The following adverse reactions reported during Metrodin® therapy are listed in decreasing order of potential severity:

1. Pulmonary and vascular complications (see WARNINGS),

2. Ovarian Hyperstimulation Syndrome (see WARNINGS),

3. Adnexal torsion (as a complication of ovarian enlargement),

4. Mild to moderate ovarian enlargement,

5. Abdominal pain,

6. Sensitivity to Metrodin®,

(Febrile reactions which may be accompanied by chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue have occurred after the administration of Metrodin®. It is not clear whether or not these were pyrogenic responses or possible allergic reactions.)

7. Ovarian cysts,

8. Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating),

9. Pain, rash, swelling, and/or irritation at the site of injection,

10. Breast tenderness,

11. Headache,

12. Dermatological symptoms (dry skin, body rash, hair loss, hives),

13. Hemoperitoneum has been reported during menotropins therapy and, therefore, may also occur during Metrodin® 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® therapy:

1. Ectopic pregnancy

2. Congenital abnormalities

(Three incidents of chromosomal abnormalities and four birth defects have been reported following Metrodin®-hCG or Metrodin®, 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®.

No clinically significant drug/drug or drug/food interactions have been reported during Metrodin® therapy.

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