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Gonal-f Side Effects

Generic Name: follicle stimulating hormone

Note: This document contains side effect information about follicle stimulating hormone. Some of the dosage forms listed on this page may not apply to the brand name Gonal-f.

For the Consumer

Applies to follicle stimulating hormone: subcutaneous powder for solution, subcutaneous solution

Other dosage forms:

Side effects requiring immediate medical attention

Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Gonal-f) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking follicle stimulating hormone and get emergency help immediately if any of the following effects occur:

Check with your doctor as soon as possible if any of the following side effects occur while taking follicle stimulating hormone:

More common

For patients treated for female infertility or patients pretreated with a gonadotropin-releasing hormone agonist (GnRHa) undergoing assisted reproduction technologies (ART)

For patients treated for female infertility

  • Acne
  • breast pain or tenderness
  • mood swings

Less common

For patients treated for female infertility or patients pretreated with GnRHa undergoing ART

  • Dizziness
  • painful menstrual periods
  • redness, pain, or swelling at injection site
  • sleepiness
  • vaginal bleeding unrelated to menstrual periods (heavy)
  • white vaginal discharge

For patients treated for female infertility

For patients treated pretreated with a GnRHa undergoing ART

  • Fast, racing heartbeat
  • itching of skin
  • loss of appetite
  • thirst (unusual)

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 pain (severe), nausea, vomiting, and weight gain (rapid)

For Healthcare Professionals

Applies to follicle stimulating hormone: injectable powder for injection, injectable solution, subcutaneous powder for injection, subcutaneous solution

General

The most common adverse events were headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection).[Ref]

Genitourinary

Very common (10% or more): Multiple births (up to 35.1%), ovarian cysts, mild to moderate ovarian enlargement

Common (1% to 10%): Mild or moderate OHSS (including symptomatology), intermenstrual bleeding, pelvic discomfort, ovarian hyperstimulation, ectopic pregnancy, miscarriage, gynecomastia (males), varicocele, epididymal cyst, vaginal hemorrhage, pelvic pain

Uncommon (0.1% to 1%): Severe OHSS (including symptomatology), breast complaints, metrorrhagia, ovarian cyst, ovarian enlargement, ovarian torsion, uterine enlargement, vaginal hemorrhage

Rare (less than 0.1%): Complications of severe OHSS, adnexal torsion associated with ovarian enlargement

Frequency not reported: Ectopic pregnancy, miscarriage, multiple gestations

Postmarketing reports: Breast tenderness[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 23.2%), abdomen enlarged (13.9%)

Common (1% to 10%): Abdominal distension, abdominal discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain lower, flatulence

Uncommon (0.1% to 1%): Swollen abdomen[Ref]

Nervous system

Very common (10% or more): Headache (up to 26.5%), dizziness

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

Local

Very common (10% or more): Injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection)[Ref]

Dermatologic

Common (1% to 10%): Acne, rash, dermoid cyst

Frequency not reported: Bruising, swelling, erythema, urticaria, pruritus[Ref]

Metabolic

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

Hypersensitivity

Uncommon (0.1% to 1%): Generalized hypersensitivity reaction

Very rare (less than 0.01%): Mild to severe hypersensitivity reactions including anaphylactic reactions and shock[Ref]

Cardiovascular

Very rare (less than 0.01%): Thromboembolism, usually associated with severe OHSS[Ref]

Other

Uncommon (0.1% to 1%): Pain, influenza-like symptoms[Ref]

Respiratory

Very rare (less than 0.01%): Exacerbation or aggravation of asthma[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Follistim (follicle stimulating hormone)." Organon, West Orange, NJ.

3. "Product Information. Gonal-F (follicle stimulating hormone)." Serono Laboratories Inc, Norwell, MA.

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

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.