Sudden death: in adverse event reports for animal drugs

Clinical sign, a VeDDRA term

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.

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From October 2004 to May 2026, FDA received 1,275 adverse event reports for animal drugs that list this sign. That is under 0.1% of the 1,378,761 reports that FDA received from January 1987 to June 2026. In the 12 months to June 2026, FDA received 45 reports that list this sign.

Of the 1,275 reports, 56.5% are about dogs. A report can list more than one sign and more than one drug. A report is not proof that a drug caused a sign.

By number of reports in all years, this sign is number 408 of 1,149 clinical signs with a page. Reports that list this sign fell by 32.8% 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 dogs are 56.5% of the reports that list this sign, and 72.6% of all reports.

Search engines list a sign page with 3,000 reports or more in all years. The page also needs 300 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.

Drug pages with reports that list this sign

The table has every drug page with 20 or more reports that list this sign, in order of name. No count decides which drug is in the table. The table has 29 drug pages.

Show the 29 drug pages

Drug pages with 20 or more reports that list this sign, in order of name
Active ingredients	Reports that list the sign
Afoxolaner	21
Atipamezole Hydrochloride	20
Bedinvetmab	30
Buprenorphine	32
Butorphanol Tartrate	46
Carprofen	58
Cefovecin sodium	80
Ceftiofur Crystalline Free Acid	71
Dexmedetomidine	26
Dexmedetomidine hydrochloride	30
Doramectin	29
Enrofloxacin	24
Fluralaner	44
Ivermectin	22
Ivermectin + Pyrantel Pamoate	32
Ketamine Hydrochloride	23
Maropitant	63
Meloxicam	28
Milbemycin Oxime + Spinosad	113
Monensin	25
Moxidectin	53
Nitenpyram	23
Oclacitinib	34
Prednisone	33
Pyrantel Pamoate	20
Selamectin	42
Spinosad	61
Trilostane	26
Tulathromycin	24

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. A report can name more than one drug.

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.
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

Ingredients, all combinations

The list has every active ingredient with 20 or more reports that list this sign, in order of name. It has 30 ingredients.

Show the 30 ingredients

Reports by species

Dog56.5%720
Cat19.1%244
Cattle16.8%214
Horse3.3%42
Pig1.4%18
Sheep0.7%9

The share is of the 1,275 reports that list this sign. The sign is in 0.1% of all reports about the species dog. The sign is in 0.2% of all reports about the species cat.

Reports by month and by year

Reports for each month, Jul 2021 to Jun 2026. The month is the month in which FDA received the report.

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 that list Sudden death, by the year in which FDA received them
Year	Reports
2026	26
2025	56
2024	65
2023	50
2022	52
2021	44
2020	56
2019	94
2018	116
2017	138
2016	118
2015	111
2014	110
2013	90
2012	96
2011	26
2010	3
2009	2
2008	8
2007	4
2006	2
2005	6
2004	2

What these reports record

Outcome at the time of the report

Reports with this sign
All reports

Recovered/Normal2.2%28, All reports: 20.7%
Recovered with Sequela[recovered, with a lasting effect]0%0, All reports: 2.3%
Ongoing0.7%9, All reports: 17.4%
Died99.6%1,270, All reports: 4.9%
Euthanized0.6%8, All reports: 1.5%
Outcome Unknown1.8%23, All reports: 22.7%

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 1,275 reports that list this sign.

Age of the animal

Reports with this sign
All reports

Under 1 year14.9%190, All reports: 9.5%
1 to 3 years15.6%199, All reports: 23.9%
4 to 7 years18.7%239, All reports: 20.2%
8 to 11 years22.9%292, All reports: 15.4%
12 years and over14%178, All reports: 10.7%
Age not given13.9%177, All reports: 20.3%

The outcome is for the full report, not for this sign only.

Next in the A to Z list of signs

Stress leukogram
Stroke
Stumbling gait
Stupor[barely responsive]
Surgical site disorder
Suspected infectious agent transmission
Suspension, Abnormal[a product quality report, not a sign in an animal]
Swallowing difficult

All clinical signs

Cite this page

Pet Drug Reports. Sudden death: adverse event reports for animal drugs. https://petdrugreports.com/reaction/sudden-death/ 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 counts the different spellings of one VeDDRA term together.

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 this sign

What does this term mean in a report?: It is a term from VeDDRA, the list of terms that FDA and drug companies use to code a report. The person who coded the report selected the term.
How does the count of the latest 12 months compare with the 12 months before?: FDA received 45 reports in the 12 months to June 2026. It received 67 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.
How many of these reports have a serious flag?: Of the 1,212 reports that say if the event was serious, 99.5% have the serious flag. The person who sends a report sets the flag.
Does a drug in the table cause this sign?: The reports do not show that. A report can name more than one drug. 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