danazol (Rx)

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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 50mg
  • 100mg
  • 200mg

Endometriosis

Mild: 200-400 mg/day PO divided BID

Moderate-to-severe: 800 mg/day PO divided BID

Titrate downward to dose sufficient to maintain amenorrhea

Therapy typically continued for 6 months; may continue up to 9 months

Fibrocystic Breast Disease

100-400 mg/day PO divided BID

Maintenance therapy continued for 3-6 months

Hereditary Angioedema

200 mg PO BID/TID initially, THEN

Decrease dose by 50% at intervals of at least 1-3 months

If attack occurs, increase dose by increments up to 200 mg/day

Safety & efficacy not established

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Interactions

Interaction Checker

and danazol

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • simvastatin

              danazol increases toxicity of simvastatin by decreasing metabolism. Contraindicated. Contraindicated. Increased risk for rhabdomyolysis with drugs that increase simvastatin systemic exposure.

            Serious - Use Alternative (6)

            • cyclosporine

              danazol increases effects of cyclosporine by decreasing metabolism. Avoid or Use Alternate Drug.

            • lonafarnib

              danazol will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

            • pexidartinib

              danazol and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

            • pretomanid

              danazol, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

            • vilazodone

              danazol increases levels of vilazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If intolerable adverse effects occur when coadministered with moderate CYP3A4 inhibitors, reduce daily dose to 20 mg.

            • warfarin

              danazol increases levels of warfarin by decreasing metabolism. Avoid or Use Alternate Drug.

            Monitor Closely (16)

            • avapritinib

              danazol will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • axitinib

              danazol increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • carbamazepine

              danazol will increase the level or effect of carbamazepine by decreasing metabolism. Modify Therapy/Monitor Closely. Monitor plasma levels when used concomitantly

            • dienogest/estradiol valerate

              danazol will increase the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for potential adverse effects such as nausea, irregular uterine bleeding, breast tenderness and headache.

            • finerenone

              danazol will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

            • flibanserin

              danazol will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

            • insulin degludec

              danazol decreases effects of insulin degludec by pharmacodynamic antagonism. Use Caution/Monitor. Danazol may cause insulin resistance.

            • insulin degludec/insulin aspart

              danazol decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Use Caution/Monitor. Danazol may cause insulin resistance.

            • insulin inhaled

              danazol decreases effects of insulin inhaled by pharmacodynamic antagonism. Use Caution/Monitor. Danazol may cause insulin resistance.

            • ivacaftor

              danazol increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

            • lemborexant

              danazol will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

            • lomitapide

              danazol increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

            • lurasidone

              danazol increases levels of lurasidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Manufacturer recommends decreasing starting dose of lurasidone to 20 mg/day and maximum daily dose of lurasidone 80 mg when coadministered with moderate CYP3A4 inhibitors. Concurrent use may increase risk of lurasidone-related adverse reactions.

            • midazolam intranasal

              danazol will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

            • tazemetostat

              danazol will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tinidazole

              danazol will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            Minor (39)

            • acarbose

              danazol increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.

            • androstenedione

              androstenedione increases effects of danazol by pharmacodynamic synergism. Minor/Significance Unknown.

            • budesonide

              danazol, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • chlorpropamide

              danazol increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

            • clobetasone

              danazol, clobetasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • cortisone

              danazol, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • deflazacort

              danazol, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • dexamethasone

              danazol, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • epoetin alfa

              danazol increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.

            • fludrocortisone

              danazol, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • glimepiride

              danazol increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

            • glipizide

              danazol increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

            • glyburide

              danazol increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

            • hydrocortisone

              danazol, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • insulin aspart

              danazol increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.

            • insulin detemir

              danazol increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.

            • insulin glargine

              danazol increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.

            • insulin glulisine

              danazol increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.

            • insulin lispro

              danazol increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.

            • insulin NPH

              danazol increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.

            • insulin regular human

              danazol increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.

            • metformin

              danazol increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.

            • methylprednisolone

              danazol, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • miglitol

              danazol increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.

            • nateglinide

              danazol increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.

            • pioglitazone

              danazol increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

            • prednisolone

              danazol, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • prednisone

              danazol, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • repaglinide

              danazol increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.

            • rosiglitazone

              danazol increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

            • ruxolitinib

              danazol will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • saw palmetto

              saw palmetto decreases effects of danazol by pharmacodynamic antagonism. Minor/Significance Unknown.

            • saxagliptin

              danazol increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

            • sitagliptin

              danazol increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

            • tacrolimus

              danazol increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.

            • tolazamide

              danazol increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

            • tolbutamide

              danazol increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

            • triamcinolone acetonide injectable suspension

              danazol, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • vildagliptin

              danazol increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

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            Adverse Effects

            Frequency Not Defined

            Intracranial hypertension

            Increased blood pressure

            Thromboembolism

            Anxiety

            Depression

            Dizziness

            Urticaria

            Androgenic Effects (common)

            • Mild hirsutism
            • Decreased breast size
            • Voice changes
            • Sore throat, acne
            • Increased oiliness of skin or hair
            • Hair loss

            Menstrual irregularities (common)

            Gastroenteritis

            Nausea

            Vomiting

            Elevated LFTs

            Joint pain

            Muscle spasm

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            Warnings

            Black Box Warnings

            Contraindicated in pregnancy

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

            Peliosis hepatitis and benign hepatic adenoma have been observed with long-term use

            Benign intracranial hypertension (pseudotumor cerebri) has been reported

            Contraindications

            Pregnancy, breastfeeding

            Porphyria

            Undiagnosed abnormal genital bleeding

            Severe liver/renal/cardiac disease,

            Hypersensitivity

            Cautions

            Breast cancer

            Epilepsy

            Migraine

            Cardiac dysfunction

            Renal impairment

            Preliminary epidemiological evidence suggests that the use of danazol might increase the baseline risk of ovarian cancer in patients being treated for endometriosis

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: enters breast milk/contraindicated

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Half-Life: 4.5 hr

            Peak Plasma Time: 2 hr

            Bioavailability: well absorbed

            Metabolism: extensively in the liver to 2-hydroxymethyl ethisterone

            Metabolites: 2-hydroxymethyl ethisterone (activity unknown)

            Excretion: mainly in urine, small amount in feces

            Mechanism of Action

            Suppresses pituitary-ovarian axis by inhibition of pituitary gonadotropin output

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            danazol oral
            -
            100 mg capsule
            danazol oral
            -
            50 mg capsule
            danazol oral
            -
            200 mg capsule
            danazol oral
            -
            50 mg capsule
            danazol oral
            -
            200 mg capsule
            danazol oral
            -
            100 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            danazol oral

            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 right away.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, trouble speaking, 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.

            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 this medication has been prescribed because your doctor 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 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            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 right away. (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.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin), certain "statin" cholesterol medications (lovastatin, simvastatin).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.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature 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.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            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.

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.