Danazol 200mg 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; Synthetic androgen
Pharmacologic Class
Androgen; Antigonadotropin
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 uterus grows outside the uterus), fibrocystic breast disease (non-cancerous breast lumps), and hereditary angioedema (a rare genetic disorder causing swelling). It can cause side effects, especially those related to male hormones, and requires careful monitoring.
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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
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 cause birth defects.
- Report any signs of liver problems (yellow skin/eyes, dark urine, severe stomach pain) immediately.
- Report any signs of blood clots (chest pain, shortness of breath, sudden severe headache, leg pain/swelling) immediately.
- Report any changes in voice, increased hair growth, acne, or other signs of virilization.
- Regularly monitor blood pressure and cholesterol as advised by your doctor.
- Avoid alcohol or limit intake due to potential for liver effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and patient response
Dose Range:
50 - 800 mg
Condition-Specific Dosing:
Endometriosis:
200-800 mg/day in 2-4 divided doses for 3-9 months. Initial dose often 400 mg/day.
Fibrocystic Breast Disease:
50-200 mg/day in 2 divided doses for 3-6 months.
Hereditary Angioedema:
Initial: 200 mg 2-3 times/day. Maintenance: 50-200 mg/day or every other day, adjusted to prevent attacks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (limited use for hereditary angioedema in adolescents, but generally avoided due to virilizing effects)
Adolescent:
Not established (use for hereditary angioedema in adolescents should be carefully considered due to potential for premature epiphyseal closure and virilization)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Use with caution; monitor for adverse effects.
Dialysis:
Not specifically studied; use with caution.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function closely.
Moderate:
Contraindicated or extreme caution; monitor liver function closely.
Severe:
Contraindicated due to risk of hepatic dysfunction and peliosis hepatis.
Pharmacology
Mechanism of Action
Danazol is a synthetic androgen, a derivative of ethisterone. It suppresses the pituitary-ovarian axis by inhibiting the output of pituitary gonadotropins (FSH and LH), leading to anovulation and amenorrhea. It also binds to androgen, progesterone, and glucocorticoid receptors, and inhibits several enzymes involved in steroidogenesis, including cytochrome P450 enzymes. Its effects on hereditary angioedema are thought to be due to increased synthesis of C1 esterase inhibitor.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 20-80%)
Tmax:
2-8 hours (dose-dependent)
FoodEffect:
Food can increase absorption and bioavailability.
Distribution:
Vd:
Not precisely quantified, but widely distributed.
ProteinBinding:
>90% (primarily to albumin, some to sex hormone-binding globulin)
CnssPenetration:
Limited (lipophilic, but clinical significance of CNS penetration is not well-defined)
Elimination:
HalfLife:
4.5 hours (initial), 24 hours (terminal, after multiple doses)
Clearance:
Not precisely quantified
ExcretionRoute:
Primarily urine (metabolites), some feces
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Weeks to months for therapeutic effect (e.g., reduction in endometriosis lesions, prevention of angioedema attacks)
PeakEffect:
Varies by indication, typically after several weeks to months of continuous therapy.
DurationOfAction:
Effects persist for some time after discontinuation, especially hormonal suppression.
Safety & Warnings
BLACK BOX WARNING
Thrombotic events, including stroke and thrombosis of other sites, have been reported. Peliosis hepatis and benign hepatic adenoma have been reported, sometimes fatal. Pseudotumor cerebri (benign intracranial hypertension) has been reported. Danazol is contraindicated in pregnancy due to the risk of virilization of a female fetus.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 attention immediately:
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:
- Swelling
- Weight gain
- Trouble breathing
Common Side Effects
Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following common side effects and they bother you or do not go away, contact your doctor:
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 attention immediately:
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:
- Swelling
- Weight gain
- Trouble breathing
Common Side Effects
Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following common side effects and they bother you or do not go away, contact your doctor:
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
- Pale stools
- Persistent nausea or vomiting
- Severe abdominal pain
- Unusual tiredness or weakness
- Sudden chest pain or shortness of breath
- Sudden severe headache with vision changes
- Swelling or pain in one leg
- Deepening of voice
- Increased facial or body hair (hirsutism)
- Acne
- Enlargement of the clitoris
- Significant weight gain or swelling (fluid retention)
- Mood changes, depression
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. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ 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. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ 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 closely monitor your blood sugar levels 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 may experience changes in their menstrual cycle while taking this medication, 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 closely monitor your blood sugar levels 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 may experience changes in their menstrual cycle while taking this medication, 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:
- No specific symptoms of acute overdose are well-documented, but may include exacerbation of known side effects such as virilization, fluid retention, or liver enzyme elevations.
