Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Polymyxin B Sulfate: adverse event reports, pooled

15 ingredient sets in reports · 13 FDA-approved applications in the Green Book

740reports naming the ingredient, 1995–20260.1% of all reports · about 24 a year
35reports, 12 months to March 202636 in the 12 months before
47.4%classed serious, as reportedall reports: 38.6%
49.9%of reports concern dogscat 26.8%

740 adverse event reports received by FDA list a drug containing polymyxin b sulfate, alone or in combination, from April 1995 to March 2026. This page pools every ingredient set that includes it; 15 such sets appear in reports.

The Green Book lists 13 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.

35 reports arrived in the 12 months to March 2026, close to the 36 of 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. That is about 24 reports a year over its reporting history and 0.1% of all reports.

Pooled across every set, the terms listed most often are deafness (10.7%), vomiting (9.2%) and lethargy (6.9%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.

Of reports that state seriousness, 47.4% were classed as serious (38.6% across the whole database); 3.5% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.

Ingredient sets that include polymyxin b sulfate

Active ingredients recorded for the drugReportsShare of this page's reportsLatest 12 months
Oxytetracycline + Polymyxin B Sulfate38652.2%17
Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate25434.3%8
Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate304.1%5
Hydrocortisone + Polymyxin B Sulfate182.4%0
Bacitracin Zinc + Neomycin Sulfate + Polymyxin B Sulfate172.3%2
Bacitracin Zinc + Polymyxin B Sulfate131.8%0
Miconazole Nitrate + Polymyxin B Sulfate131.8%0
Dexamethasone + Polymyxin B Sulfate30.4%0
Polymyxin B Sulfate20.3%0
Bacitracin + Polymyxin B Sulfate20.3%2
Polymyxin B Sulfate + Prednisolone Acetate10.1%0
Neomycin Sulfate + Polymyxin B Sulfate + Prednisolone10.1%0
Polymyxin B Sulfate + Prednisolone10.1%0
Oxytetracycline Hydrochloride + Polymyxin B Sulfate10.1%0
Bacitracin + Dexamethasone + Polymyxin B Sulfate10.1%1

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"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.

Signs listed in reports, pooled

share of polymyxin b sulfate reports listing the termall reports in the database

  1. Deafness10.7%79
  2. Vomiting9.2%68
  3. Lethargy[unusually tired or inactive]6.9%51
  4. Diarrhoea[diarrhea]5.8%43
  5. Color, Abnormal[a product quality report, not a sign in an animal]5.7%42
  6. Lack of efficacy - NOS[the product did not have the expected effect]5.4%40
  7. Behavioural disorder NOS[behaviour change, type not specified]4.1%30
  8. Emesis[vomiting]3.1%23
  9. Containers, Leaking[a product quality report, not a sign in an animal]3%22
  10. Anaphylaxis[sudden severe allergic-type reaction]2.6%19
  11. Anorexia[not eating]2.4%18
  12. Eye pain2.4%18
  13. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.4%18
  14. Containers, Damaged[a product quality report, not a sign in an animal]2.3%17
  15. Ear infection NOS[NOS: not otherwise specified]2.3%17
  16. Squinting2.3%17
  17. Underfilling, Container[a product quality report, not a sign in an animal]2.3%17
  18. Accidental exposure[exposure that was not intended]2.2%16
  19. Tubes, Leaking[a product quality report, not a sign in an animal]2.2%16
  20. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2%15

Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.

Monthly reports by species, five years

Dog51 · peak 3
Apr 2021: 1May 2021: 2Jun 2021: 1Aug 2021: 1Sep 2021: 1Feb 2022: 1May 2022: 1Jun 2022: 2Aug 2022: 2Nov 2022: 1Mar 2023: 1Jun 2023: 1Aug 2023: 2Sep 2023: 3Oct 2023: 1Dec 2023: 1Feb 2024: 2Mar 2024: 1May 2024: 1Jun 2024: 1Aug 2024: 1Sep 2024: 2Oct 2024: 1Nov 2024: 1Dec 2024: 1Jan 2025: 1Apr 2025: 2May 2025: 3Jul 2025: 1Sep 2025: 2Oct 2025: 2Nov 2025: 2Dec 2025: 1Feb 2026: 2Mar 2026: 22022202320242025
Cat62 · peak 6
Apr 2021: 1May 2021: 4Jul 2021: 1Nov 2021: 1Dec 2021: 1Feb 2022: 2Mar 2022: 1Apr 2022: 2May 2022: 2Jun 2022: 2Nov 2022: 2Dec 2022: 1Jan 2023: 2Feb 2023: 1Mar 2023: 1Apr 2023: 1May 2023: 2Jun 2023: 6Jul 2023: 2Aug 2023: 2Mar 2024: 1Apr 2024: 2Jun 2024: 2Aug 2024: 1Sep 2024: 4Nov 2024: 2Jan 2025: 2Feb 2025: 1Mar 2025: 2Apr 2025: 1May 2025: 1Jun 2025: 1Jul 2025: 4Nov 2025: 12022202320242025
Horse0 · peak 1
2022202320242025
Other43 · peak 2
Apr 2021: 2Jun 2021: 2Sep 2021: 2Nov 2021: 2Jan 2022: 1Feb 2022: 2Mar 2022: 1Apr 2022: 1Aug 2022: 1Sep 2022: 1Nov 2022: 2Nov 2023: 2Jan 2024: 2Mar 2024: 1Apr 2024: 1May 2024: 2Jun 2024: 1Jul 2024: 1Aug 2024: 2Sep 2024: 1Nov 2024: 1Jan 2025: 1Feb 2025: 1May 2025: 1Jun 2025: 2Jul 2025: 1Aug 2025: 1Nov 2025: 2Dec 2025: 1Feb 2026: 22022202320242025

By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.

