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 Androcur® Depot treatment 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 in the process of post-marketing observations and for which it is not possible to reliably 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 - oily pulmonary embolism *), vasovagal reactions *), 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 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, excessive sweating; very rarely - the development of benign or malignant liver tumors *); frequency unknown - 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 Androkur® Depot is not proven is marked with asterisks **. §) - refer to the section "Contraindications".
To indicate a specific adverse reaction, the most appropriate term from MedDRA is the Medical Dictionary for Regulatory Activities (version 8.0). Synonyms or concomitant states are not listed, but they should also be taken into account.
In men, against the background of treatment with the drug Androkur® Depot, sexual desire and potency decrease, in addition, the function of the sex glands is suppressed. These changes are reversible and pass after the withdrawal of therapy.
Within a few weeks, as a result of anti-androgenic and antigonadotropic actions of Androkur® Depot, suppression of spermatogenesis occurs, which is gradually restored several months after the abolition of therapy.
In men, taking Androkur® Depot 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 antiandrogen drugs, the long-term androgen deficiency caused by Androkur® Depot can lead to the development of osteoporosis. It was reported on the development of meningiomas due to the long (for several years)
and Androcur® (in other dosage forms) at a dose of 25 mg or more (see "Contraindications" and "Special instructions").