Mifepristone Linepharma
Antiprogestogen – Progesterone Receptor Antagonist
Mifepristone Linepharma is a prescription-only antiprogestogen medication containing 200 mg of mifepristone. It is used primarily for medical termination of pregnancy in combination with a prostaglandin analogue such as misoprostol, as well as for cervical preparation before surgical procedures. Mifepristone works by blocking progesterone receptors, which are essential for maintaining pregnancy. This medication must be administered under close medical supervision in an appropriate healthcare setting.
Quick Facts
Key Takeaways
- Mifepristone Linepharma is an antiprogestogen that blocks progesterone, a hormone necessary for maintaining pregnancy, and is used in combination with misoprostol for medical termination of pregnancy.
- The medication is listed on the WHO Model List of Essential Medicines and has been used safely in clinical practice for over 30 years in multiple countries worldwide.
- Mifepristone must only be administered under medical supervision in a healthcare facility with access to emergency services, as serious complications such as heavy bleeding can occur.
- Common side effects include uterine cramping, nausea, and vaginal bleeding, which are expected effects related to the mechanism of action of the medication.
- A follow-up visit 14–21 days after treatment is essential to confirm complete termination and to rule out ongoing pregnancy or complications.
What Is Mifepristone Linepharma and What Is It Used For?
Mifepristone Linepharma contains the active substance mifepristone, a synthetic steroid compound that acts as a competitive antagonist at progesterone receptors. Progesterone is a hormone that plays a critical role in maintaining the uterine lining (endometrium) and supporting early pregnancy. By blocking the action of progesterone, mifepristone causes the endometrium to break down, leading to detachment of the embryo from the uterine wall. Additionally, mifepristone softens and dilates the cervix and increases the sensitivity of the uterine muscle (myometrium) to prostaglandins, which are substances that stimulate uterine contractions.
The primary approved indications for Mifepristone Linepharma include medical termination of developing intrauterine pregnancy, used sequentially with a prostaglandin analogue (typically misoprostol). The regimen can be used for pregnancies up to 49 days of amenorrhea when misoprostol is given orally, or up to 63 days (9 weeks) when misoprostol is administered vaginally, buccally, or sublingually. In clinical practice, some protocols extend usage further depending on national guidelines and regulatory approvals.
Mifepristone Linepharma is also authorized for softening and dilating the cervix of the uterus prior to surgical termination of pregnancy during the first trimester. In this context, it is used as a preparatory agent to make the surgical procedure safer and easier. Furthermore, it can be used for preparation of the uterus for the action of prostaglandin analogues in medical termination of pregnancy beyond the first trimester, where different dosing protocols apply.
The World Health Organization (WHO) includes mifepristone on its Model List of Essential Medicines, recognizing its importance in reproductive healthcare. The combination of mifepristone followed by misoprostol is considered the gold-standard medical method for pregnancy termination by major international health organizations, including WHO, the American College of Obstetricians and Gynecologists (ACOG), the Royal College of Obstetricians and Gynaecologists (RCOG), and the International Federation of Gynecology and Obstetrics (FIGO).
Pharmacologically, mifepristone is rapidly absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours. The drug is approximately 98% bound to plasma proteins, primarily alpha-1-acid glycoprotein and albumin. It undergoes extensive hepatic metabolism, predominantly by the cytochrome P450 3A4 (CYP3A4) enzyme system, and has a relatively long elimination half-life of approximately 25 to 30 hours, which allows for sustained pharmacological activity after a single dose.
What Should You Know Before Taking Mifepristone Linepharma?
Contraindications
There are several absolute contraindications to the use of mifepristone. The medication must not be used if you have a known hypersensitivity (allergy) to mifepristone or any of the excipients. It is contraindicated in chronic adrenal failure (adrenal insufficiency), as mifepristone also has antiglucocorticoid activity that can worsen this condition. Patients with severe uncontrolled asthma should not receive mifepristone due to the risk that prostaglandin analogues used in the sequential regimen may trigger bronchospasm.
Mifepristone must not be used when ectopic pregnancy (a pregnancy developing outside the uterus) is suspected or confirmed, as the medication will not terminate an ectopic pregnancy and delay in diagnosis could be life-threatening. Inherited porphyria is another absolute contraindication. The medication should not be used when a pregnancy has not been confirmed by ultrasound or biological tests, and it must not be taken beyond the gestational age limits specified in the approved indication.
