Active ingredient · pooled across combinations
Tylosin Phosphate: adverse event reports, pooled
5 ingredient sets in reports · 141 FDA-approved applications in the Green Book
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 drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Tylosin Phosphate | 227 | 73.2% | 18 |
| Monensin + Tylosin Phosphate | 72 | 23.2% | 0 |
| Melengestrol Acetate + Monensin + Tylosin Phosphate | 5 | 1.6% | 0 |
| Melengestrol Acetate + Monensin + Ractopamine Hydrochloride + Tylosin Phosphate | 4 | 1.3% | 0 |
| Sulfamethazine + Tylosin Phosphate | 2 | 0.6% | 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
- Death47.1%146
- Pneumonia[lung infection or inflammation]17.4%54
- Lameness16.1%50
- Respiratory tract disorder NOS[NOS: not otherwise specified]12.6%39
- Ruminal bloat12.3%38
- Unclassifiable adverse event[event that fits no dictionary term]11%34
- Bloated9.4%29
- Lack of efficacy - NOS[the product did not have the expected effect]9%28
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]7.4%23
- Behavioural disorder NOS[behaviour change, type not specified]7.1%22
- Death by euthanasia[the animal was euthanized]6.8%21
- Peritonitis[inflamed abdominal lining]6.8%21
- Found dead6.5%20
- PR-liver, lesion(s)[legacy FDA term: lesions found in the liver]4.8%15
- Abscess NOS[NOS: not otherwise specified]4.2%13
- Digestive tract disorder NOS[digestive problem, type not specified]4.2%13
- Heart failure3.9%12
- Musculoskeletal disorder NOS[NOS: not otherwise specified]3.9%12
- NT - Abnormal necropsy finding NOS[NOS: not otherwise specified]3.9%12
- Respiratory signs3.9%12
- Claw / hoof / nail disorder NOS[NOS: not otherwise specified]2.9%9
- Liver disorder NOS[NOS: not otherwise specified]2.9%9
- Trauma NOS[NOS: not otherwise specified]2.9%9
- Loose stool2.6%8
- Loss of condition2.6%8
- Uncoded sign[a sign with no matching dictionary term]2.6%8
- Anorexia[not eating]2.3%7
- Diarrhoea[diarrhea]2.3%7
- Liver abscess2.3%7
- 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
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 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
| Measure | Tylosin Phosphate | All reports |
|---|---|---|
| Reports | 310 | 1,357,245 |
| Latest 12 months against the 12 before | -31% | -5% |
| Classed serious, of reports stating it | 41.9% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 564.5 | 63.8 |
| 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 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 5 Sulfa-G; Tylan 10 Sulfa-G; Tylan 20 Sulfa-G; Tylan 40 Sulfa-G | Sulfamethazine, Tylosin Phosphate | Elanco US Inc. | Swine | NADA 041-275 |
| Tylan 40 | Tylosin Phosphate | Phibro Animal Health Corp. | Cattle, Swine | NADA 046-415 |
| Tylan 10 Sulfa-G; Tylan 40 Sulfa-G | Sulfamethazine, Tylosin Phosphate | Phibro Animal Health Corp. | Swine | NADA 091-749 |
| Tylan 20; Tylan 40 | Tylosin Phosphate | Phibro Animal Health Corp. | Cattle, Swine | NADA 098-431 |
| Rumensin and Tylan | Monensin, Tylosin Phosphate | Elanco US Inc. | Cattle | NADA 104-646 |
| Tylan and Banminth | Pyrantel Tartrate, Tylosin Phosphate | Phibro Animal Health Corp. | Swine | NADA 110-047 |
| MGA and Rumensin and Tylan | Melengestrol Acetate, Monensin, Tylosin Phosphate | Phibro Animal Health Corp. | Cattle | NADA 138-870 |
| MGA and Bovatec and Tylan | Lasalocid sodium, Melengestrol Acetate, Tylosin Phosphate | Phibro Animal Health Corp. | Cattle | NADA 138-992 |
| MGA and Tylan | Melengestrol Acetate, Tylosin Phosphate | Phibro Animal Health Corp. | — | NADA 139-192 |
| Paylean and Tylan | Ractopamine Hydrochloride, Tylosin Phosphate | Elanco US Inc. | Swine | NADA 141-172 |
| Optaflexx and Rumensin and Tylan | Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Elanco US Inc. | Cattle | NADA 141-224 |
| Optaflexx and Rumensin and Tylanand MGA | Melengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Elanco US Inc. | Cattle | NADA 141-233 |
| Zilmax and Rumensin and Tylan | Monensin, Tylosin Phosphate, Zilpaterol Hydrochloride | Intervet, Inc. | Cattle | NADA 141-276 |
| Zilmax and Rumensin and Tylan and MGA | Melengestrol Acetate, Monensin, Tylosin Phosphate, Zilpaterol Hydrochloride | Intervet, Inc. | Cattle | NADA 141-280 |
