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Prometrium® (progesterone) 400mg soft vaginal capsules

Prometrium (progesterone) 400mg soft vaginal capsules safety and tolerability

Learn about the safety profile of the UK’s first and only licensed progesterone treatment for the prevention of miscarriage in women with a history of recurrent miscarriage who present with bleeding in the first trimester.¹
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Undesirable effects observed with Prometrium¹

Local intolerance (burning, itching or oily discharge) has been observed. When used as recommended, transient fatigue or dizziness may occur within 1 to 3 hours of taking the medicine.

The information given in the table below is based on frequency of occurrence of adverse drug reactions for progesterone. Please refer to the Summary of Product Characteristics (SmPC) for more information on adverse events.

System Organ Class (SOC)

Frequency Not known      
(Cannot be estimated from the available data)

Skin and subcutaneous tissue disorders
Pruritus
Reproductive system and breast disorders
Vaginal discharge     
Vaginal haemorrhage
General disorders and administrative site conditions
Burning sensation

Prometrium contraindications¹

Hypersensitivity to the active substance or to any of the excipients listed in the SmPC. 

  • Jaundice
  • Severe hepatic dysfunction
  • Undiagnosed vaginal bleeding
  • Mammary or genital tract carcinoma
  • Thrombophlebitis
  • Thromboembolic disorders
  • Cerebral haemorrhage
  • Porphyria
  • Allergy to nuts or soya 

Special warnings and precautions for use¹

Warnings

  • A complete medical examination must be performed before starting the treatment and regularly during the treatment
  • Prometrium should only be used for threatened miscarriage during the first trimester, up to the 16th week of pregnancy, and must only be administered by the vaginal route
  • Not suitable as a contraceptive
  • Treatment should be discontinued upon diagnosis of a missed abortion
Precautions
  • Any vaginal bleeding should always be investigated
  • Prometrium contains soybean lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients)
  • As there is a possible relationship between allergy to soya and allergy to peanut, patients with peanut allergy should avoid using

Prometrium efficacyPrometrium dosing

Abbreviations

SmPC, Summary of Product Characteristics.

References

  1. Prometrium 400mg soft vaginal capsules Summary of Product Characteristics. Available at:
    https://www.medicines.org.uk/emc/product/16016/smpcAccessed June 2026
June 2026 | MAT-PROMO-PTM-0100

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: drugsafety@besins-healthcare.com

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