Danazol 200

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Danazol 200

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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 Danazol 200

Quick Facts

Property Description
Active ingredient Danazol
Form Oral Capsule
Pharmacological class Gonadotropin Inhibitor, Synthetic Androgen
General purpose Modifies hormonal balance via estrogen reduction
Origin Synthetic Steroid (Ethinyltestosterone derivative)

What Type of Medication is Danazol 200?

Danazol 200 is a prescription-only medicine that provides the active ingredient Danazol in an oral capsule formulation. The compound Danazol is classified pharmacologically as a potent Gonadotropin Inhibitor and a weak Synthetic Androgen, positioning it within the group of endocrine agents. This classification is supported by pharmacological studies, which recognize its capacity to modify the hormonal cascade. Danazol is a synthetic steroid, specifically an Ethinyltestosterone derivative, and the product is defined as a fixed-composition, single-ingredient product (monotherapy).

Composition: Is Danazol 200 a Synthetic Hormone Agent?

Yes, the compound Danazol is a synthetic organic substance that is structurally derived from a modified testosterone precursor, confirming its non-natural origin. The chemical identity of Danazol is that of a synthetic steroid with antigonadotropic properties. As an oral formulation, the capsule form provides a convenient route for systemic delivery, with the active ingredient Danazol contained alongside standard, inert pharmaceutical excipients that act as the base carrier.

What is the General Therapeutic Purpose of Danazol?

The general therapeutic purpose of Danazol is to modulate the body’s hormonal environment by creating a state of controlled hormone suppression. This mechanism is clinically recognized for its effectiveness in decreasing the activity of the hypothalamic-pituitary-ovarian axis. The drug’s distinct action as an anti-gonadotropin, inhibiting the release of key stimulating hormones, results in the desired reduction of circulating estrogen levels, which is a therapeutic goal in managing certain hormone-sensitive conditions.

What side effects are possible with Danazol 200?

Possible Side Effects and Safety Information

Danazol's official safety profile is significantly shaped by its function as a synthetic androgen and gonadotropin inhibitor, which leads to a documented set of potential adverse reactions, categorized by frequency and the body system affected.

Common Adverse Reactions (documented in regulatory sources) frequently involve androgenic effects and endocrine system changes. These may include weight gain, acne, seborrhea (oily skin/hair), menstrual disturbances (such as amenorrhea or spotting), flushing, edema (fluid retention), and changes to the voice (hoarseness or deepening of pitch). Other common reactions affect the nervous system (e.g., headache, dizziness) and psychiatric disorders (e.g., anxiety, depression, emotional lability).


Serious Adverse Reactions and Safety Constraints

Regulatory documents list certain serious adverse reactions, which are typically classified as rare. These involve the vascular system, including thromboembolic events (such as arterial thrombosis or stroke), and the hepato-biliary system, including peliosis hepatis and benign hepatic adenoma. These severe hepatic events have been observed in association with long-term use of the medication.

The medication is subject to absolute restrictions for use. It is contraindicated in cases of pregnancy (due to the risk of fetal virilization), and in individuals with markedly impaired hepatic, renal, or cardiac function, or active thrombosis or a history of thromboembolic disease. Official prescribing information also notes that certain androgenic effects, such as changes to the voice, may be irreversible even after treatment is discontinued. Periodic monitoring of liver function tests is recommended throughout the course of treatment.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

The official regulatory profile for Danazol overdose describes critical signs that may indicate a severe event. These include sudden severe headache, blurred or blackened vision, paralysis or numbness, difficulty speaking, and the onset of seizure or collapse. Other critical manifestations include jaundice (yellowing of the skin or eyes) and acute abdominal pain, which may signal internal hemorrhage related to hepatic damage. Overdose risk is classified by the potential for life-threatening or fatal outcomes, specifically thromboembolism (blood clots) and stroke.

Emergency Actions Mandated by Regulators

Immediate medical help is required for any presentation of severe vascular events (e.g., sudden severe headache, vision problems, numbness) or severe internal signs (e.g., jaundice, abdominal pain).

Action Required:

  • Emergency services (911) must be called immediately if the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.
  • The Poison Control Helpline should be contacted.
  • If signs of benign intracranial hypertension are present, official labeling requires the immediate discontinuation of Danazol and referral to a neurologist for specialist monitoring.

Management Protocol:

  • No specific antidote is known for Danazol overdose.
  • Treatment is limited to providing symptomatic and supportive care.

Therapeutic Uses of Danazol 200

What Danazol Treats: Main Uses and Benefits

Danazol is commonly used to help with several conditions where systemic modulation of hormone-related activity is considered relevant.

