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Zoladex

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Zoladex 10.8 mg

Zoladex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zoladex (goserelin acetate implant) is used in men to treat symptoms of prostate cancer, and in women to treat breast cancer or endometriosis. It is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding). Zoladex treats only the symptoms of prostate cancer but does not treat the cancer itself. It is a man-made form of a hormone. Common side effects include hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, vaginal dryness (in women), hair loss, or mental/mood changes (such as depression, mood swings, hallucinations). Pain, bruising, bleeding, redness, or swelling at the injection site may also occur.

Zoladex, at a dose of 10.8 mg, is administered subcutaneously every 12 weeks under the supervision of a physician. For female patients the 3.6 mg implant is used. There may be other drugs that can interact with Zoladex. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Zoladex is not recommended for use during pregnancy. It may harm a fetus. Women of child-bearing age must not be pregnant when starting this medication. Consult your doctor to discuss use of birth control. For women, this medication should stop the release of an egg (ovulation) and your periods, but this should not be used as a reliable method of birth control. It is recommended that men and women using this medication use 2 forms of non-hormonal birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Continue using birth control until the return of the woman's period or for at least 12 weeks after stopping this medication. It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended.

Our Zoladex (goserelin acetate implant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zoladex in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zoladex (Goserelin Acetate Implant) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zoladex Overview - Patient Information: Side Effects

SIDE EFFECTS: Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, hair loss, or mental/mood changes (such as depression, mood swings, hallucinations) may occur. Pain, bruising, bleeding, redness, or swelling at the injection site may also occur. In women, vaginal dryness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal burning/pain (in women), pain during sex (in women), breast pain/tenderness, new/worsening bone pain, new broken bone, burning feeling in feet/toes, swelling of the ankles/feet, unusual tiredness, change in the amount of urine.

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes. High blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, trouble breathing, confusion, vision changes, slurred speech, weakness on one side of the body.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.

In men using this medication for prostate cancer, a rare but very serious urinary blockage problem or spinal cord problem (compression) can occur, especially during the first month of treatment. Tell your doctor immediately if you experience any of the following serious side effects: severe back pain, numbness/tingling/weakness of the arms/legs, inability to move, painful/difficult urination, blood in the urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zoladex (Goserelin Acetate Implant)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zoladex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

General

Rarely, hypersensitivity reactions (including urticaria and anaphylaxis) have been reported in patients receiving ZOLADEX.

As with other endocrine therapies, hypercalcemia (increased calcium) has rarely been reported in cancer patients with bone metastases following initiation of treatment with ZOLADEX or other LHRH agonists.

ZOLADEX has been found to be generally well tolerated in clinical trials. Adverse reactions reported in these trials were rarely severe enough to result in the patients' withdrawal from ZOLADEX treatment. As seen with other hormonal therapies, the most commonly observed adverse events during ZOLADEX therapy were due to the expected physiological effects from decreased testosterone levels. These included hot flashes, sexual dysfunction and decreased erections.

Initially, ZOLADEX, like other LHRH agonists, causes transient increases in serum levels of testosterone. A small percentage of patients experienced a temporary worsening of signs and symptoms (see WARNINGS section), usually manifested by an increase in cancer-related pain which was managed symptomatically. Isolated cases of exacerbation of disease symptoms, either ureteral obstruction or spinal cord compression, occurred at similar rates in controlled clinical trials with both ZOLADEX and orchiectomy. The relationship of these events to therapy is uncertain.

There have been post-marketing reports of osteoporosis, decreased bone mineral density and bony fracture in men treated with ZOLADEX for prostate cancer.

Changes in blood pressure, manifest as hypotension or hypertension, have been occasionally observed in patients administered ZOLADEX. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with ZOLADEX. Rarely, such changes have been sufficient to require medical intervention including withdrawal of treatment from ZOLADEX.

Prostatic Carcinoma

Two controlled clinical trials using ZOLADEX 10.8 mg (goserelin acetate implant) versus ZOLADEX 3.6 mg were conducted. During a comparative phase, patients were randomized to receive either a single 10.8 mg implant or three consecutive 3.6 mg implants every 4 weeks over weeks 0-12. During this phase, the only adverse event reported in greater than 5% of patients was hot flashes, with an incidence of 47% in the ZOLADEX 10.8 mg (goserelin acetate implant) group and 48% in the ZOLADEX 3.6 mg group.

From weeks 12-48 all patients were treated with a 10.8 mg implant every 12 weeks. During this noncomparative phase, the following adverse events were reported in greater than 5% of patients:

Adverse Event ZOLADEX 10.8 mg (n = 157 ) %
Hot Flashes 64
Pain (General) 14
Gynecomastia 8
Pelvic Pain 6
Bone Pain 6
Asthenia 5

The following adverse events were reported in greater than 1%, but less than 5% of patients treated with ZOLADEX 10.8 mg (goserelin acetate implant) implant every 12 weeks. Some of these are commonly reported in elderly patients.

