Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.
Pharmaceutical Name
Trade (marketing or proprietary) name: MIFEPREX® and Cytotec®
Generic (nonproprietary or active ingredient) name: mifepristone and misoprostol
Indication and Usage
Reason the product has been approved for sale on the market.
FDA has approved MIFEPREX® (mifepristone) to end a pregnancy through ten weeks gestation, however Cytotec® (misoprostol) is used off-label and is not FDA approved for this indication.
Manufacturer Insert
MIFEPREX® (mifepristone)
Cytotec® (misoprostol)
Ingredients
MIFEPREX® (mifepristone) contains: 200 mg of mifepristone (a synthetic steroid with
antiprogestational effects), colloidal silica anhydrous, corn starch, povidone, microcrystalline cellulose, and magnesium stearate.
Cytotec® (misoprostol) contains: 100 mcg or 200 mcg of misoprostol (a synthetic prostaglandin E1 analog), hydrogenated castor oil, hydroxypropyl methylcellulose, microcrystalline cellulose, and sodium starch glycolate.
Contraindications
Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.
MIFEPREX® (mifepristone) contraindications:
Cytotec® (misoprostol) contraindications:
Warnings and Precautions
Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.
MIFEPREX® (mifepristone) warnings and precautions:
Cytotec® (misoprostol) warnings and precautions:
Manufacturer-Listed Adverse Reactions
Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.
MIFEPREX® (mifepristone) can cause: Atypical presentation of infection including serious bacterial infections and sepsis, Prolonged heavy bleeding due to incomplete abortion or other complication requiring prompt medical or surgical intervention, Serious bacterial infection including fatal septic shock, Fever of 100.4°F or higher, Severe abdominal pain, Pelvic tenderness, Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications. Prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Allergic reaction (including anaphylaxis, angioedema, hives, rash, itching), Pain, Anemia, Loss of consciousness, Nausea, Weakness, Vomiting, Headache, Diarrhea, Post-abortal infection (including endometritis, endomyometritis, parametritis, pelvic infection, pelvic inflammatory disease, and salpingitis), Anxiety, Tachycardia (including racing pulse, heart palpitations, heart pounding), Syncope (fainting), Hypotension (including orthostatic), Light-headedness, Shortness of breath, Dyspepsia (indigestion), Back/leg pain, Uterine rupture, Ruptured ectopic pregnancy, Hematometra (retention of blood in the uterus), and Leukorrhea (thick, whitish, yellowish or greenish vaginal discharge).
Cytotec® (misoprostol) can cause: Aches/pains, Asthenia (weakness), Fatigue, Fever, Rigors, Weight changes, Rash, Dermatitis, Alopecia (hair loss), Pallor, Breast/chest pain, Abnormal taste/vision, Conjunctivitis, Syncope (fainting), Deafness, Tinnitus (ringing ears), Earache, Upper respiratory tract infection, Bronchitis, Bronchospasm, Dyspnea (shortness of breath), Pneumonia, Epistaxis (nosebleed), Edema, Diaphoresis, Reflux, Hypotension/hypertension, Arrhythmia, Phlebitis, Increased cardiac enzymes, GI bleeding, GI inflammation/infection, Rectal disorder, Abnormal hepatobiliary function, Gingivitis, Dysphagia (difficulty swallowing), Amylase increase, Anaphylaxis, Glycosuria (sugar in the urine), Gout, Increased nitrogen, Increased alkaline phosphatase, Polyuria (large urine production), Dysuria (painful urination), Hematuria (blood in urine), Urinary tract infection, Abnormal differential, Neuropathy, Neurosis, Confusion, Arthralgia (joint stiffness), Myalgia (muscle pain), Muscle cramps, Stiffness, Back pain, Anemia, Anxiety, Change in appetite, Depression, Drowsiness, Dizziness, Impotence, Loss of libido, Sweating increase, Purpura, ESR increased, and Thrombocytopenia
Specific Populations
Pregnancy
MIFEPREX is indicated, in a regimen with misoprostol, for the medical termination of
intrauterine pregnancy through 70 days gestation. Risks to pregnant patients are discussed
throughout the labeling. The risk of adverse developmental outcomes with a continued pregnancy after a failed pregnancy termination with MIFEPREX in a regimen with misoprostol is unknown; however, the process of a failed pregnancy termination could disrupt normal embryo-fetal development and result in adverse developmental effects. Birth defects have been reported with a continued pregnancy after a failed pregnancy termination with MIFEPREX in a regimen with misoprostol. In animal reproduction studies, increased fetal losses were observed in mice, rats, and rabbits and skull deformities were observed in rabbits with administration of mifepristone at doses lower than the human exposure level based on body surface area.
