Adverse reactions : תופעות לוואי

4.8   Undesirable effects
For undesirable effects that may occur when using androgens, see also section 4.4.
The most commonly observed undesirable effects are injection site pain, injection-site redness, cough and/or dyspnoea during or immediately after the injection.

The frequency of adverse drug reactions reported with Testosterone-Depot preparations is summarised by System Organ Class (according to MedDRA) and frequency in the table below.

The table contains undesirable effects from spontaneous reports and from scientific literature.


System organ class           Side effect
Common                Rare                 Unknown
(≥1/100 to <1/10) (≥1/10,000 to            (frequency cannot be
<1/1,000)                estimated based on the available data)
Neoplasms benign,                                                       Benign and malignant liver malignant and unspecified                                               tumours (incl. cysts and polyps)
Blood and lymphatic          Haematocrit                                Polycythaemia system disorders             increased,                                 (erythrocytosis) red blood cell count increased,
haemoglobin increased
Immune system disorders                                                 Hypersensitivity reactions Metabolism and nutrition                                                Weight gain, changes in disorders                                                               electrolyte values (retention of sodium, chloride,
potassium, calcium and phosphate ions and water) under higher doses and/or
System organ class            Side effect
Common            Rare            Unknown
(≥1/100 to <1/10) (≥1/10,000 to   (frequency cannot be
<1/1,000)       estimated based on the available data) long-term therapy
Nervous system disorders                                        Nervousness, aggressiveness, depression,
headache and fatigue
Respiratory, thoracic and                                       Sleep apnoea, upper airway mediastinal disorders                                           infections Gastrointestinal disorders                                      Constipation, diarrhoea, meteorism and abdominal pain
Hepatobiliary disorders                                         Jaundice and abnormal liver function tests
Skin and subcutaneous                                           Various skin reactions tissue disorders                                                (including acne, redness, urticaria, pruritus and hair loss [alopecia])
Musculoskeletal and                                             Muscle cramps connective tissue disorders
Reproductive system and                                         Changes in libido, increased breast disorders                                                erection frequency; high- dose use of testosterone preparations generally causes a reversible interruption or reduction in spermatogenesis and hence a decrease in testicular size; in rare cases, testosterone replacement therapy in hypogonadism can cause painful and persistent erection (priapism), prostate abnormalities, prostate cancer* as well as urinary outflow obstruction.
Mastodynia, gynaecomastia
General disorders and                                           Various types of injection- administration site                                             site reactions (injection-site conditions                                                      pain, injection-site induration, injection-site swelling, injection-site inflammation)
Investigations                                                  Elevation of prostate- specific antigen
System organ class             Side effect
Common                  Rare                  Unknown
(≥1/100 to <1/10) (≥1/10,000 to               (frequency cannot be <1/1,000)                   estimated based on the available data)
Injury, poisoning and                                  Pulmonary oil procedural complications                               microembolism
* Data are inconclusive as regards the risk of the emergence of prostate cancer in association with testosterone treatment.

Description of selected adverse reactions

Pulmonary oil microembolism
In rare cases, a pulmonary microembolism with oily solutions can lead to symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia or syncope. These reactions can occur during or immediate after the injection and are reversible. There have been rare suspected cases of oily pulmonary embolisms reported both in clinical studies (in ≥ 1/10,000 and <1/1,000 injections) and in post-marketing experience (see section 4.4).
Hostility/aggression has been reported to occur, as well as increased growth of body and facial hair, on treatment with testosterone-containing medicines.

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/