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Zoladex 10.8 mg

Zoladex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/29/2016

Zoladex 10.8 (goserelin acetate implant) is a man-made form of a hormone used in men to treat symptoms of prostate cancer, and in women to treat breast cancer or endometriosis. Zoladex 10.8 is also used in women to prepare the lining of the uterus for endometrial ablation (a surgery to correct abnormal uterine bleeding). Zoladex 10.8 treats only the symptoms of prostate cancer but does not treat the cancer itself. Common side effects of Zoladex 10.8 include:

  • hot flashes (flushing)
  • dizziness
  • headache
  • increased sweating
  • increased or decreased sexual interest
  • impotence
  • fewer erections than usual
  • trouble sleeping
  • nausea
  • change in breast size
  • breast swelling or tenderness
  • vaginal dryness/itching/discharge
  • hair loss, mental/mood changes (such as depression, mood swings, hallucinations)
  • injection site reactions (pain, bruising, bleeding, redness, or swelling)
  • bone pain
  • diarrhea
  • constipation
  • sleep problems (insomnia)
  • acne, or
  • skin rash or itching

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, breastfeeding 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 right away if you have any serious side effects, including: 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, stomach/abdominal pain or swelling, shortness of breath.

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 you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, 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. Get medical help right away 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 right away 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, get medical help right away 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)


Stage B2-C Prostatic Carcinoma

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:

Table 1 : ADVERSE EVENTS DURING ACUTE RADIATION THERAPY (within first 90 days of radiation therapy)

flutamide + ZOLADEX + Radiation
Radiation Only
% All %All
Rectum/Large Bowel 80 76
Bladder 58 60
Skin 37 37

Table 2 : ADVERSE EVENTS DURING LATE RADIATION PHASE (after 90 days of radiation therapy)

flutamide + ZOLADEX + Radiation
Radiation Only
% All %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%).

Prostatic Carcinoma

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.

Tumor Flare Phenomenon: Initially, ZOLADEX, like other GnRH agonists, causes transient increases in serum levels of testosterone. A small percentage of patients experienced a temporary worsening of signs and symptoms, 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 [see WARNINGS AND PRECAUTIONS].

In the controlled clinical trials of ZOLADEX versus orchiectomy, the following events were reported as adverse reactions in greater than 5% of the patients.


(n=242) %
(n=254) %
Hot Flashes 62 53
Sexual Dysfunction 21 15
Decreased Erections 18 16
Lower Urinary Tract Symptoms 13 8
Lethargy 8 4
Pain (worsened in the first 30 days) 8 3
Edema 7 8
Upper Respiratory Infection 7 2
Rash 6 1
Sweating 6 4
Anorexia 5 2
Chronic Obstructive Pulmonary Disease 5 3
Congestive Heart Failure 5 1
Dizziness 5 4
Insomnia 5 1
Nausea 5 2
Complications of Surgery 0 18*
* Complications related to surgery were reported in 18% of the orchiectomy patients, while only 3% of ZOLADEX patients reported adverse reactions at the injection site. The surgical complications included scrotal infection (5.9%), groin pain (4 .7%), wound seepage (3.1%), scrotal hematoma (2.8%), incisional discomfort (1.6%) and skin necrosis (1.2%).

The following additional adverse reactions were reported in greater than 1% but less than 5% of the patients treated with ZOLADEX: CARDIOVASCULAR - arrhythmia, cerebrovascular accident, hypertension, myocardial infarction, peripheral vascular disorder, chest pain; CENTRAL NERVOUS SYSTEM - anxiety, depression, headache; GASTROINTESTINAL - constipation, diarrhea, ulcer, vomiting; HEMATOLOGIC - anemia; METABOLIC/NUTRITIONAL - gout, hyperglycemia, weight increase; MISCELLANEOUS - chills, fever; UROGENITAL - renal insufficiency, urinary obstruction, urinary tract infection, breast swelling and tenderness.


As would be expected with a drug that results in hypoestrogenism, the most frequently reported adverse reactions were those related to this effect.


In controlled clinical trials comparing ZOLADEX every 28 days and danazol daily for the treatment of endometriosis, the following events were reported at a frequency of 5% or greater:


(n=411) %
(n=207) %
Hot Flushes 96 67
Vaginitis 75 43
Headache 75 63
Emotional Lability 60 56
Libido Decreased 61 44
Sweating 45 30
Depression 54 48
Acne 42 55
Breast Atrophy 33 42
Seborrhea 26 52
Peripheral Edema 21 34
Breast Enlargement 18 15
Pelvic Symptoms 18 23
Pain 17 16
Dyspareunia 14 5
Libido Increased 12 19
Infection 13 11
Asthenia 11 13
Nausea 8 14
Hirsutism 7 15
Insomnia 11 4
Breast Pain 7 4
Abdominal Pain 7 7
Back Pain 7 13
Flu Syndrome 5 5
Dizziness 6 4
Application Site Reaction 6 -
Voice Alterations 3 8
Pharyngitis 5 2
Hair Disorders 4 11
Myalgia 3 11
Nervousness 3 5
Weight Gain 3 23
Leg Cramps 2 6
Increased Appetite 2 5
Pruritus 2 6
Hypertonia 1 10

The following adverse events not already listed above were reported at a frequency of 1% or greater, regardless of causality, in ZOLADEX-treated women from all clinical trials: WHOLE BODY - allergic reaction, chest pain, fever, malaise; CARDIOVASCULAR - hemorrhage, hypertension, migraine, palpitations, tachycardia; DIGESTIVE - anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence; HEMATOLOGIC - ecchymosis; METABOLIC AND NUTRITIONAL - edema; MUSCULOSKELETAL - arthralgia, joint disorder; CNS - anxiety, paresthesia, somnolence, thinking abnormal; RESPIRATORY - bronchitis, cough increased, epistaxis, rhinitis, sinusitis; SKIN - alopecia, dry skin, rash, skin discoloration; SPECIAL SENSES - amblyopia, dry eyes; UROGENITAL - dysmenorrhea, urinary frequency, urinary tract infection, vaginal hemorrhage.

