Follicle stimulating hormone is used to treat infertility in women who cannot ovulate. This medicine is not effective in women with primary ovarian failure (when the ovaries are unable to produce an egg).

Follicle stimulating hormone is also used in men to stimulate sperm production. This medicine is not effective in men with primary testicular failure (when the testicles are unable to produce sperm).

Follicle stimulating hormone is often used together with another medication called human chorionic gonadotropin (hCG).

Follicle stimulating hormone may also be used for purposes not listed in this medication guide.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using follicle stimulating hormone.

You should not use follicle stimulating hormone if you are allergic to it, or if you have:

• an untreated or uncontrolled disorder of the thyroid, pituitary gland, or adrenal glands;
• heavy or abnormal vaginal bleeding that has not been checked by a doctor;
• an ovarian cyst;
• cancer of the breast, ovary, uterus, testicle, hypothalamus, or pituitary gland; or
• if you are allergic to benzyl alcohol, follitropin, sucrose, neomycin, sodium phosphate, or streptomycin.

Do not use this medicine if you are already pregnant. You may need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant.

Tell your doctor if you have ever had:

• unusual vaginal bleeding;
• polycystic ovary disease;
• twisting (torsion) of your ovary;
• a stroke or blood clot;
• asthma; or
• stomach surgery.

Fertility treatment may increase your chance of having multiple births (twins, triplets, etc). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

You should not breastfeed while using follicle stimulating hormone.

Use Gonal-F RFF (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening condition. Stop using this medicine and call your doctor right away if you have symptoms of OHSS during or shortly after using follicle stimulating hormone:

• severe pain in your lower stomach, nausea, vomiting, diarrhea;
• bloating, rapid weight gain;
• little or no urination; or
• trouble breathing.

Also call your doctor at once if you have:

• severe pelvic pain on one side;
• a cough with bloody mucus;
• fever, sore throat, swollen glands;
• a lump or swelling in your testicles;
• signs of acute respiratory distress syndrome--fever with shortness of breath or rapid breathing; or
• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

• redness, swelling, or bruising where an injection was given;
• an ovarian cyst;
• headache, tiredness;
• breast pain or swelling;
• stuffy nose, sneezing, sinus pain;
• acne; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.