"Investigators from the Women's Health Initiative (WHI) Hormone Trials are reaffirming conclusions that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management "...
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 following serious adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity and Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Abnormal Ovarian Enlargement [see WARNINGS AND PRECAUTIONS]
- Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
- Thromboembolic events [see WARNINGS AND PRECAUTIONS]
- Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
- Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
- Congenital Malformations [see WARNINGS AND PRECAUTIONS]
- Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
- Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
- Ovarian Neoplasms [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of BRAVELLE® was examined in four clinical studies that enrolled a total of 222 women who received BRAVELLE® .
In a randomized, multi-center, active controlled study, a total of 72 women received BRAVELLE® (35 in a subcutaneous administration arm and 37 in an intramuscular administration arm) for induction of ovulation. Adverse reactions occurring at an incidence of ≥ 2% incidence in women receiving BRAVELLE® are shown in Table 1.
Table 1: Ovulation Induction Safety Profile
|Adverse Events (%)||All Patients with Adverse Events ≥ 2%|
|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)|
Assisted Reproductive Technology
Three studies examined the safety profile of BRAVELLE® in ART. A total of 150 women received treatment with BRAVELLE® in these studies. Adverse reactions occurring at an incidence of ≥ 2% incidence for this integrative assessment are presented in Table 2.
Table 2: Integrated IVF
|All Patients with Adverse Events ≥ 2%|
|Adverse Events (%)||BRAVELLE® subcutaneous
|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 adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to BRAVELLE® cannot be reliably determined.
Gastrointestinal disorders: Abdominal pain, Nausea, Vomiting, Abdominal distension, Abdominal discomfort, Diarrhea, Constipation
General disorders and administration site conditions: Pain, Injection site reactions (redness, bruising, swelling and/or pruritus)
Infections and infestations: Urinary tract infection, Nasopharyngitis
Musculoskeletal and connective tissue disorders: Muscle spasm
Nervous system disorders: Headache
Reproductive system disorders: Vaginal hemorrhage, OHSS [see WARNINGS AND PRECAUTIONS], Pelvic pain, Breast tenderness, Vaginal discharge. Ovarian enlargement, Multiple pregnancies [see WARNINGS AND PRECAUTIONS]
Skin and subcutaneous tissue disorders: Rash
Vascular disorders: Hot flushes
Read the entire FDA prescribing information for Bravelle (Urofollitropin Injection) »
Additional Bravelle Information
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