Pet Drug Reports

Drugs by active ingredient › Neomycin Sulfate + Nystatin + Thiostrepton

Drug · combination of 3 active ingredients

Neomycin Sulfate + Nystatin + Thiostrepton: adverse event reports

All products with this ingredient combination · no approved product with exactly this set

63reports naming this combination, 2020–20260% of all reports · about 10 a year
1reports, 12 months to March 20260 in the 12 months before
74.6%classed serious, as reportedof 63 reports stating it
6.3%record death or euthanasia, as reported4 reports
79.4%of reports concern dogs0% of all dog reports

63 adverse event reports in FDA's database list a drug whose active ingredients are recorded as the combination neomycin sulfate, nystatin and thiostrepton. The earliest was received in February 2020, the latest in January 2026. No FDA-approved product has exactly this set of ingredients; the ingredient field of a report can be incomplete.

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

In the 12 months to March 2026, 1 report named it, with none 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 10 reports a year and 0% of all 1,357,245 reports (0% 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.

The signs named most often are deafness (54%), emesis (12.7%) and ataxia (6.3%). A report can list several signs, so shares add to more than 100%; 96 different terms appear across these reports. Deafness appears in 54% of these reports, a larger share than in the pooled reports for every drug containing thiostrepton (28.5%).

79.4% of reports concern dogs. Of reports that state seriousness, 74.6% were classed as serious, and 6.3% 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

Dog41 · peak 7
Apr 2021: 1Jun 2021: 4Jul 2021: 3Aug 2021: 4Sep 2021: 2Oct 2021: 1Nov 2021: 4Dec 2021: 2Jan 2022: 3Feb 2022: 1Mar 2022: 1Apr 2022: 7Jun 2022: 2Jul 2022: 2Sep 2022: 42022202320242025
Cat13 · peak 2
Jul 2021: 1Aug 2021: 2Sep 2021: 1Jan 2022: 1Feb 2022: 2Mar 2022: 2Jun 2022: 2Jul 2022: 1Jan 2026: 12022202320242025
Horse0 · peak 1
2022202320242025
Other0 · peak 1
2022202320242025

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

015292020: 520202021: 2920212022: 2820222026: 12026

2026 covers reports received through March 2026 only.

Signs listed in reports

share of neomycin sulfate + nystatin + thiostrepton reports listing the termall drugs containing thiostreptonall dog reports

  1. Emesis[vomiting]12.7%8
  2. Ataxia[unsteady, uncoordinated movement]6.3%4
  3. Behavioural disorder NOS[behaviour change, type not specified]6.3%4
  4. Lack of efficacy - NOS[the product did not have the expected effect]6.3%4
  5. Accidental exposure[exposure that was not intended]4.8%3
  6. Anorexia[not eating]4.8%3
  7. Ear canal disorder4.8%3
  8. Application site hair change[hair change where the product was applied]3.2%2
  9. Dyspnoea[difficulty breathing]3.2%2
  10. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]3.2%2
  11. Ineffective, other drug(s)[legacy FDA term: the product did not have the expected effect (other drug(s))]3.2%2
  12. Lethargy[unusually tired or inactive]3.2%2
  13. Tachycardia[fast heart rate]3.2%2
  14. Vocalisation[crying out or unusual noise]3.2%2
  15. Abnormal histology NOS[NOS: not otherwise specified]1.6%1
  16. Adipsia[not drinking]1.6%1
  17. Allergic oedema1.6%1
  18. Anaphylactoid reaction[sudden allergic-type reaction]1.6%1
  19. Anxiety1.6%1
  20. Application site erythema[reddened skin where the product was applied]1.6%1
  21. Application site hair loss[hair loss where the product was applied]1.6%1
  22. Application site oedema[oedema where the product was applied]1.6%1
  23. Azotaemia[raised kidney values in blood]1.6%1

Top 30 of 96 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/Normal11.1%7
Recovered with Sequela9.5%6
Ongoing7.9%5
Died4.8%3
Euthanized1.6%1
Outcome Unknown65.1%41

