Misoprostol
Angusta®, Cyprostol, Gyxiny, Topogyne · ATC code A02BB01
Brand names: Angusta®, Cyprostol, Gyxiny, Topogyne, Angusta, Misoone, Cytotec
- Key facts
- Active substance
- Misoprostol
- ATC code
- A02BB01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Boxed warning
MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.
UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (see also PRECAUTIONS and LABOR AND DELIVERY ).
MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.
Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, misoprostol may be prescribed if the patient
- •has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
- •is capable of complying with effective contraceptive measures.
- •has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
- •will begin misoprostol only on the second or third day of the next normal menstrual period.
Key facts
Misoprostol is a synthetic prostaglandin E1 analogue. Per the US label it is used to reduce the risk of NSAID-induced gastric ulcers in high-risk patients.
What it is used for
- Reducing the risk of NSAID (including aspirin)-induced gastric ulcers in patients at high risk of complications or ulceration, e.g. the elderly or those with a history of ulcer
- Not shown to reduce the risk of duodenal ulcers in patients taking NSAIDs
- Taken for the duration of NSAID therapy
Dosing
- Adults: 200 mcg four times daily with food, the last dose at bedtime
- If not tolerated, 100 mcg can be used
- Renal impairment: adjustment not routinely needed; dose can be reduced if not tolerated
Contraindications
- Pregnancy (for reducing the risk of NSAID-induced ulcers)
- History of allergy to prostaglandins
Important warnings
- Boxed warning: in pregnant women can cause birth defects, abortion, premature birth or uterine rupture; risk rises with gestational age and prior uterine surgery including caesarean delivery
- Patients must be advised of the abortifacient property and not give the drug to others
- Women of childbearing potential only if at high risk, with a negative serum pregnancy test, effective contraception and start on the second or third day of the next menstrual period
- Off-label use for labour induction or post-partum haemorrhage is for hospital use only
Side effects
- Most frequent: diarrhoea and abdominal pain
- Diarrhoea is dose-related, usually early and self-limiting; rare profound diarrhoea with severe dehydration
- Monitor carefully in inflammatory bowel disease or where dehydration would be dangerous
Interactions
- Antacids reduce misoprostol acid bioavailability, which does not appear clinically important
Pregnancy and breastfeeding
- Contraindicated in pregnant women for ulcer prevention (see boxed warning)
- The active metabolite is excreted in breast milk; caution in nursing women
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- Angusta®Norgine B.V. · 1 register entry
- CyprostolPfizer Corporation Austria Ges.M.B.H. · 1 register entry
- GyxinyAfyx Therapeutics A/S · 1 register entry
- TopogyneExelgyn Sa · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- AngustaNorgine B.V. · 1 register entry
- MisooneExelgyn Sa · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- CytotecALİ RAİF İLAÇ SAN. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- CytotecPfizer Laboratories Div Pfizer Inc · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 27 more European countries
- Belgium
- Angusta, Cytotec, Gyxiny, Topogyne
- Bulgaria
- Ангуста, Топогин
- Croatia
- Angusta, Mispregnol
- Cyprus
- Angusta, Misoone
- Czechia
- Angusta, Mispregnol
- Denmark
- Angusta, Cytotec, Gyxiny, Topogyne
- Estonia
- Angusta, Gyxiny, Topogyne
- Finland
- Angusta, Cytotec, Gyxiny, Topogyne
- France
- Angusta, Gymiso, Gyxiny, Misoone
- Greece
- Angusta, Cytotec, Gyxiny, Misoone
- Hungary
- Angusta
- Iceland
- Angusta, Cytotec, Gyxiny
- Ireland
- Angusta, Cytotec, Gyxiny, Misoone
- Italy
- Angusta, Cytotec, Misoone
- Latvia
- Angusta, Gyxiny, Misoone
- Lithuania
- Gyxiny, Misoone
- Luxembourg
- Angusta, Cytotec, Gyxiny, Topogyne
- Malta
- Angusta
- Netherlands
- Angusta, Cytotec, Gyxiny, Misoone
- Norway
- Angusta, Cytotec, Gyxiny, Topogyne
- Poland
- Angusta, Cytotec
- Portugal
- Angusta, Cytotec, Topogyne
- Romania
- Angusta, Topogyne
- Slovakia
- Angusta
- Slovenia
- Angusta, Topogyne
- Spain
- Angusta, Cytotec, Gyxiny, Misofar, Misoone
- Sweden
- Angusta, Cytotec, Gyxiny, Topogyne
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. misoprostol (Mylan Pharmaceuticals Inc.) – Prescribing Information, 2026-08-25. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c4fe14fb-0a43-4c31-9cd6-29eb0d156705
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.