FDA label 4e0aed90-7777-4e1d-b467-800ba6d7b9df
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
- 6c3cdbf4-2219-4df3-aca1-5b214803677b
- SPL ID
- 4e0aed90-7777-4e1d-b467-800ba6d7b9df
- Version
- 3
- Effective date
- 2011-10-12
- Source export date
- 2026-08-01
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:21:38
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 | 4e0aed90-7777-4e1d-b467-800ba6d7b9df | id | |
| spl set id | 6c3cdbf4-2219-4df3-aca1-5b214803677b | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS Pitocin, when given for induction of labor or augmentation of uterine activity, should be administered only by the intravenous route and with adequate medical supervision in a hospital.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction Premature ventricular contractions Postpartum hemorrhage Pelvic hematoma Cardiac arrhythmia Subarachnoid hemorrhage Fatal afibrinogenemia Hypertensive episodes Nausea Rupture of the uterus Vomiting 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 neonate: Due to induced uterine motility: Due to use of oxytocin in the mother: Bradycardia Low Apgar scores at five minutes Premature ventricular contractions and other arrhythmias Neonatal jaundice Permanent CNS or brain damage Neonatal retinal hemorrhage Fetal death Neonatal seizures have been reported with the use of Pitocin.
adverse reactions table
<table width="0.000" ID="id_024b6ed5-961d-4079-8bdb-8eda25bf5a20"> <col/> <col/> <tbody> <tr ID="id_4575a90b-9f72-42ca-8df5-bd72cc8b79ef"> <td align="left" valign="top" styleCode="Botrule Rrule">Anaphylactic reaction</td> <td align="left" valign="top" styleCode="Lrule Botrule">Premature ventricular contractions</td> </tr> <tr ID="id_1c7e8396-809f-4015-a2f7-d7e756527d6d"> <td align="left" valign="top" styleCode="Botrule Rrule">Postpartum hemorrhage</td> <td align="left" valign="top" styleCode="Lrule Botrule">Pelvic hematoma</td> </tr> <tr ID="id_59ab9a56-d2fa-4da4-b11a-2de1e3b22b1a"> <td align="left" valign="top" styleCode="Botrule Rrule">Cardiac arrhythmia</td> <td align="left" valign="top" styleCode="Lrule Botrule">Subarachnoid hemorrhage</td> </tr> <tr ID="id_ddad3adf-49e6-43a1-a656-f07cc0e64340"> <td align="left" valign="top" styleCode="Botrule Rrule">Fatal afibrinogenemia</td> <td align="left" valign="top" styleCode="Lrule Botrule">Hypertensive episodes</td> </tr> <tr ID="id_cbdd3326-f92a-4eef-b834-ae3a5f5620d2"> <td align="left" valign="top" styleCode="Botrule Rrule">Nausea</td> <td align="left" valign="top" styleCode="Lrule Botrule">Rupture of the uterus</td> </tr> <tr ID="id_4e266420-4063-4601-b593-1acf71c31da7"> <td align="left" valign="top" styleCode="Rrule">Vomiting</td> <td align="left" valign="top" styleCode="Botrule"/> </tr> </tbody> </table>
adverse reactions table
<table width="0.000" ID="id_3d53016b-dfd9-4450-9a55-eb9825287894"> <col/> <col/> <tbody> <tr ID="id_f5b6c008-6cc0-41af-afb0-2ac947f174ee"> <td align="left" valign="top" styleCode="Botrule Rrule">Due to induced uterine motility:</td> <td align="left" valign="top" styleCode="Lrule Botrule">Due to use of oxytocin in the mother: </td> </tr> <tr ID="id_9cb22918-0988-435e-842e-13562542f2e3"> <td align="left" valign="top" styleCode="Botrule Rrule">Bradycardia</td> <td align="left" valign="top" styleCode="Lrule Botrule">Low Apgar scores at five minutes</td> </tr> <tr ID="id_d88ea9fe-f975-48d8-aa40-d0215e7b9ec8"> <td align="left" valign="top" styleCode="Botrule Rrule">Premature ventricular contractions and other arrhythmias</td> <td align="left" valign="top" styleCode="Lrule Botrule">Neonatal jaundice</td> </tr> <tr ID="id_b2e47d7f-46e0-48f6-9c2c-6ed210865882"> <td align="left" valign="top" styleCode="Botrule Rrule">Permanent CNS or brain damage</td> <td align="left" valign="top" styleCode="Lrule Botrule">Neonatal retinal hemorrhage </td> </tr> <tr ID="id_ad9cabe9-0ce3-46a8-9fd6-a019d83aab72"> <td align="left" valign="top" styleCode="Botrule Rrule">Fetal death</td> <td align="left" valign="top" styleCode="Lrule Botrule"/> </tr> <tr ID="id_53db88c1-855a-4eb1-a041-fb6edf74e472"> <td align="left" valign="top" styleCode="Rrule">Neonatal seizures have been reported with the use of Pitocin.</td> <td align="left" valign="top" styleCode="Botrule"/> </tr> </tbody> </table>