Danazol
Danazol is a hormone-suppressing oral medicine used to treat endometriosis and to prevent attacks of hereditary angioedema.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Danazol is an older male-hormone-like (androgen) medicine, on the market since the 1970s and available generically, that quiets brain-to-ovary hormone signals to treat endometriosis and helps prevent hereditary angioedema (inherited swelling) attacks. It is often hard to tolerate, with weight gain, acne, fluid swelling and period changes common, and a deepened or hoarse voice may not reverse. The boxed warning covers pregnancy (it can masculinize a female baby), blood clots and strokes, and liver problems, so expect a pregnancy test first, use non-hormonal birth control, and keep up with lab tests. Severe belly pain, or headache with vomiting or vision changes, needs a doctor right away.
Clinical pearls
- Food can greatly boost danazol absorption, so take it the same way every day, either always with or always without meals.
- For endometriosis, start danazol during your period and expect to take it without breaks for several months.
- With simvastatin, atorvastatin or lovastatin, danazol raises the risk of serious muscle damage, so report unexplained muscle pain or weakness.
- Danazol can lengthen clotting time on warfarin and blunt insulin's effect, so expect closer clotting or blood sugar checks.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Danazol must not be used during pregnancy. It can cause male-hormone-like effects in a female baby, including changes to the genitals. A sensitive pregnancy test is recommended right before starting, and a non-hormonal birth control method should be used during treatment. If you become pregnant, stop danazol and contact your doctor.
Blood clots, clotting events and strokes, some fatal, have been reported. Long-term use has been linked to liver problems (peliosis hepatis and benign liver tumors) that may cause no symptoms until they bleed dangerously inside the abdomen.
Danazol has also been linked to raised pressure around the brain (benign intracranial hypertension). Warning signs include headache, nausea, vomiting and vision changes. If these occur, stop danazol and see a doctor right away.
Your doctor should use the lowest dose that protects you from hereditary angioedema attacks.
Patient information guide A plain-language walkthrough of Danazol, written from its FDA label.
What Danazol is used for
▾
Danazol capsules are used for two conditions:
- Danazol capsules treat endometriosis that can be managed with hormone therapy.
- Danazol capsules prevent attacks of hereditary angioedema (cutaneous, abdominal and laryngeal swelling) in males and females.
How Danazol works
▾
Danazol suppresses the communication between the pituitary gland and the ovaries. It lowers FSH and LH, binds to sex hormone receptors, and has weak androgenic (male-hormone-like) activity.
In endometriosis, it makes both normal and misplaced uterine lining tissue inactive and shrunken. In hereditary angioedema, it increases the missing C1 esterase inhibitor protein, which helps prevent swelling attacks.
Danazol dosage
▾
Danazol capsules are taken by mouth, usually divided into two or three doses a day.
- Endometriosis: treatment should begin during your period, or after a pregnancy test. It generally continues without interruption for 3 to 6 months, and sometimes up to 9. If symptoms return, treatment can be restarted.
- Hereditary angioedema: the dose is individualized and often lowered gradually once attacks are controlled. Your prescriber may raise it temporarily if an attack occurs.
- Food: a meal can greatly increase how much is absorbed, so ask your pharmacist about taking it consistently.
Follow your prescriber's directions exactly.
Dosing details from the FDA-approved label
From the Danazol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Endometriosis, moderate to severe disease, or patients infertile due to endometriosis
- Starting dose of 800 mg given in two divided doses
- Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response
- Therapy should begin during menstruation; continue uninterrupted for 3 to 6 months, may be extended to 9 months if necessary
- Endometriosis, mild cases
- Initial daily dose of 200 mg to 400 mg given in two divided doses, may be adjusted depending on patient response
- Therapy should begin during menstruation; continue uninterrupted for 3 to 6 months, may be extended to 9 months if necessary
- Hereditary Angioedema
- Start on 200 mg, two or three times a day
- After a favorable initial response, decrease the dosage by 50% or less at intervals of one to three months or longer
- If an attack occurs, the daily dosage may be increased by up to 200 mg
- Individualize on clinical response; close monitoring during dose adjustment, particularly if history of airway involvement
Read the label’s full dosing text
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.
