Ladogal

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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 Ladogal

What is Ladogal?

Ladogal is a therapeutic medication containing the active substance danazol, a synthetic derivative of ethisterone. It is classified as an antigonadotropin and works primarily by inhibiting the release of gonadotropins from the pituitary gland. This action leads to a reduction in the production of certain hormones, such as estrogen, and suppresses ovarian function in women.

Mechanism of Action

The active component in Ladogal exerts its effect by modifying the hormonal environment of the body. By suppressing the pituitary-ovarian axis, it creates a state of temporary, reversible hormonal suppression. In addition to its antigonadotropic properties, it possesses mild androgenic activity but lacks estrogenic or progestogenic effects.

Primary Uses

Ladogal is utilized in the management of various conditions that are sensitive to hormonal fluctuations. These include:

  • Endometriosis: It is used to treat the symptoms of endometriosis by causing the regression and atrophy of ectopic endometrial tissue.
  • Fibrocystic Breast Disease: The medication may be used to manage severe pain and tenderness associated with benign fibrocystic breast changes when other treatments are not suitable.
  • Hereditary Angioedema: It is indicated for the prevention of attacks of hereditary angioedema in both males and females by increasing the serum levels of the deficient C1 esterase inhibitor.

Clinical Role

As a specialized hormonal treatment, Ladogal is typically reserved for cases where specific suppression of the hormonal cycle is required to alleviate chronic symptoms. Its role is to provide systemic management of hormone-dependent tissues or to correct specific protein deficiencies in the blood related to immune system regulation.

Regulatory References

  1. NIH DailyMed

What side effects are possible with Ladogal?

Possible Side Effects and Safety Information

The safety profile for Ladogal (Danazol) is classified by regulatory authorities into categories based on frequency, the physiological system affected, and the seriousness of the reaction.

Adverse Reaction Scope

The most frequently documented adverse reactions relate to the medicine’s mild androgenic and systemic effects. Very Common effects include weight increase and acne. Common effects can involve voice changes (hoarseness, deepening), fluid retention, flushing, headache, emotional lability, and menstrual disturbances such as spotting or amenorrhea.

System-Organ Class
Hepatobiliary disorders (Liver)
Metabolism and nutrition disorders (Weight, Fluid retention)
Reproductive system disorders (Menstrual changes, Reduced breast size)
Skin and subcutaneous tissue disorders (Acne, Hirsutism, Seborrhea)

Serious Adverse Reactions and Constraints

Official regulatory documents identify a risk of rare but serious adverse reactions. These include thromboembolism (blood clots in arteries or veins, including stroke) and benign hepatic tumors (peliosis hepatis and hepatic adenoma). The risk of hepatic tumors is particularly associated with long-term use, and certain voice changes may be persistent or irreversible.

The medicine is subject to population-specific safety constraints. It is strictly contraindicated during pregnancy due to the risk of androgenic effects on the female fetus, and is also contraindicated in patients with a history of active thrombosis or markedly impaired hepatic, renal, or cardiac function. Use requires careful observation in individuals with conditions sensitive to fluid retention, such as epilepsy or hypertension.

Overdose and Emergency Response

Ladogal (Danazol) Overdose and When to Seek Help

Official regulatory information describes overdose from Ladogal primarily in terms of documented acute manifestations and required emergency response measures.

Documented Overdose Presentations

Symptoms that have been recorded in cases of acute overexposure or that are associated with significant toxicity from Ladogal include specific signs of liver and gastrointestinal distress. Immediate medical attention should be sought if the following manifestations are observed:

  • Yellowing of the eyes or skin (Jaundice)
  • Severe stomach or abdominal pain
  • Dark urine

Emergency Response and Management

Official prescribing information mandates that the treatment of overexposure is symptomatic and supportive. No specific antidote is officially listed for Ladogal. Any individual experiencing the documented signs of overdose must seek urgent medical help immediately.

Furthermore, because long-term use of danazol has been associated with serious, potentially life-threatening complications, including intra-abdominal hemorrhage from hepatic lesions (such as peliosis hepatis), immediate medical evaluation is required if any symptoms suggesting such complications appear. These include signs of stroke (e.g., weakness on one side of the body or vision changes) or symptoms related to increased intracranial pressure (e.g., persistent or severe headache).

Therapeutic Uses of Ladogal

What Ladogal Treats: Main Uses and Benefits

This medication is applied across domains where additional symptomatic support is needed, primarily for managing conditions characterized by periods of heightened symptoms. It is commonly used to help with Endometriosis, symptomatic Fibrocystic Breast Disease, and support for recurrent episodic manifestations of Hereditary Angioedema attacks.


