Prescription medicine
Danazol First approved as Danocrine
Danazol (Danocrine) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $2.65 per danazol 200 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the danazol FDA label on DailyMed (effective April 30, 2020, Lannett Company, Inc.); the NDA 17557 record on Drugs@FDA; every danazol label on DailyMed.
Highlights of the record
FDA label of April 30, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. […]
Used for
From the label: indications and usageEndometriosis.
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
Capsule.
On the market
- Earliest approval on file
- June 21, 1976 Danocrine, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first August 9, 1996; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.65 per capsule Danazol 200 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,803 through July 30, 2026
What is danazol used for?
From the label: indications and usageEndometriosis. 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.
FDA pharmacologic class: Androgen.
Source: FDA drug label (Danazol), Lannett Company, Inc., effective April 30, 2020 (SPL set f2c9b713-aafc-49ca-866e-334d9b5c2e2d), via openFDA; the full label on DailyMed
Is there a generic for danazol (Danocrine)?
The FDA approved the first generic danazol on August 9, 1996. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists danazol from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 1996 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for danazol (Danocrine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.65 per Danazol 200 mg capsule, down 34% from $4.02 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Danazol 200 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Danazol 100 mg capsule | Generic | $2.23 per capsule | $66.95 | -0.5% |
| Danazol 200 mg capsule | Generic | $2.65 per capsule | $79.57 | -34% |
| Danazol 50 mg capsule | Generic | $1.56 per capsule | $46.93 | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the danazol label say about other medicines?
The danazol label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name danazol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin and lovastatin. |
| Lovastatin | drug interactions | The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin and lovastatin. |
| Simvastatin | drug interactions | The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin and lovastatin. |
| Tacrolimus | drug interactions | Danazol may raise the plasma levels of cyclosporin and tacrolimus, leading to an increase of the renal toxicity of these drugs. |
| Warfarin | drug interactions | Drug Interactions: Prolongation of prothrombin time occurs in patients stabilized on warfarin. |
Other labels that name danazol
Source: FDA drug label (Danazol), Lannett Company, Inc., effective April 30, 2020 (SPL set f2c9b713-aafc-49ca-866e-334d9b5c2e2d), via openFDA; the full label on DailyMed
What do FAERS reports show for danazol?
The FDA Adverse Event Reporting System holds 2,803 reports that list danazol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 376 are coded as a death and 983 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other androgens
- the pharmacologic class, with prices and generics
- Danazol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other