Bedside Snapshot

Use It For: Postpartum hemorrhage (PPH) when IV oxytocin is unavailable or fails, per protocol; NSAID-ulcer risk reduction (labeled); off-label cervical ripening, labor induction and early pregnancy loss
Adult Dose: PPH treatment: 800 mcg SL once if IV oxytocin is unavailable or fails
PPH prevention: 400 or 600 mcg PO once after birth
NSAID ulcer: 200 mcg PO four times daily with food (100 mcg if not tolerated)
Pediatric Dose: Not established in children: no pediatric dosing; specialist use only
Onset / Duration: Uterine onset and duration not labeled; oral peak about 12 min, half-life 20–40 min (see Pharmacology)
Do Not Give / Hold If: Pregnancy for NSAID-ulcer use; prostaglandin allergy; prior uterine surgery including cesarean for labor use; uterine tachysystole or fetal distress with delivery not imminent: stop
Watch For: Uterine tachysystole and uterine rupture; fever over 40°C (104°F) with PPH use, with tachycardia, agitation or convulsions; diarrhea and dehydration
Reversal / Rescue: No specific antidote: supportive care and stop further doses; dialysis is unlikely to help (label). Treat PPH per protocol
Must Remember: Routes and doses are not interchangeable: 400–600 mcg PO for PPH prevention; 800 mcg SL for PPH treatment; 200 mcg PO four times daily is the NSAID-ulcer regimen

Indications

Emergency & Prehospital

Postpartum hemorrhage from uterine atony: the second-line uterotonic. Use it when IV oxytocin is unavailable or is not stopping the bleeding, per WHO 2025. This is off-label. The FDA label limits serious PPH to hospital use. Prehospital use is set by agency protocol and medical direction
PPH prevention: the stand-in for oxytocin or carbetocin at birth, used where heat-stable carbetocin is not available , per WHO 2025. Off-label

ED / ICU / Transport

NSAID-induced gastric ulcer risk reduction: the only labeled use. It covers patients at high risk of NSAID ulcer complications (label)
Cervical ripening and labor induction: off-label. This page does not reproduce the regimens (see Dosing). Hospital use only (label)

Other Uses

Early pregnancy loss and medical abortion: off-label, given with or without mifepristone per protocol. The regimens are left out of this page on purpose. For related context, see the ectopic pregnancy and Rho(D) immune globulin pages. EMS may get the call for bleeding, cramping or fever after outpatient use. Assess for PPH and infection

Dosing & Administration

Doses vary by protocol; follow local protocols and medical direction.

Available Forms

100 mcg oral tablet (Cytotec, Pfizer): white, round; 60-count bottle
200 mcg oral tablet (Cytotec, Pfizer): white, hexagonal; 60- and 100-count bottles and 100-count unit-dose cartons
No injectable or parenteral product in the US labeling. Obstetric routes (sublingual, buccal, vaginal) use the same oral tablets, and that use sits outside the label

High-Alert Medication Check: Not on the ISMP acute-care high-alert list (2024). The main errors are the route and the indication: 200 mcg tablets four times daily (NSAID regimen) versus 800 mcg SL once (PPH treatment) versus 400–600 mcg PO (PPH prevention). Confirm the indication and the dose on your own before you give it.

