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Bravelle Side Effects

Generic Name: urofollitropin

Note: This document contains side effect information about urofollitropin. Some of the dosage forms listed on this page may not apply to the brand name Bravelle.

For the Consumer

Applies to urofollitropin: powder for solution

Along with its needed effects, urofollitropin (the active ingredient contained in Bravelle) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking urofollitropin:

More common
  • Abdominal or pelvic pain
  • bloating (mild)
Less common or rare
  • Abdominal or stomach pain (severe)
  • bloating (moderate to severe)
  • chest pain or trouble breathing
  • decreased amount of urine
  • feeling of indigestion
  • headache, sudden and severe
  • nausea, vomiting, or diarrhea (continuing or severe)
  • pelvic pain (severe)
  • shortness of breath or wheezing
  • skin rash or hives
  • swelling of the arms or lower legs
  • weight gain (rapid)

Some side effects of urofollitropin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare
  • Breast tenderness
  • diarrhea (mild)
  • headache
  • hot flashes
  • nausea
  • redness, pain, or swelling at the injection site
  • vomiting

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Abdominal or stomach pain (severe)
  • bloating (moderate to severe)
  • decreased amount of urine
  • feeling of indigestion
  • nausea, vomiting, or diarrhea (continuing or severe)
  • pelvic pain (severe)
  • shortness of breath
  • swelling of the lower legs
  • weight gain (rapid)

For Healthcare Professionals

Applies to urofollitropin: injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection

General

The most common adverse events were multi-fetal gestation and birth, abdominal cramps, headache, and ovarian hyperstimulation syndrome (OHSS).[Ref]

Genitourinary

Very common (10% or more): Multi-fetal gestation and birth (up to 66.7%), ovarian hyperstimulation syndrome (OHSS) (11.4%)
Common (1% to 10%): Hot flashes, vaginal hemorrhage, ovarian disorder (pain, cyst), urinary tract infection, cervix disorder, post retrieval pain, uterine spasms, vaginal spotting, breast tenderness, vaginal discharge, infection fungal, pelvic pain
Frequency not reported: Abnormal ovarian enlargement
Postmarketing reports: Ovarian enlargement, pelvic pain, hot flushes[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Acne, exfoliative dermatitis, rash[Ref]

Gastrointestinal

Very common (10% or more): Abdominal cramps (14%), abdominal pain
Common (1% to 10%): Nausea, enlarged abdomen, vomiting, diarrhea, constipation, abdominal discomfort[Ref]

Local

Common (1% to 10%): Injection site pain and reactions (redness, bruising, swelling, and/or itching)[Ref]

Metabolic

Common (1% to 10%): Weight gain, dehydration[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain
Postmarketing reports: Muscle spasm[Ref]

Nervous system

Very common (10% or more): Headache (12.7%)[Ref]

Other

Common (1% to 10%): Pain, fever, accidental injury[Ref]

Psychiatric

Common (1% to 10%): Emotional lability, depression[Ref]

Respiratory

Common (1% to 10%): Respiratory disorder, sinusitis
Postmarketing reports: Nasopharyngitis[Ref]

Hypersensitivity

Frequency not reported: Allergic, local or generalized skin reactions, delayed-type hypersensitivity[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Bravelle (urofollitropin)." Ferring Pharmaceuticals Inc, Tarrytown, NY.

Some side effects of Bravelle may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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