Cyclomen

Quick links to important sections

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.

Overview of Cyclomen

What is Cyclomen? Foundational Overview

Property Description
Active ingredient Danazol
Form Hard Gelatin Capsules
Pharmacological class Synthetic Steroid, Antigonadotropin
General purpose Manages symptoms of hormone-dependent conditions
Origin Synthetic derivative of ethinyltestosterone

What is Cyclomen? Classification and Origin

Cyclomen is the trade name for the active ingredient Danazol, which is classified primarily as a synthetic steroid and a powerful endocrine agent. This medication is a prescription-only medicine that is chemically derived from ethinyltestosterone, establishing its synthetic origin. Danazol's core pharmacological action defines it as an antigonadotropin, meaning it works by opposing or suppressing the signaling of the pituitary hormones that control the ovaries. This mechanism is clinically recognized for inducing a reliable hormonal shift necessary for therapy.

Danazol's pharmacological profile classifies it as a steroidal isoxazole and a synthetic androgen derivative.


Composition and High-Level Purpose

The medication is a single-ingredient product available as hard gelatin capsules, designed exclusively for oral administration. The capsule contains only the active compound Danazol mixed with standard, non-active excipients. While Cyclomen is one trade name, the active ingredient Danazol is also found under other brands like Danocrine. This consistency ensures the reliable delivery of the agent for patients requiring systemic hormonal modification.

The general purpose of this endocrine agent is to create a controlled hormonal environment beneficial for managing symptoms of various hormone-dependent conditions. It achieves this by the mechanism of inhibiting pituitary gonadotropin secretion, which indirectly leads to a decrease in circulating estrogen levels. The medication functions to decrease the amount of hormones that the ovaries make. This means the medication works to calm down the hormonal stimulation of sensitive tissues in the body, a necessary step when addressing conditions where tissue activity is driven by female hormones.

Regulatory References

  1. MedlinePlus Drug Information for Danazol

What side effects are possible with Cyclomen?

Possible side effects and safety information

The safety profile for Cyclomen (Danazol) is characterized by effects stemming from its hormonal activity, which are systematically documented in official regulatory classifications. The majority of adverse reactions are related to its anti-gonadotropic and mild androgenic properties.


Adverse Reaction Classifications

Side effects are categorized based on their likelihood, aligning with standard regulatory frameworks (e.g., Common, Rare). Common adverse reactions, defined as occurring in 1% to 10% of users, often include androgen-like effects such as weight gain, acne, hirsutism, and voice changes (e.g., hoarseness or deepening of pitch). Other common effects involve estrogen-lowering consequences like menstrual disturbances (e.g., spotting or amenorrhea), flushing, and emotional lability. The systemic organization of effects involves classes such as Endocrine/Metabolic, Vascular, and Hepatobiliary disorders.


Serious Adverse Reactions and Safety Restrictions

Official labeling highlights the risk of rare but serious adverse reactions. These include thromboembolic events (such as stroke and arterial or venous thrombosis) and significant hepatic toxicity, including hepatocellular injury, jaundice, and rare documented cases of peliosis hepatis and benign hepatic adenoma, particularly with long-term use. Some effects, such as the deepening of the voice, may be irreversible following continued use.

The medication is subject to several strict contraindications documented in prescribing information. It is contraindicated during pregnancy (due to the risk of fetal harm) and lactation. It is also restricted for use in patients with a history of thromboembolic disease, porphyria, or markedly impaired hepatic, renal, or cardiac function. Due to these risks, periodic evaluation of hepatic function is often noted in regulatory prescribing instructions.

Overdose and Emergency Response

Overdose and when to seek help

This section describes the officially documented information regarding overdosage with Cyclomen (Danazol) as defined by government regulatory agencies.

Overdose Scope

Category Official Regulatory Statement
Documented Overdose Presentations No serious acute symptoms are anticipated or documented following an acute overdosage.
Dose-related or Exposure-related Factors Acute overexposure to Danazol rarely results in serious complications.
When to Seek Urgent Help Seek professional medical care or contact a Poison Control Center immediately upon suspicion of acute overdose.

Official Overdose Statements

Official regulatory information indicates that no specific antidote is known to exist for Cyclomen overdosage. Consequently, management must be symptomatic and supportive. The regulatory guidance states that procedures such as gastric emptying (including gastric lavage) may be considered as part of the supportive treatment regimen.

This official profile, structured on the documented low acute toxicity, emphasizes that immediate medical attention must be sought for observation and care, even when serious acute manifestations are not initially expected. Patient monitoring is a required component of general supportive care.

Therapeutic Uses of Cyclomen

What Cyclomen Treats: Main Uses and Benefits

Cyclomen (Danazol) is commonly used to help with symptomatic support and management in conditions marked by heightened patient distress or risk. Therapeutic applications are relevant for hormone-dependent and genetic conditions, generally focusing on easing the overall symptom load.

Symptom Relief and Clinical Contexts

The medication is relevant for managing symptoms related to: endometriosis, symptomatic fibrocystic breast disease, and the prophylactic management of Hereditary Angioedema (HAE). This therapy is relevant in contexts marked by increased discomfort or tension, and it is applied in addressing the chronic pelvic pain and severe dysmenorrhea associated with endometriosis. It is also applied in clinical settings that involve acute or unstable symptom patterns, such as severe mastalgia (breast pain) and nodularity in fibrocystic breast disease. Applied when appropriate, it may provide support that helps ease the overall symptom burden.

For the rare condition of HAE, Cyclomen is commonly used across conditions presenting with acute episodes, notably serving as a prophylactic measure. It is relevant for managing symptoms that create noticeable physiological strain, as it may assist with managing the occurrence of recurrent, episodic swelling attacks that interfere with functional stability.

“This therapy generally assists with helping patients cope more steadily with difficult episodes and contributes to maintaining functional stability when symptoms are more noticeable.”


Quick Fact

Quick Fact: Relevant for Severe Chronic Pain and Recurrent Swelling Management

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility profile for Cyclomen (Danazol) is strictly defined by regulatory documents, establishing clear rules for use, restriction, and absolute prohibition.

Category Eligibility Status
Contraindications Use is absolutely prohibited in patients who are pregnant or breastfeeding, or who have a history of thromboembolic disease (e.g., blood clots) or Porphyria. Contraindication also applies to patients with androgen-dependent tumors or markedly impaired function of the liver, kidneys, or heart. Use is also contraindicated in cases of undiagnosed abnormal genital bleeding.
Conditional Use Females of childbearing potential are eligible only if they use an effective non-hormonal contraceptive method and pregnancy is excluded prior to starting therapy. Caution and careful observation are required for patients with conditions like epilepsy, hypertension, or migraine headaches due to the potential for fluid retention. Malignancy must be excluded before treating fibrocystic breast disease.
Age-Related Rules Cyclomen is generally permitted for use in adults. Use in pediatric patients and the elderly (≥ 65) is not recommended by regulatory agencies because safety and effectiveness have not been established in these age groups.

These classifications establish that while Cyclomen is permitted for use in the adult population for its licensed indications, eligibility is severely restricted by physiological state and comorbidity. The regulatory basis requires strict adherence to these eligibility criteria.

What should I know about interactions with other medicines?

Interactions with other medicines and products


Interaction Scope

Category Official Regulatory Entity / Pattern
Medicinal product categories with documented interactions Oral Anticoagulants, HMG-CoA Reductase Inhibitors (Statins), Immunosuppressants, Antidiabetic Drugs, Synthetic Vitamin D Analogs, Hormonal Contraceptives.
Specific interacting medicines (if explicitly listed) Simvastatin (Contraindicated), Warfarin, Cyclosporine, Tacrolimus, Carbamazepine, Atorvastatin, Lovastatin.
Mechanistic basis of interactions (only if stated in label) Pharmacokinetic: Inhibition of hepatic/intestinal enzyme CYP3A4 metabolism, leading to increased exposure of co-administered drugs. Pharmacodynamic: Potentiation of hypoprothrombinemic response and systemic counteraction.
Timing-based interaction rules (if applicable) None explicitly stated as time separation. Restriction is the mandatory use of non-hormonal contraception.

Interaction Classifications (High-Level)

Classification Official Regulatory Pattern
Interaction severity classification (as defined in official documents) Contraindicated Combination (e.g., Simvastatin). Clinically Significant Interaction (e.g., Warfarin, Cyclosporine) requiring monitoring.
Regulatory basis (EMA / FDA / etc.) Formal statements from FDA Prescribing Information (DailyMed) and SmPC documentation.
Interaction-context constraints (as defined in official documents) Interaction necessitates Non-Hormonal Contraception (restriction based on drug efficacy reduction). Interaction requires Monitoring (e.g., Prothrombin Time/INR; plasma levels for Cyclosporine/Tacrolimus).

