Generic Danazol

Introduction

Danazol is a synthetic androgenic-androgenic steroid used primarily to treat hormonal disorders that benefit from its ability to suppress the pituitary-gonadal axis. The medication is supplied as oral tablets in strengths of 50 mg, 100 mg, and 200 mg. It belongs to the class of gonadotropin-releasing hormone (GnRH) modulators, although its exact classification is often listed as a weak androgen and a steroidal anti-estrogen. Danazol is marketed under brand names such as Danocrine and Danol, and it is also available as a generic product. In addition to its approved uses, clinicians sometimes employ Danazol off-label for rare endocrinopathies, but such applications must be guided by specialist supervision.

What is Danazol?

Danazol is a synthetic steroid derived from ethisterone. It was first synthesized in the s and introduced in the United States in 1971. The drug is produced by several pharmaceutical manufacturers; one of the most widely recognized brand versions is Danocrine (Pfizer). Danazol tablets contain the active molecule Danazol, along with inactive excipients such as lactose, magnesium stearate, and microcrystalline cellulose that aid tablet formation and stability.

“Danazol is the generic version of well-known medications, containing the active compound Danazol. Our online pharmacy provides this generic alternative as a cost-effective treatment option.”

How Danazol Works

Danazol exerts its therapeutic effect through multiple hormonal pathways:

1. Suppression of Gonadotropin Release - Danazol binds to estrogen receptors in the hypothalamus and pituitary gland, reducing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The resulting hypo-gonadotropic state lowers ovarian estrogen production.

2. Weak Androgenic Activity - By acting as a weak agonist at androgen receptors, Danazol provides modest androgenic stimulation, which can counterbalance estrogen-driven symptoms such as menstrual bleeding.

3. Inhibition of Steroidogenesis - Danazol interferes with enzymes involved in the conversion of cholesterol to sex steroids, further diminishing endogenous estrogen levels.

The combined actions produce a rapid decline in circulating estrogen, often within a few days, and the effect persists as long as the drug is taken. The drug’s half-life is approximately 3-4 hours, but steady-state hormonal suppression is achieved after 5-7 days of regular dosing.

Conditions Treated with Danazol

Endometriosis (approved)

Endometriosis is characterized by ectopic implantation of endometrial tissue, causing painful menstrual bleeding and pelvic pain. Danazol’s estrogen suppression limits the growth of ectopic tissue, leading to reduced pain and bleeding. Clinical trials have demonstrated significant symptom relief after 3-6 months of therapy.

Hereditary Angioedema (HAE) - prophylaxis (approved in some regions)

HAE results from deficient or dysfunctional C1-esterase inhibitor, causing episodic swelling. Danazol’s androgenic effect raises hepatic production of C1-esterase inhibitor, thereby decreasing attack frequency.

Fibrocystic Breast Disease (approved)

The drug’s anti-estrogenic properties reduce breast tissue proliferation and associated tenderness.

Menstrual Disorders (e.g., secondary amenorrhea, menorrhagia) - approved in several countries

By lowering estrogen, Danazol can induce amenorrhea or reduce heavy menstrual bleeding when other treatments are unsuitable.

These indications are supported by regulatory approvals from agencies such as the U.S. FDA (for endometriosis) and the European Medicines Agency (for HAE prophylaxis).

Off-Label and Investigational Uses of Danazol

• Premature Ovarian Failure (POF) - Small case series have reported that Danazol can increase ovarian reserve markers by attenuating excessive follicular recruitment. Evidence remains limited and the therapy is not approved.

• Polycystic Ovary Syndrome (PCOS) with Hyperandrogenism - Occasionally used to suppress LH surge and reduce ovarian androgen production; however, larger trials favor other agents (e.g., metformin, oral contraceptives).

• Benign Prostatic Hyperplasia (BPH) - Historical research suggested a modest reduction in prostate volume due to androgenic modulation, but modern management prefers 5-alpha-reductase inhibitors.

• Aplastic Anemia - Early s studies explored Danazol’s immunomodulatory potential; current practice does not include it because of safety concerns.

