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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

Along with its needed effects, misoprostol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking misoprostol:

Rare

  • 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

Some side effects of misoprostol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

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

General

The most commonly reported side effects included uterine contractions/cramping, diarrhea, and abdominal pain.[Ref]

Genitourinary

Uterine contractions/cramping usually occurred within hours of oral administration.

Heavy bleeding required hemostatic curettage in up to 1.4% of patients.[Ref]

Very common (10% or more): Uterine contractions/cramping (up to 45%)

Common (1% to 10%): Endometritis, heavy bleeding, pelvic inflammatory disease

Uncommon (0.1% to 1%): Cramps, dysmenorrhea, hypermenorrhea, intermenstrual bleeding, menstrual disorder, spotting, vaginal hemorrhage

Rare (0.01% to 0.1%): Menorrhagia

Frequency not reported: Abnormal uterine contractions, breast pain, dysuria, hematuria, impotence, polyuria, postmenopausal vaginal bleeding, urinary tract infection, uterine hemorrhage, uterine perforation, uterine rupture[Ref]

Gastrointestinal

Diarrhea usually occurred early in treatment, and was typically dose-related, self-limiting, and required discontinuation in approximately 2% of patients in clinical trials.[Ref]

Very common (10% or more): Diarrhea (up to 40%), abdominal pain (up to 20%)

Common (1% to 10%): Constipation, dyspepsia, flatulence, nausea, vomiting

Uncommon (0.1% to 1%): Light to moderate cramping

Frequency not reported: Dysphagia, gastrointestinal bleeding, gastrointestinal inflammation and infection, gingivitis, loose stools, profound diarrhea, rectal disorder, reflux[Ref]

Nervous system

Vagal symptoms included hot flush, dizziness, and chills.[Ref]

Common (1% to 10%): Dizziness, headache

Rare (0.01% to 0.1%): Vagal symptoms

Frequency not reported: Abnormal taste, drowsiness, neuropathy, syncope[Ref]

Other

Common (1% to 10%): Infection following abortion

Uncommon (0.1% to 1%): Fever/pyrexia

Rare (0.01% to 0.1%): Birth defects, chills, fetal death, malaise

Very rare (less than 0.01%): Serious/fatal septic shock, serious/fatal toxic shock

Frequency not reported: Aches/pains, asthenia, deafness, earache, fatigue, incomplete abortion, premature birth, retained placenta, rigors, tinnitus[Ref]

Dermatologic

Common (1% to 10%): Skin rash/rash

Rare (0.01% to 0.1%): Erythema nodosum, erythroderma, toxic epidermal necrolysis, urticaria

Frequency not reported: Alopecia, dermatitis, diaphoresis/increased sweating[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hot flushes

Frequency not reported: Amniotic fluid embolism, arrhythmia, arterial thrombosis, cardiovascular accidents, cerebrovascular accident, chest pain, coronary artery spasm, edema, hypertension, hypotension, increased cardiac enzymes, myocardial infarction/fatal myocardial infarction, pallor, phlebitis, severe hypotension, thromboembolic events[Ref]

Hypersensitivity

Very rare (less than 0.01%): Angioedema

Frequency not reported: Anaphylactic reaction, anaphylaxis, hypersensitivity[Ref]

Respiratory

Frequency not reported: Bronchitis, bronchospasm, dyspnea, epistaxis, pneumonia, pulmonary embolism, upper respiratory tract infection[Ref]

Metabolic

Frequency not reported: Appetite change, gout, increased alkaline phosphatase, increased nitrogen, severe dehydration, thirst, weight changes[Ref]

Hematologic

Frequency not reported: Abnormal differential, anemia, increased erythrocyte sedimentation rate, purpura, thrombocytopenia[Ref]

Psychiatric

Frequency not reported: Anxiety, confusion, depression, loss of libido, neurosis[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, back pain, myalgia, muscle cramps. stiffness[Ref]

Ocular

Frequency not reported: Abnormal vision, conjunctivitis[Ref]

Hepatic

Frequency not reported: Abnormal hepatobiliary function[Ref]

Renal

Frequency not reported: Glycosuria[Ref]

References

1. "Product Information. Cytotec (misoprostol)." Searle, Skokie, IL.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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