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Gonal-f RFF Pen 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 RFF Pen.

For the Consumer

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

Other dosage forms:

Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Gonal-f RFF Pen) 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 follicle stimulating hormone:

More Common

  • Abdominal or stomach pain that is severe
  • bloating
  • diarrhea
  • severe nausea or vomiting
  • stomach or pelvic discomfort, aching, or heaviness
  • weight gain that is rapid

Less Common

  • Heavy non-menstrual vaginal bleeding
  • redness, pain, or swelling at the injection site
  • unusual tiredness or weakness

Incidence Not Known

  • Difficulty with breathing
  • pain in the chest, groin, or legs, especially the calves
  • severe, sudden headache
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • vision changes

Some side effects of follicle stimulating hormone 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:

More Common

  • Blemishes on the skin
  • headache
  • pimples

Less Common

  • Body aches or pain
  • chills
  • difficulty having a bowel movement (stool)
  • dizziness
  • dry skin
  • fast or racing heart
  • fever
  • hair loss
  • hives
  • quick or shallow breathing
  • rash
  • swelling of the breasts or breast soreness in both females and males

Incidence Not Known

  • Breast tenderness
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected

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

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

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.

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