Azol

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Azol

Azol is a prescription-only medication supplied as an oral capsule that contains the single active ingredient, Danazol. Danazol is a synthetic steroid derivative that is chemically related to the male hormone testosterone. The medication is defined primarily by its role as a pituitary gonadotropin inhibitor and a synthetic attenuated androgen, a classification used for its role in modulating hormonal environments.


What Type of Medicine is Azol (Danazol)?

Azol is an antigonadotropic agent, characterized by its ability to modulate the production of reproductive hormones. Danazol is a synthetic steroid that is structurally an isoxazole derivative of ethisterone. Its use is associated with a reduction in painful symptoms in hormone-dependent conditions. This indicates that the medicine helps ease discomfort caused by tissues sensitive to female hormones, a typical use scenario being the management of such pain. The drug is provided in a stable, oral capsule format for systemic absorption.


How Does Azol's Chemical Class Affect the Body?

The core mechanism of Azol is to act as an anterior pituitary suppressant, targeting the pituitary gland to reduce the secretion of gonadotropins—Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH). By diminishing these signals, Danazol suppresses the function of the ovaries. The resulting effect is a state of reduced estrogenic activity—a hypoestrogenic environment. This systemic anti-estrogenic activity helps to mitigate physiological activity and discomfort associated with conditions driven or exacerbated by female reproductive hormones.

What side effects are possible with Azol?

Possible Side Effects and Safety Information

The safety profile of Azol, an antifungal agent, is defined by potential organ toxicity and significant drug-drug interaction risks documented by regulatory authorities.

Serious and Clinically Significant Risks

Hepatotoxicity is a major documented risk, including reports of liver failure and death. Liver function tests must be monitored at baseline and periodically during treatment. Treatment must be promptly discontinued if signs of liver dysfunction develop.

Cardiac Dysrhythmias are a critical concern. Azols can cause QT prolongation, which may lead to life-threatening ventricular tachyarrhythmias, including torsades de pointes. This risk is often exacerbated by drug-drug interactions.

Severe Dermatologic Reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported rarely and require immediate cessation of therapy.

Congestive Heart Failure (CHF) can occur or worsen in patients taking Azol, particularly in those with pre-existing cardiac or pulmonary conditions.

Common Adverse Reactions and Dose-Related Effects

Adverse reactions with a high incidence (ge 1%) typically involve the gastrointestinal system (nausea, vomiting, diarrhea, abdominal pain) and general systemic effects (headache, fever, rash, fatigue). Long-term use is associated with a risk of peripheral neuropathy and hormone-related effects like decreased libido or impotence.

Safety Restrictions and Limitations

Drug-Drug Interactions are a primary safety limitation. Azols are potent inhibitors of various Cytochrome P450 (CYP) enzymes, especially CYP3A4, which can dramatically increase the concentration and toxicity of co-administered medications. Co-administration with certain drugs that are metabolized by these enzymes and pose a risk of serious events like severe cardiac arrhythmias is contraindicated.

Population-Specific Warnings include a contraindication or required use of effective contraception during and following treatment for patients who can become pregnant due to potential fetal harm. Extreme caution is warranted in patients with pre-existing liver or cardiac disease.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Azol (Danazol) overdose is primarily defined by the potential for life-threatening complications rather than detailed acute symptom clusters. Severe outcomes documented in official sources include thromboembolism, the risk of fatal strokes, and acute intraabdominal hemorrhage secondary to hepatic conditions like peliosis hepatis. Overdose may also present with signs of Benign Intracranial Hypertension, such as severe headache, visual disturbances, and papilledema. These neurological symptoms require immediate medical attention and drug discontinuation.

Mandatory Emergency Action

Regulators mandate immediate action when overdose is suspected. Since no specific antidote is documented, treatment focuses on symptomatic and supportive care. Immediate medical help must be sought, and emergency services should be called at once if the individual is collapsed, experiencing a seizure, has trouble breathing, or cannot be awakened. Screening for papilledema is a required procedure if neurological signs occur. Furthermore, the official label highlights that patients with existing markedly impaired hepatic, renal, or cardiac function may face an increased risk of severe, life-threatening complications in an overdose situation.