Adult Dosing

Indication	Dose & Route	Repeat / Max	Notes
PPH treatment (uterine atony), after IV oxytocin fails or is unavailable	800 mcg SL (PPH only), once (four 200 mcg tablets)	Single dose; no fixed max. WHO 2025: if misoprostol was already given for prevention and injectables are unavailable, there is insufficient evidence to guide more doses; weigh toxicity	Off-label (not labeled for PPH); the FDA label restricts serious PPH use to hospital use. Not an add-on to oxytocin: WHO 2025 finds no added benefit. Monitor temperature (hyperpyrexia reported)
PPH prevention, all births (when oxytocin or carbetocin is not used)	400 mcg or 600 mcg PO, once, immediately after birth	Single dose; no repeat regimen in WHO 2025 prevention recommendation	Off-label. Use only one uterotonic for prevention. Diarrhea, shivering and fever are the common effects
NSAID-induced gastric ulcer risk reduction (labeled)	200 mcg PO four times daily with food; 100 mcg if 200 mcg is not tolerated	Max 800 mcg/day; take for the duration of NSAID therapy	Contraindicated in pregnancy for this use (boxed warning). Last dose at bedtime; avoid magnesium antacids
Cervical ripening or labor induction (off-label, hospital use)	Oral: 25 mcg every 2 h, or 50–100 mcg every 4 h (static dosing preferred to hourly titration). Vaginal: 25 mcg every 3–6 h. Follow the obstetric protocol for the final regimen	No fixed max; titrate to protocol. Tachysystole favors the 25 mcg vaginal dose over 50 mcg	Off-label, hospital use only, with continuous uterine and fetal monitoring. Setting is a term, singleton, vertex pregnancy with membranes intact. Contraindicated with prior uterine surgery, including cesarean (ACOG CPG No. 9). Sublingual or buccal use gives higher peak levels but more uterine tachysystole than vaginal use in a meta-analysis; outside the label. ACOG CPG No. 9 does not recommend sublingual misoprostol for routine cervical ripening

Pediatric Dosing

Indication	Dose (per kg) & Route	Max Single / Max Total	Notes
Any indication in children	Not established in children	Not applicable	Label: safety and effectiveness in pediatric patients have not been established. Specialist use only

Pediatric note: No pediatric dose exists for this drug. For weight-based dosing of other agents, use pediatric weight-based dosing.

Preparation & Administration

Oral: give it with food to cut down on diarrhea and nausea. The last daily dose goes at bedtime (label). Food lowers the peak levels
Sublingual (PPH treatment): 800 mcg placed under the tongue, once. Four 200 mcg tablets equal 800 mcg. Confirm tablet count and strength at the bedside
Obstetric routes: vaginal, buccal and sublingual use for cervical ripening or labor is hospital protocol only. It needs continuous uterine and fetal monitoring
Rectal and other routes: some agency and teaching protocols include them, and the dose and route depend on the protocol. WHO 2025 specifies 800 mcg SL for PPH treatment. This page gives no rectal dose
Storage: keep it at or below 25°C (77°F) in a dry area (label). It is heat-stable, so WHO 2025 says it needs no refrigeration
Timing with oxytocin: the label says the two are not recommended together, especially within 4 hours before starting oxytocin. Do not give misoprostol as an add-on for PPH

Dosing Notes:

PPH treatment and the NSAID regimen use different routes and doses. Check the indication first, then the dose
Label: studies tolerated cumulative daily doses of 1,600 mcg. That is not a treatment target
Indication and the uterine or bleeding response set the dose. Weight does not
Don't stop at the uterotonic. PPH care also includes uterine massage, early tranexamic acid (within 3 hours, see the tranexamic acid page), and a check for a retained placenta or a second fetus

Contraindications & Precautions

Contraindications (label)

Pregnancy when used to reduce NSAID-induced ulcer risk (boxed warning; label)
Known allergy to prostaglandins (label)
Use in women of childbearing potential for NSAID ulcer prevention is restricted by the boxed warning: only if at high risk, after a negative serum pregnancy test within 2 weeks, with effective contraception, after both oral and written warnings, and starting therapy only on the second or third day of a normal menstrual period

Warnings (label)

Third-trimester use after cesarean or major uterine surgery, because of uterine rupture risk
Uterine use where uterotonics are generally contraindicated: cephalopelvic disproportion, grand multiparity, hypertonic or hyperactive uterine pattern, or fetal distress where delivery is not imminent; or when surgery is more appropriate

