Drugs Details

Drugs Info of Danocrine
Drugs Details
  • Drugs Type  : FDA
  • Date : 13th Jan 2015 02:38 am
  • Brand Name : Danocrine
  • Generic Name :  danazol (Pronunciation: DAN a zol
Descriptions

DANOCRINE, brand of danazol, is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, danazol is 17α-Pregna-2,4-dien-20-yno [2,3-d]isoxazol-17-ol. The molecular formula is C22H27NO2. It has a molecular weight of 337.46 and the following structural formula:

 

DANOCRINE®  Brand of DANAZOL Structural Formula Illustration

Danocrine capsules for oral administration contain 50 mg, 100 mg or 200 mg danazol.

Inactive Ingredients: Corn Starch, Lactose, Magnesium Stearate, Talc. Capsules 50 mg, 100 mg and 200 mg contain D&C Yellow #10, FD&C Red #40, Gelatin, Silicon Dioxide, Sodium Lauryl Sulfate, Titanium Dioxide. The 50 mg and 200 mg capsules also contain D&C Red #28.

What are the possible side effects of danazol (Danocrine)?

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.

In rare cases, danazol can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

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

  • sudden numbness or weakness (especially on one...

Read All Potential Side Effects and See Pictures of Danocrine »

What are the precautions when taking danazol (Danocrine)?

Before taking danazol, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease (such as coronary artery disease, stroke), high blood pressure (hypertension), diabetes, high cholesterol levels, breast cancer, liver disease, kidney disease, seizures, migraine headaches, unusual vaginal bleeding, certain blood disorders (porphyria, polycythemia), prostate cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,...

Read All Potential Precautions of Danocrine »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Endometriosis

DANOCRINE is indicated for the treatment of endometriosis amenable to hormonal management.

Fibrocystic Breast Disease

Most cases of symptomatic fibrocystic breast disease may be treated by simple measures (e.g., padded brassieres and analgesics).

In infrequent patients, symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function. DANOCRINE is usually effective in decreasing nodularity, pain, and tenderness. It should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy.

Hereditary Angioedema

DANOCRINE is indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

Dosage Administration

Endometriosis

In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg given in two divided doses is recommended. Amenorrhea and rapid response to painful symptoms is best achieved at this dosage level. Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response. For mild cases, an initial daily dose of 200 mg to 400 mg given in two divided doses is recommended and may be adjusted depending on patient response.

Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with DANOCRINE. (See CONTRAINDICATIONS and WARNINGS.) It is essential that therapy continue uninterrupted for 3 to 6 months but may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted.

Fibrocystic Breast Disease

The total daily dosage of DANOCRINE for fibrocystic breast disease ranges from 100 mg to 400 mg given in two divided doses depending upon patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with DANOCRINE. A nonhormonal method of contraception is recommended when DANOCRINE is administered at this dose, since ovulation may not be suppressed.

In most instances, breast pain and tenderness are significantly relieved by the first month and eliminated in 2 to 3 months. Usually elimination of nodularity requires 4 to 6 months of uninterrupted therapy. Regular menstrual patterns irregular menstrual patterns and amenorrhea each occur in approximately one-third of patients treated with 100 mg of DANOCRINE. Irregular menstrual patterns and amenorrhea are observed more frequently with higher doses. Clinical studies have demonstrated that 50% of patients may show evidence of recurrence of symptoms within one year. In this event, treatment may be reinstated.

Hereditary Angioedema

The dosage requirements for continuous treatment of hereditary angioedema with DANOCRINE should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be started on 200 mg, two or three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage by 50% or less at intervals of one to three months or longer if frequency of attacks prior to treatment dictates. If an attack occurs, the daily dosage may be increased by up to 200 mg. During the dose adjusting phase, close monitoring of the patient's response is indicated, particularly if the patient has a history of airway involvement.

How Supplied

Capsules of 200 mg (orange), bottles of 60 (NDC 0024-0305-60).
Capsules of 200 mg (orange), bottles of 100 (NDC 0024-0305-06).
Capsules of 100 mg (yellow), bottles of 100 (NDC 0024-0304-06).
Capsules of 50 mg (orange and white), bottles of 100 (NDC 0024-0303-06).

Store at controlled room temperature, 15° C to 30° C (59° F to 86° F).

sanofi-aventis U.S. LLC Bridgewater, New Jersey 08807. Revised December 2011.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following events have been reported in association with the use of DANOCRINE:

Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.

Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with DANOCRINE, persistent amenorrhea has occasionally been reported.

Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.

Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of DANOCRINE of 400 mg or more. It is recommended that patients receiving DANOCRINE be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported. (See WARNINGS and PRECAUTIONS.)

