Drug profile

The FDA adverse-event record for Flea Shampoo

455 FDA reports name Flea Shampoo, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#323 of 2,679
by report volume (all drugs)
455
adverse-event reports
1.3%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Flea Shampoo ranks #323 of 2679 by total reports (455) and #1045 of 1130 by death-coded share (1.3%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#323
This drug, reports of 2679
#1045
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Flea Shampoo has 455 reports now versus 454 in that prior snapshot: 1 more (0.2%).

Report change
+1
Death-coded reports
+0
Death-coded share
−0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Flea Shampoo changes

Signature read: 455 reports place Flea Shampoo in the upper third of FDA AER volume (#323 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
455
Total Reports
6
Deaths Reported
1.3%
Death-coded share of reports

Active Ingredients

Flea Shampoo

Administration Routes

TopicalCutaneousUnknownImmersionOral

Species Affected

Dog 367
Cat 87
Human 1

Most Affected Breeds

Chihuahua 51
Domestic Shorthair 36
Dog (unknown) 32
Crossbred Canine/dog 30
Terrier - Yorkshire 22
Shih Tzu 21
Retriever - Labrador 21
Maltese 13
Pit Bull 11
Dachshund (unspecified) 10

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 268
Lack of efficacy (flea) 83
Pruritus 42
Lack of efficacy - NOS 29
Lethargy (see also Central nervous system depression in 'Neurological') 27
Vomiting 21
Itching 20
Scratching 19
Behavioural disorder NOS 17
Emesis 15
Overdose 11
Diarrhoea 11

Outcome Breakdown

Outcome Unknown
328 (72.1%)
Ongoing
61 (13.4%)
Recovered/Normal
51 (11.2%)
Recovered with Sequela
9 (2.0%)
Died
5 (1.1%)
Euthanized
1 (0.2%)

Flea Shampoo: low death-coded share in the FDA AER row

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Flea Shampoo, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Flea Shampoo (#323 of 2,679 by report volume); death-coded 1.3%. PlainBreed drug row · report volume stamp 455 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →