Danasin

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Danasin

Property Description
Active ingredient Danazol
Form Oral Capsule
Pharmacological class Antigonadotropin, Synthetic Steroid
General purpose Hormonal modulation / Suppression of cyclical activity
Origin Synthetic steroid derivative (modified testosterone)

Danasin is a prescription-only medication primarily categorized as an antigonadotropin, containing the sole active substance Danazol. The compound is scientifically defined as a synthetic steroid derivative, which originates from a modified testosterone backbone, differentiating it from non-steroidal hormonal agents. This classification as an antigonadotropin establishes its distinct role in endocrine regulation. The compound suppresses the pituitary's hormonal output, acting as a tool for reducing the body's overall hormonal activity.

Composition and Physical Form of Danasin

The pharmaceutical product Danasin delivers the therapeutic effect of Danazol as a single-component product housed within an oral capsule. The solid dosage form is designed for systemic action, ensuring the active ingredient is absorbed via the oral route of administration. Unlike other hormonal preparations, Danasin's capsule form provides a consistent and regulated oral delivery method, containing the Danazol powder combined with necessary excipients.

General Purpose and Action of Danasin

The primary general purpose of Danasin is to act as a hormonal modulator by effectively suppressing the pituitary-ovarian axis. This systemic effect creates a temporary, low-estrogen environment to manage conditions characterized by the growth or activity of hormone-sensitive tissue. This action confirms that the drug works by changing the hormonal conditions that drive symptoms.

Regulatory References

  1. NIH StatPearls

What side effects are possible with Danasin?

Possible Side Effects and Safety Information

Danasin’s safety profile is characterized by common hormonal effects, as well as a range of serious, though less frequent, adverse reactions that have led to specific regulatory warnings.

Common and Expected Adverse Reactions

The most frequently reported side effects are generally related to the drug's hormonal (androgenic) properties and typically include:

  • Androgenic Effects: Weight gain, acne, seborrhea (oily skin/hair), mild hirsutism (unusual hair growth), and, rarely, hypertrophy of the clitoris.
  • Endocrine and Menstrual Changes: Irregular menstrual periods, spotting, or the absence of periods (amenorrhea). Other effects may include flushing, sweating, vaginal dryness, irritation, and a reduction in breast size.
  • Other Common Effects: Headache, nervousness, and emotional lability.

Serious and Clinically Significant Adverse Reactions

Official regulatory labeling includes warnings for several serious risks, including:

System-Organ Class Serious Adverse Reactions (Examples)
Hepatobiliary Serious hepatic toxicity, including cholestatic jaundice, peliosis hepatis (a rare condition involving blood-filled cysts in the liver), and hepatic adenoma.
Cardiovascular/Thrombotic Thromboembolism, thrombotic, and thrombophlebitic events, including strokes and blood clots (e.g., sagittal sinus thrombosis), which can be life-threatening.
Neurological Benign intracranial hypertension (pseudotumor cerebri), characterized by symptoms like severe headache, nausea, vomiting, or vision changes.

Safety Restrictions and Monitoring

Danasin is contraindicated in patients with markedly impaired hepatic, renal, or cardiac function; undiagnosed abnormal genital bleeding; active or history of thromboembolic disease; porphyria; pregnancy; and during breastfeeding. Long-term use requires specific safety monitoring.

  • Pregnancy Risk: Danasin is contraindicated in pregnancy due to the risk of androgenic effects on a female fetus, such as clitoral hypertrophy and labial fusion. A non-hormonal method of contraception must be used during therapy.
  • Monitoring: Regular clinical observation and laboratory tests are recommended to monitor for hepatic dysfunction, particularly with daily doses of 400 mg or more.

Overdose and Emergency Response

The official regulatory information states that Danasin overdose is generally not expected to produce life-threatening symptoms solely from acute ingestion. However, immediate medical attention is mandatory for any suspected overdose due to the potential for severe, documented complications.

Documented Manifestations and Required Actions

Emergency services (911) or the Poison Control helpline must be contacted immediately if the affected individual exhibits critical signs of distress. These life-threatening manifestations include collapse, seizure, trouble breathing, or inability to be awakened.

