Pet Drug Reports

September 2016: 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 6,534 adverse event reports for animal drugs in September 2016. It received 6,402 reports in September 2015. The average of the 12 months before September 2016 is 6,192 reports for each month.

Of the 6,534 reports, 74% are about dogs, 8.7% are about cats and 0.9% 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.

Search engines do not list month pages. The site keeps the page, and the list of months links it.

The months before and after

Reports for each month, Mar 2015 to Mar 2017. The column with the outline is September 2016.

Reports by species

  • Dog74%4,833
  • Cat8.7%570
  • Horse0.9%59
  • Other species, or species not given16.4%1,072

Drug pages with reports received in September 2016

The table has every drug page with 10 or more reports that FDA received in September 2016, in order of name. No count decides which drug is in the table. The table has 75 drug pages.

Show the 75 drug pages
Drug pages with 10 or more reports received in September 2016, in order of name
Active ingredientsReports received in September 2016
(S) - methoprene24
Afoxolaner647
Amoxicillin17
Amoxicillin + Clavulanate Potassium26
Amoxicillin Trihydrate + Clavulanate Potassium14
Atipamezole Hydrochloride11
Buprenorphine16
Butorphanol Tartrate22
Carprofen121
Cefovecin sodium73
Cefpodoxime proxetil23
Cephalexin33
Cyclosporine84
Deracoxib25
Dexamethasone13
Dexmedetomidine hydrochloride39
Dinoprost Tromethamine10
Diphenhydramine30
Doxycycline10
Emodepside + Praziquantel31
Enalapril Maleate10
Enrofloxacin36
Eprinomectin13
Estradiol Benzoate + Trenbolone Acetate20
Estriol13
Famotidine26
Febantel + Praziquantel + Pyrantel Pamoate49
Fenbendazole16
Firocoxib25
Florfenicol + Mometasone furoate + Terbinafine272
Florfenicol + Terbinafine59
Fluralaner642
Furosemide15
Gabapentin12
Hydroxyzine10
Imidacloprid20
Imidacloprid + Moxidectin119
Insulin102
Isoflurane13
Ivermectin76
Ivermectin + Praziquantel22
Ivermectin + Pyrantel Pamoate836
Ketamine Hydrochloride13
Ketoconazole16
Levothyroxine sodium18
Lufenuron + Milbemycin Oxime207
Lufenuron + Praziquantel73
Maropitant56
Melarsomine Dihydrochloride93
Meloxicam53
Methylprednisolone Acetate13
Metronidazole21
Milbemycin Oxime78
Milbemycin Oxime + Praziquantel141
Milbemycin Oxime + Spinosad938
Mirtazapine12
Monensin17
Moxidectin138
Nitenpyram273
Oclacitinib396
Pegbovigrastim10
Pimobendan19
Polysulfated Glycosaminoglycan60
Praziquantel + Pyrantel Pamoate10
Prednisolone22
Prednisolone + Trimeprazine Tartrate18
Prednisone44
Pyrantel Pamoate18
Robenacoxib15
Sarolaner64
Selamectin242
Spinosad459
Sucralfate11
Tramadol25
Trilostane54

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 6,534 reports of the month.

The sign that is in the largest number of the reports comes first.

  1. Vomiting21.9%1,434 reports
  2. Lethargy[unusually tired or inactive]9%591 reports
  3. Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]6.3%410 reports
  4. Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]6%393 reports
  5. Diarrhoea[diarrhea]5.7%372 reports
  6. Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]5.4%352 reports
  7. Digestive tract disorder NOS[digestive problem, type not specified]4.5%296 reports
  8. Tubes, Leaking[a product quality report, not a sign in an animal]3.9%253 reports
  9. Unpalatable[legacy FDA term: the animal would not take it]3.2%212 reports
  10. Product problem[a product quality report, not a sign in an animal]3%194 reports
  11. Seizure NOS[seizure, type not specified]2.9%192 reports
  12. Lack of efficacy (ectoparasite) - NOS[the product did not have the expected effect: target not specified]2.9%189 reports
  13. Lack of efficacy - NOS[the product did not have the expected effect]2.8%184 reports
  14. Anorexia[not eating]2.8%182 reports
Show the next 1 signs
  1. Other abnormal test result NOS[abnormal laboratory result, type not specified]2.7%177 reports

Ingredients, all combinations

The list has every active ingredient with 10 or more reports received in September 2016, in order of name. It has 76 ingredients.

Show the 76 ingredients

The same month in other years

Cite this page

Pet Drug Reports. September 2016: adverse event reports for animal drugs. https://petdrugreports.com/month/2016-09/ 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 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 September 2016 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 1,434 reports of the 6,534 reports of September 2016 (21.9%).