Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following adverse reactions may occur, depending on the dose and duration of therapy.
Infections and infestations
Masking of infections; manifestation, exacerbation or reactivation of viral infections, fungal infections, bacterial, parasitic and opportunistic infections; activation of strongyloidiasis (see section 4.4).

Blood and lymphatic system disorders
Moderate leucocytosis, lymphopenia, eosinopenia, polycythaemia.

Immune system disorders
Hypersensitivity reactions (e.g. drug eruption), severe anaphylactic reactions such as arrhythmias, bronchospasms, hypo- or hypertension, circulatory collapse, cardiac arrest, weakening of the immune system.

Endocrine disorders
Adrenal suppression and induction of Cushing’s syndrome (typical symptoms: moon face, truncal obesity and plethora).

Metabolism and nutrition disorders
Sodium retention with oedema formation, increased potassium excretion (caution: cardiac arrhythmias), weight gain, reduced glucose tolerance, diabetes mellitus, hypercholesterolaemia and hypertriglyceridaemia, increased appetite.

Psychiatric disorders
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, affect lability, feelings of anxiety, sleep disorders, suicidal ideation.

Nervous system disorders
Pseudotumor cerebri, manifestation of latent epilepsy, increased seizure susceptibility in patients with manifest epilepsy.

Eye disorders
Cataract, particularly with posterior subcapsular opacification, glaucoma, aggravation of corneal ulcer symptoms, promotion of viral, fungal and bacterial eye infections, exacerbation of bacterial corneal inflammation, ptosis, mydriasis, chemosis, iatrogenic scleral perforation, chorioretinopathy, blurred vision (see also section 4.4).

Vascular disorders
Hypertension, increased risk of arteriosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term therapy), increased capillary fragility.

Gastrointestinal disorders
Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, gastric complaints.

Skin and subcutaneous tissue disorders
Striae rubrae, atrophy, telangiectasia, petechiae, ecchymosis, hypertrichosis, steroid acne, rosacea-like (perioral) dermatitis, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders
Myopathy, muscular atrophy and muscle weakness, osteoporosis (dose-dependent, possible even with short-term use), aseptic osteonecrosis, tendinopathies, tendinitis, tendon rupture, epidural lipomatosis, growth inhibition in children.

Note:
If the dose is reduced too rapidly after long-term treatment, complaints such as myalgia and arthralgia may occur.

Reproductive system and breast disorders
Impaired sex hormone secretion (resulting in onset of irregular menstruation and even amenorrhoea, hirsutism, impotence).

General disorders
Delayed wound healing.

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 at https://sideeffects.health.gov.il