December 2003: adverse event reports that FDA received
Month in which FDA received the reports
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 .
FDA received 1,063 adverse event reports for animal drugs in December 2003. It received 807 reports in December 2002. The average of the 12 months before December 2003 is 1,118 reports for each month.
Of the 1,063 reports, 61.5% are about dogs, 10.5% are about cats and 3% are about horses. The other reports are about other species, or give no species. A report is not proof that a drug caused a sign.
This month is more than 24 months before the newest month in the data. The site keeps the page and keeps it out of search engines.
The months before and after
Reports by species
- Dog61.5%654
- Cat10.5%112
- Horse3%32
- Other species, or species not given24.9%265
Drug pages with reports received in December 2003
The table has every drug page with 10 or more reports that FDA received in December 2003, in order of name. No count decides which drug is in the table. The table has 23 drug pages.
| Active ingredients | Reports received in December 2003 |
|---|---|
| Amoxicillin | 24 |
| Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate | 11 |
| Carprofen | 103 |
| Clomipramine Hydrochloride | 18 |
| Deracoxib | 131 |
| Desoxycorticosterone Pivalate | 10 |
| Enrofloxacin | 16 |
| Ivermectin | 37 |
| Ivermectin + Praziquantel | 26 |
| Ivermectin + Pyrantel Pamoate | 44 |
| Ketamine Hydrochloride | 15 |
| Lufenuron | 11 |
| Lufenuron + Milbemycin Oxime | 11 |
| Medetomidine | 12 |
| Melarsomine Dihydrochloride | 26 |
| Meloxicam | 31 |
| Milbemycin Oxime | 42 |
| Monensin | 11 |
| Moxidectin | 105 |
| Selamectin | 53 |
| Selegiline Hydrochloride | 20 |
| Tepoxalin | 48 |
| Tilmicosin Phosphate | 26 |
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 of the month 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 1,063 reports of the month.
The sign that is in the largest number of the reports comes first.
- Vomiting13.9%148 reports
- Depression[dull, quiet or withdrawn]13.8%147 reports
- Anorexia[not eating]12.5%133 reports
- Death11.1%118 reports
- Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]8.5%90 reports
- Accidental exposure[exposure that was not intended]8.4%89 reports
- Diarrhoea[diarrhea]7.8%83 reports
- Death by euthanasia[the animal was euthanized]6.2%66 reports
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]5.6%59 reports
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]5.4%57 reports
- Ataxia[unsteady, uncoordinated movement]5.1%54 reports
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.5%48 reports
- Anaphylaxis[sudden severe allergic-type reaction]4.1%44 reports
- Unclassifiable adverse event[event that fits no dictionary term]3.8%40 reports
Show the next 1 signs
- Anaemia NOS[low red blood cell count]3.7%39 reports
Ingredients, all combinations
The list has every active ingredient with 10 or more reports received in December 2003, in order of name. It has 24 ingredients.
- Amoxicillin
- Betamethasone Valerate
- Carprofen
- Clomipramine Hydrochloride
- Clotrimazole
- Deracoxib
- Desoxycorticosterone Pivalate
- Enrofloxacin
- Gentamicin Sulfate
- Ivermectin
- Ketamine Hydrochloride
- Lufenuron
- Medetomidine
- Melarsomine Dihydrochloride
- Meloxicam
- Milbemycin Oxime
- Monensin
- Moxidectin
- Praziquantel
- Pyrantel Pamoate
- Selamectin
- Selegiline Hydrochloride
- Tepoxalin
- Tilmicosin Phosphate
The same month in other years
Cite this page
Pet Drug Reports. December 2003: adverse event reports for animal drugs. https://petdrugreports.com/month/2003-12/ 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 month is the month in which FDA received the report, not the month of the event.
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 month
- Can the count for December 2003 change?
Yes. 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.
- Does the month show when the event occurred?
No. The month is the month in which FDA received the report. The event can be from an earlier month.
- Which sign is in the largest number of the reports of the month?
"Vomiting" is in 148 reports of the 1,063 reports of December 2003 (13.9%).