WHOLE BODY - Abdominal pain, Back pain, Flu syndrome, Headache, Sepsis, Aggravation reaction

CARDIOVASCULAR - Angina pectoris, Cerebral ischemia, Cerebrovascular accident, Heart failure, Pulmonary embolus, Varicose veins

DIGESTIVE - Diarrhea, Hematemesis

ENDOCRINE - Diabetes mellitus

HEMATOLOGIC - Anemia

METABOLIC - Peripheral edema

NERVOUS SYSTEM - Dizziness, Paresthesia, Urinary retention

RESPIRATORY - Cough increased, Dyspnea, Pneumonia SKIN - Herpes simplex, Pruritus

UROGENITAL - Bladder neoplasm, Breast pain, Hematuria, Impotence, Urinary frequency, Urinary incontinence, Urinary tract disorder, Urinary tract infection, Urination impaired.

The following adverse events not already listed above were reported in patients receiving ZOLADEX 3.6 mg in other clinical trials. Inclusion does not necessarily represent a causal relationship to ZOLADEX 10.8 mg (goserelin acetate implant) .

WHOLE BODY - Allergic reaction, Chills, Fever, Infection, Injection site reaction, Lethargy, Malaise

CARDIOVASCULAR - Arrhythmia, Chest pain, Hemorrhage, Hypertension, Migraine, Myocardial infarction, Palpitations, Peripheral vascular disorder, Tachycardia

DIGESTIVE - Anorexia, Constipation, Dry mouth, Dyspepsia, Flatulence, Increased appetite, Nausea, Ulcer, Vomiting

HEMATOLOGIC - Ecchymosis

METABOLIC - Edema, Gout, Hyperglycemia, Weight increase

MUSCULOSKELETAL - Arthralgia, Hypertonia, Joint disorder, Leg cramps, Myalgia, Osteoporosis

NERVOUS SYSTEM - Anxiety, Depression, Emotional lability, Headache, Insomnia, Nervousness, Somnolence, Thinking abnormal

RESPIRATORY - Bronchitis, Chronic obstructive pulmonary disease, Epistaxis, Rhinitis, Sinusitis, Upper respiratory infection, Voice alterations

SKIN - Acne, Alopecia, Dry skin, Hair disorders, Rash, Seborrhea, Skin discoloration, Sweating

SPECIAL SENSES - Amblyopia, Dry eyes

UROGENITAL - Breast tenderness, Decreased erections, Renal insufficiency, Sexual dysfunction, Urinary obstruction

Stage B2-C Prostatic Carcinoma

Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing ZOLADEX + flutamide + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below:

ADVERSE EVENTS DURING ACUTE RADIATION THERAPY (within first 90 days of radiation therapy)

  (n=231)
flutamide +
ZOLADEX +
Radiation
% All
(n=235)
Radiation Only
% All
Rectum/Large Bowel 80 76
Bladder 58 60
Skin 37 37

ADVERSE EVENTS DURING LATE RADIATION PHASE (after 90 days of radiation therapy)

  (n=231)
flutamide +
ZOLADEX +
Radiation
% All
(n=235)
Radiation Only
% All
Diarrhea 36 40
Cystitis 16 16
Rectal Bleeding 14 20
Proctitis 8 8
Hematuria 7 12

Additional adverse event data was collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).

Changes in Laboratory Values During Treatment

Plasma Enzymes

Elevation of liver enzymes (AST, ALT) have been reported in female patients exposed to ZOLADEX 3.6 mg (representing less than 1% of all patients). There was no other evidence of abnormal liver function. Causality between these changes and ZOLADEX have not been established.

Lipids

In a controlled trial in females, ZOLADEX 3.6 mg implant therapy resulted in a minor, but statistically significant effect on serum lipids (ie, increases in LDL cholesterol of 21.3 mg/dL; increases in HDL cholesterol of 2.7 mg/dL; and triglycerides increased by 8.0 mg/dL).

Post-marketing

Pituitary Apoplexy

During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed. Most of the pituitary apoplexy cases occurred within 2 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.

Reduction in glucose tolerance, manifesting as diabetes or a loss of glycemic control in those with pre-existing diabetes, has been reported during treatment with LHRH agonists, including ZOLADEX. The following adverse reactions have occurred very rarely in post-marketing experience with ZOLADEX: psychotic disorders and pituitary tumors.

Read the entire FDA prescribing information for Zoladex (Goserelin Acetate Implant) »

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Zoladex 10.8 mg - User Reviews

Zoladex 10.8 mg User Reviews

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Here is a collection of user reviews for the medication Zoladex 10.8 mg sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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