Pet Drug Reports

Drugs by active ingredient

Drug · single active ingredient

Tylosin Phosphate: adverse event reports

All products with this active ingredient · 58 FDA-approved applications in the Green Book

227reports naming this ingredient, 2009–20260% of all reports · about 14 a year
18reports, 12 months to March 202626 in the 12 months before
41.9%classed serious, as reportedof 210 reports stating it
59.5%record death or euthanasia, as reported135 reports
64.8%of reports concern cattle0.5% of all cattle reports

227 adverse event reports in FDA's database list a drug whose active ingredient is recorded as tylosin phosphate. The earliest was received in December 2009, the latest in March 2026. The Green Book lists 58 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, 18 reports named it, down 31% from 26 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. Over its whole reporting history that is about 14 reports a year and 0% of all 1,357,245 reports (0.5% of all cattle reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.

The most frequently coded terms are death (49.8%), pneumonia (22.9%) and lameness (21.1%). A report can list several signs, so shares add to more than 100%; 259 different terms appear across these reports. Death appears in 49.8% of these reports, about the same share as in the pooled reports for every drug containing tylosin phosphate (47.1%).

64.8% of reports concern cattle. Not every report describes illness: 15.9% were filed wholly or partly as lack of expected effectiveness and 7.9% as product or packaging defects. Of reports that state seriousness, 41.9% were classed as serious, and 59.5% 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

Dog16 · peak 3
Aug 2022: 1Feb 2023: 1Sep 2023: 1Oct 2023: 1Jul 2024: 1Aug 2024: 3Sep 2024: 3Oct 2024: 1Nov 2024: 1Feb 2025: 1Dec 2025: 1Mar 2026: 12022202320242025
Cat0 · peak 1
2022202320242025
Horse0 · peak 1
2022202320242025
Other62 · peak 12
Jun 2021: 4Jul 2021: 2Apr 2022: 1May 2022: 1Jul 2022: 1Aug 2022: 2Feb 2023: 1Mar 2023: 1Apr 2023: 2May 2023: 2Jun 2023: 1Jul 2023: 6Sep 2023: 1Oct 2023: 4Feb 2024: 1Aug 2024: 3Dec 2024: 12Mar 2025: 1Apr 2025: 3Jun 2025: 1Aug 2025: 7Sep 2025: 3Jan 2026: 22022202320242025

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

015292009: 120092010: 22011: 720112012: 292013: 2220132014: 102015: 1420152016: 182017: 1020172018: 172019: 420192020: 112021: 1020212022: 62023: 2120232024: 252025: 1720252026: 3

2026 covers reports received through March 2026 only.

Signs listed in reports

share of tylosin phosphate reports listing the termall drugs containing tylosin phosphateall cattle reports

  1. Death49.8%113
  2. Pneumonia[lung infection or inflammation]22.9%52
  3. Lameness21.1%48
  4. Respiratory tract disorder NOS[NOS: not otherwise specified]16.7%38
  5. Unclassifiable adverse event[event that fits no dictionary term]14.5%33
  6. Bloated12.8%29
  7. Lack of efficacy - NOS[the product did not have the expected effect]12.3%28
  8. Behavioural disorder NOS[behaviour change, type not specified]9.7%22
  9. Peritonitis[inflamed abdominal lining]9.3%21
  10. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]8.8%20
  11. Death by euthanasia[the animal was euthanized]8.4%19
  12. Abscess NOS[NOS: not otherwise specified]5.7%13
  13. Digestive tract disorder NOS[digestive problem, type not specified]5.7%13
  14. NT - Abnormal necropsy finding NOS[NOS: not otherwise specified]5.3%12
  15. Musculoskeletal disorder NOS[NOS: not otherwise specified]4.8%11
  16. Liver disorder NOS[NOS: not otherwise specified]4%9
  17. Trauma NOS[NOS: not otherwise specified]4%9
  18. Claw / hoof / nail disorder NOS[NOS: not otherwise specified]3.5%8
  19. Uncoded sign[a sign with no matching dictionary term]3.5%8
  20. Liver abscess3.1%7
  21. Myocarditis3.1%7
  22. Other abnormal test result NOS[abnormal laboratory result, type not specified]3.1%7

Top 30 of 259 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/Normal11.9%27
Recovered with Sequela0.9%2
Ongoing3.5%8
Died58.6%133
Euthanized8.8%20
Outcome Unknown55.5%126

