Reaction profile

The FDA adverse-event record for drug label confusion

254 FDA adverse-event reports reference drug label confusion (VeDDRA 3206). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#930 of 2,481
by report volume (all reactions)
254
reports citing this reaction
2.0%
death-coded share
Unknown
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. Drug label confusion has 254 reports now versus 249 in that prior snapshot: 5 more (2.0%).

Report change
+5
Death-coded reports
+1
Death-coded share
+0.4 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 Drug label confusion changes

FDA AER · VeDDRA plate

Code 3206 VOL-LOW

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

  • VOL-LOW 254 reports
  • DEATH-LOW 2.0%
  • MID-PACK #930/2481
  • PHOTO-FINISH Constricted pupils
  • SPECIES-UNKNOWN Unknown · 172
  • DRUG-LEAD Nitenpyram · 163
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Constricted pupils (±0 reports)

Instrument codes from this reaction’s FDA CVM adverse-event extract: volume band, death-coded share, corpus rank, photo-finish peer, lead species, lead drug, breed desk, and book completeness. Not a clinical diagnosis.

Report-volume neighbourhood around Drug label confusion

Highest and lowest poles plus nearest volume peers, not a full 2,500-reaction corpus board reprint.

Vomiting · highest174348Drug dispensing error · near255Constricted pupils · near254Drug label confusion · this …254Hearing affected · near254Cardiorespiratory arr… · near253Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Drug label confusion

Drug label confusion: low death-coded share in the FDA AER plate

Signature read: Drug label confusion's 2.0% death-coded share is among the lowest in the openFDA reaction corpus. Report volume sits in the middle third of the reaction corpus. Death-coded share is lower-third: 5 of 254 reports (2.0% of named reports). Nearest volume peer: Constricted pupils (±0 reports). Lead species Unknown (172). Lead co-reported drug Nitenpyram (163).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Nitenpyram 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

Unknown 172
Dog 63
Cat 15
Human 1
Cattle 1
Other 1
Marsupial 1

Breeds Most Affected

Unknown 174
Chihuahua 11
Domestic Shorthair 10
Dog (unknown) 8
Crossbred Canine/dog 7
Pit Bull 4
Spitz - German Pomeranian 4
Terrier (unspecified) 3
Shih Tzu 3
Terrier - Jack Russell 2

Associated Drugs

Nitenpyram 163
Milbemycin Oxime + Praziquantel 9
Imidacloprid 9
Milbemycin Oxime + Spinosad 8
Spinosad 8
Ivermectin 7
Praziquantel 6
Heartworm Prevention (Unknown) 4
Robenacoxib 4
Betamethasone + Florfenicol + Terbinafine 4
Lotilaner 4
Flea Collar 3
Grapiprant 3
Levothyroxine Sodium 3
Flea Product (Unknown) 2
Flea Shampoo 2
Milbemycin Oxime 2
Ivermectin + Pyrantel As Pamoate Salt 2
Febantel + Praziquantel + Pyrantel Pamoate 2
Cloprostenol Sodium 1

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Drug label confusion, 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 (254 here).

Similar death-coded share

Nearest other reactions by death-coded share (2.0% 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 Drug label confusion (#930 of 2,481 by report volume); death-coded 2.0%. PlainBreed reaction plate · death-coded share stamp 2.0% · 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 →