing9.2%735
Died9.5%761
Euthanized6.3%507
Outcome Unknown14.5%1,158

What kind of report it was

Safety issue68%5,437
Lack of expected effectiveness1.6%127
Both safety and lack of expected effectiveness3%242
Manufacturing or product defect27.4%2,187
Other0%3

Coloured bar: reports naming enrofloxacin. Grey bar: all 1,357,245 reports in the database. Outcomes are the status at the time of the last report, as stated by the reporter; a report covering several animals can carry more than one outcome. FDA has not necessarily determined whether any drug played a part in any outcome.

Species and breeds in the reports

Species

Dog44.1%3,527
Cat19.4%1,553
Human exposure3.4%270
Cattle2.9%233
Horse0.9%74
Pig0.7%53

Single-breed animals

Breed shares follow how common each breed is. Crossbred animals and reports with no breed stay in the species figure only.

Age, weight and route

Age of the animal

Under 1 year7.1%570
1 to 3 years10.6%849
4 to 7 years16.1%1,287
8 to 11 years16.5%1,323
12 years and over16.2%1,297
Age not given33.4%2,670

Weight of the animal

Under 5 kg (11 lb)15.5%1,242
5 to 9.9 kg (11–22 lb)17.2%1,374
10 to 24.9 kg (22–55 lb)12.2%977
25 to 44.9 kg (55–99 lb)12.3%986
45 kg and over (99 lb+)5.5%443
Weight not given37.2%2,974

Route of administration stated in reports: oral (2,822), subcutaneous (653), intramuscular (418), intravenous (402), other (109), parenteral (102).

In context

MeasureEnrofloxacinAll dog reportsAll reports
Reports7,996985,6751,357,245
Share of that pool's reports naming this drug—0.4%0.6%
Classed serious, of reports stating it75.6%38.3%38.6%
Death or euthanasia recorded, per 1,000 reports157.15563.8
Filed as lack of expected effectiveness (wholly or partly)4.6%—23%
Top term, share of reportsSolution, Abnormal 11.8%0%—

This set accounts for 90.6% of all reports naming enrofloxacin, so no separate ingredient column is shown. Shares are of reports, not of animals treated. The number of doses sold is not public, so none of these figures is a rate of occurrence, and differences between columns reflect which animals receive a drug and who reports as much as anything else.

Other ingredient sets sharing an ingredient

Active ingredientsReportsLatest 12 months
Enrofloxacin + Silver sulfadiazine73444
Enrofloxacin + Ketoconazole + Triamcinolone9717

Listed for navigation, ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another": drugs differ in formulation, in the animals they are given to, in sales volume and in years on the market. A report's ingredient field can be incomplete, so reports about one product may sit under more than one set.

FDA-approved products containing enrofloxacin (Green Book)

Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 30 Sep 2026; nothing on this page says which of these products, if any, a report concerned.

Trade nameActive ingredientsSponsorApproved forApplication
Baytril Antibacterial Tablets; Baytril Taste Tabs Antibacterial TabletsEnrofloxacinElanco US Inc.Dogs, CatsNADA 140-441
Baytril Antibacterial Injectable SolutionEnrofloxacinElanco US Inc.DogsNADA 140-913
Baytril 100EnrofloxacinElanco US Inc.Cattle, SwineNADA 141-068
Enroflox 100EnrofloxacinNorbrook Laboratories, Ltd.Cattle, SwineANADA 200-495
Enroflox Injection for Dogs 2.27%EnrofloxacinNorbrook Laboratories, Ltd.DogsANADA 200-513
ZobuxaEnrofloxacinElanco US Inc.Dogs, CatsANADA 200-517
Enrofloxacin Antibacterial Injectable SolutionEnrofloxacinDechra Veterinary Products LLCDogsANADA 200-527
Enrofloxacin Flavored TabletsEnrofloxacinDechra Veterinary Products LLCDogs, CatsANADA 200-551
EnroMed 100EnrofloxacinBimeda Animal Health Ltd.Cattle, SwineANADA 200-598
Baytril Soft Chewable TabletsEnrofloxacinElanco US Inc.Dogs, CatsANADA 200-608
Enrofloxacin 100EnrofloxacinSparhawk Laboratories, Inc.Cattle, SwineANADA 200-628
Enrofloxacin Flavored TabletsEnrofloxacinFelix Pharmaceuticals Pvt. Ltd.Dogs, CatsANADA 200-680
TenotrylEnrofloxacinVirbac AH, Inc.Cattle, SwineANADA 200-688
EnrofloxacinEnrofloxacinAccord Healthcare, Inc.DogsANADA 200-697
EnrofloxacinEnrofloxacinFelix Pharmaceuticals Pvt. Ltd.DogsANADA 200-708
Enroflox Chewable TabletsEnrofloxacinNorbrook Laboratories, Ltd.Dogs, CatsANADA 200-720
EnrofloxacinEnrofloxacinZyVet Animal Health, Inc.Dogs, CatsANADA 200-737
EnrofloxacinEnrofloxacinFelix Pharmaceuticals Pvt. Ltd.Cattle, SwineANADA 200-758
EnroPro 22.7EnrofloxacinCronus Pharma Specialities India Private Ltd.DogsANADA 200-764
EnroPro 100EnrofloxacinCronus Pharma Specialities India Private Ltd.Cattle, SwineANADA 200-765
Enrofloxacin Flavored TabletsEnrofloxacinHikma Pharmaceuticals USA, Inc.Dogs, CatsANADA 200-810
EnroProEnrofloxacinCronus Pharma Specialities India Private Ltd.Dogs, CatsANADA 200-835
Baytril 100-CA1approval voluntarily withdrawnEnrofloxacinElanco US Inc.CattleNADA 141-527

Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).

Questions about enrofloxacin reports

How many adverse event reports has FDA received for enrofloxacin?

7,996 reports record a drug with enrofloxacin as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 302 of them arrived in the latest 12 months.

Which brand do these reports concern?

That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book lists 23 approved applications with this ingredient alone; the reference list on this page names them without any counts.

What signs are reported most often?

solution, Abnormal (11.8%), vomiting (11.2%), lethargy (9.6%), death (7.8%) and death by euthanasia (7.4%). These are the coded terms listed in reports; several can appear in one report, and a term's presence is not a finding that the drug was responsible.

Which species and breeds appear in these reports?

dog (44.1%), cat (19.4%) and human exposure (3.4%). Among single-breed animals the most frequent labels are Domestic, Domestic Shorthair, Labrador Retriever and Shih Tzu; popular breeds appear often in any drug's reports because there are more of them.

Are reports rising?

302 reports in the 12 months to March 2026, down 26% from 407 in the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Counts also move with sales, publicity and time on the market.

Do these reports show that enrofloxacin harms pets?

Report counts cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." FDA also notes that commonly used products may have more reports simply because more animals receive them.

Are these the side effects of enrofloxacin?

They are signs listed in reports, not an established list of side effects. The adverse reactions observed in studies are printed on each product's FDA-approved label, which a veterinarian can go through with you. This page is a record of what was reported to FDA.

How do I report a problem with an animal drug?

FDA asks owners and veterinarians to call the drug company first (the number is on the label); companies must pass reports to FDA. Reports can also go directly to FDA on Form FDA 1932a. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 30 Sep 2026. Drug entries are grouped by the active ingredients their unmasked ingredient field discloses; the application number that records also carry is not used. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.