Pet Drug Reports

August 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 7,511 adverse event reports for animal drugs in August 2016. It received 6,516 reports in August 2015. The average of the 12 months before August 2016 is 6,109 reports for each month.

Of the 7,511 reports, 78.1% are about dogs, 8.6% are about cats and 0.7% 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, Feb 2015 to Feb 2017. The column with the outline is August 2016.

Reports by species

  • Dog78.1%5,865
  • Cat8.6%649
  • Horse0.7%52
  • Other species, or species not given12.6%945

Drug pages with reports received in August 2016

The table has every drug page with 10 or more reports that FDA received in August 2016, in order of name. No count decides which drug is in the table. The table has 83 drug pages.

Show the 83 drug pages
Drug pages with 10 or more reports received in August 2016, in order of name
Active ingredientsReports received in August 2016
(S) - methoprene35
Acepromazine Maleate16
Afoxolaner862
Amoxicillin13
Amoxicillin + Clavulanate Potassium27
Amoxicillin Trihydrate + Clavulanate Potassium13
Atipamezole Hydrochloride13
Atropine12
Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate16
Buprenorphine27
Butorphanol Tartrate36
Carprofen114
Cefovecin sodium82
Cefpodoxime proxetil33
Ceftiofur Crystalline Free Acid11
Cephalexin31
Clindamycin13
Cyclosporine98
Deracoxib26
Desoxycorticosterone Pivalate11
Dexamethasone19
Dexmedetomidine hydrochloride52
Diphenhydramine41
Doxycycline16
Emodepside + Praziquantel38
Enalapril Maleate16
Enrofloxacin31
Estradiol Benzoate + Trenbolone Acetate21
Estriol19
Famotidine23
Febantel + Praziquantel + Pyrantel Pamoate40
Firocoxib44
Florfenicol + Mometasone furoate + Terbinafine73
Florfenicol + Terbinafine63
Fluralaner776
Furosemide13
Gabapentin15
Hyaluronate Sodium10
Hydroxyzine11
Imidacloprid33
Imidacloprid + Moxidectin140
Insulin107
Isoflurane13
Ivermectin91
Ivermectin + Praziquantel + Pyrantel Pamoate15
Ivermectin + Pyrantel Pamoate1,073
Ketamine Hydrochloride19
Ketoconazole21
Levetiracetam10
Levothyroxine sodium24
Lufenuron + Milbemycin Oxime189
Lufenuron + Praziquantel124
Marbofloxacin13
Maropitant82
Melarsomine Dihydrochloride112
Meloxicam52
Methylprednisolone Acetate14
Metronidazole29
Milbemycin Oxime74
Milbemycin Oxime + Praziquantel164
Milbemycin Oxime + Spinosad1,170
Monensin21
Moxidectin138
Nitenpyram308
Oclacitinib423
Omeprazole14
Phenobarbital17
Pimobendan31
Polysulfated Glycosaminoglycan80
Praziquantel10
Praziquantel + Pyrantel Pamoate11
Prednisolone25
Prednisolone + Trimeprazine Tartrate22
Prednisone58
Propofol17
Pyrantel Pamoate35
Robenacoxib19
Sarolaner67
Selamectin292
Spinosad510
Tramadol34
Trilostane80
Tulathromycin10

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 7,511 reports of the month.

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

  1. Vomiting23.6%1,771 reports
  2. Lethargy[unusually tired or inactive]9.3%695 reports
  3. Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]7%523 reports
  4. Diarrhoea[diarrhea]6.3%470 reports
  5. Ineffective, heartworm larvae[legacy FDA term: the product did not have the expected effect (heartworm larvae)]6%453 reports
  6. Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]5.4%402 reports
  7. Digestive tract disorder NOS[digestive problem, type not specified]4.5%338 reports
  8. Lack of efficacy (ectoparasite) - NOS[the product did not have the expected effect: target not specified]3.5%265 reports
  9. Anorexia[not eating]3.2%240 reports
  10. Product problem[a product quality report, not a sign in an animal]2.9%219 reports
  11. Unpalatable[legacy FDA term: the animal would not take it]2.9%215 reports
  12. Lack of efficacy - NOS[the product did not have the expected effect]2.8%209 reports
  13. Seizure NOS[seizure, type not specified]2.6%198 reports
  14. Behavioural disorder NOS[behaviour change, type not specified]2.6%196 reports
Show the next 1 signs
  1. Emesis[vomiting]2.5%186 reports

Ingredients, all combinations

The list has every active ingredient with 10 or more reports received in August 2016, in order of name. It has 85 ingredients.

Show the 85 ingredients

The same month in other years

Cite this page

Pet Drug Reports. August 2016: adverse event reports for animal drugs. https://petdrugreports.com/month/2016-08/ 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 August 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 1,771 reports of the 7,511 reports of August 2016 (23.6%).