Lupron Side Effects
Generic Name: leuprolide,leuprolide acetate
Please note - some side effects for Lupron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Lupron - for the Consumer
Lupron
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron:Constipation; dizziness; general body pain; headache; hot flashes; loss of appetite; nausea or vomiting; stuffy nose; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; fever; mood or mental changes (eg, depression); new or worsening bone pain; paralysis; redness or hardening of the skin at the injection site; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath or cough; slow, fast, or irregular heartbeat; sweating; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; unusual stomach pain; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lupron Depot
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron Depot:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron Depot:Breast tenderness; constipation; decreased sexual desire or ability; difficulty sleeping; hot flashes or sweating; infection (fever, chills, sore throat); nausea or vomiting; pain, redness, or swelling at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; burning, numbness, tingling, or weakness; fainting; fast, slow, or irregular heartbeat; mental or mood changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); trouble urinating or inability to urinate; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lupron Depot 11.25 mg Depot Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron Depot 11.25 mg Depot Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron Depot 11.25 mg Depot Suspension:Acne; changes in weight; dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); nausea or vomiting; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, or tingling; decreased hearing; fainting; memory problems; new or worsening bone pain; new or worsening mood or mental changes (eg, anxiety, delusions, depression, memory problems, nervousness); paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual vaginal itching, irritation, discharge, or odor; vision changes or blurred vision; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lupron Depot Depot Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron Depot Depot Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron Depot Depot Suspension:Constipation; dizziness; hot flashes; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); mild joint or back pain; tiredness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lupron Depot-PED Kit
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron Depot-PED Kit:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron Depot-PED Kit:Acne; hot flushes; mild headache; mild pain at the injection site; oily skin; sweating.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; injection-site irritation (eg, burning, itching, oozing, pain, stinging, swelling); mood or mental changes (eg, anxiety, depression, nervousness); numbness or tingling of the arms or legs; seizures; severe drowsiness; severe or persistent dizziness, lightheadedness, or headache; shortness of breath; signs of infection (eg, fever, chills, sore throat); slow, fast, or irregular heartbeat; trouble urinating (eg, loss of bladder control); unusual swelling of the hands, ankles, or feet; unusual weight gain; vaginal itching, irritation, odor, bleeding, or discharge; vision changes or blurred vision.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lupron Depot Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron Depot Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron Depot Suspension:Dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); tiredness; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lupron Depot 3.75 mg Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lupron Depot 3.75 mg Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Lupron Depot 3.75 mg Suspension:Acne; changes in weight; dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); nausea or vomiting; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; burning, numbness, or tingling; decreased hearing; fainting; memory problems; new or worsening bone pain; new or worsening mood or mental changes (eg, anxiety, delusions, depression, memory problems, nervousness); paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual vaginal itching, irritation, discharge, or odor; vision changes or blurred vision; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopSide Effects by Body System - for Healthcare Professionals
Endocrine
Endocrine side effects of leuprolide have included hot flashes (56% to 91%), gynecomastia (7%), breast changes (7%), breast enlargement (7%), breast tenderness (7% to 14%), decrease in testicular size, diabetes, and impotence. In addition, rare cases of pituitary apoplexy have been reported after the use of gonadotropin-releasing hormone agents.
Endocrine side effects occur in the majority of patients treated with leuprolide and are due to drug-induced hypoestrogenism and hypoandrogenism.
Pituitary apoplexy is a clinical syndrome secondary to infarction of the pituitary gland. In a majority of the cases reported, a pituitary adenoma was diagnosed. A majority of pituitary apoplexy cases occurred within two weeks of the first dose, and some occurred within the first hour. In those cases, pituitary apoplexy presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.
Psychiatric
Psychiatric side effects have included depression and emotional lability (up to 45%), insomnia (2% to 7%), anxiety, nervousness, decreased libido (both males and females), increased libido (females), and short-term memory loss.
Nervous system
Nervous system side effects have included headache (7% to 39%), dizziness (5%), blurred vision, lethargy, paresthesias, numbness, peripheral neuropathy, spinal fracture, convulsions, transient ischemic attack, and paralysis. A case of atypical absence seizures induced by leuprolide acetate has also been reported.
Genitourinary
A number of cases of vaginal hemorrhage are reported in the literature. The presence of submucous leiomyomatas may be responsible for these events. These patients typically required emergency surgery and blood transfusions.