All off-label applications should only be pursued under direct supervision of a qualified healthcare professional, and patients must be informed that regulatory bodies have not evaluated safety or efficacy for these uses.

Is Danazol the Right Medication for You?

Danazol is most suitable for adult patients who:

• Have confirmed endometriosis causing moderate-to-severe pain and have not responded adequately to first-line hormonal therapies (e.g., combined oral contraceptives, progestins).
• Require HAE prophylaxis and have contraindications to newer agents such as lanadelumab or berotralstat.
• Experience symptomatic fibrocystic breast disease or refractory menstrual bleeding where estrogen suppression is indicated.

Contraindications include:

• Known hypersensitivity to Danazol or any tablet excipients.
• Active liver disease (elevated transaminases > 3 × ULN).
• Uncontrolled hypertension or a history of thromboembolic events.
• Pregnancy, because Danazol is teratogenic; effective contraception is mandatory.

Patients with a history of lipid abnormalities, severe acne, or mood disorders should be evaluated carefully, as Danazol can exacerbate these conditions.

Risks, Side Effects, and Interactions

Common (≥ 1 % frequency)

• Weight gain - Often due to fluid retention or increased appetite.
• Acne or oily skin - Reflects its weak androgenic activity.
• Menstrual irregularities - Including amenorrhea or breakthrough bleeding.
• Headache - Usually mild and transient.

Rare (.01 %-1 % frequency)

• Hepatotoxicity - Elevations in AST/ALT; monitoring of liver function tests is recommended every 3 months.
• Voice deepening - May be reversible after discontinuation.
• Menstrual-related mood swings - Particularly in patients with underlying mood disorders.

Serious (≤ .01 % frequency)

• Severe hepatic injury - Rare cases of cholestatic hepatitis have been reported.
• Thromboembolic events - Including deep-vein thrombosis and pulmonary embolism, especially in patients with additional risk factors (e.g., smoking, oral contraceptive use).
• Androgenic virilization - Persistent hirsutism or clitoral enlargement in females, generally reversible after stopping the drug.

Drug-Drug Interactions

• Warfarin - Danazol may increase INR; more frequent coagulation monitoring is advised.
• Cytochrome P450 inducers (e.g., rifampin, carbamazepine) - May reduce Danazol plasma concentrations, diminishing efficacy.
• Oral contraceptives - Combined estrogen-progestin pills can counteract Danazol’s estrogen-suppressing effect, possibly requiring dose adjustments.

Drug-Food Interactions

• Alcohol - Excessive intake can exacerbate liver toxicity; moderate consumption is recommended.
• High-fat meals - Slightly increase absorption but have no clinical significance; tablets can be taken with or without food.

Patients should avoid operating heavy machinery or driving until they know how Danazol affects them, as dizziness or visual disturbances can occur.

Use: Dosing, Missed Dose, Overdose

Standard dosing varies according to the indication:

• Endometriosis - 200 mg twice daily for the first 2 months, then reduced to 100 mg twice daily for maintenance.
• HAE prophylaxis - 200 mg once daily for adult patients; dose may be adjusted based on attack frequency and hepatic function.
• Fibrocystic breast disease / menstrual disorders - 100 mg once or twice daily, depending on response.

Missed dose: Take the missed tablet as soon as remembered unless it is within 6 hours of the next scheduled dose. In that case, skip the missed tablet and continue with the regular schedule. Do not double-dose.

Overdose: Symptoms may include severe nausea, vomiting, abdominal pain, and hepatic dysfunction. If an overdose is suspected, seek emergency medical care promptly. Activated charcoal may be administered if presentation is within one hour of ingestion.

Practical precautions:

• Take tablets with a full glass of water.
• Do not consume alcohol excessively while on therapy.
• Avoid starting new hormonal contraceptives without discussing with a prescriber.
• Regularly monitor blood pressure, liver enzymes, and lipid profile throughout treatment.

FAQ

• What should I do if I travel internationally with Danazol?

