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Capsules containing danazol

Drugs List

  • danazol 200mg capsules
  • Therapeutic Indications


    Benign fibrocystic breast disease - unresponsive to other treatment
    Endometriosis - unresponsive to other treatment
    Thinning of uterine endometrium before or instead of surgery
    Treatment of severe cyclical mastalgia with/without nodularity

    Unlicensed Uses

    Hereditary angioedema



    Danazol should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient's response.
    A dosage reduction may be possible once a satisfactory response has been achieved.
    In fertile females, who should employ non-hormonal contraception throughout treatment, danazol should be started during menstruation, preferably on the first day. Appropriate checks to exclude pregnancy should be made prior to treatment, if necessary.

    The recommended dosage is 200 mg to 800 mg daily in a course of treatment lasting normally 3 to 6 months. Dosage should be increased if normal cyclical bleeding still persists after two months therapy, a higher dosage (not exceeding 800 mg per day) may also be needed for severe disease.

    Benign fibrocystic breast disease
    Initially 300 mg daily in a course of treatment lasting normally 3 to 6 months.

    200 mg daily in a course of treatment lasting normally 3 months.

    400 mg daily in up to four divided doses for 6 months.

    Severe cyclical mastalgia
    Initially 200 mg to 300 mg daily, according to the severity of the symptoms, a course of treatment normally lasting 3 to 6 months.

    Pre-operative thinning of the endometrium
    400 mg to 800 mg daily in up to four divided doses for 3 to 6 weeks.

    Hereditary Angioedema (Unlicensed Use)
    Initially 100 to 200 mg daily then reducing dose according to response.


    200 mg daily, increased to 400 mg daily if no response after two months.


    Children under 12 years
    Androgen-dependent neoplasm
    History of thrombosis
    Severe cardiac dysfunction
    Severe hepatic impairment
    Severe renal impairment
    Thromboembolic disorder
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Children aged 12 to 18 years
    Disorders aggravated by fluid retention
    Females of childbearing potential
    Marked or persistent androgenic reaction to previous gonadal steroids
    Breast nodules
    Cardiac impairment
    Cardiovascular disorder
    Diabetes mellitus
    Disorder of lipoprotein metabolism
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Lactose intolerance
    Malignant neoplasm
    Renal impairment

    Diabetes mellitus: May cause insulin resistance
    Exclude malignancy before treatment
    Not all available brands are licensed for all indications
    Contains lactose
    During treatment > than 6 months, perform biannual hepatic ultra sonography
    Monitor haematological parameters periodically
    Monitor hepatic function
    Exclude cancer if breast nodules persist/enlarge during therapy
    May increase baseline risk of ovarian carcinoma
    May affect results of some laboratory tests
    Advise patient to seek advice at first indications of pregnancy
    Discontinue at first signs of thrombophlebitis or thromboembolism
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if signs of raised intracranial pressure
    Discontinue treatment if evidence of virilisation appears
    Female: Barrier or non-hormonal contraception advised during treatment

    Monitor hepatic function and haematological parameters periodically.
    The long term risks of repeated courses of treatment should be considered as danazol is chemically related to steroids which have known long term risks of benign hepatic adenomata, peliosis hepatis and hepatic carcinoma. If treatment extends beyond 6 months, or repeated courses are given, biannual hepatic ultrasonography is recommended.

    Pregnancy and Lactation


    Danazol is contraindicated during pregnancy.

    Danazol should not be used during pregnancy as there is epidemiological and toxicological evidence of hazard. Danazol is known to be associated with a risk of virilisation of the female foetus if administered during pregnancy. If the patient conceives during pregnancy, danazol should be discontinued.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Danazol is contraindicated in breastfeeding.

    Danazol has the theoretical potential for androgenic effects in breast-fed infants and therefore either danazol therapy or breast-feeding should be discontinued.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    "Spotting" bleeding
    Altered glucose tolerance
    Altered lipoproteins
    Altered thyroid hormone levels
    Amenorrhoea during and after treatment
    Arterial thrombosis
    Back pain
    Benign hepatic adenomata
    Benign raised intracranial pressure
    Breast size reduction
    Carpal tunnel syndrome
    Cerebral thrombosis
    Changes in libido
    Cholestatic jaundice
    Clitoral hypertrophy
    Creatine phosphokinase increased
    Emotional lability
    Epigastric pain
    Erythema multiforme
    Exacerbation of epilepsy
    Exfoliative dermatitis
    Facial oedema
    Fluid retention
    Gastro-intestinal disturbances
    Haematological disorders
    Hair loss
    Hepatic failure
    Hepatic tumours
    Hepatocellular damage
    Hepatocellular jaundice
    Increase in serum glucose
    Increase in serum transaminases
    Increased appetite
    Inflammatory erythematous nodules
    Insulin resistance
    Interstitial pneumonitis
    Joint pain
    Joint swelling
    Limb pain
    Menstrual disturbances
    Muscle cramps
    Muscle spasm
    Myocardial infarction
    Oily skin
    Peliosis hepatis
    Pleuritic pain
    Reduction in spermatogenesis (in male)
    Skin pigmentation changes
    Skin reactions
    Splenic peliosis
    Vaginal dryness
    Vaginal irritation
    Visual disturbances
    Voice changes
    Weight gain


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2013

    Reference Sources

    Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on December 16, 2013]

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013. Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on December 16, 2013].

    Summary of Product Characteristics: Danol 200mg capsules.Sanofi. Revised August 2013.
    Summary of Product Characteristics: Danazol 200mg capsules. Generics UK Ltd. Revised February 2013.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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