Adverse reactions reported in clinical trials: The following adverse reactions have been reported at the approximate frequencies (not necessarily implicating a causal relationship) indicated as follows: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000.
General: Very common: tiredness, weight increase.
Common: headache, depressive moods.
Cardiovascular: Common: thrombotic phenomena.
Gastrointestinal: Common: nausea and other gastrointestinal complaints.
Reproductive: Very common: Diminished libido.
Common: mastodynia, irregular menstrual cycles.
Skin: Rare: rash.
The most commonly reported adverse drug reactions (ADRs) in female patients receiving Androcur are spotting, weight increase and depressed mood.
The most frequently observed ADRs in male patients receiving Androcur are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.
The most serious ADRs in patients receiving Androcur are hepatic toxicity, benign and malignant liver tumours which may lead to intra-abdominal haemorrhage, and thromboembolic events.
Over the course of several weeks Androcur gradually impairs spermatogenesis as a result of the antiandrogenic and antigonadotropic actions. Spermatogenesis recovers gradually within several months of discontinuing therapy.
In male patients Androcur occasionally leads to gynaecomastia (sometimes combined with tenderness to touch of the breast) which usually regresses after withdrawal of the preparation or reduction of the dose.
As with other antiandrogenic treatments, in male patients long-term androgen deprivation with Androcur may lead to osteoporosis.
In women ovulation is inhibited under the combined treatment so that a state of infertility exists.
A feeling of tension in the breasts may occur.
In individual cases, disturbances of liver function, some of them severe, have been reported with high-dosed Androcur treatment.
Changes in body weight are possible.
Other adverse events reported at a low incidence were dysmenorrhoea, vaginal discharge, skin discolouration, striae.
Post-marketing information: The following adverse effects have been reported in users of cyproterone acetate and are based on post-marketing data and cumulative experience with Androcur. The most appropriate MedDRA term to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well. (See table.)
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The ADRs identified only during post-marketing surveillance and for which a frequency could not be estimated are: anaemia
*, meningioma, intra-abdominal haemorrhage
*, rash, menstrual spotting
*, thromboembolic events
*†.
In male patients under treatment with Androcur, sexual drive and potency are reduced and gonadal function is inhibited. These changes are reversible after discontinuation of therapy.
The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate. (See Contraindications and Precautions.)
Reporting suspected adverse effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.