Menopur
Infertility Treatment May Raise Birth Defect Risk »
"Oct. 20, 2012 -- Babies conceived with the help of high-tech fertility treatments such as in vitro fertilization (IVF) have an increased risk for birth defects, a new study shows.
Compared to infants born to mothers who conceived with"...
Read the Infertility Treatment May Raise Birth Defect Risk article »
Menopur
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 Menopur (menotropins injection) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
No information provided.
Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.
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