Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Nystatin: adverse event reports, pooled

13 ingredient sets in reports · 10 FDA-approved applications in the Green Book

1,309reports naming the ingredient, 1990–20260.1% of all reports · about 36 a year
178reports, 12 months to March 2026115 in the 12 months before
57.7%classed serious, as reportedall reports: 38.6%
77.5%of reports concern dogscat 17%

Nystatin appears, alone or combined with other ingredients, in 1,309 reports in FDA's animal adverse event database (March 1990 to March 2026). The figures here pool all 13 ingredient sets that include it.

The Green Book lists 10 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.

178 reports arrived in the 12 months to March 2026, up 55% from 115 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. That is about 36 reports a year over its reporting history and 0.1% of all reports.

Pooled across every set, the terms listed most often are deafness (26%), vomiting (9.4%) and lethargy (8.8%). 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, 57.7% were classed as serious (38.6% across the whole database); 6.1% 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 nystatin

Active ingredients recorded for the drugReportsShare of this page's reportsLatest 12 months
Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone Acetonide95072.6%133
Neomycin Sulfate + Nystatin1007.6%1
Nystatin + Thiostrepton + Triamcinolone Acetonide906.9%16
Neomycin Sulfate + Nystatin + Thiostrepton634.8%1
Nystatin + Thiostrepton + Triamcinolone554.2%17
Nystatin221.7%2
Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone141.1%5
Nystatin + Triamcinolone50.4%0
Nystatin + Thiostrepton30.2%0
Neomycin Sulfate + Nystatin + Triamcinolone Acetonide30.2%3
Nystatin + Prednisolone20.2%0
Nystatin + Triamcinolone Acetonide20.2%0
Enrofloxacin + Nystatin + Triamcinolone10.1%0

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 nystatin reports listing the termall reports in the database

  1. Deafness26%340
  2. Vomiting9.4%123
  3. Lethargy[unusually tired or inactive]8.8%115
  4. Lack of efficacy - NOS[the product did not have the expected effect]6.3%83
  5. Diarrhoea[diarrhea]4.9%64
  6. Anorexia[not eating]3.9%51
  7. PR-ear(s), lesion(s)[legacy FDA term: lesions found in the ears]3.2%42
  8. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.9%38
  9. Behavioural disorder NOS[behaviour change, type not specified]2.8%37
  10. Death by euthanasia[the animal was euthanized]2.8%37
  11. Death2.8%36
  12. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.7%35
  13. Emesis[vomiting]2.6%34
  14. Pruritus[itching]2.5%33
  15. Ataxia[unsteady, uncoordinated movement]2.4%32
  16. Skin lesion NOS[NOS: not otherwise specified]2.4%31
  17. Accidental exposure[exposure that was not intended]2.2%29
  18. Application site alopecia[hair loss where the product was applied]2.1%27
  19. Seizure NOS[seizure, type not specified]2.1%27
  20. Medication error NOS[a mistake in giving the product, type not specified]1.9%25
  21. Polyuria[passing more urine than usual]1.8%24
  22. Polydipsia[drinking more than usual]1.8%23

