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Benzol (Danazol)

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Medically reviewed

Laura Arias

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.

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Overview of Benzol (Danazol)

Property Description
Active ingredient Danazol
Form Capsule (Orally Active)
Pharmacological class Synthetic Steroid Hormone, Antigonadotropin
General Purpose Creates a low-estrogen, pseudo-menopausal environment
Origin Synthetic derivative of 17alpha-ethinyltestosterone

Benzol (Danazol): Identity and Pharmacological Classification

Benzol is the trade name for the medicine containing the active ingredient Danazol, which is classified as a synthetic steroid hormone and a pituitary gonadotropin inhibitor. Danazol is structurally a heterocyclic steroid derived from 17alpha-ethinyltestosterone, establishing its synthetic origin and chemically linking it to the androgen class, although its androgenic effects are attenuated. The classification as an antigonadotropin confirms the molecule's principal action is to interfere with the signaling of hormones, setting it apart from other synthetic steroids like progestins or corticosteroids.

Composition, Form, and General Therapeutic Role

Danazol is a single-ingredient product supplied as an orally active capsule designed for systemic absorption via the gastrointestinal tract. The high-level objective of Danazol's presence in the body is to suppress the production of reproductive hormones, specifically Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH). By significantly reducing circulating estrogen levels through this inhibition of ovarian steroidogenesis, the medication induces a controlled low-estrogen environment, frequently described as a pseudo-menopausal state. This action serves the general therapeutic role of inhibiting the function and growth of tissues that are sensitive to and stimulated by estrogen, a mechanism that is clinically recognized for addressing conditions like Endometriosis where this suppression is required.

Regulatory References

  1. NIH StatPearls: Danazol
  2. MedlinePlus - NIH: Danazol
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What side effects are possible with Benzol (Danazol)?

Possible Side Effects and Safety Information

The safety profile of Benzol, which contains Danazol, is defined by officially documented adverse reactions and strict regulatory constraints. The most frequent side effects are related to the medicine's hormonal class, while serious risks are addressed in official warnings.


Documented Adverse Reactions

The majority of commonly reported adverse effects stem from the medication's androgenic activity and impact on the reproductive system.

System-Organ Class (SOC) Officially Listed Adverse Reactions
Hormone-Driven Effects Weight gain, acne, hirsutism (unusual hair growth), voice changes (deepening, potentially irreversible), and fluid retention (edema).
Reproductive System Amenorrhea (absence of periods), irregular menstrual periods, and decreased breast size.
Other Common Effects Headache, flushing, nausea, and changes in liver enzyme levels.

Serious Safety Warnings

Regulatory labeling highlights specific, less common but serious adverse events that require immediate attention.

  • Thromboembolism: The drug is associated with a risk of thrombotic events, including deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke.
  • Hepatic Toxicity: Severe liver issues are documented, including Peliosis Hepatis (blood-filled cysts) and Benign Hepatic Adenoma, particularly with long-term use.
  • Neurological Risk: Benign Intracranial Hypertension (Pseudotumor Cerebri) is listed as a serious adverse reaction.

Safety Restrictions and Contraindications

Danazol is contraindicated (should not be used) under specific conditions and for certain populations.

  • Populations: The medication is contraindicated during pregnancy and breast-feeding due to the risk of androgenic effects on the female fetus.
  • Pre-existing Conditions: It is strictly restricted in patients with markedly impaired hepatic, renal, or cardiac function, and in those with active thromboembolic disease.
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Overdose and Emergency Response

Acute overdosage of Danazol is generally not expected to cause immediate, life-threatening symptoms. However, any suspected overdose should be treated as a serious medical event due to the potential for severe effects associated with high levels of the drug or long-term complications.

When to Seek Immediate Medical Help

Contact emergency services or a poison control center immediately if an overdose is suspected or if you experience any of the following serious symptoms, as these may indicate significant or worsening adverse reactions related to Danazol, rather than a direct acute overdose effect:

  • Signs of Blood Clot: Sudden numbness or weakness, severe headache, problems with vision or speech, sudden chest pain, or swelling, warmth, or pain in an arm or leg.
  • Signs of Liver Problems: Yellowing of the skin or eyes (jaundice), persistent upper right abdominal pain, dark urine, or light-colored stools.
  • Signs of Increased Pressure Around the Brain (Pseudotumor Cerebri): Severe headache, nausea, vomiting, or sudden changes in vision.
  • Signs of Allergic Reaction: Rash, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Overdose Management

In the event of an overdose, management is primarily supportive. There is no specific antidote for Danazol. Healthcare providers may monitor vital signs, liver function, and manage any symptoms that arise. Do not induce vomiting unless instructed by a medical professional. Always provide the healthcare team with information about what was taken, how much, and when.