Resulting Interaction Structure

Official interaction statements:

  • Co-administration with Simvastatin is contraindicated due to the officially described increased systemic exposure of Simvastatin, which elevates the documented risk of rhabdomyolysis.
  • Danazol increases the plasma concentration of Cyclosporine and Tacrolimus by decreasing their metabolism, officially increasing the risk of renal toxicity from the immunosuppressants.
  • Concomitant use with oral anticoagulants like Warfarin may potentiate the hypoprothrombinemic response, requiring mandated monitoring of Prothrombin Time (PT) or International Normalized Ratio (INR).
  • Danazol can cause insulin resistance, officially affecting the action of antidiabetic drugs.
  • The effectiveness of hormonal contraceptives may be decreased; therefore, a non-hormonal method of contraception must be used during Danazol therapy.

Connection to the overall interaction profile (2–4 sentences): The regulatory documents establish Danazol's interaction profile as primarily exposure-modifying due to its documented inhibition of the CYP3A4 metabolic pathway. This pharmacokinetic effect dictates the contraindication with certain statins and the mandated monitoring for drugs like the immunosuppressants. A distinct pharmacodynamic effect is noted by the officially described potentiation of anticoagulants and the systemic induction of insulin resistance.

Mechanism of Action

The mechanism of action for Danazol (Cyclomen) is based on a multifaceted intervention that targets both central hormonal control and peripheral regulatory systems, resulting in a multifaceted change in physiological signaling.

Endocrine Suppression via the HPO Axis

This primary mechanism involves the drug acting as an antigonadotropin by suppressing the release of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH) from the pituitary gland. This central inhibition of the Hypothalamic-Pituitary-Ovarian (HPO) Axis fundamentally alters the hormonal environment, initiating a cascade that leads to a sustained hypoestrogenic state and modifying downstream signaling by estrogens.

Receptor and Enzyme Interference in Tissues

Danazol exerts peripheral control by directly binding to intracellular Androgen and Progesterone receptors while simultaneously inhibiting key steroidogenic enzymes in target tissues. These direct actions modify local cellular responses and serve as a necessary mechanistic reinforcement to the central suppression, contributing to the overall suppression over the synthesis and local effects of steroid hormones.

️ Regulation of the Complement System

The drug also engages a distinct mechanism by stimulating the liver to increase the production of C1 Esterase Inhibitor ( C1EI). This action stabilizes the C1EI-regulated pathways, which regulates pathways that influence inflammatory signaling and **affects plasma protein activity involved in the complement cascade and fluid homeostasis.***>>

Dosage and Administration Information

How to Use Cyclomen: Official Administration Guidelines

Cyclomen (Danazol) is administered orally and is available exclusively as hard gelatin capsules for systemic use. All official regimens specify that the total daily dose must be administered in divided doses (typically two or three times per day) to ensure a stable delivery profile.


Key Usage Conditions

Condition Official Labeling Principle
Route and Form Oral capsules only; no other routes are authorized.
Timing with Food Must be taken with a meal to significantly enhance the amount of drug absorbed into the body.
Initiation Therapy for hormone-sensitive conditions must begin during menstruation or following appropriate testing.
Duration Treatment for endometriosis and fibrocystic breast disease is generally continuous and uninterrupted for 3 to 9 months.

Standard Dosing and Schedule

The daily dose ranges vary by condition: 200 mg to 800 mg per day for endometriosis, 100 mg to 400 mg per day for fibrocystic breast disease, and 400 mg to 600 mg per day initially for Hereditary Angioedema (HAE). For HAE, the protocol includes gradual dose reduction (by 50% or less every one to three months) to determine the minimum dose necessary for maintenance.

Procedural Rules

If a dose is missed, it should be taken as soon as it is remembered. However, a missed dose should not be doubled to compensate for the lapse. Safety and effectiveness have not been established in children, which restricts use in this population.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes what clinical research has investigated regarding chronic pain relief.


Overview of Efficacy Studies

Overall, the evidence has examined the drug’s role in reducing moderate-to-severe chronic pain, particularly for neuropathic conditions. The combination has been investigated in studies examining fibromyalgia treatment.

