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Therapy Areas

Utrogestan 100mg (micronised progesterone) is generally well tolerated

is generally well tolerated1
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Utrogestan 100mg safety profile

Undesirable effects1

The information given below is based on extensive post marketing experience, from oral administration of progesterone.
System organ classCommon (≥1/100; <1/10)Uncommon (≥1/1,000; <1/100);Rare (≥1/10,000; <1/1,000)Very rare (<1/10,000)Frequency Not known (cannot be estimated from the available data)
Infections and infestationsUrinary tract infections, Vaginitis
Blood and lymphatic disordersThromboembolic disordersAnaemia
Metabolism and nutrition disordersWeight fluctuationFluid retentionChange in glucose tolerance
Psychiatric disordersInsomniaAgitation, Anxiety, Apathy, Depression, Disorientation, Mood swings, NervousnessChange in libido
Nervous system disordersDizziness, Headache, SomnolenceAmnesia, Migraine, Paraesthesia, Speech disorder, Syncope
Eye disordersVisual DisturbanceEye irritation
Ear and labyrinth disordersTinnitus, Vertigo
Cardiac disordersPalpitations, Tachycardia
Vascular disordersHaemorrhage, Hot flush, Hypotension Thrombotic events (mainly when taken in combination with oestrogen)
Respiratory, thoracic and mediastinal disordersDyspnoea
Gastrointestinal disordersAbdominal distension, Abdominal pain, NauseaConstipation, Diarrhoea, VomitingLoss of appetiteTaste disturbances
Hepatobiliary disordersNon-severe and reversible liver disorders, Cholestatic jaundice
Skin and subcutaneous tissue disordersPruritusAcne, Alopecia, Erythema, Hyperhidrosis, Rash, UrticariaChloasma
Musculoskeletal and connective tissue disordersArthralgia, Back pain, Limb discomfort, Muscle spasms, Myalgia
Renal and urinary disordersDysuria
Reproductive system and breast disordersIntermenstrual bleeding, Vaginal haemorrhage, Menstruation irregular, Amenorrhoea, Metrorrhagia, Breast pain and breast tenderness, Breakthrough bleeding or irregular withdrawal bleedingAbnormal withdrawal bleeding, Breast discomfort, Endometrial hyperplasia, Vaginal discharge, Vulvovaginal discomfort, Menstrual cycle abnormal, Mastodynia, HirsutismDysmenorrhea, Cervical erosion, Cervical secretions
Immune system disordersAnaphylactoid reactions
General disorders and administration site conditionsFatigue, MalaiseAsthenia, Chest discomfort, Chest pain, OedemaPyrexia