Cytotec (misoprostol): Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient but the drug’s teratogenic mechanism has not been demonstrated. Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects.
Cytotec may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Cytotec may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by Cytotec may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus.
Breastfeeding
MIFEPREX is present in human milk. Limited data demonstrate undetectable to low levels of
the drug in human milk with the relative (weight-adjusted) infant dose 0.5% or less as compared to maternal dosing. There is no information on the effects of MIFEPREX in a regimen with misoprostol in a breastfed infant or on milk production.
It is unlikely that Cytotec is excreted in human milk since it is rapidly metabolized
throughout the body. However, it is not known if the active metabolite (misoprostol acid) is excreted in human milk. Therefore, Cytotec should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause significant diarrhea in nursing infants.
Fertility
Misoprostol, when administered to breeding male and female rats at doses 6.25 times to 625 times the maximum recommended human therapeutic dose, produced dose-related pre- and post-implantation losses and a significant decrease in the number of live pups born at the highest dose. These findings suggest the possibility of a general adverse effect on fertility in males and females.
Mechanism of Action
This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.
MIFEPREX® (mifepristone): The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit, and monkey), the compound inhibits the activity of endogenous or exogenous progesterone, resulting in effects on the uterus and cervix that, when combined with misoprostol, result in termination of an intrauterine pregnancy. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
In layman’s terms, Mifepristone works by blocking the hormone progesterone, which is essential for maintaining pregnancy. It does this by competing with progesterone at the sites where the hormone normally acts in the body. In studies involving animals (like mice, rats, rabbits, and monkeys), mifepristone was shown to prevent progesterone from doing its job, which affects the uterus and cervix. When used together with another medication, misoprostol, it causes the pregnancy to end. During pregnancy, mifepristone also makes the uterus more sensitive to misoprostol, which helps trigger contractions needed to end the pregnancy.
Cytotec® (misoprostol): Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 mcg and above that are also antisecretory. It is therefore not possible to tell whether the ability of misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.
Uterine effects: Cytotec has been shown to produce uterine contractions that may endanger pregnancy.
Analytical Deep Dive
What is informed consent?
Alternatives
Looking for alternatives? Here are some resources:
Option Line
Option Line offers a confidential live chat, text line, and toll-free hotline that is available 24/7. The website contains additional resources for women who are considering abortion, have had an abortion, or are seeking alternatives to abortion.
Care Net
Care Net offers free resources and a confidential, toll-free, phone line available from 6 AM to 10 PM ET.
International Helpline For Abortion Recovery
International Helpline for Abortion Recovery provides confidential care 24/7 for those needing help after abortion. The helpline is staffed by consultants who have personally experienced the pain of abortion, but have also found hope and healing.
Rachel’s Vineyard
Rachel’s Vineyard offers confidential, weekend programs and other services across the United States and Canada, with additional sites around the world, for anyone affected by abortion.
Abortion Pill Reversal
Abortion Pill Reversal offers a 24/7 hotline, staffed by medical professionals, for women seeking an abortion pill reversal. The APR program has a network of over 270 physicians worldwide to assist people who call the hotline.
Other Abortion Procedures
For more information about other types of procedures, click here.