home > drugs a-z list > bravelle (urofollitropin injection) drug center > bravelle (urofollitropin injection) drug - side effects and drug interactions

The safety of Bravelle® (urofollitropin injection) was examined in four clinical studies that enrolled a total of 222 patients receiving Bravelle® (urofollitropin injection) including 72 for ovulation induction and 150 for IVF.

All adverse events (without regard to causality assessment) occurring ≥2% incidence in the clinical study patients receiving Bravelle® (urofollitropin injection) are listed in Table 6, (FPI FSH 99-03 study for ovulation induction) and Table 7 (FPI FSH 99-04, FPI FSH 99-05 and FPI FSH 2001 -01 studies for IVF).

Table 6. FPI FSH 99-03 Ovulation Induction Safety Profile

Table 7. Integrated IVF Safety Profile

The following medical events have been reported subsequent to pregnancies resulting from gonadotropin therapy in published clinical studies:

1. Spontaneous Abortion
2. Ectopic Pregnancy
3. Premature Labor
4. Postpartum fever
5. Congenital abnormalities

The following adverse reactions have been previously reported during urofollitropin for injection, purified therapy:

1. Pulmonary and vascular complications (see WARNINGS),
2. Adnexal torsion (as a complication of ovarian enlargement),
3. Mild to moderate ovarian enlargement,
4. Hemoperitoneum,
5. 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.

Drug abuse and Dependence

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

No information provided.

Last reviewed on RxList: 11/18/2008
This monograph has been modified to include the generic and brand name in many instances.