Read the full Dosage and Administration section on DailyMed →
Danazol side effects
▾
Many side effects come from danazol's male-hormone-like and estrogen-lowering effects.
Common side effects
- Weight gain
- Acne and oily skin
- Swelling (edema) and mild extra hair growth
- Hair loss
- Voice changes such as hoarseness or deepening
- Menstrual changes, including spotting or missed periods
- Hot flushes, sweating and vaginal dryness
- Nervousness and mood swings
- Voice changes such as hoarseness or deepening, which may persist after stopping
- Flushing, sweating, vaginal dryness and smaller breast size
When to get medical help
- Call your doctor right away if you think you might be pregnant.
- Get emergency help for signs of a blood clot or stroke, such as sudden weakness, trouble speaking, severe headache, or leg or chest pain.
- Call your doctor for severe belly pain, which could signal liver problems or bleeding.
- Report yellowing of the skin or eyes (jaundice).
- Stop danazol and call your doctor for headache with nausea, vomiting or vision changes, which can be signs of raised pressure around the brain (benign intracranial hypertension).
- Tell your doctor about voice changes or other male-hormone-like effects, since some may not reverse.
- Seek help for a severe skin rash or blistering.
Danazol warnings and precautions
▾
- Pregnancy: danazol must not be used in pregnancy and can cause male-hormone-like changes in a female fetus.
- Blood clots and stroke: serious and sometimes fatal events have been reported.
- Liver: liver injury, peliosis hepatis, benign tumors and rarely malignant tumors have been reported, mostly with long-term use. Liver monitoring is recommended.
- Brain pressure: benign intracranial hypertension has been reported. Stop danazol and get care if you have headache, nausea, vomiting or vision changes.
- Cholesterol: HDL may drop and LDL may rise, which can matter for heart and artery disease risk.
- Androgenic effects: some may not reverse after stopping.
Danazol interactions
▾
Danazol can affect or be affected by several medicines.
- Warfarin: clotting time can lengthen.
- Carbamazepine: levels may increase.
- Diabetes medicines and insulin: danazol can cause insulin resistance.
- Cyclosporine and tacrolimus: levels may rise and increase kidney toxicity.
- Statins (simvastatin, atorvastatin, lovastatin): higher risk of muscle damage.
- Synthetic vitamin D analogs: stronger calcium-raising effect in primary hypoparathyroidism.
Interactions listed in the FDA-approved label
From the Danazol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Warfarin: Prolongation of prothrombin time occurs in patients stabilized on warfarin.
- Carbamazepine: Danazol may cause an increase in carbamazepine levels in patients taking both drugs.
- Antidiabetic drugs: Danazol can cause insulin resistance. Caution should be exercised when used with antidiabetic drugs.
- Cyclosporin: Danazol may raise plasma levels of cyclosporin, leading to an increase of its renal toxicity. Monitoring of systemic concentrations and appropriate dose adjustments may be needed.
- Tacrolimus: Danazol may raise plasma levels of tacrolimus, leading to an increase of its renal toxicity. Monitoring of systemic concentrations and appropriate dose adjustments may be needed.
- Synthetic vitamin D analogs: Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism.
- Statins (simvastatin, atorvastatin, lovastatin): The risk of myopathy and rhabdomyolysis is increased by concomitant administration with danazol. Caution should be exercised if used concomitantly; consult the statin product labeling for specific information on dose restrictions in presence of danazol.
Read the label’s full interactions text
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.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Danazol
▾
- Do not use if pregnant, and use non-hormonal birth control during treatment.
- Do not use while breastfeeding.
- Not for undiagnosed abnormal genital bleeding.
- Not for markedly impaired liver, kidney or heart function.
- Not for porphyria or androgen-dependent tumors.
- Not for active or past blood clots or thromboembolic disease.
- Not for anyone allergic to danazol.
