Danazol 50mg Capsules
WARNING: This drug may cause harm to the unborn baby if you take it while you are pregnant.Do not take this drug if you are pregnant. A pregnancy test will be done to show that you are NOT pregnant before starting this drug.Use a non-hormone type of birth control like condoms to prevent pregnancy while taking this drug.If you are pregnant or you get pregnant while taking this drug, call your doctor right away.Blood clots have happened with this drug. Sometimes, blood clots like stroke have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.Severe liver problems have happened with long-term use of this drug. This could lead to life-threatening bleeding in the belly area. Follow how to take this drug as you were told by your doctor. Do not take this drug for longer than you were told.Raised pressure in the brain has happened with this drug. This can cause long lasting loss of eyesight and sometimes death. Call your doctor right away if you have a bad headache, dizziness, upset stomach or throwing up, or seizures. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight. @ COMMON USES: It is used to treat endometriosis.It is used to prevent swelling attacks in people with hereditary angioedema (HAE).It is used to treat fibrocystic breast disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Gonadotropin Inhibitor
Pharmacologic Class
Synthetic Androgen; Attenuated Androgen
Pregnancy Category
Category X
FDA Approved
Jun 1976
DEA Schedule
Not Controlled
Overview
What is this medicine?
Danazol is a medication that works by affecting certain hormones in your body. It is used to treat conditions like endometriosis (where tissue similar to the lining of the womb grows outside it), fibrocystic breast disease (non-cancerous breast lumps), and hereditary angioedema (a rare genetic disorder causing swelling episodes). It can reduce pain and symptoms by lowering levels of hormones like estrogen.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to use it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to use it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Use effective non-hormonal contraception during treatment and for at least 3 months after stopping, as Danazol can harm an unborn baby.
- Report any signs of virilization (e.g., voice changes, increased body hair, acne) to your doctor immediately.
- Monitor for signs of fluid retention (e.g., swelling in ankles/feet, sudden weight gain).
- Avoid alcohol or use in moderation, as Danazol can affect the liver.
- Maintain regular follow-up appointments for blood tests and physical exams.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For fibrocystic breast disease: 50 mg twice daily. For hereditary angioedema: 50 mg to 200 mg daily (maintenance dose, after initial higher dose).
Dose Range:
50 - 800 mg
Condition-Specific Dosing:
fibrocysticBreastDisease:
50 mg twice daily (100 mg/day) up to 400 mg/day in divided doses for 3-6 months.
hereditaryAngioedema:
Initial: 200 mg 2-3 times daily. Maintenance: 50 mg to 200 mg daily or every other day, adjusted to prevent attacks.
endometriosis:
200 mg to 800 mg daily in 2-4 divided doses for 3-9 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (except for hereditary angioedema in some cases, with extreme caution)
Adolescent:
Not established (except for hereditary angioedema in some cases, with extreme caution and careful monitoring for virilization)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for fluid retention.
Moderate:
Use with caution; monitor for fluid retention.
Severe:
Contraindicated.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Use with caution; monitor liver function.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Danazol is a synthetic androgen, an attenuated androgen, that suppresses the pituitary-ovarian axis by inhibiting the output of gonadotropins (FSH and LH). This leads to anovulation and amenorrhea. It also has direct inhibitory effects on steroidogenesis in the ovaries and adrenal glands, and may bind to androgen, progesterone, and glucocorticoid receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 20-80%)
Tmax:
2-8 hours
FoodEffect:
Food can increase the extent of absorption (AUC) and peak plasma concentrations (Cmax).
Distribution:
Vd:
Not available
ProteinBinding:
>90% (to albumin and sex hormone-binding globulin)
CnssPenetration:
Limited
Elimination:
HalfLife:
4.5 hours (single dose); 24 hours (multiple doses)
Clearance:
Not available
ExcretionRoute:
Primarily renal (60%) and fecal (30%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Weeks to months for therapeutic effect (e.g., reduction in endometriosis symptoms)
PeakEffect:
Varies by indication and individual response
DurationOfAction:
Effects persist for some time after discontinuation due to hormonal changes.
Safety & Warnings
BLACK BOX WARNING
Thrombotic events (including stroke and myocardial infarction), benign hepatic adenomas, peliosis hepatis, and intracranial hypertension have been reported. Danazol is contraindicated in pregnancy due to the risk of virilization of a female fetus.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other severe side effects:
+ Orgasm with less or no semen
+ Vaginal irritation
+ Change in breast size
+ Swelling or fluid retention in the body, which may cause:
- Weight gain
- Trouble breathing
Common Side Effects
Most people experience few or no side effects when taking this medication. However, some common side effects may occur. If you experience any of the following, contact your doctor if they bother you or do not go away:
Flushing
Excessive sweating
Hair loss
Feeling nervous and excitable
Emotional ups and downs
Weight gain
Pimples (acne)
Scaly or flaky patches on the skin or scalp
For females:
+ Deep voice
+ Facial hair
+ Pimples
+ Period changes
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other severe side effects:
+ Orgasm with less or no semen
+ Vaginal irritation
+ Change in breast size
+ Swelling or fluid retention in the body, which may cause:
- Weight gain
- Trouble breathing
Common Side Effects
Most people experience few or no side effects when taking this medication. However, some common side effects may occur. If you experience any of the following, contact your doctor if they bother you or do not go away:
Flushing
Excessive sweating
Hair loss
Feeling nervous and excitable
Emotional ups and downs
Weight gain
Pimples (acne)
Scaly or flaky patches on the skin or scalp
For females:
+ Deep voice
+ Facial hair
+ Pimples
+ Period changes
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Yellowing of skin or eyes (jaundice)
- Dark urine or pale stools
- Persistent nausea, vomiting, or abdominal pain
- Sudden, severe headache with vision changes
- Weakness or numbness on one side of the body
- Chest pain, shortness of breath, or sudden leg pain/swelling
- Significant voice deepening or clitoral enlargement (may be irreversible)
- Unexplained muscle pain or weakness (especially if taking statins)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Androgen-dependent tumors
+ Genital cancer
+ Heart disease
+ Kidney disease
+ Liver disease
+ Porphyria
A history of blood clots or current blood clots
Unexplained vaginal bleeding
* If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Androgen-dependent tumors
+ Genital cancer
+ Heart disease
+ Kidney disease
+ Liver disease
+ Porphyria
A history of blood clots or current blood clots
Unexplained vaginal bleeding
* If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this drug.
There is a risk of developing high cholesterol associated with this medication. If you have concerns or questions, discuss them with your doctor.
Regular blood tests are necessary as directed by your doctor. Be sure to follow their instructions and discuss any questions or concerns you may have with them.
This medication may interfere with certain laboratory tests. Therefore, it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Some women taking this medication may experience changes in their menstrual cycle, including spotting, changes in period timing, or cessation of periods. In most cases, these changes resolve on their own within 60 to 90 days after stopping the medication. However, if your periods have stopped and do not resume normally after discontinuing this drug, consult your doctor.
Additionally, this medication may decrease sperm count in men. If you have questions or concerns about this potential effect, discuss them with your doctor.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this drug.
There is a risk of developing high cholesterol associated with this medication. If you have concerns or questions, discuss them with your doctor.
Regular blood tests are necessary as directed by your doctor. Be sure to follow their instructions and discuss any questions or concerns you may have with them.
This medication may interfere with certain laboratory tests. Therefore, it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Some women taking this medication may experience changes in their menstrual cycle, including spotting, changes in period timing, or cessation of periods. In most cases, these changes resolve on their own within 60 to 90 days after stopping the medication. However, if your periods have stopped and do not resume normally after discontinuing this drug, consult your doctor.
Additionally, this medication may decrease sperm count in men. If you have questions or concerns about this potential effect, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Exaggerated androgenic effects (e.g., virilization)
- Fluid retention
- Nausea, vomiting
- Headache
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or emergency services immediately. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Warfarin (increased anticoagulant effect)
- Statins (increased risk of myopathy/rhabdomyolysis, especially simvastatin, lovastatin, atorvastatin)
- Cyclosporine (increased cyclosporine levels and toxicity)
- Tacrolimus (increased tacrolimus levels and toxicity)
- Alpha-blockers (e.g., prazosin, may potentiate hypotensive effects)
Moderate Interactions
- Insulin and oral hypoglycemics (may alter glucose tolerance, requiring dose adjustment)
- Anticonvulsants (e.g., carbamazepine, phenytoin - danazol may increase levels)
- Corticosteroids (may increase corticosteroid levels)
- Lithium (may increase lithium levels)
- Migraine medications (e.g., ergot alkaloids - theoretical increased risk of vasospasm)
Minor Interactions
- Laboratory tests (may interfere with thyroid function tests, glucose tolerance tests, and lipid profiles)
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: Danazol can cause hepatic dysfunction, including peliosis hepatis and hepatic adenomas.
