What the label lists and what reports show
Atropine and diphenoxylate side effects
Atropine and diphenoxylate's FDA label lists its adverse reactions in its own words. FAERS holds 13,618 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (2,729 reports).
- Generic listed
- DEA Schedule V
Check it at the source: the atropine and diphenoxylate FDA label on DailyMed (effective February 23, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are described elsewhere in labeling: • Respiratory and/or CNS depression (see WARNINGS ) • Anticholinergic and opioid-toxicities, including atroponism (see WARNINGS and PRECAUTIONS ) • Dehydration and electrolyte imbalance (see WARNINGS ) • GI Complications in patients with infectious diarrhea (see WARNINGS ) • Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS ) At therapeutic doses of Lomotil, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus Gastrointestinal system: megacolon, paralytic ileus …
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective February 23, 2026 (SPL set f170584a-1072-4fd7-b1dc-6756703483b9), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,618 reports list atropine and diphenoxylate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,339 are coded as a death and 5,218 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Atropine and diphenoxylate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions