# Oxytocin: FDA Status, Research and Uses

> Oxytocin: FDA-approved obstetric uses of Pitocin and generic injections, label warnings, intranasal research, compounding rules and WADA status.

- Canonical URL: https://livingpluspeptides.com/peptides/oxytocin/
- Last updated: October 25, 2026
- Publisher: Living+

Oxytocin is a 9-amino-acid hormone made in the hypothalamus and released from the pituitary. FDA-approved injections, including Pitocin, are indicated for medically indicated induction of labor, stimulation of labor in selected cases of uterine inertia, adjunctive therapy in incomplete or inevitable abortion, and control of postpartum bleeding. Intranasal oxytocin has been studied for autism and obesity [1, 4, 6, 7].

## Regulatory status

- FDA approved: Yes: [Pitocin (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad), [Oxytocin Injection, USP generic (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7fd585a-99b7-4309-b003-a6cbef05372c)
- 503A compounding: [Component of an FDA-approved drug](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act). Active ingredient of FDA-approved Pitocin (NDA 018261) and oxytocin injection (NDA 018248).
- 503B bulks list: [Under evaluation (Category 1)](https://www.fda.gov/media/94164/download). 503B Category 1 (under evaluation), marked as a component of FDA-approved drugs, on the FDA list updated March 21, 2025.
- WADA prohibited: [No](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 List)
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22oxytocin%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [DailyMed: PITOCIN label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad), [DailyMed: Oxytocin Injection, USP label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7fd585a-99b7-4309-b003-a6cbef05372c), [Drugs@FDA: NDA 018261 (Pitocin)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261), [Drugs@FDA: NDA 018248 (oxytocin injection)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018248), [FDA: 503B nominated bulk drug substances list (March 21, 2025)](https://www.fda.gov/media/94164/download), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [Drugs@FDA: NDA 018245 Syntocinon](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018245), [openFDA drug shortages query: oxytocin](https://api.fda.gov/drug/shortages.json?search=generic_name:%22oxytocin%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Hormone (nonapeptide); oxytocic drug that acts on oxytocin receptors in the uterus [1]
- Amino-acid length: 9 amino acids, with a disulfide bridge [1, 4]
- Half-life: About 1 to 6 minutes in plasma (label) [1]
- Route used in studies: Intravenous infusion or intramuscular injection (label); intranasal in research studies [1, 6, 7]
- First studied: Uterine effects described in 1906; amino acid sequence worked out in 1953 [4]

## How it works

Oxytocin is a small hormone made of nine amino acids, with a sulfur bridge between its two cysteines. Most of it is made in nerve cells of the hypothalamus. It travels to the posterior pituitary, where it is released into the blood to help control labor and milk release [4].

In the uterus, oxytocin binds to its own receptors on the muscle wall. This raises calcium inside the muscle cells, which makes the uterus contract. The number of these receptors rises sharply during pregnancy and peaks in early labor at term. Because of this, the response to a given dose varies a lot from person to person [1].

The drug form is made in a lab, not taken from animal glands. The Pitocin label says it is made synthetically to avoid contamination with vasopressin, a closely related hormone [1].

Oxytocin also has a natural effect on the kidneys that makes the body hold on to water. At large doses this can lead to water intoxication. It can also raise blood pressure at high doses [1].

Inside the brain, oxytocin acts as a signaling chemical. This is why researchers have studied nasal sprays for social behavior, autism and appetite. Those uses are not approved [4, 6, 7].

It leaves the blood within minutes. The label gives a plasma half-life of about 1 to 6 minutes, cleared mainly by the kidney and liver [1].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Intranasal oxytocin for obesity (Plessow et al.) | 2024 | 61 adults with obesity | Randomized, double-blind, placebo-controlled, 8 weeks, intranasal | Studied for weight loss. Body weight change did not differ from placebo. Calorie intake at a test meal was lower with oxytocin [7]. | [Source](https://pubmed.ncbi.nlm.nih.gov/38815173/) |
| Human trial: SOARS-B autism trial (Sikich et al.) | 2021 | 290 children and adolescents, ages 3 to 17, with autism spectrum disorder | Randomized, placebo-controlled phase 2 trial, 24 weeks, intranasal | Studied for social withdrawal in autism. No significant difference from placebo on social or cognitive measures. Side effects were similar in both groups [6]. | [Source](https://pubmed.ncbi.nlm.nih.gov/34644471/) |
| Human trial: Registered replication of oxytocin and trust (Declerck et al.) | 2020 | Healthy volunteers | Large double-blind, placebo-controlled replication study | Found no effect of oxytocin on trusting behavior in the main test condition, which did not confirm the 2005 finding [9]. | [Source](https://pubmed.ncbi.nlm.nih.gov/32514040/) |
| Human trial: WHO CHAMPION trial (Widmer et al.) | 2018 | 29,645 women giving birth vaginally, 23 sites in 10 countries | Randomized, double-blind, noninferiority trial of heat-stable carbetocin versus oxytocin 10 IU by intramuscular injection | Blood loss of at least 500 ml or extra uterotonic use occurred in 14.4% with oxytocin and 14.5% with carbetocin [5]. | [Source](https://pubmed.ncbi.nlm.nih.gov/29949473/) |
| Human trial: Oxytocin and trust (Kosfeld et al.) | 2005 | Healthy volunteers | Single intranasal dose versus placebo in an economic trust game | Studied for trust. Reported a large rise in trust after oxytocin [8]. | [Source](https://pubmed.ncbi.nlm.nih.gov/15931222/) |

## Doses used in studies

Label dosing for the approved uses: for labor, the Pitocin label says intravenous infusion is the only acceptable method. The starting dose is 0.5 to 1 mU per minute, raised by 1 to 2 mU per minute every 30 to 60 minutes until a good contraction pattern is reached. At term, rates above 9 to 10 mU per minute are rarely required. To control bleeding after birth, 10 units can be given intramuscularly after the placenta is delivered [1].

