Dog /
FDA CVM · 2025 release 3,845 reports on file

Havanese - FDA Adverse Event Profile

Adverse-event records for Havanese (Dog) from the FDA Center for Veterinary Medicine.

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Annual adverse-event report trend Yearly FDA CVM adverse-event report counts for this breed. 324 243 162 81 0 2018 2019 2020 2021 2022 2023 2024 2025 Reports filed Death-coded reports
Annual report volume for Havanese drawn from FDA CVM filings.

Data updated June 2026

The record at a glance

Among dog breeds, Havanese is #52 by FDA report volume; 2.1% of its 3,845 reports (80) were death-coded.

#52
most-reported dog breed
2.1%
death-coded report share
1,141
Vomiting - top reaction
4.9 yr
average age at report

Report counts track breed popularity and reporting activity, not real-world risk, read this alongside how common the breed is.

Total Reports

3,845

FDA CVM filings

Deaths Reported

80

of 3,845 reports

Death Rate

2.1%

death-coded share

Avg Age at Report

4.9 yr

6.3 kg avg weight

Death-Coded Outcome Share

Havanese death-coded reports 2.1%
Cross-breed median

2.1% of 3,845 havanese reports involved a death outcome.

How to read this number

Read alongside breed popularity, veterinary access, and owner awareness, these shape how many events ever reach the FDA. The comparison line marks the cross-breed median death-coded share (about 4.8%) among breeds with 50 or more reports; values above it suggest higher reporting bias toward severe outcomes, not necessarily higher true mortality.

Average weight at time of report: 6.3 kg (13.9 lbs)

Top Reported Reactions

Vomiting 1,141
Lethargy (see also Central nervous system depression in 'Neurological') 419
Diarrhoea 411
Emesis 371
Lack of efficacy (ectoparasite) - flea 209
Lack of efficacy (endoparasite) - hookworm 185
Seizure NOS 151
Anorexia 148
Lack of efficacy - NOS 142
Emesis (multiple) 123
Behavioural disorder NOS 119
Digestive tract disorder NOS 96
Shaking 92
Decreased appetite 84
Lethargy (see also Central nervous system depression in Neurological) 82

Most Referenced Drugs

Milbemycin Oxime + Spinosad 729
Ivermectin + Pyrantel As Pamoate Salt 410
Afoxolaner 364
Pyrantel Pamoate;Sarolaner 287
Spinosad 210
Moxidectin 199
Fluralaner Chew Tablets 181
Oclacitinib Maleate 146
Fluralaner 13.64% 12-Week Chew 132
Milbemycin Oxime + Praziquantel 127
Sarolaner 108
Trilostane 83
Selamectin 80
Lotilaner 62
Carprofen 60

Outcome Breakdown

Recovered/Normal
1,669 (44.9%)
Outcome Unknown
1,069 (28.8%)
Ongoing
812 (21.9%)
Recovered with Sequela
84 (2.3%)
Died
46 (1.2%)
Euthanized
34 (0.9%)

Gender Distribution

Male 2,046 (53.2%)
Female 1,727 (44.9%)
Unknown 63 (1.6%)
Mixed 9 (0.2%)

Reports by Year

Year Reports Trend
2010 56
2011 120
2012 239
2013 214
2014 252
2015 266
2016 308
2017 271
2018 324
2019 278
2020 264
2021 271
2022 280
2023 250
2024 274
2025 178

Havanese Pet Health Insights

Havanese accounts for 3,845 FDA adverse event reports, ranking #52 by volume among dog breeds, with 80 reports (2.1%) coded as a death outcome. Mean age at report: 4.9 years, average weight 6.3 kg (13.9 lbs).

Top reported signs: Vomiting (1,141), Lethargy (see also Central nervous system depression in 'Neurological') (419), Diarrhoea (411). Most-referenced drug: Milbemycin Oxime + Spinosad (729 reports), followed by Ivermectin + Pyrantel As Pamoate Salt (410) and Afoxolaner (364).

Outcome coding on 3,714 status-recorded reports is dominated by Recovered/Normal (44.9%). Annual submissions ranged 2,010-2,025 across 16 years on file.

Dog Breeds With a Similar Report Volume

Frequently Asked Questions

How many FDA adverse event reports involve Havanese?
There are 3,845 adverse event reports involving Havanese in the FDA database, with 80 reports involving death (2.1% death rate). Havanese ranks #52 by report volume.
What are the most common adverse reactions reported for Havanese?
The most commonly reported adverse reactions for Havanese are Vomiting (1,141 reports), Lethargy (see also Central nervous system depression in 'Neurological') (419 reports), Diarrhoea (411 reports), Emesis (371 reports), Lack of efficacy (ectoparasite) - flea (209 reports).
What drugs are most frequently associated with Havanese adverse events?
The drugs most frequently referenced in Havanese adverse event reports are Milbemycin Oxime + Spinosad (729 reports), Ivermectin + Pyrantel As Pamoate Salt (410 reports), Afoxolaner (364 reports), Pyrantel Pamoate;Sarolaner (287 reports), Spinosad (210 reports).
What is the average age of Havanese in adverse event reports?
The average age of Havanese at the time of adverse event reports is 4.9 years, with an average weight of 6.3 kg (13.9 lbs).
Does a high number of adverse event reports mean Havanese 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 Havanese 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.

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. Breed figures are computed directly from FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.