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Menopur

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Menopur

Menopur

Menopur Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Menopur (menotropins injection) is used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. It is also used to stimulate the development of multiple eggs for in vitro fertilization, and is likewise used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient. It is an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Common side effects include headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness.

Menopur is administered through a subcutaneous (under the skin) injection. The recommended initial dose of Menopur for patients who have received a GnRH agonist for pituitary suppression is 225 IU. The maximum daily dose should not exceed 450 IU and dosing beyond 20 days is not recommended. It is unknown if other medications will interact with Menopur. Tell your doctor all prescription or over-the-counter medicines or supplements you use. Stop using Menopur when you become pregnant. Menopur must not be used during pregnancy. If you think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Menopur (menotropins injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Menopur in Detail - Patient Information: Side Effects

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Serious pulmonary (lung and breathing) conditions have been reported in patients using menotropins. Seek medical attention if you experience any sudden changes in your breathing.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
  • nausea, vomiting, or diarrhea;
  • shortness of breath;
  • pain, warmth, or tenderness centralized in an arm or leg;
  • fever or chills;
  • headache or drowsiness;
  • weakness or aching of muscles or joints;
  • breast enlargement or tenderness;
  • pain, swelling, or irritation at the injection site; or
  • rash.

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Menopur (Menotropins Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Menopur Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: flu-like symptoms (e.g., fever, chills, joint pain, muscle ache, tiredness).

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, sudden vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, shortness of breath.

This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy or after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain/swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Menopur (Menotropins Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Menopur FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

In two single cycle, open label, multinational, multicenter, comparative trials, a total of 434 normal ovulatory infertile women were randomized and received subcutaneously administered MENOPUR® as part of an in vitro fertilization (IVF) cycle (both trials) or intracytoplasmic sperm injection (ICSI)] cycle (one of the two trials). All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring at an incidence of ≥ 2% in women receiving MENOPUR® are shown in Table 1.

Table 1: MENOPUR® Administered subcutaneously in Women Undergoing IVF and ICSI. Adverse Reactions with Incidence of 2% or Greater Occurring on or After GnRH Administration.

Body System/ Preferred Term   IVF
n=434
N %
Body as a whole Abdominal cramps 13 3
  Abdomen enlarged 10 2.3
  Abdominal pain 29 6.7
  Headache 27 6.2
  Injection site pain + reaction 17 3.9
  Injection site inflammation 10 2.3
Urogenital OHSS 27 6.2

In addition, thrombophlebitis was reported in less than 1% of subjects.

In a second open label, multinational, multicenter, comparative IVF and ICSI trial, MENOPUR® and BRAVELLE® were administered in the same syringe to 60 normal ovulatory infertile women. OHSS, post retrieval cramping and nausea and spontaneous abortion were the most common adverse reactions occurring at an incidence of ≥ 5% in women receiving the combination of MENOPUR® and BRAVELLE® .

In a third open label, US multicenter, comparative trial for ovulation induction in anovulatory or oligovulatory infertile women, 76 subjects received subcutaneous or intramuscular injections of MENOPUR® . The most common adverse reactions occurring at an incidence of ≥ 5% in women receiving MENOPUR® were: headache; OHSS; injection site reaction, abdominal cramps, fullness and pain; and nausea.

Postmarketing Experience

The following adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to MENOPUR® cannot be reliably determined.

Gastrointestinal disorders: abdominal pain, abdominal pain lower, abdominal distension, nausea, vomiting, abdominal discomfort

General disorders and administration site conditions: injection site reactions (most frequently reported injection site reaction was injection site pain), fatigue

Nervous system disorders: headache, dizziness

Reproductive system disorders: OHSS [see WARNINGS AND PRECAUTIONS], pelvic pain, ovarian cyst, breast complaints (including breast pain, breast tenderness, breast discomfort and breast swelling)

Skin and subcutaneous tissue disorders: acne, rash

Vascular disorders: hot flush

Read the entire FDA prescribing information for Menopur (Menotropins Injection) »

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Menopur - User Reviews

Menopur User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Menopur sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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