warnings
WARNINGS Syntocinon ® (oxytocin), when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.
FDA label 22b96c4c-fe2c-47dd-a973-a61f65b375fa
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
- 1f7d5370-94d6-4be4-9fb5-990dc924c815
- SPL ID
- 22b96c4c-fe2c-47dd-a973-a61f65b375fa
- Version
- 2
- Effective date
- 2017-09-07
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:25:38
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 | 22b96c4c-fe2c-47dd-a973-a61f65b375fa | id | |
| spl set id | 1f7d5370-94d6-4be4-9fb5-990dc924c815 | set_id |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction, Postpartum hemorrhage, Cardiac arrhythmia, Fatal afibrinogenemia, Nausea, Vomiting, Premature ventricular contractions, and Pelvic hematoma. Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction, or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred, associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported. The following adverse reactions have been reported in the fetus or infant: Due to induced uterine motility: Bradycardia, Premature ventricular contractions and other arrhythmias, Permanent CNS or brain damage, and Fetal death. Due to use of oxytocin in the mother: Low Apgar scores at 5 minutes. Neonatal jaundice, and Neonatal retinal hemorrhage.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.