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2026 FDA CVM data 3,106 reports on file official source

Holstein-Friesian also known as Holstein — FDA Adverse Event Profile

Adverse-event records and label data for Holstein-Friesian also known as Holstein (Cattle), 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. 210 157.5 105 52.5 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Holstein-Friesian also known as Holstein drawn from FDA CVM filings.

Holstein-Friesian also known as Holstein (Cattle) has 3,106 FDA adverse event reports on record, with 1,207 deaths reported (3890.0% death rate) — ranking #58 by report volume. The most frequently reported reaction is Death (911 cases). The top associated drug is Monensin Sodium. Average age at report: 1.7 years.

Total Reports

3,106

FDA CVM filings

Deaths Reported

1,207

of 3,106 reports

Death Rate

3890.0%

death-coded share

Avg Age at Report

1.7 yr

194.7 kg avg weight

Death-Coded Outcome Share

Holstein-Friesian also known as Holstein death-coded reports 100.0%
Database median

3890.0% of 3,106 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: 194.7 kg (429.3 lbs)

Top Reported Reactions

Death 911
Lack of efficacy (bacteria) - NOS 306
Lack of efficacy - NOS 293
Milk production decrease 200
Residues in milk 190
Diarrhoea 165
Lack of efficacy (protozoa) - Coccidia 140
Alteration of milk quality 135
INEFFECTIVE, PRODUCTION (MILK) 122
Injection site swelling 116
Residues in meat/offal 112
Mastitis NOS 105
CULTURE/TITER DATA ABNORMAL 102
Recumbency 99
Death by euthanasia 98

Most Referenced Drugs

Monensin Sodium 838
Sometribove 257
Cephapirin Sodium 199
Ceftiofur Hydrochloride 174
Ceftiofur Crystalline Free Acid 139
Tulathromycin 138
Dinoprost Tromethamine 110
Eprinomectin 77
Ampicillin Trihydrate 73
Cloxacillin Benz Intramam Dc 69
Florfenicol, Flunixin 62
Tildipirosin 61
Pegbovigrastim 61
Moxidectin 60
Eprinomectin 5 Mg/Ml Pour-On Solution 57

Outcome Breakdown

Outcome Unknown
1,295 (37.8%)
Died
1,101 (32.1%)
Recovered/Normal
599 (17.5%)
Ongoing
194 (5.7%)
Euthanized
140 (4.1%)
Recovered with Sequela
96 (2.8%)

Gender Distribution

Female 2,411 (77.6%)
Male 445 (14.3%)
Unknown 148 (4.8%)
Mixed 102 (3.3%)

Reports by Year

Year Reports Trend
2010 169
2011 197
2012 334
2013 310
2014 311
2015 318
2016 275
2017 295
2018 210
2019 129
2020 152
2021 116
2022 82
2023 75
2024 81
2025 52
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 Holstein-Friesian also known as Holstein sits in the registered size-class taxonomy. Average reported weight: 194.7 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.

Holstein-Friesian also known as Holstein Pet Health Insights

Across the FDA Center for Veterinary Medicine adverse event database, Holstein-Friesian also known as Holstein accounts for 3,106 submitted reports and currently ranks #58 by report volume within the cattle population. Of those reports, 1,207 involved a death outcome — a 3890.0% case-fatality figure calculated directly from the underlying FDA records rather than from external mortality studies. The mean age at time of reporting is 1.7 years, with an average recorded body weight of 194.7 kg (429.3 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 Holstein-Friesian also known as Holstein are Death (911 reports), Lack of efficacy (bacteria) - NOS (306 reports), Lack of efficacy - NOS (293 reports), together capturing a substantial share of the top-reaction traffic seen in this breed's record. On the product side, Monensin Sodium appears in 838 reports and is the single most-referenced drug, followed by Sometribove (257) and Cephapirin Sodium (199). Counts like these surface which therapeutic classes dominate the reporting stream — useful context when comparing reactions across breeds of the same cattle species.

Outcome coding on the 3,425 reports with a recorded status is dominated by Outcome Unknown (37.8% 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 cattle.

Understanding Holstein-Friesian also known as Holstein Adverse Event Data

Holstein-Friesian also known as Holstein has a moderate volume of adverse event reports (3,106). Report counts are influenced by breed popularity, owner awareness, and veterinary reporting practices.

The 3890.0% 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 Monensin Sodium, appearing in 838 reports. This may indicate widespread use of the medication rather than a specific safety concern for Holstein-Friesian also known as Holstein.

Other Cattle Breeds

Frequently Asked Questions

How many FDA adverse event reports involve Holstein-Friesian also known as Holstein?
There are 3,106 adverse event reports involving Holstein-Friesian also known as Holstein in the FDA database, with 1,207 reports involving death (3890.0% death rate). Holstein-Friesian also known as Holstein ranks #58 by report volume.
What are the most common adverse reactions reported for Holstein-Friesian also known as Holstein?
The most commonly reported adverse reactions for Holstein-Friesian also known as Holstein are Death (911 reports), Lack of efficacy (bacteria) - NOS (306 reports), Lack of efficacy - NOS (293 reports), Milk production decrease (200 reports), Residues in milk (190 reports).
What drugs are most frequently associated with Holstein-Friesian also known as Holstein adverse events?
The drugs most frequently referenced in Holstein-Friesian also known as Holstein adverse event reports are Monensin Sodium (838 reports), Sometribove (257 reports), Cephapirin Sodium (199 reports), Ceftiofur Hydrochloride (174 reports), Ceftiofur Crystalline Free Acid (139 reports).
What is the average age of Holstein-Friesian also known as Holstein in adverse event reports?
The average age of Holstein-Friesian also known as Holstein at the time of adverse event reports is 1.7 years, with an average weight of 194.7 kg (429.3 lbs).
Does a high number of adverse event reports mean Holstein-Friesian also known as Holstein 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 Holstein-Friesian also known as Holstein 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.

Holstein-Friesian also known as Holstein ranks #58 by total report volume. Death rate (3890.0%) 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