The therapy is relevant for easing symptoms that interfere with daily comfort, such as pronounced symptoms related to pelvic pain, painful menstrual cycles, and cyclical breast tenderness and nodularity. It is also applied in clinical settings to help manage the occurrence of acute, episodic swelling in patients with Hereditary Angioedema.

“The treatment may support the patient during difficult episodes by easing distress and can contribute to a sense of stability when symptoms are more noticeable.”

This supportive relief is relevant, as the medicine is often used when symptoms intensify and supportive relief is needed. It helps address symptom clusters that may become intense or disruptive, contributing to support for comfort and functional stability.

Quick Fact: Support for Symptoms of Cyclical Breast Pain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Ladogal (Danazol)

Official regulatory documents define strict criteria for using Ladogal, based primarily on the drug's absolute contraindications and the requirement for caution in specific patient populations.

Contraindicated Populations

Ladogal must not be used by individuals with the following conditions or states:

Category Exclusion Criteria
Physiological State Pregnancy (Category X) and Breastfeeding. Females of childbearing potential must use effective, non-hormonal contraception.
Organ Impairment Markedly impaired hepatic, renal, or cardiac function.
Specific Diseases Porphyria, Androgen-dependent tumor, Active thrombosis or thromboembolic disease (including history of such events).
Diagnosis Status Undiagnosed abnormal genital bleeding.

Restricted or Conditional Use

Use of Ladogal requires caution and careful observation in patients with pre-existing conditions that may be exacerbated by fluid retention, such as epilepsy, migraine, hypertension, or cardiac/renal dysfunction. Caution is also advised for those with diabetes mellitus or polycythemia.

Age-Related Eligibility

Pediatric Use is not established as the safety and effectiveness in children have not been documented by regulatory bodies. Use in the elderly is generally not recommended.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Ladogal (Danazol), based strictly on government regulatory documents.


Documented Interaction Restrictions

Co-administration with Simvastatin is formally contraindicated due to the metabolic interaction. Danazol's effect on enzyme metabolism significantly increases the systemic exposure of Simvastatin, leading to an elevated risk of severe muscle complications, including myopathy and rhabdomyolysis.


Pharmacokinetic and Pharmacodynamic Interactions

Danazol is officially documented to inhibit the CYP3A4 enzyme. This metabolic interaction increases the plasma levels of co-administered medicines that are substrates of this enzyme, including the immunosuppressants Cyclosporin and Tacrolimus, which raises the risk of their associated renal toxicity. This effect also increases plasma levels of Carbamazepine.

Danazol also exhibits Pharmacodynamic interactions. Co-administration with oral anticoagulants, such as Warfarin, requires caution as it may cause a documented prolongation of prothrombin time, increasing the risk of bleeding. Furthermore, Danazol can induce insulin resistance, potentially counteracting the therapeutic effect of antidiabetic drugs.

No mandatory administration timing rules or specific interactions with food, alcohol, or herbal products are explicitly documented in the high-level prescribing information.

Mechanism of Action

Ladogal, which is danazol, exerts its effects through multiple, complex pharmacodynamic mechanisms primarily targeting the hypothalamic-pituitary-gonadal (HPG) axis and steroidogenesis enzymes. The synthetic steroid acts as an agonist at the androgen receptor (AR) and the progesterone receptor (PR), and exhibits weak antiprogestogenic activity.

At the central level, danazol acts as a negative modulator of the gonadotropin-releasing hormone (GnRH) receptor, leading to the suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from the anterior pituitary gland. Peripherally, it functions as a non-competitive inhibitor of several steroidogenic enzymes within the gonads and adrenal glands, including 3beta-hydroxysteroid dehydrogenase/Delta5-4 isomerase and 17alpha-hydroxylase/17,20-lyase. These interactions reduce the de novo synthesis and circulating levels of estradiol and progesterone, resulting in a systemic hypoestrogenic-hypoprogestational state.

Furthermore, danazol binds to circulating sex hormone-binding globulin (SHBG), displacing endogenous sex hormones and increasing their free fraction in the plasma. Separately, danazol has been shown to increase the synthesis and serum concentration of C1 esterase inhibitor protein.

Dosage and Administration Information

How Ladogal is Used: Official Administration Guidelines

Ladogal, which contains the active ingredient Danazol, is administered following specific high-level protocols outlined in prescribing information. The medication is an oral capsule and the method of intake, frequency, and course duration are determined by the specific condition being addressed.


Administration Pattern and Dosing

The total daily amount of the medicine must always be taken in divided doses throughout the day. For all gynecological uses, the total dose is typically split for twice daily (BID) administration. Crucially, the capsule must be taken with food to enhance the compound's absorption and systemic availability.

The official dose ranges vary significantly by use:

  • Endometriosis: Initial doses range from 200 to 400 mg daily for mild cases, up to 800 mg daily for moderate-to-severe disease.
  • Fibrocystic Breast Disease: Total daily doses typically fall between 100 and 400 mg.
  • Hereditary Angioedema: Initial stabilization regimens usually begin between 400 and 600 mg per day.

