Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following frequency conventions are used in the evaluation of undesirable effects:
 very common: (≥ 1/10) common: (≥ 1/100 to < 1/10) uncommon: (≥ 1/1,000 to < 1/100) rare: (≥ 1/10,000 to < 1/1,000) very rare: (<1/10,000) not known (cannot be estimated from the available data)

System organ             Frequency according to           Adverse reaction class                    MedDRA convention
Metabolism and           Common                           Cushing’s syndrome: e.g.
nutrition disorders                                       with moon face, truncal obesity, reduced glucose tolerance, diabetes mellitus, hypertension,
sodium retention with oedema, increased potassium excretion,
inactivity or atrophy of the adrenal cortex, red striae,
steroid acne, disturbance of sex hormone secretion (e.g.
amenorrhoea, hirsutism,
impotence).
Very rare                        Growth retardation in children.

Eye disorders            Rare                             Glaucoma, cataract, blurred vision (see also section 4.4)
Gastrointestinal         Common                           Dyspepsia, abdominal pain disorders
Uncommon                         Duodenal or gastric ulcer
System organ            Frequency according to          Adverse reaction class                   MedDRA convention
Rare                            Pancreatitis
Very rare                       Constipation
Immune system           Common                          Increased risk of infection disorders
Musculoskeletal         Common                          Muscle and joint pain, and connective                                          muscle weakness and tissue disorders                                        twitching, osteoporosis 
Rare
Osteonecrosis
Nervous system          Common                          Headache disorders

Very rare                       Pseudotumor cerebri including papilloedema in adolescents
Psychiatric             Common                         Depression, irritability, disorders                                              euphoria

Uncommon                       Psychomotor hyperactivity,
anxiety

Rare                            Aggression
Skin and                Common                          Allergic exanthema, subcutaneous                                            petechiae, delayed wound tissue disorders                                        healing, contact dermatitis Rare                            Ecchymosis

Vascular disorders      Very rare                       Increased risk of thrombosis, vasculitis
(withdrawal syndrome after long-term therapy)
General disorders       Very rare                       Fatigue, malaise and administration site conditions
Most of the adverse events mentioned in this leaflet can also be expected for treatments with other glucocorticosteroids.

Occasionally, adverse events may occur which are typical for systemic glucocorticosteroids. These adverse events depend on the dosage, the period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity.


Clinical studies showed that the frequency of glucocorticosteroid associated adverse events is lower with oral Budeson than with oral treatment of equivalent dosages of prednisolone.

An exacerbation or the reappearance of extra-intestinal manifestations (especially affecting skin and joints) can occur on switching a patient from systemically acting glucocorticosteroids to the locally acting budesonide.

Side effects in clinical studies with paediatric patients
Crohn's disease
In clinical trials with Budeson 3mg capsules in 82 paediatric patients with Crohn's disease adrenal suppression and headache were the most frequent undesirable effects.
Side effects which are typical for glucocorticosteroids were reported as well as other rare reactions such as dizziness, nausea, vomiting, and hyperacusis (see also section 5.1).
Autoimmune hepatitis
Safety data from the subset of a total of 42 paediatric patients in an autoimmune hepatitis clinical trial revealed that undesirable effects reported were not different and not more frequent compared to the adult population in this study (see also section 5.1).


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/