Mifepristone does not treat ectopic pregnancy. If you have risk factors for ectopic pregnancy (previous ectopic pregnancy, history of pelvic inflammatory disease, IUD in place at conception), your doctor must rule out ectopic pregnancy before prescribing mifepristone. An undiagnosed ectopic pregnancy can rupture and cause life-threatening internal bleeding.
Warnings and Precautions
Medical termination of pregnancy with mifepristone requires the active participation of the patient, who must be informed of the requirements of the method: the need for a combination treatment with a prostaglandin analogue administered at a subsequent visit, the need for a follow-up visit within 14 to 21 days to verify that expulsion has been complete, and the possibility that surgical intervention may be required in case of failure of the method (ongoing pregnancy occurring in approximately 1–5% of cases).
Heavy vaginal bleeding is expected during the medical termination process. However, excessive bleeding requiring blood transfusion occurs in fewer than 1% of cases. Patients should be informed about what constitutes abnormal bleeding (soaking two or more thick full-size sanitary pads per hour for two or more consecutive hours) and should have clear instructions on when and where to seek emergency medical attention. Rare but serious infections, including fatal cases of sepsis caused by Clostridium sordellii, have been reported following medical termination, though these remain extremely uncommon.
Rhesus (Rh) blood group determination should be carried out according to local guidelines, and anti-D immunoglobulin should be administered to Rh-negative patients as indicated to prevent Rh sensitization in future pregnancies. Patients with cardiovascular risk factors (e.g., smoking, obesity, age over 35 years) or pre-existing cardiovascular disease should be assessed carefully, as prostaglandin analogues used sequentially can have cardiovascular effects.
Patients using hormonal contraception should be informed that mifepristone may reduce the efficacy of hormonal contraception. Alternative non-hormonal contraceptive methods should be used during the treatment cycle and until the next menstrual period. An intrauterine device (IUD), if present, must be removed before mifepristone administration.
Pregnancy and Breastfeeding
Mifepristone is specifically used to terminate pregnancy. If the pregnancy continues despite mifepristone administration (treatment failure), there is a theoretical risk of fetal malformations due to the exposure to prostaglandins. If a patient changes her mind about termination after taking mifepristone but before taking misoprostol, the likelihood of the pregnancy continuing normally is uncertain, and close monitoring would be required. For these reasons, when the combination treatment fails, termination by another method is strongly recommended.
Regarding breastfeeding, mifepristone is a lipophilic compound and may be excreted in breast milk. However, no data are available on its concentration in breast milk. As a precautionary measure, breastfeeding should be discontinued for 3 days after taking mifepristone. Breast milk expressed during this period should be discarded.
If you are breastfeeding, you should express and discard breast milk for 3 days after taking mifepristone. You may resume breastfeeding after this period. Prepare in advance by expressing and storing breast milk before the procedure if you wish to continue feeding your infant during the waiting period.
How Does Mifepristone Linepharma Interact with Other Drugs?
Drug interactions with mifepristone are clinically significant and must be considered before prescribing. Mifepristone is extensively metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme system in the liver. Medications that strongly inhibit CYP3A4 can increase plasma levels of mifepristone, potentially intensifying both its therapeutic and adverse effects. Conversely, drugs that induce CYP3A4 can accelerate the metabolism of mifepristone, potentially reducing its efficacy.
Additionally, mifepristone possesses antiglucocorticoid activity due to its structural similarity to glucocorticoids. This means it can interfere with the action of corticosteroid medications used for conditions such as asthma, autoimmune diseases, and adrenal insufficiency. Patients requiring corticosteroid therapy may need dose adjustments during and immediately after mifepristone use.
