Dog /

Maltese

13,674 adverse event reports submitted to the FDA

Important: Adverse event reports are voluntarily submitted and do not prove causation. Consult your veterinarian for medical decisions about your dog.
13,674
Total Reports
443
Deaths Reported
320.0%
Death Rate
5.6 yr
Avg Age at Report
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

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Rank #14 by report volume. Data reflects voluntary submissions and may not represent actual incidence rates.