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2026 FDA CVM data 1,623 reports on file official source

Shepherd Dog - Belgian Malinois — FDA Adverse Event Profile

Adverse-event records and label data for Shepherd Dog - Belgian Malinois (Dog), sourced from the FDA Center for Veterinary Medicine. Refreshed as new reports are filed. Cite PlainBreed when reusing this analysis.

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Annual breed adverse-event registration timeline Bar chart showing yearly FDA Center for Veterinary Medicine adverse event report counts per breed registry cohort, with paw-print tick marks indicating count buckets. 168 126 84 42 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Shepherd Dog - Belgian Malinois drawn from FDA CVM filings.

Shepherd Dog - Belgian Malinois (Dog) has 1,623 FDA adverse event reports on record, with 48 deaths reported (300.0% death rate) — ranking #83 by report volume. The most frequently reported reaction is Lack of efficacy (endoparasite) - heartworm (418 cases). The top associated drug is Ivermectin + Pyrantel As Pamoate Salt. Average age at report: 4.4 years.

Total Reports

1,623

FDA CVM filings

Deaths Reported

48

of 1,623 reports

Death Rate

300.0%

death-coded share

Avg Age at Report

4.4 yr

29.2 kg avg weight

Death-Coded Outcome Share

Shepherd Dog - Belgian Malinois death-coded reports 100.0%
Database median

300.0% of 1,623 reports involved a death outcome. Read alongside breed popularity, veterinary access, and owner awareness — these shape how many events ever reach the FDA. The 12% comparison line is the rough cross-breed median in the FDA CVM database; values above suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.

Average weight at time of report: 29.2 kg (64.4 lbs)

Top Reported Reactions

Lack of efficacy (endoparasite) - heartworm 418
INEFFECTIVE, HEARTWORM LARVAE 257
Vomiting 178
Diarrhoea 91
Lack of efficacy - NOS 90
Cardiac disorder NOS 72
Lethargy (see also Central nervous system depression in 'Neurological') 70
Lack of efficacy (ectoparasite) - flea 66
Lack of efficacy (endoparasite) - hookworm 65
Seizure NOS 52
Emesis 48
Lack of efficacy (ectoparasite) - tick NOS 40
Lack of efficacy (bacteria) - Borrelia 34
Decreased appetite 31
Emesis (multiple) 30

Most Referenced Drugs

Ivermectin + Pyrantel As Pamoate Salt 300
Milbemycin Oxime + Spinosad 229
Moxidectin 176
Pyrantel Pamoate;Sarolaner 149
Milbemycin Oxime + Praziquantel 96
Afoxolaner 89
Fluralaner 13.64% 12-Week Chew 72
Bedinvetmab 47
Milbemycin Oxime 40
Fluralaner Chew Tablets 38
Carprofen 36
Spinosad 32
Melarsomine Dihydrochloride 32
Ivermectin, Pyrantel 29
Ivermectin/Pyrantel Pamoate Chewable 272Mcg/652Mg 29

Outcome Breakdown

Ongoing
566 (36.8%)
Outcome Unknown
507 (32.9%)
Recovered/Normal
297 (19.3%)
Recovered with Sequela
122 (7.9%)
Died
24 (1.6%)
Euthanized
24 (1.6%)

Gender Distribution

Male 950 (58.5%)
Female 641 (39.5%)
Unknown 29 (1.8%)
Mixed 3 (0.2%)

Reports by Year

Year Reports Trend
2010 33
2011 70
2012 57
2013 56
2014 59
2015 97
2016 95
2017 88
2018 105
2019 123
2020 128
2021 130
2022 131
2023 160
2024 168
2025 123
Size-class weight distribution across registered breeds Vertical bar chart showing the distribution of registered breeds across five size classes (Toy, Small, Medium, Large, Giant), each represented by a scaled dog-silhouette and a count value. 118 89 59 30 0 Breeds in class 38 Toy 0–6 kg Chihuahua 64 Small 6–14 kg Beagle 92 Medium 14–27 kg Border Collie 118 Large 27–45 kg Labrador Retriever 41 Giant 45–90 kg Great Dane Size-Class Distribution
Where Shepherd Dog - Belgian Malinois sits in the registered size-class taxonomy. Average reported weight: 29.2 kg.
Breed-group distribution donut chart Donut chart with kennel-club-ribbon center showing breed counts across the eight standard breed groups (Sporting, Hound, Working, Terrier, Toy, Non-Sporting, Herding, Miscellaneous). CH Sporting 32 · 14.2% Hound 36 · 15.9% Working 33 · 14.6% Terrier 31 · 13.7% Toy 23 · 10.2% Non-Sporting 21 · 9.3% Herding 32 · 14.2% Misc. 18 · 8.0% Breed-Group Classification 226 breeds across 8 taxonomic groups
Eight standard breed-group classifications used by major registries (AKC's seven groups plus Miscellaneous). Provides taxonomic context for breed lookups.

