Leuprolide Side Effects

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

For the Consumer

Applies to leuprolide: intramuscular kit, intramuscular powder for injection extended release, subcutaneous kit, subcutaneous powder for injection extended release, subcutaneous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking leuprolide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• bone pain, loss of movement in any part of your body;

• swelling, rapid weight gain;

• pain, burning, stinging, bruising, or redness where the medication was injected;

• feeling like you might pass out;

• sudden chest pain or discomfort, wheezing, dry cough or hack;

• painful or difficult urination;

• urinating more often than usual;

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

• sudden numbness or weakness (especially on one side of the body), problems with speech or balance;

• sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or

• chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Rare but serious side effects may include:

• pain or unusual sensations in your back;

• numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use;

• loss of bowel or bladder control; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of leuprolide may include:

• acne, increased growth of facial hair;

• breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;

• dizziness, weakness, tired feeling;

• hot flashes, night sweats, chills, clammy skin;

• nausea, diarrhea, constipation, stomach pain;

• skin redness, itching, or scaling;

• joint or muscle pain;

• vaginal itching or discharge;

• breast swelling or tenderness;

• testicle pain;

• impotence, loss of interest in sex;

• depression, sleep problems (insomnia), memory problems; or

• redness, burning, stinging, or pain where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

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. Postmarketing reports have included interstitial lung disease.

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. Postmarketing reports of serious liver injury have been received.

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.

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