Massive ascites developed in one patient 3 weeks after receiving a 3.75 mg leuprolide depot injection for the treatment of leiomyomata uteri. Upon surgical resection, the uterine myomas were noted to be seeping large amounts of serous fluid.
Genitourinary side effects have included vaginal dryness (37%), urinary frequency, hematuria, ovarian hyperstimulation, testicular soreness/pain, breast soreness/tenderness,testicular atrophy, erectile dysfunction, penile disorder, reduced penis size and vaginal hemorrhage.
Cardiovascular
Cardiovascular side effects have included ECG changes (19%), ischemia (19%), peripheral edema (12%), hypertension, hypotension, murmur, phlebitis, venous and arterial thromboembolism, deep vein thrombosis, stroke, sudden cardiac death, arrhythmias, angina, pulmonary edema, pulmonary embolism, and myocardial infarction.
Gastrointestinal
Gastrointestinal side effects have included constipation (7%), anorexia (3% to 6%), nausea and vomiting (5%), weight loss, flatulence, dyspepsia, and weight gain.
Dermatologic
Dermatologic side effects have included skin rash (7%), acne, dry skin, ecchymosis, hair loss (up to 18% of females), pruritus, photosensitivity, clamminess, night sweats, increased sweating, and skin pigmentation.
Musculoskeletal
An initial increase in testosterone levels may occur during the first 2 weeks of therapy with leuprolide. An increase in bone pain, as well as worsening of other signs and symptoms of advanced prostate cancer, may be noted during this time period.
Hypoestrogenism induced by leuprolide may result in small losses in bone density. Prolonged use of leuprolide in females may increase the risk of osteoporosis.
Musculoskeletal side effects have included increased bone pain in patients with advanced prostate cancer, myalgias, arthralgias, muscle atrophy, limb pain, lower bone density scores, and tenosynovitis-like symptoms. A case of polymyositis and a case of noninflammatory myopathy have also been reported.
Hypersensitivity
A case of anaphylaxis after a single intramuscular injection of leuprolide depot is reported in the literature. On two occasions, 24 hours and 6 weeks after injection, the patient required emergency airway management. The patient continued to require regular doses of antihistamines and intermittent epinephrine injections up to 14 weeks after leuprolide administration.
Hypersensitivity reactions have included a rare report of urticaria, shortness of breath, and anaphylaxis with the depot form. Other reports of anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have also been reported in the medical literature.
Hematologic
Hematologic side effects have included anemia, leukopenia, and hemoptysis.
Respiratory
Respiratory side effects have included dyspnea, sinus congestion, cough, pleural rub, and pulmonary fibrosis.
Local
Local side effects have included erythema, ecchymosis, induration, abscess, and irritation at the site of injection.
Oncologic
Oncologic side effects have been reported including case reports of granulomas. Animal studies including an increase in benign pituitary hyperplasia and benign pituitary adenomas, an increase of pancreatic islet cell adenomas in females, and an increase of testicular cell adenomas in males have also been reported.
Other
Other side effects including symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported. Hearing disorder, hard nodule in throat, weight gain, and increased uric acid have also been reported.
Hepatic
Hepatic side effects including hepatic dysfunction have been reported.
General
General side effects including sweating, syncope, rigors, weakness, and lethargy have been reported.
Renal
Renal side effects have included difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, and aggravated nocturia.
Metabolic
Metabolic side effects have included hyperglycemia.
TopMore Lupron resources
- Lupron Advanced Consumer (Micromedex) - Includes Dosage Information
- Lupron Consumer Overview
- Lupron MedFacts Consumer Leaflet (Wolters Kluwer)
- Leuprolide Prescribing Information (FDA)
- Eligard Prescribing Information (FDA)
- Eligard Consumer Overview
- Eligard Kit MedFacts Consumer Leaflet (Wolters Kluwer)
- Leuprolide Acetate Monograph (AHFS DI)
- Lupron Depot Prescribing Information (FDA)
- Lupron Depot MedFacts Consumer Leaflet (Wolters Kluwer)
- Lupron Depot-PED Prescribing Information (FDA)
- Lupron Depot-PED Kit MedFacts Consumer Leaflet (Wolters Kluwer)
- Viadur Prescribing Information (FDA)
- Viadur Implant MedFacts Consumer Leaflet (Wolters Kluwer)
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