Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza. In the clinical studies BUL-1/EEA and BUL-2/EER, a total of 44 out of 268 patients (16.4%) exposed to Jorveza experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild or moderate intensity. The total number of infections (including those diagnosed by endoscopy and histology without symptoms) was 92, occurring in 72 out of 268 patients (26.9%). Long-term treatment with Jorveza of up to 3 years (48-weeks in the BUL-2/EER followed by 96-week open-label treatment) did not increase the rate of side effects including local candidiasis.


Tabulated list of adverse reactions
Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency. Frequencies are defined as 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) or not known (cannot be estimated from the available data).

MedDRA system         Very common        Common                               Uncommon organ class
Infections and        Esophageal                                              Nasopharyngitis, infestations          candidiasis,                                            pharyngitis Oral and/or oropharyngeal candidiasis
Immune system                                                                 Angioedema disorders
Psychiatric                              Sleep disorder                       Anxiety, agitation disorders
Nervous system                           Headache, dysgeusia                  Dizziness disorders
Eye disorders                            Dry eyes
Vascular disorders                                                            Hypertension Respiratory,                                                                  Cough, dry throat, thoracic and                                                                  oropharyngeal pain mediastinal disorders
Gastrointestinal                         Gastroesophageal reflux disease,     Abdominal pain, disorders                                nausea, oral paraesthesia,           abdominal distension, dyspepsia, upper abdominal pain,     dysphagia, erosive dry mouth, glossodynia, tongue       gastritis, gastric ulcer,
disorder, oral herpes                lip edema, gingival pain
Skin and                                                                      Rash, urticaria subcutaneous tissue disorders
General disorders                        Fatigue                              Sensation of foreign and administration                                                            body site conditions
Investigations                           Blood cortisol decreased             Osteocalcin decreased, weight increased


The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could also occur with Jorveza (frequency = not known).

MedDRA system organ class               Adverse reactions
Immune system disorders                 Increased risk of infection
Endocrine disorders                     Cushing’s syndrome, adrenal suppression, growth retardation in children
Metabolism and nutrition disorders      Hypokalaemia, hyperglycaemia
Psychiatric disorders                   Depression, irritability, euphoria, psychomotor hyperactivity, aggression
Nervous system disorders                Pseudotumor cerebri including papilloedema in adolescents 

MedDRA system organ class             Adverse reactions
Eye disorders                         Glaucoma, cataract (including subcapsular cataract), blurred vision, central serous chorioretinopathy (CSCR) (see also section 4.4)

Vascular disorders               Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
Gastrointestinal disorders       Duodenal ulcers, pancreatitis, constipation 
Skin and subcutaneous            Allergic exanthema, petechiae, delayed wound healing, tissue disorders                 contact dermatitis, ecchymosis
Musculoskeletal and              Muscle and joint pain, muscle weakness and twitching, connective tissue disorders      osteoporosis, osteonecrosis
General disorders and            Malaise administration site conditions



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/