Medical Editor: John P. Cunha, DO, FACOEP
Cytotec (misoprostol) is a synthetic (man-made) prostaglandin used to prevent the formation of ulcers in the stomach during treatment with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs and aspirin are used to treat pain, fever, arthritis, and inflammatory conditions. Cytotec is available in generic form. Common side effects of Cytotec include:
- stomach cramps,
- menstrual cramps,
- spotting, or
- increased or irregular menstruation.
The recommended adult oral dose of Cytotec for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. Cytotec may interact with antacids that contain magnesium. Other drugs may also interact with Cytotec. Tell your doctor all prescription and over-the-counter medications and supplements you use. Cytotec must not be used during pregnancy to prevent stomach ulcers because of possible harm to a fetus. Use birth control while taking Cytotec and for at least one month or one completed menstrual cycle after you stop taking it. This medication passes into breast milk. This drug is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Cytotec (misoprostol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Stop taking misoprostol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These problems usually occur during the first few weeks of treatment and stop after about a week. The occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these symptoms persist for longer than 8 days or if they are severe.
Other, less serious side effects may also occur. Continue to take misoprostol and talk to your doctor if you experience
- headache; or
- menstrual cramps, spotting, or increased or irregular menstruation.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cytotec (Misoprostol)
The following have been reported as adverse events in subjects receiving Cytotec:
In subjects receiving Cytotec 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 Cytotec (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 Cytotec is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Cytotec with magnesium-containing antacids.
Women who received Cytotec 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 Cytotec administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (See BOXED WARNINGS.)
There were no significant differences in the safety profile of Cytotec 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 Cytotec 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 Cytotec and placebo.
Causal Relationship Unknown
The following adverse events were infrequently reported. Causal relationships between Cytotec 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.
Read the entire FDA prescribing information for Cytotec (Misoprostol)
© Cytotec Patient Information is supplied by Cerner Multum, Inc. and Cytotec Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.