Leuprolide overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer (but does not treat the cancer itself). Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children at least 2 years old.

Leuprolide may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Leuprolide can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength.

Tell your doctor if you have ever had:

• depression, mental illness or psychosis;
• seizures or epilepsy;
• a blood vessel disorder;
• a brain tumor or spinal cord injury;
• heart disease, congestive heart failure, long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Do not give this medicine to any child without medical advice.

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy. Leuprolide can make hormonal birth control less effective (birth control pills, injections, implants, skin patches, vaginal rings).

Call your doctor if your periods continue while you are being treated with this medicine.

You should not breast-feed while using this medicine.

Use Lupron Depot (Intramuscular) 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, sweating, fast heartbeats, dizziness, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• problems with your pituitary gland--sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• bone pain, loss of movement in any part of your body;
• swelling, rapid weight gain;
• a seizure;
• unusual changes in mood or behavior (crying spells, anger, feeling irritable);
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination; or
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

Rare but serious side effects may occur. Call your doctor if you have:

• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
• muscle weakness or loss of use, loss of bowel or bladder control;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech.

Common side effects may include:

• pituitary gland problems;
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, constipation;
• wheezing, chest tightness, trouble breathing;
• hot flashes, sweating;
• dizziness, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• decreased interest in sex; or
• redness, pain, swelling, or oozing where the shot was given.

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.