|The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see Warnings and Precautions).|
Endocrine/metabolicSuppression of the hypothalamic-pituitary-adrenal axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea. Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy. Negative protein and calcium balance. Increased appetite.
Anti-inflammatory and immunosuppressive effectsIncreased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see Warnings and Precautions).
MusculoskeletalOsteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture. Muscle wasting or myopathy (acute myopathy may be precipitated by non-depolarising muscle relaxants see section 4.5), negative nitrogen balance.
Fluid and electrolyte disturbanceSodium and water retention with hypertension, oedema and heart failure, potassium loss, hypokalaemic alkalosis.
NeuropsychiatricHeadache, vertigo, psychological dependence, hypomania or depression, , restlessness. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal. Aggravation of epilepsy.A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
OphthalmicIncreased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts especially in children, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.
GastrointestinalDyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis (especially in children), candidiasis. Nausea.
DermatologicalImpaired healing, skin atrophy, bruising, telangiectasia, striae, acne.
GeneralHypersensitivity including anaphylaxis has been reported. Leucocytosis. Thromboembolism. Rare incidence of benign intracranial hypertension.
Withdrawal symptoms and signsToo rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see Warnings and Precautions).A 'withdrawal syndrome' may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight. This may occur in patients even without evidence of adrenal insufficiency.