Precautions

Uterine hyperstimulation: tachysystole can progress to tetany with reduced uteroplacental blood flow. It can also lead to uterine rupture, amniotic fluid embolism and adverse fetal heart changes (label)
Cardiovascular disease: be cautious (label)
Dehydration risk: patients with inflammatory bowel disease, or any condition where dehydration is dangerous, need close monitoring (label)
Older patients: exposure to misoprostol acid runs higher above age 64 (label). There is no routine dose change

Hold / Reassess If

Uterine tachysystole or hyperstimulation, or fetal heart rate changes: stop further doses and manage per obstetric protocol. The label gives no number to act on
Temperature above 40°C (104°F) after PPH dosing: look again for infection and hyperpyrexia. Give supportive care to fit the presentation (label)
Persistent or severe diarrhea (more than 8 days, or severe cramping): reassess hydration and call the prescriber (label leaflet)
Bleeding that continues after a dose: escalate per PPH protocol. Don't repeat misoprostol unless a protocol decision says so, per WHO 2025

FDA Boxed Warning: Misoprostol given to a pregnant woman can cause birth defects, abortion, premature birth or uterine rupture. A pregnant woman must not take it to reduce NSAID-induced ulcers. Patients must be told it can end a pregnancy, and warned not to give it to anyone else.

Uterine rupture: The risk climbs as gestation advances, and it climbs again after prior uterine surgery, cesarean delivery included. Grand multiparity is also a risk factor (label). Obstetric use outside the label needs trained obstetric staff in a hospital setting.

Adverse Effects & Toxicity

Common

Diarrhea: about 13% overall in label trials and 14–40% at 800 mcg in NSAID trials; usually early and self-limiting (label)
Abdominal pain and cramping: about 7% overall (label)
Nausea, flatulence, headache, dyspepsia: each reported in 2–3% (label)
Spotting or menstrual disorder: reported in gynecologic trials (label)

Serious / Life-Threatening

Effect	Recognition	Management
Uterine tachysystole or tetany	Frequent or sustained contractions; fetal heart rate changes	Stop further doses; obstetric emergency management per protocol
Uterine rupture	Sudden pain, bleeding, loss of fetal station, hemodynamic change	Emergency obstetric surgery per protocol
Hyperpyrexia with PPH use	Temperature over 40°C (104°F), tachycardia, disorientation, agitation, convulsions (label)	Cooling and supportive care per presentation; look for infection
Severe diarrhea and dehydration	Profound diarrhea, hypotension, tachycardia	Fluid and electrolyte replacement; stop misoprostol
Maternal shock, fetal bradycardia, amniotic fluid embolism	Hypotension, fetal heart rate decelerations, dyspnea (label reports, obstetric use)	Emergency obstetric and resuscitation protocol

Overdose & Toxicity Management

Signs: sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension or bradycardia (label)
Immediate management: supportive therapy, and stop the drug. The human toxic dose has not been established (label)
Antidote: none. Dialysis is unlikely to be the right move, because misoprostol is metabolized like a fatty acid (label)
Pediatric ingestion: treat supportively and call poison control. There is no pediatric dose reference (label)

Monitoring

Parameter	When / How Often	Target / Act If
Clinical (PPH)	Continuously after each dose	Temperature over 40°C (104°F), tachycardia, convulsions: reassess, cool, support (label)
Clinical (uterine)	Continuous uterine and fetal monitoring in obstetric use	Tachysystole or fetal distress: stop and manage per protocol
Clinical (GI)	Stool frequency and fluid intake over the course of therapy	Severe or prolonged diarrhea (more than 8 days): assess hydration
Laboratory	Hemoglobin and clotting status in PPH per protocol (hemoglobin)	Ongoing blood loss: escalate per PPH protocol

