Drug profile

The FDA adverse-event record for Diphenoxylate Hcl & Atropine Sulfate

16 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Diphenoxylate Hcl & Atropine Sulfate. See the species affected, top reactions, and outcomes below.

16
adverse-event reports
37.5%
death-coded share
Dog
most-reported species
9
Lethargy (see also Central nervous system depression in 'Neurological') - 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.
16
Total Reports
6
Deaths Reported
37.5%
Death Rate

Active Ingredients

Diphenoxylate Hcl & Atropine Sulfate

Administration Routes

OralUnknown

Species Affected

Dog 16

Most Affected Breeds

Retriever - Labrador 2
Terrier - Yorkshire 2
Spitz - German Pomeranian 2
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 1
Chihuahua 1
Collie (unspecified) 1
Shih Tzu 1
Havanese 1
Boxer (German Boxer) 1
Papillon - Spaniel - Continental Toy (with erect ears or with dropped ears (Phaléne)) 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 9
Anorexia 5
Vomiting 5
Diarrhoea 4
Decreased appetite 4
Panting 3
Death by euthanasia 3
Weight loss 3
Death 3
Abnormal ultrasound finding 2
Pain NOS 2
Other abnormal test result NOS 2

Outcome Breakdown

Ongoing
6 (37.5%)
Recovered/Normal
4 (25.0%)
Euthanized
3 (18.8%)
Died
3 (18.8%)

Diphenoxylate Hcl & Atropine Sulfate Adverse Event Insights

16 reports name Diphenoxylate Hcl & Atropine Sulfate; 6 recorded a death outcome (37.5% of reported events, not a population-level mortality rate). Active ingredient: Diphenoxylate Hcl & Atropine Sulfate. Administration routes: Oral, Unknown.

By species: Dog (16 reports). By breed: Retriever - Labrador (2), Terrier - Yorkshire (2), Spitz - German Pomeranian (2).

Leading clinical signs: Lethargy (see also Central nervous system depression in 'Neurological') (9), Anorexia (5), Vomiting (5), Diarrhoea (4). Outcome, 16 coded reports: Ongoing leads at 37.5%.

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.