Summary
Commonly reported side effects of misoprostol include: abdominal pain. Continue reading for a comprehensive list of adverse effects.
Applies to misoprostol: oral tablets.
Warning
- May cause serious fetal harm (e.g., birth defects, abortion, premature birth, uterine rupture).1 5 70
- Uterine rupture reported when misoprostol was administered in pregnant women to induce labor or to induce abortion; risk increases with advancing gestational age and with prior uterine surgery, including cesarean delivery.
- Misoprostol should not be taken by pregnant women to reduce the risk of nonsteroidal anti-inflammatory agent (NSAIA)-induced ulcers.1
- Misoprostol should not be used for reducing the risk of NSAIA-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAIA, or is at high risk of developing gastric ulceration.1 In such women, pregnancy must be excluded before the start of treatment and prevented thereafter by use of reliable contraception.1 Misoprostol should only be initiated on the second or third day of the next normal menstrual period.1
- Advise patients of the abortifacient property of misoprostol and warn them not to give the drug to others because of the danger to women of childbearing potential should the drug be taken by mistake.1
Side effects include:
Diarrhea, abdominal pain.
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
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
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]
