Legal Status of Cytotec Around the World

Cytotec (misoprostol) is a prescription medication approved for preventing stomach ulcers. However, it also has widespread off-label use for medical abortion. The legality of Cytotec varies across different countries.

This article examines Cytotec’s legal status for both ulcer treatment and abortion indications in nations around the world.

Cytotec for Ulcer Treatment

Cytotec original is legally approved for preventing NSAID-induced stomach ulcers in over 80 countries worldwide. Some nations with legal prescription access include:

  • United States – Approved in 1985, available generically
  • Canada – Approved, sold under brand name Cytotec
  • United Kingdom – Approved as Cytotec and generics
  • Australia – TGA approved, PBS subsidized
  • New Zealand – Medsafe approved, prescription required
  • South Africa – SAHPRA approved
  • India – Approved and marketed under various brands
  • China – SFDA approved, requires prescription
  • Brazil – ANVISA approved, prescription only
  • Argentina – ANMAT approved, prescription regulations

So in most countries, Cytotec is an approved prescription ulcer medication, either under the brand name or as generics containing misoprostol. Availability and insurance coverage varies.

Cytotec for Abortion

The legal status of Cytotec for inducing abortion is more variable worldwide:

  • Approved use – Very few countries like China and India
  • Off-label use permitted – Canada, UK, some EU countries
  • Restricted or prohibited – United States, Australia, New Zealand, Latin America
  • Illegal but tolerated – Parts of Southeast Asia, Eastern Europe
  • Strictly banned – Many parts of Africa, Middle East

So approval of Cytotec specifically for abortion is uncommon. Most Western nations allow off-label use under certain limits. However, it remains prohibited or heavily restricted in many developing regions.

Accessibility depends on national abortion laws and local regulations on off-label medications. In countries with strict bans, black markets often persist.

Country-Specific Legal Status

Here are more details on Cytotec’s legality for ulcer and abortion indications in select nations:

United States

  • Ulcer prevention – FDA approved since 1985
  • Abortion – Restricted, varies by state


  • Ulcer prevention – Approved as Cytotec
  • Abortion – Off-label use permitted

United Kingdom

  • Ulcer prevention – Approved for NHS use
  • Abortion – Allowed off-label up to 10 weeks


  • Ulcer prevention – TGA approved, PBS subsidized
  • Abortion – Prohibited, only for miscarriage


  • Ulcer prevention – Approved under various brands
  • Abortion – Approved in combo pack with mifepristone


  • Ulcer prevention – Legal by prescription
  • Abortion – Approved for medical abortion

South Africa

  • Ulcer prevention – Approved by SAHPRA
  • Abortion – Allowed under 12 weeks per laws


  • Ulcer prevention – Registered for sale by ANVISA
  • Abortion – Prohibited except for rape/health risks

Saudi Arabia

  • Ulcer prevention – Legal for approved indications
  • Abortion – Completely illegal under all circumstances

So legality varies significantly for abortion based on national laws. But most countries permit Cytotec at least for ulcer treatment under prescription.


Cytotec is legally available as an approved ulcer medication in most countries worldwide. However, regulations are stricter for its off-label use as an abortifacient, ranging from prohibited to fully approved depending on regional abortion laws. Accessibility ultimately depends on both medical regulations and social norms in any given nation.

Regional Legal Status Summary

Region Ulcer Treatment Abortion
North America Approved Varies by country
Europe Approved Off-label use allowed
Australia/NZ Approved Restricted
Asia Approved Banned to approved
Middle East Approved Mostly prohibited
Africa Approved Prohibited – tolerated
Latin America Approved Heavily restricted

Frequently Asked Questions

Is Cytotec legal in the USA?

Yes, Cytotec is FDA approved in the USA for ulcer treatment since 1985. Its use for abortion varies by state.

What countries have legal abortion with Cytotec?

Very few countries approve Cytotec specifically for abortion. China and India are two examples with approved medical abortion.

Is Cytotec legal in Australia?

Cytotec is TGA approved in Australia only for ulcer prevention, not abortion. It cannot be prescribed for abortion under regulations.

Can you buy Cytotec over the counter?

No, Cytotec is a prescription-only medication worldwide. It is not available over the counter in any country.

Is Cytotec banned anywhere?

No countries completely ban Cytotec for ulcer treatment when used correctly. But many nations prohibit its off-label use for abortion.

Is Cytotec illegal in the UK?

No, Cytotec can be prescribed in the UK for ulcer prevention and is allowed off-label for abortion under certain limits.

Where is abortion legal with Cytotec?

Abortion with Cytotec is approved in few areas like China and India. Elsewhere, legality for abortion varies from allowed to completely prohibited.

Can Cytotec be imported?

Importing Cytotec for personal use may be illegal in some nations. Patients should use caution and check regulations when travelling or importing.

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