Drug profile

The FDA adverse-event record for Artificial Tears

94 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Artificial Tears. See the species affected, top reactions, and outcomes below.

94
adverse-event reports
12.8%
death-coded share
Dog
most-reported species
26
Corneal ulcer - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
94
Total Reports
12
Deaths Reported
12.8%
Death Rate

Active Ingredients

Artificial Tears

Administration Routes

UnknownOphthalmicIntraocularTopicalOther

Species Affected

Dog 88
Cat 6

Most Affected Breeds

Shih Tzu 12
Chihuahua 11
Spaniel - King Charles Cavalier 6
Bulldog 5
Domestic Shorthair 4
Shiba Inu 4
Maltese 4
Terrier - Yorkshire 3
Lhasa Apso 3
Poodle - Toy 2

Most Reported Reactions

Corneal ulcer 26
Lethargy (see also Central nervous system depression in 'Neurological') 22
Vomiting 20
Ocular discharge 19
Corneal disorder NOS 18
Anorexia 17
Keratoconjunctivitis sicca 16
Dry eye 14
Schirmer tear test 14
Adipsia 12
Behavioural disorder NOS 11
Other abnormal test result NOS 11

Outcome Breakdown

Recovered/Normal
26 (27.7%)
Ongoing
25 (26.6%)
Outcome Unknown
22 (23.4%)
Recovered with Sequela
9 (9.6%)
Died
7 (7.4%)
Euthanized
5 (5.3%)

Artificial Tears Adverse Event Insights

94 reports name Artificial Tears; 12 recorded a death outcome (12.8% of reported events, not a population-level mortality rate). Active ingredient: Artificial Tears. Administration routes: Unknown, Ophthalmic, Intraocular, Topical.

By species: Dog (88 reports), Cat (6 reports). By breed: Shih Tzu (12), Chihuahua (11), Spaniel - King Charles Cavalier (6).

Leading clinical signs: Corneal ulcer (26), Lethargy (see also Central nervous system depression in 'Neurological') (22), Vomiting (20), Ocular discharge (19). Outcome, 94 coded reports: Recovered/Normal leads at 27.7%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on 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.