Timing: Prior to initiation of therapy.
Lipid Profile (Total Cholesterol, HDL, LDL, Triglycerides)
Rationale: Danazol can alter lipid metabolism, decreasing HDL and increasing LDL.
Timing: Prior to initiation of therapy.
Blood Glucose
Rationale: Danazol may impair glucose tolerance.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: Danazol can cause fluid retention and hypertension.
Timing: Prior to initiation of therapy.
Pregnancy Test
Rationale: Danazol is contraindicated in pregnancy due to teratogenicity.
Timing: Prior to initiation of therapy in women of childbearing potential.
Routine Monitoring
Liver Function Tests (LFTs)
Frequency: Monthly for the first 3-6 months, then every 3-6 months or as clinically indicated.
Target: Within normal limits or stable baseline.
Action Threshold: Significant elevation (e.g., >3x ULN) requires dose reduction or discontinuation.
Lipid Profile
Frequency: Every 3-6 months.
Target: Maintain within acceptable cardiovascular risk profile.
Action Threshold: Significant adverse changes may require intervention or discontinuation.
Blood Glucose
Frequency: Periodically, especially in patients with diabetes or risk factors.
Target: Within normal limits.
Action Threshold: Persistent hyperglycemia may require dose adjustment or discontinuation.
Blood Pressure
Frequency: Regularly.
Target: Within normal limits.
Action Threshold: Development of hypertension may require management or discontinuation.
Physical Examination for Virilization
Frequency: Regularly (e.g., every 3-6 months).
Target: Absence of new or worsening virilizing effects.
Action Threshold: Development of irreversible virilization (e.g., voice deepening, clitoral enlargement) may necessitate discontinuation.
Symptom Monitoring
- Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
- Signs of fluid retention (e.g., edema, weight gain)
- Signs of virilization (e.g., voice deepening, hirsutism, clitoral enlargement, acne, oily skin, male pattern baldness)
- Headache, visual disturbances (signs of intracranial hypertension)
- Symptoms of thrombotic events (e.g., chest pain, shortness of breath, leg pain/swelling, sudden weakness/numbness)
- Muscle pain or weakness (especially if on statins)
Special Patient Groups
Pregnancy
Contraindicated. Danazol is a Category X drug due to significant risk of virilization of a female fetus (e.g., clitoral hypertrophy, labial fusion, urogenital sinus defects). Effective non-hormonal contraception must be used during treatment and for at least 3 months after discontinuation.
Trimester-Specific Risks:
First Trimester:
High risk of virilization of female fetus.
Second Trimester:
High risk of virilization of female fetus.
Third Trimester:
High risk of virilization of female fetus.
Lactation
Contraindicated. Danazol is excreted in breast milk and can cause serious adverse effects in the nursing infant, including virilization.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Generally not recommended due to potential for irreversible virilization and premature epiphyseal closure. Use in hereditary angioedema in children should be considered only when benefits outweigh risks and with extreme caution and close monitoring.
Geriatric Use
Use with caution. Elderly patients may be more susceptible to adverse effects, particularly fluid retention, cardiovascular effects, and hepatic dysfunction. Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Danazol is a potent androgen with significant side effects, particularly virilization, which can be irreversible. Patient counseling on these effects is crucial.
- Due to its teratogenic potential, strict adherence to non-hormonal contraception is mandatory for women of childbearing potential.
- Regular monitoring of liver function, lipid profiles, and blood pressure is essential throughout therapy.
- The lowest effective dose should be used, especially for long-term conditions like hereditary angioedema, to minimize side effects.
- Consider alternative therapies with more favorable side effect profiles before initiating danazol, especially for endometriosis or fibrocystic breast disease.
Alternative Therapies
- For Endometriosis: GnRH agonists (e.g., leuprolide), progestins (e.g., medroxyprogesterone acetate, norethindrone), oral contraceptives, aromatase inhibitors (e.g., anastrozole, letrozole), NSAIDs, surgery.
- For Fibrocystic Breast Disease: NSAIDs, vitamin E, evening primrose oil, bromocriptine (rarely), surgery.
- For Hereditary Angioedema: C1 esterase inhibitor concentrate (human), ecallantide, icatibant, lanadelumab, berotralstat, antifibrinolytics (e.g., tranexamic acid, aminocaproic acid).
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 30 capsules (50mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.