Danazol 100mg 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; Androgen
Pharmacologic Class
Synthetic Androgen; Attenuated Androgen
Pregnancy Category
Category X
FDA Approved
Jul 1976
DEA Schedule
Not Controlled
Overview
What is this medicine?
Danazol is a medication that works by affecting certain hormones in your body. It's used to treat conditions like endometriosis (where tissue similar to the lining of the womb grows outside it), fibrocystic breast disease (lumpy, painful breasts), and hereditary angioedema (a rare condition causing swelling attacks). It helps reduce symptoms by lowering levels of hormones that cause these conditions.
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 doctor 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 doctor 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 (e.g., condoms, diaphragm with spermicide) during treatment and for at least 3 months after stopping, as Danazol can cause birth defects.
- Report any signs of pregnancy immediately.
- Attend all scheduled doctor appointments and laboratory tests (blood tests for liver function, cholesterol, etc.).
- Report any unusual symptoms, especially yellowing of skin/eyes, dark urine, severe headache, vision changes, or pain/swelling in legs.
- Limit alcohol intake, as Danazol can affect the liver.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For endometriosis: 200-800 mg/day in 2-4 divided doses. For fibrocystic breast disease: 100-400 mg/day in 2 divided doses. For hereditary angioedema: Initial 200 mg 2-3 times/day, then titrate to minimum effective dose.
Dose Range:
100 - 800 mg
Condition-Specific Dosing:
endometriosis:
200-800 mg/day in 2-4 divided doses for 3-9 months.
fibrocystic_breast_disease:
100-400 mg/day in 2 divided doses for 3-6 months.
hereditary_angioedema:
Initial 200 mg 2-3 times/day; maintenance dose individualized to prevent attacks, typically 200 mg/day or every other day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (limited use in precocious puberty, but generally not recommended due to androgenic effects)
Adolescent:
Not established (limited use in precocious puberty, but generally not recommended due to androgenic effects)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution.
Dialysis:
Not available; use with caution.
Hepatic Impairment:
Mild:
Contraindicated in patients with markedly impaired hepatic function.
Moderate:
Contraindicated in patients with markedly impaired hepatic function.
Severe:
Contraindicated in patients with markedly impaired hepatic function.
Pharmacology
Mechanism of Action
Danazol is a synthetic androgen, an attenuated androgen, that suppresses the pituitary-ovarian axis by inhibiting the output of pituitary gonadotropins (FSH and LH). It also binds to androgen, progesterone, and glucocorticoid receptors, and inhibits several enzymes involved in steroidogenesis. This leads to an anovulatory and amenorrheic state in women, and reduces the frequency and severity of attacks in hereditary angioedema by increasing C1 esterase inhibitor levels.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 20-80%)
Tmax:
2-4 hours
FoodEffect:
Food can increase absorption, particularly fatty meals.
Distribution:
Vd:
Not available
ProteinBinding:
Approximately 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 urine (as metabolites), some fecal
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
Weeks to months (for clinical effect)
PeakEffect:
Not precisely defined, depends on clinical outcome
DurationOfAction:
Effects persist for some time after discontinuation, depending on duration of therapy.
Safety & Warnings
BLACK BOX WARNING
Thrombotic Events: Serious thromboembolic events, including stroke, deep vein thrombosis, and pulmonary embolism, have been reported. Hepatic Effects: Peliosis hepatis and benign hepatic adenomas have been reported, sometimes fatal. Intracranial Hypertension (Pseudotumor Cerebri): Has been reported. Birth Defects: Danazol is contraindicated in pregnancy due to the risk of virilization of a female fetus.
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention 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, such as:
+ 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
Other Possible Side Effects
Like all medications, this drug can cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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
+ Changes in menstrual period
Reporting Side Effects
If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention 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, such as:
+ 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
Other Possible Side Effects
Like all medications, this drug can cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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
+ Changes in menstrual period
Reporting Side Effects
If you have questions or concerns about side effects, consult 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
- Unusual tiredness or weakness
- Severe headache, especially with vision changes (blurred vision, double vision, blind spots)
- Swelling, pain, or tenderness in one leg
- Sudden chest pain or shortness of breath
- Sudden numbness or weakness on one side of the body
- Changes in voice (deepening), increased hair growth (hirsutism), acne, or oily skin
- Significant weight gain or swelling in ankles/feet
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 symptoms you experienced.
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 symptoms you experienced.
