Danazol 50 mg Capsule, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Androgen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Danazol is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding)..Danazol is also used to treat fibrocystic breast disease (swollen, tender breasts with noncancerous lumps) when other treatments are not successful. Danazol is also used to prevent attacks in people with hereditary angioedema (inherited condition that causes episodes of swelling in the hands, feet, face, airway, or in...
Read the full MedlinePlus article ↗- That depends on why it was prescribed for you. For endometriosis, danazol suppresses the hormonal signals that cause abnormal tissue to grow outside your uterus — over several mont...
- What exactly is danazol treating in my body?
- Taking danazol with a meal — especially one that contains some fat — significantly increases how much of the drug your body absorbs. Studies show absorption can be 3 to 4 times hig...
- Should I take my danazol capsule with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Danazol — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII CQ3XH3DET6
D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
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UNII J9EQA3S2JM
FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
15 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.564 | $156.44 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.99 | $199.01 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $2.27 | $226.95 / 100 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Danazol 50 mg 00527-1392-01 | Lannett | 100 capsules | $1.564 | — | Availability likely | — |
| Danazol 50 mgthis 00555-0633-02 | Teva | 100 capsules | $1.564 | AB | Availability likely | — |
| Danazol 50 mg 62135-0475-60 | Chartwell | 60 capsules | $1.564 | AB | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00555-0633-02 You're viewing this | 100 CAPSULE in 1 BOTTLE (0555-0633-02) | 1998-06-25 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Endometriosis Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
⏱️ Dosage and Administration ▾
DOSAGE AND 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 danazol capsules (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. Hereditary Angioedema The dosage requirements for continuous treatment of hereditary angioedema with danazol capsules 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Danazol should not be administered to patients with: Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function. Pregnancy. (See WARNINGS .) Breastfeeding. Porphyria - Danazol can induce ALA synthetase activity and hence porphyrin metabolism. Androgen-dependent tumor. Active thrombosis or thromboembolic disease and history of such events. Hypersensitivity to danazol.
⚠️ Warnings ▾
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. Patients should be watched closely for signs of androgenic effects some of which may not be reversible even when drug administration is stopped.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following events have been reported in association with the use of danazol: 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 to 90 days after discontinuation of therapy with danazol, 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 danazol of 400 mg or more. It is recommended that patients receiving danazol be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, hepatic adenoma, hepatocellular injury, hepatocellular jaundice and hepatic failure have been reported (see WARNINGS and PRECAUTIONS ).
Abnormalities in laboratory tests may occur during therapy with danazol 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 danazol 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. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects (See CONTRAINDICATIONS. ) Danazol administered orally to pregnant rats from the 6th through the 15th day of gestation at doses up to 250 mg/kg/day (7 to 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 danazol on days 6 to 18 of gestation at doses of 60 mg/kg/day and above (2 to 4 times the human dose) resulted in inhibition of fetal development.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Danazol suppresses the pituitary-ovarian axis. This suppression is probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of sex steroid metabolism, and interaction of danazol with sex hormone receptors. The only other demonstrable hormonal effect is weak androgenic activity.
Danazol depresses the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Recent evidence suggests a direct inhibitory effect at gonadal sites and a binding of danazol to receptors of gonadal steroids at target organs. In addition, danazol has been shown to significantly decrease IgG, IgM and IgA levels, as well as phospholipid and IgG isotope autoantibodies in patients with endometriosis and associated elevations of autoantibodies, suggesting this could be another mechanism by which it facilitates regression of the disease.
In the treatment of endometriosis, danazol alters the normal and ectopic endometrial tissue so that it becomes inactive and atrophic. Complete resolution of endometrial lesions occurs in the majority of cases. Changes in vaginal cytology and cervical mucus reflect the suppressive effect of danazol on the pituitary-ovarian axis.
Changes in the menstrual pattern may occur. Generally, the pituitary-suppressive action of danazol is reversible. Ovulation and cyclic bleeding usually return within 60 to 90 days when therapy with danazol is discontinued.