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Therapeutic Uses of Benzol (Danazol)

What Benzol (Danazol) Treats: Main Uses and Benefits

Benzol (Danazol) is commonly used across conditions presenting with episodic or fluctuating manifestations, applied across domains where additional symptomatic support is needed. The medication is relevant for easing challenging symptoms in multiple areas.

The medication is used in areas where short-term symptom management is appropriate, including in situations involving Endometriosis, Hereditary Angioedema (HAE), and Fibrocystic Breast Disease.

Targeting Symptom Clusters

The medication helps address symptom clusters that may become intense or disruptive, such as chronic pelvic pain, painful cramping menstruation (dysmenorrhea), and breast tenderness or nodularity. It is also applied in scenarios where additional management of discomfort is required, primarily to help manage symptoms associated with acute or episodic changes, such as swelling in HAE.

Symptomatic relief is relevant in contexts involving heightened systemic burden, as illustrated by the general therapeutic concept:

“The medication may be part of symptomatic management, supporting the patient during difficult episodes by easing distress.”

The medication helps ease the overall symptom load, which supports general well-being and assists with maintaining functional stability when symptoms are more noticeable.


Quick Fact: Relief for Hormone-Driven Pain Danazol is commonly used to help manage symptoms related to physical discomfort stemming from hormone-sensitive conditions, providing supportive relief when those symptoms interfere with routine activities.

Regulatory References

  1. NIH Medlineplus Drug Information
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Eligibility and Restrictions for Use

Who can and cannot use Benzol (Danazol)?

Official regulatory guidelines define specific populations for whom the use of Benzol (Danazol) is either allowed, restricted, or strictly contraindicated. Use is generally established for Adults with approved indications.

Contraindications and Restrictions

Danazol is contraindicated and must not be used in individuals with Markedly Impaired Hepatic, Renal, or Cardiac Function. Absolute contraindications also include patients with Active Thrombosis or Thromboembolic Disease, Porphyria, and those with an Androgen-Dependent Tumor or Undiagnosed Abnormal Genital Bleeding.

Pregnancy, Lactation, and Reproductive Status

Use is contraindicated during Pregnancy and Lactation. Women of childbearing potential must use effective non-hormonal contraception immediately prior to and throughout Danazol therapy, and pregnancy must be ruled out before treatment begins.

Age and Condition-Based Restrictions

Safety and efficacy have not been established for pediatric patients. Caution and careful observation are required for patients with pre-existing conditions that may be worsened by fluid retention, such as epilepsy, migraine, hypertension, or diabetes mellitus.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Danazol is defined by its potential to alter the exposure of other medicines and cause functional, pharmacodynamic effects, based on regulatory documentation.

Formal Contraindicated Combinations

Co-administration with Simvastatin is formally restricted. This combination is contraindicated because Danazol significantly increases the systemic exposure of Simvastatin, raising the risk of severe muscle toxicity, including myopathy and rhabdomyolysis.


Pharmacokinetic and Pharmacodynamic Interactions

Danazol is documented as an inhibitor of the Cytochrome P450 3A4 (CYP3A4) enzyme, which can elevate the plasma concentration of co-administered drugs that rely on this pathway for metabolism.

Interaction Type Interacting Agent Formal Outcome
Exposure-Altering Warfarin and other Coumarin Anticoagulants Potentiation of effect, resulting in prolonged prothrombin time.
Exposure-Altering Cyclosporin, Tacrolimus Elevated plasma levels, increasing the risk of renal toxicity.
Exposure-Altering Atorvastatin, Lovastatin Increased risk of myopathy and rhabdomyolysis due to elevated plasma levels.
Pharmacodynamic Antidiabetic Drugs Causes insulin resistance, leading to decreased therapeutic efficacy.
Pharmacodynamic Synthetic Vitamin D Analogs Increases the calcemic response to these agents.

No mandatory timing separation rules or explicit restrictions for co-administration with food, alcohol, or herbal products are documented in the official regulatory prescribing information.

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Mechanism of Action

Blocking Ovarian Hormone Production

Danazol acts on the ovaries as an inhibitor of key steroidogenic enzymes, including the P450scc and 3beta-hydroxysteroid dehydrogenase (3beta-HSD). This peripheral mechanism curtails the synthesis of estrogen and progesterone, directly resulting in a state of hypoestrogenism and tissue atrophy mediated by low hormone concentrations.


Suppression of the HPO Axis

Danazol's steroid-like structure enables it to act centrally to suppress the Hypothalamic-Pituitary-Ovarian (HPO) axis. This action reduces the pituitary release of the essential signals Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH). This central effect works alongside peripheral enzyme inhibition, resulting in anovulation and persistent ovarian quiescence.


