Reaction profile

The FDA adverse-event record for drug label incomplete

37 FDA reports name drug label incomplete, a lower-volume reaction in the CVM extract (VeDDRA 99969). Plate stamps and neighbourhood peers follow.

#1892 of 2,481
by report volume (all reactions)
37
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. Drug label incomplete has 37 reports now versus 37 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
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 Drug label incomplete changes

FDA AER · VeDDRA plate

Code 99969 VOL-TRACE

VOL-TRACE · DEATH-RARE · LOWER-Q · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-NARROW · BOOK-FULL

  • VOL-TRACE 37 reports
  • DEATH-RARE 0.0%
  • LOWER-Q #1892/2481
  • PHOTO-FINISH Blistering of mouth
  • SPECIES-UNKNOWN Unknown · 37
  • DRUG-LEAD Nitenpyram · 11
  • DESK-NARROW 1 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Blistering of mouth (±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.

Lower-volume neighbourhood around Drug label incomplete

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

Vomiting · highest174348Blistering of mouth · near37CARBON DIOXIDE HIGH,… · near37Cartilage degeneration · near37Cleft palate · near37Drug label incomplete · this…37Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Drug label incomplete

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

Signature read: Drug label incomplete's 0.0% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is lower-third scale: 37 named reports in the openFDA extract. Death-coded share is lower-third: 0 of 37 reports (0.0% of named reports). Nearest volume peer: Blistering of mouth (±0 reports). Lead species Unknown (37). Lead co-reported drug Nitenpyram (11).

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 37

Breeds Most Affected

Unknown 37

Associated Drugs

Nitenpyram 11
Polysulfated Glycosaminoglycan 8
Robenacoxib 4
Grapiprant 3
Moxidectin + Pyrantel + Sarolaner 3
Tiamulin Hydrogen Fumarate 2
Afoxolaner 2
Cyclosporine 1
Ceftiofur Hydrochloride 1
Cloprostenol 263 Inj Cattle 1
Phenylpropanolamine 1
Device: Enteral Feeding 1
Oclacitinib 1
Imidacloprid 1
Phenylbutazone 1

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 incomplete (#1892 of 2,481 by report volume); death-coded 0.0%. PlainBreed reaction plate · death-coded share stamp 0.0% · 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 →