FDA-filed SPL labeling · retrieved through openFDA

Oxytocin Injection

Oxytocin Injection is a synthetic hormone used to induce or stimulate labor for medical reasons, manage certain abortions, and control postpartum (after-delivery) uterine bleeding.

Brand name Pitocin
Drug class Oxytocic
Rx Form 1 Routes Intravenous · Intramuscular, Intravenous · Intramuscular; Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 12, 2026
Clinical labels in scope 11
AvailabilityRx
Earliest approval/marketing year 1980
FDA-listed product records 22
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Oxytocin Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Oxytocin Injection is a closely monitored hospital medication used to start or strengthen labor for medical reasons, assist with managing abortion, and control heavy bleeding after delivery. It must only be given by IV infusion (or IM injection postpartum) under continuous medical supervision — never for convenience-based induction. Because it can cause serious complications including uterine rupture and water intoxication, the dose is adjusted carefully and both mother and baby are watched throughout.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Oxytocin Injection is approved only for medically necessary induction of labor — not for convenience. Using it to induce labor when there is no medical reason (elective induction) has not been shown to be safe or beneficial based on available evidence. This warning applies to Oxytocin Injection, USP (synthetic). If you have questions about why labor induction has been recommended for you, ask your care team to explain the medical reason.

Read the full warning on DailyMed →

📖 Oxytocin Injection: Patient Information Guide

A plain-language walkthrough of Oxytocin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Oxytocin Injection is a synthetic hormone used in obstetric (pregnancy-related) care for several specific medical situations.

  • Induction of labor when there is a medical need — such as Rh blood incompatibility, maternal diabetes, pre-eclampsia (high blood pressure in pregnancy), or premature rupture of membranes
  • Stimulation or reinforcement of labor when uterine contractions are too weak to progress (uterine inertia)
  • Adjunctive therapy (supportive treatment) in the management of incomplete or inevitable abortion, including second-trimester abortion by IV infusion
  • Producing uterine contractions during the third stage of labor (after the baby is born, before the placenta delivers)
  • Controlling postpartum hemorrhage (heavy bleeding after delivery)
  • Not approved for elective induction of labor (induction for convenience with no medical reason)
⚙️How it works

Oxytocin works by binding to specific receptors in the uterine muscle (myometrium) and increasing calcium levels inside those muscle cells. That calcium activates a key enzyme that triggers the muscle-contracting protein actomyosin — causing the uterus to squeeze and contract. The number of oxytocin receptors in the uterus rises dramatically during pregnancy and peaks in early labor, which is why the uterus becomes increasingly sensitive to even small amounts of oxytocin as the due date approaches.

At high doses, oxytocin also shares properties with vasopressin — a hormone that raises blood pressure and causes the body to hold onto water. This can become clinically significant (noticeable and potentially harmful) when large doses are used.

💊How it's taken

Oxytocin Injection is always given by a healthcare professional in a hospital — never at home. The dose is adjusted based on how the uterus responds, not on a fixed schedule.

  • Labor induction or stimulation: given only by intravenous (IV) infusion using an infusion pump, with continuous monitoring
  • Postpartum bleeding control: given either by IV infusion or by intramuscular (IM) injection after the placenta is delivered
  • Incomplete abortion: given by IV infusion

There is no food interaction since this medication is given intravenously or by injection in a clinical setting. Your care team will determine the appropriate rate and duration based on your response.

🤒Side effects — in detail

Like all medications, Oxytocin Injection can cause side effects — your care team will monitor for these during administration.

  • Nausea and vomiting
  • Abnormal heart rhythms (cardiac arrhythmia) in the mother
  • Premature ventricular contractions (extra, abnormal heartbeats)
  • High blood pressure episodes
  • Postpartum hemorrhage (heavy bleeding after delivery)
  • Pelvic hematoma (pooling of blood in pelvic tissue)
  • Slow heart rate (bradycardia) or abnormal rhythms in the newborn
  • Neonatal jaundice (yellowing of newborn's skin)

Serious reactions — including uterine rupture, severe allergic reaction (anaphylaxis), seizures from water intoxication, and fetal distress — require immediate medical attention and are monitored for throughout treatment.

