Goserelin Side Effects

Some side effects of goserelin 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 goserelin: subcutaneous implant

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

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

• back pain, severe numbness or tingling in your legs or feet;

• muscle weakness, problems with balance or coordination;

• loss of bladder or bowel control;

• urinating less than usual or not at all;

• pain or burning when you urinate;

• blood in your urine or stools;

• feeling like you might pass out;

• trouble breathing;

• pale skin, easy bruising;

• nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;

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

• sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or

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

Less serious side effects of goserelin may include:

• hot flashes, sweating, headache, dizziness;

• mood changes, increased or decreased interest in sex;

• vaginal dryness, itching, or discharge;

• impotence, fewer erections than normal;

• breast swelling or tenderness;

• bone pain;

• diarrhea, constipation;

• sleep problems (insomnia); or

• acne, mild skin rash or itching.

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 goserelin: subcutaneous implant

General

Some clinicians have used the addition of the oral progestational agent megestrol acetate to reduce the hot flashes. A dose of megestrol acetate 20 mg two times a day may be appropriate. Tumor flare may also occur in males if antiandrogens are not administered.

In general, hot flashes (in males (M) 54% to 80% and in females (F) 70% to 96%) have been the most frequently reported side effect. Headache (F 59% to 75% and M 14%), tumor flare (F 23%), flu syndrome, malaise, fatigue and lethargy (all F 5%) have been reported. Pain (F 17% and M 8% to 14%) has been reported including; breast pain (F 7%), abdominal pain (F 7%), back pain (F 7%) and pelvic bone pain (M 6%).

Genitourinary

During the first two months of therapy, some women have reported vaginal bleeding. This bleeding may have been due to estrogen withdrawal.

Genitourinary side effects in female patients have included vaginitis (75%), libido decrease (61%) or increase (12%), vaginal dryness (58%), breast atrophy (33%) or enlargement (18%), pelvic symptoms (18%) and dyspareunia (14%). In male patients, sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%) and gynecomastia (8%) have been reported. Renal insufficiency, urinary obstruction, urinary tract infection, bladder neoplasm, hematuria, impotence, urinary frequency, urinary incontinence, urinary tract disorder and impaired urination have also been reported to occur in 1% to 5% of patients. Breast tenderness, breast pain, ovarian cyst formation, and ovarian hyperstimulation syndrome, and prolonged hypogonadism have also been reported.

Psychiatric

Psychiatric side effects including emotional lability (F 47% to 60%) and depression (F 40% to 54%) have been reported. Anxiety, psychotic disorders, and abnormal thinking have also been reported.

Dermatologic

Dermatologic side effects including sweating (F 45% to 77% and M 6% to 10%), acne (F 42%), seborrhea (F 26%), hirsutism (F 7%), rash (M 6% to 14 %), hair disorders (F 4%) and pruritus (F 2%) have been reported. Alopecia, dry skin, skin discoloration and herpes simplex have also been reported.

Cardiovascular

Cardiovascular side effects including edema (F 21% and M 7% to 26%), chest pain (M 13%) and congestive heart failure (M 5%) have been reported. Cerebrovascular accident, arrhythmia, hypertension, myocardial infarction, peripheral vascular disorder, angina pectoris, cerebral ischemia, heart failure, pulmonary embolus and varicose veins have been reported to occur in 1% to 5% of patients. Hemorrhage, migraine, palpitations and tachycardia have also been reported. Myocardial infarction, sudden cardiac death, and stroke have been reported in patients treated with GnRH agonists.

Nervous system

Nervous system side effects including lethargy (M 8% to 26%), dizziness (F 6% and M 1% to 18%), paresthesia (M 12%), asthenia (F 11%), insomnia (F 5% to 11% and M 12%) and nervousness (F 3%) have been reported. Anxiety and urinary retention have been reported to occur in 1% to 5% of patients. Somnolence has also been reported. As a result of increased prostate tumor growth caused by initial testosterone level elevation, a case of spinal cord compression resulting in paraplegia has been reported.

Gastrointestinal

Gastrointestinal side effects including constipation (M 12%), nausea (F 8% to 11% and M 5%), anorexia (M 5%), vomiting (F 4%) and increased appetite (2%) have been reported. Diarrhea and hematemesis have been reported to occur in 1% to 5% of patients. Ulcer, dyspepsia, dry mouth and flatulence have also been reported.

Respiratory

Respiratory side effects including pharyngitis (F 5%) and voice alterations (F 3%) have been reported.

Hypersensitivity

Hypersensitivity reactions, both at the injection site (F 6%) and to the whole body have been reported.

Musculoskeletal

Data suggest the decrease in BMD is partially reversible upon discontinuation of therapy.

Musculoskeletal side effects including an average 4.3% decrease in vertebral trabecular bone mineral density (BMD) after six months of therapy (n=109 F patients), when compared to their pretreatment values. Myalgia (F 3%), leg cramps (F 3%) and hypertonia (F 1%) have been reported. Arthralgia and joint disorders have also been reported.

Metabolic

Metabolic side effects including gout, hyperglycemia, weight increase, and diabetes mellitus have been reported to occur in 1% to 5% of patients.

Hematologic

Hematologic side effects including ecchymosis and sepsis have been reported to occur in 1% to 5% of patients.

Ocular

Ocular side effects including amblyopia and dry eyes have been reported.

Endocrine

Pituitary apoplexy is a clinical syndrome secondary to infarction of the pituitary gland. In a majority of the cases of pituitary apoplexy, a pituitary adenoma was diagnosed. Most of the pituitary apoplexy cases occurred within two weeks of the first dose, and some occurred within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Endocrine side effects including very rare cases of pituitary apoplexy have been reported. Reduction in glucose tolerance, manifesting as diabetes or loss of glycemic control in those with preexisting diabetes, has also been reported during treatment with GnRH agonists, including goserelin.

Oncologic

Oncologic side effects including very rare cases of pituitary tumors have been reported.

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