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

Dog388 · peak 17
Apr 2021: 4May 2021: 3Jun 2021: 7Jul 2021: 4Aug 2021: 7Sep 2021: 6Oct 2021: 4Nov 2021: 7Dec 2021: 5Jan 2022: 6Feb 2022: 4Mar 2022: 2Apr 2022: 8May 2022: 2Jun 2022: 2Jul 2022: 4Sep 2022: 6Oct 2022: 1Nov 2022: 9Dec 2022: 6Jan 2023: 7Feb 2023: 5Mar 2023: 2Apr 2023: 6May 2023: 4Jun 2023: 8Jul 2023: 3Aug 2023: 8Sep 2023: 3Oct 2023: 5Nov 2023: 5Dec 2023: 3Jan 2024: 5Feb 2024: 2Mar 2024: 5Apr 2024: 7May 2024: 14Jun 2024: 4Jul 2024: 4Aug 2024: 12Sep 2024: 7Oct 2024: 10Nov 2024: 7Dec 2024: 5Jan 2025: 6Feb 2025: 7Mar 2025: 11Apr 2025: 7May 2025: 14Jun 2025: 12Jul 2025: 6Aug 2025: 13Sep 2025: 7Oct 2025: 17Nov 2025: 14Dec 2025: 12Jan 2026: 11Feb 2026: 4Mar 2026: 92022202320242025
Cat106 · peak 8
May 2021: 1Jul 2021: 1Aug 2021: 2Sep 2021: 1Jan 2022: 3Feb 2022: 2Mar 2022: 2Jun 2022: 3Jul 2022: 1Sep 2022: 1Oct 2022: 1Nov 2022: 1Jan 2023: 2Feb 2023: 1Apr 2023: 1May 2023: 3Jun 2023: 2Jul 2023: 2Aug 2023: 1Sep 2023: 1Oct 2023: 1Nov 2023: 5May 2024: 3Jun 2024: 2Jul 2024: 2Aug 2024: 1Oct 2024: 1Nov 2024: 1Dec 2024: 2Jan 2025: 1Feb 2025: 2Mar 2025: 3Apr 2025: 4May 2025: 8Jun 2025: 3Jul 2025: 2Aug 2025: 7Oct 2025: 6Nov 2025: 5Dec 2025: 5Jan 2026: 7Feb 2026: 1Mar 2026: 22022202320242025
Horse1 · peak 1
May 2023: 12022202320242025
Other13 · peak 3
Sep 2021: 1Oct 2021: 1Feb 2022: 1Mar 2022: 1Jan 2023: 1Jul 2023: 1Oct 2023: 1Nov 2023: 1Oct 2024: 3Apr 2025: 1Oct 2025: 12022202320242025

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.

0871741990: 119901991: 61992: 51993: 161994: 1519941995: 101996: 91997: 71998: 1019981999: 132000: 112001: 142002: 820022003: 62004: 72005: 102006: 420062007: 92008: 122009: 292010: 1520102011: 252012: 622013: 552014: 3220142015: 462016: 712017: 452018: 6720182019: 682020: 992021: 682022: 6620222023: 832024: 972025: 1742026: 342026

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal18.6%244
Recovered with Sequela6.3%83
Ongoing21.8%286
Died3.4%44
Euthanized2.8%36
Outcome Unknown24.4%320

What kind of report it was

Safety issue88.2%1,155
Lack of expected effectiveness3.6%47
Both safety and lack of expected effectiveness3.3%43
Manufacturing or product defect4.7%62
Other0.2%2

Species

Dog77.5%1,015
Cat17%223
Human exposure0.6%8
Other Birds0.2%3
Horse0.2%2
Other0.2%2

Age of the animal

Under 1 year5.7%74
1 to 3 years13.1%172
4 to 7 years16.3%214
8 to 11 years27.9%365
12 years and over26.2%343
Age not given10.8%141

Coloured bar: reports naming nystatin. 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

MeasureNystatinAll reports
Reports1,3091,357,245
Latest 12 months against the 12 before+55%-5%
Classed serious, of reports stating it57.7%38.6%
Death or euthanasia recorded, per 1,000 reports61.163.8
Filed as lack of expected effectiveness (wholly or partly)6.9%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 nystatin (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
Panolog OintmentNeomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone AcetonideZoetis Inc.Dogs, CatsNADA 012-258
Pharmastatin-20 Type A Medicated ArticleNystatinZoetis Inc.TurkeysNADA 012-680
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 nystatin reports

How many FDA adverse event reports mention nystatin?

1,309 reports through March 2026, 178 of them in the latest 12 months, counting nystatin 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 nystatin without any counts.

In which combinations is nystatin reported?

Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone Acetonide (72.6% of these reports), Neomycin Sulfate + Nystatin (7.6% of these reports), Nystatin + Thiostrepton + Triamcinolone Acetonide (6.9% of these reports), Neomycin Sulfate + Nystatin + Thiostrepton (4.8% of these reports) and Nystatin + Thiostrepton + Triamcinolone (4.2% of these reports).

What reactions are reported for nystatin?

deafness (26%), vomiting (9.4%), lethargy (8.8%), loss of hearing (6.5%) and lack of efficacy - NOS (6.3%). Shares are of reports naming the ingredient; one report can list several terms.

Which animals are these reports about?

dog (77.5%), cat (17%) and human exposure (0.6%).

Does a high count mean nystatin 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.