Lupron Side Effects

Generic Name: leuprolide

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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lupron - for the Consumer

Lupron Depot-PED

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:

Acne; breast enlargement; excessively oily skin; pain; vaginal bleeding or spotting; vaginal discharge; vaginal inflammation.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; increased sexual maturity; irritation at the injection site; mood or mental changes.

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:

Breast tenderness; constipation; decreased sex drive; difficulty sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain; swelling; urination problems.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; chest pain; dizziness or lightheadedness; fast or irregular heartbeat; increase in bone pain; severe drowsiness; severe headache; swelling of the lungs; unusual or one-sided weakness; vision changes.

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:

Breast tenderness; constipation; decreased sex drive; difficulty sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain, redness, or swelling at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; dizziness or lightheadedness; fast or irregular heartbeat; increase in bone pain; muscle weakness; paralysis; severe drowsiness; severe headache; shortness of breath; trouble urinating or inability to urinate; unusual or one-sided numbness or weakness; vision changes.

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:

Breast tenderness; constipation; decreased sex drive; difficulty sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain, redness, or swelling at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; dizziness or lightheadedness; increase in bone pain; muscle weakness; paralysis; severe drowsiness; severe headache; shortness of breath; trouble urinating or inability to urinate; unusual or one-sided numbness or weakness; vision changes.

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:

Breast tenderness; constipation; decreased sex drive; difficulty breathing; difficulty sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain; swelling; urination problems.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; difficulty breathing; dizziness or lightheadedness; emphysema; increase in bone pain; severe drowsiness; severe headache; swelling of the lungs; unusual or one-sided weakness; vision changes.

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:

Abnormal hair growth; abnormal skin sensations; acne; breast pain and tenderness; changes in breast size; changes in weight; decreased sex drive; depression; dizziness; headache; hot flashes/sweats; joint disorder; mood changes; muscle pain; nausea/vomiting; nervousness; pain; skin reactions; swelling; vaginal dryness; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continued vaginal bleeding; delusions; depression; dizziness; joint pain; memory loss; suicidal thoughts; swelling of the ankles or hands; weight gain or loss.

Lupron Depot 11.25 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 11.25 mg Suspension:

Abnormal hair growth; abnormal skin sensations; acne; breast pain and tenderness; changes in breast size;changes in bowel function; change in weight; decreased sex drive; dizziness; headache; hot flashes/sweats; mood changes; muscle or joint pain; nausea or vomiting; nervousness; trouble sleeping; vaginal dryness; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continued vaginal bleeding or menstrual periods; decreased urination; delusions; depression; fainting; fast or irregular heartbeat; memory problems; mental changes; severe or persistent mood changes; shortness of breath; suicidal thoughts; swelling of the ankles or hands.

Side Effects by Body System

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, 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, thrombosis, 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

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.

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.

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.

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