Misoprostol Side Effects

Brand Names: Cytotec

Please note - some side effects for Misoprostol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Misoprostol - for the Consumer

Misoprostol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Misoprostol:

Diarrhea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Misoprostol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; changes in hearing or deafness; chest pain; fever; headache, dizziness, or blurred vision; irregular heartbeat; mood or mental changes (eg, anxiety, confusion, depression); persistent or severe vomiting or diarrhea; severe fatigue or fainting; unusual bleeding or bruising; unusual tiredness or weakness; vomit that looks like coffee grounds; wheezing or shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Misoprostol Side Effects - for the Professional

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 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 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..

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

Anaphylaxis

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

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects, especially diarrhea, are dose-related and typically transient. However, profound diarrhea has led to severe dehydration in rare cases. Diarrhea may be aggravated by magnesium-containing antacids.

While administration with meals helps to minimize gastrointestinal side effects, dosage reductions may be necessary in some patients who develop severe diarrhea.

Gastrointestinal side effects, including diarrhea (up to 40%), abdominal pain (up to 20%), nausea (3.2%), flatulence, and dyspepsia, are commonly associated with misoprostol therapy.

Genitourinary

Genitourinary side effects occur in up to 3.3% of female patients and include spotting, cramps, hypermenorrhea, dysmenorrhea, and postmenopausal vaginal bleeding. In addition, urinary incontinence has been reported.

Postmenopausal bleeding may occur in patients treated with misoprostol. It is recommended that patients who develop postmenopausal bleeding undergo gynecological evaluation to rule out non-drug related pathology.

A 25-year-old female developed stress urinary incontinence after one month of misoprostol therapy. The patient was rechallenged with misoprostol with symptoms recurring after 7 days of therapy. Urodynamic studies revealed a deficiency in urethral resistance while on misoprostol.

Nervous system

Nervous system side effects of misoprostol are rare, but include headache, dizziness, and neuropathy. Lethargy and delusions have been described with concomitant use of misoprostol and phenylbutazone or naproxen.

A case of severe hyperthermia has been reported in a 20-year-old woman, in the immediate postpartum period, shortly after receiving an oral dose of misoprostol 800 mcg for prophylaxis against postpartum hemorrhage.

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, have been reported.

Hematologic

Hematologic abnormalities are uncommon, but include thrombocytopenia, purpura, anemia, abnormal differential, and increases in ESR.

Other

A case of misoprostol-induced fever has been reported in the literature.

Other

A higher rate of caesarian delivery is reported in a study (n=425) of women, with a prior history of cesarean, given misoprostol for induction of labor.

Metabolic

Metabolic side effects have included chills.

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