Mifeprex Side Effects

Generic name: mifepristone

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

Some side effects of Mifeprex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to mifepristone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking mifepristone (the active ingredient contained in Mifeprex) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Korlym and call your doctor at once if you have a serious side effect such as:

• nausea, weakness, tired feeling, feeling like you might pass out;

• fever, chills, cough with yellow or green mucus;

• stabbing chest pain, wheezing, feeling short of breath;

• swelling in your hands or feet;

• unusual or irregular vaginal bleeding;

• low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects of mifepristone may include:

• stomach pain, mild nausea or vomiting;

• diarrhea or constipation;

• dry mouth;

• stuffy nose, sinus congestion, sore throat;

• headache, dizziness;

• muscle pain or weakness, joint pain, back pain;

• decreased appetite; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to mifepristone: oral tablet

Hematologic

Hematologic side effects have included anemia and a decrease in hemoglobin of greater than 2 g/dL in 2% of patients.

Genitourinary

Genitourinary side effects have included uterine cramping (83%), uterine hemorrhage (9%), vaginitis (3%), leukorrhea (2%), and pelvic pain (2%). Postmarketing reports have included postabortion infection (including endometritis and parametritis) and ruptured ectopic pregnancy. Additional postmarketing reports have included pelvic infection and hematometra. Additional side effects in patients with Cushing syndrome included endometrial hypertrophy.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (96%), nausea (43% to 61%), vomiting (2% to 31%), diarrhea (18% to 26%), and dyspepsia (3%). Additional side effects in patients with Cushing syndrome included decreased appetite, dry mouth, and constipation.

Nervous system

Nervous system side effects have included headache (2% to 31%), dizziness (1% to 12%), fatigue (10%), insomnia (3%), asthenia (3%), and fainting (2%). Postmarketing reports have included reports of light headedness and loss of consciousness. Additional side effects in patients with Cushing syndrome included somnolence.

Musculoskeletal

Musculoskeletal side effects have included back pain (9%) and leg pain (2%). Additional side effects in patients with Cushing syndrome included arthralgia, myalgia, and pain in extremity.

Immunologic

Immunologic side effects have included fever (4%) and viral infections (4%).

Psychiatric

Psychiatric side effects have included increased anxiety (2%).

Cardiovascular

Cardiovascular side effects have included syncope (1%). Postmarketing reports have included tachycardia (including racing pulse, heart palpitations, and pounding heart. Hypotension, including orthostatic hypotension, has also reported in after marketing use. Additional side effects in patients with Cushing syndrome included hypertension and peripheral edema.

Respiratory

Respiratory side effects have included sinusitis (2%). Additional side effects in patients with Cushing syndrome included nasopharyngitis and dyspnea.

Hypersensitivity

Hypersensitivity side effects have included shortness of breath, rash, hives and itching.

General

General side effects in patients with Cushing syndrome included pain and fatigue.

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