Leuprolide (Intradermal Route, Intramuscular Route, Subcutaneous Route)

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Side Effects

Along with its needed effects, a medicine 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:

• Fast or irregular heartbeat

• Bone, muscle, or joint pain
• Fainting
• Fast or irregular breathing
• Numbness or tingling of the hands or feet
• Puffiness or swelling of the eyelids or around the eyes
• Shortness of breath
• Skin rash, hives, or itching
• Sudden, severe decrease in blood pressure and collapse
• Tightness in the chest or wheezing
• Troubled breathing

• Arm, back, or jaw pain
• Bloody or cloudy urine
• Blurred vision
• Burning while urinating
• Chest pain or discomfort
• Chest tightness or heaviness
• Difficult or labored breathing
• Difficult, burning, or painful urination
• Difficulty with moving
• Dizziness
• Frequent urge to urinate
• Headache
• Increased urge to urinate during the night
• Muscle pain or stiffness
• Nausea
• Nervousness
• Pain in the joints
• Pale skin
• Pounding in the ears
• Slow or fast heartbeat
• Sweating
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Waking to urinate at night

• Pain in the groin or legs (especially in the calves of the legs)

• Altered mental status
• Cardiovascular collapse
• Double vision
• Visual changes
• Vomiting

• Anxiety
• Deepening of voice
• Increased hair growth
• Mental depression
• Mood changes

• Body pain
• Burning, itching, redness, or swelling at the injection site
• Skin rash

• Vaginal bleeding (continuing)
• White vaginal discharge (continuing)

Some side effects 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:

• Sudden sweating and feelings of warmth (also called hot flashes)

• Bleeding, bruising, burning, itching, pain, redness, or swelling at the injection site
• Decreased interest in sexual intercourse
• Swelling of the feet or lower legs
• Swelling or increased tenderness of the breasts
• Trouble with sleeping
• Weight gain

• Light, irregular vaginal bleeding
• Stopping of menstrual periods

• Burning, dryness, or itching of the vagina
• Pelvic pain

• Back pain
• Chills
• Constipation
• Cough
• Diarrhea
• Fever
• General feeling of discomfort or illness
• Loss of appetite
• Pain or discomfort at the injection site
• Redness of the face, neck, arms, and occasionally, upper chest
• Runny nose
• Shivering
• Sleeplessness
• Sore throat
• Sudden sweating
• Trouble sleeping
• Unable to sleep
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Bone pain
• Decreased size of the testicles
• Inability to have or keep an erection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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