FDA label ef30c837-3623-42df-a0c5-6b9bed186459
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
- fddac942-2138-432f-95a1-90f41817cdde
- SPL ID
- ef30c837-3623-42df-a0c5-6b9bed186459
- Version
- 1
- Effective date
- 2010-07-12
- Source export date
- 2026-10-12
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:07:38
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 | ef30c837-3623-42df-a0c5-6b9bed186459 | id | |
| spl set id | fddac942-2138-432f-95a1-90f41817cdde | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings All oxytocic agents are potentially dangerous. Mothers and infants have been injured, and some have died because of their injudicious use. Hyperstimulation of the uterus during labor may lead to uterine tetany and marked impairment of the uteroplacental blood flow, uterine rupture, cervical and perineal lacerations, amniotic fluid embolism, and trauma to the infant (e.g. hypoxia, intracranial hemorrhage). Because of these hazards which result from overdosage, oxytocic agents must be administered under conditions of meticulous observation.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions Nausea and vomiting may occur, but they are uncommon. Allergic phenomena, including shock, have been reported. Ergotism has also been reported. Elevation of blood pressure (sometimes extreme) may appear in a small percentage of patients, most frequently in association with regional anesthesia (caudal or spinal), previous administration of a vasoconstrictor, and the intravenous route of administration of the oxytocic. The mechanism of such hypertension is obscure, since it may occur in the absence of anesthesia, vasoconstrictors, and oxytocics. These elevations are no more frequent with ergonovine maleate than with other oxytocics. They usually subside promptly following intravenous administration of 15 mg of chlorpromazine.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.