Drug · single active ingredient
Tylosin Phosphate: adverse event reports
All products with this active ingredient · 58 FDA-approved applications in the Green Book
- Mostly cattle reports
- Oral route most often
- Brands masked by FDA
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
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
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
- Death49.8%113
- Pneumonia[lung infection or inflammation]22.9%52
- Lameness21.1%48
- Respiratory tract disorder NOS[NOS: not otherwise specified]16.7%38
- Unclassifiable adverse event[event that fits no dictionary term]14.5%33
- Bloated12.8%29
- Ruminal bloat12.8%29
- Lack of efficacy - NOS[the product did not have the expected effect]12.3%28
- Behavioural disorder NOS[behaviour change, type not specified]9.7%22
- Peritonitis[inflamed abdominal lining]9.3%21
- Found dead8.8%20
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]8.8%20
- Death by euthanasia[the animal was euthanized]8.4%19
- Abscess NOS[NOS: not otherwise specified]5.7%13
- Digestive tract disorder NOS[digestive problem, type not specified]5.7%13
- NT - Abnormal necropsy finding NOS[NOS: not otherwise specified]5.3%12
- Respiratory signs5.3%12
- Musculoskeletal disorder NOS[NOS: not otherwise specified]4.8%11
- Heart failure4.4%10
- Liver disorder NOS[NOS: not otherwise specified]4%9
- Trauma NOS[NOS: not otherwise specified]4%9
- Claw / hoof / nail disorder NOS[NOS: not otherwise specified]3.5%8
- Loose stool3.5%8
- Uncoded sign[a sign with no matching dictionary term]3.5%8
- Liver abscess3.1%7
- Loss of condition3.1%7
- Myocarditis3.1%7
- Not eating3.1%7
- Other abnormal test result NOS[abnormal laboratory result, type not specified]3.1%7
- Necropsy performed2.6%6
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
What kind of report it was
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
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
Weight of the animal
Route of administration stated in reports: oral (173), other (3), cutaneous (1), respiratory (inhalation) (1).
In context
| Measure | Tylosin Phosphate | All drugs containing tylosin phosphate | All cattle reports | All reports |
|---|---|---|---|---|
| Reports | 227 | 310 | 31,229 | 1,357,245 |
| Share of that pool's reports naming this drug | — | 73.2% | 0.5% | 0% |
| Classed serious, of reports stating it | 41.9% | 41.9% | 58.4% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 594.7 | 565 | 368 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 15.9% | — | — | 23% |
| Top term, share of reports | Death 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 ingredients | Reports | Latest 12 months |
|---|---|---|
| Monensin + Tylosin Phosphate | 72 | 0 |
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 name | Active ingredients | Sponsor | Approved for | Application |
|---|---|---|---|---|
| Tylan 10; Tylan 40; Tylan 100; Tylan 100 CAL | Tylosin Phosphate | Elanco US Inc. | Cattle, Swine | NADA 012-491 |
| Tylan 40 | Tylosin Phosphate | Phibro Animal Health Corp. | Cattle, Swine | NADA 046-415 |
| Tylan 20; Tylan 40 | Tylosin Phosphate | Phibro Animal Health Corp. | Cattle, Swine | NADA 098-431 |
| Tylovet 40; Tylovet 100 | Tylosin Phosphate | Huvepharma EOOD | Cattle, Swine | ANADA 200-484 |
| Tylan Premix No.10approval voluntarily withdrawn | Tylosin Phosphate | Elanco US, Inc. | Chickens | NADA 013-162 |
| Tylan 100 Premixapproval voluntarily withdrawn | Tylosin Phosphate | Elanco US, Inc. | Chickens | NADA 015-166 |
| Medi-Flex T Tylan Premix; Pro Mix T Medicatedapproval voluntarily withdrawn | Tylosin Phosphate | Land OLakes Purina Feed LLC | — | NADA 042-489 |
| Broiler Premix 18586; Swine Premix 18586approval voluntarily withdrawn | Tylosin Phosphate | Roche Vitamins, Inc. | — | NADA 042-755 |
| Purina Hog Plus IIapproval voluntarily withdrawn | Tylosin Phosphate | Virbac AH, Inc. | Cattle, Swine, Chickens | NADA 043-387 |
| Tylosin Premix 4approval voluntarily withdrawn | Tylosin Phosphate | Henwood Feed Additives | — | NADA 045-690 |
