Amoxicillin: adverse event reports that FDA received
Active ingredient
The Green Book lists no brand name for exactly this active ingredient.
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 . 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 January 1987 to June 2026, FDA received 8,680 adverse event reports that name a drug with amoxicillin as its active ingredient. Of the 8,680 reports, 3,389 (39%) are about dogs. 1,623 reports are about cats (18.7%).
In January to March 2026, FDA received 33 reports that name this drug. The signs that appear in the largest number of the 8,680 reports are "Color, Abnormal", "Suspension, Abnormal" and "Vomiting". A report is not proof that a drug caused a sign.
Reports that name this drug fell by 15.5% 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 39% of the reports that name this drug, and 72.6% of all reports.
Since the last update of the FDA data
The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:
- All species: from 24 to 33.
- Dog: from 20 to 27.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 33 reports that name amoxicillin: 27 dog, 6 cat, 0 horse, 0 other or not given.
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 8,680 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.
- Color, Abnormal[a product quality report, not a sign in an animal]29.1%2,528 reports
- Suspension, Abnormal[a product quality report, not a sign in an animal]16.5%1,431 reports
- Vomiting13.9%1,204 reports
- Anorexia[not eating]8.9%774 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]6.4%559 reports
- Depression[dull, quiet or withdrawn]6%519 reports
- Death5.8%504 reports
- Diarrhoea[diarrhea]5.7%494 reports
- Lethargy[unusually tired or inactive]4.8%418 reports
- Death by euthanasia[the animal was euthanized]4.6%400 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]4.4%379 reports
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]3.6%316 reports
- Underfilling, Package[a product quality report, not a sign in an animal]3.3%287 reports
- Seal, Abnormal[a product quality report, not a sign in an animal]3.2%282 reports
Show the next 16 signs
- Anaemia NOS[low red blood cell count]3.1%265 reports
- Weight loss2.9%256 reports
- Ataxia[unsteady, uncoordinated movement]2.9%254 reports
- Fever2.9%253 reports
- Leucocytosis NOS[high white blood cell count]2.8%239 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]2.7%237 reports
- Elevated total bilirubin[bilirubin above the normal range]2.6%225 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]2.4%212 reports
- Abnormal radiograph finding2.4%208 reports
- No sign[no clinical sign was reported]2.2%190 reports
- Convulsion[seizure]2%174 reports
- Dehydration2%173 reports
- Elevated creatinine[a kidney value above the normal range]2%172 reports
- Granules/Powder, Abnormal1.8%152 reports
- Polydipsia[drinking more than usual]1.7%151 reports
- Abnormal ultrasound finding1.6%143 reports
The list shows 30 of 1,501 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)
Reports by species
The share is of all 8,680 reports that name amoxicillin. The other reports give a different species or no species.
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
No chart: no month has 5 or more reports.
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
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 66 | 11 | 0 | 1 | 78 |
| 2025 | 187 | 35 | 0 | 4 | 226 |
| 2024 | 134 | 27 | 0 | 6 | 167 |
| 2023 | 75 | 23 | 0 | 1 | 99 |
| 2022 | 50 | 10 | 0 | 1 | 61 |
| 2021 | 67 | 10 | 0 | 6 | 83 |
| 2020 | 52 | 10 | 0 | 2 | 64 |
| 2019 | 56 | 18 | 0 | 4 | 78 |
| 2018 | 72 | 13 | 0 | 10 | 95 |
| 2017 | 80 | 17 | 0 | 8 | 105 |
| 2016 | 104 | 40 | 0 | 3 | 147 |
| 2015 | 72 | 20 | 0 | 9 | 101 |
