Drug profile

The FDA adverse-event record for Sarolaner

17,358 FDA reports name Sarolaner, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#16 of 2,679
by report volume (all drugs)
17,358
adverse-event reports
3.1%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Sarolaner ranks #16 of 2679 by total reports (17,358) and #908 of 1130 by death-coded share (3.1%). 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)
#16
This drug, reports of 2679
#908
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. Sarolaner has 17,358 reports now versus 17,197 in that prior snapshot: 161 more (0.9%).

Report change
+161
Death-coded reports
+11
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 Sarolaner changes

Signature read: 17,358 reports place Sarolaner in the upper third of FDA AER volume (#16 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.
17,358
Total Reports
531
Deaths Reported
3.1%
Death-coded share of reports

Active Ingredients

Sarolaner

Administration Routes

OralUnknownTopicalSubcutaneousOphthalmicOtherIntradermalEndotrachealRectalRespiratory (Inhalation)

Species Affected

Dog 16,434
Unknown 645
Cat 251
Human 28

Most Affected Breeds

Retriever - Labrador 1,701
Dog (unknown) 1,326
Retriever - Golden 929
Chihuahua 777
Terrier - Yorkshire 747
Unknown 680
Shih Tzu 593
Shepherd Dog - German 559
Terrier - Bull - American Pit 470
Crossbred Canine/dog 434

Most Reported Reactions

Vomiting 3,858
Seizure NOS 2,852
Lethargy (see also Central nervous system depression in 'Neurological') 1,592
Tremor 1,393
Diarrhoea 1,342
Lack of efficacy (ectoparasite) - tick NOS 1,212
Lack of efficacy (ectoparasite) - flea 1,054
Ataxia 1,028
Lack of efficacy (tick) 850
Lack of efficacy (bacteria) - Borrelia 746
Anorexia 565
Twitching 557

Outcome Breakdown

Ongoing
6,997 (41.8%)
Outcome Unknown
5,147 (30.8%)
Recovered/Normal
4,049 (24.2%)
Died
286 (1.7%)
Euthanized
245 (1.5%)
Recovered with Sequela
14 (0.1%)

Sarolaner: 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 Sarolaner, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other drugs by FDA report count (17,358 here).

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 Sarolaner (#16 of 2,679 by report volume); death-coded 3.1%. PlainBreed drug row · report volume stamp 17,358 · 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 →