Labels, Abnormal: in adverse event reports for animal drugs
Clinical sign, a VeDDRA term
In plain words: a product quality report, not a sign in an animal.
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 FDAFrom June 1997 to January 2026, FDA received 212 adverse event reports for animal drugs that list this sign. That is under 0.1% of the 1,357,245 reports that FDA received from January 1987 to March 2026. In the 12 months to March 2026, FDA received 16 reports that list this sign.
Of the 212 reports, 2.8% 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.
Fewer than 50 reports listed this sign in the latest 12 months. The site keeps the page for its links 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 one drug page.
| Active ingredients | Reports that list the sign |
|---|---|
| Fluralaner | 32 |
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 2 ingredients.
Reports by species
The share is of the 212 reports that list this sign. The sign is in 0% of all reports about the species dog. The sign is in 0% of all reports about the species human exposure.
Reports by month and by year
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.
| Year | Reports |
|---|---|
| 2026 | 3 |
| 2025 | 15 |
| 2024 | 11 |
| 2023 | 5 |
| 2022 | 6 |
| 2021 | 15 |
| 2020 | 6 |
| 2019 | 27 |
| 2018 | 25 |
| 2017 | 35 |
| 2016 | 19 |
| 2015 | 8 |
| 2014 | 13 |
| 2013 | 4 |
| 2012 | 7 |
| 2011 | 4 |
| 2010 | 5 |
| 2009 | 2 |
| 2008 | 1 |
| 1997 | 1 |
What these reports record
Outcome at the time of the report
- Reports with this sign
- All reports
- Recovered/Normal2.4%5, All reports: 20.7%
- Recovered with Sequela[recovered, with a lasting effect]0%0, All reports: 2.4%
- Ongoing2.8%6, All reports: 17.1%
- Died0.9%2, All reports: 4.9%
- Euthanized0%0, All reports: 1.5%
- Outcome Unknown1.9%4, 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 212 reports that list this sign.
Age of the animal
- Reports with this sign
- All reports
- Under 1 year0%0, All reports: 9.6%
- 1 to 3 years0.9%2, All reports: 24%
- 4 to 7 years0.9%2, All reports: 20.1%
- 8 to 11 years1.4%3, All reports: 15.4%
- 12 years and over1.9%4, All reports: 10.6%
- Age not given94.8%201, 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
- Ketosis[ketones building up in the body]
- Knuckling
- Labeled drug-species interaction
- Labelled drug-drug interaction medication error
- Laboured breathing
- Lack of coordination
- Lack of efficacy - NOS[the product did not have the expected effect]
- Lack of efficacy (bacteria) - Anaplasma[the product did not have the expected effect: Anaplasma bacteria]
Cite this page
Pet Drug Reports. Labels, Abnormal: adverse event reports for animal drugs. https://petdrugreports.com/reaction/labels-abnormal/ 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 2 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 31 Mar 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 1 Oct 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?
In plain words: a product quality report, not a sign in an animal. 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 16 reports in the 12 months to March 2026. It received 9 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 15 reports that say if the event was serious, 13.3% 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