Adverse reactions : תופעות לוואי

4.8 Undesirable effects

System Organ Class            Frequency†        Undesirable Effects Infections and infestations   Common            Infection (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs)
Not Known         Opportunistic infection; recurrence of dormant tuberculosis, Peritonitis†
Blood and lymphatic system    Not Known         Leukocytosis disorders
Immune system disorders       Not Known         Drug hypersensitivity Anaphylactic reaction
Anaphylactoid reaction
Endocrine disorders           Common            Cushingoid
Not Known         Hypothalamic pituitary adrenal axis suppression
Neoplasms benign, malignant   Not Known         Kaposi’s sarcoma and unspecified (including cysts and polyps)
Metabolism and nutrition      Common            Sodium retention; Fluid retention disorders                     Not Known         Metabolic acidosis ;Alkalosis hypokalaemic; Dyslipidaemia; Glucose tolerance impaired;
increased requirements for insulin (or oral hypoglycemic agents in diabetics);
Lipomatosis;; Increased appetite (which may result in Weight increased); Epidural lipomatosis
Psychiatric disorders         Common            Affective disorder (including Depressed mood and Euphoric mood)
Not Known         Psychotic disorder (including Mania, Delusion,
Hallucination, and Schizophrenia; Psychotic behaviour; Affective disorder (including Affect lability, Psychological dependence, Suicidal ideation); Mental disorder; Personality change;
Confusional state; Anxiety; Mood swings;
Abnormal behaviour; Insomnia; Irritability
Nervous system disorders      Not Known         Intracranial pressure increased (with Papilloedema [Benign intracranial hypertension]); Seizure; Amnesia; Cognitive disorder; Dizziness; Headache
Eye disorders                 Common            Cataract
Rare              Vision blurred (see also section 4.4)
Not Known         Glaucoma; Exophthalmos; Corneal thinning;
Scleral thinning; Chorioretinopathy
Ear and labyrinth disorders   Not Known         Vertigo
Cardiac disorders             Not Known         Cardiac failure congestive (in susceptible patients); Myocardial rupture following myocardial infarction
Vascular disorders            Common            Hypertension
Not Known         Hypotension; Embolism arterial; Thrombotic events; Flushing

2019-0049349
Respiratory, thoracic and            Not Known             Pulmonary embolism, Hiccups mediastinal disorders
Gastrointestinal disorders           Common                Peptic ulcer (with possible Peptic ulcer perforation and Peptic ulcer haemorrhage)
Not Known             Intestinal perforation; Gastric haemorrhage;
Pancreatitis; Oesophagitis ulcerative;
Oesophagitis;Abdominal distension;
Abdominal pain; Diarrhoea; Dyspepsia;
Nausea
Hepatobiliary disorders          Not Known             Increase of liver enzymes (e.g alanine aminotransferase increased, aspartate aminotransferase increased)
Skin and subcutaneous tissue     Common                Skin atrophy; Acne disorders                        Not Known             Angioedema; Hirsutism; Petechiae; Ecchymosis; Erythema; Hyperhidrosis; Skin striae; Rash Pruritus; Urticaria; Telangiectasia
Musculoskeletal and              Common                Muscular weakness; Growth retardation connective tissue disorders      Not Known             Myalgia; Myopathy; Muscle atrophy; Osteoporosis; Osteonecrosis; Pathologic fracture; Neuropathic arthropathy; Arthralgia;
Reproductive system and          Not Known             Menstruation irregular breast disorders
General disorders and            Common                Impaired healing administration site conditions   Not Known             Oedema peripheral ;Fatigue; Malaise; Withdrawal symptoms - too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see section 4.4)

Investigations                   Common                Blood potassium decreased Not Known             Intraocular pressure increased; Carbohydrate tolerance decreased; Urine calcium increased
Blood alkaline phosphatase increased; Blood urea increased; Suppression of reactions to skin tests*
Injury, poisoning and            Not Known             Tendon rupture (particularly of the Achilles procedural complications                               tendon); Spinal compression fracture 
* Not a MedDRA PT
†
Peritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis (see section 4.4)

Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated from the available data)

The incidence of predictable undesirable side-effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment (see section 4.4).


2019-0049349
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