The most frequently observed side effects: decreased libido, impotence and reversible suppression of spermatogenesis.
The most serious side effects are hepatotoxicity, benign and malignant liver tumors, which can lead to intra-abdominal bleeding and the development of thromboembolic processes.
The adverse events reported in the use of Androkur® are listed below. The frequency is defined as: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely (from ≥ 1/10000 to < 1/1000), very rarely (<1/10000). For undesirable effects, revealed only in the process of postmarketing observations and for which it is not possible to estimate the frequency, "frequency is unknown" is indicated.
From the hematopoietic system:
frequency unknown - anemia *).
From the immune system:
rarely - hypersensitivity reactions.
Disorders of the psyche:
often - depression, depressed mood, anxiety (temporarily).
From the side of the vessels:
frequency unknown - thrombosis and thromboembolism *) **).
On the part of the respiratory system:
often - shortness of breath *).
From the gastrointestinal tract:
frequency unknown - intra-abdominal hemorrhage *).
From the liver and biliary tract:
often - jaundice, hepatitis, liver failure *).
From the skin and subcutaneous tissues:
infrequent - rash.
From the musculoskeletal system:
frequency is unknown - osteoporosis.
From the genitals and mammary glands:
very often - reversible suppression of spermatogenesis, decreased libido, erectile dysfunction; often - gynecomastia.
Other:
often - increase or decrease in body weight, increased fatigue, "hot flashes", increased sweating; very rarely - the development of benign or malignant liver tumors *); frequency unknown - development of meningioma *) §).
Undesirable phenomena for which you can find more detailed information in the section "Special instructions" are marked with an asterisk *). Undesirable phenomena for which a causal relationship with the administration of Androcur® has not been proven is indicated by asterisks **. §) - refer to the section "Contraindications".
Against the background of treatment with the drug Androkur®, sexual desire and potency decrease, in addition, the function of the sexual glands is suppressed. These changes are reversible and pass after the withdrawal of therapy.
Within a few weeks, as a result of antiandrogenic and antigonadotropic actions of the Androkur® preparation, spermatogenesis is suppressed, which is gradually restored several months after the abolition of therapy.
In men, taking Androcur® can lead to the development of gynecomastia (which is sometimes accompanied by increased tactile sensitivity and soreness of the nipples), which usually occurs after drug withdrawal or dose reduction.
As with the use of other anti-androgenic drugs, the long-term androgen deficiency caused by Androkur® can lead to the development of osteoporosis. The development of meningiomas has been reported due to the long-term (for several years) administration of Androkur® in a dose of 25 mg or more.