0611221995: 319951996: 11997: 11998: 1419981999: 42000: 162001: 1620012002: 92003: 52004: 1420042005: 32006: 112007: 1220072008: 132009: 122010: 720102011: 302012: 222013: 2620132014: 802015: 1222016: 2420162017: 172018: 262019: 3120192020: 522021: 352022: 2820222023: 282024: 352025: 3720252026: 6

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal18.9%140
Recovered with Sequela9.1%67
Ongoing12.7%94
Died2.3%17
Euthanized1.2%9
Outcome Unknown21.9%162

What kind of report it was

Safety issue73.4%543
Lack of expected effectiveness4.2%31
Both safety and lack of expected effectiveness1.5%11
Manufacturing or product defect20.9%155
Other0%0

Species

Dog49.9%369
Cat26.8%198
Human exposure2%15
Rabbit0.5%4
Other0.4%3
Horse0.3%2

Age of the animal

Under 1 year10.7%79
1 to 3 years13.2%98
4 to 7 years14.1%104
8 to 11 years18.9%140
12 years and over15%111
Age not given28.1%208

Coloured bar: reports naming polymyxin b sulfate. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.

In context

MeasurePolymyxin B SulfateAll reports
Reports7401,357,245
Latest 12 months against the 12 before-3%-5%
Classed serious, of reports stating it47.4%38.6%
Death or euthanasia recorded, per 1,000 reports35.163.8
Filed as lack of expected effectiveness (wholly or partly)5.7%23%

Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.

FDA-approved products containing polymyxin b sulfate (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 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.

Trade nameActive ingredientsSponsorApproved forApplication
TerramycinOxytetracycline Hydrochloride, Polymyxin B SulfateZoetis Inc.Dogs, Cats, Horses, Cattle, SheepNADA 008-763
Anaprime Ophthalmic SolutionFlumethasone, Neomycin Sulfate, Polymyxin B SulfateZoetis Inc.Dogs, CatsNADA 038-801
Anaprime Opthakote OphthalmicFlumethasone, Neomycin Sulfate, Polymyxin B SulfateZoetis Inc.DogsNADA 049-725
Optiprime Opthakote Ophthalmic SolutionNeomycin Sulfate, Polymyxin B SulfateZoetis Inc.DogsNADA 049-726
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment; Vetropolycin HC Ophthalmic OintmentBacitracin Zinc, Hydrocortisone Acetate, Neomycin Sulfate, Polymyxin B SulfateDechra Veterinary Products LLCDogs, CatsNADA 065-015
Bac-Neo-Poly Ophthalmic Ointment; Vetropolycin Ophthalmic OintmentBacitracin Zinc, Neomycin Sulfate, Polymyxin B SulfateDechra Veterinary Products LLCDogs, CatsNADA 065-016
Mycitracin Sterile Ophthalmic OintmentBacitracin Zinc, Neomycin Sulfate, Polymyxin B SulfateZoetis Inc.Dogs, CatsNADA 065-114
Forte Topical OintmentHydrocortisone Acetate, Neomycin Sulfate, Penicillin G Procaine, Polymyxin B SulfateZoetis Inc.Dogs, CatsNADA 065-119
Cortisporin Veterinary Ophthalmic OintmentBacitracin Zinc, Hydrocortisone, Neomycin Sulfate, Polymyxin B SulfateIntervet, Inc.Dogs, CatsNADA 065-476
Neosporin Ophthalmic OintmentBacitracin Zinc, Neomycin Sulfate, Polymyxin B SulfateIntervet, Inc.Dogs, CatsNADA 065-485
SurolanMiconazole Nitrate, Polymyxin B Sulfate, Prednisolone AcetateElanco US Inc.DogsNADA 141-298
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic OintmentBacitracin Zinc, Neomycin Sulfate, Polymyxin B SulfateDomes Pharma S.A.Dogs, CatsANADA 200-553
Toptic Ointment (15 g)approval voluntarily withdrawnCephalonium, Flumethasone, Iodochlorhydroxyquin, Piperocaine Hydrochloride, Polymyxin B SulfateElanco Animal Health, A Division of Eli Lilly & Co.—NADA 040-123

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 polymyxin b sulfate reports

How many FDA adverse event reports mention polymyxin b sulfate?

740 reports through March 2026, 35 of them in the latest 12 months, counting polymyxin b sulfate alone and in combinations.

Which brands 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 reference list on this page names approved products containing polymyxin b sulfate without any counts.

In which combinations is polymyxin b sulfate reported?

Oxytetracycline + Polymyxin B Sulfate (52.2% of these reports), Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate (34.3% of these reports), Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate (4.1% of these reports), Hydrocortisone + Polymyxin B Sulfate (2.4% of these reports) and Bacitracin Zinc + Neomycin Sulfate + Polymyxin B Sulfate (2.3% of these reports).

What reactions are reported for polymyxin b sulfate?

deafness (10.7%), vomiting (9.2%), lethargy (6.9%), loss of hearing (6.4%) and diarrhoea (5.8%). Shares are of reports naming the ingredient; one report can list several terms.

Which animals are these reports about?

dog (49.9%), cat (26.8%) and human exposure (2%).

Does a high count mean polymyxin b sulfate is a problem ingredient?

A count 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." Widely used ingredients collect more reports because more animals receive them.

How do I report a problem?

Call the drug company using the number on the label, or send Form FDA 1932a to FDA. 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 1 Oct 2026. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. 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.