Generic Name: GOSERELIN - INJECTION
Pronounced: (go-SIR-eh-lin)

Zoladex SubQ Side Effects

Hot flashes (flushing), dizziness, headache, increased sweating, decreased sexual interest/ability, trouble sleeping, nausea, change in breast size, 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
• fast/irregular heartbeat
• 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.

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
• fainting

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.

Zoladex SubQ Precautions

Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., triptorelin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• unexplained abnormal vaginal bleeding

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• long-term alcohol use
• smoking
• personal or family history of bone loss (osteoporosis)
• high cholesterol/triglyceride levels
• urinary blockage problem (in men)
• spinal cord problem (in men)

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of child-bearing age must make sure they are not pregnant before starting this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms 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 effective forms of nonhormonal birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Continue using effective 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. Consult your doctor before breast-feeding.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.