Mouse: adverse event reports for animal drugs
Species
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 August 1996 to May 2025, FDA received 123 adverse event reports about mice for animal drugs. 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 2 reports about mice. The signs that appear in the largest number of the 123 reports are "Death", "Ineffective, anesthesia" and "Death by euthanasia". A report is not proof that a drug caused a sign.
Since the last update of the FDA data
No update is on record. The record starts with the next closed quarter that FDA adds to the data.
Drug pages with reports about mice
The table has every drug page with 20 or more reports about mice, in order of name. No count decides which drug is in the table. The table has 2 drug pages.
| Active ingredients | Reports about mice |
|---|---|
| Ketamine Hydrochloride | 48 |
| Xylazine | 20 |
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.
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.
Commonly used products may have a higher number of reported adverse events due to the higher total number of animals being given the product.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
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 123 reports about mice that list the sign.
The sign that is in the largest number of the reports comes first.
- Death50.4%62 reports
- Ineffective, anesthesia[legacy FDA term: the product did not have the expected effect (anesthesia)]14.6%18 reports
- Death by euthanasia[the animal was euthanized]7.3%9 reports
- Dermatitis[inflamed skin]4.9%6 reports
- Lack of efficacy - NOS[the product did not have the expected effect]4.1%5 reports
- Unrelated death4.1%5 reports
- Anorexia[not eating]3.3%4 reports
- Apnoea[breathing stopped]3.3%4 reports
- Ataxia[unsteady, uncoordinated movement]3.3%4 reports
- Behavioural disorder NOS[behaviour change, type not specified]3.3%4 reports
- Hyperkeratosis3.3%4 reports
- Ineffective, sedation[legacy FDA term: the product did not have the expected effect (sedation)]3.3%4 reports
- Lethargy[unusually tired or inactive]3.3%4 reports
- Necropsy performed3.3%4 reports
Show the next 16 signs
- Seizure NOS[seizure, type not specified]3.3%4 reports
- Abnormal breathing2.4%3 reports
- Bradypnoea2.4%3 reports
- Depression[dull, quiet or withdrawn]2.4%3 reports
- Dyspnoea[difficulty breathing]2.4%3 reports
- Injection site nodule[nodule where the injection was given]2.4%3 reports
- Recovery prolonged2.4%3 reports
- Abnormal posture NOS[NOS: not otherwise specified]1.6%2 reports
- Color, Abnormal[a product quality report, not a sign in an animal]1.6%2 reports
- Decreased respiratory rate1.6%2 reports
- Excessive licking and/or grooming1.6%2 reports
- Hyperexcitation1.6%2 reports
- Hypoxia1.6%2 reports
- Injection site alopecia[hair loss where the injection was given]1.6%2 reports
- Injection site lesion[lesion where the injection was given]1.6%2 reports
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 |
|---|---|
| 2025 | 2 |
| 2024 | 6 |
| 2023 | 6 |
| 2022 | 9 |
| 2021 | 3 |
| 2020 | 3 |
| 2019 | 10 |
| 2018 | 3 |
| 2017 | 2 |
| 2016 | 9 |
| 2015 | 3 |
| 2014 | 7 |
| 2013 | 8 |
| 2012 | 5 |
| 2011 | 2 |
| 2010 | 20 |
| 2009 | 6 |
| 2008 | 1 |
| 2007 | 3 |
| 2006 | 2 |
| 2005 | 3 |
| 2004 | 1 |
| 2002 | 3 |
| 2001 | 1 |
| 1999 | 2 |
| 1997 | 2 |
| 1996 | 1 |
What the reports record
Age of the animal
- Under 1 year34.1%42
- 1 to 3 years2.4%3
- 4 to 7 years0%0
- 8 to 11 years0%0
- 12 years and over0%0
- Age not given63.4%78
Weight of the animal
- Under 5 kg (11 lb)33.3%41
- 5 to 9.9 kg (11 to 22 lb)0%0
- 10 to 24.9 kg (22 to 55 lb)0.8%1
- 25 to 44.9 kg (55 to 99 lb)0%0
- 45 kg and over (99 lb and over)0%0
- Weight not given65.9%81
Outcome at the time of the report
- Reports about mice
- All reports
- Recovered/Normal15.4%19, All reports: 20.7%
- Recovered with Sequela[recovered, with a lasting effect]1.6%2, All reports: 2.4%
- Ongoing3.3%4, All reports: 17.1%
- Died49.6%61, All reports: 4.9%
- Euthanized14.6%18, All reports: 1.5%
- Outcome Unknown10.6%13, 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 123 reports about mice.
Kind of report
- Reports about mice
- All reports
- Safety issue83.7%103, All reports: 64.8%
- Lack of expected effectiveness5.7%7, All reports: 18.7%
- Both safety and lack of expected effectiveness6.5%8, All reports: 4.3%
- Manufacturing or product defect2.4%3, All reports: 12.2%
- Other1.6%2, All reports: 0.1%
Each share of age, weight and kind is of the 123 reports about mice. The thin bar is the same share in all 1,357,245 reports.
Ingredients, all combinations
The list has every active ingredient with 20 or more reports about mice, in order of name. It has 2 ingredients.
Cite this page
Pet Drug Reports. Mouse: adverse event reports for animal drugs. https://petdrugreports.com/species/mouse/ 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 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
- What ages are the mice in the reports?
The figures are shares of the 123 reports about mice received from August 1996 to May 2025. 34.1% give an age of under 1 year. 2.4% give an age of 1 to 3 years. 63.4% give no age.
- How does the count of the latest 12 months compare with the 12 months before?
FDA received 2 reports in the 12 months to March 2026. It received 5 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 123 reports received from August 1996 to May 2025, 83.7% are about a safety issue only. 12.2% are about a lack of expected effectiveness, alone or with a safety issue. 2.4% are about a defect of the product or its package.
- Do more reports for mice show a higher risk for mice?
No. FDA states 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.
Commonly used products may have a higher number of reported adverse events due to the higher total number of animals being given the product.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices