Cytotec Side Effects
Generic Name: misoprostol
Note: This page contains information about the side effects of misoprostol. Some of the dosage forms included on this document may not apply to the brand name Cytotec.
Not all side effects for Cytotec may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to misoprostol: oral tablet
In addition to its needed effects, some unwanted effects may be caused by misoprostol (the active ingredient contained in Cytotec). In the event that any of these side effects do occur, they may require medical attention.
Some of the side effects that can occur with misoprostol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Abdominal or stomach pain (mild)
- Bleeding from vagina
- cramps in lower abdomen or stomach area
- heartburn, indigestion, or acid stomach
- nausea and/or vomiting
- Abdominal pain
- convulsions (seizures)
- fast or pounding heartbeat
- low blood pressure
- slow heartbeat
- troubled breathing
For Healthcare Professionals
Applies to misoprostol: oral tablet
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
Hypersensitivity reactions, including anaphylaxis, have been reported.[Ref]
Hematologic abnormalities are uncommon, but include thrombocytopenia, purpura, anemia, abnormal differential, and increases in ESR.[Ref]
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.[Ref]
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.[Ref]
Metabolic side effects have included chills.
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3. Karim A, Rozek LF, Smith ME, Kowalski KG "Effects of food and antacid on oral absorption of misoprostol, a synthetic prostaglandin E1 analog." J Clin Pharmacol 29 (1989): 439-43
4. Fossaluzza V, Di Benedetto P, Zampa A, De Vita S "Misoprostol-induced urinary incontinence." J Intern Med 230 (1991): 463-4
5. Chassagne P, Humez C, Gourmelen O, Moore N, Le Loet X, Deshayes P "Neurosensory adverse effects after combined phenylbutazone and misoprostol ." Br J Rheumatol 30 (1991): 392
6. ElRefaey H, Nooh R, OBrien P, Abdalla M, Geary M, Walder J, Rodeck C "The misoprostol third stage of labour study: a randomised controlled comparison between orally administered misoprostol and standard management." Br J Obstet Gynaecol 107 (2000): 1104-10
7. Huq M "Neurological adverse effects of naproxen and misoprostol combination." Br J Gen Pract 40 (1990): 432
8. Morton MR, Robbins ME "Delirium in an elderly woman possibly associated with administration of misoprostol." DICP 25 (1991): 133-4
9. Chong YS, Chua S, Arulkumaran S "Severe hyperthermia following oral misoprostol in the immediate postpartum period." Obstet Gynecol 90(4 Pt 2) (1997): 703-4
10. Jacquemier JM, Lassoued S, Laroche M, Mazieres B "Neurosensory adverse effects after phenylbutazone and misoprostol combined treatment ." Lancet 2 (1989): 1283
11. Elati A, Weeks A "Risk of Fever after misoprostol for the prevention of postpartum hemorrhage: a meta-analysis." Obstet Gynecol 120 (2012): 1140-8
12. ChoyHee L, Raynor BD "Misoprostol induction of labor among women with a history of cesarean delivery." Am J Obstet Gynecol 184 (2001): 1115-7
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