Pet Recall Facts

Ingredients / Mirtazapine

Mirtazapine: FDA adverse event reports for pets

Reports received through June 26, 2026. Data and limitations.

3,061Total reports
285Dog reports
1,836Cat reports

FDA-approved products with this ingredient (Green Book)

All approved products with this ingredient, for any species.

Brand names come only from the Green Book. Brand names in FDA's public report data are masked, so counts cannot be attributed to any brand. Ingredient names in the reports are written many ways; we group them under one ingredient name and count each report once per ingredient (method).

Reports by year received

20081
20111
201224
201344
201416
201524
201654
201744
2018102
2019244
2020199
2021207
2022197
2023218
2024591
2025654
2026441

Species named in reports

Cat1,836
Not given881
Dog285
Human56
Tiger1
Other1
Other Mammals1

Signs reported after Mirtazapine

Product defect, product difficult to use/handle (see also Drug device difficult to use/handle)366
Lethargy (see also Central nervous system depression in Neurological)359
Tubes, Leaking352
Lack of efficacy - NOS307
Death by euthanasia302
Appearance, Abnormal297
Vomiting285
Weight loss224
Anorexia212
Not eating198
Death166
Diarrhoea164
Decreased appetite161
Application site reddening159
Behavioural disorder NOS147
Other abnormal test result NOS123
Vocalisation121
Ataxia116
Elevated blood urea nitrogen (BUN)114
Elevated alanine aminotransferase (ALT)113
Dehydration112
Application site crust108
Anaemia NOS104
Underfilling, Container102
Elevated creatinine95

Breeds named in reports

Domestic Shorthair1,042
Cat (unknown)257
Domestic Longhair175
Siamese76
Domestic Mediumhair75
Maine Coon43
Retriever - Labrador40
Ragdoll30
Cat (other)30
Dog (unknown)24
Persian24
Himalayan20
Chihuahua20
Retriever - Golden19
Crossbred Canine/dog19

Reported outcomes

Outcome Unknown724
Recovered/Normal543
Ongoing431
Euthanized302
Died179
Recovered with Sequela7

Report a problem to FDA