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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
Oral route (Tablet)
Administration of misoprostol 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 used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of developing gastric ulcers or complications. Women must have a negative serum pregnancy test within 2 weeks prior to beginning therapy, use effective contraceptive measures, and initiate therapy only on the second or third day of the next normal menstrual period. Oral and written warnings of the hazards of misoprostol, including the risk of possible contraception failure, must be given to the patient prior to initiating therapy.
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:
Incidence not known
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:
Incidence not known
For Healthcare Professionals
Applies to misoprostol: oral tabletGeneral
The most commonly reported side effects included uterine contractions/cramping, diarrhea, and abdominal pain.Genitourinary
Uterine contractions/cramping usually occurred within hours of oral administration.
Heavy bleeding required hemostatic curettage in up to 1.4% of patients.
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 ruptureGastrointestinal
Diarrhea usually occurred early in treatment, and was typically dose-related, self-limiting, and required discontinuation in approximately 2% of patients in clinical trials.
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, refluxNervous system
Vagal symptoms included hot flush, dizziness, and chills.
Common (1% to 10%): Dizziness, headache
Rare (0.01% to 0.1%): Vagal symptoms
Frequency not reported: Abnormal taste, drowsiness, neuropathy, syncopeOther
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, tinnitusDermatologic
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 sweatingCardiovascular
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 eventsHypersensitivity
Very rare (less than 0.01%): Angioedema
Frequency not reported: Anaphylactic reaction, anaphylaxis, hypersensitivityRespiratory
Frequency not reported: Bronchitis, bronchospasm, dyspnea, epistaxis, pneumonia, pulmonary embolism, upper respiratory tract infectionMetabolic
Frequency not reported: Appetite change, gout, increased alkaline phosphatase, increased nitrogen, severe dehydration, thirst, weight changesHematologic
Frequency not reported: Abnormal differential, anemia, increased erythrocyte sedimentation rate, purpura, thrombocytopeniaPsychiatric
Frequency not reported: Anxiety, confusion, depression, loss of libido, neurosisMusculoskeletal
Frequency not reported: Arthralgia, back pain, myalgia, muscle cramps. stiffnessOcular
Frequency not reported: Abnormal vision, conjunctivitisHepatic
Frequency not reported: Abnormal hepatobiliary functionRenal
Frequency not reported: Glycosuria
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