Prescription medication · Oxytocic Hormone
oxytocin
Also sold as Pitocin. This medicine is used to begin or strengthen labor.
Data updated 2026-05-15
- 2,902
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- 1
- Recall record
What the data shows
oxytocin (Pitocin) is a prescription Oxytocic Hormone, among the least-reported drugs the FDA tracks (2,902 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
oxytocin (Pitocin) is a prescription Oxytocic Hormone. This medicine is used to begin or strengthen labor.
Oxytocin (Pitocin) is a hormone medicine. It is used to start or improve contractions during labor.
Verify with FDA → · CMS NADAC pricing →
What it does
This medicine is used to begin or strengthen labor.
Common side effects
Nausea, Vomiting, Pain
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from oxytocin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Oxytocin works by mimicking the natural hormone of the same name. It increases contractions of the uterus. These contractions help to deliver the baby.
How to Take It
Take 20 drops in a little water. Do this two times per day. Take it 15 minutes before you eat your meals. Follow your doctor's instructions carefully.
This is a plain-language summary of oxytocin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
This drug is used during pregnancy and delivery. Talk to your doctor about the risks and benefits.
This is a plain-language summary of oxytocin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of oxytocin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store this medicine as directed by your doctor or pharmacist.
Side Effects (from patient reports)
Based on 2,902 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for oxytocin, by number of reports
- Baby exposed to drug during pregnancy
Baby exposed to drug during pregnancy
429 reports
- Mother exposed to drug during pregnancy
Mother exposed to drug during pregnancy
426 reports
- Exposure to drug during pregnancy
Exposure to drug during pregnancy
359 reports
- Baby born too early
Baby born too early
205 reports
- Low blood pressure
Low blood pressure
191 reports
- Delivery before term 159
Delivery before term
159 reports
- Exposure to drug during pregnancy 143
Exposure to drug during pregnancy
143 reports
- Excessive bleeding after childbirth 131
Excessive bleeding after childbirth
131 reports
- Mother exposed to drug during delivery 117
Mother exposed to drug during delivery
117 reports
- C-section 105
C-section
105 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for oxytocin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where oxytocin sits
oxytocin has more FDA adverse-event reports than 18% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is oxytocin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 2,902 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1996–2025.
Total Reports
2,902
Reports Mentioning Death
149
5.1% of reports — not proof of cause
Hospitalization Reports
848
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FOETAL EXPOSURE DURING PREGNANCY | 429 |
| 2 | MATERNAL EXPOSURE DURING PREGNANCY | 426 |
| 4 | EXPOSURE DURING PREGNANCY | 359 |
| 5 | PREMATURE BABY | 205 |
| 6 | HYPOTENSION | 191 |
| 8 | PREMATURE DELIVERY | 159 |
| 9 | DRUG EXPOSURE DURING PREGNANCY | 143 |
| 10 | POSTPARTUM HAEMORRHAGE | 131 |
| 11 | MATERNAL EXPOSURE DURING DELIVERY | 117 |
| 12 | CAESAREAN SECTION | 105 |
| 13 | LOW BIRTH WEIGHT BABY | 104 |
| 14 | NAUSEA | 96 |
| 15 | DYSPNOEA | 90 |
| 16 | VOMITING | 79 |
| 17 | TACHYCARDIA | 77 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Examples: norepinephrine, epinephrine, oxytocin.
Mechanism: These medications both cause blood vessels to narrow, which can lead to a combined effect that raises blood pressure to unsafe levels.
What to do: Your medical team should watch your blood pressure carefully to ensure it stays within a safe range during treatment.
( 7 .1) Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. ( 7 .4) 7.1 Drugs Antagonizing Pressor Effects of Epinephrine • α-blockers, such as phentolamine • Vasodilators, such as nitrates • Diuretics • Antihypertensives • Ergot alkaloids • Phenothiazine antipsychotics 7.2 Drugs Potentiating Pressor Effects of Epinephrine • Sympathomimetics • β-blockers, such as propranolol • Tricyclic anti-depressants •...
Mechanism: Oxytocin can increase the blood pressure-raising effects of epinephrine. This combination might cause your blood pressure to go higher than expected.
What to do: Your healthcare provider should monitor your blood pressure carefully when using these medications at the same time.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What is oxytocin used for?
How often should I take this medicine?
What should I do if I miss a dose?
Can this medicine cause side effects?
Is it safe to use during pregnancy?
How should I store this medicine?
What if the medicine doesn't seem to be working?
Can this medicine cause high blood pressure?
Can this medicine cause allergic reactions?
Does this medicine affect the baby?
What are the common side effects of oxytocin?
Does oxytocin interact with other medications?
What drug class is oxytocin?
Is oxytocin safe during pregnancy?
Has oxytocin been recalled?
Active Recalls
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
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What the FDA Data Shows for oxytocin
The FDA label for oxytocin (sold under brand names such as Pitocin) classifies it as a prescription-only medication in the Oxytocic Hormone class. This medicine is used to begin or strengthen labor. Official labeling lists 3 commonly reported side effects, including Nausea, Vomiting, Pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,902 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 22, 2018
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages