Lupron Depot (3-month)

Note: This document contains side effect information about leuprolide. Some of the dosage forms listed on this page may not apply to the brand name Lupron.

Applies to leuprolide: powder for suspension 1 month, powder for suspension 3 month, powder for suspension 4 month, powder for suspension 6 month, solution

Along with its needed effects, leuprolide (the active ingredient contained in Lupron) 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 leuprolide:

For adults

Less common

• Fast or irregular heartbeat

Rare

• 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
• skin rash, hives, or itching
• sudden, severe decrease in blood pressure and collapse
• tightness in the chest
• troubled breathing

For males only (adults)

More common

• Arm, back, or jaw pain
• bloody or cloudy urine
• blurred vision
• chest pain or discomfort
• 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

Rare

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

Incidence not known

• Altered mental status
• cardiovascular collapse
• double vision
• visual changes
• vomiting

For females only (adults)

Rare

• Anxiety
• deepening of voice
• increased hair growth
• mental depression
• mood changes

For children

Rare

• Body pain
• burning, itching, redness, or swelling at the injection site

For females only (children)—expected in first few weeks

Rare

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

Some side effects of leuprolide 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:

For adults

More common

• Sudden sweating and feelings of warmth (hot flashes)

Less common

• 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 sleeping
• weight gain

For females only (adults)

More common

• Light, irregular vaginal bleeding
• stopping of menstrual periods

Less common

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

For males only (adults)

More common

• 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
• sore throat
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Decreased size of the testicles
• inability to have or keep an erection

Applies to leuprolide: intramuscular kit, intramuscular powder for injection, intramuscular powder for injection extended release, subcutaneous implant, subcutaneous kit, subcutaneous powder for injection extended release, subcutaneous solution

The most commonly reported side effects were general pain, peripheral edema, hot flashes, hair loss, ECG changes, ischemia.

Postmarketing reports: Anaphylactoid reactions

Very common (10% or more): Vaginal dryness (37%), breast tenderness (up to 14%)

Common (1% to 10%): Urinary frequency/urgency, hematuria, urinary tract infection, ovarian hyperstimulation, testicular soreness/pain, breast soreness/tenderness, testicular atrophy, erectile dysfunction, penile disorder, reduced penis size, vaginal hemorrhage, gynecomastia, breast changes, breast enlargement, decrease in testicular size, impotence

Very common (10% or more): ECG changes (19%), ischemia (19%)

Common (1% to 10%): Hypertension, murmur, phlebitis, thrombosis, arrhythmias, angina, myocardial infarction

Very common (10% or more): Hot flashes (up to 91%)

Very rare (less than 0.01%): Pituitary apoplexy

Frequency not reported: Transient increase in serum testosterone concentrations during the first 2 days of therapy, 'flare' phenomenon

Common (1% to 10%): Depression, insomnia/sleep disorder, anxiety, nervousness, decreased libido, increased libido

Common (1% to 10%): Dizziness/lightheadedness, headache

Common (1% to 10%): Constipation, nausea/vomiting, flatulence, dyspepsia, gastroenteritis/colitis, diarrhea, dysphagia, gastrointestinal bleeding, gastrointestinal disturbance, peptic ulcer, rectal polyps

Very common (10% or more): Hair loss (up to 18%)

Common (1% to 10%): Skin rash, acne, itching, dry skin, ecchymosis, pruritus, photosensitivity, clamminess, night sweats, increased sweating, skin pigmentation

Common (1% to 10%): Bone/joint pain, myalgia, ankylosing spondylosis, arthritis, blurred disc margins, bone fracture, muscle stiffness, muscle tenderness, pelvic fibrosis, spasms/cramps

Frequency not reported: Backache, muscle atrophy, limb pain

Postmarketing reports: : Spinal fracture/paralysis, tenosynovitis-like symptoms

Common (1% to 10%): Anemia

Postmarketing reports: Decreased WBC

Frequency not reported: Decreased red blood cell count/hematocrit/hemoglobin

Common (1% to 10%): Dyspnea, sinus congestion, chest tightness, decreased breathing sounds, hemoptysis, pleuritic chest pain, pulmonary infiltrate, rales/rhonchi, rhinitis, strep throat, wheezing/bronchitis, pulmonary edema, pulmonary embolism

Frequency not reported: Erythema, ecchymosis, induration, abscess, pain, swelling, nodules, ulcers, irritation, necrosis at the site of injection

Very common (10% or more): General pain (up to 32.7%), peripheral edema (12.5%), asthenia (10%)

Common (1% to 10%): Tinnitus

Frequency not reported: Disturbance of smell/taste, vertigo

Postmarketing reports: Hearing disorder

Frequency not reported: Hepatitis, hepatomegaly

Postmarketing reports: Hepatic dysfunction

Common (1% to 10%): Anorexia

Frequency not reported: Weight gain/loss

Postmarketing reports: Diabetes