Leuprolide Side Effects

Brand Names: Lupron Depot, Viadur, Lupron, Eligard

Please note - some side effects for Leuprolide 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 Leuprolide - for the consumer

Leuprolide

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 Leuprolide:

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.

Leuprolide 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 Leuprolide 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.

Leuprolide Implant

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 Leuprolide Implant:

Breast tenderness; burning, redness, itching, pain, or swelling around the implant; constipation; decreased sex drive; difficulty sleeping; headache; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting.

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.

Leuprolide Injection 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 Leuprolide Injection Kit:

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; 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.

Leuprolide 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 Leuprolide 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.

For the professional

Leuprolide

In the majority of patients, testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. This transient increase was occasionally associated with a temporary worsening of signs and symptoms, usually manifested by an increase in bone pain. In a few cases, a temporary worsening of existing hematuria and urinary tract obstruction occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported in a few cases.

Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction which, if aggravated, may lead to neurological problems or increase the obstruction.

In a comparative trial of Leuprolide Acetate Injection versus DES, in 5% or more of the patients receiving either drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug related are excluded.

In this same study, the following adverse reactions were reported in less than 5% of the patients on Leuprolide acetate.

Cardiovascular System --Angina, Cardiac arrhythmias, Myocardial infarction, Pulmonary emboli;Gastrointestinal System--Diarrhea, Dysphagia, Gastrointestinal bleeding, Gastrointestinal disturbance, Peptic ulcer, Rectal polyps; Endocrine System --Libido decrease, Thyroid enlargement; Musculoskeletal System--Joint pain; Central/Peripheral Nervous System--Anxiety, Blurred vision, Lethargy, Memory disorder, Mood swings, Nervousness, Numbness, Paresthesia, Peripheral neuropathy, Syncope/blackouts, Taste disorders;Respiratory System--Cough, Pleural rub, Pneumonia, Pulmonary fibrosis; Integumentary System--Carcinoma of skin/ear, Dry skin, Ecchymosis, Hair loss, Itching, Local skin reactions, Pigmentation, Skin lesions; Urogenital System--Bladder spasms, Dysuria, Incontinence, Testicular pain, Urinary obstruction; Miscellaneous--Depression, Diabetes, Fatigue, Fever/chills, Hypoglycemia, Increased BUN, Increased calcium, Increased creatinine, Infection/inflammation, Ophthalmologic disorders, Swelling (temporal bone).

The following additional adverse reactions have been reported with Leuprolide acetate during other clinical trials and/or during postmarketing surveillance. Reactions considered as nondrug related by the treating physician are excluded.

Cardiovascular System --Hypotension, Transient ischemic attack/stroke; Gastrointestinal System--Hepatic dysfunction; Endocrine System --Libido increase; Hemic and Lymphatic System--Decreased WBC, Hemoptysis; Musculoskeletal System--Ankylosing spondylosis, Pelvic fibrosis; Central/Peripheral Nervous System--Hearing disorder, Peripheral neuropathy, Spinal fracture/paralysis; Respiratory System--Pulmonary infiltrate, Respiratory disorders; Integumentary System--Hair growth; Urogenital System--Penile swelling, Prostate pain; Miscellaneous--Hypoproteinemia, Hard nodule in throat, Weight gain, Increased uric acid.

By body system

Endocrine side effects

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 side effects

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 side effects

Nervous system side effects have included headache (7% to 39%), dizziness (5%), blurred vision, lethargy, paresthesias, numbness, peripheral neuropathy, spinal fracture, and paralysis. A case of atypical absence seizures induced by leuprolide acetate has also been reported.

Genitourinary side effects

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.

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.

Cardiovascular side effects

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 side effects

Gastrointestinal side effects have included constipation (7%), anorexia (3% to 6%), nausea and vomiting (5%), weight loss, flatulence, dyspepsia, and weight gain.

Dermatologic side effects

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 side effects

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 side effects

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 side effects

Hematologic side effects have included anemia, leukopenia, and hemoptysis.

Respiratory side effects

Respiratory side effects have included dyspnea, sinus congestion, cough, pleural rub, and pulmonary fibrosis.

Local side effects

Local side effects have included erythema, ecchymosis, induration, abscess, and irritation at the site of injection.

Oncologic side effects

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 side effects

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 side effects

Hepatic side effects including hepatic dysfunction have been reported.

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