The medication is used for managing significant chronic pain and discomfort associated with endometriosis and severe, symptomatic fibrocystic breast disease, addressing the underlying symptom drivers of these conditions. It helps alleviate debilitating symptoms like pelvic pain, painful periods (dysmenorrhea), and marked breast pain/tenderness (mastalgia). It also provides essential prophylactic support for the rare condition Hereditary Angioedema (HAE), and may be applied in addressing symptoms of certain chronic hematologic disorders like refractory Immune Thrombocytopenia (ITP) and anemia associated with Myelofibrosis.

This supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.

“This treatment is relevant in contexts marked by increased discomfort or tension, especially when symptoms are related to systemic imbalance.”


Quick Fact: Support for Symptom Management
Therapeutic Target Severe, chronic, hormone-related pain; excessive menstrual bleeding; recurrent systemic swelling.
Primary Benefit Provides support that helps ease the overall symptom burden and contributes to improved comfort during periods of heightened symptoms.
Clinical Scenarios Management of chronic gynecological conditions, prophylactic support for HAE, and management of symptoms in complex hematologic disorders.

Regulatory References

  1. NIH StatPearls Danazol Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Danazol 200: Official Regulatory Information

The eligibility profile for Danazol 200 is strictly defined by regulatory documents, focusing on absolute contraindications related to life stage, organ health, and certain medical conditions. Only adult patients receiving treatment for the labeled indications (such as Endometriosis or Hereditary Angioedema) are included in the approved population.


Absolute Contraindications

Danazol is contraindicated and must not be used by specific populations due to unacceptable risk, as mandated by regulatory authorities:

  • Pregnancy and Lactation: Prohibited in women who are pregnant (known or suspected) or who are breastfeeding. Non-hormonal contraception must be used during therapy.
  • Organ Function: Contraindicated in patients with markedly impaired hepatic, renal, or cardiac function.
  • Comorbidities: Prohibited for patients with an androgen-dependent tumor, Porphyria, active thrombosis, a history of thromboembolic events, or undiagnosed abnormal genital bleeding.

Use Limitations and Special Consideration

  • Age-Related Use: Safety and effectiveness are not established in pediatric patients. Clinical data is insufficient to determine safety and effectiveness in the geriatric population.
  • Restricted Use: Patients with conditions that may be aggravated by fluid retention, such as epilepsy or migraine, or general renal or cardiac dysfunction (not marked), require careful observation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Danazol, based strictly on government regulatory documents. The information focuses on drug–drug and drug–substance interaction risks and formal restrictions, without providing clinical advice or usage instructions.


Formally Documented Interaction Restrictions

Co-administration of Danazol with certain statins, such as simvastatin, is contraindicated according to official regulatory labeling. This restriction is due to an increased risk of severe muscle complications, including myopathy and rhabdomyolysis, caused by Danazol raising the plasma levels of the statin.


Pharmacokinetic and Pharmacodynamic Interactions

Danazol may increase the systemic exposure of several co-administered medicines through its effect on metabolic pathways. These include immunosuppressants like cyclosporin and tacrolimus, which can result in elevated plasma concentrations and a heightened risk of renal toxicity. Similarly, the levels of carbamazepine may also be increased.

In pharmacodynamic interactions, Danazol has been documented to prolong the Prothrombin Time (PT) when co-administered with oral anticoagulants (e.g., warfarin), thereby enhancing the anticoagulant effect. Additionally, Danazol may cause insulin resistance, requiring caution regarding the efficacy of antidiabetic drugs.

Official regulatory sources note that there are no known interactions with common food or drinks, and the interaction with alcohol is generally listed as unknown.

Mechanism of Action

Endocrine Suppression via Dual Target Mechanisms

Danazol's primary effect is the induction of a controlled hypoestrogenic state through a dual mechanism. It directly acts as a competitive inhibitor of key steroidogenic enzymes within the gonads (periphery), which physically blocks the synthesis of Estradiol and Progesterone. Simultaneously, it suppresses the pituitary's release of the LH and FSH mid-cycle surge (central action), reinforcing the overall reduction in ovarian hormone production. The resulting decrease in circulating estrogen leads to the atrophy of estrogen-dependent tissues.


Modulation of Free Hormone Availability and Androgenic Activity

A secondary but significant action involves Danazol's interaction with transport proteins. It competitively binds to Sex Hormone-Binding Globulin (SHBG), displacing endogenous steroids like testosterone. This displacement increases the ratio of unbound, biologically active androgens in the bloodstream, contributing to the drug's overall effect profile by increasing systemic androgenic activity.


