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Clomifene citrate oral


Tablets containing clomifene

Drugs List

  • CLOMID 50mg tablets
  • clomifene 50mg tablets
  • Therapeutic Indications


    Infertility - female - anovulatory



    The recommended dose for the first course of treatment is 50 mg once daily for 5 days, starting within 5 days of onset of spontaneous or induced menstrual bleeding. Treatment may begin at any time in women who have had no recent menstrual bleeding. If ovulation occurs at this dosage, there is no advantage to increasing the dose in future treatment cycles.

    If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg as a single daily dose for 5 days should be given. This course may be started as early as 30 days after the previous one. An increase in the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.

    If ovulation occurs but is not followed by pregnancy, subsequent courses at the same dosage may be given up to a maximum of 3 cycles. Long term therapy past 6 cycles is not recommended.

    The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended for patients who do not show evidence of ovulation.


    Children under 18 years
    Hepatic disorder
    History of hepatic impairment
    Hormone dependent neoplasm
    Non-polycystic ovarian cyst
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Predisposition to thrombophlebitis
    Glucose-galactose malabsorption syndrome
    History of seizures
    Lactose intolerance
    Polycystic ovarian syndrome
    Uterine fibroids

    Reduce subsequent dosage +/or duration if history of ovarian enlargement
    Advise ability to drive/operate machinery may be affected by side effects
    Consider monitoring at risk patients for hypertriglyceridaemia
    Contains lactose
    Examine patients complaining of abdominal/pelvic pain for ovarian cysts
    If pregnancy occurs possibility of ectopic pregnancy should be considered
    If visual disturbances occur, perform ophthalmic evaluation
    Monitor closely patient with depression
    Advise patient to report any abdominal or pelvic pain
    May increase baseline risk of ovarian carcinoma
    Ovarian hyperstimulation syndrome can occur
    Pregnancy: Increased risk of multiple pregnancies
    Uterine fibroids may increase in size
    Discontinue if any kind of visual disturbance occurs
    Withhold therapy in ovarian enlargement until return to pre-treatment size
    Use beyond 6 cycles is not recommended

    Ovarian hyperstimulation syndrome (OHSS) has been reported in patients receiving clomifene citrate treatment when used either cyclically or in combination with gonadotrophins. If pregnancy occurs, a progression towards the more severe form of ovarian hyperstimulation syndrome can occur.

    In ovarian enlargement, withhold treatment until the ovaries return to pre-treatment size. Ovarian enlargement and cyst formation associated with clomifene therapy usually regress spontaneously within a few days or weeks after discontinuing treatment. Dosage and/or duration of the next course of treatment should be reduced.

    Pregnancy and Lactation


    Clomifene is contraindicated in pregnancy.

    Although there is no evidence of harmful effects on the human foetus, animal studies have shown a deleterious effect on the foetus when high doses have been given to the mother.

    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 ( ).


    Use clomifene with caution in breastfeeding.

    It is not known if clomifene citrate is excreted in breast milk.

    Clomifene can stop established milk production when used up to 4 days postpartum. Its effectiveness in stopping established lactation months after breastfeeding commences is believed to be minimal.

    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

    Abdominal discomfort
    Abdominal distension
    Acute abdomen
    Acute respiratory distress
    Allergic reaction
    Angioneurotic oedema
    Biliary stasis
    Blurred vision
    Breast discomfort
    Breast tenderness
    Cerebral thrombosis
    Cerebrovascular accident
    Cyclic ovarian pain
    Deep vein thrombosis (DVT)
    Endometriosis (aggravation of)
    Erythema multiforme
    Hair loss
    Hair thinning
    Increase in bromsulphalein retention
    Increased risk of ectopic pregnancy
    Increased size of uterine fibroids
    Intermenstrual spotting
    Multiple pregnancy
    Nervous tension
    Neurological effects
    Optic neuritis
    Ovarian cancer
    Ovarian cysts
    Ovarian enlargement
    Ovarian haemorrhage
    Ovarian hyperstimulation syndrome (OHSS)
    Pericardial effusion
    Prolonged luteal phase of cycle
    Psychotic reactions
    Pulmonary oedema
    Reduced visual acuity
    Renal failure
    Scintillating scotoma
    Speech disturbances
    Torsion of the ovary
    Visual disturbances
    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 (

    Further Information

    Last Full Review Date: April 2014

    Reference Sources

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on March 31, 2014].

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

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Clomid 50mg tablets. Sanofi. Revised November 2013.

    Summary of Product Characteristics: Clomifene 50mg Tablets. Wockhardt UK Ltd. Revised January 2012.

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

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.