Modulating Hormone Transport

The drug modulates hormone availability by acting on the liver to reduce the production of Sex Hormone Binding Globulin (SHBG). By decreasing this transport protein and displacing other hormones from it, Danazol causes an increase in the biologically active, free fraction of androgens (like testosterone), leading to changes in androgen-mediated tissue response.

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Dosage and Administration Information

Benzol is administered through the oral route as a capsule in 50 mg, 100 mg, and 200 mg strengths. The usage protocol dictates that the total daily dose, which ranges from 100 mg to 800 mg depending on the condition, is generally administered in two equally divided portions (BID).

Administration Rules

Instruction Type Requirement
Initiation Timing Therapy must be initiated during menstruation or after appropriate tests confirm the patient is not pregnant.
Intake Condition The capsule must be ingested with a meal (specifically one containing > 30 grams of fat) to enhance bioavailability by three- to four-fold.
Course Duration Treatment for endometriosis is generally continuous and uninterrupted for a course of 3 to 9 months.
Dose Adjustment Following the initial course, a gradual downward titration of the dose is performed to establish the minimum effective amount needed for maintenance.
Missed Dose Rule If a dose is missed, the instruction is to skip the missed dose and resume the regular schedule if the next dose time is imminent; double doses are not to be taken.

Safety and efficacy in the pediatric population have not been established. The administration protocol is therefore structured around strict attention to dose division, meal-dependent timing, and adherence to the defined continuous course duration.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Benzol (Danazol)

Benzol (Danazol) was studied for use in several conditions characterized by fluctuating or episodic manifestations. The available research is largely based on clinical trials and observational studies that were used in research exploring how symptoms change over time in the observed patient populations. The information presented here highlights what has been observed so far but does not determine whether an individual will respond similarly.


Evidence for use in Endometriosis

Research was evaluated in women with endometriosis, examining patient-reported experiences of symptoms like pelvic pain and physical findings. The findings describe patterns observed in short-term studies, reporting measurements of patient-reported pain levels. While evidence contributes to understanding symptom patterns, studies described the presence of residual disease and symptom activity was observed in some studies after the observation period. Research exploring short-term changes does not determine the long-term status of the condition.


Evidence for use in Fibrocystic Breast Disease

Studies were observed in women with this condition, examining outcomes related to physical discomfort and physical examination findings. The research highlights changes measured during the study period, with data showing patterns related to measurements of reported physical discomfort in some participants. Certainty remains low for long-term management because follow-up durations were limited in these studies.


Evidence for use in Hereditary Angioedema (HAE)

Benzol (Danazol) was studied for use in HAE, a condition associated with acute episodes of swelling. The research, which includes long-term observational studies, monitored the frequency and severity of these episodic outcomes. Studies report how symptoms evolved in the observed populations, often describing measurements related to the number of acute episodes. Findings were mixed regarding complete elimination of all episodes, and research is ongoing.


Long-term Studies and Follow-up

Research explored outcomes over extended periods, particularly in the context of HAE. However, long-term effects are not fully established via controlled study designs across all indications, as follow-up durations were limited in many initial trials. What is available often describes group patterns, not personal outcomes, emphasizing the need for ongoing monitoring.


Evidence in Special Populations

The research base primarily reflects studies conducted in general adult populations. Consequently, data for certain groups remain insufficient. Few data are available for children, adolescents, or the elderly, and controlled study data is lacking for pregnancy-related populations. Subgroup findings are uncertain for those with significant comorbid conditions.


What is still uncertain about Benzol (Danazol)

Evidence is limited in several key areas. Comparative evidence is lacking for many long-term endpoints, meaning it is difficult to determine how the observed outcomes compare to other available interventions over many years. Sample sizes were modest in many initial trials, which limits the precision of the findings, and evidence quality varies across studies.

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Frequently Asked Questions (FAQ)

Common questions about Benzol (Danazol) (FAQ)


Q: How quickly does Benzol (Danazol) usually start to reduce symptoms?

Studies and official information indicate that for certain conditions, such as fibrocystic breast disease, patient-reported relief from symptoms is often described as beginning within the first month of continuous treatment. Symptom response patterns can vary among individuals and depend on the condition being addressed.


Q: What happens if a dose of Benzol (Danazol) is missed?

According to the official product information, if a dose is missed, regulatory instructions state to skip the missed dose if the time for the next scheduled dose is near. It is specifically directed that a double dose should not be taken to make up for the missed one.


Q: What kind of routine monitoring is needed while taking Benzol (Danazol)?

Regulatory documents recommend that individuals taking the medicine undergo periodic liver function tests. This is recommended due to the possibility of effects on the liver noted in official warnings.


Q: Can Danazol interact with common over-the-counter pain relievers?

