Cytotec Side Effects

Generic name: misoprostol

Note: This document contains side effect information about misoprostol. Some of the dosage forms listed on this page may not apply to the brand name Cytotec.

Some side effects of Cytotec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to misoprostol: oral tablet

Stop taking misoprostol (the active ingredient contained in Cytotec) 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

• vomiting;

• flatulence;

• constipation;

• 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.

For Healthcare Professionals

Applies to misoprostol: oral tablet

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 (the active ingredient contained in Cytotec) 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

Misoprostol-induced fever has been reported in the literature. The incidence of fever is related to misoprostol (the active ingredient contained in Cytotec) dosage and route (highest incidence found in the high-dose sublingual routes). However, there appears to be genetic variations between ethnic groups and intrapartum clinical factors.

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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