Pet Drug Reports

Tiamulin Hydrogen Fumarate (Denagard, TiaGard)adverse event reports that FDA received

Active ingredient

Also sold as: Denagard, TiaGard, Triamulox, BimaGard 12.5%, Vetmulin 12.5%, TIA 12.5%.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarianHow to report to FDA

From February 1988 to October 2024, FDA received 106 adverse event reports that name a drug with tiamulin hydrogen fumarate as its active ingredient. Of the 106 reports, 71 (67%) are about pigs. 3 reports are about people who were exposed to the drug (2.8%).

In January to March 2026, FDA received no reports that name this drug. The signs that appear in the largest number of the 106 reports are "Death" and "Lack of efficacy - NOS". A report is not proof that a drug caused a sign.

Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change. Reports about pigs are 67% of the reports that name this drug, and 0.2% of all reports.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on , changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 0 reports that name tiamulin hydrogen fumarate: 0 dog, 0 cat, 0 horse, 0 other or not given.

All updatesFeed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 106 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

  1. Death33%35 reports
  2. Lack of efficacy - NOS[the product did not have the expected effect]26.4%28 reports
  3. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]19.8%21 reports
  4. NT - Abnormal necropsy finding NOS[NOS: not otherwise specified]8.5%9 reports
  5. Diarrhoea[diarrhea]6.6%7 reports
  6. Product Defect, General[a product quality report, not a sign in an animal]6.6%7 reports
  7. Death by euthanasia[the animal was euthanized]5.7%6 reports
  8. Solution, Abnormal[a product quality report, not a sign in an animal]5.7%6 reports
  9. Vials, Leaking[a product quality report, not a sign in an animal]5.7%6 reports
  10. Digestive tract disorder NOS[digestive problem, type not specified]3.8%4 reports
  11. Lethargy[unusually tired or inactive]3.8%4 reports
  12. Other abnormal test result NOS[abnormal laboratory result, type not specified]3.8%4 reports
  13. Accidental exposure[exposure that was not intended]2.8%3 reports
  14. Cardiac disorder NOS[heart problem, type not specified]2.8%3 reports
Show the next 16 signs
  1. Containers, Leaking[a product quality report, not a sign in an animal]2.8%3 reports
  2. Depression[dull, quiet or withdrawn]2.8%3 reports
  3. Granules/Powder, Abnormal2.8%3 reports
  4. Abnormal necropsy finding1.9%2 reports
  5. Ataxia[unsteady, uncoordinated movement]1.9%2 reports
  6. Drug label incomplete1.9%2 reports
  7. Dyspnoea[difficulty breathing]1.9%2 reports
  8. General illness1.9%2 reports
  9. Ileitis1.9%2 reports
  10. Labelled drug-drug interaction medication error1.9%2 reports
  11. Lameness1.9%2 reports
  12. Not eating1.9%2 reports
  13. PR-small intestine, lesion(s)[legacy FDA term: lesions found in the small intestine]1.9%2 reports
  14. Pneumonia[lung infection or inflammation]1.9%2 reports
  15. Potency, High1.9%2 reports
  16. Product label information incorrect[a product quality report, not a sign in an animal]1.9%2 reports

The list shows 30 of 111 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Pig67%71
  • Human exposure2.8%3
  • Other Birds0.9%1

The share is of all 106 reports that name tiamulin hydrogen fumarate. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog0 reports

No chart: no month has 5 or more reports.

Cat0 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given3 reports

No chart: no month has 5 or more reports.

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

  • Dog
  • Cat
  • Horse
  • Other or not given
Reports that name tiamulin hydrogen fumarate, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
202400011
202300011
202100011
201500099
201400055
20130001515
20120001313
201100066
201000055
20090001010
200800022
200700088
200600077
200500011
200400011
200300011
199000066
19880001414

2024 has the reports that FDA received through Oct 2024. Download the years (CSV)

What the reports record

Outcome at the time of the report

  • Recovered/Normal4.7%5
  • Recovered with Sequela[recovered, with a lasting effect]0%0
  • Ongoing0.9%1
  • Died39.6%42
  • Euthanized6.6%7
  • Outcome Unknown17.9%19

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 106 reports that name tiamulin hydrogen fumarate.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue57.5%61
  • Lack of expected effectiveness13.2%14
  • Both safety and lack of expected effectiveness0%0
  • Manufacturing or product defect29.2%31
  • Other0%0

31 reports say if the event was serious. 80.6% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year28.3%30
  • 1 to 3 years0%0
  • 4 to 7 years0%0
  • 8 to 11 years0%0
  • 12 years and over1.9%2
  • Age not given69.8%74

Weight of the animal

  • Under 5 kg (11 lb)0%0
  • 5 to 9.9 kg (11 to 22 lb)1.9%2
  • 10 to 24.9 kg (22 to 55 lb)4.7%5
  • 25 to 44.9 kg (55 to 99 lb)8.5%9
  • 45 kg and over (99 lb and over)29.2%31
  • Weight not given55.7%59

Breed, where the report gives one breed

  • Commercial hybrid4.7%5

A breed with many animals has many reports.

Route in the report

  • Oral67.9%72
  • Topical1.9%2

Each bar is on a scale of 0 to 100%.

Approved animal drugs with this active ingredient (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Brand names

  • Denagard
  • TiaGard
  • Triamulox
  • BimaGard 12.5%
  • Vetmulin 12.5%
  • TIA 12.5%

What the Green Book records give

Applications with an approval in force
9
Approved species
Swine
Dose forms
Liquid concentrate, Liquid (Solution), Liquid, Concentrated Solution, Type A Medicated Article
Routes
Oral, Oral, in drinking water
Sale
OTC (over the counter)
Earliest approval date in the records

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
Denagard 80% CoatedTiamulin Hydrogen FumarateElanco US Inc.SwineNADA 139-472
Denagard 12.5%Tiamulin Hydrogen FumarateElanco US Inc.SwineNADA 140-916
TiaGard; Tiamulin Soluble AntibioticTiamulin Hydrogen FumaratePhibro Animal Health Corp.SwineANADA 200-344
Tiagard; Tiamulin Liquid ConcentrateTiamulin Hydrogen FumarateElanco US Inc.SwineANADA 200-360
TriamuloxTiamulin Hydrogen FumaratePhibro Animal Health Corp.SwineANADA 200-512
BimaGard 12.5%Tiamulin Hydrogen FumarateBimeda Animal Health Ltd.SwineANADA 200-546
Vetmulin 12.5%Tiamulin Hydrogen FumarateHuvepharma EOODSwineANADA 200-682
TIA 12.5%Tiamulin Hydrogen FumarateVirbac AH, Inc.SwineANADA 200-695
TiaGard 12.5%Tiamulin Hydrogen FumarateAurora Pharmaceutical, Inc.SwineANADA 200-717

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Tiamulin Hydrogen Fumarate: adverse event reports that FDA received. https://petdrugreports.com/drug/tiamulin-hydrogen-fumarate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.

Do the reports show that the drug caused the signs?

No. FDA states this about the data.

When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.

The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

How many reports did FDA receive in the latest 12 months?

FDA received no reports in the 12 months to June 2026. It received 1 report in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

What kinds of report are in the count?

Of the 106 reports received from February 1988 to October 2024, 57.5% are about a safety issue only. 13.2% are about a lack of expected effectiveness, alone or with a safety issue. 29.2% are about a defect of the product or its package.