Bravelle Side Effects
Generic Name: urofollitropin
Please note - some side effects for Bravelle may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Bravelle - for the Consumer
Bravelle
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bravelle:
Seek medical attention right away if any of these SEVERE side effects occur when using Bravelle:Breast tenderness; headache; hot flashes; nausea; stomach pain; vaginal bleeding.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chills; continuing diarrhea; fever; infrequent urination; nausea; pain or redness at the injection site; severe headache; severe pelvic pain; severe stomach pain or swelling; shortness of breath; swelling of the lower legs; vomiting; weakness; weight gain.
Bravelle Side Effects - for the Professional
Bravelle
The safety of Bravelle® was examined in four clinical studies that enrolled a total of 222 patients receiving Bravelle® 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® 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).
| All Patients with Adverse Events ≥ 2% | ||
| Adverse Events(%) | Bravelle® SC | Bravelle® IM |
| N=35 | N=37 | |
| Genitourinary/Reproductive | ||
| OHSS | 4(11.4) | 2(5.4) |
| Vaginal Hemorrhage | 3(8.6) | 0(0.0) |
| Ovarian Disorder (Pain, Cyst) | 1 (2.9) | 3(8.1) |
| Urinary tract infection | 0 | 1 (2.7) |
| Cervix disorder | 1 (2.9) | 0 |
| Gastrointestinal | ||
| Nausea | 2 (5.7) | 0(0.0) |
| Enlarged Abdomen | 1 (2.9) | 1 (2.7) |
| Abdominal Pain | 1 (2.9) | 2 (5.4) |
| Vomiting | 0 | 1 (2.7) |
| Constipation | 0 | 1 (2.7) |
| Diarrhea | 0 | 1 (2.7) |
| Metabolic/Nutritional | ||
| Dehydration | 0 | 1 (2.7) |
| Weight gain | 1 (2.9) | 0 |
| Skin/Appendages | ||
| Acne | 1 (2.9) | 0 |
| Exfoliative dermatitis | 0 | 1 (2.7) |
| Other Body Systems | ||
| Headache | 4(11.4) | 3(8.1) |
| Pain | 2(5.7) | 0(0.0) |
| Neck pain | 0 | 1 (2.7) |
| Respiratory Disorder | 2 (5.7) | 0 (0.0) |
| Hot Flashes | 2(5.7) | 0(0.0) |
| Fever | 0 | 1 (2.7) |
| Hypertension | 0 | 1 (2.7) |
| Emotional lability | 0 | 1 (2.7) |
| Depression | 0 | 1 (2.7) |
| Accidental injury | 0 | 1 (2.7) |
| All Patients with Adverse Events ≥ 2% | |
| Adverse Events (%) | Bravelle® SC N=150 |
| Genitourinary/Reproductive | |
| Vaginal hemorrhage | 7(4.7) |
| Post retrieval pain | 12(8.0) |
| Pelvic pain/cramps | 10.(6.7) |
| OHSS | 9(6.0) |
| Uterine spasms | 4(2.7) |
| Vaginal spotting | 4(2.7) |
| Urinary tract infection | 5 (3.3) |
| Ovarian disorder | 3(2.0) |
| Breast tenderness | 3 (2.0) |
| Vaginal Discharge | 4(2.7) |
| Infection fungal | 3 (2.0) |
| Gastrointestinal | |
| Abdominal cramps | 21(14.0) |
| Nausea | 13(8.7) |
| Abdominal pain | 7(4.7) |
| Abdominal fullness/enlargement | 10(6.7) |
| Constipation | 3(2.0) |
| Other Body Systems | |
| Headache | 19 (12.7) |
| Pain | 8(5.3) |
| Rash | 4(2.7) |
| Respiratory disorder | 6 (4.0) |
| Sinusitis | 3(2.0) |
| Injection site reaction | 6(4.0) |
| Hot flash | 6(4.0) |
| Emotional lability | 3(2.0) |
The following medical events have been reported subsequent to pregnancies resulting from gonadotropin therapy in published clinical studies:
- Spontaneous Abortion
- Ectopic Pregnancy
- Premature Labor
- Postpartum fever
- Congenital abnormalities
The following adverse reactions have been previously reported during urofollitropin for injection, purified therapy:
- Pulmonary and vascular complications,
- Adnexal torsion (as a complication of ovarian enlargement),
- Mild to moderate ovarian enlargement,
- Hemoperitoneum,
- 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.
Side Effects by Body System
Cardiovascular
Cardiovascular side effects have include venous thrombophlebitis, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, thromboembolic events have resulted in death.
Dermatologic
Dermatologic side effects have included dry skin, body rash, hair loss, and hives.
Gastrointestinal
Gastrointestinal side effects have included nausea, vomiting, diarrhea, abdominal cramps, and bloating.
General
General side effects have included headache and abdominal pain.
Genitourinary
Mild to moderate uncomplicated ovarian enlargement has been reported to generally regress without treatment within two or three weeks.
Severe OHSS may progress over one to several days to become a serious medical event. Severe OHSS is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Early warning signs include severe pelvic pain, nausea, vomiting, and weight gain. Cases of OHSS may include abdominal pain, abdominal distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events. Transient liver function test abnormalities have also been associated with OHSS.
Genitourinary side effects have included mild to moderate ovarian enlargement sometimes accompanied by abdominal distention and/or abdominal pain (20%), severe ovarian hyperstimulation syndrome (OHSS)(6%), breast tenderness, and ovarian cysts.
Local
Local side effects have included pain, rash, swelling, and/or irritation at the site of injection.
Oncologic
Oncologic side effects have included infrequent reports of neoplasms (both benign and malignant) in women who have undergone multiple drug regimens for ovulation induction. However, a causal relationship has not been established.
Other
Other side effects have included reactions including chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.
It is not clear whether the febrile reactions were pyrogenic responses or possible allergic reactions.
Respiratory
Respiratory side effects have included atelectasis, pulmonary embolism, pulmonary infarction, and acute respiratory distress syndrome. In rare cases, pulmonary complications have resulted in death.
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