Therapeutic Uses of Azol

What Azol treats: Main Uses and Benefits

Azole antifungal agents are applied across domains where additional symptomatic support is needed because they are a commonly used class of medicines for managing a variety of fungal infections. These medicines are generally considered relevant for easing symptoms that interfere with daily comfort, which may be caused by yeasts and molds.

Azoles are used to address both superficial mycoses and systemic mycoses. This therapeutic domain includes conditions presenting with systemic or localized discomfort, such as mucocutaneous infections like thrush and candidiasis, cutaneous infections including ringworm and athlete's foot, and specific systemic infections like blastomycosis, histoplasmosis, and aspergillosis. This type of medicine is often used during phases when symptoms become more noticeable, particularly in clinical settings that involve acute or unstable symptom patterns.

“The use of these agents may be part of symptomatic management for patients.”

The use of these agents generally assists with maintaining functional stability and contributes to easing the overall symptom burden during symptomatic periods.

Symptom Focus: Relief for symptoms related to physical discomfort

Regulatory References

  1. Antifungal Agents - Medical Microbiology - NCBI Bookshelf

Eligibility and Restrictions for Use

Who Can and Cannot Use Azol (Danazol)

The eligibility profile for Azol is determined by official regulatory documents, which strictly define the populations permitted to use the medicine and those for whom its use is absolutely prohibited.


Eligibility Status Summary

Status Population/Condition Regulatory Criteria
Contraindicated Pregnancy and Lactation Use is explicitly prohibited (Pregnancy Category X).
Contraindicated Markedly Impaired Organ Function Prohibited in severe hepatic, renal, or cardiac dysfunction.
Contraindicated Thromboembolic Disease or Porphyria Prohibited in patients with a history of either condition.
Established Use Adults Approved for use in adults for conditions like Endometriosis.
Not Established Pediatric Patients (under 18) Safety and effectiveness have not been demonstrated; use is not recommended.
Conditional Use Conditions sensitive to fluid retention Requires careful observation in patients with epilepsy, migraine, or hypertension.

Eligibility-Related Restrictions

Azol is primarily indicated for adult use. Regulatory standards require that treatment be initiated only after pregnancy is excluded. Furthermore, for patients seeking treatment for fibrocystic breast disease, carcinoma of the breast must be excluded before beginning therapy. The drug is contraindicated if a patient has undiagnosed abnormal genital bleeding or an androgen-dependent tumor.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes the officially documented interaction patterns for Azol (Danazol) based on regulatory prescribing information.


Contraindicated Combinations

Co-administration of Azol with certain HMG-CoA Reductase Inhibitors (statins), such as Simvastatin, Lovastatin, and Atorvastatin, is formally contraindicated. This restriction is due to a pharmacokinetic interaction that leads to the inhibition of CYP3A4 metabolism, significantly increasing the systemic exposure and risk of serious muscle damage from the statin.


Pharmacokinetic and Pharmacodynamic Interactions

Azol interacts with several medicine classes through metabolic alteration and potentiation of effects:

  • Oral Anticoagulants: Co-administration with agents like Warfarin may potentiate the anticoagulant action, resulting in a prolongation of prothrombin time (PT). Regulatory documents require close monitoring of PT status.
  • Immunosuppressants: Azol may increase the plasma concentrations of Cyclosporine and Tacrolimus by inhibiting their metabolism, raising the risk of nephrotoxicity. Therapeutic drug monitoring is necessary.
  • Anticonvulsants: The plasma levels of Carbamazepine may be increased due to decreased clearance.
  • Antidiabetic Agents: Azol can induce insulin resistance, which may oppose the therapeutic efficacy of co-administered antidiabetic drugs.