  • Keep the medication in its original labeled container, carry a copy of the prescription (or a physician’s letter) and store it in your hand luggage to avoid temperature extremes.

• Can Danazol affect laboratory drug tests?

  • Danazol is not typically screened for in standard drug-of-interest panels, but it may cause false-positive results for anabolic steroids in certain specialized assays.

• Is Danazol safe for post-menopausal women?

  • The drug can still suppress residual estrogen production, but the risk-benefit ratio should be carefully evaluated, especially concerning bone density loss.

• What are the inactive ingredients in the tablets?

  • Common excipients include lactose monohydrate, microcrystalline cellulose, magnesium stearate, and silicon dioxide. Patients with severe lactose intolerance should discuss alternatives with their clinician.

• How long can Danazol be used continuously?

  • Long-term therapy (> 12 months) is possible under close monitoring of liver function, lipid profile, and blood pressure; periodic “drug holidays” may be considered to mitigate side-effects.

• Does Danazol interact with herbal supplements?

  • St. John’s wort induces CYP3A4 and may reduce Danazol efficacy; other supplements with androgenic activity (e.g., DHEA) could increase androgen-related side effects.

• Can Danazol be taken with vitamin D supplements?

  • Yes; in fact, maintaining adequate vitamin D and calcium intake is advisable to counteract potential bone mineral loss during prolonged therapy.

• What storage conditions are recommended?

  • Store tablets at controlled room temperature (15-30 °C). Protect from moisture and direct sunlight; do not refrigerate.

• Is it possible to become dependent on Danazol?

  • Physical dependence is not described; however, abrupt cessation after long-term use can lead to a rebound rise in estrogen levels, potentially worsening the original condition. Tapering is recommended.

• How does Danazol differ from newer GnRH antagonists?

  • Danazol suppresses estrogen indirectly and retains weak androgenic activity, whereas modern GnRH antagonists (e.g., elagolix) provide more selective pituitary blockade with fewer androgenic side effects.

Glossary

GnRH Modulator

A drug that influences the release or action of gonadotropin-releasing hormone, thereby altering the secretion of LH and FSH.

Androgenic Activity

The ability of a compound to stimulate androgen receptors, producing effects such as increased body hair, acne, or deepening of the voice.

C1-Esterase Inhibitor

A plasma protein that controls the complement and contact systems; deficiency leads to hereditary angioedema.

Hepatotoxicity

Liver injury caused by chemicals, drugs, or toxins, often manifested by elevated liver enzymes or clinical hepatitis.

Buying Danazol from Our Online Pharmacy

Patients who need reliable access to Danazol can obtain it through our online pharmacy. We source the medication directly from licensed, FDA-registered manufacturers, ensuring that each batch meets strict quality-control standards. Because we operate as a pharmacy-broker service, we are able to offer the generic formulation at a price close to wholesale cost, markedly lower than many brick-and-mortar pharmacies.

Our service provides:

• Affordability: Competitive pricing that reduces out-of-pocket expenses for patients without insurance coverage.
• Verified Quality: All products are verified against the manufacturers’ certificates of analysis and stored under optimal conditions.
• Discreet Delivery: Packages are packed in unmarked, secure containers and shipped via reliable carriers, with options for express (≈ 7 days) or standard airmail (≈ 3 weeks).
• Global Reach: We cooperate with overseas licensed pharmacies, granting access to medications that may be unavailable locally.

By choosing our online pharmacy, patients gain a confidential, convenient, and cost-effective pathway to obtain Danazol when traditional pharmacy channels are limited or prohibitively expensive.

Disclaimer

The information provided about Danazol is intended for general educational purposes and does not replace professional medical advice. Treatment decisions-including the use of Danazol for off-label conditions-should be made under the guidance of a qualified healthcare professional. Readers are presumed to be responsible adults capable of making informed health choices. Our online pharmacy offers access to Danazol for individuals who may encounter limited availability through conventional pharmacies, insurance formularies, or who seek affordable generic options. Always discuss with a healthcare provider before initiating, altering, or stopping any medication.