Shepherd Dog - Belgian Malinois Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Shepherd Dog - Belgian Malinois accounts for 1,623 submitted reports and currently ranks #83 by report volume within the dog population. Of those reports, 48 involved a death outcome — a 300.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 4.4 years, with an average recorded body weight of 29.2 kg (64.4 lbs). These figures reflect the voluntary reporting pool only and should be read alongside breed popularity, veterinary access, and owner awareness — all of which shape how many events ever reach the FDA.

The most frequently reported clinical signs for Shepherd Dog - Belgian Malinois are Lack of efficacy (endoparasite) - heartworm (418 reports), INEFFECTIVE, HEARTWORM LARVAE (257 reports), Vomiting (178 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Ivermectin + Pyrantel As Pamoate Salt appears in 300 reports and is the single most-referenced drug, followed by Milbemycin Oxime + Spinosad (229) and Moxidectin (176). Counts like these surface which therapeutic classes dominate the reporting stream — useful context when comparing reactions across breeds of the same dog species.

Outcome coding on the 1,540 reports with a recorded status is dominated by Ongoing (36.8% of coded outcomes). Annual submission volume ranges from 2,010 to 2,025 reports across the 16 years on file, indicating the reporting trend is shaped as much by awareness cycles as by underlying clinical events. Because FDA adverse event reports describe correlation rather than causation, these numbers are most useful as a signal of where to ask further questions with a veterinarian — not as a standalone risk score for any individual dog.

Understanding Shepherd Dog - Belgian Malinois Adverse Event Data

Shepherd Dog - Belgian Malinois has a moderate volume of adverse event reports (1,623). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 300.0% death rate is above average, though this statistic should be interpreted cautiously. Death reports may be overrepresented because serious outcomes are more likely to be reported than mild reactions.

The most frequently referenced drug in adverse reports is Ivermectin + Pyrantel As Pamoate Salt, appearing in 300 reports. This may indicate widespread use of the medication rather than a specific safety concern for Shepherd Dog - Belgian Malinois.

Other Dog Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Shepherd Dog - Belgian Malinois?
There are 1,623 adverse event reports involving Shepherd Dog - Belgian Malinois in the FDA database, with 48 reports involving death (300.0% death rate). Shepherd Dog - Belgian Malinois ranks #83 by report volume.
What are the most common adverse reactions reported for Shepherd Dog - Belgian Malinois?
The most commonly reported adverse reactions for Shepherd Dog - Belgian Malinois are Lack of efficacy (endoparasite) - heartworm (418 reports), INEFFECTIVE, HEARTWORM LARVAE (257 reports), Vomiting (178 reports), Diarrhoea (91 reports), Lack of efficacy - NOS (90 reports).
What drugs are most frequently associated with Shepherd Dog - Belgian Malinois adverse events?
The drugs most frequently referenced in Shepherd Dog - Belgian Malinois adverse event reports are Ivermectin + Pyrantel As Pamoate Salt (300 reports), Milbemycin Oxime + Spinosad (229 reports), Moxidectin (176 reports), Pyrantel Pamoate;Sarolaner (149 reports), Milbemycin Oxime + Praziquantel (96 reports).
What is the average age of Shepherd Dog - Belgian Malinois in adverse event reports?
The average age of Shepherd Dog - Belgian Malinois at the time of adverse event reports is 4.4 years, with an average weight of 29.2 kg (64.4 lbs).
Does a high number of adverse event reports mean Shepherd Dog - Belgian Malinois is unhealthy?
No. FDA adverse event reports are voluntarily submitted and do not prove causation. Popular breeds with more veterinary visits tend to have more reports. The data reflects reporting patterns, not actual incidence rates. Always consult a veterinarian for health decisions.
Where does this Shepherd Dog - Belgian Malinois safety data come from?
All data comes from the FDA Center for Veterinary Medicine's adverse event reporting system. Pet owners, veterinarians, and manufacturers voluntarily submit reports about adverse events potentially linked to animal drugs and other products.

Guides & Resources

Related Data Sources

Data Sources & Methodology

Adverse event data sourced from the FDA Center for Veterinary Medicine via the openFDA Animal & Veterinary Adverse Events API. Reports are voluntarily submitted by pet owners, veterinarians, and product manufacturers.

Shepherd Dog - Belgian Malinois ranks #83 by total report volume. Death rate (300.0%) reflects the proportion of reports involving death and should not be interpreted as a breed-specific mortality rate. Reporting biases, breed popularity, and veterinary access all influence report counts.

Related

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