FDA label 4e0c4bc1-6f2b-530e-d40b-b116db0c4766

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

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

SPL set ID
27156ba6-3a64-b463-5d85-d1b959d5032c
SPL ID
4e0c4bc1-6f2b-530e-d40b-b116db0c4766
Version
2
Effective date
2012-10-21
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:01:29

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 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.