0 mmol/l. The adverse reactions usually subside with a temporary reduction or discontinuation of lithium treatment. Mild gastrointestinal effects such as nausea, a general discomfort and vertigo, may occur initially, but frequently disappear after the first few days of lithium administration.
Fine hand tremors, polyuria and mild thirst may persist. Tabulated list of adverse reactions System Organ Class Adverse reactions Blood and lymphatic system disorders Leucocytosis. Endocrine disorders • Long-term adverse effects may include thyroid function disturbances such as euthyroid goitre and/or hypothyroidism and thyrotoxicosis.
Lithium-induced hypothyroidism may be managed successfully with concurrent thyroxine. • Hypermagnesaemia has been reported. • Very frequent: Hypercalcaemia • Frequency not known: Hyperparathyroidism, parathyroid adenoma, parathyroid hyperplasia Metabolism and nutrition disorders Weight increase, hyperglycaemia.
Psychiatric disorders Confusion, delirium Nervous system disorders • Ataxia, hyperactive deep tendon reflexes, slurred speech, dizziness, stupor, coma, myasthenia gravis, giddiness, dazed feeling, memory impairment. 4). 5), extrapyramidal disorders, encephalopathy, cerebellar syndrome (usually reversible), nystagmus.
The above symptoms may result in fall. • Peripheral neuropathy may occur on long- term treatment and is usually reversible at cessation of lithium. • Dysgeusia. • Serotonin syndrome • Neuroleptic malignant syndrome Eye disorders Blurred vision, scotoma.
5), AV block, cardiomyopathy.
Frequency not known:
Brugada syndrome (Unmasking/aggravation) Gastrointestinal disorders Abdominal discomfort, taste disorder, nausea, vomiting, diarrhoea, gastritis, salivary hypersecretion, dry mouth, anorexia. Skin and subcutaneous tissue disorder Folliculitis, pruritus, papular skin disorders, acne or acneform eruptions, aggravation or occurrence of psoriasis, allergic rashes, alopecia, cutaneous ulcers Frequency unknown: lichenoid drug reaction.
4). This is usually reversible on lithium withdrawal. • Long-term treatment with lithium may result in permanent changes in kidney histology, and impairment of renal function. • High serum concentrations of lithium including episodes of acute lithium toxicity may aggravate these changes.
• Rare cases of nephrotic syndrome have been reported. 4). Reproductive system and breast disorders Sexual dysfunction. General disorders and administration site conditions • Peripheral oedema. • Urticaria and angioedema, attributed to some excipients such as acacia powder (or Arabic gum).
If any of the above symptoms appear, treatment should be stopped immediately and arrangements made for serum lithium measurement. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.