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Bravelle Side Effects

Generic name: urofollitropin

Medically reviewed by Drugs.com. Last updated on Nov 3, 2020.

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: injection solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Vaginal bleeding that is not normal.
  • Pelvic pain.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some women who use this drug. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.
  • Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where the shot is given.
  • Upset stomach.
  • Headache.
  • Stomach cramps.
  • Hot flashes.
  • Bloating.
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.