Danazol Dosage

Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

Applies to the following strengths: 50 mg; 100 mg; 200 mg

Usual Adult Dose for:

Endometriosis
Fibrocystic Breast Disease
Angioedema

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Endometriosis

Mild Disease:

Initial dose: 200 to 400 mg orally per day, given in 2 divided doses
Maintenance dose: Gradual downward titrations should be performed to maintain amenorrhea.
Duration of therapy: Up to 9 months

Moderate to Severe Disease or Patients Infertile due to Endometriosis:

Initial dose: 800 mg orally per day, given in 2 divided doses
Maintenance dose: Gradual downward titrations should be performed to maintain amenorrhea.
Duration of therapy: Up to 9 months

Comments:

Treatment should begin during menstruation, OR appropriate pregnancy tests should be performed prior to starting treatment ensure that the patient is not pregnant while on treatment.
Treatment should continue uninterrupted 3 to 6 months, but may continue for up to 9 months.
Treatment may be reinstituted if symptoms recur.

Use: Treatment of endometriosis amenable to hormonal management

Usual Adult Dose for Fibrocystic Breast Disease

100 to 400 mg orally per day, given in 2 divided doses

Comments:

Most patients may be treated with simple measures (e.g., padded brassieres, analgesics). Patients requiring treatment with this drug may have symptoms of severe pain and tenderness.
Patients should be advised that treatment is not innocuous; hormone level alterations and symptom recurrence are very common after discontinuation of treatment.
This drug is usually effective in decreasing symptoms of fibrocystic breast disease (e.g., nodularity, pain, tenderness); pain and tenderness are typically eliminated in 2 to 3 months, and nodularity is usually eliminated after 4 to 6 months of uninterrupted treatment.
Approximately 50% of patients will have symptom recurrence within 1 year; treatment may be reinstated in this patient population if necessary.

Use: Treatment of symptomatic fibrocystic breast disease by suppression of ovarian function

Usual Adult Dose for Angioedema

Initial dose: 200 mg orally 2 to 3 times a day

After a favorable initial response, continuing doses should be determined by decreasing the dose by 50% or less at intervals of 1 to 3 months (or longer).
If an attack occurs, the daily dose may be increased by 200 mg.

Comment: Patients should be monitored closely during dose adjustments, especially in patients with airway involvement.

Use: Prevention of all types of angioedema (e.g., cutaneous, abdominal, laryngeal) in male and female patients

Renal Dose Adjustments

Renal dysfunction: Data not available
Marked renal dysfunction: Contraindicated

Liver Dose Adjustments

Liver dysfunction: Frequent monitoring recommended.
Marked liver dysfunction: Contraindicated

Precautions

US BOXED WARNINGS:
PREGNANCY:

Use of this drug 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 this drug, administration of the drug should be discontinued and the patient should be apprised of the potential risk to the fetus.
Exposure to this drug in utero may result in androgenic effects of the female fetus; reports of clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been received.

STROKE RISK:

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

HEPATIC EFFECTS:

Experience with long-term therapy with this drug is limited. Peliosis hepatitis and benign hepatic adenoma have been observed with long-term use. Peliosis hepatitis 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 prove 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.

PSEUDOTUMOR CEREBRI:

This drug 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 this drug immediately and be referred to a neurologist for further diagnosis and care.

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Non-hormonal contraceptive devices should be used during treatment.

Storage requirements:

Protect from light.

General:

Ovulation and cyclic bleeding usually resume within 60 to 90 days after discontinuation of treatment.
This drug may be used in conjunction with surgery or in patients not responding to other treatments (as sole therapy) for the treatment of endometriosis.

Monitoring:

Hematologic: Periodic hematologic tests
Hepatic: Periodic liver function tests; hepatic ultrasonography (for patients receiving repeated treatment courses or on long-term treatment)
Respiratory: Change in voice

Patient advice:

Patients, especially professional singers, should be told to immediately report any change in voice during or after treatment.
Patients should be told to use non-hormonal methods of contraception during treatment.
Patients of childbearing potential should be apprised of the potential harm to the fetus.
Female patients should discontinue treatment and should speak to a healthcare provider immediately if pregnancy occurs.