Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The frequencies of undesirable effects are ranked according to the following: 
Very common (≥1/10)
Common (≥1/100, <1/10)
Uncommon (≥1/1,000, <1/100)
Rare (≥1/10,000, <1/1,000)
Very rare
(<1/10,000)
Not known (frequency cannot be estimated from the available data)
Table 1: Undesirable effects that occurred with
 systemic betamethasone
System organ                                          Undesirable classes and                                          effects
Endocrine disorders
Not known                  Cushing’s syndrome, inactivation or atrophy of the adrenal cortex 
Gastrointestinal disorders
Not known                Abdominal discomfort, Ulcus ventriculi or duodeni (risk of perforation), ulcerative oesophagitis, bleeding, pancreatitis; risk of perforation with pre-existing Colitis ulcerosa
Infections and infestations

Not known               Increased risk of susceptibility to infections; masking of infections; exacerbation of latent infections (mycosis, virus infections, bacterial infections, protozoa infection, candidosis,
Blood and lymphatic system disorders
Not known               Leucocytosis.
Immune system disorders
Not known               Decreased immune response; allergic reaction, anaphylactic reactions including shock.
Eye disorders
Not known               Cataract, glaucoma, exophthalmos, blurred vision (see also section Cardiac disorders
Not known                Myocardial rupture after recent infarct
Metabolism and nutritional disorders
Not known              decreased carbohydrate tolerance, diabetes mellitus, oedema, osteoporosis, sodium retention with formation of oedema,
increased potassium excretion, catabolic effect on protein metabolism (negative nitrogen balance),
Musculoskeletal and connective tissue and bone disorders
Not known              Muscle atrophy and weakness, myopathy, growth retardation in children, osteoporosis, osteonecrosis (Femur and Capitulum humeri), tendon rupture
Psychiatric disorders
Not known              Mental disorders, psychosis, personality changes, confusion.
Nervous system disorders
Not known              Insomnia, vertigo, headache, Pseudotumor cerebri (particularly in children), manifestation of latent epilepsy und increase of seizures in manifest epilepsy, increased nervousness and
Reproductive system and breast disorders
Not known              Disturbance of sexual hormone secretion (menstrual disorders, Skin and subcutaneous tissue disorders
Not known                  Striae rubrae,
atrophy,
telangiec tasia,
Vascular disorders
Not known               Hypertension, thrombosis, vasculitis
Respiratory, thoracic and mediastinal disorders
Not known               Hiccups

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