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Zoladex Side Effects

Generic Name: goserelin

Note: This document contains side effect information about goserelin. Some of the dosage forms listed on this page may not apply to the brand name Zoladex.

In Summary

Common side effects of Zoladex include: headache, vasodilatation, and diaphoresis. Other side effects include: hypertension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to goserelin: subcutaneous implant

Along with its needed effects, goserelin (the active ingredient contained in Zoladex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking goserelin:

For all adults

Less common

Rare

  • Bone, muscle, or joint pain
  • changes in skin color of the face
  • fainting
  • fast or irregular breathing
  • numbness or tingling of the hands or feet
  • puffiness or swelling of the eyelids or around the eyes
  • skin rash, hives, or itching
  • sudden, severe decrease in blood pressure and collapse
  • tightness in the chest
  • troubled breathing

For females only

Rare

For males only

Rare

  • Pain in the chest
  • pain in the groin or legs (especially in the calves of the legs)

Some side effects of goserelin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For all adults

More common

  • Sudden sweating and feelings of warmth (also called hot flashes)

Less common

  • Blurred vision
  • burning, itching, redness, or swelling at the place of injection
  • decreased interest in sexual intercourse
  • dizziness
  • headache
  • nausea or vomiting
  • swelling and increased tenderness of the breasts
  • swelling of the feet or lower legs
  • trouble sleeping
  • weight gain

For females only

More common

Less common

  • Burning, dryness, or itching of the vagina
  • pelvic pain

For males only

Less common

  • Bone pain
  • constipation
  • decreased size of the testicles
  • inability to have or keep an erection

For Healthcare Professionals

Applies to goserelin: subcutaneous implant

General

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%).[Ref]

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.[Ref]

Genitourinary

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.[Ref]

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

Psychiatric

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

Postmarketing psychiatric side effects including psychotic disorders and mood swings have been reported.[Ref]

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.

Postmarketing dermatologic side effects including acne have been reported.[Ref]

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.[Ref]

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.

Postmarketing nervous system side effects including convulsions have been reported.[Ref]

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.[Ref]

Respiratory

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

Hypersensitivity

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

Musculoskeletal

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.[Ref]

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

Metabolic

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

Hematologic

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

Ocular

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

Endocrine

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 (the active ingredient contained in Zoladex) [Ref]

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.[Ref]

Oncologic

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

References

1. Stevens MJ, Bell DR, Blome SA, Begbie SD "Prolonged hypogonadism after pulsed gonadotropin-releasing hormone agonist for prostate cancer." Lancet 344 (1994): 274-5

2. Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT "Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group." Urology 46 (1995): 220-6

3. "Product Information. Zoladex (goserelin)." Zeneca Pharmaceuticals, Wilmington, DE.

4. Chrisp P, Goa KL "Goserelin. A review of its pharmacodynamic and pharmacokinetic properties, and clinical use in sex hormone-related conditions." Drugs 41 (1991): 254-88

5. Miller RM, Frank RA "Zoladex (goserelin) in the treatment of benign gynaecological disorders: an overview of safety and efficacy." Br J Obstet Gynaecol 99 Suppl 7 (1992): 37-41

6. Seiichi A, Hoshino T, Mihara S "Pituitary apoplexy after goserelin." Lancet 345 (1995): 458

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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