⚠️Warnings & precautions
  • Hospital-only use: Pitocin must only be given for labor induction or augmentation by IV infusion in a hospital with continuous medical supervision and monitoring of contractions and fetal heart rate.
  • Uterine hyperstimulation: Too-strong or too-frequent contractions can lead to uterine rupture, cervical lacerations, heavy bleeding, and serious harm to the baby — the infusion must be stopped immediately if this occurs.
  • Water intoxication: High-dose, prolonged infusions can cause the body to retain water dangerously, leading to convulsions, coma, and potentially death. This is a known and serious risk.
  • Fetal risks: Oxytocin use has been associated with fetal bradycardia (slow heart rate), low Apgar scores, permanent brain damage, neonatal seizures, and fetal death in serious cases.
  • Anaphylaxis: Severe allergic reactions have been reported and require emergency treatment.
  • Not for elective induction: The available evidence does not support using this drug to induce labor for convenience — only for clear medical reasons.
🔀What it interacts with

Oxytocin Injection can interact with certain anesthetic agents and vasoactive (blood-vessel-affecting) drugs used during labor.

  • Vasoconstrictors with caudal block anesthesia: If a vasoconstrictor (a drug that narrows blood vessels) was given as part of a caudal (lower-back) anesthetic block within the past 3–4 hours, adding oxytocin can cause severe high blood pressure.
  • Cyclopropane anesthesia: This anesthetic can unpredictably change how oxytocin affects the heart and blood pressure — potentially causing low blood pressure or abnormal heart rhythms, including slow heart rate with irregular beats between the heart's upper and lower chambers.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your care team about any history of allergic reactions to oxytocin or similar medications
  • Pitocin must not be used if the baby is in a position (such as lying sideways across the uterus) that makes vaginal delivery unsafe without first correcting the position
  • Pitocin must not be used if there is a significant size mismatch between the baby's head and the mother's pelvis (cephalopelvic disproportion)
  • Pitocin must not be used if the uterus is already contracting too strongly or too frequently (hyperactive or hypertonic uterus)
  • Pitocin must not be used in cases where vaginal delivery is contraindicated — including complete placenta previa, cord prolapse or presentation, active genital herpes, or invasive cervical cancer
  • Pitocin must not be used when the baby is showing signs of fetal distress and delivery is not imminent
  • Inform your provider of all other medications, especially any anesthetics or vasoactive drugs planned for use during labor
🚑If you take too much

Too much oxytocin causes the uterus to contract too hard or too long — this can lead to uterine rupture, severe bleeding, lacerations, and serious or fatal complications for both mother and baby. Large doses given over a long period can also cause water intoxication (dangerous fluid buildup), leading to seizures and coma. If overdose is suspected, the oxytocin infusion is stopped immediately and supportive medical treatment is provided.

📡Pharmacodynamics — effects in the body

Oxytocin causes the uterine muscle to contract by raising calcium levels inside muscle cells, activating the proteins needed for contraction. After an IV infusion, the uterus begins responding almost immediately, and the effect fades within about one hour after the infusion stops. After an intramuscular injection, contractions begin within 3 to 5 minutes and can last 2 to 3 hours. At high doses, oxytocin also raises blood pressure (pressor effect) and reduces urine output (antidiuretic effect), because of its chemical similarity to vasopressin.

🔬Pharmacokinetics — how your body processes it

Oxytocin is distributed throughout the fluid surrounding body cells (extracellular fluid), and small amounts can reach the baby's circulation. Its half-life in the bloodstream — the time it takes for the body to clear half the drug — is very short: about 1 to 6 minutes, and it is even shorter during late pregnancy and breastfeeding. The kidneys and liver are the main organs responsible for clearing it from the body, with only small amounts leaving unchanged in the urine.

📦How to store it

Store between 20° to 25°C (68° to 77°F).