What kind of report it was

Safety issue75.8%172
Lack of expected effectiveness9.3%21
Both safety and lack of expected effectiveness6.6%15
Manufacturing or product defect7.9%18
Other0.4%1

Coloured bar: reports naming tylosin phosphate. 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

Cattle64.8%147
Pig14.1%32
Dog7.5%17
Human exposure1.8%4
Horse0.4%1

Single-breed animals

Cornish Cobb1.3%3
Commercial hybrid0.9%2
Pug0.4%1

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 year19.4%44
1 to 3 years19.8%45
4 to 7 years0.9%2
8 to 11 years3.1%7
12 years and over2.2%5
Age not given54.6%124

Weight of the animal

Under 5 kg (11 lb)2.6%6
5 to 9.9 kg (11–22 lb)3.5%8
10 to 24.9 kg (22–55 lb)0.4%1
25 to 44.9 kg (55–99 lb)2.6%6
45 kg and over (99 lb+)62.6%142
Weight not given28.2%64

Route of administration stated in reports: oral (173), other (3), cutaneous (1), respiratory (inhalation) (1).

In context

MeasureTylosin PhosphateAll drugs containing tylosin phosphateAll cattle reportsAll reports
Reports22731031,2291,357,245
Share of that pool's reports naming this drug—73.2%0.5%0%
Classed serious, of reports stating it41.9%41.9%58.4%38.6%
Death or euthanasia recorded, per 1,000 reports594.756536863.8
Filed as lack of expected effectiveness (wholly or partly)15.9%——23%
Top term, share of reportsDeath 49.8%47.1%29.4%—

The tylosin phosphate pool is every report naming tylosin phosphate alone or in any combination; this single-ingredient set accounts for 73.2% 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
Monensin + Tylosin Phosphate720