The medicine is documented as an inhibitor of the CYP3A4 enzyme, which is responsible for metabolizing certain other drugs. This characteristic indicates the potential to affect the levels of some co-administered medicines, including common over-the-counter agents such as acetaminophen.


Q: How long does the drug stay in your system after the last pill?

Pharmacokinetic data from studies describe how the medicine is processed and eliminated by the body. The elimination half-life of the active ingredient is variable, with published values typically ranging from approximately 9.7 to 24 hours.


Q: Is it necessary to use a barrier method of birth control while on Benzol (Danazol)?

Official regulatory documents state that women of childbearing potential must use effective non-hormonal contraception throughout the entire course of therapy, as using the drug during pregnancy is strictly contraindicated. The selection of a specific non-hormonal method is based on individual health needs, as outlined by regulatory information.


Q: Does alcohol consumption affect how Benzol (Danazol) works?

Official regulatory prescribing information does not document explicit restrictions or mandatory timing separation rules for co-administration with alcohol.


Q: Are the side effects of Benzol (Danazol) reversible?

Official warnings indicate that some androgenic effects—side effects related to increased male hormones—may be irreversible. For instance, changes to the voice, such as deepening, may not be reversible even after the medication is discontinued.


Q: Are there known interactions between Danazol and herbal supplements?

Official regulatory prescribing information does not document explicit restrictions or mandatory timing separation rules for co-administration with herbal products.


Q: Is there a list of symptoms that require immediate medical attention while on Danazol?

Official warnings for rare but serious adverse events, such as thromboembolism (blood clots) and intracranial hypertension (pressure in the head), describe specific symptoms. These include a sudden, severe headache; visual changes; or a warm, swollen leg, which are described in official warnings as requiring attention.


Q: What does the research say about Danazol's use in younger patients?

Regulatory documents state that the safety and effectiveness have not been established for use in the pediatric population, which includes children and adolescents. The research base primarily reflects studies conducted in general adult populations.


Q: Are there different brand names for the same drug as Benzol (Danazol)?

Yes, the active ingredient, Danazol, has been marketed under various brand names over time. These include Danocrine and others, as reflected in drug regulatory databases.


Q: Does Benzol (Danazol) affect the results of blood tests?

Regulatory labeling states that treatment may interfere with laboratory determinations of certain specific hormones. This interference is noted for assays measuring hormones such as testosterone, androstenedione, and dehydroepiandrosterone.


Q: Is Benzol (Danazol) available in generic form?

Yes, the active ingredient Danazol is manufactured and available as a generic capsule (Danazol Capsules, USP).


Q: What is the process for stopping the use of Benzol (Danazol)?

Official administration rules indicate that following the initial treatment course, guidance includes a recommendation for a gradual downward titration of the dose. This process is intended to help establish the minimum effective amount needed for maintenance.


Q: Can men use Benzol (Danazol) for any medical conditions?

Yes, the official regulatory indications for the drug include use for the prevention of attacks of hereditary angioedema (HAE) in both males and females. The usage for other conditions is generally specific to female reproductive health.


Q: Is it safe to drive or operate machinery while taking Danazol?

Official warnings note the risk of a rare but serious adverse reaction called benign intracranial hypertension, which can cause visual disturbances. Due to the potential for impaired vision associated with this rare adverse reaction, individuals should be aware of the official warning before performing skilled tasks.


Q: Can Benzol (Danazol) be taken by individuals who have diabetes?

Official documents advise that caution is required for use in patients with diabetes mellitus. This is because the drug may cause insulin resistance, which could potentially decrease the therapeutic effectiveness of antidiabetic drugs.


Q: What does research indicate about recurrence of symptoms after stopping Benzol (Danazol)?

Research and official labeling note that the recurrence of symptoms has been observed after the treatment course is terminated. Due to this possibility, official information states that treatment can be reinstituted if symptoms return.

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How should Benzol (Danazol) be stored and disposed of?

How to Store and Dispose of Benzol (Danazol)?

Official regulatory guidelines define precise conditions for storing and discarding Danazol capsules to maintain product stability and safety. This medication must be stored at controlled room temperature, typically between 20 C and 25 C.

Required Storage Environment

  • Protection: Must be protected from light, moisture, and excess heat.
  • Container: Keep the medication in its original, tightly closed container.
  • Prohibited: Do not store Danazol in a bathroom and keep from freezing.

Child Safety and Disposal

For security, storage is required to be out of the sight and reach of children, often necessitating the use of locked safety caps.

Regarding disposal, it is strictly mandated to not flush unused or expired capsules down the toilet or discard them in household trash. Official instructions recommend utilizing a medicine take-back program or consulting a pharmacist for guidance on regulatory-compliant disposal methods.

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

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