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Gonal-f RFF 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.

For the Consumer

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

Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Gonal-f RFF) 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. "Product Information. Follistim (follicle stimulating hormone)." Organon, West Orange, NJ.

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

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

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

Some side effects of Gonal-f RFF 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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