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 tylosin phosphate (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
Tylan 10; Tylan 40; Tylan 100; Tylan 100 CALTylosin PhosphateElanco US Inc.Cattle, SwineNADA 012-491
Tylan 40Tylosin PhosphatePhibro Animal Health Corp.Cattle, SwineNADA 046-415
Tylan 20; Tylan 40Tylosin PhosphatePhibro Animal Health Corp.Cattle, SwineNADA 098-431
Tylovet 40; Tylovet 100Tylosin PhosphateHuvepharma EOODCattle, SwineANADA 200-484
Tylan Premix No.10approval voluntarily withdrawnTylosin PhosphateElanco US, Inc.ChickensNADA 013-162
Tylan 100 Premixapproval voluntarily withdrawnTylosin PhosphateElanco US, Inc.ChickensNADA 015-166
Medi-Flex T Tylan Premix; Pro Mix T Medicatedapproval voluntarily withdrawnTylosin PhosphateLand OLakes Purina Feed LLC—NADA 042-489
Broiler Premix 18586; Swine Premix 18586approval voluntarily withdrawnTylosin PhosphateRoche Vitamins, Inc.—NADA 042-755
Purina Hog Plus IIapproval voluntarily withdrawnTylosin PhosphateVirbac AH, Inc.Cattle, Swine, ChickensNADA 043-387
Tylosin Premix 4approval voluntarily withdrawnTylosin PhosphateHenwood Feed Additives—NADA 045-690
Tylan 10; Tylan 20; Tylan 40; Tylan 5approval voluntarily withdrawnTylosin PhosphateHubbard Milling Co.—NADA 048-645
Norco T-2 Pre-Pakapproval voluntarily withdrawnTylosin PhosphateNorco Mills Of Norfolk, Inc.SwineNADA 049-890
Gilt Edge Tylan Mixapproval voluntarily withdrawnTylosin PhosphateADM Alliance Nutrition, Inc.Cattle, Swine, ChickensNADA 091-582
Pioneer Hog Care Premixapproval voluntarily withdrawnTylosin PhosphateTriple "F", Inc.—NADA 091-783
Tylan 10 Plusapproval voluntarily withdrawnTylosin PhosphateBioproducts, Inc.—NADA 093-518
Tylan 5 Premixapproval voluntarily withdrawnTylosin PhosphateInternational Nutrition, Inc.Cattle, Swine, ChickensNADA 095-551
Tylosin Antibiotic Premixapproval voluntarily withdrawnTylosin PhosphateHeinold Feeds, Inc.—NADA 095-628
Moormaboost TY 4000 Medicatedapproval voluntarily withdrawnTylosin PhosphateADM Alliance Nutrition, Inc.SwineNADA 095-953
Hy-Con Tylan Premixapproval voluntarily withdrawnTylosin PhosphateYoder FeedCattle, Swine, ChickensNADA 096-161
Hog Grow-R-Mix-4000; Hog-Grow-R-Mix-800approval voluntarily withdrawnTylosin PhosphateYoungs, Inc.—NADA 096-162
Alley Tylan-10 Premixapproval voluntarily withdrawnTylosin PhosphateDale Alley Co.—NADA 096-512
Simonsen Tylan Vitamin Premixapproval voluntarily withdrawnTylosin PhosphateSimonsen Mill-Rendering Plant, Inc.—NADA 096-776
Tylan 10; Tylan 40approval voluntarily withdrawnTylosin PhosphateJ & R Specialty Supply Co.Cattle, Swine, ChickensNADA 096-780
M & M Tylosin Premixapproval voluntarily withdrawnTylosin PhosphateM & M Livestock Products Co.SwineNADA 096-837
Fasco Super Tylosin Premixapproval voluntarily withdrawnTylosin PhosphateFasco Mills Co.—NADA 096-839
Vita Plus N-Richer Pig Growerapproval voluntarily withdrawnTylosin PhosphateVita Plus Corp.—NADA 097-287
Tylan 10approval voluntarily withdrawnTylosin PhosphateFeed Specialties Co., Inc.—NADA 097-289
Tylan 10 Premixapproval voluntarily withdrawnTylosin PhosphateGolden Sun Feeds, Inc.—NADA 097-567
Quali-Tech Tylan-10 Premixapproval voluntarily withdrawnTylosin PhosphateQuali-Tech Products, Inc.Cattle, Swine, ChickensNADA 097-980
Walnut Grove 4x4 Add-Mix Tapproval voluntarily withdrawnTylosin PhosphateCargill, Inc., Nutrena Feed Division—NADA 098-595
Hy-Test Hy-Boost TY 5 Medicatedapproval voluntarily withdrawnTylosin PhosphateKerber Milling Co.SwineNADA 098-687
FS Tylan 40 Mix Med.approval voluntarily withdrawnTylosin PhosphateGrowmark, Inc.—NADA 099-098
Waynextra For Swineapproval voluntarily withdrawnTylosin PhosphateWayne Feed Division, Continental Grain Co.Cattle, Swine, ChickensNADA 099-468
Supersweet Medipak Tylan 10approval voluntarily withdrawnTylosin PhosphateCross Vetpharm Group Ltd.SwineNADA 100-128
Seeco Inc T-10 Premixapproval voluntarily withdrawnTylosin PhosphateTruow Nutrition, Inc.Cattle, Swine, ChickensNADA 100-352
Vigorena Feeds Hy-Ty Premixapproval voluntarily withdrawnTylosin PhosphateSpringfield Milling Corp.SwineNADA 100-556
McNess Custom Premix L200approval voluntarily withdrawnTylosin PhosphateFurst-McNess Co.Cattle, Swine, ChickensNADA 100-991
Mill Co-Medicator TY-10; Mill Co-Medicator TY-4approval voluntarily withdrawnTylosin PhosphateWaterloo Mills Co.SwineNADA 101-905
Rx-Link-Tylan 1600approval voluntarily withdrawnTylosin PhosphateUnited Suppliers, Inc.—NADA 102-590
Tylan 10; Tylan 20; Tylan 40; Tylan 5approval voluntarily withdrawnTylosin PhosphateProvimi North America, Inc.Cattle, Swine, ChickensNADA 103-089

Showing 40 of 58 applications; the full list is at Animal Drugs @ FDA.

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 tylosin phosphate reports

How many adverse event reports has FDA received for tylosin phosphate?

227 reports record a drug with tylosin phosphate as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 18 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 58 approved applications with this ingredient alone; the reference list on this page names them without any counts.

What signs are reported most often?

death (49.8%), pneumonia (22.9%), lameness (21.1%), respiratory tract disorder NOS (16.7%) and unclassifiable adverse event (14.5%). 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?

cattle (64.8%), pig (14.1%) and dog (7.5%). Among single-breed animals the most frequent labels are Holstein-Friesian, Aberdeen Angus, Cornish Cobb and Brussels Griffon; popular breeds appear often in any drug's reports because there are more of them.

Are reports rising?

18 reports in the 12 months to March 2026, down 31% from 26 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 tylosin phosphate 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 tylosin phosphate?

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.