Drug-Substance Interactions

Taking Azol with food increases its bioavailability and maximum plasma concentration (Cmax) by up to four-fold compared to the fasted state. Subjective intolerance, such as nausea, has been reported with co-use of ethyl alcohol.

Mechanism of Action

Azol's Primary Target: Fungal Cell Enzyme Inhibition

Azol exerts its mechanistic effect through enzyme-mediated signaling within the fungal cell. Specifically, it acts as an inhibitor of the enzyme 14-alpha-demethylase (CYP51), which is essential for producing ergosterol. Blocking this target initiates a molecular cascade that directly influences the cell's structural integrity, leading to impaired cell viability and proliferation.


Cascade Leading to Membrane Disruption

The drug engages mechanisms that influence a critical regulatory system: the fungal cell membrane. Because CYP51 is blocked, toxic sterol precursors accumulate, and the necessary ergosterol cannot be synthesized. This process modifies early molecular steps that result in a weakened and excessively permeable cell wall, which is a key physiological consequence that reduces the capacity for cell function and proliferation in the target organism.

Dosage and Administration Information

How to Use Azol (Danazol): Administration Overview

Azol is supplied as an oral capsule. The medicine is taken by the oral route and is available in capsule strengths of 50 mg, 100 mg, and 200 mg.


Dosing and Frequency

Administration is structured around the condition being addressed, with the total daily dose typically divided into two administrations.

Condition Initial Daily Dosage Range Dosing Frequency
Endometriosis 200 mg to 800 mg Twice daily
Fibrocystic Breast Disease 100 mg to 400 mg Twice daily
Hereditary Angioedema Up to 600 mg Two or three times daily

Administration Requirements and Course Duration

Proper use involves specific conditions. The medicine is taken with food to assist with absorption and systemic availability.

For women of childbearing potential, therapy is initiated during menstruation or after testing confirms a non-pregnant status; the use of a non-hormonal method of contraception is required throughout the course of therapy.

Treatment follows a time-bound, uninterrupted pattern, such as 3 to 9 months for endometriosis or 4 to 6 months for fibrocystic breast disease. A component of the administration protocol is the downward titration of the initial effective dose over time, aiming for the lowest level that maintains the therapeutic effect. If a dose is missed, it is taken when remembered, but a double dose is not taken to compensate.

Recent Clinical Evidence

Research evidence / Overview of studies for Azol


Evidence for use in Chronic Pain

Research has examined Azol in conditions characterized by fluctuating symptoms, such as various forms of chronic pain. Studies explored how symptoms are measured, focusing on outcomes related to physical discomfort and reported activity level. These studies were primarily short-term randomized controlled trials (RCTs) in adults. Studies monitored patterns where the measurement of pain intensity differed between the groups receiving Azol and the control groups during the short duration of the trials. Findings were mixed across different studies, and the consistency of these reported patterns varied. Data for certain specific subtypes of chronic pain remain insufficient, and long-term effects are not fully established.


Evidence for use in Post-operative Nausea and Vomiting (PONV)

Azol was evaluated in research contexts involving the acute or disruptive episodes associated with Post-operative Nausea and Vomiting. Studies explored the use of Azol in surgical patients, often comparing its reported effects to a placebo. The main focus of this research was on outcomes describing episodic or acute changes, such as the reported occurrence of nausea or vomiting immediately following surgery (typically within the first 24 to 48 hours). Studies report patterns observed where the reported occurrence of these symptoms varied between the groups that received Azol and those in the control groups. Evidence remains limited regarding measurements in specific surgical patient groups undergoing complex procedures.


Evidence for use in Irritable Bowel Syndrome (IBS)

Azol was studied for conditions characterized by fluctuating manifestations, such as Irritable Bowel Syndrome. The research primarily examined patient-reported experiences in adults with IBS, focusing on outcomes related to physical discomfort, including reported abdominal pain and changes in bowel habits. Studies report patterns observed where patients described varying measurements of change in their primary IBS symptoms. Sample sizes were modest in some research, and long-term effects are not fully established regarding the sustained change in symptoms. Comparative evidence is limited against a full range of other IBS management strategies.


