Adverse reactions : תופעות לוואי

4.8. Undesirable effects

In most cases, undesirable effects are a prolongation of the pharmacological action and are more frequent with high doses, and in prolonged treatments.

Common (between ≥1/100 and ≤1/10 of patients):

Immune system disorders: decreased resistance to infection, oropharyngeal candidiasis.
Endocrine disorders: hyperglycaemia, adrenocortical insufficiency.
With high doses: signs of adrenal hyperactivity (Cushing's syndrome) with acneiform eruptions.
Metabolism and nutrition disorders: polyphagia.
Eye disorders: cataracts.
Vascular disorders: with high doses, flushing.
Gastrointestinal disorders: with high doses: gastric ulcer.
Skin and subcutaneous tissue disorders: delayed wound healing, local allergic reaction.
With high doses: hirsutism, skin hyperpigmentation, scleroderma.
Musculoskeletal and connective tissue disorders: osteoporosis, bone fragility.
With prolonged treatment: muscular atrophy.

Uncommon (between ≥1/1,000 and ≤1/100 of patients):

Blood and lymphatic system disorders: lymphopenia, eosinopenia.
Immune system disorders: generalised allergic reaction.
Endocrine disorders: amenorrhoea.
Metabolism and nutrition disorders: hypokalaemia, acute pancreatitis.
Nervous system disorders: intracranial hypertension, neurological disorders, psychotic states.
Cardiac disorders: heart failure.
Vascular disorders: thromboembolism, edema, hypertension.
Skin and subcutaneous tissue disorders: sweating.
Musculoskeletal and connective tissue disorders: myasthenia
General disorders and administration site alterations: With rapid intravenous administration of high doses: allergic reactions and local injection site infection, generalised anaphylaxis, reddening of the face or cheeks, irregular heartbeat or palpitations, seizures.

Unknown frequency (cannot be estimated from the available data):

General disorders: hiccups.
Eye disorders: blurred vision (see also section 4.4.), chorioretinopathy.
Cardiac disorders: hypertrophic cardiomyopathy in premature babies (see section 4.4).
They occur mainly during long-term use and require medical attention: acne or other skin problems, avascular necrosis, Cushing's syndrome, edema, endocrine imbalance, gastrointestinal irritation, hypokalaemic syndrome, osteoporosis or bone fractures, pancreatitis, peptic ulcer or intestinal perforation, injection site scarring, steroid myopathy, stretch marks, tendon rupture. Local injection, unusual bruising, wounds that do not heal.

If the appearance of adverse reactions is observed, treatment should be discontinued and the pharmacovigilance systems notified.

Treatment should be discontinued immediately in the event that the patient experiences an episode of adrenal hyperactivity, for example: acne, hirsutism, skin hyperpigmentation, flushing and scleroderma.

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