Abnormalities in laboratory tests may occur during therapy with DANOCRINE including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.

The following reactions have been reported, a causal relationship to the administration of DANOCRINE has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme; other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure, interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

Read the Danocrine (danazol) Side Effects Center for a complete guide to possible side effects

Interactions

Prolongation of prothrombin time occurs in patients stabilized on warfarin.

Therapy with danazol may cause an increase in carbamazepine levels in patients taking both drugs.

Danazol can cause insulin resistance. Caution should be exercised when used with antidiabetic drugs.

Danazol may raise the plasma levels of cyclosporin and tacrolimus, leading to an increase of the renal toxicity of these drugs. Monitoring of systemic concentrations of these drugs and appropriate dose adjustments may be needed when used concomitantly with danazol.

Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism.

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin and lovastatin. Caution should be exercised if used concomitantly. Consult the product labeling for statin drugs for specific information on dose restrictions in presence of danazol.

Laboratory Tests

Danazol treatment may interfere with laboratory determinations of testosterone, androstenedione and dehydroepiandrosterone. Other metabolic events include a reduction in thyroid binding globulin and T4 with increased uptake of T3, but without disturbance of thyroid stimulating hormone or of free thyroxin index.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Use of danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally a non-hormonal method of contraception should be used during therapy. If a patient becomes pregnant while taking danazol, administration of the drug should be discontinued and the patient should be apprised of the potential risk to the fetus. Exposure to danazol in utero may result in androgenic effects on the female fetus; reports of clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been received. (See PRECAUTIONS: Pregnancy, Teratogenic Effects.)

Thromboembolism, thrombotic and thrombophlebitic events including sagittal sinus thrombosis and life-threatening or fatal strokes have been reported.

Experience with long-term therapy with danazol is limited. Peliosis hepatis and benign hepatic adenoma have been observed with long-term use. Peliosis hepatis and hepatic adenoma may be silent until complicated by acute, potentially life-threatening intraabdominal hemorrhage. The physician therefore should be alert to this possibility. Attempts should be made to determine the lowest dose that will provide adequate protection. If the drug was begun at a time of exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause, periodic attempts to decrease or withdraw therapy should be considered.

Danazol has been associated with several cases of benign intracranial hypertension also known as pseudotumor cerebri. Early signs and symptoms of benign intracranial hypertension include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, the patients should be advised to discontinue danazol immediately and be referred to a neurologist for further diagnosis and care.

A temporary alteration of lipoproteins in the form of decreased high density lipoproteins and possibly increased low density lipoproteins has been reported during danazol therapy. These alterations may be marked, and prescribers should consider the potential impact on the risk of atherosclerosis and coronary artery disease in accordance with the potential benefit of the therapy to the patient.

Before initiating therapy of fibrocystic breast disease with DANOCRINE, carcinoma of the breast should be excluded. However, nodularity, pain, tenderness due to fibrocystic breast disease may prevent recognition of underlying carcinoma before treatment is begun. Therefore, if any nodule persists or enlarges during treatment, carcinoma should be considered and ruled out.

Patients should be watched closely for signs of androgenic effects some of which may not be reversible even when drug administration is stopped.

Precautions

Because DANOCRINE may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or cardiac or renal dysfunction, polycythemia and hypertension require careful observation. Use with caution in patients with diabetes mellitus.

Since hepatic dysfunction manifested by modest increases in serum transaminases levels has been reported in patients treated with DANOCRINE, periodic liver function tests should be performed (see WARNINGS and ADVERSE REACTIONS).

Administration of danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria. (See CONTRAINDICATIONS.)

Laboratory monitoring of the hematologic state should be considered.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Current data are insufficient to assess the carcinogenicity of danazol.

Pregnancy, Teratogenic Effects

(See CONTRAINDICATIONS.) Pregnancy Category X. DANOCRINE administered orally to pregnant rats from the 6th through the 15th day of gestation at doses up to 250 mg/kg/day (7-15 times the human dose) did not result in drug-induced embryotoxicity or teratogenicity, nor difference in litter size, viability or weight of offspring compared to controls. In rabbits, the administration of DANOCRINE on days 6-18 of gestation at doses of 60 mg/kg/day and above (2-4 times the human dose) resulted in inhibition of fetal development.

Nursing Mothers

(See CONTRAINDICATIONS.)

