Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Tylosin Phosphate: adverse event reports, pooled

5 ingredient sets in reports · 141 FDA-approved applications in the Green Book

310reports naming the ingredient, 2003–20260% of all reports · about 13 a year
18reports, 12 months to March 202626 in the 12 months before
41.9%classed serious, as reportedall reports: 38.6%
72.6%of reports concern cattlepig 10.6%

310 adverse event reports received by FDA list a drug containing tylosin phosphate, alone or in combination, from April 2003 to March 2026. This page pools every ingredient set that includes it; 5 such sets appear in reports.

The Green Book lists 141 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.

18 reports arrived 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. That is about 13 reports a year over its reporting history and 0% of all reports.

Pooled across every set, the terms listed most often are death (47.1%), pneumonia (17.4%) and lameness (16.1%). 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, 41.9% were classed as serious (38.6% across the whole database); 56.5% 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 tylosin phosphate

Active ingredients recorded for the drugReportsShare of this page's reportsLatest 12 months
Tylosin Phosphate22773.2%18
Monensin + Tylosin Phosphate7223.2%0
Melengestrol Acetate + Monensin + Tylosin Phosphate51.6%0
Melengestrol Acetate + Monensin + Ractopamine Hydrochloride + Tylosin Phosphate41.3%0
Sulfamethazine + Tylosin Phosphate20.6%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 tylosin phosphate reports listing the termall reports in the database

  1. Death47.1%146
  2. Pneumonia[lung infection or inflammation]17.4%54
  3. Lameness16.1%50
  4. Respiratory tract disorder NOS[NOS: not otherwise specified]12.6%39
  5. Unclassifiable adverse event[event that fits no dictionary term]11%34
  6. Bloated9.4%29
  7. Lack of efficacy - NOS[the product did not have the expected effect]9%28
  8. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]7.4%23
  9. Behavioural disorder NOS[behaviour change, type not specified]7.1%22
  10. Death by euthanasia[the animal was euthanized]6.8%21
  11. Peritonitis[inflamed abdominal lining]6.8%21
  12. PR-liver, lesion(s)[legacy FDA term: lesions found in the liver]4.8%15
  13. Abscess NOS[NOS: not otherwise specified]4.2%13
  14. Digestive tract disorder NOS[digestive problem, type not specified]4.2%13
  15. Musculoskeletal disorder NOS[NOS: not otherwise specified]3.9%12
  16. NT - Abnormal necropsy finding NOS[NOS: not otherwise specified]3.9%12
  17. Claw / hoof / nail disorder NOS[NOS: not otherwise specified]2.9%9
  18. Liver disorder NOS[NOS: not otherwise specified]2.9%9
  19. Trauma NOS[NOS: not otherwise specified]2.9%9
  20. Uncoded sign[a sign with no matching dictionary term]2.6%8
  21. Anorexia[not eating]2.3%7
  22. Diarrhoea[diarrhea]2.3%7
  23. Liver abscess2.3%7
  24. Myocarditis2.3%7

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

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

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.

015292003: 820032004: 272005: 1220052006: 32007: 1120072008: 82009: 920092010: 52011: 820112012: 292013: 2220132014: 102015: 1420152016: 202017: 1020172018: 172019: 420192020: 112021: 1020212022: 62023: 2120232024: 252025: 1720252026: 3

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal8.7%27
Recovered with Sequela0.6%2
Ongoing2.6%8
Died55.8%173
Euthanized6.5%20
Outcome Unknown40.6%126

What kind of report it was

Safety issue81.6%253
Lack of expected effectiveness6.8%21
Both safety and lack of expected effectiveness4.8%15
Manufacturing or product defect6.5%20
Other0.3%1

Species

Cattle72.6%225
Pig10.6%33
Dog5.5%17
Chicken3.2%10
Human exposure1.6%5
Horse0.3%1

Age of the animal

Under 1 year14.8%46
1 to 3 years20%62
4 to 7 years0.6%2
8 to 11 years2.3%7
12 years and over1.9%6
Age not given60.3%187

Coloured bar: reports naming tylosin phosphate. 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

