Reaction profile
The FDA adverse-event record for product label information incorrect
169 FDA adverse-event reports reference product label information incorrect (VeDDRA 99856). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.
- #1131 of 2,481
- by report volume (all reactions)
- 169
- reports citing this reaction
- 0.0%
- 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. Product label information incorrect has 169 reports now versus 156 in that prior snapshot: 13 more (8.3%).
- Report change
- +13
- 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 Product label information incorrect changesFDA AER · VeDDRA plate
Code 99856 VOL-LOW
VOL-LOW · DEATH-RARE · MID-PACK · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-WIDE · BOOK-FULL
- VOL-LOW 169 reports
- DEATH-RARE 0.0%
- MID-PACK #1131/2481
- PHOTO-FINISH Administration device…
- SPECIES-UNKNOWN Unknown · 151
- DRUG-LEAD Selamectin · 17
- DESK-WIDE 15 breeds
- BOOK-FULL 8/8 fields
Nearest volume peer: Administration device NOS, damaged (±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 Product label information incorrect
Highest and lowest poles plus nearest volume peers, not a full 2,500-reaction corpus board reprint.
Product label information incorrect: low death-coded share in the FDA AER plate
Signature read: Product label information incorrect's 0.0% 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: 0 of 169 reports (0.0% of named reports). Nearest volume peer: Administration device NOS, damaged (±0 reports). Lead species Unknown (151). Lead co-reported drug Selamectin (17).
Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Selamectin 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
Breeds Most Affected
Associated Drugs
Nationwide reactions with similar profiles
Two openFDA-derived peer sets for Product label information incorrect, 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 (169 here).
Similar death-coded share
Nearest other reactions by death-coded share (0.0% here), distinct from the volume row.
What to do with this reaction
- Compare Product label information incorrect's report profile against similar reactions nationwide. See similar reactions
- Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
- Browse the full reaction directory to compare report counts across reaction types. All reactions
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
Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →