Summary of the safety profile: In Phase II and III clinical trials, the incidence of adverse events for CORTIMENT tablets, at the recommended dose of 9 mg/day, was comparable to placebo. Most adverse events were of mild to moderate intensity and of a non-serious nature.
CORTIMENT drug-related adverse events reported during Phase III clinical trials: A summary of the adverse reactions reported during clinical trials can be seen in Table 2. (See Table 2.)
Adverse reactions reported are listed according to the following frequency: 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).
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Occasionally, side effects typical of systemic glucocorticosteroids may occur. These side effects depend on the dosage, duration of treatment, concomitant or previous treatment with other glucocorticosteroids and individual sensitivity. Steroids class side effects include:
Skin and subcutaneous tissue disorders: Allergic exanthema, red striae, petechiae, ecchymosis, steroid acne, delayed wound healing, contact dermatitis.
Musculoskeletal, connective tissue and bone disorders: Aseptic necrosis of bone (femur and head of the humerus).
Eye disorders: Glaucoma, cataract.
Psychiatric disorders: Depression, irritability, euphoria.
Gastrointestinal disorders: Stomach complaints, duodenal ulcer, pancreatitis.
Metabolism and nutrition disorders: Cushing's syndrome, moon-face, truncal obesity, reduced glucose tolerance, diabetes mellitus, sodium retention with oedema formation, increased excretion of potassium, inactivity and/or atrophy of the adrenal cortex, growth retardation in children, disturbance of sex hormone secretion (e.g. amenorrhoea, hirsutism, impotence).
Vascular disorders: Hypertension, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy).
Immune system disorders: Interference with the immune response (e.g. increase in risk of infections).
Paediatric population: No data available.
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.
Healthcare professionals are asked to report any suspected adverse reactions.