MeasureTylosin PhosphateAll reports
Reports3101,357,245
Latest 12 months against the 12 before-31%-5%
Classed serious, of reports stating it41.9%38.6%
Death or euthanasia recorded, per 1,000 reports564.563.8
Filed as lack of expected effectiveness (wholly or partly)11.6%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 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 5 Sulfa-G; Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-GSulfamethazine, Tylosin PhosphateElanco US Inc.SwineNADA 041-275
Tylan 40Tylosin PhosphatePhibro Animal Health Corp.Cattle, SwineNADA 046-415
Tylan 10 Sulfa-G; Tylan 40 Sulfa-GSulfamethazine, Tylosin PhosphatePhibro Animal Health Corp.SwineNADA 091-749
Tylan 20; Tylan 40Tylosin PhosphatePhibro Animal Health Corp.Cattle, SwineNADA 098-431
Rumensin and TylanMonensin, Tylosin PhosphateElanco US Inc.CattleNADA 104-646
Tylan and BanminthPyrantel Tartrate, Tylosin PhosphatePhibro Animal Health Corp.SwineNADA 110-047
MGA and Rumensin and TylanMelengestrol Acetate, Monensin, Tylosin PhosphatePhibro Animal Health Corp.CattleNADA 138-870
MGA and Bovatec and TylanLasalocid sodium, Melengestrol Acetate, Tylosin PhosphatePhibro Animal Health Corp.CattleNADA 138-992
MGA and TylanMelengestrol Acetate, Tylosin PhosphatePhibro Animal Health Corp.—NADA 139-192
Paylean and TylanRactopamine Hydrochloride, Tylosin PhosphateElanco US Inc.SwineNADA 141-172
Optaflexx and Rumensin and TylanMonensin, Ractopamine Hydrochloride, Tylosin PhosphateElanco US Inc.CattleNADA 141-224
Optaflexx and Rumensin and Tylanand MGAMelengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin PhosphateElanco US Inc.CattleNADA 141-233
Zilmax and Rumensin and TylanMonensin, Tylosin Phosphate, Zilpaterol HydrochlorideIntervet, Inc.CattleNADA 141-276
Zilmax and Rumensin and Tylan and MGAMelengestrol Acetate, Monensin, Tylosin Phosphate, Zilpaterol HydrochlorideIntervet, Inc.CattleNADA 141-280
Experior and Rumensin and TylanLubabegron, Monensin, Tylosin PhosphateElanco US Inc.CattleNADA 141-512
MGA and Experior and Rumensin and TylanLubabegron, Melengestrol Acetate, Monensin, Tylosin PhosphateElanco US Inc.CattleNADA 141-591
HeifermaX 500 / Rumensin / TylanMelengestrol Acetate, Monensin, Tylosin PhosphateElanco US Inc.CattleANADA 200-375
Heifermax / Optaflexx / Rumensin / TylanMelengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin PhosphateElanco US Inc.CattleANADA 200-424
Heifermax 500 Liquid Premix and TylanMelengestrol Acetate, Tylosin PhosphateElanco US Inc.CattleANADA 200-427
HeifermaX 500 plus Bovatec and TylanLasalocid, Melengestrol Acetate, Tylosin PhosphateElanco US Inc.CattleANADA 200-430
Heifermax 500/Zilmax/Rumensin/TylanMelengestrol Acetate, Monensin, Tylosin Phosphate, ZilpaterolElanco US Inc.CattleANADA 200-480
Tylovet 40; Tylovet 100Tylosin PhosphateHuvepharma EOODCattle, SwineANADA 200-484
Paylean and TylovetRactopamine Hydrochloride, Tylosin PhosphateHuvepharma EOODSwineANADA 200-530
Rumensin plus Tylovet 100Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-531
MGA plus Tylovet 100Melengestrol Acetate, Tylosin PhosphateHuvepharma EOODCattleANADA 200-532
Deccox and Rumensin and TylovetDecoquinate, Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-533
MGA, Rumensin and Tylovet 100Melengestrol Acetate, Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-534
MGA/ Bovatec/ Tylovet 100Lasalocid, Melengestrol Acetate, Tylosin PhosphateHuvepharma EOODCattleANADA 200-535
Zilmax/Rumensin/Tylovet 100/MGAMelengestrol Acetate, Monensin, Tylosin Phosphate, ZilpaterolHuvepharma EOODCattleANADA 200-544
