Injection site swelling: in adverse event reports for animal drugs

Clinical sign, a VeDDRA term

In plain words: swelling where the injection was given.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarian How to report to FDA

From January 1987 to June 2026, FDA received 8,528 adverse event reports for animal drugs that list this sign. That is 0.6% of the 1,378,761 reports that FDA received from January 1987 to June 2026. In the 12 months to June 2026, FDA received 435 reports that list this sign.

Of the 8,528 reports, 61.7% are about dogs. A report can list more than one sign and more than one drug. A report is not proof that a drug caused a sign.

By number of reports in all years, this sign is number 78 of 1,149 clinical signs with a page. Reports that list this sign fell by 9.8% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about cattle are 13.8% of the reports that list this sign, and 2.3% of all reports.

Drug pages with reports that list this sign

The table has every drug page with 20 or more reports that list this sign, in order of name. No count decides which drug is in the table. The table has 80 drug pages.

Show the 80 drug pages

Drug pages with 20 or more reports that list this sign, in order of name
Active ingredients	Reports that list the sign
Acepromazine Maleate	68
Afoxolaner	62
Amoxicillin	28
Amoxicillin + Clavulanate Potassium	21
Amoxicillin Trihydrate + Clavulanate Potassium	33
Ampicillin Trihydrate	30
Atipamezole Hydrochloride	142
Bedinvetmab	101
Bupivacaine	45
Buprenorphine	105
Butorphanol Tartrate	280
Carprofen	601
Cefovecin sodium	117
Cefpodoxime proxetil	26
Ceftiofur Crystalline Free Acid	475
Clorsulon + Ivermectin	24
Desoxycorticosterone Pivalate	54
Detomidine Hydrochloride	21
Dexamethasone	65
Dexmedetomidine	144
Dexmedetomidine hydrochloride	85
Dinoprost Tromethamine	188
Diphenhydramine	227
Doramectin	52
Doramectin + Levamisole Hydrochloride	22
Doxycycline	63
Enrofloxacin	129
Eprinomectin	32
Famotidine	145
Fenprostalene	31
Firocoxib	33
Florfenicol	47
Flunixin Meglumine	123
Fluralaner	45
Frunevetmab	23
Gabapentin	214
Gamithromycin	48
Hyaluronate Sodium	41
Hydromorphone	68
Imidocarb Dipropionate	23
Insulin	34
Isoflurane	72
Ivermectin	110
Ivermectin + Pyrantel Pamoate	139
Ketamine Hydrochloride	52
Lidocaine	24
Lotilaner	26
Lufenuron	89
Maropitant	285
Medetomidine	20
Melarsomine Dihydrochloride	2,302
Meloxicam	94
Methylprednisolone Acetate	36
Metronidazole	33
Midazolam	59
Milbemycin Oxime + Praziquantel	39
Moxidectin	694
Oclacitinib	37
Omeprazole	30
Oxytetracycline	139
Penicillin G Benzathine + Penicillin G Procaine	39
Penicillin G Procaine	26
Pentosan polysulfate sodium	65
Polysulfated Glycosaminoglycan	120
Praziquantel	86
Prednisolone	34
Prednisone	278
Propofol	100
Pyrantel Pamoate	26
Robenacoxib	59
Selamectin	20
Tigilanol tiglate	704
Tildipirosin	24
Tilmicosin	31
Tilmicosin Phosphate	241
Tramadol	55
Trazodone	55
Tulathromycin	114
Tylosin	38
Vitamin E	35

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. A report can name more than one drug.

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

Ingredients, all combinations

The list has every active ingredient with 20 or more reports that list this sign, in order of name. It has 83 ingredients.

Show the 83 ingredients

Reports by species

Dog61.7%5,258
Cattle13.8%1,181
Horse11.9%1,018
Human exposure7.8%668
Cat3.8%320
Pig0.3%26

The share is of the 8,528 reports that list this sign. The sign is in 0.5% of all reports about the species dog. The sign is in 3.8% of all reports about the species cattle.

Reports by month and by year

Reports for each month, Jul 2021 to Jun 2026. The month is the month in which FDA received the report.

FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports that list Injection site swelling, by the year in which FDA received them
Year	Reports
2026	197
2025	471
2024	525
2023	459
2022	439
2021	345
2020	318
2019	331
2018	295
2017	320
2016	287
2015	298
2014	284
2013	222
2012	261
2011	304
2010	276
2009	277
2008	235
2007	223
2006	252
2005	151
2004	233
2003	257
2002	227
2001	127
2000	121
1999	116
1998	146
1997	74
1996	146
1995	129
1994	44
1993	29
1992	29
1991	23
1990	7
1989	17
1988	13
1987	20

What these reports record

Outcome at the time of the report

Reports with this sign
All reports

Recovered/Normal14%1,190, All reports: 20.7%
Recovered with Sequela[recovered, with a lasting effect]0.9%73, All reports: 2.3%
Ongoing21.6%1,843, All reports: 17.4%
Died4.9%419, All reports: 4.9%
Euthanized1.3%115, All reports: 1.5%
Outcome Unknown21.3%1,817, All reports: 22.7%

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 8,528 reports that list this sign.

Age of the animal

Reports with this sign
All reports

Under 1 year8.4%718, All reports: 9.5%
1 to 3 years25.3%2,160, All reports: 23.9%
4 to 7 years23.6%2,011, All reports: 20.2%
8 to 11 years13.9%1,183, All reports: 15.4%
12 years and over13.8%1,177, All reports: 10.7%
Age not given15%1,279, All reports: 20.3%

The outcome is for the full report, not for this sign only.

Next in the A to Z list of signs

Injection site scab[scab where the injection was given]
Injection site seroma[seroma where the injection was given]
Injection site serosanguinous discharge[serosanguinous discharge where the injection was given]
Injection site skin discolouration[skin discolouration where the injection was given]
Injection site ulcer[ulcer where the injection was given]
Injection site warmth[warmth where the injection was given]
Injection site weeping[weeping where the injection was given]
Intentional misuse[use that was knowingly different from the label]

All clinical signs

Cite this page

Pet Drug Reports. Injection site swelling: adverse event reports for animal drugs. https://petdrugreports.com/reaction/injection-site-swelling/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site counts the different spellings of one VeDDRA term together.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about this sign

What does this term mean in a report?: In plain words: swelling where the injection was given. It is a term from VeDDRA, the list of terms that FDA and drug companies use to code a report. The person who coded the report selected the term.
How does the count of the latest 12 months compare with the 12 months before?: FDA received 435 reports in the 12 months to June 2026. It received 482 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
How many of these reports have a serious flag?: Of the 5,011 reports that say if the event was serious, 52.7% have the serious flag. The person who sends a report sets the flag.
Does a drug in the table cause this sign?: The reports do not show that. A report can name more than one drug. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices