Clinical Summary: Danogen 200 is an oral antigonadotropic and androgenic agent containing Danazol 200mg per capsule, manufactured by Cipla Ltd. Derived synthetically from ethisterone, it is clinically indicated for the management of endometriosis-associated chronic pelvic pain, severe fibrocystic breast disease, and the prevention of hereditary angioedema (HAE) attacks. By creating a controlled hypoestrogenic, hyperandrogenic internal state (often described as “pseudomenopause”), Danogen 200 leads to the inactive atrophy of ectopic endometrial implants. Patients in Australia require clinical oversight to monitor hepatic function, lipid shifts, and early signs of androgenic effects.
Product Specifications
| Clinical Parameter | Product Specification Details |
| Product Trade Name | Danogen 200 / Danogen 200 mg Capsule |
| Active Pharmaceutical Ingredient (API) | Danazol USP (200 mg per capsule) |
| Pharmacological Class | Synthetic Steroid / -Ethisterone Derivative / Antigonadotropin |
| Formulation | Hard gelatin oral capsule |
| Primary Clinical Indications | Endometriosis, Fibrocystic Breast Disease, Hereditary Angioedema (HAE) |
| Standard Treatment Duration | 3 to 6 months continuously for gynecological indications |
| Pregnancy Classification | Category X (Contraindicated; causes fetal virilization) |
| Australian Schedule | Schedule 4 (S4 / Prescription Only Medicine) |
What is Danogen 200 (Danazol 200mg)?
Danogen 200 is an established hormonal modulator primarily prescribed when front-line gynecological treatments (such as standard combined oral contraceptives or nonsteroidal anti-inflammatory drugs) fail to resolve deep pelvic pain, dyspareunia, and dysmenorrhea caused by endometriosis.
While it does not eradicate the underlying disease permanently, a course of Danazol 200mg suppresses ovarian estrogen production, halting the monthly cyclical bleeding of lesions outside the uterus and providing symptom relief.
What are the Uses of Danogen 200?
Danogen 200 is an antigonadotropic agent and synthetic steroid derived from – ethisterone. It is primarily prescribed for:
- Endometriosis Management: Used to treat pelvic pain, dysmenorrhea (painful periods), and painful intercourse (dyspareunia) caused by endometriosis. By lowering estrogen levels and blunting the mid-cycle surge of LH and FSH, it creates a temporary state of “pseudomenopause,” which starves ectopic endometrial implants and causes them to shrink and regress.
- Fibrocystic Breast Disease: Prescribed for severe, painful nodularity and breast tenderness that do not respond to simple analgesics or supportive lifestyle changes.
- Hereditary Angioedema (HAE) Prophylaxis: Indicated for both men and women to prevent recurrent attacks of cutaneous, abdominal, and laryngeal swelling by increasing hepatic synthesis of the deficient C1 esterase inhibitor (C1-INH).
- Severe Menorrhagia (Heavy Menstrual Bleeding): In selected, treatment-resistant cases, it can be used short-term to thin the uterine lining (endometrium) and suppress heavy blood loss.
Danazol Mechanism of Action
The Danazol mechanism of action operates through central pituitary suppression combined with direct peripheral binding to multiple steroid receptors:
- Central Antigonadotropic Action: Danazol blunts the pulsatile release of pituitary gonadotropins, specifically abolishing the mid-cycle surges of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) without completely shutting down baseline tonic secretion.
- Direct Ovarian Suppression: It inhibits key enzymes in the steroidogenesis pathway within the ovaries, leading to a marked decrease in circulating estradiol and progesterone.
- Tissue Atrophy: By binding directly to intracellular androgen and progesterone receptors in endometrial tissue, danazol causes the cellular regression, thinning, and functional dormancy of both normal uterine endometrium and ectopic endometriotic plaques.
- C1 Esterase Elevation in Angioedema: In patients with hereditary angioedema, danazol acts on the liver to increase circulating levels of C1 esterase inhibitor (C1-INH) and C4 complement factors, preventing acute attacks of swelling in the airway, face, and abdomen.
