Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 effects of warfarin by anticoagulation. Avoid or Use Alternate Drug.
Monitor Closely (18)
- atogepant
danazol will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- isavuconazonium sulfate
danazol will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- 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.
- ruxolitinib topical
danazol will increase the level or effect of ruxolitinib topical 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.
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
Warnings
Black Box Warnings
A sensitive test (eg, beta subunit test if available) capable of determining early pregnancy recommended immediately prior to start of therapy; non-hormonal method of contraception should be used during therapy
If patient becomes pregnant while receiving therapy, administration of the drug should be discontinued and the patient should apprised of potential risk to fetus
Experience with long-term therapy is limited; peliosis hepatis and benign hepatic adenoma observed with long-term use; peliosis hepatis and hepatic adenoma may be silent until complicated by acute, potentially life-threatening intraabdominal hemorrhage; the physician 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, 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
Contraindications
Pregnancy, breastfeeding
Porphyria
Undiagnosed abnormal genital bleeding
Severe liver/renal/cardiac disease
Androgen-dependent tumor
Active thrombosis or thromboembolic disease and history of such events
Hypersensitivity
Cautions
A temporary alteration of lipoproteins in the form of decreased high-density lipoproteins and possibly increased low-density lipoproteins reported during therapy
These alterations may be marked, and prescribers should consider potential impact on risk of atherosclerosis and coronary artery disease in accordance with potential benefit of therapy to the patient
Before initiating therapy of fibrocystic breast disease, 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
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
Because this drug may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, 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 reported in patients receiving therapy, periodic liver function tests should be performed
Administration of this drug has been reported to cause exacerbation of manifestations of acute intermittent porphyria; laboratory monitoring of hematologic state should be considered
Drug interaction overview
- Prolongation of prothrombin time occurs in patients stabilized on warfarin
- Therapy may cause an increase in carbamazepine levels in patients taking both drugs
- This drug can cause insulin resistance; use caution when using with antidiabetic drugs
- This drug may raise plasma levels of cyclosporin and tacrolimus, leading to an increase of 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 hyperparathyroidism; 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 this drug
Pregnancy & Lactation
Pregnancy
Exposure to drug in utero may result in androgenic effects on female fetus; clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia reported
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 this drug 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
Lactation
Contraindicated in breastfeeding patients
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.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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| danazol oral - | 200 mg capsule |  | |
| danazol oral - | 100 mg capsule |  | |
| danazol oral - | 200 mg capsule |  | |
| danazol oral - | 50 mg capsule |  | |
| danazol oral - | 100 mg capsule |  | |
| danazol oral - | 50 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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). Get medical help right away if you have any symptoms of these side effects, including nausea/vomiting that doesn't stop, headache that is severe or doesn't go away, weakness on one side of the body, trouble speaking, vision changes, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as confusion).
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 last or get worse, 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 March 2022. Copyright(c) 2022 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.
Formulary
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