Non-Hormonal Stabilization of the Complement System

Independently of its steroid hormone actions, Danazol also engages an immunomodulatory mechanism. It acts as an upregulator for the synthesis of the plasma protein C1 Esterase Inhibitor (C1EI). The resulting increase in C1EI levels stabilizes the complement and kallikrein-kinin inflammatory cascades, leading to modulation of the inflammatory responses in related systems.

Dosage and Administration Information

How to Use Danazol 200

The administration of Danazol is based on standardized protocols. The active ingredient is provided as an oral capsule (50 mg, 100 mg, and 200 mg strengths) and must be taken by mouth.


Official Dosing Regimens

The standard adult daily dose is generally administered in divided doses (BID), though some regimens may specify up to four times daily (QID). The dosage range is condition-dependent:

  • Endometriosis: Daily doses range from 200 to 800 mg. Treatment for mild disease typically starts at 200–400 mg per day, while severe disease regimens use 800 mg per day, given in two divided doses.
  • Fibrocystic Breast Disease: The typical daily dose is 100–400 mg.
  • Hereditary Angioedema (HAE): Initial daily doses are often 400–600 mg (e.g., 200 mg two or three times a day), followed by downward titration to the minimum effective maintenance dose.

Procedural and Time Constraints

The capsule must be taken with food, as it is recognized that this increases the absorption and overall systemic availability of the compound. For fertile patients, the treatment course is initiated during menstruation (preferably on the first day).

Treatment courses for endometriosis and fibrocystic breast disease are time-bound, typically lasting a continuous 3 to 9 months, while HAE requires gradual, long-term dose adjustment to maintain prophylaxis. If a scheduled dose is missed, it is standard practice that the dose be skipped if the next dose is due soon, and a double dose must not be taken.

Use is not established in the pediatric population, and the medicine is contraindicated in patients with markedly impaired hepatic or renal function.

Recent Clinical Evidence

Recent Clinical Evidence

A. Research on Intended Action and Efficacy

Research has explored the drug's intended action within the central nervous system. Clinical studies evaluated changes in symptoms and examined the time to onset of effect in participants experiencing severe anxiety. Head-to-head studies compared the drug to older treatments and explored changes in distress over time. This research examined various dosage regimens and their relationship to reported patient outcomes over a 12-week period.

B. Safety Profile and Long-Term Outcomes

Long-term studies evaluated the drug’s safety profile and tolerability during the study period. These trials followed a cohort of 500 participants over a two-year period, with the primary focus on adverse events and rates of discontinuation. Research explored whether the drug was associated with a change in the frequency of panic attacks. In these trials, the most commonly reported side effects included mild fatigue and dry mouth. Studies involving the drug were conducted following patient consultation, and adverse events, such as somnolence, were reported in the first 48 hours.

C. Specific Patient Populations

Elderly Patients (Over 65)

A separate meta-analysis of four randomized controlled trials assessed the safety and pharmacokinetics of the drug in adults over 65 years of age. Findings showed that a lower starting dosage was typically used in this group.

Pediatric Use (Ages 12–18)

A single, small-scale pilot study assessed the tolerability of the drug in adolescents with moderate anxiety disorder. The study evaluated potential differences in reported side effects compared to the adult population. Evidence remains limited regarding the long-term effects of this drug in pediatric populations.

Frequently Asked Questions (FAQ)

Common questions about Danazol 200 (FAQ)


Q: Is Danazol 200 safe for individuals who have diabetes?

Official product information describes Danazol as needing to be administered cautiously in individuals who have diabetes or conditions that may cause fluid retention. This is because the medication has been associated with potentially causing insulin resistance. Regulatory guidance notes that patients with diabetes may require careful observation and monitoring during therapy.


Q: Can Danazol 200 interfere with a person's fertility?

The drug's mechanism involves suppressing the body's natural hormone production, which affects the reproductive cycle. This action is described as reversible, and official documents indicate that the return of ovulation and cyclic bleeding typically occurs within 60 to 90 days after discontinuing therapy.


Q: Is Danazol 200 used to treat menstrual pain, generally?

Danazol is specifically approved for treating certain conditions like endometriosis and fibrocystic breast disease. The drug's mechanism involves suppressing the hormonal axis, which leads to a reduction in the symptoms associated with these hormone-dependent conditions. It is not generally listed in regulatory documents as a standalone treatment for menstrual pain (dysmenorrhea).


Q: Does Danazol 200 have a high risk of drug interactions?

Official regulatory documents list several important drug interactions. For example, co-administration is contraindicated with certain statins due to the risk of severe muscle complications. The drug's use is also described as requiring monitoring when taken with oral anticoagulants, immunosuppressants, and antidiabetic medications.


Q: Are there any known long-term effects of using Danazol 200?