Interactions & Compatibility

Clinically Significant Interactions

Drug / Class	Effect	What To Do
Oxytocin and other uterotonics	Prostaglandins may augment oxytocic activity; the label states concomitant use is not recommended, especially within 4 hours before oxytocin. Other prostaglandins (for example carboprost) and ergot agents are also uterotonic, and their combined effect with misoprostol is not characterized on this page	Do not give as an add-on. WHO 2025 finds no added benefit of adjunct misoprostol for PPH treatment. Sequential use after oxytocin failure follows WHO 2025 but is outside the label: watch for uterine hyperstimulation and rupture
Magnesium-containing antacids	Reduce misoprostol acid exposure; increase diarrhea (label)	Avoid coadministration
NSAIDs, including aspirin	Intended combination for ulcer prevention. No clinically significant effect on ibuprofen or diclofenac kinetics; aspirin AUC down about 20%, not significant (label)	Use for the duration of NSAID therapy; prescriber decides dose
Food	Lowers peak misoprostol acid levels; reduces diarrhea when taken with meals (label)	Take with meals

This is not an IV drug, so IV compatibility does not come up. For any co-administered agent, check an institutional compatibility resource.

Special Populations

Pediatrics: not established; see the Pediatric Dosing table.
Pregnancy: the boxed warning covers abortion, birth defects, premature birth and uterine rupture. The first-trimester birth defect reports describe skull defects, cranial nerve palsies, facial malformations and limb defects. Obstetric use is meant for labor and PPH, under hospital protocol. It is not for NSAID-ulcer use in pregnancy.
Lactation: misoprostol acid passes into breast milk. After a 200 mcg dose, levels fell below 1 pg/mL by 5 hours. The label advises caution. No reports of adverse effects in breastfeeding infants have been published (label).
Older Adults: exposure to misoprostol acid runs higher above age 64, with no routine dose change. In ulcer trials, safety in patients 65 and older was similar (label).
Renal Impairment: in renal impairment, half-life and exposure roughly double. There is no routine adjustment. If the usual dose is not tolerated, reduce it (label).
Hepatic Impairment: no specific adjustment has been established. The label contains no hepatic data.
Obesity / Dosing Weight: the dose is not weight-based. In a randomized trial of vaginal misoprostol for labor induction in patients with BMI 30 or higher, 50 mcg and 25 mcg doses gave similar times to delivery and similar cesarean rates overall. Multiparous patients, though, delivered sooner with 50 mcg. Tachysystole with reassuring FHR was more frequent with 50 mcg (22% vs 10.2%, P=.043). Tachysystole with non-reassuring FHR changes did not differ (2.3% vs 2.2%) (Am J Obstet Gynecol 2024; see References; also cited in ACOG CPG No. 9).

Field & Transport Considerations

Scope: Can you carry it, and can you give it? Provider level, state and agency protocol all play a part, and they vary. Confirm local rules before you carry misoprostol.
Label status: the FDA label says serious PPH, cervical ripening and labor induction are hospital use only. Prehospital SL use for PPH is off-label. It is supported only where agency protocol and medical direction authorize it. WHO 2025 supports use where IV oxytocin is unavailable or fails.
Storage & Stability: keep it at or below 25°C (77°F), dry (label). It is heat-stable, so WHO 2025 says it needs no cold chain. Protect it from moisture.
Carried Concentration: only 100 mcg and 200 mcg oral tablets exist. Count out four 200 mcg tablets for the 800 mcg SL dose, and write the count on the medication record.
Infusions in Transport: not an infusion drug.
Handoff Essentials: time and dose given, route (SL), time since birth, blood loss estimate, temperature trend, uterine tone and any other uterotonic given. Say it at handoff: misoprostol given in the field is an obstetric risk.

Clinical Pearls

Heat-stable backup: When injectable uterotonics are not on hand, WHO 2025 lists misoprostol as an option. It is cheap and heat-stable, and it can go in by mouth or under the tongue. It needs no cold chain.

Fever trap: The 800 mcg sublingual PPH dose has been linked to hyperpyrexia. WHO notes that some members of its guideline group were worried about this risk. Watch the temperature after the dose.