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
Contraindicated Interactions
- Warfarin (increased anticoagulant effect, major bleeding risk)
- Simvastatin (increased risk of rhabdomyolysis, other statins also high risk)
- Porphyria-inducing drugs (may exacerbate porphyria)
Major Interactions
- Cyclosporine (increased cyclosporine levels, nephrotoxicity)
- Tacrolimus (increased tacrolimus levels, nephrotoxicity)
- Carbamazepine (increased carbamazepine levels, toxicity)
- Phenobarbital (increased phenobarbital levels)
- Phenytoin (increased phenytoin levels)
- Oral Hypoglycemics/Insulin (may alter glucose tolerance, requiring dose adjustment)
- Corticosteroids (may increase corticosteroid levels)
- Alpha-blockers (e.g., prazosin, may increase hypotensive effect)
- Antihypertensives (may reduce efficacy)
- Lithium (increased lithium levels, toxicity)
Moderate Interactions
- Oral Contraceptives (danazol reduces efficacy of hormonal contraceptives; use non-hormonal methods)
- Other hepatotoxic drugs (additive liver toxicity risk)
- Drugs metabolized by CYP3A4 (potential for altered metabolism)
Minor Interactions
- Not specifically identified as minor, most interactions are significant.
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: Danazol is contraindicated in pregnancy.
Timing: Before initiation of therapy.
Liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
Rationale: Risk of hepatotoxicity, including peliosis hepatis and hepatic adenoma.
Timing: Before initiation of therapy.
Lipid profile (total cholesterol, LDL, HDL, triglycerides)
Rationale: Danazol can cause adverse changes in lipid parameters.
Timing: Before initiation of therapy.
Blood pressure
Rationale: Risk of hypertension.
Timing: Before initiation of therapy.
Complete Blood Count (CBC)
Rationale: Rare reports of hematologic abnormalities.
Timing: Before initiation of therapy.
Routine Monitoring
Liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
Frequency: Monthly for the first 3-6 months, then every 3-6 months or as clinically indicated.
Target: Within normal limits or stable.
Action Threshold: Significant elevation (e.g., >3x ULN) requires dose reduction or discontinuation.
Lipid profile
Frequency: Every 3-6 months or as clinically indicated.
Target: Maintain within acceptable cardiovascular risk profile.
Action Threshold: Significant adverse changes may require intervention or discontinuation.
Blood pressure
Frequency: Regularly (e.g., monthly or every few months).
Target: Within normal limits.
Action Threshold: Sustained hypertension requires management.
Clinical assessment for virilization (e.g., hirsutism, voice changes, clitoral enlargement)
Frequency: Regularly (e.g., monthly).
Target: Absence or minimal progression.
Action Threshold: Significant or bothersome virilization may require dose reduction or discontinuation.
Symptom Monitoring
- Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
- Signs of virilization (e.g., deepening voice, hirsutism, acne, clitoral enlargement)
- Signs of thrombotic events (e.g., chest pain, shortness of breath, sudden severe headache, vision changes, leg pain/swelling)
- Signs of pseudotumor cerebri (e.g., headache, visual disturbances, papilledema)
- Signs of fluid retention (e.g., swelling of ankles/feet, weight gain)
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated. Danazol is a Category X drug due to the risk of virilization of a female fetus, including clitoral hypertrophy, labial fusion, and urogenital sinus abnormalities. 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. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
High risk (virilization, other hormonal effects).
Pediatric Use
Generally not recommended due to potential for premature epiphyseal closure and virilization. Limited use in adolescents for hereditary angioedema, but benefits must outweigh significant risks. Growth and development should be closely monitored.
Geriatric Use
Use with caution. Elderly patients may be more susceptible to adverse effects, particularly cardiovascular and hepatic effects. Dosage adjustments may be necessary based on individual tolerance and comorbidities.
Clinical Information
Clinical Pearls
- Danazol is a potent synthetic androgen with significant side effects; it is generally reserved for patients who have failed or cannot tolerate other therapies.
- Due to its teratogenic potential, strict adherence to non-hormonal contraception is crucial for all female patients of childbearing potential.
- Close monitoring of liver function tests, lipid profiles, and blood pressure is essential throughout therapy.
- Patients should be educated on the signs of virilization and advised to report them promptly, as some changes (e.g., voice deepening) may be irreversible.
- Consider the risk of thrombotic events, especially in patients with pre-existing risk factors.
- For hereditary angioedema, the goal is to find the lowest effective dose to prevent attacks while minimizing side effects.
Alternative Therapies
- For Endometriosis: GnRH agonists (e.g., leuprolide, goserelin), progestins (e.g., medroxyprogesterone, norethindrone), oral contraceptives, aromatase inhibitors (e.g., anastrozole, letrozole), NSAIDs, surgery.
- For Fibrocystic Breast Disease: NSAIDs, dietary changes, supportive bras, tamoxifen (off-label).
- For Hereditary Angioedema: C1 esterase inhibitor (C1-INH) concentrate (e.g., Cinryze, Berinert, Haegarda), kallikrein inhibitors (e.g., ecallantide, lanadelumab), attenuated androgens (e.g., stanozolol, methyltestosterone - less common now).
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 capsules (200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often preferred)
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 this 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 occurred.