Reaction profile
The FDA adverse-event record for patient instructions for use on label confusing
647 FDA reports name patient instructions for use on label confusing, a high-volume reaction in the CVM extract (VeDDRA 93081). Plate stamps and neighbourhood peers follow.
- #541 of 2,481
- by report volume (all reactions)
- 647
- reports citing this reaction
- 0.3%
- 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. Patient instructions for use on label confusing has 647 reports now versus 633 in that prior snapshot: 14 more (2.2%).
- Report change
- +14
- 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 Patient instructions for use on label confusing changesFDA AER · VeDDRA plate
Code 93081 VOL-MID
VOL-MID · DEATH-RARE · UPPER-Q · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-WIDE · BOOK-FULL
- VOL-MID 647 reports
- DEATH-RARE 0.3%
- UPPER-Q #541/2481
- PHOTO-FINISH Temporary deafness
- SPECIES-UNKNOWN Unknown · 534
- DRUG-LEAD Nitenpyram · 259
- DESK-WIDE 20 breeds
- BOOK-FULL 8/8 fields
Nearest volume peer: Temporary deafness (±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 Patient instructions for use on label confusing
Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.
Patient instructions for use on label confusing: low death-coded share in the FDA AER plate
Signature read: Patient instructions for use on label confusing's 0.3% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 647 named reports in the openFDA extract. Death-coded share is lower-third: 2 of 647 reports (0.3% of named reports). Nearest volume peer: Temporary deafness (±0 reports). Lead species Unknown (534). Lead co-reported drug Nitenpyram (259).
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
Breeds Most Affected
Associated Drugs
Nationwide reactions with similar profiles
Two openFDA-derived peer sets for Patient instructions for use on label confusing, 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 (647 here).
Similar death-coded share
Nearest other reactions by death-coded share (0.3% here), distinct from the volume row.
What to do with this reaction
- Compare Patient instructions for use on label confusing'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 →