Breed · Dog

Maltese: adverse event reports

FDA breed label "Maltese" · single-breed animals only

Read this first · FDA's caveat, in its words

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources. FDA Center for Veterinary Medicine

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Not veterinary advice. This site lists what was reported to FDA. For an animal that is unwell, contact a veterinarian.

10,060reports, 1987–20261% of dog reports

217reports, 12 months to March 2026226 in the 12 months before

35.9%classed serious, as reportedall dogs: 38.3%

17.2%name milbemycin oxime + spinosadall dogs: 13.1%

FDA's database holds 10,060 reports where the animal's breed is given as "Maltese", shown here as Maltese: 1% of reports about dogs. Reports on crossbred animals are left out of breed pages.

217 reports arrived in the 12 months to March 2026, close to the 226 of the 12 months before. A breed's count mostly mirrors how common the breed is; registration and ownership figures by breed are not public data, so no per-animal rate can be given.

By active ingredient, the drugs named most often are milbemycin oxime + spinosad, spinosad and ivermectin + pyrantel pamoate. Milbemycin Oxime + Spinosad is named in 17.2% of this breed's reports, a larger share than in reports about all dogs (13.1%).

The terms listed most often are vomiting (24.3%), lethargy (12.2%) and diarrhoea (9.2%). Vomiting appears in 24.3% of reports, about the same share as in all dog reports (19.7%). 35.9% of reports stating seriousness were classed as serious, against 38.3% for dogs overall.

Drugs named most often, by active ingredient

Active ingredients recorded for the drug	Reports	Share of Maltese reports	Share of all dog reports
Milbemycin Oxime + Spinosad	1,726	17.2%	13.1%
Spinosad	1,036	10.3%	5.8%
Ivermectin + Pyrantel Pamoate	895	8.9%	14.9%
Fluralaner	683	6.8%	6.7%
Afoxolaner	522	5.2%	5.7%
Moxidectin	437	4.3%	5%
Selamectin	376	3.7%	3%
Oclacitinib	340	3.4%	2.9%
Trilostane	312	3.1%	1.2%
Lufenuron + Milbemycin Oxime	282	2.8%	2.7%
Carprofen	273	2.7%	4.8%
Imidacloprid + Moxidectin	235	2.3%	1.3%
Cyclosporine	231	2.3%	1.5%
Ivermectin + Praziquantel + Pyrantel Pamoate	201	2%	0.9%
Pyrantel Pamoate + Sarolaner	198	2%	5.1%
Milbemycin Oxime	190	1.9%	3%
Sarolaner	188	1.9%	1.7%
Meloxicam	168	1.7%	0.8%
Insulin	159	1.6%	0.7%
Pimobendan	158	1.6%	0.6%

Ordered by report count. Differences from the species column often come from body size (which drugs a breed is prescribed) and from how common the breed was in the years a drug sold most. FDA states that these data cannot be used to estimate risk or to compare one product with another. Brand and manufacturer names are masked by FDA in these records.

Signs listed in reports

share of Maltese reports listing the termall dog reports

Vomiting24.3%2,446
Lethargy[unusually tired or inactive]12.2%1,230
Diarrhoea[diarrhea]9.2%921
Lack of efficacy (ectoparasite) - flea[the product did not have the expected effect: fleas]8.8%886
Emesis[vomiting]8.3%830
Anorexia[not eating]5.7%575
Depression[dull, quiet or withdrawn]4.9%494
Lack of efficacy - NOS[the product did not have the expected effect]4.1%414
Seizure NOS[seizure, type not specified]3.4%339
Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.3%335
Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]3.3%328
Ataxia[unsteady, uncoordinated movement]3.2%322
Behavioural disorder NOS[behaviour change, type not specified]3.1%314
Shaking2.9%290
Death2.7%275
Pruritus[itching]2.7%271
Other abnormal test result NOS[abnormal laboratory result, type not specified]2.5%251
Trembling2.4%246
Lack of efficacy (endoparasite) - hookworm[the product did not have the expected effect: hookworms]2.1%210
Not eating2.1%209
Emesis (multiple)[vomiting more than once]2%200
Decreased appetite2%198
Panting1.9%192
Weight loss1.9%190
Death by euthanasia[the animal was euthanized]1.8%186

Age and weight

Age of the animal

Under 1 year10.6%1,068

1 to 3 years25.5%2,562

4 to 7 years25%2,513

8 to 11 years21.9%2,202

12 years and over13.3%1,337

Age not given3.8%378

Weight of the animal

Under 5 kg (11 lb)66.7%6,713

5 to 9.9 kg (11–22 lb)28.3%2,844

10 to 24.9 kg (22–55 lb)1.3%135

25 to 44.9 kg (55–99 lb)0.1%6

45 kg and over (99 lb+)0%2

Weight not given3.6%360

Coloured bar: Maltese reports. Grey bar: all dog reports.

Trend and outcomes

Reports by month FDA received them. The newest months are incomplete because FDA posts reports with a delay of three to six months.

Outcome recorded in the report

Recovered/Normal31.1%3,124

Recovered with Sequela2.9%291

Ongoing16.1%1,622

Died3.4%346

Euthanized1.3%131

Outcome Unknown23.6%2,376

Beside all dogs

Measure	Maltese	All dogs
Reports	10,060	985,675
Latest 12 months	217	53,292
Classed serious, of reports stating it	35.9%	38.3%
Death or euthanasia recorded, per 1,000 reports	47.4	55

Questions about Maltese reports

How many FDA adverse event reports involve Malteses?

10,060 reports through March 2026, 1% of reports about dogs; 217 in the latest 12 months.

Which drugs are named most often in Maltese reports?

By active ingredient: milbemycin oxime + spinosad (1,726), spinosad (1,036), ivermectin + pyrantel pamoate (895), fluralaner (683) and afoxolaner (522). Brands are masked in the public data.

What signs are reported most for this breed?

vomiting (24.3%), lethargy (12.2%), diarrhoea (9.2%), lack of efficacy (ectoparasite) - flea (8.8%) and emesis (8.3%).

Is the Maltese more sensitive to certain drugs?

Report counts cannot answer that. They show what was reported, not what a drug did, and they are not adjusted for how many Maltese animals exist or were treated. Breed-related drug sensitivities that are established are described on FDA-approved labels; a veterinarian is the person to ask about an individual animal.

Why are crossbreds not included?

FDA records crossbred animals with one or more component breeds. Counting them under each component would double count, so breed pages use single-breed reports only. Crossbreds remain in the species totals.

How do I report a problem?

Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Breed names are FDA's labels rearranged into everyday order ("Maltese" becomes "Maltese"). No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.