| Tylan 10; Tylan 20; Tylan 40; Tylan 5approval voluntarily withdrawn | Tylosin Phosphate | Hubbard Milling Co. | — | NADA 048-645 |
| Norco T-2 Pre-Pakapproval voluntarily withdrawn | Tylosin Phosphate | Norco Mills Of Norfolk, Inc. | Swine | NADA 049-890 |
| Gilt Edge Tylan Mixapproval voluntarily withdrawn | Tylosin Phosphate | ADM Alliance Nutrition, Inc. | Cattle, Swine, Chickens | NADA 091-582 |
| Pioneer Hog Care Premixapproval voluntarily withdrawn | Tylosin Phosphate | Triple "F", Inc. | — | NADA 091-783 |
| Tylan 10 Plusapproval voluntarily withdrawn | Tylosin Phosphate | Bioproducts, Inc. | — | NADA 093-518 |
| Tylan 5 Premixapproval voluntarily withdrawn | Tylosin Phosphate | International Nutrition, Inc. | Cattle, Swine, Chickens | NADA 095-551 |
| Tylosin Antibiotic Premixapproval voluntarily withdrawn | Tylosin Phosphate | Heinold Feeds, Inc. | — | NADA 095-628 |
| Moormaboost TY 4000 Medicatedapproval voluntarily withdrawn | Tylosin Phosphate | ADM Alliance Nutrition, Inc. | Swine | NADA 095-953 |
| Hy-Con Tylan Premixapproval voluntarily withdrawn | Tylosin Phosphate | Yoder Feed | Cattle, Swine, Chickens | NADA 096-161 |
| Hog Grow-R-Mix-4000; Hog-Grow-R-Mix-800approval voluntarily withdrawn | Tylosin Phosphate | Youngs, Inc. | — | NADA 096-162 |
| Alley Tylan-10 Premixapproval voluntarily withdrawn | Tylosin Phosphate | Dale Alley Co. | — | NADA 096-512 |
| Simonsen Tylan Vitamin Premixapproval voluntarily withdrawn | Tylosin Phosphate | Simonsen Mill-Rendering Plant, Inc. | — | NADA 096-776 |
| Tylan 10; Tylan 40approval voluntarily withdrawn | Tylosin Phosphate | J & R Specialty Supply Co. | Cattle, Swine, Chickens | NADA 096-780 |
| M & M Tylosin Premixapproval voluntarily withdrawn | Tylosin Phosphate | M & M Livestock Products Co. | Swine | NADA 096-837 |
| Fasco Super Tylosin Premixapproval voluntarily withdrawn | Tylosin Phosphate | Fasco Mills Co. | — | NADA 096-839 |
| Vita Plus N-Richer Pig Growerapproval voluntarily withdrawn | Tylosin Phosphate | Vita Plus Corp. | — | NADA 097-287 |
| Tylan 10approval voluntarily withdrawn | Tylosin Phosphate | Feed Specialties Co., Inc. | — | NADA 097-289 |
| Tylan 10 Premixapproval voluntarily withdrawn | Tylosin Phosphate | Golden Sun Feeds, Inc. | — | NADA 097-567 |
| Quali-Tech Tylan-10 Premixapproval voluntarily withdrawn | Tylosin Phosphate | Quali-Tech Products, Inc. | Cattle, Swine, Chickens | NADA 097-980 |
| Walnut Grove 4x4 Add-Mix Tapproval voluntarily withdrawn | Tylosin Phosphate | Cargill, Inc., Nutrena Feed Division | — | NADA 098-595 |
| Hy-Test Hy-Boost TY 5 Medicatedapproval voluntarily withdrawn | Tylosin Phosphate | Kerber Milling Co. | Swine | NADA 098-687 |
| FS Tylan 40 Mix Med.approval voluntarily withdrawn | Tylosin Phosphate | Growmark, Inc. | — | NADA 099-098 |
| Waynextra For Swineapproval voluntarily withdrawn | Tylosin Phosphate | Wayne Feed Division, Continental Grain Co. | Cattle, Swine, Chickens | NADA 099-468 |
| Supersweet Medipak Tylan 10approval voluntarily withdrawn | Tylosin Phosphate | Cross Vetpharm Group Ltd. | Swine | NADA 100-128 |
| Seeco Inc T-10 Premixapproval voluntarily withdrawn | Tylosin Phosphate | Truow Nutrition, Inc. | Cattle, Swine, Chickens | NADA 100-352 |
| Vigorena Feeds Hy-Ty Premixapproval voluntarily withdrawn | Tylosin Phosphate | Springfield Milling Corp. | Swine | NADA 100-556 |
| McNess Custom Premix L200approval voluntarily withdrawn | Tylosin Phosphate | Furst-McNess Co. | Cattle, Swine, Chickens | NADA 100-991 |
| Mill Co-Medicator TY-10; Mill Co-Medicator TY-4approval voluntarily withdrawn | Tylosin Phosphate | Waterloo Mills Co. | Swine | NADA 101-905 |
| Rx-Link-Tylan 1600approval voluntarily withdrawn | Tylosin Phosphate | United Suppliers, Inc. | — | NADA 102-590 |
| Tylan 10; Tylan 20; Tylan 40; Tylan 5approval voluntarily withdrawn | Tylosin Phosphate | Provimi North America, Inc. | Cattle, Swine, Chickens | NADA 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.