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

1. Pulmonary and vascular complications (see WARNINGS)

2. Ovarian Hyperstimulation Syndrome (see WARNINGS)

3. Hemoperitoneum

4. Adnexal torsion (as a complication of ovarian enlargement)

5. Mild to moderate ovarian enlargement

6. Ovarian cysts

7. Abdominal pain

8. Sensitivity to menotropins (Febrile reactions suggestive of allergic response have been reported following the administration of menotropins. Reports of flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headaches, and malaise have also been reported).

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

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

11. Body rashes

12. Dizziness, tachycardia, dyspnea, tachypnea

The following medical events have been reported subsequent to pregnancies resulting from menotropins therapy:

1. Ectopic pregnancy

2. Congenital abnormalities

With menotropin therapy congenital abnormalities have been reported. One infant was shown to have multiple congenital anomalies consisting of aplasia of the sigmoid colon, cecovesicle fistula, bifid scrotum, meningocele, bilateral internal tibial torsion, and right metatarsus adductus. Other reported anomalies include imperforate anus, congenital heart lesions, supernumerary digits, hypospadias, extrophy of the bladder, Down's syndrome and hydrocephalus. The incidence of congenital abnormalities does not exceed that found in the general population.

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.

Adverse events occurring in ³1% of patients exposed to Repronex® IM or Repronex® SC are described in Table 4.

* Fisher's Exact/Chi-Squared Tests-significant for Repronex SC vs Repronex IM.

DRUG ABUSE AND DEPENDENCE

There have been no reports of abuse or dependence with menotropins.

There have been no reports of abuse or dependence with menotropins.

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