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Metrodin Side Effects Center
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Metrodin FDA Prescribing Information: Side Effects
The following adverse reactions reported during Metrodin® (urofollitropin for injection) therapy are listed in decreasing order of potential severity:
3. Adnexal torsion (as a complication of ovarian enlargement),
4. Mild to moderate ovarian enlargement,
5. Abdominal pain,
6. Sensitivity to Metrodin® (urofollitropin for injection) ,
(Febrile reactions which may be accompanied by chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue have occurred after the administration of Metrodin® (urofollitropin for injection) . It is not clear whether or not these were pyrogenic responses or possible allergic reactions.)
7. Ovarian cysts,
10. Breast tenderness,
13. Hemoperitoneum has been reported during menotropins therapy and, therefore, may also occur during Metrodin® (urofollitropin for injection) therapy.
14. There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
The following medical events have been reported subsequent to pregnancies resulting from Metrodin® (urofollitropin for injection) therapy:
2. Congenital abnormalities
(Three incidents of chromosomal abnormalities and four birth defects have been reported following Metrodin® (urofollitropin for injection) -hCG or Metrodin® (urofollitropin for injection) , Pergonal® (menotropins for injection, USP) hCG therapy in clinical trials for stimulation prior to in vitro fertilization. The aborted pregnancies included one Trisomy 13, one Trisomy 18, and one fetus with multiple congenital anomalies (hydrocephaly, omphalocele, and meningocele). One meningocele, one external ear defect, one dislocated hip and ankle, and one dilated cardiomyopathy in presence of maternal Systemic Lupus Erythematosis were reported. None of these events was thought to be drug-related. The incidence does not exceed that found in the general population.)
Drug Abuse and Dependence
There have been no reports of abuse or dependence with Metrodin® (urofollitropin for injection) .
Read the entire FDA prescribing information for Metrodin (Urofollitropin for Injection) »
Additional Metrodin Information
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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