Course Duration and Procedural Timing

Therapy for Endometriosis and Fibrocystic Breast Disease is generally uninterrupted for a course of three to six months, and up to nine months for Endometriosis. For gynecological conditions, therapy should be initiated during menstruation to adhere to the established use protocol.

In Hereditary Angioedema, the official use involves a gradual downward dose titration following a favorable response, with doses potentially decreasing by 50% or less every one to three months. If a dose is missed, guidance states it should be skipped if it is almost time for the next scheduled dose, and a double dose must be avoided.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ladogal

Evidence for use in Conditions Characterized by Pelvic Discomfort (Endometriosis)

Studies explored whether the medicine was associated with changes in pain observed in endometriosis research. Research often compares the effects of this medicine to those of a placebo (inactive treatment) or to other hormonal agents. Findings from several trials indicate that the medicine was studied for its association with changes in painful symptoms, such as chronic pelvic pain and painful menstruation, when compared with taking an inactive substance. Research has monitored whether symptoms were observed to return after the treatment period had ended.

Evidence for use in Conditions Involving Acute, Disruptive Episodes (Hereditary Angioedema)

A significant body of research examines Ladogal's use as a long-term preventive treatment for Hereditary Angioedema (HAE) attacks. HAE involves sudden, disruptive swelling episodes, and studies explore whether the medication was associated with changes in the frequency and severity of these attacks. Early, small-scale, controlled studies reported a pattern of reduction in the number of attacks for the majority of participants receiving the treatment compared to those receiving placebo.

Subsequent, larger studies and long-term observational reviews describe findings that align with the initial reported patterns, showing the medication was studied in settings examining symptom control.

Evidence for use in Conditions Marked by Functional Limitations (Symptomatic Fibrocystic Breast Disease)

Studies have investigated Ladogal's role in addressing symptoms of symptomatic fibrocystic breast disease, primarily focusing on pain (mastalgia) and nodularity (lumpiness). Research, including double-blind crossover trials, examined whether the medicine was associated with a decrease in both breast pain and the physical measurements of nodularity when compared to inactive treatment. Findings indicate that changes were reported across a range of women experiencing moderate to severe breast discomfort.

Research Gaps and What Remains Uncertain

Despite several decades of study, certain aspects of Ladogal’s use remain uncertain or require further investigation. A primary limitation across some studies is the small number of participants involved, which can make it challenging to draw universally applicable conclusions. In all indications, the long-term effects on the body are continuously being monitored, and the research experience with uninterrupted, decades-long therapy is recognized as limited. Comparative evidence for this medicine and currently available treatment options is often limited.

Frequently Asked Questions (FAQ)

Common questions about Ladogal (FAQ)


Q: What is the difference between Ladogal and other medicines commonly used for the same condition?

A: Regulatory documents classify this medicine as an antigonadotropin and a synthetic steroid. It is described as having a unique, multifaceted action that involves suppressing the release of pituitary hormones and binding to certain steroid receptors. This process allows it to modulate the hormonal system, which is a differentiating factor in its therapeutic profile compared to other treatments.


Q: Are there any known interactions between Ladogal and common over-the-counter pain relievers?

A: Official labeling does not list common over-the-counter (OTC) pain relievers such as ibuprofen or acetaminophen as major contraindications. However, due to the drug's potential for metabolic interactions, official guidance emphasizes the importance of informing the clinician of all prescription and non-prescription drugs being taken. This includes all OTC medications and supplements.


Q: Are there any known dietary considerations or food interactions for Ladogal?

A: Official labeling emphasizes that the capsule must be taken with food to ensure the medication is properly absorbed into the body and to enhance its systemic availability. No specific foods or beverages are explicitly listed as restricted or requiring avoidance.


Q: Is there any research evidence describing Ladogal's use in younger adult populations?

A: Official documentation states that the safety and effectiveness for pediatric use (use in children) have not been established. Ladogal is used for specific conditions in the adult population, and decisions about treatment require individual assessment by a clinician.


Q: How is the mechanism of action of Ladogal explained in simple, non-clinical terms?

A: The medicine works primarily by acting as an antigonadotropin, meaning it inhibits the signaling process that controls hormone production. This action lowers the circulating levels of reproductive hormones like estrogen and progesterone in the body. This hormonal suppression is the core function that helps to alleviate symptoms in conditions sensitive to these hormones.


Q: Is it possible for Ladogal to interact with certain common herbal remedies?

A: Official labeling does not explicitly document specific interactions with common herbal products. Patients are strongly advised to inform their prescribing clinician of all herbal remedies, vitamins, and supplements they are taking. This ensures that any potential, undocumented interactions can be monitored.


