Misoprostol Side Effects

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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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:

Constipation; diarrhea; gas; headache; indigestion; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; persistent or severe vomiting or diarrhea; vomit that looks like coffee grounds.

Side Effects by Body System

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

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