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Leuprolide Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 7, 2020.

In Summary

Commonly reported side effects of leuprolide include: arthropathy, asthenia, decreased testicular size, dermatological reaction, edema, gastrointestinal disease, headache, hot flash, increased lactate dehydrogenase, pain, signs and symptoms of injection site, urination disorder, and diaphoresis. Other side effects include: respiratory system disorder, abnormal hepatic function tests, dehydration, dizziness, dyspnea, impotence, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, insomnia, myalgia, nausea and vomiting, neuromuscular disease, paresthesia, prolonged partial thromboplastin time, sleep disorder, and vertigo. See below for a comprehensive list of adverse effects.

For the Consumer

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

Side effects requiring immediate medical attention

Along with its needed effects, leuprolide 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

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
  • trouble 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
  • 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
  • cold, clammy, pale skin
  • confusion
  • double vision
  • irregular heartbeat
  • visual changes
  • vomiting

For females only (adults)

Rare

For children

More common

  • Body aches or pain
  • chills
  • cough
  • cough producing mucus
  • difficulty in breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • muscle aches
  • noisy breathing
  • pain or redness at the injection site
  • runny or stuffy nose
  • sneezing
  • sore throat
  • tightness in the chest
  • unusual tiredness or weakness

Less common

  • Irritability
  • mood or mental changes

Rare

  • Burning, itching, or swelling at the injection site

Incidence not known

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

Rare

Side effects not requiring immediate medical attention

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

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 children

More common

  • Constipation
  • feeling of warmth
  • nausea
  • redness of the face, neck, arms and occasionally, upper chest
  • stomach pain
  • vomiting

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: Anaphylactic reactions (e.g., rash, pruritus, urticaria, wheezing or interstitial pneumonitis, anaphylactic reactions)[Ref]

Genitourinary

Very common (10% or more): Vaginal dryness (37%), breast tenderness (14%), libido decreased, erectile dysfunction, testicular atrophy

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

Frequency not reported: Urinary tract obstruction[Ref]

Cardiovascular

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

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

Endocrine

Very common (10% or more): Hot flashes (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, mood changes, decreased libido, increased libido[Ref]

Nervous system

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

Uncommon (0.1% to 1%): Paresthesia

Very rare (less than 0.01%): Pituitary apoplexy (following initial administration in patients with pituitary adenoma)[Ref]

Gastrointestinal

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

Dermatologic

Very common (10% or more): Hair loss (18%), hyperhidrosis

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

Musculoskeletal

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

Uncommon (0.1% to 1%): Myalgia, weakness of lower extremities

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 white blood cell count (WBC)

Frequency not reported: Decreased red blood cell count (RBC)/hematocrit/hemoglobin, thrombocytopenia, leucopenia[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

Frequency not reported: Interstitial lung disease (ILD)[Ref]

Local

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

Other

Common (1% to 10%): Tinnitus, general pain, edema peripheral

Frequency not reported: Disturbance of smell/taste, vertigo

Postmarketing reports: Hearing disorder[Ref]

Hepatic

Frequency not reported: Hepatitis, hepatomegaly, jaundice

Postmarketing reports: Hepatic dysfunction[Ref]

Metabolic

Common (1% to 10%): Anorexia

Frequency not reported: Weight gain/loss

Postmarketing reports: Diabetes[Ref]

Ocular

Frequency not reported: Visual impairment

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

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.