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of DANOCRINE did not include sufficient numbers of subjects aged 65 and over to determine the safety and effectiveness of Danocrine in elderly patients.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

DANOCRINE should not be administered to patients with:

  1. Undiagnosed abnormal genital bleeding.
  2. Markedly impaired hepatic, renal, or cardiac function.
  3. Pregnancy. (See WARNINGS.)
  4. Breast feeding.
  5. Porphyria-DANOCRINE can induce ALA synthetase activity and hence porphyrin metabolism.
  6. Androgen-dependent tumor.
  7. Active thrombosis or thromboembolic disease and history of such events.
  8. Hypersensitivity to danazol.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

The following events have been reported in association with the use of DANOCRINE:

Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.

Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with DANOCRINE, persistent amenorrhea has occasionally been reported.

Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.

Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of DANOCRINE of 400 mg or more. It is recommended that patients receiving DANOCRINE be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported. (See WARNINGS and PRECAUTIONS.)

Abnormalities in laboratory tests may occur during therapy with DANOCRINE including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.

The following reactions have been reported, a causal relationship to the administration of DANOCRINE has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme; other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure, interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

Read the Danocrine (danazol) Side Effects Center for a complete guide to possible side effects

Learn More »

DRUG INTERACTIONS

Prolongation of prothrombin time occurs in patients stabilized on warfarin.

Therapy with danazol may cause an increase in carbamazepine levels in patients taking both drugs.

Danazol can cause insulin resistance. Caution should be exercised when used with antidiabetic drugs.

Danazol may raise the plasma levels of cyclosporin and tacrolimus, leading to an increase of the renal toxicity of these drugs. Monitoring of systemic concentrations of these drugs and appropriate dose adjustments may be needed when used concomitantly with danazol.

Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism.

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin and lovastatin. Caution should be exercised if used concomitantly. Consult the product labeling for statin drugs for specific information on dose restrictions in presence of danazol.

Laboratory Tests

Danazol treatment may interfere with laboratory determinations of testosterone, androstenedione and dehydroepiandrosterone. Other metabolic events include a reduction in thyroid binding globulin and T4 with increased uptake of T3, but without disturbance of thyroid stimulating hormone or of free thyroxin index.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DANAZOL - ORAL

 

(DAY-nuh-zole)

 

COMMON BRAND NAME(S): Danocrine

 

WARNING: This medication must not be used during pregnancy. It may harm an unborn baby. In women of childbearing age, this medication should be started during their menstrual period. If not, then they should have a negative pregnancy test before starting this medication. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss the use reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Danazol has rarely caused very serious (possibly fatal) blood clots (such as stroke), liver disease, and increased pressure on the brain (benign intracranial hypertension). Seek immediate medical attention if you have any symptoms of these side effects, including weakness on one side of the body, slurred speech, vision changes, severe stomach/abdominal pain, dark urine, persistent nausea/vomiting, yellowing eyes/skin, mental/mood changes (such as confusion), severe/persistent headache.

 

USES: This medication is used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis) and also to treat breast pain/tenderness/nodules due to a certain breast condition (fibrocystic breast disease). It is also used in both men and women to prevent swelling of the abdomen/arms/legs/face/airway due to a certain congenital disease (hereditary angioedema).

Danazol is an androgen similar to testosterone. For the treatment of endometriosis and fibrocystic breast disease, it works by decreasing the amount of hormones made by the ovaries. These hormones usually make the conditions worse. For the treatment of angioedema, danazol helps to increase the amount of a certain protein in your body's defense system (immune system).

 

HOW TO USE: Take this medication by mouth, usually twice daily or as directed by your doctor. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Weight gain, acne, flushing, sweating, voice changes (hoarseness, change in pitch), abnormal growth of body hair (in women), vaginal dryness/irritation, or decreased breast size may 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: swelling hands/ankles/feet, menstrual changes (such as spotting, missed periods), mental/mood changes (such as nervousness, mood swings).

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 Danocrine (danazol) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking danazol, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease (such as coronary artery disease, stroke), high blood pressure (hypertension), diabetes, high cholesterol levels, breast cancer, liver disease, kidney disease, seizures, migraine headaches, unusual vaginal bleeding, certain blood disorders (porphyria, polycythemia), prostate cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may affect the sperm. Consult your doctor for more details.

This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. (See also Warning section.)

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), carbamazepine, certain "statin" cholesterol medications (lovastatin, simvastatin), cyclosporine, tacrolimus.

This medication may interfere with certain laboratory tests (including blood levels of male hormones such as testosterone), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: yellowing eyes/skin, severe stomach/abdominal pain, dark urine.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as liver function, cholesterol levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Danocrine

Generic Name: danazol (Pronunciation: DAN a zol)

  • What is danazol (Danocrine)?
  • What are the possible side effects of danazol (Danocrine)?
  • What is the most important information I should know about danazol (Danocrine)?
  • What should I discuss with my healthcare provider before taking danazol (Danocrine)?
  • How should I take danazol (Danocrine)?
  • What happens if I miss a dose (Danocrine)?
  • What happens if I overdose (Danocrine)?
  • What should I avoid while taking danazol (Danocrine)?
  • What other drugs will affect danazol (Danocrine)?
  • Where can I get more information?