Q: Why does the label include warnings about specific pre-existing conditions?

A: Regulatory documents warn that the medication can cause salt and water retention (fluid retention) in the body. This fluid retention may worsen certain pre-existing conditions such as epilepsy, migraine, hypertension, or heart/kidney dysfunction. Official information states that patients with these conditions should be under careful observation while using this medication.


Q: How quickly should I expect to notice the intended effects of Ladogal?

A: The time required to observe effects varies by condition. For fibrocystic breast disease, relief of pain and tenderness is typically observed in 2 to 3 months of continuous treatment. Elimination of nodularity (lumpiness) usually requires a longer course of 4 to 6 months.


Q: Is feeling tired or fatigued a common initial experience with Ladogal?

A: Fatigue and lethargy have been reported as adverse effects of the medication. Official information suggests that caution should be exercised when performing activities that require alertness if drowsiness is experienced.


Q: What is the official guidance on consuming alcohol while using Ladogal?

A: Official guidance indicates that alcohol consumption is generally not recommended while taking this medication. The combination may cause unpleasant effects such as feeling sick or short of breath.


Q: Can Ladogal interact with common daily vitamins or mineral supplements?

A: Official information advises patients to inform their clinician of all vitamins, minerals, and supplements they are using, as the drug can interact with other medicines.


Q: Where can I find publicly available official clinical trial data about Ladogal?

A: Information on clinical studies and research related to the medicine can typically be accessed via public databases. Resources such as ClinicalTrials.gov (run by the NIH) or the FDA Prescribing Information sections related to Clinical Studies are available resources.


Q: What does 'contraindication' mean in the context of this specific medicine?

A: A contraindication is an official regulatory statement that the medicine must not be used in a specific situation or with a specific pre-existing condition. Official documentation states that a contraindication is issued when the potential for harm may outweigh the potential benefit of the drug.


Q: What is the expected fate of Ladogal in the body (e.g., how is it cleared)?

A: The medicine's active ingredient is metabolized (broken down) by the liver. It is then primarily cleared from the body through the elimination of its metabolites via urinary and fecal excretion. The time it takes for the drug to be eliminated from the body is measured by its half-life, which is approximately 4.5 to 9.7 hours.


Q: Does the patient information leaflet mention any need for specific medical monitoring while taking Ladogal?

A: Yes, the label requires periodic liver function tests and periodic hematologic (blood) tests to be performed throughout the course of treatment. Hepatic ultrasonography (an imaging test of the liver) may also be considered for patients on long-term or repeated courses.


Q: How is the term 'off-label use' defined, and why is it not discussed for Ladogal?

A: Off-label use is defined as using a medication for a condition or in a way that is not specifically listed and approved by the regulatory body (e.g., the FDA). Official patient information does not discuss or recommend off-label uses.


Q: Are there any reported effects of Ladogal on a person's ability to drive or operate machinery?

A: The official label states that the medication generally has no or negligible influence on the ability to drive or use machines. However, if side effects such as dizziness, tiredness, or visual disturbances are experienced, official guidance indicates that driving and operating machinery should be avoided.


Q: What does the term 'adverse reaction' signify in relation to Ladogal's side effects list?

A: An adverse reaction is any unexpected, unwanted, or harmful effect that is medically related to the use of the medicine. These are effects that are reported to or recognized by regulatory authorities after they have been identified in clinical trials or through post-marketing surveillance.


Q: How do official sources describe the conditions for safely stopping the use of Ladogal?

A: The official label advises that therapy for certain conditions, like hereditary angioedema, may be gradually decreased (titrated) or withdrawn after an attack-free period. For other conditions, if symptoms recur after stopping, treatment may be reinstated. The decision to stop the medication is one that is always made in consultation with a clinician.


Q: Why is consistency in taking Ladogal emphasized in the patient information?

A: Consistency in use is considered important because the medicine works by maintaining specific hormone levels in the body to help control symptoms. Regulatory guidance emphasizes that regular, uninterrupted dosing is necessary to achieve and maintain the therapeutic effect over the required course of treatment.

How should Ladogal be stored and disposed of?

How to Store and Dispose of Ladogal? (Official Regulatory Information)

Official regulatory documents define specific requirements for the storage, handling, and disposal of Ladogal to maintain product stability and public safety.

Storage Category Official Requirements
Environmental Control Store in a cool and dry place, protected from direct sunlight.
Child Safety Keep out of the sight and reach of children and pets.
Handling Take the capsule whole; do not cut, break, or chew the contents.
Disposal Dispose of any unused or expired product in accordance with local regulations; do not dispose of via wastewater or household trash.

These official statements ensure the product maintains its chemical integrity throughout its shelf-life and restrict access to prevent accidental exposure. Disposal instructions require specific methods to minimize environmental impact.

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

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