Zilmax/Rumensin/Tylovet 100Monensin, Tylosin Phosphate, ZilpaterolHuvepharma EOODCattleANADA 200-547
Engain and TylanRactopamine Hydrochloride, Tylosin PhosphatePhibro Animal Health Corp.SwineANADA 200-558
Actogain and Rumensin and TylanMonensin, Ractopamine Hydrochloride, Tylosin PhosphatePhibro Animal Health Corp.CattleANADA 200-561
Actogain 45/Rumensin/Tylan/MGAMelengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin PhosphatePhibro Animal Health Corp.CattleANADA 200-562
Optaflexx 45/Rumensin/Tylovet 100Monensin, Ractopamine Hydrochloride, Tylosin PhosphateHuvepharma EOODCattleANADA 200-566
Optaflexx 45/Rumensin/Tylovet 100/MGAMelengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin PhosphateHuvepharma EOODCattleANADA 200-567
Actogain 45/Rumensin/Tylovet 100/MGAMelengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin PhosphatePhibro Animal Health Corp.CattleANADA 200-583
Engain and TylovetRactopamine Hydrochloride, Tylosin PhosphatePhibro Animal Health Corp.SwineANADA 200-584
Actogain 45/Rumensin/Tylovet 100Monensin, Ractopamine Hydrochloride, Tylosin PhosphatePhibro Animal Health Corp.CattleANADA 200-585
Optaflexxand Monovet and TylanMonensin, Ractopamine Hydrochloride, Tylosin PhosphateHuvepharma EOODCattleANADA 200-646
Optaflexx and Monovet and Tylovet and MGAMelengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin PhosphateHuvepharma EOODCattleANADA 200-648
Deccox and Rumensin and TylovetDecoquinate, Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-653
Deccox and Rumensin and TylovetDecoquinate, Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-656
MGA and Monovet and TylovetMelengestrol Acetate, Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-660
MGA and Monovet and TylanMelengestrol Acetate, Monensin, Tylosin PhosphateHuvepharma EOODCattleANADA 200-661
Optigrid and Monovet and TylovetMonensin, Ractopamine Hydrochloride, Tylosin PhosphateHuvepharma EOODCattleANADA 200-676
Tylosin / Hygromixapproval voluntarily withdrawnHygromycin B, Tylosin PhosphateElanco US, Inc.SwineNADA 012-548
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
Purina Pork-Plus Medicatedapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateVirbac AH, Inc.SwineNADA 042-660
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
Hubbard Tylan Plus Sulfa Premixapproval voluntarily withdrawnSulfamethazine, Tylosin PhosphateHubbard Milling Co.—NADA 094-402

Showing 60 of 141 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 FDA adverse event reports mention tylosin phosphate?

310 reports through March 2026, 18 of them in the latest 12 months, counting tylosin phosphate 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 tylosin phosphate without any counts.

In which combinations is tylosin phosphate reported?

Tylosin Phosphate (73.2% of these reports), Monensin + Tylosin Phosphate (23.2% of these reports), Melengestrol Acetate + Monensin + Tylosin Phosphate (1.6% of these reports), Melengestrol Acetate + Monensin + Ractopamine Hydrochloride + Tylosin Phosphate (1.3% of these reports) and Sulfamethazine + Tylosin Phosphate (0.6% of these reports).

What reactions are reported for tylosin phosphate?

death (47.1%), pneumonia (17.4%), lameness (16.1%), respiratory tract disorder NOS (12.6%) and ruminal bloat (12.3%). Shares are of reports naming the ingredient; one report can list several terms.

Which animals are these reports about?

cattle (72.6%), pig (10.6%) and dog (5.5%).

Does a high count mean tylosin phosphate 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.