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 inform 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 inform 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., severe acne, hirsutism, voice changes)
- 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
Contraindicated Interactions
- Warfarin (potentiates anticoagulant effect, leading to increased bleeding risk)
- Statins (e.g., simvastatin, lovastatin - increased risk of myopathy/rhabdomyolysis)
- Cyclosporine (increases cyclosporine levels, leading to nephrotoxicity)
- Tacrolimus (increases tacrolimus levels)
- Alpha-glucosidase inhibitors (e.g., acarbose - may alter glucose tolerance)
Major Interactions
- Insulin and oral antidiabetic agents (may alter glucose tolerance, requiring dose adjustment)
- Corticosteroids (may increase corticosteroid levels)
- Lithium (may increase lithium levels)
- Antihypertensives (may increase blood pressure)
Moderate Interactions
- Carbamazepine (may increase carbamazepine levels)
- Phenytoin (may increase phenytoin levels)
- Oral contraceptives (may reduce efficacy of oral contraceptives; use non-hormonal contraception)
Minor Interactions
- Not specifically documented for minor interactions, but caution with any drug metabolized by CYP3A4.
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: Danazol can cause hepatic dysfunction, including peliosis hepatis and hepatic adenomas.
Timing: Prior to initiation
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Rationale: Danazol can alter lipid metabolism, decreasing HDL and increasing LDL.
Timing: Prior to initiation
Blood pressure
Rationale: Danazol can cause fluid retention and hypertension.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: Rarely, hematologic abnormalities have been reported.
Timing: Prior to initiation
Pregnancy test
Rationale: Danazol is teratogenic and contraindicated in pregnancy.
Timing: Prior to initiation (for women of childbearing potential)
Routine Monitoring
Liver function tests (ALT, AST, bilirubin)
Frequency: Monthly for the first 3-6 months, then every 3-6 months or as clinically indicated.
Target: Within normal limits
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 discontinuation or lipid-lowering therapy.
Blood pressure
Frequency: Regularly (e.g., monthly or at each visit).
Target: <130/80 mmHg (or patient-specific target)
Action Threshold: Sustained hypertension requires management or discontinuation.
Weight and fluid status
Frequency: At each visit.
Target: Stable
Action Threshold: Significant weight gain or edema may indicate fluid retention.
Pregnancy test
Frequency: Monthly or every 4-6 weeks for women of childbearing potential.
Target: Negative
Action Threshold: Positive test requires immediate discontinuation.
Symptom Monitoring
- Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
- Signs of androgenic effects (e.g., hirsutism, voice deepening, acne, oily skin, clitoral hypertrophy)
- Signs of fluid retention (e.g., edema, weight gain, shortness of breath)
- Signs of thrombotic events (e.g., chest pain, shortness of breath, leg pain/swelling, sudden severe headache, vision changes)
- Signs of intracranial hypertension/pseudotumor cerebri (e.g., headache, visual disturbances, papilledema)
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated. Danazol is a Category X drug due to the risk of virilization of a female fetus (e.g., clitoral hypertrophy, labial fusion, urogenital sinus abnormalities). Effective non-hormonal contraception must be used during treatment and for 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 androgenic effects. Breastfeeding should be discontinued during treatment.
Infant Risk:
High (androgenic effects, potential for liver toxicity)
Pediatric Use
Generally not recommended due to potential for irreversible androgenic effects (e.g., voice deepening, clitoral enlargement, premature epiphyseal closure). Limited use in specific conditions like precocious puberty, but risks often outweigh benefits.
Geriatric Use
Use with caution. Elderly patients may be more susceptible to adverse effects, particularly cardiovascular and hepatic effects. Monitor closely for fluid retention, hypertension, and liver function.
Clinical Information
Clinical Pearls
- Danazol is a potent synthetic androgen with significant side effects, particularly virilization in women and potential for serious hepatic and thrombotic events.
- Strictly contraindicated in pregnancy; ensure effective non-hormonal contraception is used.
- Regular monitoring of liver function, lipid profile, and blood pressure is crucial.
- Consider alternative therapies with more favorable safety profiles before initiating danazol, especially for long-term use.
- Patients should be educated on the signs and symptoms of serious adverse events (e.g., liver toxicity, DVT/PE, intracranial hypertension) and instructed to seek immediate medical attention if they occur.
- Dose titration is important, especially for hereditary angioedema, to find the minimum effective dose.
Alternative Therapies
- For Endometriosis: GnRH agonists (e.g., leuprolide, goserelin), progestins (e.g., medroxyprogesterone, norethindrone), oral contraceptives, aromatase inhibitors (off-label), NSAIDs, surgery.
- For Fibrocystic Breast Disease: NSAIDs, hormonal therapies (e.g., tamoxifen, bromocriptine - less common), dietary modifications.
- For Hereditary Angioedema: C1 esterase inhibitor concentrate (human), icatibant, ecallantide, lanadelumab, berotralstat, attenuated androgens (e.g., stanozolol, oxandrolone - less common due to side effects).
Cost & Coverage
Average Cost:
Varies, typically $100-$400 per 30 capsules (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.