Three doses, three indications: Each indication has its own regimen. 200 mcg PO four times daily is for NSAID ulcer risk. 400–600 mcg PO once is for PPH prevention. 800 mcg SL once is for PPH treatment. Check the indication before you check the dose.

Treatment is not an add-on: while oxytocin is available and PPH is ongoing, WHO 2025 finds no added benefit from giving misoprostol at the same time. Reach for it when oxytocin fails or is unavailable.

Exam discriminator (FP-C, CCP-C, CFRN): The 800 mcg SL dose is the PPH treatment regimen. The 200 mcg four-times-daily dose is the NSAID-ulcer regimen. Mix them up and you have made a route and indication error. It is not a dose-rounding error.

Reduce diarrhea: take it with food, and keep the last dose for bedtime. Avoid magnesium antacids (label).

Pharmacology

Mechanism of Action

Target: E-type prostaglandin receptors on gastric parietal cells and on uterine myometrium (label)
Gastric effect: it cuts basal and stimulated acid secretion, and it may raise mucus and bicarbonate. That is the basis for NSAID-ulcer risk reduction (label)
Uterine effect: it drives uterine contractions and can ripen the cervix. That is the basis for PPH and induction use (label)

Pharmacokinetics

Route	Onset	Peak	Duration
Oral (labeled)	Acid suppression apparent about 30 min	Misoprostol acid Tmax about 12 min	Acid suppression at least 3 hr (label)
Sublingual / buccal (obstetric)	Not quantified in label	Not quantified in label; the sublingual PPH dose is a WHO 2025 regimen	Not quantified in label

Half-life: the terminal half-life of misoprostol acid is 20–40 min. Repeated dosing does not accumulate, and steady state arrives within two days (label)
Metabolism: it is rapidly de-esterified to misoprostol acid, the active form. Beta and omega oxidation follow (label)
Elimination: about 80% of an oral dose appears in urine (label)
Protein binding: less than 90% for misoprostol acid, concentration-independent (label)

Names & Classification

Generic name: Misoprostol
Brand names (US): Cytotec (Pfizer)
Pharmacologic class: Prostaglandin E1 analog
Therapeutic class: Gastroprotective agent (NSAID-ulcer risk reduction); off-label uterotonic
Controlled substance: Not controlled
ISMP High-Alert: No (not on the ISMP 2024 acute-care list)
Look-alike / sound-alike: None identified in the sources reviewed
Error-prone abbreviations: None identified in the sources reviewed

References

Pfizer Laboratories Div Pfizer Inc. (2026). Cytotec (misoprostol) tablets: Prescribing information (revised April 2026). DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4ab12da7-5731-4e06-bf1c-bc3f2e711f12
World Health Organization, International Federation of Gynecology and Obstetrics, & International Confederation of Midwives. (2025). Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage. World Health Organization. https://www.who.int/publications/i/item/9789240115637
American College of Obstetricians and Gynecologists. (2025). Cervical Ripening in Pregnancy: ACOG Clinical Practice Guideline No. 9. Obstetrics & Gynecology, 146(1), 148–160. https://doi.org/10.1097/AOG.0000000000005951
Cochrane Database of Systematic Reviews. (2025). Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis (CD011689.pub4). https://doi.org/10.1002/14651858.CD011689.pub4
ECRI Institute, on behalf of the Institute for Safe Medication Practices. (2024). ISMP List of High-Alert Medications in Acute Care Settings (PDF). https://www.ismp.org/system/files/resources/2024-01/ISMP_HighAlert_AcuteCare_List_010924_MS5760.pdf
Saucedo, A. M., Alvarez, M., Macones, G. A., Cahill, A. G., & Harper, L. M. (2024). Optimal misoprostol dosing among patients with a body mass index greater than 30: a randomized controlled trial. American Journal of Obstetrics and Gynecology, 230(5), 565.e1–565.e16. https://doi.org/10.1016/j.ajog.2024.02.004

Last updated October 2026 Spotted something wrong? Report an error and include the page URL.

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