Major Interactions
| Drug / Drug Class | Type | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole, Itraconazole | CYP3A4 inhibitor | Increased mifepristone plasma levels | Avoid concomitant use; if necessary, monitor closely |
| Erythromycin, Clarithromycin | CYP3A4 inhibitor | Increased mifepristone exposure | Use with caution; consider dose adjustment |
| Rifampicin, Rifabutin | CYP3A4 inducer | Reduced mifepristone efficacy | Avoid; may cause treatment failure |
| Phenytoin, Carbamazepine, Phenobarbital | CYP3A4 inducer | Reduced mifepristone plasma levels | Avoid; risk of incomplete termination |
| Corticosteroids (systemic) | Pharmacodynamic | Mifepristone antagonizes corticosteroid action | May need increased corticosteroid dose during treatment |
| Anticoagulants (Warfarin) | Bleeding risk | Increased risk of severe bleeding | Use with extreme caution; specialist management required |
Minor Interactions
| Drug / Drug Class | Type | Effect | Recommendation |
|---|---|---|---|
| NSAIDs (Ibuprofen, Aspirin) | Pharmacodynamic | May reduce misoprostol efficacy | Avoid for 8–12 days after mifepristone; use paracetamol for pain |
| Grapefruit juice | CYP3A4 inhibitor | Mildly increased mifepristone levels | Avoid large quantities during treatment period |
| St John’s Wort | CYP3A4 inducer | Reduced mifepristone levels | Discontinue before treatment |
| Hormonal contraceptives | Pharmacodynamic | Reduced contraceptive efficacy | Use non-hormonal methods during treatment cycle |
It is important to inform your healthcare provider about all medications you are currently taking, including prescription drugs, over-the-counter medicines, herbal remedies, and dietary supplements. Your doctor will assess potential interactions and advise accordingly. In particular, if you are taking any medication for epilepsy, tuberculosis, HIV, or fungal infections, these are likely to interact with mifepristone through the CYP3A4 pathway.
What Is the Correct Dosage of Mifepristone Linepharma?
Mifepristone Linepharma dosing varies according to the indication, gestational age, and local protocols. All doses must be prescribed and, in most jurisdictions, administered under the supervision of a qualified healthcare provider in an appropriate medical facility. The following dosage information reflects international guidelines and approved regimens.
Medical Termination Up to 49 Days of Amenorrhea
Day 1: Mifepristone
A single oral dose of 600 mg (three 200 mg tablets) or 200 mg (one tablet, as recommended by WHO) taken in the presence of a healthcare provider. The patient should remain under observation for at least 1 hour after ingestion in some protocols.
Day 2–3: Misoprostol (36–48 hours later)
400 micrograms of misoprostol taken orally. The patient should return to the healthcare facility or, where protocols allow, take misoprostol at home. Expulsion usually occurs within 4–6 hours of taking misoprostol.
Medical Termination from 50 to 63 Days of Amenorrhea
Day 1: Mifepristone
A single oral dose of 200 mg (one tablet) taken under medical supervision.
Day 2–3: Misoprostol (36–48 hours later)
800 micrograms of misoprostol administered vaginally, buccally, or sublingually. Vaginal or buccal administration is preferred at this gestational age as it achieves higher efficacy. The patient should have access to medical support during this period.
Cervical Preparation Before Surgical Termination (First Trimester)
Mifepristone
A single oral dose of 200 mg taken 36 to 48 hours before the planned surgical procedure. This softens and dilates the cervix, making the procedure safer and easier to perform.
Second Trimester Medical Termination
Mifepristone
A single oral dose of 200 mg (or 600 mg depending on the protocol) taken 36 to 48 hours before prostaglandin administration. Misoprostol is then given in repeated doses according to institutional protocol until expulsion occurs. This process typically requires hospital admission and close monitoring.
Missed Dose
The concept of a missed dose does not typically apply to mifepristone as it is administered as a single dose under medical supervision. If the patient vomits within 30 minutes of taking the tablet, another dose may need to be administered. The healthcare provider will make this determination based on clinical assessment. If misoprostol is not taken at the scheduled time, contact your healthcare provider immediately for instructions.
Overdose
There is limited clinical experience with mifepristone overdose. In clinical studies, single doses up to 2,000 mg have been administered without serious adverse effects. Symptoms of overdose could theoretically include signs of adrenal insufficiency (fatigue, weakness, nausea, low blood pressure) due to the antiglucocorticoid activity of mifepristone. There is no specific antidote. In case of significant overdose, monitoring of adrenal function and supportive treatment should be provided. Contact your local poison control center or emergency department if overdose is suspected.
The World Health Organization recommends a simplified regimen of 200 mg mifepristone (rather than 600 mg) for medical termination of pregnancy, as clinical trials have demonstrated equivalent efficacy with fewer side effects at the lower dose. This recommendation has been adopted in many national guidelines worldwide.
What Are the Side Effects of Mifepristone Linepharma?