Adverse event

Infections and infestations
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)Urinary tract infections, Vaginitis
Blood and lymphatic disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Thromboembolic disorders
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)Anaemia
Metabolism and nutrition disorders
Common (≥1/100; <1/10)Weight fluctuation
Uncommon (≥1/1,000; <1/100);Fluid retention
Rare (≥1/10,000; <1/1,000)Change in glucose tolerance
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Psychiatric disorders
Common (≥1/100; <1/10)Insomnia
Uncommon (≥1/1,000; <1/100);Agitation, Anxiety, Apathy, Depression, Disorientation, Mood swings, Nervousness
Rare (≥1/10,000; <1/1,000)Change in libido
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Nervous system disorders
Common (≥1/100; <1/10)Dizziness, Headache, Somnolence
Uncommon (≥1/1,000; <1/100);Amnesia, Migraine, Paraesthesia, Speech disorder, Syncope
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Eye disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Visual Disturbance
Rare (≥1/10,000; <1/1,000)Eye irritation
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Ear and labyrinth disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Tinnitus, Vertigo
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Cardiac disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Palpitations, Tachycardia
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Vascular disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Haemorrhage, Hot flush, Hypotension Thrombotic events (mainly when taken in combination with oestrogen)
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Respiratory, thoracic and mediastinal disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Dyspnoea
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Gastrointestinal disorders
Common (≥1/100; <1/10)Abdominal distension, Abdominal pain, Nausea
Uncommon (≥1/1,000; <1/100);Constipation, Diarrhoea, Vomiting
Rare (≥1/10,000; <1/1,000)Loss of appetite
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)Taste disturbances
Hepatobiliary disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Non-severe and reversible liver disorders, Cholestatic jaundice
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Skin and subcutaneous tissue disorders
Common (≥1/100; <1/10)Pruritus
Uncommon (≥1/1,000; <1/100);Acne, Alopecia, Erythema, Hyperhidrosis, Rash, Urticaria
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)Chloasma
Frequency Not known (cannot be estimated from the available data)
Musculoskeletal and connective tissue disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);Arthralgia, Back pain, Limb discomfort, Muscle spasms, Myalgia
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Renal and urinary disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);
Rare (≥1/10,000; <1/1,000)Dysuria
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
Reproductive system and breast disorders
Common (≥1/100; <1/10)Intermenstrual bleeding, Vaginal haemorrhage, Menstruation irregular, Amenorrhoea, Metrorrhagia, Breast pain and breast tenderness, Breakthrough bleeding or irregular withdrawal bleeding
Uncommon (≥1/1,000; <1/100);Abnormal withdrawal bleeding, Breast discomfort, Endometrial hyperplasia, Vaginal discharge, Vulvovaginal discomfort, Menstrual cycle abnormal, Mastodynia, Hirsutism
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)Dysmenorrhea, Cervical erosion, Cervical secretions
Immune system disorders
Common (≥1/100; <1/10)
Uncommon (≥1/1,000; <1/100);
Rare (≥1/10,000; <1/1,000)Anaphylactoid reactions
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)
General disorders and administration site conditions
Common (≥1/100; <1/10)Fatigue, Malaise
Uncommon (≥1/1,000; <1/100);Asthenia, Chest discomfort, Chest pain, Oedema
Rare (≥1/10,000; <1/1,000)
Very rare (<1/10,000)
Frequency Not known (cannot be estimated from the available data)Pyrexia
Please refer to the Summary of Product Characteristics for more information on adverse events. Hormone replacement therapy (HRT) should only be continued as long as the benefit outweighs the risk.

Contraindications1

  • Known hypersensitivity to the active substance, soya, peanut or to any of the excipients listed in the Summary of Product Characteristics
  • Known, past or suspected breast cancer
  • Known or suspected hormone-dependent malignant tumours (e.g. endometrial cancer)
  • Undiagnosed vaginal (genital) bleeding
  • Untreated endometrial hyperplasia
  • Previous or current thromboembolism (e.g. deep venous thrombosis, pulmonary embolism, thromboembolic disorders) or thrombophlebitis
  • Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency)
  • Active or recent arterial thromboembolic disease (e.g. angina pectoris, myocardial infarction)
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
  • Porphyria
  • Cerebral haemorrhage has been observed with synthetic progestogens
  • Breast feeding

Special warnings and precautions

  • For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life1
  • In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and HRT should only be continued as long as the benefit outweighs the risk1
  • The risk of venous thromboembolism (VTE) increases with HRT1
  • Oral HRT is associated with increased risk of stroke, compared with no HRT1,3
  • Combined oestrogen-progestogen and oestrogen-only treatment is associated with increased risk of ischemic stroke1
  • Combined HRT use is associated with an increased risk of developing breast cancer, whereas oestrogen-only HRT is associated with a possible increased risk of breast cancer1,3
  • The overall evidence shows an increased risk of breast cancer in women taking HRT, that is dependent on the duration of taking HRT. Combined HRT use is associated with an increased risk of developing breast cancer, whereas oestrogen-only HRT is associated with a possible increased risk of breast cancer1,3
  • Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women1
  • Utrogestan 100mg capsules are not suitable in confirmed pregnancy or as a contraceptive1

Please refer to the Summary of Product Characteristics for full information on contraindications, warnings and precautions.

Abbreviations

HRT, hormone replacement therapy; VTE, venous thromboembolism.

References

  1. Utrogestan 100mg (micronised progesterone) Summary of Product Characteristics.
    https://www.medicines.org.uk/emc/product/352/smpc.Accessed June 2026
  2. Data on file. REF-UTO-00078 July 2025
  3. National Institute for Health and Care Excellence, Clinical Guideline 23.
    https://www.nice.org.uk/guidance/ng23Accessed June 2026
June 2026 | MAT-PROMO-UTO-0027

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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