Reaction profile
The FDA adverse-event record for swollen mouth
367 FDA reports name swollen mouth, a high-volume reaction in the CVM extract (VeDDRA 1819). Plate stamps and neighbourhood peers follow.
- #785 of 2,481
- by report volume (all reactions)
- 367
- reports citing this reaction
- 0.3%
- death-coded share
- Horse
- 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. Swollen mouth has 367 reports now versus 365 in that prior snapshot: 2 more (0.5%).
- Report change
- +2
- 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 Swollen mouth changesFDA AER · VeDDRA plate
Code 1819 VOL-LOW
VOL-LOW · DEATH-RARE · MID-PACK · PHOTO-FINISH · SPECIES-HORSE · DRUG-LEAD · DESK-WIDE · BOOK-FULL
- VOL-LOW 367 reports
- DEATH-RARE 0.3%
- MID-PACK #785/2481
- PHOTO-FINISH Administration device…
- SPECIES-HORSE Horse · 297
- DRUG-LEAD Ivermectin(1.55%)… · 211
- DESK-WIDE 20 breeds
- BOOK-FULL 8/8 fields
Nearest volume peer: Administration device NOS, malfunction (±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 Swollen mouth
Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.
Swollen mouth: low death-coded share in the FDA AER plate
Signature read: Swollen mouth's 0.3% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 367 named reports in the openFDA extract. Death-coded share is lower-third: 1 of 367 reports (0.3% of named reports). Nearest volume peer: Administration device NOS, malfunction (±0 reports). Lead species Horse (297). Lead co-reported drug Ivermectin(1.55%)/Praziquantel(7.75%) Paste (211).
Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Ivermectin(1.55%)/Praziquantel(7.75%) Paste 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 Swollen mouth, 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 (367 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 Swollen mouth'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 →