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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 sections page 1 of 1 · 1 matching rows.

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.