The CHAMPION trial used 10 IU by intramuscular injection right after vaginal birth [5]. The autism trial used intranasal oxytocin with a total target dose of 48 IU daily for 24 weeks [6]. The obesity trial used 24 IU intranasally four times daily for 8 weeks [7].

**Dosing is set by a licensed provider.**

## Side effects and safety

Boxed warning, not for elective induction: the boxed notice on the label says data are not adequate to judge benefits and risks, so Pitocin is not indicated for elective induction of labor. Elective induction means starting labor when there is no medical reason [1].

Uterine overstimulation: the label warns that improper use can overstimulate the uterus and harm both mother and baby. Maternal deaths from high blood pressure episodes, bleeding in the brain and uterine rupture, and fetal deaths, have been reported with oxytocic drugs used to induce or speed up labor [1].

Water intoxication: oxytocin makes the body hold water. Severe water intoxication with seizures and coma has occurred with slow infusion over 24 hours, and maternal death from it has been reported [1].

Other reactions on the label include anaphylaxis, postpartum hemorrhage and irregular heartbeat in the mother. In newborns, the label lists jaundice, bleeding in the retina and seizures [1].

In the research trials of nasal oxytocin, side effects were similar to placebo in the autism trial, and the obesity trial reported no serious adverse events [6, 7].

## Legal and regulatory status

- 2026-01-01: The WADA 2026 Prohibited List took effect. Oxytocin is not named on it [12]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2025-03-21: FDA's 503B nominated substances list (updated March 21, 2025) shows oxytocin in Category 1, under evaluation, and marks it as a component of FDA-approved drugs [11]. [Source](https://www.fda.gov/media/94164/download)
- 2012-08-07: FDA Import Alert 66-41, on unapproved new drugs promoted in the U.S., includes an entry for an oxytocin injection from a foreign firm [13]. [Source](https://www.accessdata.fda.gov/cms_ia/importalert_190.html)
- 1980-11-19: Drugs@FDA lists the original approval of Pitocin, NDA 018261, on this date [3]. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261)
- 1980-07-09: Drugs@FDA lists the original approval of oxytocin injection NDA 018248 on this date [14]. [Source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018248)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-oxytocin).

## Frequently asked questions

### Is oxytocin FDA approved?

Yes. Oxytocin injection is FDA approved under the brand Pitocin and as generic oxytocin injection [1, 2, 3]. The approved uses are obstetric only.

### What is Pitocin used for?

The label lists induction of labor when there is a medical reason, stimulation of labor in selected cases of uterine inertia, adjunctive therapy for incomplete or inevitable abortion, and uterine contractions after delivery to control postpartum bleeding [1].

### Is Pitocin approved for elective induction of labor?

No. The label says available data are not adequate to evaluate benefits and risks, so Pitocin is not indicated for elective induction [1].

### Is oxytocin nasal spray FDA approved?

The FDA labels cited here cover intravenous infusion and intramuscular injection only [1, 2]. Nasal oxytocin has been studied for autism and obesity, but those uses are not on these labels [6, 7].

### Does oxytocin increase trust or bonding?

A 2005 study reported more trust after a nasal dose [8]. A large 2020 replication found no effect in the main test condition [9].

### Did oxytocin help autism in trials?

In a 24-week trial of 290 children and teens, intranasal oxytocin did not differ from placebo on social or cognitive measures [6].

### What are the main risks of oxytocin?

The label warns of uterine overstimulation, uterine rupture and water intoxication, and reports rare maternal and fetal deaths with oxytocic drugs during labor [1].

### Can pharmacies compound oxytocin?

Under section 503A, pharmacies may use bulk substances that are components of FDA-approved drugs, along with other conditions [10]. For outsourcing facilities, the FDA 503B list shows oxytocin in Category 1, under evaluation [11].

### Is oxytocin banned by WADA?

Oxytocin is not named on the WADA 2026 Prohibited List [12]. Athletes should still check with their anti-doping body.

## Sources

1. [DailyMed: PITOCIN (oxytocin injection) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad)
2. [DailyMed: Oxytocin Injection, USP (generic) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7fd585a-99b7-4309-b003-a6cbef05372c)
3. [Drugs@FDA: NDA 018261 (Pitocin)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261)
4. [Lee et al. 2009, Oxytocin: the Great Facilitator of Life (PMC)](https://pmc.ncbi.nlm.nih.gov/articles/PMC2689929/)
5. [Widmer et al. 2018, N Engl J Med (PubMed)](https://pubmed.ncbi.nlm.nih.gov/29949473/)
6. [Sikich et al. 2021, N Engl J Med (PubMed)](https://pubmed.ncbi.nlm.nih.gov/34644471/)
7. [Plessow et al. 2024, NEJM Evidence (PubMed)](https://pubmed.ncbi.nlm.nih.gov/38815173/)
8. [Kosfeld et al. 2005, Nature (PubMed)](https://pubmed.ncbi.nlm.nih.gov/15931222/)
9. [Declerck et al. 2020, Nat Hum Behav (PubMed)](https://pubmed.ncbi.nlm.nih.gov/32514040/)
10. [FDA: Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)
11. [FDA: 503B nominated bulk drug substances list (March 21, 2025)](https://www.fda.gov/media/94164/download)
12. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
13. [FDA: Import Alert 66-41](https://www.accessdata.fda.gov/cms_ia/importalert_190.html)
14. [Drugs@FDA: NDA 018248 (oxytocin injection)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018248)

Educational information, not medical advice. This site sells nothing.