Gale Adverse Reactions

The most frequently observed adverse drug reactions (ADRs) in patients receiving cyproterone acetate are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.
The most serious ADRs in patients receiving cyproterone acetate are hepatic toxicity, benign and malignant liver tumours which may lead to intra-abdominal haemorrhage and thromboembolic events.
The following approximate incidents were estimated from published reports of a number of small clinical trials and spontaneous ADR reports: very common: incidence ≥1:10; common: incidence <1:10 but ≥1:100; uncommon: incidence <1:100 but ≥1:1,000; rare: incidence <1:1,000 but ≥1:10,000; very rare: incidence <1:10,000; not known (cannot be estimated from available data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Very rare: Benign and malignant liver tumours which may lead to life threatening intra-abdominal haemorrhage (see Precautions).
Rare: The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate (see Precautions).
Blood and lymphatic system disorders: Not known: Anaemia during long-term treatment.
Immune system disorders: Rare: Hypersensitivity reactions.
Endocrine disorders: Not known: Suppression of adrenocortical function.
Metabolism and nutritional disorders: Common: Changes in bodyweight during long-term treatment (chiefly weight gains in association with fluid retention).
Psychiatric disorders: Common: Depressive moods and restlessness (temporary).
Vascular disorders: Not known: Thromboembolic events, although a causal relationship has not been established (see Precautions).
Respiratory, thoracic & mediastinal disorders: Common: Dyspnoea (see Precautions).
Hepatobiliary disorders: Common: Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, which has been fatal in some cases, have been reported in patients treated with 200-300 mg cyproterone acetate (usually at dosages of 100 mg and above) (see Precautions). Most reported fatal cases were in men with advanced carcinoma of the prostate.
Toxicity is dose related and develops, usually, several months after treatment has begun.
Skin & subcutaneous tissue disorders: Uncommon: Rash.
Not known: Reduction of sebum production leading to dryness of the skin and consequently improvement of existing acne vulgaris has been reported as well as; transient patchy loss and reduced growth of body hair, increased growth of scalp hair, lightening of hair colour and female type of pubic hair growth.
Musculoskeletal, connective tissue and bone disorders: Not known: Osteoporosis (due to long-term androgen deprivation).
Reproductive system disorders: Very common: Decreased libido, erectile dysfunction, reduced sexual drive and inhibition of gonadal function. These changes are reversible after discontinuation of therapy.
Inhibition of spermatogenesis: Very common: Sperm count and the volume of ejaculate is reduced.
Infertility is usual, and there may be azoospermia after eight weeks. There is usually slight atrophy of the seminiferous tubules. Follow up examinations have shown these changes to be reversible, spermatogenesis usually reverting to its previous state about three to five months after stopping treatment or in some users up to 20 months. That spermatogenesis can recover even after very long treatment is uncertain. There is evidence that abnormal sperms, which might give rise to malformed embryos, are produced during treatment.
Gynaecomastia: Common: Gynaecomastia (sometimes combined with tenderness to touch of the mamillae) which usually regresses after withdrawal of the preparation.
Rare: Galactorrhoea and tender benign nodules.
Symptoms mostly subside after discontinuation of treatment or reduction of dosage.
General and administration site disorders: Common: Hot flushes, sweating, fatigue and lassitude.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.