📄 Written from Oxytocin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Oxytocin Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I being given oxytocin? I thought labor was supposed to start on its own.
That's a really common question. Oxytocin is used when there's a medical reason to start or speed up labor — for example, if your water has broken and contractions haven't started, if you have pre-eclampsia, diabetes, or a blood incompatibility with the baby, or if your contractions aren't strong enough to move labor forward. It's only approved for these kinds of medical reasons, not simply because it's more convenient. Your care team should be able to explain the specific reason it's been recommended for you.
How will the oxytocin be given to me?
For starting or strengthening labor, oxytocin is always given through an IV drip in your arm using a pump that carefully controls the flow rate. Your contractions and your baby's heart rate will be monitored closely throughout. After delivery, if it's being used to prevent heavy bleeding, it can be given either through the IV or as an injection into the muscle. You won't be doing any of this yourself — it's all managed by your hospital team.
What side effects should I know about?
The most common ones are nausea and vomiting. Your heart rate and blood pressure will be watched for any changes. If the contractions become too strong or too frequent, that's something the team will catch and address right away by stopping or slowing the drip. There are also potential effects on your baby — like changes in heart rate — which is exactly why continuous monitoring is done. If at any point you feel something isn't right, tell your nurse immediately.
Is there anything that could make oxytocin dangerous to use with me?
Yes, there are a few important ones your care team will check. Oxytocin shouldn't be used if your baby is in a position that makes vaginal delivery unsafe, if your uterus is already contracting too hard, or if there are certain conditions like complete placenta previa or active genital herpes. Also, if certain anesthetic drugs are being used — like a caudal block with a vasoconstrictor — the timing matters, because combining them too closely can cause a dangerous spike in blood pressure. Make sure your team knows your full medication history before labor.
Can getting too much oxytocin hurt me or the baby?
Yes, that's why the infusion pump and constant monitoring are so important. Too much oxytocin can make contractions too strong or too long, which in rare but serious cases can put stress on the baby or, very rarely, cause uterine rupture. Very high doses over a long period can also cause water retention in your body, leading to a dangerous condition called water intoxication, which can cause seizures. The team is specifically watching for these signs, and the infusion can be stopped immediately if needed.
Will oxytocin affect my baby?
Small amounts of oxytocin can reach the baby's bloodstream. The main risks to the baby are related to how strongly the uterus contracts — very strong contractions can temporarily reduce oxygen flow to the baby, which is why the baby's heart rate is monitored throughout. In rare cases, oxytocin use has been linked to a slow newborn heart rate, low Apgar scores (a measure of how well the baby is doing at birth), and neonatal jaundice (yellowing of the skin). These are exactly the reasons close monitoring is a standard part of oxytocin use.
Is Oxytocin Injection available over the counter?
Oxytocin Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Oxytocin Injection first available?
Oxytocin Injection has been available in the United States since at least 1980, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Oxytocin Injection?
Oxytocin Injection is supplied by 8 manufacturers listed in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Par Health USA, LLC, Par Pharmaceutical, Inc..

💬 Answers drafted from Oxytocin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Oxytocin Injection comes

Oxytocin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a muscle · Into a vein
Brands Pitocin
How this form is used
What it may be used for
  • Used intravenously to induce or stimulate labor when there is a medical reason (e.g., maternal diabetes, pre-eclampsia, premature membrane rupture)
  • Used intravenously or intramuscularly to control postpartum uterine bleeding or hemorrhage after delivery
  • Used intravenously to help manage incomplete or inevitable abortion
  • Pitocin is contraindicated for elective (non-medical) induction of labor
Important instructions
  • For labor induction or stimulation: must be given only by intravenous infusion using an infusion pump, with continuous monitoring of contractions and fetal heart rate
  • For postpartum bleeding control: may be given as an intravenous infusion or as an intramuscular injection after delivery of the placenta
  • For incomplete abortion: given as an intravenous infusion
  • Pitocin for labor induction or augmentation must be administered in a hospital under close medical supervision
Available strengths 2 strengths
22 FDA-listed product records

📊 Oxytocin Injection across the U.S. market

How Oxytocin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
8
Manufacturers
2
Brand names
22
FDA-listed product records
1980
First marketed
Fresenius Kabi USA, LLC27%
Par Health USA, LLC18%
Par Pharmaceutical, Inc.14%
Cardinal Health 107, LLC9%
Hikma Pharmaceuticals USA Inc.9%
Remedyrepack Inc.9%
Other makers14%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Oxytocin Injection is used

A general measure of how commonly Oxytocin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Oxytocin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,478
Medicaid prescriptions filled (Q1–Q4 2025)
$26,278 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oxytocin Injection prescribed? Of the 1,596 medications we measure, Oxytocin Injection ranks #1,230 by Medicaid prescriptions — more than 23% of them.

