Tacrolimus

210 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.

210

Total Reports

Deaths Reported

1140.0%

Death Rate

Active Ingredients

Tacrolimus

Administration Routes

UnknownOphthalmicTopicalIntraocularOtherOralAuricular (Otic)

Species Affected

Dog 208

Unknown 1

Human 1

Most Affected Breeds

Shih Tzu 25

Shepherd Dog - German 17

Pug 14

Chihuahua 12

Dog (unknown) 10

Retriever - Labrador 9

Terrier - Yorkshire 8

Maltese 7

Bulldog 6

Terrier - West Highland White 6

Most Reported Reactions

Vomiting 33

Diarrhoea 23

Lethargy (see also Central nervous system depression in 'Neurological') 18

Weight loss 18

Lack of efficacy - NOS 18

Death by euthanasia 16

Lethargy (see also Central nervous system depression in Neurological) 15

Polyuria 14

Corneal ulcer 14

Behavioural disorder NOS 13

Dry eye 12

Other abnormal test result NOS 11

Outcome Breakdown

Ongoing

62 (29.5%)

Recovered/Normal

61 (29.0%)

Outcome Unknown

57 (27.1%)

Euthanized

17 (8.1%)

Died

7 (3.3%)

Recovered with Sequela

6 (2.9%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.