Reaction profile

The FDA adverse-event record for swollen tongue

306 FDA adverse-event reports reference swollen tongue (VeDDRA 1820). Plate codes and volume neighbourhood below; species, breeds, and drugs follow.

#861 of 2,481
by report volume (all reactions)
306
reports citing this reaction
10.1%
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 tongue has 306 reports now versus 303 in that prior snapshot: 3 more (1.0%).

Report change
+3
Death-coded reports
+0
Death-coded share
−0.1 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 tongue changes

FDA AER · VeDDRA plate

Code 1820 VOL-LOW

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

  • VOL-LOW 306 reports
  • DEATH-ELEV 10.1%
  • MID-PACK #861/2481
  • PHOTO-FINISH Dermal thickening
  • SPECIES-HORSE Horse · 128
  • DRUG-LEAD Ivermectin(1.55%)… · 73
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Dermal thickening (±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 Swollen tongue

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

Vomiting · highest174348Blood in faeces NOS · near307Dermal thickening · near306Swollen tongue · this reacti…306Increased bowel movem… · near305Increased seizure fre… · near305Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Swollen tongue

What the FDA AER plate says about Swollen tongue

Signature read: report volume at 306 (#861 of 2,481) is the standout scale stamp on Swollen tongue. Report volume sits in the middle third of the reaction corpus. 31 of 306 reports were death-coded (10.1% of named reports, not a population mortality rate). Nearest volume peer: Dermal thickening (±0 reports). Lead species Horse (128). Lead co-reported drug Ivermectin(1.55%)/Praziquantel(7.75%) Paste (73).

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

Horse 128
Dog 111
Cat 46
Human 16
Cattle 5

Breeds Most Affected

Quarter Horse 34
Domestic Shorthair 26
Horse (unknown) 24
Unknown 19
Thoroughbred 16
Retriever - Labrador 11
Paint 8
Terrier - Bull - American Pit 8
Crossbred Canine/dog 7
Shepherd Dog - German 6

Associated Drugs

Ivermectin(1.55%)/Praziquantel(7.75%) Paste 73
Ivermectin + Praziquantel 45
Moxidectin 25
Maropitant Citrate 17
Isoflurane 13
Butorphanol 11
Milbemycin Oxime + Spinosad 10
Cefovecin 10
Robenacoxib 9
Oclacitinib Maleate 9
Afoxolaner 8
Spinosad 7
Dexmedetomidine Hydrochloride 7
Dexamethasone 7
Buprenorphine 6
Selamectin 5
Prednisone 5
Diphenhydramine 5
Carprofen 5
Propofol 5

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Swollen tongue, both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar death-coded share

Nearest other reactions by death-coded share (10.1% 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 Swollen tongue (#861 of 2,481 by report volume); death-coded 10.1%. PlainBreed reaction plate · report volume stamp 306 · 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 →