Endometrial Thinning

The following adverse events were reported at a frequency of 5% or greater in premenopausal women presenting with dysfunctional uterine bleeding in Trial 0022 for endometrial thinning. These results indicate that headache, hot flushes and sweating were more common in the ZOLADEX group than in the placebo group.


(n=180) %
(n=177) %
Whole Body
Headache 32 22
Abdominal Pain 11 10
Pelvic Pain 9 6
Back Pain 4 7
Vasodilatation 57 18
Migraine 7 4
Hypertension 6 2
Nausea 5 6
Nervousness 5 3
Depression 3 7
Pharyngitis 6 9
Sinusitis 3 6
Skin and appendages
Sweating 16 5
Dysmenorrhea 7 9
Uterine Hemorrhage 6 4
Vulvovaginitis 5 1
Menorrhagia 4 5
Vaginitis 1 6

Breast Cancer

The adverse event profile for women with advanced breast cancer treated with ZOLADEX is consistent with the profile described above for women treated with ZOLADEX for endometriosis. In a controlled clinical trial (SWOG-8692) comparing ZOLADEX with oophorectomy in premenopausal and perimenopausal women with advanced breast cancer, the following events were reported at a frequency of 5% or greater in either treatment group regardless of causality.


(n=57) % of Pts.
(n=55) % of Pts.
Hot Flashes 70 47
Tumor Flare 23 4
Nausea 11 7
Edema 5 0
Malaise/Fatigue/Lethargy 5 2
Vomiting 4 7

In the Phase II clinical trial program in 333 pre- and perimenopausal women with advanced breast cancer, hot flashes were reported in 75.9% of patients and decreased libido was noted in 47.7% of patients. These two adverse events reflect the pharmacological actions of ZOLADEX.

Injection site reactions were reported in less than 1% of patients.

Hormone Replacement Therapy

Clinical studies suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to ZOLADEX may decrease the occurrence of vasomotor symptoms and vaginal dryness associated with hypoestrogenism without compromising the efficacy of ZOLADEX in relieving pelvic symptoms. The optimal drugs, dose and duration of treatment has not been established.

Changes In Bone Mineral Density

After 6 months of ZOLADEX treatment, 109 female patients treated with ZOLADEX showed an average 4.3% decrease of vertebral trabecular bone mineral density (BMD) as compared to pretreatment values. BMD was measured by dual-photon absorptiometry or dual energy x-ray absorptiometry. Sixtysix of these patients were assessed for BMD loss 6 months after the completion (posttherapy) of the 6- month therapy period. Data from these patients showed an average 2.4% BMD loss compared to pretreatment values. Twenty-eight of the 109 patients were assessed for BMD at 12 months posttherapy. Data from these patients showed an average decrease of 2.5% in BMD compared to pretreatment values. These data suggest a possibility of partial reversibility. Clinical studies suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to ZOLADEX is effective in reducing the bone mineral loss which occurs with ZOLADEX alone without compromising the efficacy of ZOLADEX in relieving the symptoms of endometriosis. The optimal drugs, dose and duration of treatment has not been established [see PATIENT INFORMATION].

Changes In Laboratory Values During Treatment

Plasma Enzymes: Elevation of liver enzymes (AST, ALT) have been reported in female patients exposed to ZOLADEX (representing less than 1% of all patients).

Lipids: In a controlled trial, ZOLADEX therapy resulted in a minor, but statistically significant effect on serum lipids. In patients treated for endometriosis at 6 months following initiation of therapy, danazol treatment resulted in a mean increase in LDL cholesterol of 33.3 mg/dL and a decrease in HDL cholesterol of 21.3 mg/dL compared to increases of 21.3 and 2.7 mg/dL in LDL cholesterol and HDL cholesterol, respectively, for ZOLADEX-treated patients. Triglycerides increased by 8.0 mg/dL in ZOLADEX-treated patients compared to a decrease of 8.9 mg/dL in danazol-treated patients.

In patients treated for endometriosis, ZOLADEX increased total cholesterol and LDL cholesterol during 6 months of treatment. However, ZOLADEX therapy resulted in HDL cholesterol levels which were significantly higher relative to danazol therapy. At the end of 6 months of treatment, HDL cholesterol fractions (HDL2 and HDL2) were decreased by 13.5 and 7.7 mg/dL, respectively, for danazol-treated patients compared to treatment increases of 1.9 and 0.8 mg/dL, respectively, for ZOLADEX-treated patients.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ZOLADEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Bone Mineral Density: Osteoporosis, decreased bone mineral density and bone fracture in men [see PATIENT INFORMATION].

Cardiovascular: Deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, and transient ischemic attack have been observed in women treated with GnRH agonists. Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a causal association between the use of GnRH analogs and these events.

Ovarian Cyst: Ovarian cyst formation and, in combination with gonadotropins, ovarian hyperstimulation syndrome (OHSS).

Changes in Blood Pressure: Hypotension and hypertension have been reported. These changes are usually transient, resolving either during continued therapy or after cessation of therapy.

Pituitary Apoplexy and Tumors: Pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) and pituitary adenoma have been 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. Pituitary tumors have been reported.

Acne: Usually within one month of starting treatment.

Other Adverse Reactions: Psychotic disorders, convulsions and mood swings.

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

Zoladex 10.8 mg - User Reviews

Zoladex 10.8 mg User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

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

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