The trials examined the drug’s effects on pain, focusing on its potential interaction with specific pain receptors and its use in individuals with opioid resistance. This focus was the subject of several phase III clinical trials.

Chronic Low Back Pain (CLBP)

In patients with chronic low back pain (CLBP), studies have evaluated the drug for use in individuals unresponsive to first-line NSAIDs. These studies primarily used the Visual Analogue Scale (VAS) to assess pain intensity over a 12-week period.

Research examined the drug’s potential to address associated symptoms, such as sleep disturbances, often reported alongside CLBP.

Migraine and Headache Studies

Research has also explored whether the drug combination has a role in managing chronic migraine. The evidence is inconclusive, but for some people, research has examined the drug's role in chronic migraine flare-ups. Future studies are needed to clarify the drug’s effect profile for this patient group.


Safety and Tolerability Profile

Studies show the drug was examined for long-term use, even up to 5 years. The trials recorded side effects, which were generally described as dose-dependent.

Research investigated how dose levels, including lower starting doses, related to the occurrence of potential side effects. The most frequently reported adverse events included drowsiness, dry mouth, and dizziness.

The combination’s effects when combined with muscle relaxants have been evaluated in research. The interaction was investigated in a Phase I study involving healthy volunteers.

Key Studies & References

  1. Gabapentin versus tricyclic antidepressants for diabetic neuropathy and post-herpetic neuralgia: discrepancies between direct and indirect meta-analyses of randomized controlled trials
  2. NICE Guideline: Neuropathic pain in adults: pharmacological management in non-specialist settings (CG173)
  3. Update on Treatment Guideline in Fibromyalgia Syndrome with Focus on Pharmacology

Frequently Asked Questions (FAQ)

Common questions about Cyclomen (FAQ)

Q: Is it okay to drink alcohol while taking Cyclomen?

According to the official regulatory information, it is stated that it is unsafe to consume alcohol while taking Danazol (Cyclomen). This is a general safety caution provided in the drug's prescribing information and is a caution noted in the regulatory documents.


Q: Can Cyclomen affect my sleep schedule?

Official sources indicate that side effects such as fatigue (feeling tired), nervousness, and mood changes have been reported. These kinds of effects are documented and can potentially influence a person's energy levels and sleep schedule.


Q: Are there any specific vitamins or supplements I should avoid with Cyclomen?

Official warnings note that Danazol can increase the effect of certain other substances, such as synthetic Vitamin D analogs, in the body. Regulatory guidance describes the importance of informing the healthcare provider about all medicines, vitamins, and herbal supplements that are being taken.


Q: Does food change how Cyclomen is absorbed?

Yes, the absorption of the active ingredient, Danazol, is significantly affected by the timing of meals. Official pharmacological data indicates that the amount of drug absorbed into the body is approximately doubled when the capsule is taken immediately after a meal.


Q: Do I need to get blood tests while taking Cyclomen?

According to the official prescribing information, Danazol treatment often involves monitoring. Prescribing information for Cyclomen often mentions periodic blood tests as part of monitoring various bodily functions. This monitoring is mandated particularly for hepatic function (liver health).


Q: Does taking Cyclomen require any special diet changes?

Official documents do not mandate that patients follow a specific, special diet for this medication. However, to achieve the best possible absorption, the capsule is required to be taken with a meal.


Q: Why do people sometimes say Cyclomen made them feel dizzy?

Dizziness is a documented adverse reaction that is listed in the official prescribing information for Danazol. This is one of the documented effects, along with others such as headache and fatigue, that has been reported by users.


Q: Is Cyclomen an addictive medication?

Cyclomen is not classified as a controlled substance under the U.S. Controlled Substances Act (CSA). This means the medication does not carry the same legal classification as drugs that have a potential for abuse or dependency.


Q: Can Cyclomen cause mood changes or depression?

Yes, mood changes, nervousness, and depression are effects that are documented in the official regulatory information for Danazol. These are listed among the reported side effects associated with the drug's use.


Q: What should I do if a side effect seems mild but doesn't go away?

Patient information derived from regulatory sources generally references the importance of informing a healthcare provider of any new or persistent symptoms or side effects. This guidance applies even if the side effect seems mild but does not resolve.


Q: What are the signs that Cyclomen is actually working?

Official labeling describes the drug’s intended therapeutic effect, which is the creation of a hypoestrogenic state (lowered estrogen). This state leads to expected outcomes such as amenorrhea (the cessation of menstrual periods) and the physical regression of abnormal endometrial tissue.


