|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).The following CIOMS frequency rating is used, when applicable: Very common (≥10%); common (≥1% and <10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (<0.01%); not known (cannot be estimated from available data).|
Endocrine disordersUncommon: Suppression of the hypothalamic-pituitary-adrenal axis, amenorrhoea, Cushingoid facies.Not known: Growth suppression in infancy, childhood and adolescence.
Metabolism and nutrition disordersCommon: Weight gain.Uncommon: impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, sodium and water retention with hypertension, potassium loss and hypokalaemic alkalosis when coadministered with beta 2-agonist and xanthines.Not known: Negative protein and calcium balance, increased appetite.
Infections and InfestationsUncommon: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see Warnings and Precautions).Not known: candidiasis.
Musculoskeletal and connective tissue disordersUncommon: Osteoporosis, vertebral and long bone fractures.Rare: Muscle wastingNot known: avascular osteonecrosis, tendonitis and tendon rupture when coadministered with quinolones (see warnings and precautions), myopathy (acute myopathy may be precipitated by non-depolarising muscle relaxants see section 4.5), negative nitrogen balance.
Reproductive system and breast disordersNot known: Menstrual irregularity
Cardiac disordersNot known: Heart failure
Nervous system disordersUncommon: Headache, vertigo. Not known: restlessness, Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal, aggravation of epilepsy.
Psychiatric disordersA wide range of psychiatric reactions including affective disorders such as:Uncommon: depressed and labile mood.Not known: irritable, euphoric, suicidal thoughts. Psychotic reactions including:Not known: mania, delusions, hallucinations, aggravation of schizophreniaOther reactions including:Uncommon: behavioural disturbances Not known: 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.
Eye disordersNot known: Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts especially in children, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.
Gastrointestinal disordersUncommon: Dyspepsia, peptic ulceration, haemorrhage, nausea. Not known: perforation of peptic ulcer, acute pancreatitis (especially in children), candidiasis.
Skin and subcutaneous tissue disordersUncommon: hirsutism, striae, acne,Rare: bruisingNot known: Skin atrophy, telangiectasia.
General disorders and administration site conditionsUncommon: Oedema.Not known: impaired healing.
Immune system disordersUncommon: Hypersensitivity including anaphylaxis has been reported.
Blood and lymphatic system disordersNot known: Leukocytosis
Vascular disordersNot known: Thromboembolism in particular in patients with underlying conditions associated with increased thrombotic tendency, rare incidence of benign intracranial hypertension
Withdrawal symptoms and signsNot known: Too 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.