DESIRE Protocol
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.
FDA-approved oxytocin products are injections used in labor and delivery (PITOCIN). No nasal, buccal or sublingual oxytocin is FDA-approved in the U.S. The one nasal product once approved (Syntocinon) had its approval withdrawn in 1997 after it was no longer marketed. Nuvari's oxytocin is compounded by a licensed U.S. pharmacy into a sublingual tablet with bremelanotide (Olympus) or with bremelanotide and tadalafil (Olympus Peak). This use is off-label, and the product is not FDA-approved. FDA does not review compounded medications for safety, effectiveness or quality before they reach patients. Most of the FDA label below concerns use during labor and delivery. It does not describe our formulation or how it is taken. Oxytocin causes the uterus to contract. Do not use it if you are pregnant or may be pregnant. The label also describes an antidiuretic (water-retaining) effect and allergic reactions. Your prescribing provider decides whether this product is appropriate for you.
Antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion; In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery; In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; In fetal distress where delivery is not imminent; Where adequate uterine activity fails to achieve satisfactory progress; Where the uterus is already hyperactive or hypertonic; In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord; In patients with hypersensitivity to the drug.
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. For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch .
Full prescribing information
Transcribed word for word from the FDA label for Pitocin (oxytocin, intravenous), effective May 6, 2026. Source details
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. Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
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.
Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin's cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with oxytocin. There are no known indications for use in the first trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated. Nonteratogenic Effects See ADVERSE REACTIONS in the fetus or neonate. Teratogenic Effects Animal reproduction studies have not been conducted with oxytocin. There are no known indications for use in the first trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated. Labor and Delivery See INDICATIONS AND USAGE section.
Every clinical sentence on this page is transcribed word for word from the U.S. FDA prescribing information for the product below. Nothing is summarised or rewritten. Sections describing the approved product's dosage forms, administration devices, packaging and storage are not included, because Nuvari dispenses a compounded formulation.