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Cytotec Side Effects

Generic name: misoprostol

Medically reviewed by Drugs.com. Last updated on Mar 28, 2023.

Note: This document contains side effect information about misoprostol. Some dosage forms listed on this page may not apply to the brand name Cytotec.

Applies to misoprostol: oral tablet.

Warning

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.

Serious side effects of Cytotec

Along with its needed effects, misoprostol (the active ingredient contained in Cytotec) 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

Incidence not known

Other side effects of Cytotec

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

Incidence not known

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]

References

1. Product Information. Cytotec (misoprostol). Searle. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

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.