This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Ospemifene oral

Updated 2 Feb 2023 | Oestrogens and HRT

Drugs List

  • ospemifene 60mg tablets
  • SENSHIO 60mg film coated tablets
  • Therapeutic Indications


    Atrophic vaginitis - post-menopausal

    Treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.



    60mg once daily at the same time each day with food.

    Additional Dosage Information

    Missed doses
    If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day.


    Children under 18 years
    Breast cancer
    Deep vein thrombosis
    Endometrial hyperplasia
    History of venous thromboembolism
    Hormone dependent neoplasm
    Pulmonary embolism
    Retinal vein thrombosis
    Severe hepatic impairment
    Undiagnosed gynaecological haemorrhage
    Venous thromboembolism

    Precautions and Warnings

    Body mass index above 30kg per square metre
    Family history of venous thromboembolism
    Predisposition to venous thromboembolism
    Prolonged immobilisation
    Recent surgery
    Risk of cerebrovascular accident
    Severe trauma
    Cerebrovascular disorder
    CYP2C9 poor metaboliser genotype
    Glucose-galactose malabsorption syndrome
    History of cerebrovascular accident
    Lactose intolerance
    Systemic lupus erythematosus

    Exclude breast cancer before treatment
    Exclude oestrogen dependent neoplasm before treatment
    Contains lactose
    Perform a complete physical and gynaecological examination before therapy
    Abnormal and/or irregular bleeding should be investigated
    Advise patients of risks/benefits & review need for treatment regularly
    Breakthrough bleeding should be investigated
    Advise patient to contact a doctor if symptoms of thromboembolism develop
    Discontinue if venous thromboembolism develops
    Discontinue in the event of a prolonged period of immobilisation
    Advise patient not to take St John's wort concurrently

    A careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks. Ospemifene should only be continued as long as the benefit outweighs the risk.

    If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.

    Due to a risk of venous thromboembolic events, ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation. Treatment should be resumed only after the patient is mobilised.

    Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency. In some asymptomatic patients, hot flushes may occur upon beginning therapy. About 1% of subjects discontinued in the phase 2 to 3 clinical programme due to hot flushes.

    Co-administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.

    Pregnancy and Lactation


    Ospemifene is contraindicated during pregnancy.
    Use of ospemifene is contraindicated by the manufacturer. If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately. Animals studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Ospemifene is contraindicated during breastfeeding.

    Use of ospemifene when breastfeeding is contraindicated by the manufacturer. Effects on exposed infants are unknown.

    Side Effects

    Endometrial hypertrophy
    Hot flushes
    Hypersensitivity reactions
    Muscle spasm
    Pharyngeal oedema
    Subcutaneous tissue disorders
    Throat tightness
    Tongue swelling
    Vaginal discharge
    Vaginal haemorrhage
    Vulvovaginal infections


    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: January 2020

    Reference Sources

    Summary of Product Characteristics: Senshio 60mg film coated tablets. Shionogi. Revised November 2019.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

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

    FDB Logo

    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.