warnings
WARNINGS Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.
Oxytocin
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
- Brand name
- Oxytocin
- Generic name
- OXYTOCIN
- Manufacturer
- REMEDYREPACK INC.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242
- SPL ID
- 5a6d19ba-e226-8433-e063-6394a90a1028
- Version
- 3
- Effective date
- 2026-09-01
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:48:27
| Harmonized routes |
|---|
| INTRAMUSCULAR, INTRAVENOUS |
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 |
|---|---|---|---|
| application applno | NDA | 018248 | derived:openfda.application_number |
| application number | NDA018248 | openfda.application_number | |
| brand name | Oxytocin | openfda.brand_name | |
| generic name | OXYTOCIN | openfda.generic_name | |
| manufacturer name | REMEDYREPACK INC. | openfda.manufacturer_name | |
| ndc | package | 70518-4233-1 | openfda.package_ndc |
| ndc | package | 70518-4233-0 | openfda.package_ndc |
| ndc | product | 70518-4233 | openfda.product_ndc |
| ndc11 | package | 70518423301 | derived:openfda.package_ndc |
| ndc11 | package | 70518423300 | derived:openfda.package_ndc |
| rxcui | 1791721 | openfda.rxcui | |
| spl id | 5a6d19ba-e226-8433-e063-6394a90a1028 | id | |
| spl set id | b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242 | set_id | |
| unii | 1JQS135EYN | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been reported in the mother: Anaphylactic reaction Postpartum hemorrhage Cardiac arrhythmia Fatal afibrinogenemia Nausea Vomiting Premature ventricular contractions 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, and is 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 mobility: Bradycardia Premature ventricular contractions and other arrhythmias Permanent CNS or brain damage Fetal death Due to use of oxytocin in the mother: Neonatal retinal hemorrhage Low Apgar scores at five minutes Neonatal jaundice
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.