Where Oxytocin Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Oxytocin Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mL / 10 units/mL injection is the most-dispensed Oxytocin Injection product — about 86% of these Medicaid prescriptions.

1 ML oxytocin 10 UNT/ML Injection Most dispensed

1,276 Medicaid prescriptions (Q1–Q4 2025) 86% of Oxytocin Injection prescriptions shown $26,270 gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 3 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1791721

oxytocin 10 UNT/ML Injectable Solution

202 Medicaid prescriptions (Q1–Q4 2025) 14% of Oxytocin Injection prescriptions shown $8 gross reimbursement (before rebates) ≈ $0.04 per prescription (gross)

Summed across the 3 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238013

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Oxytocin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 30 listed Oxytocin Injection NDCs with Medicaid activity.

🔍 Compare Oxytocin Injection products

A representative set of FDA-listed product records for Oxytocin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
10 [USP'U]/mL Intramuscular; Intravenous Cardinal Health NDA View NDC →
10 [USP'U]/mL Intramuscular, Intravenous Cardinal Health 107, LLC NDA View NDC →
10 [USP'U]/mL Intramuscular; Intravenous Cardinal Health 107, LLC NDA View NDC →
10 [USP'U]/mL Intramuscular, Intravenous Fresenius Kabi USA, LLC × 3 listings NDA View NDC →
10 [USP'U]/mL Intramuscular; Intravenous Fresenius Kabi USA, LLC × 3 listings NDA View NDC →
10 [USP'U]/mL Intramuscular; Intravenous Hikma Pharmaceuticals USA Inc. × 2 listings NDA View NDC →
10 [IU]/mL Intravenous Par Health USA, LLC × 4 listings NDA View NDC →
10 [IU]/mL Intravenous Par Pharmaceutical, Inc. × 3 listings NDA View NDC →
10 [USP'U]/mL Intramuscular, Intravenous Remedyrepack Inc. × 2 listings NDA View NDC →
10 [USP'U]/mL Intramuscular, Intravenous West-Ward Pharmaceuticals Corp × 2 listings ANDA View NDC →

Showing 22 of 22 products — FDA National Drug Code Directory. See every product, package size and price: browse all 22 Oxytocin Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Oxytocin Injection RxCUI 7824 2 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 93672 In current FDA listings
    Clinical drug / strength (SCD) 5 UNT/ML RxCUI 245271 10 UNT/ML RxCUI 238013 20 UNT/ML RxCUI 584302
  2. Dose form (SCDF) Injection RxCUI 1791720 In current FDA listings
    Clinical drug / strength (SCD) 1 ML oxytocin 10 UNT/ML RxCUI 1791721

Look up RxCUI 7824 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Pitocin

🏭 Manufacturers & labelers

Fresenius Kabi USA, LLC 6 Par Health USA, LLC 4 Par Pharmaceutical, Inc. 3 Cardinal Health 107, LLC 2 Hikma Pharmaceuticals USA Inc. 2 Remedyrepack Inc. 2 West-Ward Pharmaceuticals Corp 2 Cardinal Health 1

RxNorm drug class

Oxytocin Injection belongs to the Oxytocic class.

Pharmacologic class Oxytocic
Drug family (ATC) Oxytocin and analogues

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 12, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oxytocin Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Oxytocin Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
NDC products indexed
22
Distinct labelers/manufacturers represented
8
Linked representative label
Fresenius Kabi USA, LLC
Linked label effective
Jan 12, 2026
Composite sections available
15
Linked SPL Set ID
c7fd585a-99b7-4309-b003-a6cbef05372c
Linked SPL Document ID
3649e8ed-929c-4600-9d63-3d77fbe3a0f5
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 11 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.