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Selective oestrogen receptor modulator (SERM) Pregnancy: §8.1: not recommended during pregnancy — contraindicated in women who are or may become pregnant. If used during pregnancy, or if a woman becomes pregnant while taking the drug, she should be apprised of the potential hazard to a fetus. Based on animal data, ospemifene is likely to increase the risk of adverse outcomes during pregnancy and labour: adverse findings at maternally toxic doses included embryofetal lethality in rats and rabbits, and neonatal mortality and difficult labour in rats; drug-induced malformations were not observed in either rats or rabbits.

Ospemifene

Brand names: Senshio

Ospemifene is an oral selective oestrogen receptor modulator (SERM) used to treat moderate to severe symptomatic vulvovaginal atrophy in postmenopausal women not suitable for local vaginal oestrogen.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One 60 mg tablet taken orally with food once daily
Route: Oral — taken with food
Frequency: Once daily
Source: US prescribing information for OSPHENA (ospemifene 60 mg tablets, Duchesnay USA) — no UK SPC was fetched, so the dose must be verified against the UK Senshio SPC before sign-off. The same 60 mg once-daily-with-food dose is given for both labelled indications: §2.1 treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause, and §2.2 treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause. Ospemifene is an oestrogen agonist/antagonist which has agonistic effects on the endometrium: use for the shortest duration consistent with treatment goals and risks for the individual woman, and re-evaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. §5.3 flags severe hepatic impairment as a warning but the fetched text gives no adjusted dose for it. §6 cross-references a Boxed Warning covering cardiovascular disorders and malignant neoplasms. §8.4: not indicated in paediatric patients; clinical studies have not been conducted in the paediatric population. §8.5: of 2209 treated women in ten phase 2/3 trials, more than 19% were 65 years or older, with no clinically meaningful differences in safety or effectiveness versus women under 65.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Undiagnosed abnormal genital bleeding
  • Oestrogen-dependent neoplasia
  • Active deep vein thrombosis or pulmonary embolism, or a history of these conditions
  • Active arterial thromboembolic disease (for example stroke and myocardial infarction), or a history of these conditions
  • Hypersensitivity (for example angioedema, urticaria, rash, pruritus) to ospemifene or any ingredients
  • Women who are or may become pregnant (known or suspected pregnancy)

Side effects

  • Hot flush
  • Vaginal discharge
  • Muscle spasms
  • Headache and hyperhidrosis
  • Vaginal haemorrhage and night sweats (all of the above reported in 1% or more of patients)
  • Thromboembolic and haemorrhagic stroke reported at 1.13 and 3.39 per thousand women years respectively in the 60 mg group in trials of up to 15 months; two cases of myocardial infarction occurred in women receiving 60 mg

Interactions

  • Ospemifene is primarily metabolised by CYP3A4 and CYP2C9, with CYP2C19 and other pathways contributing
  • Oestrogens and oestrogen agonists/antagonists — do not use concomitantly (safety of combined use has not been studied)
  • Fluconazole (moderate CYP3A / strong CYP2C9 / moderate CYP2C19 inhibitor) — do not use concomitantly; increases ospemifene systemic exposure 2.7-fold and may increase the risk of adverse reactions
  • Rifampicin (strong CYP3A4 / moderate CYP2C9 / moderate CYP2C19 inducer) — do not use concomitantly; decreases ospemifene systemic exposure by 58%, and other inducers of these enzymes would be expected to do the same

Clinical monograph

How it works

It acts as an oestrogen receptor agonist on vaginal and vulvar tissue, improving epithelial maturation and reducing dyspareunia, while exerting mixed agonist-antagonist effects elsewhere.

Prescribing in practice

  • It is contraindicated in women with active or past venous thromboembolism and in undiagnosed vaginal bleeding, and carries a thromboembolic and endometrial risk like other agents with oestrogenic activity.
  • It should not be used alongside oestrogens or other oestrogen receptor agonist/antagonists.
  • It is contraindicated in known, suspected, or history of breast cancer.

Monitoring

No routine blood monitoring is required, but investigate any unexpected vaginal bleeding and review thromboembolic risk periodically.

Counselling the patient

  • Take the tablet once daily with food.
  • Report any unexpected vaginal bleeding, or leg pain, swelling, breathlessness, or chest pain promptly.
  • Hot flushes are a recognised side effect.

Evidence & guidelines

Licensed for postmenopausal vulvovaginal atrophy on the basis of randomised controlled trials, as reflected in the SPC.

Reference: NICE TA876; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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