Danazol Dosage Protocols: How to Take Danogen 200
Your physician will determine your precise Danazol dosage based on the severity of your condition, body weight, and clinical response.
| Clinical Condition | Standard Danazol 200mg Dosage | Regimen & Duration |
| Moderate to Severe Endometriosis | 400 mg to 800 mg daily | Taken as one 200 mg capsule 2 to 4 times daily in divided doses. The objective is continuous amenorrhea (no periods) for 3 to 6 months. |
| Mild Endometriosis | 200 mg to 400 mg daily | Taken as one 200 mg capsule once or twice daily in divided doses for 3 to 6 consecutive months. |
| Fibrocystic Breast Disease | 100 mg to 400 mg daily | Divided into two daily doses for 3 to 6 months. Treatment begins during menstruation. |
| Hereditary Angioedema (HAE) | 200 mg two to three times daily | Once clinical attacks are prevented, the dose is gradually reduced down to the lowest effective maintenance level (e.g., 200 mg or 100 mg every 1–2 days). |
Essential Administration Rules
- The Menstrual Day 1 Rule: Gynecological therapy must always begin on Day 1 of your menstrual period. This confirms you are not pregnant and protects a developing embryo from accidental drug exposure.
- Maintain Divided Doses: To maintain steady blood levels, take capsules with a glass of water at regular intervals throughout the day.
- Do Not Skip Doses: Inconsistent intake can lead to breakthrough ovulatory surges and irregular vaginal spotting.
Danazol Side Effects: Female Considerations & Virilization Warnings
Because danazol has mild androgenic and anabolic properties, patient education regarding Danazol side effects female patterns is an important clinical priority.
| Side Effect Classification | Specific Symptoms & Clinical Presentations | Reversibility Status |
| Hypoestrogenic Side Effects (Low Estrogen) | Hot flushes, night sweats, vaginal dryness, dyspareunia, mood instability, and decrease in breast size. | Fully Reversible: Resolves within weeks after discontinuing treatment. |
| Mild Androgenic Side Effects (Male Hormone Action) | Increased oily skin, acne vulgaris, mild fluid retention, and gradual weight gain. | Reversible: Clears gradually after stopping the medication. |
| Significant Virilization Signs (Urgent Attention Required) | Deepening of the voice (hoarseness, pitch drop), abnormal facial hair growth (hirsutism), clitoral enlargement, and male-pattern hair thinning. | POTENTIALLY IRREVERSIBLE: If voice deepening, pitch cracking, or clitoromegaly develops, contact your physician to discontinue the drug immediately to prevent permanent changes. |
Serious Precautions, Black Box Warnings & Contraindications
Danazol contraindications and safety warnings require careful review before starting therapy:
Absolute Contraindications
- Confirmed or Suspected Pregnancy (Category X): Danazol causes significant masculinization of the external genitalia in female fetuses (including labial fusion and clitoromegaly).
- Breastfeeding: The drug is excreted in breast milk and can alter infant endocrine development.
- Undiagnosed Abnormal Genital Bleeding: Must be thoroughly investigated to rule out uterine malignancy before treatment begins.
- Severely Impaired Hepatic, Renal, or Cardiac Function: Danazol is metabolized by the liver and can worsen fluid overload or organ failure.
- Porphyria: Danazol stimulates delta-aminolevulinic acid (ALA) synthetase, which can trigger acute attacks.
- Active Thromboembolic Disease: A personal history of deep vein thrombosis (DVT), pulmonary embolism, or arterial thrombosis.
- Androgen-Dependent Tumors: Any malignancy that responds to male sex hormones.
Critical Black Box Warnings
- Thromboembolism: Danazol therapy increases the risk of stroke, pelvic vein thrombosis, and benign intracranial hypertension (pseudotumor cerebri presenting with persistent severe headache, nausea, and papilledema).
- Hepatotoxicity: Long-term use can cause elevated transaminases, peliosis hepatis (blood-filled liver cavities), and benign hepatic adenomas. Routine Liver Function Tests (LFTs) are mandatory.
- Severe Dyslipidemia: Danazol stimulates hepatic triglyceride lipase, leading to a marked decrease in protective HDL cholesterol (often by 40% or more) and an increase in atherogenic LDL cholesterol.
Where Can I Buy Danogen 200 mg?
Danogen 200 mg can be sourced through verified online pharmacy platforms like AustraliaRxMeds:
- Prescription Requirement: In Australia, the UK, the US, and most global jurisdictions, Danazol is strictly a Schedule 4 (Prescription Only / S4) medication. It cannot be dispensed legally without a valid prescription from a registered medical doctor or specialist.
- TGA Personal Importation (Australia): Australian consumers purchasing imported formulations online must adhere to the Therapeutic Goods Administration (TGA) Personal Importation Scheme:
- You may import up to a 3-month supply per single order for personal medical use.
