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Misoprostol Side Effects

In Summary

Commonly reported side effects of misoprostol include: abdominal pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to misoprostol: oral tablet

In addition to its needed effects, some unwanted effects may be caused by misoprostol. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking misoprostol:

  • Cramps
  • heavy bleeding
  • painful menstruation
Incidence not known:
  • Bladder pain
  • bloody nose
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chest pain
  • chills
  • confusion
  • constipation
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear congestion
  • feeling unusually cold
  • fever
  • frequent urge to urinate
  • headache
  • hives, itching, or skin rash
  • loss of voice
  • lower back or side pain
  • muscle pain or stiffness
  • nasal congestion
  • nervousness
  • pain in the joints
  • pale skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • runny nose
  • severe stomach pain
  • shivering
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds

Minor Side Effects

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
  • diarrhea
Less common:
  • Acid or sour stomach
  • belching
  • bloated
  • excess air or gas in the stomach or intestines
  • full feeling
  • heartburn
  • indigestion
  • passing gas
  • stomach discomfort or upset
Incidence not known:
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • breast pain
  • burning, dry, or itching eyes
  • change in taste
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cracked, dry, scaly skin
  • depression
  • discharge, excessive tearing
  • hair loss or thinning of the hair
  • hearing loss
  • lack or loss of strength
  • paleness of the skin
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • weight changes

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

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.[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 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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2. Wildeman RA "Focus on misoprostol: review of worldwide safety data." Clin Invest Med 10 (1987): 243-5

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

Not all side effects for misoprostol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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