Is Misoprostol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Misoprostol, including Cytotec (200 µg, Tablet, SAR 40.35).

Is Misoprostol approved by the US FDA?

Drugs@FDA lists 5 application product lines for Misoprostol, including CYTOTEC (Prescription); MISOPROSTOL (Prescription); MISOPROSTOL (Prescription); MISOPROSTOL (Discontinued); MISOPROSTOL (Discontinued).

Is Misoprostol on the WHO Model List of Essential Medicines?

Yes — 22.3. Uterotonics (core list): Unspecified obstetric condition; Postpartum haemorrhage.

Are there safety signals or safety updates for Misoprostol?

US FDA: 2 entries (latest 2024-11-21).

Active substance

Misoprostol

SFDA 1
US FDA 5
Health Canada 3
US price lines 2
NHS prices 1
WHO EML 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cytotec	200 µg	Tablet · Oral use	28 Blister	SAR 40.35	NCE · Prescription	Pfizer Limited	Valid

Indications — CHI Daman Drug Formulary

DYSPEPSIA; MATERNAL AND CHILD HEALTHCARE- POSTPARTUM HEMORRHAGE, INDUCTION OF LABOR, MISCARRIAGE

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CYTOTEC	0.2MG; 0.1MG	tablet · oral	PFIZER	Prescription	27 Dec 1988
MISOPROSTOL	0.1MG; 0.2MG	tablet · oral	ANI PHARMS	Prescription	10 Jul 2002
MISOPROSTOL	0.1MG; 0.2MG	tablet · oral	ACQ PHARMA	Prescription	2 Jul 2019
MISOPROSTOL	0.1MG; 0.2MG	tablet · oral	NOVEL LABS INC	Discontinued	25 Jul 2012
MISOPROSTOL	0.1MG; 0.2MG	tablet · oral	MICRO LABS	Discontinued	17 Oct 2022

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP MISOPROSTOL	02545284	200 MCG	TABLET · ORAL	JAMP PHARMA CORPORATION
MISOPROSTOL	02244022	100 MCG	TABLET · ORAL	AA PHARMA INC
MISOPROSTOL	02244023	200 MCG	TABLET · ORAL	AA PHARMA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MISOPROSTOL 100 MCG TABLET	$0.4645	per EA	23 Sep 2026
US NADAC	MISOPROSTOL 200 MCG TABLET	$0.71894	per EA	23 Sep 2026
NHS Drug Tariff	Misoprostol 200microgram tablets	£10.03	60 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

22.3. Uterotonics · core
Unspecified obstetric condition; Postpartum haemorrhage
Local > Vaginal > tablet: 25 µg | Oral > Solid: 200 µg
22.4. Medicines for medical abortion · complementary
Spontaneous abortion, incomplete, without complication
Oral > Solid > tablet: 200 µg

Safety signals and safety-related labeling changes

US FDA 21 Nov 2024 ARTHROTEC — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Feb 2018 CYTOTEC — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations

All safety entries for misoprostol →

Combinations containing Misoprostol

Diclofenac + misoprostol

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.