Misoprostol Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 28, 2023.
Applies to misoprostol: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth, or uterine rupture.Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion.
The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery.Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).Patients must be advised of the abortifacient property and warned not to give the drug to others.Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration.
In such patients, misoprostol may be prescribed if the patient: has had a negative serum pregnancy test within 2 weeks prior to beginning therapy; is capable of complying with effective contraceptive measures; has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake; will begin misoprostol only on the second or third day of the next normal menstrual period.
Common side effects of misoprostol
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 side effects
- abdominal or stomach pain
- diarrhea
Less common side effects
- 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
Serious side effects of misoprostol
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 side effects
- 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
For healthcare professionals
Applies to misoprostol: oral tablet.
General adverse events
The most commonly reported side effects included uterine contractions/cramping, diarrhea, and abdominal pain.[Ref]
Genitourinary
- 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]
Uterine contractions/cramping usually occurred within hours of oral administration.
Heavy bleeding required hemostatic curettage in up to 1.4% of patients.[Ref]
Gastrointestinal
- 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]
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]
Nervous system
- Common (1% to 10%): Dizziness, headache
- Rare (0.01% to 0.1%): Vagal symptoms
- Frequency not reported: Abnormal taste, drowsiness, neuropathy, syncope[Ref]
Vagal symptoms included hot flush, dizziness, and chills.[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. (2001) "Product Information. Cytotec (misoprostol)." Searle
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Misoprostol side effects can vary depending on the individual. 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.
