Menopur Side Effects

Generic Name: menotropins

Please note - some side effects for Menopur may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Menopur - for the Consumer

Menopur

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Menopur:

Abdominal pain; back pain; breast enlargement; chills; dizziness; fever; flu-like symptoms; flushing; general body discomfort; headache; menstrual changes; muscle or joint pain; pain or rash at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal bloating; changes in speech or vision; chest pain; decreased urination; diarrhea; fast heartbeat; nausea; one-sided weakness; severe abdominal pain; severe headache; shortness of breath; sudden leg pain; vomiting; weakness; weight gain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Menopur Side Effects - for the Professional

Menopur

Clinical Study Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observes in practice.The safety of Menopur was examined in 3 clinical studies that enrolled a total of 575 patients receiving Menopur in the IVF and OI studies. All adverse events (without regard to causality assessment) occurring at an incidence of >2% in women treated with Menopur are listed in Table 1

Table 1: Highly Purified Menotropin SC and IM in Female Patients Undergoing IVF and OI Adverse Events With Onset on or After GnRH Administration, COSTART Classification (for Incidence of 2% or Greater)

 * Includes IM and SC subjects from Protocols MFK/IVF/0399E and Menopur 2000-02.

** Includes IM and SC subjects from Protocol Menopur 2000-01

Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have included injection site edema and injection site reaction.

Genitourinary

Genitourinary side effects have included Ovarian Hyperstimulation Syndrome (OHSS), vaginal hemorrhage, ovarian disease, ectopic pregnancy, pelvic pain, uterine spasm, and breast tenderness.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, abdominal cramping, abdominal pain, abdominal fullness, constipation, and enlarged abdomen.

Nervous system

Nervous system side effects have included headache, malaise, and dizziness.

Respiratory

Respiratory side effects have included dyspnea and increased cough.

General

General side effects have included infection, back pain, and flu syndrome.

Endocrine

Endocrine side effects have included elevated estradiol levels.

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