Note: This document contains side effect information about follicle stimulating hormone. Some dosage forms listed on this page may not apply to the brand name Follistim AQ Cartridge.

Applies to follicle stimulating hormone: subcutaneous powder for solution, subcutaneous solution. Other dosage forms:

• subcutaneous solution

Serious side effects

Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Follistim AQ Cartridge) 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

• Acid or sour stomach
• anxiety
• backache
• belching
• bloating
• chest pain or tightness
• confusion
• cough
• diarrhea
• difficulty breathing
• difficulty in speaking
• dizziness or lightheadedness
• double vision
• excess air or gas in the stomach or intestines
• fainting
• fast heartbeat
• fast, weak pulse
• full feeling
• headache
• heartburn
• inability to move the arms, legs, or facial muscles
• indigestion
• loss of appetite
• noisy breathing
• passing gas
• pelvic pain, discomfort, aching, or heaviness
• rapid weight gain
• severe nausea
• slow speech
• stomach discomfort, upset, or pain, or swelling
• sudden increase in stomach or shoulder pain
• sweating
• trouble breathing
• unusual or large amount of vaginal bleeding
• uterine bleeding between menstrual periods
• vomiting

Incidence not known

• Difficulty swallowing
• dizziness
• hives, itching, skin rash
• pain the chest, groin, or legs, especially the calves
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• unusual tiredness or weakness
• vision changes

Other side effects

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

• Acne
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• dandruff
• oily skin
• swelling of the breasts or breast soreness in both females and males

Less common

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

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]