Gonal-F Pen Side Effects
Generic name: follicle stimulating hormone
Medically reviewed by Drugs.com. Last updated on Oct 22, 2024.
Note: This document provides detailed information about Gonal-F Pen Side Effects associated with follicle stimulating hormone. Some dosage forms listed on this page may not apply specifically to the brand name Gonal-F Pen.
Applies to follicle stimulating hormone: subcutaneous solution.
Other dosage forms:
Serious side effects of Gonal-F Pen
Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Gonal-F 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 side effects
- bloating
- diarrhea
- severe nausea or vomiting
- severe stomach pain
- stomach or pelvic discomfort, aching, or heaviness
- weight gain that is rapid
Less common side effects
- 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
- trouble breathing
- vision changes
Other side effects of Gonal-F Pen
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 side effects
- blemishes on the skin
- headache
- pimples
Less common side effects
- 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 adverse events
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
Respiratory
- Very rare (less than 0.01%): Exacerbation or aggravation of asthma[Ref]
References
1. (2002) "Product Information. Follistim (follicle stimulating hormone)." Organon
2. (2002) "Product Information. Gonal-F (follicle stimulating hormone)." Serono Laboratories Inc
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
More about Gonal-F Pen (follicle stimulating hormone)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: gonadotropins
Patient resources
Other brands
Follistim AQ, Gonal-f RFF Redi-ject, Follistim AQ Cartridge
Professional resources
Other brands
Other formulations
Related treatment guides
Further information
Gonal-F Pen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.