In the treatment of hereditary angioedema, danazol at effective doses prevents attacks of the disease characterized by episodic edema of the abdominal viscera, extremities, face, and airway which may be disabling and, if the airway is involved, fatal. In addition, danazol corrects partially or completely the primary biochemical abnormality of hereditary angioedema by increasing the levels of the deficient C1 esterase inhibitor (C1EI). As a result of this action the serum levels of the C4 component of the complement system are also increased.
Pharmacokinetics Absorption: After oral administration of a 400 mg dose to healthy male volunteers, peak plasma concentrations of danazol are reached between 2 and 8 hours, with a median T max value of 4 hours. Steady state conditions are observed following 6 days of twice daily dosing of danazol. The pharmacokinetic parameters for danazol after administering a 400 mg oral dose to healthy males are summarized in the following table: Parameters Mean ± SD (n = 15) C max (ng/mL) 69.6 ±
29.9T max (h) 2.47 ±
1.62AUC 0-∞ (ng*h/mL) 601 ± 181 t 1/2 (h) 9.70 ±
3.29Total Body Clearance (L/h) 727 ± 221 The pharmacokinetic parameters for danazol after oral administration of 100, 200 and 400 mg single doses to healthy female volunteers are summarized in the following table: Dose (mg) Mean C max ± SD (ng/mL) Mean T max (h) Mean AUC 0-∞ ± SD (ng*h/mL) Fasting Fed Fasting Fed Fasting Fed 100 45.9 ±23.9 113.8 ± 46 1 to 8 2 to 6 484 ± 263 741 ± 265 200 63.8 ± 27.7 159 ± 57.3 1 to 6 2 to 4 681 ± 363 1252 ± 307 400 60.4 ± 30 253.7 ± 105.5 1 to 6 2 to 4 754 ± 443 1851 ± 605 Dose Proportionality Bioavailability studies indicate that blood levels do not increase proportionally with increases in the administered dose.
Single dose administration of danazol in healthy female volunteers found that a 4 fold increase in dose produced only a 1.6 and 2.5 fold increase in AUC and a 1.3 and 2.2 fold increase in C max in the fasted and fed state, respectively. A similar degree of non-dose proportionality was observed at steady state. Food Effect Single dose administration of 100 mg and 200 mg capsules of danazol to female volunteers showed that both the extent of availability and the maximum plasma concentration increased by 3 to 4 fold, respectively, following a meal (> 30 grams of fat), when compared to the fasted state.
Further, food also delayed mean time to peak concentration of danazol by about 30 minutes. Even after multiple dosing under less extreme food/fasting conditi…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Danazol capsules, USP are available as follows: 50 mg: Yellow opaque cap/white opaque body capsule. Imprinted with black ink stylized barr 633 . Available in bottles of 100 (NDC 0555-0633-02) capsules.
100 mg: Yellow opaque cap/yellow clear body capsule. Imprinted with black ink stylized barr 634 . Available in bottles of 100 (NDC 0555-0634-02) capsules.
200 mg: Orange opaque cap/orange clear body capsule. Imprinted with black ink stylized barr 635 . Available in bottles of 60 (NDC 0555-0635-09) and 100 (NDC 0555-0635-02) capsules.
Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 10/2022
📋 Description ▾
DESCRIPTION Danazol, USP 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, USP is 17α-Pregna-2,4-dien-20-yno [2,3- d ]-isoxazol-17-ol, which has the following structural formula: C 22 H 27 NO 2 M.W.
337.46 Danazol capsules, USP for oral administration, contain 50 mg, 100 mg or 200 mg of danazol, USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow no. 10, D&C yellow no.
10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no.
40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical glaze, propylene glycol, sodium starch glycolate, stearic acid and titanium dioxide The 50 mg and 100 mg capsule shells also contain FD&C yellow no. 6. The 200 mg capsule shell also contains FD&C red no.
40 and D&C red no. 28. Structural Formula