misoprostol
Tablet · Oral
Uses
Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
Dosage and administration
The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used (see Clinical Pharmacology: Clinical studies ). Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime. Renal impairment Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated (see Clinical Pharmacology ).
Contraindications
See boxed WARNINGS . Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Misoprostol should not be taken by anyone with a history of allergy to prostaglandins.
Warnings
See boxed WARNINGS . For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post-partum hemorrhage, which are outside of the approved indication.
Precautions
Caution should be employed when administering misoprostol to patients with pre-existing cardiovascular disease. Information for patients Women of childbearing potential using misoprostol to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when misoprostol therapy is initiated, and that they must use an effective contraception method while taking misoprostol. See boxed WARNINGS . Misoprostol is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer. Misoprostol should be taken only according to the directions given by a physician. If the patient has questions about or problems with misoprostol, the physician should be contacted promptly. THE PATIENT SHOULD NOT GIVE MISOPROSTOL TO ANYONE ELSE. Misoprostol has been prescribed for the patient's specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she were to become pregnant. The misoprostol package the patient receives from the pharmacist will include a leaflet containing patient information. The patient should read the leaflet before taking misoprostol and each time the prescription is renewed because the leaflet may have been revised. Keep misoprostol out of the reach of children. SPECIAL NOTE FOR WOMEN: Misoprostol may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women. Misoprostol is available only as a unit-of-use package that includes a leaflet containing patient information. See Patient Information at the end of this labeling. Drug interactions See Clinical Pharmacology . Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol has no clinically significant effect on the kinetics of diclofenac or ibuprofen. Prostaglandins such as misoprostol may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended. Animal toxicology A reversible increase in the number of normal surface gastric epithelial cells occurred in the dog, rat, and mouse. No such increase has been observed in humans administered misoprostol for up to 1 year. An apparent response of the female mouse to misoprostol in long-term studies at 100 to 1000 times the human dose was hyperostosis, mainly of the medulla of sternebrae. Hyperostosis did not occur in long-term studies in the dog and rat and has not been seen in humans treated with misoprostol. Carcinogenesis, mutagenesis, impairment of fertility There was no evidence of an effect of misoprostol on tumor occurrence or incidence in rats receiving daily doses up to 150 times the human dose for 24 months. Similarly, there was no effect of misoprostol on tumor occurrence or incidence in mice receiving daily doses up to 1000 times the human dose for 21 months. The mutagenic potential of misoprostol was tested in several in vitro assays, all of which were negative. 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. Pregnancy Teratogenic effects See boxed WARNINGS . 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. Misoprostol is not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human dose, respectively. Nonteratogenic effects See boxed WARNINGS . Misoprostol may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Misoprostol may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by misoprostol 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. Labor and delivery Misoprostol can induce or augment uterine contractions. Vaginal administration of misoprostol, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of the obstetrical use of misoprostol is uterine tachysystole which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism and lead to adverse fetal heart changes. Uterine activity and fetal status should be monitored by trained obstetrical personnel in a hospital setting. The risk of uterine rupture associated with misoprostol use in pregnancy increases with advancing gestational ages and prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture. The use of misoprostol outside of its approved indication may also be associated with meconium passage, meconium staining of amniotic fluid, and Cesarean delivery.
Side effects
The following have been reported as adverse events in subjects receiving misoprostol: Gastrointestinal In subjects receiving misoprostol 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14–40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13–20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo. Diarrhea was dose-related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of misoprostol (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if misoprostol is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of misoprostol with magnesium-containing antacids. Gynecological Women who received misoprostol during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to misoprostol administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology (see boxed WARNINGS ). Elderly There were no significant differences in the safety profile of misoprostol in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients. Additional adverse events which were reported are categorized as follows: Incidence greater than 1% In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving misoprostol and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for misoprostol and placebo. Causal relationship unknown The following adverse events were infrequently reported. Causal relationships between misoprostol and these events have not been established but cannot be excluded: Body as a whole: aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes. Skin: rash, dermatitis, alopecia, pallor, breast pain. Special senses: abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache. Respiratory: upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis. Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA). Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase. Hypersensitivity: anaphylactic reaction Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase. Genitourinary: polyuria, dysuria, hematuria, urinary tract infection. Nervous system/Psychiatric: anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion. Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain. Blood/Coagulation: anemia, abnormal differential, thrombocytopenia, purpura, ESR increased.
Drug interactions
Drug interactions See Clinical Pharmacology . Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol has no clinically significant effect on the kinetics of diclofenac or ibuprofen. Prostaglandins such as misoprostol may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended.