- The cumulative quantity imported across any 12-month period must not exceed a 15-month supply.
- A valid Australian prescription must accompany the import to clear Australian Customs and Border Force.
- Ordering Online via AustraliaRxMeds: Danogen 200 mg capsules can be ordered directly via AustraliaRxMeds with batch authentication, protective blister packaging, and tracked international shipping.
- Safety Reminder: Avoid unverified offshore storefronts that offer Danazol without requiring a prescription or clinical consultation, as counterfeit steroids carry severe risks of under-dosing, liver toxicity, or unlisted compounds.
The Contraception Rule: Non-Hormonal Methods Only
Because danazol alters reproductive hormone receptors, oral contraceptive pills, progestin implants, and hormonal patches must NOT be used concurrently. Women of childbearing potential must use effective non-hormonal barrier methods (such as condoms, diaphragms, or a copper IUD) consistently throughout treatment.
Danazol 200 mg Price & Sourcing in Australia
- Danazol 200 mg Price Factors: The cost of Danogen 200 varies depending on pack volume (30, 60, or 90 capsules per order) and international dispensing options. Sourcing generic Danazol 200mg through licensed platforms like AustraliaRxMeds provides an affordable alternative to scarce local brand-name formulations.
- Prescription & TGA Compliance: In Australia, danazol is a Schedule 4 prescription drug. Patients ordering via online services must provide a valid doctor’s prescription and comply with the Therapeutic Goods Administration (TGA) Personal Importation Scheme (importing no more than a 3-month supply per shipment).
Mandatory Pathology Monitoring Checklist
Medical References
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U.S. Food and Drug Administration (FDA). Danocrine (danazol capsules): Full Prescribing Information & Safety Review. Reference ID: NDA 017557.
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Cochrane Database of Systematic Reviews. Danazol for pelvic pain associated with endometriosis. CD000068.
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Cipla Ltd. Danogen (Danazol Capsules USP 50mg, 100mg, 200mg): Product Monograph & Clinical Index.
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Selak, V., et al. (2007). Danazol for the treatment of endometriosis: Clinical outcomes and long-term symptom relief. Human Reproduction Update, 13(4), 315–326.
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Zuraw, B. L. (2008). Clinical practice: Hereditary angioedema and the role of attenuated androgens. New England Journal of Medicine (NEJM), 359(10), 1027–1036.
FAQs
What is Danogen 200 used for?
Danogen 200 contains Danazol 200mg, an oral antigonadotropic steroid manufactured by Cipla Ltd. It is prescribed primarily for the medical management of endometriosis-related pelvic pain, severe fibrocystic breast disease, and hereditary angioedema (HAE) attacks.
What is the typical Danazol 200mg dosage for endometriosis?
The standard Danazol 200mg dosage for moderate-to-severe endometriosis ranges from 400 mg to 800 mg daily, taken as one 200 mg capsule two to four times daily in divided doses. Mild cases often start on 200 mg to 400 mg daily. Treatment must begin on Day 1 of normal menstrual bleeding and continue for 3 to 6 months.
Are Danogen 200 side effects permanent in females?
Most side effects—such as hot flushes, fluid retention, weight gain, acne, and missed periods—are fully reversible once you stop the medication. However, voice changes (such as deepening or persistent hoarseness), hair loss, and clitoral enlargement can be permanent. If your voice begins cracking or deepening, speak with your doctor immediately to discuss discontinuing the medication.
Can I take birth control pills while on Danogen 200?
No. Hormonal contraceptives (including combination pills, mini-pills, and progestin implants) should not be used with danazol because of competing interactions at steroid receptor sites. You must use reliable, non-hormonal barrier birth control methods (such as condoms) while taking this medicine.
How does Danazol work to stop endometriosis pain?
The Danazol mechanism of action blunts the mid-cycle surge of pituitary hormones (LH and FSH) and directly inhibits ovarian estrogen synthesis. This induces an artificial temporary state of "pseudomenopause," which starves ectopic endometrial tissue of estrogen and causes it to atrophy and regress.
What is the Danazol 200 mg price in Australia?
The Danazol 200 mg price generally ranges between $1.30 and $1.60 USD per capsule through international online pharmacies, depending on order quantity. Australian patients importing this medication require a valid prescription under the TGA Personal Importation Scheme.