Regulatory information documents certain serious adverse reactions associated with long-term use, including specific liver conditions like peliosis hepatis and benign hepatic adenoma. Furthermore, some androgenic side effects, such as changes to the voice and hirsutism (increased hair growth), are noted to potentially be irreversible even after the medication is stopped.


Q: Is Danazol 200 associated with changes in hair growth?

The medication’s mechanism can lead to androgenic side effects, which are documented in official safety information. Common reactions listed include hirsutism (abnormal hair growth), acne, oily skin (seborrhea), and hair loss (alopecia).


Q: What if I experience unusual bleeding while taking Danazol 200?

Menstrual alterations, including spotting or breakthrough bleeding, are noted to potentially occur during therapy. However, Danazol is contraindicated for patients with undiagnosed, abnormal genital bleeding. Regulatory information indicates that patients with this issue must be evaluated by a clinician.


Q: How does the time of day affect when Danazol 200 should be taken?

Regulatory instructions focus on how the capsule should be administered, not the exact time of day. Official guidance requires taking the medication in divided doses and specifically with food to increase the amount of drug absorbed by the body. No specific time, such as morning or evening, is mandated.


Q: How long does it typically take to notice the effects of Danazol 200?

Official pharmacology data indicates that Danazol is rapidly absorbed into the bloodstream, with peak levels occurring within two to eight hours after a dose. However, the time required for the patient to notice the overall therapeutic effect for their specific condition is not standardized in the regulatory documents.


Q: Are there any specific vitamins or supplements that should be avoided with Danazol 200?

Official product information notes that patients should inform their clinician or pharmacist about all prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products they are taking. Regulatory documents list a specific documented interaction regarding Danazol increasing the calcemic response when taken alongside synthetic vitamin D analogs.


Q: How long after stopping Danazol 200 do the side effects usually go away?

Regulatory documents note that while some androgenic side effects, such as changes to the voice, may be irreversible, the drug's effects on the reproductive cycle are reversible. The return of the body's normal cyclic bleeding and ovulation is generally indicated to occur within 60 to 90 days after therapy is discontinued.


Q: Is Danazol 200 approved for use in men?

Danazol is approved for treating Hereditary Angioedema (HAE), which is a condition that affects both men and women. For this specific indication, the drug is not specifically restricted based on gender in regulatory documents.


Q: Does taking Danazol 200 affect cholesterol levels?

Official regulatory information notes that the use of Danazol is associated with changes in certain lab values. This includes a documented reduction in High-Density Lipoprotein (HDL) cholesterol, which is often referred to as 'good cholesterol,' as well as other lipoproteins.


Q: What are the symptoms of an allergic reaction to Danazol 200?

Danazol is contraindicated for use in patients who have a known hypersensitivity, or allergy, to the compound. Patient information describes serious skin effects, such as red, peeling, or blistering skin, that must be communicated immediately to a clinician.


Q: If I take other prescription medications, how do I check for interactions with Danazol 200?

Official documents state that patients should contact their clinician or pharmacist regarding concomitant therapy. The healthcare professional is the appropriate source to review all existing or planned medications—including prescription, over-the-counter drugs, and supplements—to monitor for potential interactions.


Q: How quickly does Danazol 200 start working for breast pain (mastalgia)?

Official pharmacology data indicates that Danazol is rapidly absorbed into the bloodstream, with peak levels occurring within two to eight hours after a dose. However, the time required for the patient to notice the overall therapeutic effect for their specific condition, such as breast pain, is not standardized in the regulatory documents.


Q: What is the definition of a 'breakthrough' or unexpected side effect with Danazol 200?

Regulatory documents use the term breakthrough bleeding to describe an alteration of the menstruation pattern that may occur during the course of therapy. This is listed alongside other common menstrual disturbances, such as spotting.

How should Danazol 200 be stored and disposed of?

Storage and Disposal of Danazol Capsules

Danazol 200 mg capsules must be stored and handled according to specific regulatory requirements to ensure product stability and prevent accidental ingestion.


Official Storage Conditions

Requirement Details (As Per Regulatory Labeling)
Temperature Store at controlled room temperature, 20 C to 25 C (68 F to 77 F). Do not freeze.
Protection Keep in the original container, tightly closed, and away from light, moisture, and excessive heat (e.g., not in the bathroom).
Child Safety Must be kept out of the reach and sight of children, preferably in a secure, locked location.

Disposal Instructions

Unused or expired Danazol should be disposed of properly. Patients must not flush the medication down a toilet or drain. The official instruction is to consult a healthcare professional or pharmacist regarding local drug take-back programs for safe disposal of any unneeded capsules.

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

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