Pregnancy
Pregnancy Teratogenic effects See boxed WARNINGS . 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. Misoprostol is not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human dose, respectively. Nonteratogenic effects See boxed WARNINGS . Misoprostol may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Misoprostol may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by misoprostol 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.
Pediatric use
Pediatric use Safety and effectiveness of misoprostol in pediatric patients have not been established.
Overdosage
The toxic dose of misoprostol in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy. It is not known if misoprostol acid is dialyzable. However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.
Description
Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E 1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±): C 22 H 38 O 5 M.W. = 382.5 (±) methyl 11α, 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate. Chemical Structure
How supplied
Misoprostol 100-mcg tablets are white, round, with G and 5007 debossed on one side; supplied as: NDC Number Size 59762-5007-1 unit-of-use bottle of 60 59762-5007-2 unit-of-use bottle of 120 Misoprostol 200-mcg tablets are white, hexagonal, with G debossed above and 5008 debossed below the line on one side; supplied as: NDC Number Size 59762-5008-1 unit-of-use bottle of 60 59762-5008-2 unit-of-use bottle of 100 Store at or below 25°C (77°F), in a dry area.
Storage
Store at or below 25°C (77°F), in a dry area.
Patient information
Information for patients Women of childbearing potential using misoprostol to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when misoprostol therapy is initiated, and that they must use an effective contraception method while taking misoprostol. See boxed WARNINGS . Misoprostol is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer. Misoprostol should be taken only according to the directions given by a physician. If the patient has questions about or problems with misoprostol, the physician should be contacted promptly. THE PATIENT SHOULD NOT GIVE MISOPROSTOL TO ANYONE ELSE. Misoprostol has been prescribed for the patient's specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she were to become pregnant. The misoprostol package the patient receives from the pharmacist will include a leaflet containing patient information. The patient should read the leaflet before taking misoprostol and each time the prescription is renewed because the leaflet may have been revised. Keep misoprostol out of the reach of children. SPECIAL NOTE FOR WOMEN: Misoprostol may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women. Misoprostol is available only as a unit-of-use package that includes a leaflet containing patient information. See Patient Information at the end of this labeling.
Label text from the FDA structured product label by Mylan Pharmaceuticals Inc. (revised Aug 25, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Misoprostol in 23 products
misoprostol NDC products (23)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 60687-746 | Misoprostol 200 ug/1 Tablet | American Health Packaging | ANDA |
| 60687-735 | Misoprostol 100 ug/1 Tablet | American Health Packaging | ANDA |
| 70954-444 | Misoprostol 200 ug/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-443 | Misoprostol 100 ug/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 50268-555 | Misoprostol 200 ug/1 Tablet | AvPAK | ANDA |
| 71335-2455 | Misoprostol 100 ug/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55154-2145 | Misoprostol 200 ug/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 43393-200 | Misoprostol 200 ug/1 Tablet | GenBioPro, Inc. | ANDA |
| 43393-024 | Misoprostol 200 ug/1 Tablet | GenBioPro, Inc. | ANDA |
| 43393-023 | Misoprostol 200 ug/1 Tablet | GenBioPro, Inc. | ANDA |
| 43386-161 | Misoprostol 200 ug/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA |
| 43386-160 | Misoprostol 100 ug/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA |
| 40032-160 | Misoprostol 100 ug/1 Tablet | Novel Laboratories, Inc. | ANDA |
| 40032-161 | Misoprostol 200 ug/1 Tablet | Novel Laboratories, Inc. | ANDA |
| 68071-3762 | Misoprostol 100 ug/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-4843 | Misoprostol 200 ug/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 72789-300 | Misoprostol 200 ug/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 54348-148 | Misoprostol 200 ug/1 Tablet | PharmPak, Inc. | ANDA |
| 82804-037 | Misoprostol 200 ug/1 Tablet | Proficient Rx LP | ANDA |
| 71335-9631 | Misoprostol 100 ug/1 Tablet | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC |
| 59762-5008 | Misoprostol 200 ug/1 Tablet | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 59762-5007 | Misoprostol 100 ug/1 Tablet | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 67296-1936 | Misoprostol 200 ug/1 Tablet | Redpharm Drug | NDA AUTHORIZED GENERIC |
Frequently asked questions
What is misoprostol used for?
Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not…
What are the side effects of misoprostol?
The following have been reported as adverse events in subjects receiving misoprostol: Gastrointestinal In subjects receiving misoprostol 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14–40% and in all studies (over 5,000… See the full label for the complete list.
Who makes misoprostol?
misoprostol is listed by 15 labelers in the FDA NDC directory, including American Health Packaging, ANI Pharmaceuticals, Inc., AvPAK, Bryant Ranch Prepack.