What kind of report it was

Safety issue93.7%59
Lack of expected effectiveness3.2%2
Both safety and lack of expected effectiveness3.2%2
Manufacturing or product defect0%0
Other0%0

Coloured bar: reports naming neomycin sulfate + nystatin + thiostrepton. 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

Dog79.4%50
Cat20.6%13

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 year4.8%3
1 to 3 years6.3%4
4 to 7 years11.1%7
8 to 11 years31.7%20
12 years and over33.3%21
Age not given12.7%8

Weight of the animal

Under 5 kg (11 lb)28.6%18
5 to 9.9 kg (11–22 lb)11.1%7
10 to 24.9 kg (22–55 lb)17.5%11
25 to 44.9 kg (55–99 lb)20.6%13
45 kg and over (99 lb+)1.6%1
Weight not given20.6%13

Route of administration stated in reports: auricular (otic) (10), topical (6), ophthalmic (1).

In context

MeasureNeomycin Sulfate + Nystatin + ThiostreptonAll drugs containing thiostreptonAll dog reportsAll reports
Reports631,187985,6751,357,245
Share of that pool's reports naming this drug—5.3%0%0%
Classed serious, of reports stating it74.6%60%38.3%38.6%
Death or euthanasia recorded, per 1,000 reports63.5515563.8
Filed as lack of expected effectiveness (wholly or partly)6.3%——23%
Top term, share of reportsDeafness 54%28.5%0.6%—

The thiostrepton pool is every report naming thiostrepton alone or in any combination; this combination accounts for 5.3% of it. 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
Dexamethasone + Neomycin Sulfate + Thiabendazole1,088162
Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone Acetonide950133
Isoflupredone Acetate + Neomycin Sulfate + Tetracaine Hydrochloride12510
Neomycin Sulfate + Tetracaine Hydrochloride10922
Neomycin Sulfate + Nystatin1001
Nystatin + Thiostrepton + Triamcinolone Acetonide9016
Nystatin + Thiostrepton + Triamcinolone5517
Neomycin Sulfate341
Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate305
Nystatin222

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 (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.

No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete; these approved products contain all of the ingredients named here, together with others.

Trade nameActive ingredientsSponsorApproved forApplication
Panolog OintmentNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideZoetis Inc.Dogs, CatsNADA 012-258
Panolog CreamNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideZoetis Inc.Dogs, CatsNADA 096-676
Animax OintmentNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideFougera Pharmaceuticals, LLCDogs, CatsNADA 140-847
Derma 4 OintmentNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideZoetis Inc.Dogs, CatsNADA 140-879
Derm-Otic OintmentNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideZoetis Inc.Dogs, CatsNADA 141-003
Animax CreamNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideFougera Pharmaceuticals, LLCDogs, CatsANADA 200-330
DERMA-VET Ointmentapproval voluntarily withdrawnNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideMed-Pharmex, Inc.Dogs, CatsNADA 140-810
Derm-Otic Ointmentapproval voluntarily withdrawnNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideBiocraft Laboratories, Inc.Dogs, CatsNADA 140-889
Derma-Vet Creamapproval voluntarily withdrawnNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideMed-Pharmex, Inc.Dogs, CatsANADA 200-245

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 neomycin sulfate + nystatin + thiostrepton reports

How many adverse event reports has FDA received for the combination neomycin sulfate, nystatin and thiostrepton?

63 reports record a drug with the combination neomycin sulfate, nystatin and thiostrepton as its active ingredients in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 1 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.

What signs are reported most often?

deafness (54%), emesis (12.7%), ataxia (6.3%), behavioural disorder NOS (6.3%) and impaired hearing (6.3%). 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 (79.4%) and cat (20.6%). Among single-breed animals the most frequent labels are Domestic Shorthair, French Bulldog, Golden Retriever and Domestic Longhair; popular breeds appear often in any drug's reports because there are more of them.

Are reports rising?

1 reports in the 12 months to March 2026, with none 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 neomycin sulfate + nystatin + thiostrepton 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 neomycin sulfate + nystatin + thiostrepton?

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 1 Oct 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.