Overdose management must address the risks of severe systemic toxicity documented in official labeling, such as thromboembolic events (including stroke) and complications arising from Benign Intracranial Hypertension. This latter condition may present as persistent headache, nausea, vomiting, or visual disturbances.

Management and Monitoring

No specific antidote is known or officially documented for Danasin overdose; therefore, management is restricted to symptomatic and supportive treatment. For signs of increased intracranial pressure, immediate discontinuation of Danasin is required, as stated in FDA labeling. Patients must be referred to a neurologist for further care. The regulatory profile emphasizes that complications are generally managed through supportive observation and treatment of the resulting toxicity.

Therapeutic Uses of Danasin

What Danasin Treats: Main Uses and Benefits

Danasin (Danazol) is a targeted treatment used across distinct medical domains to manage specific symptom patterns, providing supportive therapeutic benefit where symptoms are significant or refractory. The medication is commonly applied in conditions characterized by periods of heightened symptoms, including endometriosis, Hereditary Angioedema (HAE), and symptomatic fibrocystic breast disease. It is relevant for easing symptoms related to physical discomfort and conditions where functional stability becomes affected.

Danasin plays a role in managing symptoms related to chronic pain and swelling attacks. It is utilized to help reduce the frequency and severity of sudden, debilitating swelling episodes in HAE, while also assisting with easing discomfort associated with chronic or cyclical pelvic pain related to endometriosis. It is also commonly used to manage severe breast pain, tenderness, and nodularity. This supports patients during difficult episodes by easing distress and assists with maintaining functional stability when symptoms interfere with routine activities.

“The treatment is applied in clinical settings that involve acute or unstable symptom patterns, offering symptomatic relief that helps patients cope more steadily with difficult episodes.”


Key Use: Symptom Support

Danasin is relevant in contexts marked by increased discomfort or tension, and supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Danasin?

Regulatory documentation defines strict criteria for the use of Danasin (Danazol), primarily through a series of absolute exclusions known as contraindications. Use is allowed only for individuals who do not meet any of these specified constraints.

Populations Excluded from Use (Contraindications)

The medicine must not be used by patients falling into the following official categories:

  • Reproductive Status: Women who are pregnant or are currently breastfeeding. Pregnancy must be ruled out immediately prior to starting treatment.
  • Organ Function: Individuals with markedly impaired or overt liver, kidney, or heart function.
  • Thromboembolic Disease: Patients with active or a history of blood clots or related thromboembolic disorders.
  • Specific Diseases: Individuals diagnosed with Porphyria, or any cancer that is known to be androgen-dependent.
  • Physical Signs/Allergy: Patients experiencing undiagnosed abnormal genital bleeding or known hypersensitivity (allergy) to the drug.

Age-Related Constraints

The safety and effectiveness of Danasin have not been established in children. Therefore, use in pediatric populations is not generally recommended based on the lack of official data. Official eligibility statements emphasize that treatment must be restricted to patients confirmed to be free of all listed exclusionary conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction profile of Danasin, based strictly on government regulatory information.


Formal Contraindications and Restrictions

Certain combinations are formally prohibited for co-administration due to the heightened risk of serious adverse events. These include:

  • Simvastatin: Co-administration is contraindicated due to increased risk of muscle toxicity ( rhabdomyolysis).
  • Pimozide, Cisapride, and Ranolazine: Use is restricted (prohibited) with Danasin.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Danasin is officially documented as an inhibitor of the CYP3A4 enzyme, which can significantly alter the exposure of co-administered medicines, requiring dose adjustment or close monitoring.

Interacting Substance/Class Official Interaction Effect Implication Status
Cyclosporine, Tacrolimus Increased plasma levels Requires close monitoring
Oral Anticoagulants (e.g., Warfarin) Potentiation of effect (prolonged prothrombin time) Requires monitoring/adjustment
Antihypertensive Agents Potential opposition of blood pressure lowering effect Requires caution
Antidiabetic Drugs Potential for insulin resistance Requires caution

Non-Medicinal and Procedural Interactions

Subjective intolerance (including nausea and shortness of breath) has been reported in regulatory documents when Danasin is used with alcohol. Additionally, Danasin treatment may interfere with specific laboratory determinations of endogenous androgens.

Mechanism of Action

Danasin, which is Danazol, is a synthetic steroid derivative with a pleiotropic mechanism of action, functioning as a selective receptor modulator with varied affinity for sex hormone receptors. It acts as an agonist at the androgen receptor (AR) and the glucocorticoid receptor (GR). It displays mixed agonist/antagonist activity at the progesterone receptor (PR), categorized as a selective progesterone receptor modulator. Concurrently, Danasin acts as a non-competitive inhibitor of several steroidogenic enzymes, including 3beta-hydroxysteroid dehydrogenase/Delta5-4 isomerase, 17alpha-hydroxylase, and 17,20-lyase, primarily in the ovaries and testes. This direct enzymatic inhibition modulates the steroidogenesis pathway, leading to reduced systemic biosynthesis and concentrations of estradiol and progesterone. Furthermore, Danasin binds to sex hormone-binding globulin (SHBG) and corticosteroid-binding globulin (CBG), displacing endogenous sex steroids and thereby altering the ratio of free to bound hormones. Systemically, the combined suppression of pituitary gonadotropin release, direct gonadal inhibition of steroidogenesis, and modulation of sex hormone receptor and binding protein activity result in a pronounced hypoestrogenic and mildly androgenic endocrine state.

Dosage and Administration Information

How to Use Danasin (Danazol) — Administration Guidelines

This section outlines the use instructions for Danasin (Danazol).

Danasin must be taken orally as an intact capsule. Available capsule strengths are 50 mg, 100 mg, and 200 mg.

Administration and Timing Protocol

Parameter Instruction
Route of Administration Oral only (swallowed).
Timing Relative to Meals Must be taken with a meal to significantly enhance the absorption of the drug.
Dosing Frequency The total daily dose must be divided and administered in two or three separate doses per day (e.g., twice daily or three times daily).
Missed Dose If a dose is missed, take it as soon as possible unless it is almost time for the next scheduled dose. If so, skip the missed dose and resume the regular schedule. Do not double the dose.

Procedural and Population-Specific Conditions

Correct use requires adherence to specific protocols:

  1. Treatment Initiation: For women of child-bearing potential, therapy must be initiated during the menstrual period (preferably on the first day) to ensure the patient is not pregnant before treatment begins.
  2. Duration: The course of therapy for conditions like endometriosis is typically set for a fixed duration, often three to nine months.
  3. Pediatric Use: The safety and efficacy of Danasin are not established in the pediatric population and are generally not recommended for use in children.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Danasin

Evidence for use in Conditions Characterized by Fluctuating or Episodic Manifestations (Endometriosis)

Research exploring how symptoms change over time in patients with endometriosis primarily involves Randomized Controlled Trials (RCTs) and systematic reviews that compile results from multiple studies. Danasin was studied for women of reproductive age who had endometriosis confirmed through surgery. The research examined outcomes related to physical discomfort, specifically measuring changes in reported pelvic pain. Studies also measured objective changes in the size and appearance of endometriotic lesions using surgical scoring systems.

Findings describe measurements of patient-reported pain severity during the defined treatment periods. Research describes measurements taken during the study period concerning lesion status, with some studies reporting the monitoring of lesion size and appearance. However, the consistency and magnitude of these reported changes were mixed across different early trials. Long-term effects are not fully established in the context of high-quality randomized evidence, as most core trials observed responses over defined intervals of 3 to 6 months.

Evidence for use in Conditions Associated with Acute or Disruptive Episodes (Hereditary Angioedema)

Danasin was evaluated in patients with Hereditary Angioedema (HAE), a condition characterized by fluctuating or episodic manifestations of severe swelling attacks. The research landscape here is composed mainly of long-term observational studies and cohort analyses. Data suggest patterns related to observed attack frequency compared to baseline. Long-term reports noted that studies monitored C4 and C1-Inhibitor functional levels over baseline in the studied populations.

A major scientific limitation is that comparative evidence is lacking in the form of modern, large-scale randomized trials against newer specific therapies. Furthermore, research examining patients in pediatric populations is not extensively documented, underscoring that data for certain groups remain insufficient and subgroup findings are uncertain.

What is Still Uncertain About Danasin's Research

Scientific reviews point out several research gaps. Evidence quality varies across studies, particularly for older indications where key trials may lack modern methodological standards. The relatively modest sample sizes in many studies mean research does not determine whether an individual will respond similarly, as findings describe group patterns, not personal outcomes. Limited information is available for older adults or individuals with specific comorbidities.

Key Studies & References

  1. Hereditary Angioedema: A Current State of the Art Review
  2. Management of mastalgia in women with fibrocystic breast disease
  3. Danazol for symptomatic fibrocystic breast disease (NIH StatPearls)

Frequently Asked Questions (FAQ)

Common questions about Danasin (FAQ)

Q: Can Danasin be used long-term?

Official guidance for conditions like endometriosis typically suggests a course of treatment lasting 3 to 9 months. Regulatory documents indicate that experience with therapy extending beyond this duration is limited. The risk of potential liver issues is noted in official warnings regarding prolonged use of the medicine.


Q: Do children or teenagers use Danasin?

Official product information states that the safety and effectiveness of Danasin are not established in the pediatric population. For this reason, the use of this medication is generally not recommended for children or teenagers.


Q: Is it normal to feel tired after starting Danasin?

Yes, official side effect descriptions have included unusual tiredness or weakness among the reported effects. This is noted as a less common or rare occurrence, according to clinical data.


Q: How long does it typically take before Danasin starts working?

The time it takes for effects to be noticed can vary by the condition being treated. For patients using Danasin for fibrocystic breast disease, improvement in breast tenderness and pain is often reported during the first month of treatment. For conditions like endometriosis, efficacy is evaluated over several months.


Q: What are the most commonly reported side effects of Danasin?

According to the official product information, common adverse effects reported include weight gain, acne, fluid retention, flushing, and mood changes or nervousness. Changes to the menstrual cycle, such as irregular or absent periods, are also frequently reported.


Q: What is the difference between Danasin and its generic version?

The active pharmaceutical ingredient in the brand-name product Danasin is danazol. The generic version contains the exact same active drug substance and is subject to the same regulatory standards as the brand product.


Q: Will using Danasin cause weight gain or loss?

Official drug information lists weight gain among the common side effects reported by users. There is no comparable finding for weight loss listed as a common effect.


Q: Can Danasin affect sleep patterns?

Official documentation includes reports of sleep disorders among the psychiatric adverse events associated with this medication. The frequency of such effects is not specified in all product summaries.


Q: What happens if I stop using Danasin suddenly?

Official information describes that the cessation of the medication should be determined in consultation with a healthcare provider. After treatment cessation, menstrual periods typically return to a regular schedule within 60 to 90 days.


Q: Are there any restrictions on driving or operating machinery while taking Danasin?

Regulatory documents note that the occurrence of symptoms such as dizziness, blurred vision, or severe headache is a signal to stop the medication and promptly consult a healthcare provider. Since such effects may impair a person’s coordination or vision, caution is advised when driving or operating heavy machinery.


Q: Is Danasin an opioid or controlled substance?

Danasin (danazol) is not classified as an opioid drug. It is also not listed as a federally controlled substance in the United States.


Q: Why do some people say Danasin causes headaches?

Headaches are listed in official product information as a commonly reported side effect. Clinical trials indicate this side effect occurred in 1% to 10% of users.


Q: Does Danasin need to be refrigerated or stored specially?

Danasin capsules should be stored at a controlled room temperature, typically between 20 °C and 25 °C. The medication must be kept in a dry place and protected from light, and official storage instructions indicate the medicine should not be kept in an area like a bathroom.


Q: How can I tell if Danasin is working for me?

For conditions like endometriosis, the main therapeutic goal is to achieve an amenorrheic state, meaning the absence of menstruation. For fibrocystic breast disease, a reduction in breast pain and nodularity is considered a sign of efficacy.


Q: Can Danasin cause stomach upset or nausea?

Yes, official product information describes nausea and vomiting among the common gastrointestinal side effects. These effects were reported by users during clinical trials.