Side effects of mifepristone must be understood in the context of its use: many of the reported effects are expected consequences of the medical termination process rather than adverse drug reactions in the traditional sense. Uterine contractions and vaginal bleeding are inherent to the mechanism of action and occur in virtually all patients. The following frequency classification is based on post-marketing surveillance data and clinical trial reports.
Very Common
- Uterine contractions and cramping
- Vaginal bleeding (expected effect)
- Nausea
- Vomiting
- Diarrhea
Common
- Heavy bleeding (more than expected menstrual period)
- Headache
- Dizziness
- Fatigue and malaise
- Mild fever and chills
- Abdominal pain
- Skin rash (mild, transient)
Uncommon
- Heavy bleeding requiring blood transfusion
- Incomplete expulsion requiring surgical intervention
- Uterine infection (endometritis)
- Hypotension (low blood pressure)
- Hot flushes
- Urticaria (hives)
Rare
- Severe infection / sepsis
- Toxic shock syndrome
- Uterine rupture (extremely rare, primarily in second trimester)
- Severe allergic reaction (anaphylaxis)
- Epidermal necrolysis (very rare dermatological reaction)
Vaginal bleeding following medical termination typically lasts for an average of 9 to 16 days, although some women may experience spotting for up to 30 days. This is considered normal. However, if bleeding is excessively heavy (soaking more than two thick sanitary pads per hour for two consecutive hours or more), accompanied by a foul-smelling discharge, or associated with high fever (above 38°C lasting more than 24 hours), seek immediate medical attention as these may indicate complications.
Pain is a very common experience during medical termination and is caused by uterine contractions required for expulsion. Pain management typically includes paracetamol (acetaminophen), codeine, or other opioid analgesics as prescribed. Ibuprofen and other NSAIDs should generally be avoided during the treatment period as they may theoretically reduce the efficacy of misoprostol, although more recent evidence suggests this interaction may not be clinically significant. Discuss pain management options with your healthcare provider.
Gastrointestinal side effects (nausea, vomiting, diarrhea) are common, particularly after misoprostol administration. These effects are usually transient and resolve within a few hours. If vomiting occurs within 1 hour of taking mifepristone, contact your healthcare provider as the dose may need to be repeated.
Contact your healthcare provider or go to the nearest emergency department immediately if you experience: soaking 2 or more thick sanitary pads per hour for 2 or more hours in a row; fever above 38°C lasting more than 24 hours; severe abdominal pain not relieved by prescribed pain medication; foul-smelling vaginal discharge; or feeling very ill, weak, or faint. These may be signs of serious complications requiring immediate treatment.
How Should You Store Mifepristone Linepharma?
Mifepristone Linepharma tablets should be stored at temperatures not exceeding 25°C (77°F). The tablets should be kept in their original blister packaging until ready for use in order to protect them from moisture and light. Do not store in the bathroom or near sources of heat or moisture, as this can affect the stability and potency of the medication.
As with all medications, keep Mifepristone Linepharma out of the sight and reach of children. Do not use the medication after the expiry date stated on the packaging. The expiry date refers to the last day of that month. If you have any unused tablets, do not dispose of them in household waste or via wastewater. Return unused medication to a pharmacy or healthcare facility for proper disposal according to local regulations.
In practice, because mifepristone is typically administered in a clinical setting under medical supervision, patients rarely need to store this medication at home. However, in jurisdictions where home administration is permitted following a telemedicine consultation, proper storage becomes relevant. Ensure the medication is stored in a cool, dry place away from direct sunlight until the time of administration.
What Does Mifepristone Linepharma Contain?
The active substance in Mifepristone Linepharma is mifepristone. Each tablet contains 200 mg of mifepristone. Mifepristone is a synthetic 19-norsteroid with the chemical formula C29H35NO2 and a molecular weight of 429.6 g/mol. It is a yellow powder that is practically insoluble in water.
The tablets also contain various excipients (inactive ingredients) that serve different functions in the formulation. Common excipients found in mifepristone tablet formulations include microcrystalline cellulose (a bulking agent and binder), maize starch (a disintegrant that helps the tablet break apart after swallowing), povidone (a binder), colloidal anhydrous silica (a glidant to improve powder flow during manufacturing), and magnesium stearate (a lubricant). The exact excipient composition may vary between manufacturers and should be verified on the product-specific package leaflet or Summary of Product Characteristics (SmPC).