What is danazol (Danocrine)?

Danazol is a man-made form of a steroid. Danazol affects the ovaries and pituitary gland and prevents the release of certain hormones in the body.

Danazol is used to treat endometriosis and fibrocystic breast disease. Danazol is also used to prevent attacks of angioedema in people with an inherited form of this disorder (hereditary angioedema).

Danazol may also be used for purposes not listed in this medication guide.

Danazol 100 mg-BAR

capsule, yellow, imprinted with barr, 634

What are the possible side effects of danazol (Danocrine)?

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.

In rare cases, danazol can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

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

  • sudden numbness or weakness (especially on one side of the body), confusion, problems with speech or balance;
  • severe headache, ringing in your ears, dizziness, nausea, vomiting, vision problems, pain behind your eyes;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • swelling or rapid weight gain, especially in your face and midsection;
  • bloody, black, or tarry stools;
  • cough up blood or vomit that looks like coffee grounds; or
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • acne or other skin problems, increased sweating;
  • increased hair growth or hair loss;
  • breast changes;
  • decreased amount of semen released during sex;
  • hoarse or deepened voice, sore throat;
  • flushing (warmth, redness, or tingly feeling);
  • changes in your menstrual periods;
  • unusual vaginal bleeding or spotting;
  • vaginal dryness, discomfort, 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 Danocrine (danazol) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about danazol (Danocrine)?

You should not use this medication if you are allergic to danazol, or if you have porphyria, a history of stroke or blood clot, or severe problems with your heart, liver, or kidney. You also should not take danazol if you are pregnant or breast-feeding, if you have breast or uterine cancer, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Danazol can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use if you are pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with danazol.

Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

Call your doctor at once if you have a serious side effect such as sudden numbness or weakness, problems with vision or speech, chest pain, sudden cough, or wheezing, swelling, rapid weight gain, feeling short of breath, ringing in your ears, dizziness, nausea, pain behind your eyes, stomach pain and loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Side Effects Centers
  • Danocrine

Patient Detailed How Take

What should I discuss with my healthcare provider before taking danazol (Danocrine)?

You should not use this medication if you are allergic to danazol, or if you have:

  • severe heart disease, a history of stroke or blood clot;
  • severe kidney disease;
  • severe liver disease;
  • a hormone-related cancer such as breast or uterine cancer;
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • abnormal vaginal bleeding that has not been checked by a doctor; or
  • if you are pregnant or breast-feeding.

To make sure you can safely take danazol, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, coronary artery disease, congestive heart failure;
  • high cholesterol or triglycerides;
  • a history of breast cancer;
  • diabetes;
  • hypoparathyroidism, or low levels of calcium in your blood;
  • a seizure disorder;
  • kidney or liver disease; or
  • migraine headaches.

FDA pregnancy category X. This medication can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use danazol if you are pregnant. Stop taking danazol and tell your doctor right away if you become pregnant during treatment.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with danazol.

Danazol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using danazol.

Taking danazol to treat endometriosis may increase your risk of ovarian cancer. Talk with your doctor about your individual risk.

How should I take danazol (Danocrine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Women who take danazol to treat endometriosis or fibrocystic breast disease should start the medication during a menstrual period.

Danazol is usually given for 6 to 9 months to treat fibrocystic breast disease or endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

Use danazol regularly to get the most benefit. Try not to miss any doses. Get your prescription refilled before you run out of medicine completely.

While using danazol, you may need blood tests at your doctor's office. Visit your doctor regularly.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using danazol.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Danocrine

Patient Detailed Avoid Taking

What happens if I miss a dose (Danocrine)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you have missed doses for more than 2 days in a row.

What happens if I overdose (Danocrine)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of danazol is not expected to produce life threatening symptoms. However, long term use of high doses can lead to symptoms such as weight gain, increased acne or facial hair, menstrual problems, or breast changes.

What should I avoid while taking danazol (Danocrine)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect danazol (Danocrine)?

Tell your doctor about all other medicines you use, especially:

  • carbamazepine (Carbatrol, Equetro, Tegretol);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • insulin or oral diabetes medications;
  • tacrolimus (Prograf);
  • a blood thinner such as warfarin (Coumadin, Jantoven); or
  • cholesterol lowering medicines such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync).

This list is not complete and other drugs may interact with danazol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about danazol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.02. Revision date: 7/11/2012.

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  • Danocrine

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