Pet Drug Reports

Species

Species

Rat: adverse event reports

146 reports, 0% of FDA's animal drug adverse event database

146reports about rats, 1987–2025
5reports, 12 months to March 20265 in the 12 months before
0%of all reports received in the latest 12 months0% over the whole record
71.1%classed serious, as reportedall species: 38.6%

146 adverse event reports in FDA's database concern rats: 0% of all reports received from March 1987 to December 2025. 5 arrived in the 12 months to March 2026, close to the 5 of the 12 months before. That is 0% of all reports received in those 12 months and about 4 reports a year over the whole record.

By active ingredient, the drugs named most often are ketamine hydrochloride (43.8% of rat reports), isoflurane (11.6% of rat reports), xylazine (8.9% of rat reports) and selamectin (6.2% of rat reports). Drugs given to the most animals lead the list for that reason; brands are masked in the public data.

The terms listed most often are death (53.4%), ineffective, anesthesia (17.1%) and death by euthanasia (10.3%). 71.1% of reports stating seriousness were classed as serious (38.6% across all species), and 63.7% record a death or euthanasia (6.4% overall).

FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases.

Drugs named most often, by active ingredient

Active ingredients recorded for the drugReportsShare of rat reportsShare of the drug's reports that concern rats
Ketamine Hydrochloride6443.8%0.9%
Isoflurane1711.6%0.3%
Xylazine138.9%1.2%
Selamectin96.2%0%
Dexmedetomidine hydrochloride74.8%0.1%
Buprenorphine64.1%0.1%
Ivermectin64.1%0%
Enrofloxacin53.4%0.1%
Carprofen42.7%0%
Xylazine Hydrochloride42.7%3.1%
Atipamezole Hydrochloride32.1%0.1%
Medetomidine32.1%0.1%
Meloxicam32.1%0%
Gentamicin Sulfate21.4%0.6%
Acepromazine Maleate10.7%0%
Alfaxalone10.7%0.1%
Amoxicillin10.7%0%
Atropine10.7%0.1%
Bupivacaine10.7%0.1%
Deslorelin Acetate10.7%0.3%
Enrofloxacin + Silver sulfadiazine10.7%0.1%
Estriol10.7%0%
Flunixin Meglumine10.7%0.1%
Ketoprofen10.7%0.3%
Methoxyflurane10.7%3%
Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate10.7%0.4%
Midazolam10.7%0%
Mupirocin10.7%0.5%
Pentobarbital10.7%0.1%
Pentobarbital Sodium + Phenytoin Sodium10.7%0.2%

Ordered by report count, which follows how widely a drug is used. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another". openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.

Signs listed in reports

share of rat reports listing the termall species

  1. Death53.4%78
  2. Ineffective, anesthesia[legacy FDA term: the product did not have the expected effect (anesthesia)]17.1%25
  3. Death by euthanasia[the animal was euthanized]10.3%15
  4. Lack of efficacy - NOS[the product did not have the expected effect]6.2%9
  5. Apnoea[breathing stopped]5.5%8
  6. Ineffective, sedation[legacy FDA term: the product did not have the expected effect (sedation)]5.5%8
  7. Cyanosis[bluish gums or skin from low oxygen]2.7%4
  8. Ataxia[unsteady, uncoordinated movement]2.1%3
  9. Dyspnoea[difficulty breathing]2.1%3
  10. Pain NOS[NOS: not otherwise specified]2.1%3
  11. Anorexia[not eating]1.4%2
  12. Behavioural disorder NOS[behaviour change, type not specified]1.4%2
  13. Color, Abnormal[a product quality report, not a sign in an animal]1.4%2
  14. Convulsion[seizure]1.4%2
  15. Depression[dull, quiet or withdrawn]1.4%2
  16. Hypothermia[low body temperature]1.4%2
  17. Ineffective, delayed effect[legacy FDA term: the product did not have the expected effect (delayed effect)]1.4%2
  18. Injection site necrosis[necrosis where the injection was given]1.4%2
  19. Medication error NOS[a mistake in giving the product, type not specified]1.4%2
  20. Neurological signs NOS[NOS: not otherwise specified]1.4%2
  21. Premature anaesthesia recovery1.4%2
  22. Product Defect, General[a product quality report, not a sign in an animal]1.4%2
  23. Pruritus[itching]1.4%2

Single ingredients, pooled across combinations

Age and weight

Age of the animal

Under 1 year32.9%48
1 to 3 years8.2%12
4 to 7 years0%0
8 to 11 years0%0
12 years and over0%0
Age not given58.9%86

Weight of the animal

Under 5 kg (11 lb)42.5%62
5 to 9.9 kg (11–22 lb)0%0
10 to 24.9 kg (22–55 lb)0%0
25 to 44.9 kg (55–99 lb)0.7%1
45 kg and over (99 lb+)0.7%1
Weight not given56.2%82

Outcomes and report types

Outcome recorded in the report

Recovered/Normal5.5%8
Recovered with Sequela0%0
Ongoing0.7%1
Died59.6%87
Euthanized7.5%11
Outcome Unknown8.9%13

What kind of report it was

Safety issue88.4%129
Lack of expected effectiveness4.1%6
Both safety and lack of expected effectiveness4.8%7
Manufacturing or product defect2.1%3
Other0.7%1

Coloured bar: rat reports. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter.

Trend

012Apr 2021: 0May 2021: 0Jun 2021: 0Jul 2021: 0Aug 2021: 1Sep 2021: 0Oct 2021: 1Nov 2021: 1Dec 2021: 0Jan 2022: 02022Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 0Jan 2023: 02023Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 1Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 1Jan 2024: 02024Feb 2024: 1Mar 2024: 1Apr 2024: 1May 2024: 0Jun 2024: 1Jul 2024: 0Aug 2024: 1Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 1Jan 2025: 12025Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 1Aug 2025: 0Sep 2025: 0Oct 2025: 2Nov 2025: 0Dec 2025: 2Jan 2026: 02026Feb 2026: 0Mar 2026: 0

Reports by month FDA received them. The newest months are incomplete because FDA posts reports with a delay of three to six months.

013261987: 219871988: 11989: 11991: 119911992: 21994: 31995: 319951996: 31999: 22000: 220002001: 32002: 72003: 220032004: 62005: 32006: 720062007: 22008: 32009: 520092010: 102011: 262012: 720122013: 42014: 22015: 620152016: 22017: 12018: 520182019: 32020: 52021: 320212023: 22024: 62025: 62025
MeasureRatAll reports
Reports1461,357,245
Classed serious, of reports stating it71.1%38.6%
Death or euthanasia recorded, per 1,000 reports63763.8
Filed as lack of expected effectiveness (wholly or partly)8.9%23%

Questions about rat reports

How many adverse event reports involve rats?

146 reports through March 2026, 0% of the database; 5 in the latest 12 months.

Which drugs are reported most often for rats?

By active ingredient: ketamine hydrochloride (64), isoflurane (17), xylazine (13), selamectin (9) and dexmedetomidine hydrochloride (7). The order tracks how widely each is used; brands are masked in the public data.

What signs are reported most in rats?

death (53.4%), ineffective, anesthesia (17.1%), death by euthanasia (10.3%), lack of efficacy - NOS (6.2%) and apnoea (5.5%).

What ages are the rats in these reports?

under 1 year (32.9%), 1 to 3 years (8.2%) and 4 to 7 years (0%); age is not given in 58.9% of reports.

Do more reports mean more risk for this species?

No. Counts follow how many animals are treated and how readily their owners and veterinarians report. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources."

How do I report a problem?

Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.