Menopur
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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
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 safety of Menopur® (menotropins injection) was examined in 3 clinical studies that enrolled a total of 575 patients receiving Menopur® (menotropins injection) in the IVF and 01 studies. All adverse events (without regard to causality assessment) occurring at an incidence of > 2 % in women treated with Menopur® (menotropins injection) are listed in Table 3.
Table 3: HIGHLY PURIFIED MENOTROPIN SC AND IM IN FEMALE PATIENTS
UNDERGOING IVF AND 01 ADVERSE EVENTS WITH ONSET ON OR AFTER GnRH ADMINISTRATION,
COSTART CLASSIFICATION (FOR INCIDENCE OF 2% OR GREATER)
| BODY SYSTEM/PREFERRED TERM | IVF* n=499 |
01** n=76 |
||
| N | % | N | % | |
| BODY AS A WHOLE | ||||
| Abdomen Enlarged | 12 | 2.4 | 0 | 0.0 |
| Abdominal cramps | 30 | 6.0 | 5 | 6.6 |
| Abdominal fullness | 16 | 3.2 | 7 | 9.2 |
| Abdominal pain | 88 | 17.6 | 7 | 9.2 |
| Back pain | 16 | 3.2 | 0 | 0.0 |
| Elevated estradiol | 12 | 2.4 | 0 | 0.0 |
| Flu syndrome | 13 | 2.6 | 1 | 1.3 |
| Flushing | 12 | 2.4 | 0 | 0.0 |
| Headache | 170 | 34.1 | 12 | 15.8 |
| Injection site pain | 27 | 5.4 | 0 | 0.0 |
| Injection site reaction | 48 | 9.6 | 9 | 11.8 |
| Malaise | 14 | 2.8 | 2 | 2.6 |
| Pain | 16 | 3.2 | 2 | 2.6 |
| CARDIOVASCULAR | ||||
| Migraine | 12 | 2.4 | 0 | 0.0 |
| DIGESTIVE | ||||
| Constipation | 8 | 1.6 | 0 | 0.0 |
| Diarrhea | 14 | 2.8 | 2 | 2.6 |
| Nausea | 60 | 12.0 | 6 | 7.9 |
| Vomitinq | 21 | 4.2 | 2 | 2.6 |
| NERVOUS | ||||
| Dizziness | 13 | 2.6 | 0 | 0.0 |
| RESPIRATORY | ||||
| Cough increased | 8 | 1.6 | 2 | 2.6 |
| Respiratory disorder | 29 | 5.8 | 3 | 3.9 |
| UROGENITAL | ||||
| Breast tenderness | 9 | 1.8 | 2 | 2.6 |
| Hot flash | 3 | 0.6 | 2 | 2.6 |
| Menstrual disorder | 16 | 3.2 | 0 | 0.0 |
| OHSS | 19 | 3.8 | 10 | 13.2 |
| Pelvic cramps | 0 | 0.0 | 3 | 3.9 |
| Pelvic discomfort | 2 | 0.4 | 2 | 2.6 |
| Post retrieval pain | 32 | 6.4 | 0 | 0.0 |
| Uterine spasm | 8 | 1.6 | 3 | 3.9 |
| * INCLUDES IM AND SC SUBJECTS FROM PROTOCOLS
MFK/IVF/0399E AND MENOPUR (menotropins injection) 2000-02. **INCLUDES IM AND SC SUBJECTS FROM PROTOCOL MENOPUR (menotropins injection) 2000-01. |
||||
Drug Abuse And Dependence
There have been no reports of abuse or dependence with menotropins.
Read the entire FDA prescribing information for Menopur (Menotropins Injection) »
Additional Menopur Information
Menopur - User Reviews
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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