Q: What is the risk of a serious allergic reaction to Danasin?

Official warnings include the potential for a serious allergic reaction. Signs of a severe reaction may include hives, skin rash, or swelling of the face, lips, tongue, or throat. The presence of these signs is noted in official warnings as requiring prompt consultation with a healthcare provider.


Q: Is Danasin known to interact with birth control pills?

Yes, official warnings note that Danasin may decrease the effectiveness of hormonal contraceptives, such as birth control pills. Official documents describe the use of a non-hormonal form of birth control during treatment.


Q: Is Danasin safe to use if I have high blood pressure?

High blood pressure, or hypertension, is a medical condition that requires caution when using this drug. Official information indicates that blood pressure elevation is a reported cardiovascular side effect of the medicine.


Q: What happens if I accidentally take Danasin twice in one day?

The official instructions warn specifically against doubling a dose. Symptoms such as severe headache, nausea, vomiting, or vision changes are listed as signs of potentially increased pressure around the brain. The symptoms described are noted as requiring prompt consultation with a healthcare provider.


Q: What are the common reasons why a doctor would stop prescribing Danasin?

Regulatory documents advise immediate cessation if a patient experiences severe symptoms indicative of serious adverse events. These can include symptoms of blood clots (such as stroke or deep vein thrombosis), signs of liver injury (like jaundice or dark urine), or increased pressure around the brain.


Q: Does Danasin contain lactose or gluten?

The composition of inactive ingredients (excipients) can vary by manufacturer and specific product. The official regulatory information advises that a patient’s pharmacist can provide the complete list of ingredients contained in the specific Danasin product being dispensed.


Q: Is there a maximum time someone is allowed to take Danasin according to official sources?

For approved indications like endometriosis, the typical maximum official course of therapy is nine months. Regulatory documents indicate that extended administration has been associated with specific risks like liver damage.


Q: What are the known long-term side effects that official documents describe?

Serious long-term risks mentioned in official warnings include the potential for specific types of liver damage. Additionally, some androgenic side effects, such as changes to the voice, may be permanent and irreversible even after stopping the medication.


Q: Can men and women use Danasin equally, or is it different?

Danasin is approved for use in both sexes for different conditions; for example, in men for hereditary angioedema and in women for endometriosis. However, the official instructions include specific protocols for women of child-bearing potential, such as initiating treatment during the menstrual period.


Q: Why is Danasin only available by prescription?

Danasin is available only by prescription due to the need for continuous medical supervision. This status is related to the need for monitoring the potential risk of serious adverse effects, such as liver damage and blood clots, through procedures like blood tests.


Q: What is the potential impact of Danasin on fertility?

Regulatory documents state that Danasin may damage fertility or the unborn child. Its mechanism of action suppresses the hormones necessary for ovulation, resulting in an anovulatory (non-ovulating) state during the course of treatment.


Q: What is the main therapeutic goal when using Danasin?

The main therapeutic goal for Danasin is to manage symptoms related to its approved indications. This includes managing endometriosis by creating a hypoestrogenic state and achieving amenorrhea, or preventing acute episodes in hereditary angioedema.


Q: Can Danasin affect mood?

Yes, official side effect descriptions include reports of mood changes, nervousness, irritability, emotional lability, and depression. These are categorized as psychiatric adverse events in the product information.

How should Danasin be stored and disposed of?

How to Store and Dispose of Danasin?

  • Storage: Store Danasin in its original container at room temperature, away from excessive heat and moisture, unless otherwise specified on the packaging or by a healthcare professional. Keep the medication container tightly closed and out of the sight and reach of children and pets to prevent accidental ingestion or misuse.
  • Disposal: Do not flush Danasin down a toilet or pour it down a drain unless the product labeling specifically instructs you to do so. The most preferred method for disposing of unused or expired medication is through a local drug take-back program. The U.S. Drug Enforcement Administration (DEA) and local community programs often sponsor these collection events. If a take-back program is not available, you may discard the medicine in your household trash by mixing it with an unappealing substance, such as used coffee grounds or cat litter, placing the mixture in a sealed bag or container, and throwing it away. Ensure you scratch out all personal information on the prescription label before disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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