| 2014 | 82 | 19 | 0 | 15 | 116 |
| 2013 | 113 | 28 | 0 | 7 | 148 |
| 2012 | 123 | 42 | 0 | 48 | 213 |
| 2011 | 157 | 85 | 0 | 315 | 557 |
| 2010 | 170 | 114 | 0 | 516 | 800 |
| 2009 | 154 | 132 | 0 | 1,377 | 1,663 |
| 2008 | 204 | 120 | 0 | 69 | 393 |
| 2007 | 237 | 136 | 0 | 72 | 445 |
| 2006 | 206 | 109 | 0 | 118 | 433 |
| 2005 | 112 | 73 | 0 | 182 | 367 |
| 2004 | 96 | 65 | 0 | 134 | 295 |
| 2003 | 69 | 60 | 0 | 125 | 254 |
| 2002 | 68 | 40 | 0 | 105 | 213 |
| 2001 | 99 | 60 | 0 | 132 | 291 |
| 2000 | 102 | 77 | 1 | 137 | 317 |
| 1999 | 112 | 53 | 0 | 91 | 256 |
| 1998 | 93 | 40 | 0 | 76 | 209 |
| 1997 | 35 | 23 | 0 | 27 | 85 |
| 1996 | 48 | 25 | 1 | 9 | 83 |
| 1995 | 9 | 11 | 0 | 4 | 24 |
| 1994 | 21 | 11 | 0 | 6 | 38 |
| 1993 | 26 | 22 | 0 | 5 | 53 |
| 1992 | 4 | 5 | 0 | 5 | 14 |
| 1991 | 5 | 10 | 0 | 4 | 19 |
| 1990 | 8 | 6 | 0 | 7 | 21 |
| 1989 | 3 | 12 | 0 | 2 | 17 |
| 1988 | 9 | 6 | 0 | 6 | 21 |
| 1987 | 9 | 5 | 0 | 17 | 31 |
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/Normal4.1%358
- Recovered with Sequela[recovered, with a lasting effect]0.3%26
- Ongoing6.1%526
- Died8.5%735
- Euthanized2.3%202
- Outcome Unknown4.4%381
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 8,680 reports that name amoxicillin.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue57.7%5,005
- Lack of expected effectiveness0.8%69
- Both safety and lack of expected effectiveness1.3%111
- Manufacturing or product defect40.3%3,494
- Otherunder 0.1%1
1,629 reports say if the event was serious. 60.7% 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 year9.5%826
- 1 to 3 years9.1%790
- 4 to 7 years11.6%1,004
- 8 to 11 years12.9%1,122
- 12 years and over11.5%1,001
- Age not given45.4%3,937
Weight of the animal
- Under 5 kg (11 lb)17.3%1,505
- 5 to 9.9 kg (11 to 22 lb)14%1,214
- 10 to 24.9 kg (22 to 55 lb)9.8%850
- 25 to 44.9 kg (55 to 99 lb)10%866
- 45 kg and over (99 lb and over)2.1%180
- Weight not given46.8%4,065
Breed, where the report gives one breed
- Domestic11%954
- Labrador Retriever3.8%327
- Domestic Shorthair2.2%192
- Chihuahua1.2%103
- Yorkshire Terrier1.2%102
- Golden Retriever1.1%97
- Poodle1.1%95
- Dachshund1.1%92
A breed with many animals has many reports.
Route in the report
- Oral49.9%4,334
- Intramammary0.8%66
- Subcutaneous0.6%52
- Intravenous0.3%27
- Intramuscular0.3%24
- Topical0.2%20
Each bar is on a scale of 0 to 100%.
Approved animal drugs with this active ingredient (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.
No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete. The approved products below have all the ingredients of this page and one or more other ingredients.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Kesium | Amoxicillin, Clavulanate Potassium | Ceva Sante Animale | Dogs, Cats | ANADA 200-749 |
Other pages with this ingredient
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
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.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
The site checked these addresses on . The links open in a new tab.
Cite this page
Pet Drug Reports. Amoxicillin: adverse event reports that FDA received. https://petdrugreports.com/drug/amoxicillin/ 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 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 lists no brand name for exactly this active ingredient.
- 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 186 reports in the 12 months to June 2026. It received 220 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 8,680 reports received from January 1987 to June 2026, 57.7% are about a safety issue only. 2.1% are about a lack of expected effectiveness, alone or with a safety issue. 40.3% are about a defect of the product or its package.