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Danol

Medical expert of the article

Internist, pulmonologist
, medical expert
Last reviewed: 03.07.2025

Danol is a drug that contains sex hormones and affects the sexual sphere.

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ATC classification

G03XA01 Даназол

Active ingredients

Даназол

Pharmacological group

Гормоны гипоталамуса, гипофиза, гонадотропины и их антагонисты

Pharmachologic effect

Антигонадотропные препараты

Indications Danol

Danol is indicated for the treatment of endometriosis symptoms. The drug helps well to stop or significantly reduce lesions on the uterine mucosa in endometriosis.

In addition, the drug is prescribed for surgical treatment as hormonal monotherapy when other types of treatment do not show the desired effect.

Danol is used to reduce the unpleasant symptoms of fibrocystic mastopathy.

The medication is prescribed only to those patients who do not respond to other treatments or in conditions where other therapy is not recommended.

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Release form

The medication is available in the form of gelatin capsules of 100 mg and 200 mg.

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Pharmacodynamics

Danol has moderate affinity for androgen receptors, lesser affinity for progesterone receptors, and minimal affinity for estrogen receptors.

The active substance of the drug is danazol, which is a weak steroid hormone with antiandrogenic, progestogenic, antiprogestogenic, estrogenic and antiestrogenic properties. Danol prevents the synthesis of sex steroids, the accumulation of cAMP in the corpus luteum and granulosa in response to the influence of gonadotropic hormones.

Danazol is able to change the level of protein in plasma, increase the level of plasminogen, antithrombin III, C1-esterase inhibitor and erythropoietin, decreases the level of globulins (which bind to sex hormones and thyroid hormones), fibrinogen. Danol increases the proportions and concentration of testosterone, which remains unbound in plasma.

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Pharmacokinetics

After administration, Danol is absorbed into the body depending on the dosage, and has a virtually linear nature with repeated administration (100-400 mg twice a day).

Food intake has a significant effect on the degree of absorption of the drug. After eating, absorption increases almost twofold compared to taking Danol two hours before eating.

The main metabolic products of danazol are ethisterone and 17-hydroxymethylethisterone. The plasma half-life of the drug is about 24 hours.

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Dosing and administration

Danol is prescribed orally only. The course of treatment should be started during menstruation. It is important to use non-hormonal contraception throughout the treatment.

You should always take the minimum effective dose. For endometriosis, it is recommended to take 200-800 mg per day, usually for 3-6 months.

For benign cystic fibrous mastopathy (as well as cyclic mastalgia), take 100–400 mg per day, duration of treatment is 3–6 months.

In hereditary angioedema, the initial dose is 200 mg 2-3 times a day. If the response is favorable, it is necessary to find the minimum effective dosage for maintenance preventive therapy. In this case, the drug is taken without interruption.

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Use Danol during pregnancy

Danol is not recommended for use by pregnant women, as studies have shown that taking danazol may delay fetal development.


Contraindications

Danol is contraindicated for pregnant women, during breastfeeding, in old age and in childhood.

Also contraindications to the prescription of the drug are severe disorders of liver, kidney or heart function, porphyria, androgen-dependent tumor, abnormal genital bleeding of unknown origin, blockage of blood vessels (present or past).

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Side effects Danol

Danol can cause acne, weight gain, increased appetite, increased sebum secretion, increased male-pattern hair growth, hair loss, voice changes, and in rare cases fluid retention, increased sexual activity, and clitoral hypertrophy.

In addition, menstrual irregularities, bleeding between periods, absence of periods, hot flashes, vaginal dryness, vaginal irritation, changes in libido may occur. In some cases, breast size may change.

Changes in insulin sensitivity, increased glucagon levels or abnormal glucose tolerance, changes in cholesterol levels, and other changes in blood counts may occur.

The drug may cause skin rashes, increased body temperature, facial swelling, increased sensitivity to light, and in rare cases, urticaria, skin discoloration, erythema multiforme, and exfoliative dermatitis.

In some cases, back pain, muscle cramps or tremors, increased levels of creatine phosphokinase (an enzyme of skeletal and smooth muscles) may occur, which can lead to various muscle damages, contraction of muscle fibers (one or a whole group), pain in the limbs, and joint swelling.

The medication may cause increased heart rate, increased blood pressure, thrombotic phenomena (thrombosis of arteries, cerebral vessels, myocardial infarction, etc.).

In rare cases, visual impairment (blurring, problems with focusing, etc.) may occur, which require treatment.

From the side of the central nervous system, emotional instability, anxiety, depression, irritability, headaches are possible. In rare cases, dizziness, increased intracranial pressure, worsening of epilepsy, migraine.

In some cases, cholestatic jaundice, benign liver adenoma, pancreatitis, and rarely, usually with long-term use of the drug, malignant liver tumors and hemorrhages into the liver tissue may be observed.

Vomiting, fatigue, and with prolonged use, blood in the urine, chest pain, and interstitial pneumonitis are possible.

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Overdose

Danol, when taken in high doses, practically does not cause serious negative reactions. Despite the research data, in case of overdose, all necessary measures should be taken to reduce the degree of absorption (take adsorbents). When taken in high doses, the patient should be under the supervision of a specialist in case of late negative reactions.

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Interactions with other drugs

Danol has the ability to increase the level of carbamazepine in plasma (anticonvulsant and antiepileptic drugs), which can affect the patient's response to drugs. A similar reaction is possible with simultaneous administration with phenobarbital.

When taken simultaneously with antidiabetic drugs, a change in insulin sensitivity is possible.

When taking drugs that inhibit blood clotting and Danol, the therapeutic effect may increase.

Danol reduces the effectiveness of drugs for high blood pressure.

The drug increases the toxic effects of tacrolimus and cyclosporine.

Combination therapy with steroids leads to interaction between Danol and sex hormones.

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Storage conditions

Danol should be stored in a place protected from moisture, at room temperature (not higher than 25°C). The drug should be kept away from small children.

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Shelf life

Danol is valid for five years from the date of manufacture. The drug cannot be used if storage conditions are violated.

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Manufacturer

Санофи-Синтелабо Лтд., Великобритания


Attention!

To simplify the perception of information, this instruction for use of the drug "Danol" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.

Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.

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