FDA label 45baa744-e3f5-3a4e-e063-6294a90ad3f3

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
17d61203-a462-4393-b261-72bf48d51942
SPL ID
45baa744-e3f5-3a4e-e063-6294a90ad3f3
Version
4
Effective date
2025-12-11
Source export date
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:33:39

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Oxybutynin chloride, when administered in the presence of a high environmental temperature, can cause heat prostration (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy, or colostomy. In this instance treatment with oxybutynin chloride would be inappropriate and possibly harmful. Oxybutynin chloride may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. Alcohol or other sedative drugs may enhance the drowsiness caused by oxybutynin chloride.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Following administration of oxybutynin chloride, the symptoms that can be associated with the use of other anticholinergic drugs may occur: Cardiovascular: Palpitations, tachycardia, vasodilatation Dermatologic: Decreased sweating, rash Gastrointestinal/Genitourinary: Constipation, decreased gastrointestinal motility, dry mouth, nausea, urinary hesitance and retention Nervous System: Asthenia, dizziness, drowsiness, hallucinations, insomnia, restlessness Ophthalmic: Amblyopia, cycloplegia, decreased lacrimation, mydriasis Other: Impotence, suppression of lactation