If you have any known allergies or intolerances to specific excipients (e.g., cellulose, starch, or other common tablet ingredients), inform your healthcare provider before taking this medication. The tablets are typically light yellow in color and round in shape, though physical characteristics may vary by manufacturer and market.
Frequently Asked Questions
Mifepristone Linepharma is used primarily for medical termination of early intrauterine pregnancy in combination with a prostaglandin analogue such as misoprostol. It can be used for pregnancies up to 49 days of amenorrhea (with oral misoprostol) or up to 63 days (with vaginal or buccal misoprostol). It is also used for cervical preparation before surgical termination in the first trimester and for preparation before prostaglandin administration in second trimester medical termination.
Mifepristone is a progesterone receptor antagonist (antiprogestogen). It works by blocking the action of progesterone, a hormone essential for maintaining the uterine lining and supporting early pregnancy. When progesterone is blocked, the uterine lining (endometrium) breaks down, the embryo detaches, and the cervix softens and dilates. Mifepristone also increases the sensitivity of the uterus to prostaglandins (such as misoprostol), which then stimulate uterine contractions to expel the uterine contents.
This depends on the regulations in your country or jurisdiction. In some locations, mifepristone must be taken in a hospital or clinic under direct medical supervision. In other countries (including parts of the UK, France, and certain US states), mifepristone may be taken at home following a telemedicine consultation. Regardless of where you take the medication, you must have access to emergency medical services and must attend a follow-up appointment to confirm the procedure was successful. Always follow the specific instructions from your healthcare provider and comply with local laws.
If medical termination is incomplete after taking both mifepristone and misoprostol, a surgical procedure (vacuum aspiration or curettage) is required to complete the process. Ongoing pregnancy occurs in approximately 1–5% of cases. The follow-up visit 14–21 days after treatment is essential to confirm complete expulsion using ultrasound or blood tests. If the pregnancy continues after mifepristone and prostaglandin exposure, termination by another method is strongly recommended due to potential risks of fetal abnormalities.
Mifepristone has an extensive safety record spanning over 30 years of clinical use worldwide. The WHO lists it as an essential medicine. Serious complications are rare: heavy bleeding requiring transfusion occurs in fewer than 1% of cases, and severe infection is extremely uncommon. The overall mortality rate is estimated at less than 1 per 100,000 procedures, which is significantly lower than the risks associated with continuing a pregnancy to term. However, it must be used under medical supervision with access to emergency care to ensure that any complications are managed promptly.
Fertility can return very quickly after medical termination, often within 2 weeks. Ovulation may occur before the next menstrual period, so you could become pregnant again almost immediately. If you wish to avoid pregnancy, start contraception as directed by your healthcare provider. If you wish to conceive again, most doctors recommend waiting for at least one normal menstrual period (typically 4–6 weeks) before trying, primarily to allow accurate dating of a future pregnancy. There is no evidence that mifepristone affects long-term fertility or outcomes of subsequent pregnancies.
References
- European Medicines Agency (EMA). Mifepristone – Summary of Product Characteristics. Available from: EMA Medicines.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- World Health Organization (WHO). Medical management of pregnancy termination. Geneva: WHO; 2018.
- American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 225: Medication Abortion Up to 70 Days of Gestation. Obstet Gynecol. 2020;136(4):e1–e17.
- Royal College of Obstetricians and Gynaecologists (RCOG). Best Practice in Comprehensive Abortion Care. Best Practice Paper No. 7. London: RCOG; 2022.
- Raymond EG, Shannon C, Weaver MA, Winikoff B. First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review. Contraception. 2013;87(1):26–37. doi:10.1016/j.contraception.2012.06.011.
- Chen MJ, Creinin MD. Mifepristone with buccal misoprostol for medical abortion: a systematic review. Obstet Gynecol. 2015;126(1):12–21. doi:10.1097/AOG.0000000000000897.
- Kulier R, Kapp N, Gülmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011;(11):CD002855. doi:10.1002/14651858.CD002855.pub4.
- International Federation of Gynecology and Obstetrics (FIGO). FIGO Guidelines: Prevention of unsafe abortion. Int J Gynecol Obstet. 2017;138(2):241–242.
- British National Formulary (BNF). Mifepristone. NICE Evidence Services. Updated 2025.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in obstetrics, gynecology, reproductive health, and clinical pharmacology.
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