Q: Will Cyclomen make me feel tired or drowsy?

Fatigue, or feeling tired, is listed as a documented side effect in the official product information for Danazol. This effect is part of the established safety profile reported by users.


Q: Is it safe to drive or operate machinery while on Cyclomen?

Regulatory documents state that the drug itself has no or negligible influence on the ability to drive or operate machinery. However, due to the documented possibility of side effects like drowsiness, fatigue, or dizziness, regulatory warnings indicate that avoiding driving is necessary if a person experiences these symptoms.


Q: What does the research say about the long-term safety of Cyclomen?

Official safety sections note that there is limited experience with long-term treatment involving Danazol. Furthermore, regulatory warnings highlight that rare but serious adverse reactions, such as peliosis hepatis (a liver condition) and benign hepatic adenoma, have been associated with its prolonged use.


Q: Why is Cyclomen sometimes prescribed for women's health issues?

The drug is prescribed for certain hormone-dependent conditions because its core action is the suppression of the pituitary-ovarian axis. This mechanism leads to the inhibition of pituitary hormones, ultimately creating the necessary hypoestrogenic state (low estrogen environment) that is beneficial for treating these specific conditions.


Q: How quickly can I stop taking Cyclomen if I feel better?

Official documents define treatment as typically being continuous and uninterrupted for a specific duration, which is often cited as being between 3 to 9 months for conditions like endometriosis. The duration of the therapy is part of the established protocol outlined in regulatory documents.


Q: Does Cyclomen affect blood pressure?

The official safety profile describes the potential for the medication to cause salt and water retention in the body. Consequently, high blood pressure is a documented side effect that has been reported, requiring careful observation during treatment.


Q: Are there any foods that are strictly forbidden when taking Cyclomen?

While the official advice for taking the drug emphasizes the need to take it with a meal for proper absorption, no specific foods are strictly forbidden from co-ingestion. Regulatory safety warnings, however, often mention limiting or avoiding alcohol and caffeinated beverages.


Q: Can using Cyclomen affect my fertility?

The drug's mechanism of suppressing the hormonal cycle leads to the temporary suppression of ovulation during treatment. Official documents indicate that this suppressive action is typically reversible, with ovulation and cyclical bleeding usually returning within 60 to 90 days of discontinuing the medication.


Q: Why is Cyclomen considered a hormone treatment?

Cyclomen is considered a hormone treatment because it is classified as a synthetic steroid and is chemically derived from ethinyltestosterone. Official resources categorize it as an androgenic hormone due to its structure and its action on hormone-regulating systems in the body.


Q: Is Cyclomen a maintenance drug, or is it for short-term use?

The intended use of Cyclomen depends on the condition being treated. For hormone-dependent conditions like endometriosis, it is typically prescribed for a short-term duration (e.g., 3 to 9 months). However, for chronic conditions like Hereditary Angioedema (HAE), the goal is often to establish a minimum maintenance dose for ongoing management.


Q: Is Cyclomen linked to any specific long-term health risks?

Official labeling highlights rare but serious health risks associated with its use, particularly with long-term administration. These include the documented possibility of thromboembolic events (blood clots) and severe hepatic toxicity (liver issues).


Q: Does Cyclomen cause stomach upset often?

Stomach pain and nausea are included as documented side effects in the official product information for Danazol. These effects are part of the established gastrointestinal safety profile.


Q: Is it normal to feel a mild headache when starting Cyclomen?

Headache is a documented side effect that is listed in the official prescribing information for Danazol. This effect is one of the commonly reported symptoms experienced by people taking the medication.

How should Cyclomen be stored and disposed of?

Cyclomen (Danazol) capsules must be stored according to regulatory requirements to maintain product stability.

Storage Conditions

  • Store at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F), with a permitted range of 15 C to 30 C (59 F to 86 F).
  • The capsules must be kept in the tightly closed container in which they were dispensed.
  • Protection from moisture and excessive heat is mandatory, and the product must be kept out of the sight and reach of children.

Disposal Instructions

  • Do not dispose of unused or expired Cyclomen in household waste or via wastewater (sink or toilet).
  • Return unused capsules to a pharmacist or an approved drug take-back program for proper disposal, as defined by regulatory guidelines.

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

Available in countries:

Equivalent of Cyclomen found in:

A-Z Index: