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Lupron Depot Side Effects

Generic Name: leuprolide

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 Depot.

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

Along with its needed effects, leuprolide (the active ingredient contained in Lupron Depot) 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 adultsLess 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 childrenRare
  • Body pain
  • burning, itching, redness, or swelling at the injection site
For females only (children)—expected in first few weeksRare
  • 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 adultsMore 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

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]

References

1. "Product Information. Lupron (leuprolide)." TAP Pharmaceuticals Inc, Deerfield, IL.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Lupron Depot may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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