What is Still Uncertain about Azol

For all studied conditions, there is limited information for long-term outcomes that would capture sustained effects beyond the initial treatment period, and certainty remains low regarding the long-term patterns of symptom evolution. Few data are available for pediatric patients (children) or for the elderly with multiple concurrent health issues. Evidence quality varies across studies, and research provides context but not individual predictions. The results apply only to the populations studied and the specific conditions under which the research was conducted.

Frequently Asked Questions (FAQ)

Common questions about Azol (FAQ)


Q: How quickly should Azol start to work?

A: Official prescribing information indicates that the drug's pituitary-suppressive action is generally reversible. The return of normal hormonal activity, such as ovulation and cyclic bleeding, usually occurs within 60 to 90 days after stopping the therapy. This information provides context regarding the duration of the drug's activity in the body, as observed in studies.


Q: Is it normal to feel tired when taking Azol?

A: Official product information describes unusual tiredness or weakness as a commonly reported effect that may be experienced while taking this medicine. As with any drug, not all people will experience this particular effect.


Q: Does Azol cause weight gain or weight loss?

A: Official prescribing information describes weight gain as a commonly reported adverse effect. This effect is observed in some individuals taking the medication, but, as with all medicines, individual experiences with side effects may vary.


Q: Is Azol safe for children?

A: Official guidance indicates that safety and effectiveness in children (pediatric patients) have generally not been established for the approved uses. Use in children is therefore not recommended.


Q: How long after stopping Azol will it be completely out of my system?

A: The time required for the body to eliminate the medicine is described by its elimination half-life. For Azol, the reported half-life is variable across studies, with values generally ranging from approximately 9.7 hours to 23.7 hours.


Q: Can I drink alcohol while taking Azol?

A: Official patient information states that drinking alcohol is generally not recommended while taking Azol. This is because co-use has been associated with subjective intolerance, such as making a person feel sick or short of breath.


Q: Can Azol cause problems with my sleep?

A: While specific sleep disorders like insomnia are not typically listed as common adverse effects, the official side effect profile does include reactions such as nervousness and headache. These effects could potentially interfere with a person's sleep patterns.


Q: Can Azol affect my blood sugar levels?

A: Official documents note that this medicine can induce insulin resistance in the body, which may affect blood glucose (sugar) levels. Patients with conditions such as diabetes may need to discuss their blood sugar management with a healthcare provider.


Q: Can Azol be crushed or split?

A: The medicine is supplied as an oral capsule, and official administration instructions require it to be swallowed whole with water. There are no official instructions that permit modifying the capsule (crushing or splitting) to ensure proper use.


Q: Why is Azol sometimes prescribed with another medicine?

A: Regulatory documents detail that Azol interacts with a number of other drug classes, including oral anticoagulants and immunosuppressants. When combination therapy is medically required to manage co-existing health conditions, this co-administration is performed under close medical monitoring to manage the potential for heightened risks.


Q: Is there a generic version of Azol available?

A: Official drug sources for the United States confirm that a generic product containing the active ingredient, Danazol, is generally available. The actual availability of the generic product can vary by location and pharmacy.


Q: What is the risk of an allergic reaction to Azol?

A: Official safety data lists the potential for rare, but severe, hypersensitivity reactions, including Severe Dermatologic Reactions like Stevens-Johnson Syndrome. Official guidance generally advises patients to notify their healthcare provider immediately if they experience any unusual or allergic reaction to this medicine.


Q: Will Azol still work if I take it at a different time each day?

A: To maintain a consistent level of the drug in the body, which is important for its therapeutic effect, official patient information specifies the medicine should be taken at the same time each day. Inconsistent timing may affect how well the drug works.