What Danazol does in the body
▾
Danazol lowers FSH and LH output and suppresses the pituitary-ovarian axis. This changes cervical mucus and vaginal cells and can alter periods. Ovulation and cyclic bleeding usually return within 60 to 90 days after stopping. It also raises C1 esterase inhibitor and C4 levels in hereditary angioedema, and it lowers certain antibody levels in people with endometriosis.
How your body processes Danazol
▾
After a dose by mouth, blood levels peak in about 2 to 8 hours. A meal can raise absorption by roughly 2 to 4 times, and blood levels do not rise in proportion to the dose. Danazol is fat-soluble and spreads into deep tissues. It is broken down in the body, and the byproducts leave through urine and stool. Half-life varies, averaging about 9.7 hours in healthy males and 23.7 hours after months of dosing in endometriosis patients.
How to store Danazol
▾
Store at 20° to 25°C (68° to 77°F) . Dispense in a well-closed container with a child-resistant closure as defined in the USP.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Danazol
50 supplements and herbal products have documented interactions with Danazol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 38
- Minor · 11
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Danazol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Danazol — the kind of thing our pharmacy team would talk through with you at the counter.
What is danazol for?
▾
Can I take danazol if I might be pregnant?
▾
Should I take it with food?
▾
What side effects are common?
▾
When should I call my doctor right away?
▾
Does danazol interact with my other medicines?
▾
Is Danazol available over the counter?
▾
When was Danazol first available?
▾
Who makes Danazol?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Danazol on HelloPharmacist
Danazol forms and strengths (how it comes)
Danazol is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Danazol inactive ingredients by manufacturer.
Capsule
How this form is used
- Danazol capsules treat endometriosis that can be managed with hormone therapy.
- Danazol capsules prevent attacks of hereditary angioedema in males and females.
- Danazol capsules are taken by mouth, usually in two or three daily doses depending on the condition.
- Danazol capsules for endometriosis should start during menstruation and continue uninterrupted for several months.
- Danazol capsules for hereditary angioedema are adjusted to your response, and the dose may be lowered over time.
Danazol on the U.S. market: products, makers and brands
How Danazol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
4 companies list 11 Danazol product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1976. Brand names on the directory include Danocrine; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Danazol is used (Medicaid data)
A general measure of how commonly Danazol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Danazol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Danazol prescribed? Of the 1,601 medications we measure, Danazol ranks #1,454 by Medicaid prescriptions — more than 9% of them.
Utilization by Danazol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
danazol 200 MG Oral Capsule Most dispensed
Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197555
danazol 50 MG Oral Capsule
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197556
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Danazol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 15 listed Danazol NDCs with Medicaid activity.
Compare Danazol products
A representative set of FDA-listed product records for Danazol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 50 mg | Oral | Chartwell RX, LLC. | ANDA | View NDC → |
| 100 mg | Oral | Chartwell RX, LLC. | ANDA | View NDC → |
| 200 mg | Oral | Chartwell RX, LLC. | ANDA | View NDC → |
| 50 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 200 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 50 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Danazol NDCs →
Danazol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Danazol — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Danazol are headache, angioedema, hypersensitivity; about 84% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Danazol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Danazol FDA approval history
How Danazol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Danazol was first approved by the FDA in 1976 (Brand: DANOCRINE · Sanofi Aventis Us); the first generic version was approved in 1996. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Danazol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Danazol recalls since July 2021.
✅No Danazol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3102 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 371681In current FDA listings
Look up RxCUI 3102 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Danazol supply and shortage status
Whether Danazol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Danazol costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 100 mg | $2.23 per capsule | NDC details & price history |
| Capsule · Oral | 200 mg | $2.65 per capsule | NDC details & price history |
| Capsule · Oral | 50 mg | $1.56 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Danazol brand names
Danazol is sold under one brand name in the FDA directory — Danocrine. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Danazol: manufacturers and labelers
4 companies list Danazol products with the FDA. By number of product records, the largest are Chartwell RX, LLC., Lannett Company, Inc., Teva Pharmaceuticals USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Danazol drug class (RxNorm)
Danazol belongs to the Androgen class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Danazol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →