Oral swelling

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VeDDRA Code: 2444

126 adverse event reports referencing this reaction

126
Total Reports
9
Deaths
710.0%
Death Rate

Species Most Affected

Horse 98
Dog 23
Human 2
Cat 2
Donkey 1

Breeds Most Affected

Quarter Horse 27
Horse (unknown) 12
Thoroughbred 10
Paint 9
Boxer (German Boxer) 7
Unknown 5
Crossbred Equine/horse 5
Appaloosa 4
Tennessee Walking Horse 4
Horse (other) 4

Associated Drugs

Ivermectin + Praziquantel 55
Ivermectin(1.55%)/Praziquantel(7.75%) Paste 43
Bedinvetmab 4
Carprofen 3
Oclacitinib Maleate 3
Maropitant Citrate 3
Anti-Il31 Mab Mcs Lot #1283563 2
Milbemycin Oxime + Spinosad 2
Equine Influenza Virus, Killed Virus + Equine Rhinopneumonitis Virus, Killed Virus 2
Tigilanol Tiglate 2
Marbofloxacin 2
Galliprant 2
Amoxicillin (As Trihydrate); Clavulanate Potassium ( K-Clavulanate) 1
Penicillin 1
Dexmedetomidine Hydrochloride 1
Atipamezole Hydrochloride 1
Rabies Virus, Kv 1
Bordetella Bronchiseptica, Strain 78-9159, Kb 1
Canine Adenovirus Type 2, Strain Manhattan, 12-13-76; Canine Distemper Virus, St 1
Afoxolaner 1

Data Summary

Metric Value
Total reports referencing reaction 126
Reports with fatal outcome 9
Case-fatality rate (reported events) 710.0%
Species observed 5
Breeds observed 20
Drugs associated with reaction 20

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 2444.

Oral swelling Reaction Insights

The FDA Center for Veterinary Medicine database currently lists 126 adverse event reports that reference Oral swelling as a reaction term, including 9 reports with a death outcome — a 710.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 2444, the standardized veterinary dictionary used to normalize clinical signs across submitters. Because reports are voluntary and often describe multiple concurrent signs per animal, the volume here reflects reporting intensity rather than true incidence in the broader pet population.

Oral swelling appears most frequently in reports for Horse (98 reports), Dog (23 reports), Human (2 reports) — with Horse dominating at 98 entries. Within those species, the breeds most often named alongside this reaction are Quarter Horse (27), Horse (unknown) (12), Thoroughbred (10). These distributions are influenced both by underlying breed popularity and by how veterinarians and owners code a given clinical sign, so they should be interpreted as a reporting fingerprint rather than a pure susceptibility ranking.

The drugs most commonly co-reported with Oral swelling are Ivermectin + Praziquantel (55 reports), Ivermectin(1.55%)/Praziquantel(7.75%) Paste (43 reports), Bedinvetmab (4 reports), Carprofen (3 reports), with Ivermectin + Praziquantel appearing alongside this reaction in 55 submissions. Co-reporting does not establish that any specific product caused the reaction — FDA CVM data captures temporal association only. The value of these aggregates is in flagging which therapeutic classes appear repeatedly alongside a given clinical sign, so owners and veterinarians can ask targeted questions about medications currently in use.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial