September 2025: adverse event reports received

6,856 reports in the openFDA release of 28 Sep 2026

Read this first · FDA's caveat, in its words

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

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

Not veterinary advice. This site lists what was reported to FDA. For an animal that is unwell, contact a veterinarian.

6,856reports received

7,078same month a year earlier-3%

6,465monthly average, preceding 12 months

70.5%concern dogscats 17%

FDA's database holds 6,856 adverse event reports received in September 2025, against 7,078 in the same month a year earlier and a monthly average of 6,465 over the preceding 12 months.

70.5% of the month's reports concern dogs, 17% cats and 0.9% horses; the rest concern other species, exposed people, or give no species.

By active ingredient, the drugs named most often were pyrantel pamoate + sarolaner (950), fluralaner (818) and bedinvetmab (441), and the terms listed most often were vomiting (695), lack of efficacy (ectoparasite) - flea (631) and lethargy (512). Report volume has a seasonal shape, with more reports in the warmer months when parasite products are in heavier use.

The months around it

Drugs named most often, by active ingredient

Active ingredients recorded for the drug	Reports	Share of the month's reports
Pyrantel Pamoate + Sarolaner	950	13.9%
Fluralaner	818	11.9%
Bedinvetmab	441	6.4%
Afoxolaner + Moxidectin + Pyrantel Pamoate	432	6.3%
Ivermectin + Pyrantel Pamoate	426	6.2%
Moxidectin	349	5.1%
Oclacitinib	322	4.7%
Afoxolaner	247	3.6%
Lotilaner + Moxidectin + Praziquantel + Pyrantel Pamoate	225	3.3%
Milbemycin Oxime + Praziquantel	215	3.1%
Gabapentin	214	3.1%
Carprofen	177	2.6%
Velagliflozin	175	2.6%
Frunevetmab	169	2.5%
Maropitant	165	2.4%

Ordered by report count, which follows how widely each drug was in use. FDA states that these data cannot be used to estimate risk or to compare one product with another. Brand and manufacturer names are masked by FDA in these records.

Signs listed most often

Vomiting10.1%695
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]9.2%631
Lethargy[unusually tired or inactive]7.5%512
Lack of efficacy (endoparasite) - heartworm[the product did not have the expected effect: heartworm]7.2%497
Diarrhoea[diarrhea]6.7%460
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]6.2%425
Lack of efficacy - NOS[the product did not have the expected effect]5.8%398
Medication error NOS[a mistake in giving the product, type not specified]4.3%297
Seizure NOS[seizure, type not specified]3.6%244
Not eating3.4%232
Lack of efficacy (bacteria) - Borrelia[the product did not have the expected effect: Borrelia (Lyme disease bacteria)]3%208
Death3%206
Intentional misuse[use that was knowingly different from the label]2.8%195
Death by euthanasia[the animal was euthanized]2.7%188
Weight loss2.6%178

Single ingredients, pooled

Pyrantel Pamoate30.2%2,069

Sarolaner17.2%1,176

Moxidectin16.5%1,132

Fluralaner12.9%884

Praziquantel10%689

Afoxolaner9.7%667

Ivermectin6.8%467

Bedinvetmab6.4%441

Milbemycin Oxime6.1%416

Lotilaner5.3%366

Oclacitinib4.7%322

Gabapentin3.1%214

Species

Dog70.5%4,835

Cat17%1,166

Horse0.9%59

Other or not given11.6%796

Questions about September 2025

How many animal drug adverse event reports did FDA receive in September 2025?

6,856 reports are in the openFDA release of 28 Sep 2026. The same month a year earlier has 7,078.

Which drugs were named most often?

By active ingredient: pyrantel pamoate + sarolaner (950), fluralaner (818), bedinvetmab (441), afoxolaner + moxidectin + pyrantel pamoate (432) and ivermectin + pyrantel pamoate (426). Brands are masked in the public data.

Which signs were listed most often?

vomiting (695), lack of efficacy (ectoparasite) - flea (631), lethargy (512), lack of efficacy (endoparasite) - heartworm (497) and diarrhoea (460).

Can the count for a month still change?

Yes. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Older months change little.

Does a busy month mean something went wrong that month?

Not by itself. The date is when FDA received the report, not when the event happened, and volume follows season, product launches and publicity. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources."

Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 30 Sep 2026. The month is the date FDA first received the report, not the date of the event. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.