| Experior and Rumensin and Tylan | Lubabegron, Monensin, Tylosin Phosphate | Elanco US Inc. | Cattle | NADA 141-512 |
| MGA and Experior and Rumensin and Tylan | Lubabegron, Melengestrol Acetate, Monensin, Tylosin Phosphate | Elanco US Inc. | Cattle | NADA 141-591 |
| HeifermaX 500 / Rumensin / Tylan | Melengestrol Acetate, Monensin, Tylosin Phosphate | Elanco US Inc. | Cattle | ANADA 200-375 |
| Heifermax / Optaflexx / Rumensin / Tylan | Melengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Elanco US Inc. | Cattle | ANADA 200-424 |
| Heifermax 500 Liquid Premix and Tylan | Melengestrol Acetate, Tylosin Phosphate | Elanco US Inc. | Cattle | ANADA 200-427 |
| HeifermaX 500 plus Bovatec and Tylan | Lasalocid, Melengestrol Acetate, Tylosin Phosphate | Elanco US Inc. | Cattle | ANADA 200-430 |
| Heifermax 500/Zilmax/Rumensin/Tylan | Melengestrol Acetate, Monensin, Tylosin Phosphate, Zilpaterol | Elanco US Inc. | Cattle | ANADA 200-480 |
| Tylovet 40; Tylovet 100 | Tylosin Phosphate | Huvepharma EOOD | Cattle, Swine | ANADA 200-484 |
| Paylean and Tylovet | Ractopamine Hydrochloride, Tylosin Phosphate | Huvepharma EOOD | Swine | ANADA 200-530 |
| Rumensin plus Tylovet 100 | Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-531 |
| MGA plus Tylovet 100 | Melengestrol Acetate, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-532 |
| Deccox and Rumensin and Tylovet | Decoquinate, Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-533 |
| MGA, Rumensin and Tylovet 100 | Melengestrol Acetate, Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-534 |
| MGA/ Bovatec/ Tylovet 100 | Lasalocid, Melengestrol Acetate, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-535 |
| Zilmax/Rumensin/Tylovet 100/MGA | Melengestrol Acetate, Monensin, Tylosin Phosphate, Zilpaterol | Huvepharma EOOD | Cattle | ANADA 200-544 |
| Zilmax/Rumensin/Tylovet 100 | Monensin, Tylosin Phosphate, Zilpaterol | Huvepharma EOOD | Cattle | ANADA 200-547 |
| Engain and Tylan | Ractopamine Hydrochloride, Tylosin Phosphate | Phibro Animal Health Corp. | Swine | ANADA 200-558 |
| Actogain and Rumensin and Tylan | Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Phibro Animal Health Corp. | Cattle | ANADA 200-561 |
| Actogain 45/Rumensin/Tylan/MGA | Melengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Phibro Animal Health Corp. | Cattle | ANADA 200-562 |
| Optaflexx 45/Rumensin/Tylovet 100 | Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-566 |
| Optaflexx 45/Rumensin/Tylovet 100/MGA | Melengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-567 |
| Actogain 45/Rumensin/Tylovet 100/MGA | Melengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Phibro Animal Health Corp. | Cattle | ANADA 200-583 |
| Engain and Tylovet | Ractopamine Hydrochloride, Tylosin Phosphate | Phibro Animal Health Corp. | Swine | ANADA 200-584 |
| Actogain 45/Rumensin/Tylovet 100 | Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Phibro Animal Health Corp. | Cattle | ANADA 200-585 |
| Optaflexxand Monovet and Tylan | Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-646 |
| Optaflexx and Monovet and Tylovet and MGA | Melengestrol Acetate, Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-648 |
| Deccox and Rumensin and Tylovet | Decoquinate, Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-653 |
| Deccox and Rumensin and Tylovet | Decoquinate, Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-656 |
| MGA and Monovet and Tylovet | Melengestrol Acetate, Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-660 |
| MGA and Monovet and Tylan | Melengestrol Acetate, Monensin, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-661 |
| Optigrid and Monovet and Tylovet | Monensin, Ractopamine Hydrochloride, Tylosin Phosphate | Huvepharma EOOD | Cattle | ANADA 200-676 |
| Tylosin / Hygromixapproval voluntarily withdrawn | Hygromycin B, Tylosin Phosphate | Elanco US, Inc. | Swine | NADA 012-548 |
| 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 |
| Purina Pork-Plus Medicatedapproval voluntarily withdrawn | Sulfamethazine, Tylosin Phosphate | Virbac AH, Inc. | Swine | NADA 042-660 |
| 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 |
| Hubbard Tylan Plus Sulfa Premixapproval voluntarily withdrawn | Sulfamethazine, Tylosin Phosphate | Hubbard 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.