Adverse reactions : תופעות לוואי

4.8. Undesirable effects

In most cases, the undesirable effects consist of prolonged pharmacological activity, and are more common with high doses and prolonged treatment.

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

Immune system disorders: reduction in resistance to infections, oropharyngeal candidiasis.

Endocrine disorders: hyperglycaemia, adrenocortical insufficiency.
At high doses: signs of adrenal hyperactivity (Cushing's syndrome) with acneiform eruptions.

Metabolism and nutrition disorders: polyphagia.

Eye disorders: cataract.
Vascular disorders: with high doses, hot flushes.

Gastrointestinal disorders: with high doses: gastric ulcer.

Skin and subcutaneous tissue disorders: delayed wound healing, local allergic reaction.
At 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 alterations, psychoticstates.

Cardiac disorders: heart failure.

Vascular disorders: thromboembolism, oedema, hypertension.
Skin and subcutaneous tissue disorders: sweating.
Musculoskeletal and connective tissue disorders: myasthenia

General disorders and administration site conditions: With the rapid intravenous administration of high doses: allergic reactions and infection at the local injection site, generalised anaphylaxis, a reddening of the face or cheeks, irregular heartbeat or palpitations, convulsive seizures.

Unknown frequency (can not be estimated from the available data):
General disorders: Hiccups
Eye disorders: Chorioretinopathy; vision blurred (see also section 4.4.) Cardiac disorders: hypertrophic cardiomyopathy in premature babies (see section 4.4).

They occur mainly during long-term use and require medical care: acne or other skin problems, avascular necrosis, Cushing's syndrome, oedema, endocrine imbalance, gastrointestinal irritation, hypokalaemic syndrome, osteoporosis or bone fractures, pancreatitis, peptic ulcer or intestinal perforation, scarring at the injection site, steroid myopathy, striae, tendon rupture. Local injection, unusual bruising, wounds that do not heal.

Should the onset of any adverse effects be observed, treatment should be discontinued and pharmacovigilance systems should be notified accordingly.

Treatment must be discontinued immediately if the patient has any episode of adrenal hyperactivity, e.g.: acne, hirsutism, skin hyperpigmentation, hot flushes and scleroderma.

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/