Regarding undesirable effects associated with the use of androgens, please also refer to section Clinical Particulars / Special warnings and precautions for use.
The most frequent undesirable effects under treatment with Nebido are acne and injection site pain.
Table 1 below reports adverse reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs). The frequencies are based on clinical trial data. The adverse reactions were recorded in 6 clinical studies (N=422) and considered at least possibly causally related to Nebido.
Table 1: Adverse reactions, clinical trials, N=422 (100.0%), i.e.N=302 hypogonadal men treated with i.m. injections of 4 ml and N=120 with 3ml of TU 250 mg/ml
|System Organ Class
(= 1/100 to < 1/10)
|Uncommon(= 1/1000 to <1/100)
|Blood and lymphatic system disorders
Red blood cell count increased
|Immune system disorders
|Metabolism and nutrition disorders
Glycosylated haemoglobin increased
Blood triglycerides increased
Blood cholesterol increased
|Nervous system disorders
|Respiratory, thoracic and mediastinal disorders
||Liver function test abnormal
Aspartate aminotransferase increased
|Skin and subcutaneous tissue disorders
|Musculoskeletal and connective tissue disorders
Pain in extremity
Blood creatine phosphokinase
|Renal and urinary disorders
||Urine flow decreased
Urinary tract disorder
|Reproductive system and breast disorders
||Prostate specific antigen increased
Prostate examination abnormal
Benign prostate hyperplasia
|Prostatic intraepithelial neoplasia
|General disorders and administration site conditions
||Various kinds of injection site reactions3
The most appropriate MedDRA term (version 11.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
- Rash including Rash papular
- Muscle disorders: Muscle spasm, Muscle strain and Myalgia
- Various kinds of injection site reaction: Injection site pain, Injection site discomfort, Injection site pruritus, Injection site erythema, Injection site haematoma, Injection site irritation, Injection site reaction
- Hyperhidrosis: Hyperhidrosis and Night sweats
Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported in clinical trials (2 cases in more than 4000 injections) as well as from postmarketing experience (see section Clinical Particulars / Special warnings and precautions for use.).
In addition to the above mentioned adverse reactions, nervousness, hostility, sleep apnoea, various skin reactions including seborrhoea, increased frequency of erections and in very rare cases jaundice have been reported under treatment with testosterone containing preparations. Therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.
Although these adverse reactions were not reported during the clinical studies performed with Nebido, the possibility that they also occur under treatment cannot be ruled out.