"Jan. 24, 2013 -- What's in a name? If it's polycystic ovary syndrome, a lot of confusion, says a panel of experts convened by the NIH -- and they're calling for a change.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine "...
Bravelle Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Bravelle (urofollitropin) for Injection is a purified form of a hormone called follicle-stimulating hormone (FSH) used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. It also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization. Common side effects include headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain.
The dose of Bravelle to stimulate development of ovarian follicles is individualized for each patient. Bravelle may interact with other drugs. Tell your doctor all medications and supplements you use. Stop using Bravelle when you become pregnant. Bravelle must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Bravelle (urofollitropin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Bravelle in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition.
Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:
- severe pelvic pain;
- swelling of your hands or legs;
- stomach pain and swelling;
- shortness of breath;
- weight gain;
- nausea, vomiting, diarrhea; or
- urinating less than usual.
Less serious side effects may include:
- mild stomach upset, constipation;
- mild pelvic pain, cramps;
- breast tenderness;
- skin rash;
- hot flashes;
- acne; or
- pain, swelling, redness, itching, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Bravelle (Urofollitropin Injection) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Bravelle Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding from the vagina/uterus, pain/redness/swelling of the calf muscles, cold/numb/pale skin of the arms/legs/hands/feet, swelling of ankles/hands/feet.
Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, chest pain, shortness of breath.
This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment and after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, difficult/painful breathing, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Bravelle (Urofollitropin Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Bravelle FDA Prescribing Information: Side Effects
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
|All Patients with Adverse Events ≥ 2%|
|Adverse Events (%)||Bravelle® SC||Bravelle® IM|
|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|
|Nausea||2 (5.7)||0 (0.0)|
|Enlarged Abdomen||1 (2.9)||1 (2.7)|
|Abdominal Pain||1 (2.9)||2 (5.4)|
|Weight gain||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)|
|Emotional lability||0||1 (2.7)|
|Accidental injury||0||1 (2.7)|
Table 7. Integrated IVF Safety Profile
|All Patients with Adverse Events ≥ 2%|
|Adverse Events (%)|| Bravelle® SC
|Vaginal hemorrhage||7 (4.7)|
|Post retrieval pain||12 (8.0)|
|Pelvic pain/cramps||10 (6.7)|
|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)|
|Abdominal cramps||21 (14.0)|
|Abdominal pain||7 (4.7)|
|Abdominal fullness/enlargement||10 (6.7)|
|Other Body Systems|
|Respiratory disorder||6 (4.0)|
|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 (see WARNINGS),
- Adnexal torsion (as a complication of ovarian enlargement),
- Mild to moderate ovarian enlargement,
- 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.
Read the entire FDA prescribing information for Bravelle (Urofollitropin Injection) »
Additional Bravelle Information
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Bravelle User Reviews
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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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