Active ingredient · pooled across combinations
Neomycin Sulfate: adverse event reports, pooled
25 ingredient sets in reports · 52 FDA-approved applications in the Green Book
2,554 adverse event reports received by FDA list a drug containing neomycin sulfate, alone or in combination, from September 1988 to March 2026. This page pools every ingredient set that includes it; 25 such sets appear in reports.
The Green Book lists 52 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.
342 reports arrived in the 12 months to March 2026, up 38% from 248 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 68 reports a year over its reporting history and 0.2% of all reports.
Pooled across every set, the terms listed most often are deafness (13.2%), lethargy (13%) and vomiting (9.5%). 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, 45.5% were classed as serious (38.6% across the whole database); 7.2% 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 neomycin sulfate
| Active ingredients recorded for the drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Dexamethasone + Neomycin Sulfate + Thiabendazole | 1,088 | 42.6% | 162 |
| Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone Acetonide | 950 | 37.2% | 133 |
| Isoflupredone Acetate + Neomycin Sulfate + Tetracaine Hydrochloride | 125 | 4.9% | 10 |
| Neomycin Sulfate + Tetracaine Hydrochloride | 109 | 4.3% | 22 |
| Neomycin Sulfate + Nystatin | 100 | 3.9% | 1 |
| Neomycin Sulfate + Nystatin + Thiostrepton | 63 | 2.5% | 1 |
| Neomycin Sulfate | 34 | 1.3% | 1 |
| Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate | 30 | 1.2% | 5 |
| Bacitracin Zinc + Neomycin Sulfate + Polymyxin B Sulfate | 17 | 0.7% | 2 |
| Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone | 14 | 0.5% | 5 |
| Neomycin Sulfate + Oxytetracycline | 5 | 0.2% | 0 |
| Dexamethasone + Neomycin Sulfate | 5 | 0.2% | 0 |
| Hydrocortisone Acetate + Neomycin Sulfate + Penicillin G Procaine | 4 | 0.2% | 0 |
| Neomycin Sulfate + Nystatin + Triamcinolone Acetonide | 3 | 0.1% | 3 |
| Neomycin Sulfate + Thiostrepton + Triamcinolone Acetonide | 2 | 0.1% | 1 |
| Isoflupredone Acetate + Neomycin Sulfate + Tetracaine | 2 | 0.1% | 0 |
| Isoflupredone Acetate + Neomycin Sulfate | 2 | 0.1% | 0 |
| Neomycin Sulfate + Oxytetracycline Hydrochloride | 2 | 0.1% | 0 |
| Neomycin Sulfate + Piperocaine Hydrochloride + Tylosin | 1 | 0% | 0 |
| Neomycin Sulfate + Polymyxin B Sulfate + Prednisolone | 1 | 0% | 0 |
| Neomycin Sulfate + Prednisolone | 1 | 0% | 0 |
| Bacitracin Zinc + Neomycin Sulfate | 1 | 0% | 0 |
| Neomycin Sulfate + Oxytetracycline Dihydrate + Oxytetracycline Hydrochloride | 1 | 0% | 0 |
| Neomycin Sulfate + Prednisolone Sodium Phosphate | 1 | 0% | 0 |
| Dexamethasone + Ivermectin + Neomycin Sulfate + Thiabendazole | 1 | 0% | 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 neomycin sulfate reports listing the termall reports in the database
- Deafness13.2%338
- Lethargy[unusually tired or inactive]13%331
- Vomiting9.5%242
- Lack of efficacy - NOS[the product did not have the expected effect]5.7%145
- Anorexia[not eating]4.7%119
- Diarrhoea[diarrhea]4.7%119
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]4.3%111
- Other abnormal test result NOS[abnormal laboratory result, type not specified]4.1%105
- Not eating4%101
- Loss of hearing3.8%98
- Death by euthanasia[the animal was euthanized]3.6%92
- Behavioural disorder NOS[behaviour change, type not specified]3.4%88
- Ataxia[unsteady, uncoordinated movement]3.3%85
- Weight loss3.3%85
- Death2.9%75
- Polydipsia[drinking more than usual]2.8%72
- Seizure NOS[seizure, type not specified]2.7%69
- Polyuria[passing more urine than usual]2.5%64
- Skin lesion NOS[NOS: not otherwise specified]2.3%60
- Vials, Damaged[a product quality report, not a sign in an animal]2.3%60
- Fever2.3%58
- Emesis[vomiting]2.2%56
- Pruritus[itching]2.2%56
- Temporary deafness2.2%56
- Accidental exposure[exposure that was not intended]2.2%55
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]2.1%54
- Neutrophilia[high neutrophil count]2.1%54
- Elevated total bilirubin[bilirubin above the normal range]2%50
- Hyperglycaemia[high blood sugar]2%50
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
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.