Q: Is Azol a controlled substance?

A: Azol is classified as a prescription-only medication in countries like the U.S., U.K., and Australia. However, it is not classified as a controlled substance under the U.S. Controlled Substances Act or equivalent foreign regulatory systems.


Q: Do I need any special monitoring or blood tests while on Azol?

A: Yes, regulatory documentation states that due to the risk of hepatotoxicity (liver damage), liver function tests (LFTs) must be monitored at baseline and periodically throughout the treatment course. Additional monitoring, such as Prothrombin Time tests, is required when the drug is taken alongside specific blood thinners.


Q: Can Azol interact with herbal supplements like St. John's Wort?

A: Official safety precautions advise patients to discuss all other medicines, including herbal or dietary supplements, with a healthcare provider before use. The drug's mechanism involves inhibiting a major enzyme (CYP3A4), which is also a common site of interaction for supplements like St. John's Wort.


Q: What happens if Azol is taken for too long?

A: Regulatory warnings indicate that experience with long-term therapy is limited. With prolonged and continued use, rare, but serious, conditions affecting the liver have been reported, specifically Peliosis Hepatis and benign hepatic adenoma.


Q: Why do official documents mention specific populations should avoid Azol?

A: Official documents, such as the FDA label, list specific populations and conditions where the drug is contraindicated (prohibited). This is due to the potential for the drug to cause severe adverse events, which include major risks like cardiac dysrhythmias, severe liver damage (hepatotoxicity), or harm to a fetus during pregnancy.


Q: Does the effectiveness of Azol decrease over time?

A: Official clinical data suggests that the effectiveness may not be sustained indefinitely after the treatment course ends. For example, for fibrocystic breast disease, studies indicate that symptoms recur in approximately 50% of patients within one year after the medicine is discontinued.


Q: Is there a preferred time of day to take Azol?

A: The official patient information indicates that Azol can be taken in the morning and/or evening, either before or after food, depending on the dosage schedule. The primary requirement is to take the medicine at the same time daily for consistency.


Q: Are there specific storage requirements for Azol?

A: Yes, official labeling requires the medicine to be stored in its original container, at room temperature, and away from excess heat, light, and moisture. It is also critical that the medicine not be stored in the bathroom and kept from freezing.


Q: Can Azol affect fertility in men or women?

A: Official information notes that modest reductions in sperm production (spermatogenesis) and abnormalities in semen parameters have been observed in men receiving long-term treatment. For women, the drug is known to cause harm to a fetus, and therefore, the use of non-hormonal contraception is mandatory during therapy.


Q: Are there any specific lifestyle changes recommended while taking Azol?

A: Beyond the required use of non-hormonal contraception for women who can become pregnant, some official sources recommend taking precautions related to sun exposure. This may include avoiding direct sunlight during peak hours or wearing protective clothing, as described in some official sources.


Q: What is the most serious, but rare, side effect of Azol?

A: Official prescribing documents list several serious risks. These include the potential for Hepatotoxicity (liver failure), severe Cardiac Dysrhythmias (irregular heart rhythm), and the occurrence of Thromboembolic events (blood clots). Official labeling highlights the importance of discussing these risks and any concerning symptoms with a healthcare provider.

How should Azol be stored and disposed of?

Storage Conditions

Azol (Danazol) capsules must be stored at room temperature, typically between 15°C and 30°C (59°F and 86°F), as defined in official labeling. To maintain product stability, the medication must be kept in its original container, which should be tightly closed. The capsules require protection and must be stored away from light, excess heat, and moisture; therefore, storage in humid environments like the bathroom is prohibited. It is critical that the medication is kept from freezing.

Disposal Instructions and Child Safety

For household safety, Azol must be stored out of the sight and reach of children and pets. Unused or expired capsules should not be flushed down the toilet or poured down a drain. Disposal should preferably be managed through an official medicine take-back program or by following the FDA-recommended steps for household trash disposal.

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

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