Adverse reactions : תופעות לוואי

4.8   Undesirable Effects
Blood and lymphatic system disorders
Increase in red cell and platelet count. Reversible polycythaemia, leucopoenia, thrombocytopenia, eosinophilia and splenic peliosis.


Endocrine disorders
Androgenic effects:
Acne, weight gain, increased appetite, seborrhoea, hirsutism, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch. Hypertrophy of the clitoris, fluid retention.
Other endocrine effects:
Menstrual disturbances in the form of spotting, alteration of the timing of the cycle and amenorrhoea.
Flushing, vaginal dryness, changes in libido, vaginal irritation and reduction in breast size.
Modest reduction in spermatogenesis.


Metabolism and nutrition disorders
Increased insulin resistance, increase in plasma glucagon, mild impairment of glucose tolerance.
Increase in LDL cholesterol, decrease in HDL cholesterol, affecting all subfractions, and decrease in apolipoproteins AI and AII.
Induction of aminolevulinic acid (ALA) synthetase, and reduction in thyroid binding globulin, T4, with increased uptake of T3 but without disturbance of thyroid stimulating hormone or free levothyroxine index.


Psychiatric disorders
Emotional lability, anxiety, depressed mood and nervousness.

Nervous system disorders
Dizziness, headache, vertigo, benign intracranial hypertension, migraine.
Aggravation of epilepsy, carpal tunnel syndrome.

Eye disorders
Visual disturbances such as blurring of vision, difficulty in focusing, difficulty in wearing contact lenses and refraction disorders requiring correction.


Respiratory, thoracic and mediastinal disorders
Pleuritic pain, interstitial pneumonitis.

Gastrointestinal disorders
Nausea, epigastric pain.

Cardiac disorders
Hypertension, palpitations and tachycardia.
Thrombotic events including sagittal sinus, cerebrovascular thrombosis as well as arterial thrombosis.
Myocardial infarction.


Hepatobiliary disorders
Isolated increases in serum transaminase levels, cholestatic jaundice, benign hepatic adenomata and pancreatitis. Peliosis hepatitis as well as malignant hepatic tumour observed with long term use.
Hepatocellular injury, hepatic failure, jaundices hepatocellular, hepatocellular focal nodular hyperplasia.


Skin and subcutaneous tissue disorders
Rashes, which may be maculopapular, petechial or purpuric and may be accompanied by fever or may take an urticarial form and may be accompanied by facial oedema. Sun-sensitive rash.
Inflammatory erythematosus nodules, changes in skin pigmentation, exfoliative dermatitis and erythema multiforme.


Musculoskeletal and connective tissue disorders
Backache and muscle cramps which can be severe, with elevation of creatine phosphokinase levels.
Muscle tremors, fasciculation, limb pain, joint pain and joint swelling.

Renal and urinary disorders
Haematuria with prolonged use in patients with hereditary angioedema.

General disorders and administration site conditions
Fatigue.

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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il