Florinef Adverse Reactions

Summary of the safety profile: Most adverse reactions to fludrocortisone acetate are caused by the drug's mineralocorticoid activity and include hypertension, oedema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis.
Where adverse reactions occur they are usually reversible on cessation of therapy. The incidence of predictable side-effects, including hypothalamic-pituitary-adrenal suppression correlate with the relative potency of the drug, dosage, timing of administration and duration of treatment (see Precautions).
Tabulated list of adverse reactions: The following list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: 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); Not known (cannot be estimated from the available data). (See table.)

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Description of selected adverse reactions: When fludrocortisone is used at the recommended dosages, the glucocorticoid side effects are not usually present; however, the following adverse events have been spontaneously reported in two or more patients taking Fludrocortisone acetate overdose.
Withdrawal Symptoms and Signs: On withdrawal, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss may occur. Too rapid a reduction in dose following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see Precautions).
Patients should be watched closely for the following adverse reactions which may be associated with any corticosteroid therapy: Anti-inflammatory and immunosuppressive effects: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see Precautions).
Fluid and electrolyte disturbances: Sodium retention, fluid retention, cardiac arrhythmias or ECG changes due to potassium deficiency and increased calcium excretion.
Musculoskeletal and connective tissue disorders: Fatigue, steroid myopathy, loss of muscle mass, osteoporosis, avascular osteonecrosis, vertebral compression fractures, delayed healing of fractures, aseptic necrosis of femoral and humeral heads, pathological fractures of long bones and spontaneous fractures, tendon rupture.
Gastrointestinal disorders: Dyspepsia, peptic ulcer with possible subsequent perforation and haemorrhage, pancreatitis, abdominal distension and ulcerative oesophagitis, candidiasis.
Hypersensitivity: Anaphylactic reactions, angioedema, rash, pruritus and urticaria, particularly where there is a history of drug allergies.
Skin and subcutaneous tissue disorders: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, purpura, striae, hirsutism, acneiform eruptions, lupus erythematosus-like lesions and suppressed reactions to skin tests.
Nervous system disorders: Euphoria, psychological dependence, depression, insomnia, increased intracranial pressure with papilloedema (pseudo-tumour cerebri) usually after treatment, vertigo, neuritis or paraesthesias and aggravation of pre-existing psychiatric conditions.
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.
Endocrine disorders/metabolic and nutrition disorders: Menstrual irregularities and amenorrhoea; development of the Cushingoid state; suppression of growth in childhood and adolescence; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g. trauma, surgery or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycaemic agents in diabetes, weight gain. Negative protein and calcium balance. Increased appetite.
Eye disorders: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases, vision blurred (see also Precautions).
Others: Necrotising angiitis, thrombophlebitis, thromboembolism, leukocytosis, insomnia and syncopal episodes.