Reaction profile

The FDA adverse-event record for somnolence

402 FDA reports name somnolence, a high-volume reaction in the CVM extract (VeDDRA 110). Plate stamps and neighbourhood peers follow.

#725 of 2,481
by report volume (all reactions)
402
reports citing this reaction
9.7%
death-coded share
Dog
most-affected species

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. Somnolence has 402 reports now versus 401 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 Somnolence changes

FDA AER · VeDDRA plate

Code 110 VOL-LOW

VOL-LOW · DEATH-PAR · MID-PACK · PHOTO-FINISH · SPECIES-DOG · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-LOW 402 reports
  • DEATH-PAR 9.7%
  • MID-PACK #725/2481
  • PHOTO-FINISH Drooping eyelid
  • SPECIES-DOG Dog · 329
  • DRUG-LEAD Milbemycin Oxime… · 101
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Drooping eyelid (±0 reports)

Upper-third report volume drives the scale stamps on this plate; death-coded share and co-report peers follow. Not a clinical diagnosis.

High-volume neighbourhood around Somnolence

Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.

Vomiting · highest174348Focal seizure · near404Drooping eyelid · near402Somnolence · this reaction402Increased red blood c… · near401Skin warmth · near400Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Somnolence

What the FDA AER plate says about Somnolence

Signature read: 402 reports place Somnolence in the upper third of FDA AER volume (#725 of 2,481). Report volume is upper-third scale: 402 named reports in the openFDA extract. 39 of 402 reports were death-coded (9.7% of named reports, not a population mortality rate). Nearest volume peer: Drooping eyelid (±0 reports). Lead species Dog (329). Lead co-reported drug Milbemycin Oxime + Spinosad (101).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Milbemycin Oxime + Spinosad appears in filings alongside this reaction; that is association, not causation. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Dog 329
Cat 63
Horse 4
Cattle 3
Chicken 2
Human 1

Breeds Most Affected

Crossbred Canine/dog 32
Retriever - Labrador 27
Retriever - Golden 20
Domestic (unspecified) 20
Domestic Shorthair 20
Boxer (German Boxer) 17
Chihuahua 16
Shih Tzu 13
Spitz - German Pomeranian 12
Poodle (unspecified) 11

Associated Drugs

Milbemycin Oxime + Spinosad 101
Spinosad 40
Ivermectin 15
Carprofen 13
Maropitant 11
Oclacitinib Maleate 11
Afoxolaner 11
Maropitant Citrate 9
Buprenorphine 9
Gabapentin 9
Nitenpyram 8
Cyclosporine 8
Ivermectin + Pyrantel As Pamoate Salt 7
Fluralaner Chew Tablets 7
Robenacoxib 7
Grapiprant 7
Pyrantel Pamoate;Sarolaner 7
Firocoxib 6
Imidacloprid, Moxidectin 6
Fenbendazole 6

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Somnolence, both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar report volume

Nearest other reactions by FDA report count (402 here).

Similar death-coded share

Nearest other reactions by death-coded share (9.7% here), distinct from the volume row.

What to do with this reaction

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 Somnolence (#725 of 2,481 by report volume); death-coded 9.7%. PlainBreed reaction plate · report volume stamp 402 · 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 →