Total Reports
13,674
FDA CVM filings
Dog /
FDA CVM · 2025 release 13,674 reports on file
Maltese - FDA Adverse Event Profile
Adverse-event records for Maltese (Dog) from the FDA Center for Veterinary Medicine.
Data updated June 2026
The record at a glance
Maltese's FDA record: #14 most-reported dog breed, 13,674 total reports, 3.2% death-coded (443 reports).
- #14
- most-reported dog breed
- 3.2%
- death-coded report share
- 3,343
- Vomiting - top reaction
- 5.6 yr
- average age at report
Higher volume usually means a more popular breed, not a riskier one, compare against how common the breed is.
Deaths Reported
443
of 13,674 reports
Death Rate
3.2%
death-coded share
Avg Age at Report
5.6 yr
4.8 kg avg weight
Death-Coded Outcome Share
Maltese death-coded reports 3.2%
Cross-breed median
3.2% of 13,674 maltese 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: 4.8 kg (10.6 lbs)
Top Reported Reactions
Vomiting 3,343
Lethargy (see also Central nervous system depression in 'Neurological') 1,928
Emesis 1,548
Lack of efficacy (ectoparasite) - flea 1,413
Diarrhoea 1,208
Lack of efficacy - NOS 645
Anorexia 550
Seizure NOS 541
Behavioural disorder NOS 500
Shaking 454
Other abnormal test result NOS 385
Lack of efficacy (endoparasite) - hookworm 356
Not eating 353
Ataxia 347
Emesis (multiple) 344
Most Referenced Drugs
Milbemycin Oxime + Spinosad 3,251
Spinosad 1,375
Afoxolaner 940
Ivermectin + Pyrantel As Pamoate Salt 853
Trilostane 624
Fluralaner Chew Tablets 554
Moxidectin 553
Oclacitinib Maleate 484
Pyrantel Pamoate;Sarolaner 442
Fluralaner 13.64% 12-Week Chew 370
Milbemycin Oxime + Praziquantel 332
Selamectin 327
Sarolaner 321
Imidacloprid + Moxidectin 298
Nitenpyram 229
Outcome Breakdown
Recovered/Normal
5,337 (41.3%)
Outcome Unknown
4,097 (31.7%)
Ongoing
2,621 (20.3%)
Recovered with Sequela
422 (3.3%)
Died
251 (1.9%)
Euthanized
192 (1.5%)
Gender Distribution
Female 6,774 (49.5%)
Male 6,586 (48.2%)
Unknown 288 (2.1%)
Mixed 26 (0.2%)
Reports by Year
| Year | Reports | Trend |
|---|---|---|
| 2010 | 379 | |
| 2011 | 680 | |
| 2012 | 1,160 | |
| 2013 | 1,265 | |
| 2014 | 1,162 | |
| 2015 | 1,161 | |
| 2016 | 1,123 | |
| 2017 | 1,089 | |
| 2018 | 982 | |
| 2019 | 894 | |
| 2020 | 851 | |
| 2021 | 802 | |
| 2022 | 751 | |
| 2023 | 589 | |
| 2024 | 495 | |
| 2025 | 291 | |
Maltese Pet Health Insights
Maltese accounts for 13,674 FDA adverse event reports, ranking #14 by volume among dog breeds, with 443 reports (3.2%) coded as a death outcome. Mean age at report: 5.6 years, average weight 4.8 kg (10.6 lbs).
Top reported signs: Vomiting (3,343), Lethargy (see also Central nervous system depression in 'Neurological') (1,928), Emesis (1,548). Most-referenced drug: Milbemycin Oxime + Spinosad (3,251 reports), followed by Spinosad (1,375) and Afoxolaner (940).
Outcome coding on 12,920 status-recorded reports is dominated by Recovered/Normal (41.3%). Annual submissions ranged 2,010-2,025 across 16 years on file.
Dog Breeds With a Similar Report Volume
Terrier (unspecified)
13,509 reports · 3.0% death rate
Dachshund (unspecified)
13,165 reports · 4.5% death rate
Shepherd Dog - Australian
15,583 reports · 3.7% death rate
Terrier - Jack Russell
10,210 reports · 3.7% death rate
Pit Bull
17,328 reports · 3.1% death rate
Beagle
17,507 reports · 3.6% death rate
Frequently Asked Questions
How many FDA adverse event reports involve Maltese? ▼
There are 13,674 adverse event reports involving Maltese in the FDA database, with 443 reports involving death (3.2% death rate). Maltese ranks #14 by report volume.
What are the most common adverse reactions reported for Maltese? ▼
The most commonly reported adverse reactions for Maltese are Vomiting (3,343 reports), Lethargy (see also Central nervous system depression in 'Neurological') (1,928 reports), Emesis (1,548 reports), Lack of efficacy (ectoparasite) - flea (1,413 reports), Diarrhoea (1,208 reports).
What drugs are most frequently associated with Maltese adverse events? ▼
The drugs most frequently referenced in Maltese adverse event reports are Milbemycin Oxime + Spinosad (3,251 reports), Spinosad (1,375 reports), Afoxolaner (940 reports), Ivermectin + Pyrantel As Pamoate Salt (853 reports), Trilostane (624 reports).
What is the average age of Maltese in adverse event reports? ▼
The average age of Maltese at the time of adverse event reports is 5.6 years, with an average weight of 4.8 kg (10.6 lbs).
Does a high number of adverse event reports mean Maltese 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 Maltese 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.
Compare a breed's report volume against how common the breed is before drawing conclusions. See our methodology for how death rate and rankings are computed.
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.