FDA label 45baa744-e3f5-3a4e-e063-6294a90ad3f3
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
- 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
- 2026-09-28
- 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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:26:33
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 45baa744-e3f5-3a4e-e063-6294a90ad3f3 | id | |
| spl set id | 17d61203-a462-4393-b261-72bf48d51942 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.