Ketoprofen + Tulathromycin (Draxxin KP): adverse event reports that FDA received

Name: Ketoprofen + Tulathromycin: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

Combination of 2 active ingredients

The name in brackets is a brand name with these active ingredients.

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 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

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

Contacting a veterinarian How to report to FDA

From August 2021 to June 2026, FDA received 271 adverse event reports that name a drug with ketoprofen and tulathromycin as its active ingredients. Of the 271 reports, 204 (75.3%) are about cattle. 25 reports are about people who were exposed to the drug (9.2%).

In January to March 2026, FDA received 10 reports that name this drug. The signs that appear in the largest number of the 271 reports are "Death", "Lack of efficacy - NOS" and "Necropsy performed". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 12.2% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about cattle are 75.3% of the reports that name this drug, and 2.3% 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 11 Oct 2026, changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 10 reports that name ketoprofen + tulathromycin: 0 dog, 0 cat, 0 horse, 10 other or not given.

All updates Feed 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 271 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.

Death56.1%152 reports
Lack of efficacy - NOS[the product did not have the expected effect]52.4%142 reports
Necropsy performed13.7%37 reports
Intentional misuse[use that was knowingly different from the label]10.3%28 reports
Containers, Damaged[a product quality report, not a sign in an animal]5.5%15 reports
Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]4.4%12 reports
Accidental exposure[exposure that was not intended]3.3%9 reports
Anaphylaxis[sudden severe allergic-type reaction]3.3%9 reports
Death by euthanasia[the animal was euthanized]3.3%9 reports
Inappropriate packaging or design3.3%9 reports
Lack of efficacy (bacteria) - Mannheimia haemolytica[the product did not have the expected effect: Mannheimia haemolytica]3.3%9 reports
Injection site swelling[swelling where the injection was given]3%8 reports
Lying down2.6%7 reports
Needlestick injury2.6%7 reports

Show the next 16 signs

Puncture wound2.6%7 reports
Closure, Abnormal[a product quality report, not a sign in an animal]2.2%6 reports
Injection site pain[pain where the injection was given]2.2%6 reports
Lack of efficacy (mycoplasma) - NOS[the product did not have the expected effect: target not specified]1.8%5 reports
Lateral recumbency[lying on the side, unable to rise]1.8%5 reports
Color, Abnormal[a product quality report, not a sign in an animal]1.5%4 reports
Containers, Leaking[a product quality report, not a sign in an animal]1.5%4 reports
Fibrinous (broncho) pneumonia/fibrinous pleuropneumonia1.5%4 reports
Found dead1.5%4 reports
Lack of efficacy (virus) - bovine viral diarrhoea virus[the product did not have the expected effect: bovine viral diarrhoea virus]1.5%4 reports
Unexplained death1.5%4 reports
Anaphylactic-type reaction1.1%3 reports
Anorexia[not eating]1.1%3 reports
Fever1.1%3 reports
Lack of efficacy (bacteria) - Histophilus somni[the product did not have the expected effect: Histophilus somni]1.1%3 reports
Lack of efficacy (virus) - bovine respiratory syncytial virus[the product did not have the expected effect: bovine respiratory syncytial virus]1.1%3 reports

The list shows 30 of 148 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Cattle75.3%204
Human exposure9.2%25
Sheep1.8%5

The share is of all 271 reports that name ketoprofen + tulathromycin. 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 given271 reports. Largest count in one month: 10 (Oct 2024)

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 ketoprofen + tulathromycin, by the year in which FDA received them and by species
Year	Other or not given	All species
2026	21	21
2025	52	52
2024	50	50
2023	60	60
2022	58	58
2021	30	30

2026 has the reports that FDA received through Jun 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal11.8%32
Recovered with Sequela[recovered, with a lasting effect]4.1%11
Ongoing18.8%51
Died59.4%161
Euthanized3.7%10
Outcome Unknown44.3%120

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 271 reports that name ketoprofen + tulathromycin.

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

Kind of report

Safety issue26.9%73
Lack of expected effectiveness56.5%153
Both safety and lack of expected effectiveness1.8%5
Manufacturing or product defect14.4%39
Other0.4%1

234 reports say if the event was serious. 89.3% 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 year25.8%70
1 to 3 years2.6%7
4 to 7 years0%0
8 to 11 years0.4%1
12 years and over5.9%16
Age not given65.3%177

Weight of the animal

Under 5 kg (11 lb)0%0
5 to 9.9 kg (11 to 22 lb)0%0
10 to 24.9 kg (22 to 55 lb)0.4%1
25 to 44.9 kg (55 to 99 lb)1.1%3
45 kg and over (99 lb and over)56.8%154
Weight not given41.7%113

Breed, where the report gives one breed

Aberdeen Angus5.5%15
Holstein-Friesian2.2%6
Jersey1.8%5
Guernsey0.7%2
Hereford cattle0.7%2
Red Angus0.7%2
Piedmont0.4%1
Hampshire Down0.4%1

A breed with many animals has many reports.

Route in the report

Subcutaneous70.1%190
Other2.2%6
Ophthalmic1.5%4
Topical1.5%4
Intradermal0.4%1
Intramuscular0.4%1

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

Approved animal drugs with these active ingredients (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

Draxxin KP

What the Green Book records give

Applications with an approval in force: 1
Approved species: Cattle
Dose forms: Injectable Solution
Routes: Subcutaneous
Sale: RX (prescription)
Earliest approval date in the records: 1 Jun 2021

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 name	Active ingredients	Sponsor	Approved species	Application
Draxxin KP	Ketoprofen, Tulathromycin	Zoetis Inc.	Cattle	NADA 141-543

Other pages with one of these ingredients

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
Green Book record of NADA 141-543The FDA record of the application for Draxxin KP.
Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. Ketoprofen + Tulathromycin: adverse event reports that FDA received. https://petdrugreports.com/drug/ketoprofen-tulathromycin/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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 these active ingredients.
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 55 reports in the 12 months to June 2026. It received 49 reports 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 271 reports received from August 2021 to June 2026, 26.9% are about a safety issue only. 58.3% are about a lack of expected effectiveness, alone or with a safety issue. 14.4% are about a defect of the product or its package.