Outcomes, report types and ages
Outcome recorded in the report
What kind of report it was
Age of the animal
Coloured bar: reports naming neomycin 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
| Measure | Neomycin Sulfate | All reports |
|---|---|---|
| Reports | 2,554 | 1,357,245 |
| Latest 12 months against the 12 before | +38% | -5% |
| Classed serious, of reports stating it | 45.5% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 72.4 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 7.7% | 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 neomycin 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 name | Active ingredients | Sponsor | Approved for | Application |
|---|---|---|---|---|
| Neo-Cortef with Tetracaine | Hydrocortisone Acetate, Neomycin Sulfate, Tetracaine Hydrochloride | Zoetis Inc. | Dogs, Cats | NADA 010-524 |
| Neomix 325 Soluble Powder; Neomix AG 325 Soluble Powder | Neomycin Sulfate | Phibro Animal Health Corp. | Cattle, Swine, Turkeys, Sheep, Goats | NADA 011-315 |
| Neo-Delta-Cortef with Tetracaine Ointment | Neomycin Sulfate, Prednisolone Acetate, Tetracaine Hydrochloride | Zoetis Inc. | Dogs, Cats | NADA 011-703 |
| Biosol Sterile Solution; Biosol Sterile Solution 50 mg | Neomycin Sulfate | Zoetis Inc. | Dogs, Cats | NADA 011-953 |
| Panolog Ointment | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Zoetis Inc. | Dogs, Cats | NADA 012-258 |
| Jenomycin Tablets | Aminopropazine Fumarate, Neomycin Sulfate | Intervet, Inc. | Dogs | NADA 013-181 |
| Neo-synalar Cream | Fluocinolone Acetonide, Neomycin Sulfate | Bausch Health US, LLC | Dogs, Cats | NADA 015-151 |
| Neo-Predef with Tetracaine Powder | Isoflupredone Acetate, Neomycin Sulfate, Tetracaine Hydrochloride | Zoetis Inc. | Dogs, Cats, Horses | NADA 015-433 |
| Neo-Predef with Tetracaine Top. Ointment; Tritop Topical Ointment | Isoflupredone Acetate, Neomycin Sulfate, Tetracaine Hydrochloride | Zoetis Inc. | Dogs, Cats, Horses | NADA 030-025 |
| Neo-Darbazine Spansule Capsule No.1; Neo-Darbazine Spansule Capsule No.3 | Isopropamide Iodide, Neomycin Sulfate, Prochlorperazine Dimaleate | Zoetis Inc. | Dogs | NADA 031-914 |
| Neo Predef Sterile Ointment | Isoflupredone Acetate, Neomycin Sulfate | Zoetis Inc. | Dogs, Cats, Horses, Cattle | NADA 034-872 |
| Anaprime Ophthalmic Solution | Flumethasone, Neomycin Sulfate, Polymyxin B Sulfate | Zoetis Inc. | Dogs, Cats | NADA 038-801 |
| Tresaderm Dermatologic Solution | Dexamethasone, Neomycin Sulfate, Thiabendazole | Boehringer Ingelheim Animal Health USA, Inc. | Dogs, Cats | NADA 042-633 |
| Anaprime Opthakote Ophthalmic | Flumethasone, Neomycin Sulfate, Polymyxin B Sulfate | Zoetis Inc. | Dogs | NADA 049-725 |
| Optiprime Opthakote Ophthalmic Solution | Neomycin Sulfate, Polymyxin B Sulfate | Zoetis Inc. | Dogs | NADA 049-726 |
| Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment; Vetropolycin HC Ophthalmic Ointment | Bacitracin Zinc, Hydrocortisone Acetate, Neomycin Sulfate, Polymyxin B Sulfate | Dechra Veterinary Products LLC | Dogs, Cats | NADA 065-015 |
