(danazol) dosing, indications, interactions, adverse effects, and more

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Sections danazol
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
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Patient Handout
Formulary

Dosing & Uses

AdultPediatric

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

Interaction Checker

Enter a drug name and danazol

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No Interactions Found

Interactions Found

Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

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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

Black Box Warnings

Contraindicated in pregnancy

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

Peliosis hepatitis and benign hepatic adenoma have been observed with long-term use

Benign intracranial hypertension (pseudotumor cerebri) has been reported

Contraindications

Pregnancy, breastfeeding

Porphyria

Undiagnosed abnormal genital bleeding

Severe liver/renal/cardiac disease,

Hypersensitivity

Cautions

Breast cancer

Epilepsy

Migraine

Cardiac dysfunction

Renal impairment

Preliminary epidemiological evidence suggests that the use of danazol might increase the baseline risk of ovarian cancer in patients being treated for endometriosis

Pregnancy & Lactation

Pregnancy Category: X

Lactation: enters breast milk/contraindicated

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

Patient Handout

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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Adding plans allows you to:

View the formulary and any restrictions for each plan.
Manage and view all your plans together – even plans in different states.
Compare formulary status to other drugs in the same class.
Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections danazol
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

danazol (Rx)