Cefpodoxime proxetil (Simplicef): adverse event reports that FDA received
Active ingredient
The name in brackets is a brand name with 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 October 2004 to June 2026, FDA received 4,248 adverse event reports that name a drug with cefpodoxime proxetil as its active ingredient. Of the 4,248 reports, 4,055 (95.5%) are about dogs. 87 reports are about cats (2%).
In January to March 2026, FDA received 88 reports that name this drug. The signs that appear in the largest number of the 4,248 reports are "Vomiting", "Lethargy" and "Anorexia". A report is not proof that a drug caused a sign.
Reports that name this drug rose by 17.6% 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 95.5% 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 80 to 88.
- Dog: from 79 to 87.
January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 88 reports that name cefpodoxime proxetil: 87 dog, 1 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 4,248 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.
- Vomiting17.3%737 reports
- Lethargy[unusually tired or inactive]14%595 reports
- Anorexia[not eating]9.2%390 reports
- Diarrhoea[diarrhea]7.9%337 reports
- Lack of efficacy - NOS[the product did not have the expected effect]7.7%325 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]6.3%266 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]6.1%260 reports
- Emesis[vomiting]6%256 reports
- Death by euthanasia[the animal was euthanized]5.6%239 reports
- Seizure NOS[seizure, type not specified]5.2%220 reports
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]4.6%197 reports
- Death4.4%187 reports
- Pruritus[itching]4.1%175 reports
- Depression[dull, quiet or withdrawn]4.1%173 reports
Show the next 16 signs
- Polydipsia[drinking more than usual]4%172 reports
- Ataxia[unsteady, uncoordinated movement]4%168 reports
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]3.9%164 reports
- Polyuria[passing more urine than usual]3.8%163 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]3.8%161 reports
- Weight loss3.7%158 reports
- Fever3.6%151 reports
- Anaemia NOS[low red blood cell count]3.5%150 reports
- Decreased appetite3.4%143 reports
- Leucocytosis NOS[high white blood cell count]3.2%136 reports
- Not eating3.1%131 reports
- Elevated creatinine[a kidney value above the normal range]2.9%125 reports
- Behavioural disorder NOS[behaviour change, type not specified]2.9%124 reports
- Abnormal radiograph finding2.8%121 reports
- Skin lesion NOS[NOS: not otherwise specified]2.8%119 reports
- Abnormal ultrasound finding2.7%114 reports
The list shows 30 of 1,472 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 4,248 reports that name cefpodoxime proxetil. 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.
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 | 148 | 2 | 0 | 2 | 152 |
| 2025 | 337 | 8 | 0 | 2 | 347 |
| 2024 | 244 | 3 | 0 | 6 | 253 |
| 2023 | 158 | 3 | 0 | 6 | 167 |
| 2022 | 128 | 2 | 0 | 5 | 135 |
| 2021 | 146 | 1 | 0 | 5 | 152 |
| 2020 | 159 | 0 | 0 | 7 | 166 |
| 2019 | 179 | 6 | 0 | 4 | 189 |
| 2018 | 216 | 4 | 0 | 7 | 227 |
| 2017 | 280 | 3 | 0 | 9 | 292 |
| 2016 | 314 | 5 | 0 | 3 | 322 |
| 2015 | 280 | 3 | 0 | 6 | 289 |
| 2014 | 256 | 5 | 0 | 4 | 265 |
| 2013 | 239 | 5 | 0 | 3 | 247 |
| 2012 | 228 | 4 | 0 | 6 | 238 |
| 2011 | 106 | 3 | 0 | 4 | 113 |
| 2010 | 83 | 7 | 0 | 5 | 95 |
| 2009 | 80 | 2 | 0 | 6 | 88 |
| 2008 | 122 | 5 | 0 | 11 | 138 |
| 2007 | 131 | 8 | 0 | 2 | 141 |
| 2006 | 106 | 5 | 0 | 2 | 113 |
| 2005 | 93 | 2 | 1 | 0 | 96 |
| 2004 | 22 | 1 | 0 | 0 | 23 |
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/Normal21.2%900
- Recovered with Sequela[recovered, with a lasting effect]1.1%45
- Ongoing35.9%1,524
- Died6%256
- Euthanized4.4%186
- Outcome Unknown15%637
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 4,248 reports that name cefpodoxime proxetil.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue84.1%3,573
- Lack of expected effectiveness5.6%238
- Both safety and lack of expected effectiveness7.2%306
- Manufacturing or product defect3%128
- Other0.1%3
3,368 reports say if the event was serious. 44% 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 year6.7%283
- 1 to 3 years18.1%769
- 4 to 7 years28.8%1,224
- 8 to 11 years27.2%1,157
- 12 years and over14.1%599
- Age not given5.1%216
Weight of the animal
- Under 5 kg (11 lb)5.9%250
- 5 to 9.9 kg (11 to 22 lb)19.4%824
- 10 to 24.9 kg (22 to 55 lb)28.6%1,214
- 25 to 44.9 kg (55 to 99 lb)34.6%1,469
- 45 kg and over (99 lb and over)5.3%226
- Weight not given6.2%265
Breed, where the report gives one breed
- Labrador Retriever8.9%378
- Golden Retriever4.3%184
- German Shepherd Dog3.6%155
- Shih Tzu2.5%106
- Bulldog2.3%98
- Boxer2.1%89
- American Pit Bull Terrier1.8%78
- French Bulldog1.7%73
A breed with many animals has many reports.
Route in the report
- Oral77.4%3,289
- Subcutaneous0.1%5
- Topical0.1%4
- Ophthalmicunder 0.1%2
- Otherunder 0.1%2
- Parenteralunder 0.1%2
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.
Brand names
- Simplicef
What the Green Book records give
- Applications with an approval in force
- 3
- Approved species
- Dogs
- Dose forms
- Tablet, Tablet and Chewable Tablet
- Routes
- Oral
- Sale
- RX (prescription)
- Earliest approval date in the records
The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Simplicef | Cefpodoxime proxetil | Zoetis Inc. | Dogs | NADA 141-232 |
| Cefpodoxime Proxetil Tablets | Cefpodoxime proxetil | Dechra Veterinary Products LLC | Dogs | ANADA 200-543 |
| Cefpodoxime Proxetil Tablets | Cefpodoxime proxetil | Felix Pharmaceuticals Pvt. Ltd. | Dogs | ANADA 200-815 |
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.
- Green Book record of NADA 141-232The FDA record of the application for Simplicef.
- Green Book record of ANADA 200-543The FDA record of the application for Cefpodoxime Proxetil Tablets.
- Green Book record of ANADA 200-815The FDA record of the application for Cefpodoxime Proxetil Tablets.
- 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. Cefpodoxime proxetil: adverse event reports that FDA received. https://petdrugreports.com/drug/cefpodoxime-proxetil/ 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 section of this page lists the brand names with 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 340 reports in the 12 months to June 2026. It received 289 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 4,248 reports received from October 2004 to June 2026, 84.1% are about a safety issue only. 12.8% are about a lack of expected effectiveness, alone or with a safety issue. 3% are about a defect of the product or its package.