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Bravelle Side Effects

Generic name: urofollitropin

Medically reviewed by Drugs.com. Last updated on Nov 9, 2023.

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

Applies to urofollitropin: injection solution reconstituted.

Serious side effects of Bravelle

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:

Other side effects of Bravelle

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:

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. Product Information. Bravelle (urofollitropin). Ferring Pharmaceuticals Inc. 2003.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

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.