Lupron Side Effects

Generic Name: leuprolide

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

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by leuprolide (the active ingredient contained in Lupron). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking leuprolide:

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

Minor Side Effects

Some of the side effects that can occur with leuprolide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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 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
• sore throat
• sudden sweating
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Bone pain
• decreased size of the testicles
• inability to have or keep an erection

For Healthcare Professionals

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

General

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

Hypersensitivity

Postmarketing reports: Anaphylactoid reactions^[Ref]

Genitourinary

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^[Ref]

Cardiovascular

Very common (10% or more): ECG changes (19%), ischemia (19%)
Common (1% to 10%): Hypertension, murmur, phlebitis, thrombosis, arrhythmias, angina, myocardial infarction^[Ref]

Endocrine

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^[Ref]

Psychiatric

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

Nervous system

Common (1% to 10%): Dizziness/lightheadedness, headache^[Ref]

Gastrointestinal

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

Dermatologic

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^[Ref]

Musculoskeletal

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^[Ref]

Hematologic

Common (1% to 10%): Anemia
Postmarketing reports: Decreased WBC
Frequency not reported: Decreased red blood cell count/hematocrit/hemoglobin^[Ref]

Respiratory

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^[Ref]

Local

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

Other

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^[Ref]

Hepatic

Frequency not reported: Hepatitis, hepatomegaly
Postmarketing reports: Hepatic dysfunction^[Ref]

Metabolic

Common (1% to 10%): Anorexia
Frequency not reported: Weight gain/loss
Postmarketing reports: Diabetes^[Ref]

Not all side effects for Lupron may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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