| Bac-Neo-Poly Ophthalmic Ointment; Vetropolycin Ophthalmic Ointment | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate | Dechra Veterinary Products LLC | Dogs, Cats | NADA 065-016 |
| Mycitracin Sterile Ophthalmic Ointment | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate | Zoetis Inc. | Dogs, Cats | NADA 065-114 |
| Forte Topical Ointment | Hydrocortisone Acetate, Neomycin Sulfate, Penicillin G Procaine, Polymyxin B Sulfate | Zoetis Inc. | Dogs, Cats | NADA 065-119 |
| Cortisporin Veterinary Ophthalmic Ointment | Bacitracin Zinc, Hydrocortisone, Neomycin Sulfate, Polymyxin B Sulfate | Intervet, Inc. | Dogs, Cats | NADA 065-476 |
| Neosporin Ophthalmic Ointment | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate | Intervet, Inc. | Dogs, Cats | NADA 065-485 |
| Neo-Delta Cortef Sterile Solution | Neomycin Sulfate, Prednisolone Acetate | Zoetis Inc. | Dogs, Cats | NADA 091-534 |
| Neo-Cortef Sterile Ointment | Hydrocortisone Acetate, Neomycin Sulfate | Zoetis Inc. | Dogs, Cats | NADA 093-514 |
| Neo-Terramycin 100/100; Neo-Terramycin 100/100D; Neo-Terramycin 50/50; Neo-Terramycin 50/50D | Neomycin Sulfate, Oxytetracycline | Phibro Animal Health Corp. | Cattle, Swine, Chickens, Turkeys, Sheep | NADA 094-975 |
| Panolog Cream | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Zoetis Inc. | Dogs, Cats | NADA 096-676 |
| Neo-Oxy 100/100 MR; Neo-Oxy 50/50 | Neomycin Sulfate, Oxytetracycline Hydrochloride | Pharmgate Inc. | Cattle, Swine, Chickens, Turkeys, Sheep | NADA 138-939 |
| Animax Ointment | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Fougera Pharmaceuticals, LLC | Dogs, Cats | NADA 140-847 |
| Derma 4 Ointment | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Zoetis Inc. | Dogs, Cats | NADA 140-879 |
| Neomix Ag 325; Neomix 325 | Neomycin Sulfate | Phibro Animal Health Corp. | Cattle, Swine, Sheep, Goats | NADA 140-976 |
| Derm-Otic Ointment | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Zoetis Inc. | Dogs, Cats | NADA 141-003 |
| Neomycin Sulfate | Neomycin Sulfate | Phibro Animal Health Corp. | Cattle, Swine, Sheep, Goats | ANADA 200-046 |
| NeoMed Soluble Powder | Neomycin Sulfate | Bimeda Animal Health Ltd. | Cattle, Swine, Turkeys, Sheep, Goats | ANADA 200-050 |
| Biosol Liquid | Neomycin Sulfate | Zoetis Inc. | Cattle, Swine, Sheep, Goats | ANADA 200-113 |
| Neomycin Oral Solution | Neomycin Sulfate | Huvepharma EOOD | Cattle, Swine, Sheep, Goats | ANADA 200-118 |
| Neo-Sol 50 | Neomycin Sulfate | Huvepharma EOOD | Cattle, Swine, Turkeys, Sheep, Goats | ANADA 200-130 |
| Neo 200 Oral Solution | Neomycin Sulfate | Huvepharma EOOD | Cattle, Swine, Sheep, Goats | ANADA 200-153 |
| Neosol Soluble Powder | Neomycin Sulfate | Dechra Veterinary Products LLC | Cattle, Swine, Sheep, Goats | ANADA 200-235 |
| Animax Cream | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Fougera Pharmaceuticals, LLC | Dogs, Cats | ANADA 200-330 |
| Neomycin Sulfate 325 | Neomycin Sulfate | Sparhawk Laboratories, Inc. | Cattle, Swine, Turkeys, Sheep, Goats | ANADA 200-378 |
| Neomycin Liquid | Neomycin Sulfate | Sparhawk Laboratories, Inc. | Cattle, Swine, Sheep, Goats | ANADA 200-379 |
| Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate | Domes Pharma S.A. | Dogs, Cats | ANADA 200-553 |
| Thiabendazole, Dexamethasone, Neomycin Sulfate Solution | Dexamethasone, Neomycin Sulfate, Thiabendazole | Dechra Veterinary Products LLC | Dogs, Cats | ANADA 200-565 |
| Hydeltrone Ointmentapproval voluntarily withdrawn | Neomycin Sulfate, Prednisolone Sodium Phosphate | Boehringer Ingelheim Animal Health USA Inc. | Dogs, Cats | NADA 011-437 |
| Neo-Aristovet Ointmentapproval voluntarily withdrawn | Neomycin Sulfate, Triamcinolone Acetonide | Bayer HealthCare LLC, Animal Health Division | — | NADA 030-045 |
| Tylan Plus Neomycin Eye Powderapproval voluntarily withdrawn | Neomycin Sulfate, Tylosin | Elanco Animal Health, A Division of Eli Lilly & Co. | — | NADA 031-962 |
| Liquisone F with Cerumeneapproval voluntarily withdrawn | Hexamethyltetracosane, Neomycin Sulfate, Prednisolone, Tetracaine | Evsco Pharmaceuticals, An Affiliate of IGI, Inc. | Dogs, Cats | NADA 032-322 |
| Neomycane Ophthalmic Ointmentapproval voluntarily withdrawn | Neomycin Sulfate | Evsco Pharmaceuticals, An Affiliate of IGI, Inc. | Dogs, Cats | NADA 044-655 |
| Optisoneapproval voluntarily withdrawn | Neomycin Sulfate, Prednisolone Acetate | Evsco Pharmaceuticals, An Affiliate of IGI, Inc. | Dogs, Cats | NADA 045-288 |
| DERMA-VET Ointmentapproval voluntarily withdrawn | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Med-Pharmex, Inc. | Dogs, Cats | NADA 140-810 |
| Derm-Otic Ointmentapproval voluntarily withdrawn | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Biocraft Laboratories, Inc. | Dogs, Cats | NADA 140-889 |
| Derma-Vet Creamapproval voluntarily withdrawn | Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide | Med-Pharmex, Inc. | Dogs, Cats | ANADA 200-245 |
| Neosol-Oralapproval voluntarily withdrawn | Neomycin Sulfate | Med-Pharmex, Inc. | Cattle, Swine, Turkeys, Sheep, Goats | ANADA 200-289 |
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 reports
How many FDA adverse event reports mention neomycin sulfate?
2,554 reports through March 2026, 342 of them in the latest 12 months, counting neomycin 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 neomycin sulfate without any counts.
In which combinations is neomycin sulfate reported?
Dexamethasone + Neomycin Sulfate + Thiabendazole (42.6% of these reports), Neomycin Sulfate + Nystatin + Thiostrepton + Triamcinolone Acetonide (37.2% of these reports), Isoflupredone Acetate + Neomycin Sulfate + Tetracaine Hydrochloride (4.9% of these reports), Neomycin Sulfate + Tetracaine Hydrochloride (4.3% of these reports) and Neomycin Sulfate + Nystatin (3.9% of these reports).
What reactions are reported for neomycin sulfate?
deafness (13.2%), lethargy (13%), vomiting (9.5%), lack of efficacy - NOS (5.7%) and anorexia (4.7%). Shares are of reports naming the ingredient; one report can list several terms.
Which animals are these reports about?
dog (54.6%), cat (30.4%) and human exposure (3.1%).
Does a high count mean neomycin 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.