Applies to lithium: oral capsules tablets and extended-release tablets, oral solution.

Side effects include:

Fine hand tremor, polyuria, mild thirst, transient and mild nausea, and general discomfort may appear during the first few days of lithium administration; usually subside with continued treatment, a temporary reduction of dosage, or temporary cessation. If persistent, a cessation of therapy is indicated.

For Healthcare Professionals

Applies to lithium: compounding powder, oral capsule, oral syrup, oral tablet, oral tablet extended release.

Nervous system

Drowsiness and lack of coordination may be early signs of lithium toxicity, and may occur at lithium levels below 2 mEq/L.

Ataxia and giddiness occurred at levels above 2 mEq/L.

Fine hand tremor may occur during initial therapy for the acute manic phase, and may persist during therapy.

The development of transient EEG changes, headache, dysgeusia/taste distortion, and metallic taste were unrelated to dosage.

Peripheral neuropathy may occur in patients on long-term treatment, but is usually reversible after discontinuation of therapy.^[Ref]

Frequency not reported: Abnormal reflex convulsions, acute dystonia, ataxia, benign intracranial hypertension, blackout spells, choreoathetotic movements, cerebellar syndrome, clonic movements of whole limbs, coarse tremor of the extremities and lower jaw, cogwheel rigidity, coma, convulsions, diffuse slowing of EEG, dizziness, downbeat nystagmus, drowsiness, dysarthria, dysgeusia/taste distortion, encephalopathy, encephalopathic syndrome, epileptiform seizures, extrapyramidal syndrome, fine hand tremor, giddiness, headache, hyperactive deep tendon reflexes, hypertonicity, impaired consciousness, lack of coordination, lethargy, metallic/salty taste, myoclonus, nystagmus, peripheral sensorimotor neuropathy, poor memory, potentiation and disorganization of EEG background rhythm, pseudotumor cerebri (increased intracranial pressure and papilledema), psychomotor retardation, seizures, serotonin syndrome, slowed intellectual functioning, slurred speech/speech disorder, somnolence, startle response, stupor, tendency to sleep, tongue movements, transient electroencephalogram (EEG), tremor, vertigo, widening of EEG frequency spectrum^[Ref]

Cardiovascular

The development of transient ECG changes, chest tightness, and edematous swelling of ankles/wrists were unrelated to dosage.

Painful discoloration of the fingers/toes and coldness of extremities (resembling Raynaud's syndrome) occurred within one day of initiation; the patient recovered after discontinuation. The exact mechanism for this side effect is unknown.^[Ref]

Frequency not reported: Atrioventricular block, bradycardia, cardiac arrhythmia, cardiomyopathy, chest tightness, conduction disturbance, ECG changes, edema, hypotension, inversion of T-waves, isoelectricity of ECG, peripheral circulatory collapse, peripheral edema/edematous swelling of ankles or wrists, peripheral vasculopathy, QT prolongation, Raynaud's phenomena/syndrome, reversible flattening of ECG, sinus node dysfunction with severe bradycardia and/or sinoatrial block (may result in syncope), transient ECG changes, unmasking of Brugada syndrome, ventricular tachyarrhythmia^[Ref]

Gastrointestinal

Diarrhea and vomiting may be early signs of lithium toxicity, and may occur at lithium levels below 2 mEq/L.

Transient and mild nausea may occur within the first few days of therapy.

The development of metallic/salty taste, dental caries, and swollen lips were unrelated to dosage.^[Ref]

Frequency not reported: Abdominal pain/discomfort, constipation, dental caries, diarrhea, dry mouth, excessive salivation, flatulence, gastritis, incontinence of feces, indigestion, nausea/transient and mild nausea, salivary gland swelling, swollen lips, vomiting^[Ref]

Dermatologic

Frequency not reported: Acne/acneform eruptions, alopecia, anesthesia of skin, chronic folliculitis/folliculitis, cutaneous ulcers, drying and thinning of hair, generalized pruritus with/without rash, papular skin disorders, pruritus, psoriasis onset/exacerbation, urticaria, xerosis cutis^[Ref]

The development of generalized pruritus with/without rash and cutaneous ulcers were unrelated to dosage.^[Ref]

Endocrine

Hyperthyroidism has been rarely reported, and may persist after discontinuation of treatment.

Hyperparathyroidism may persist after discontinuation of treatment.

The development of diffuse nontoxic goiter with/without hypothyroidism and hyperparathyroidism were unrelated to dosage.^[Ref]

Frequency not reported: Diffuse nontoxic goiter with/without hypothyroidism, euthyroid goiter, hyperparathyroidism, hyperthyroidism, hypothyroidism (including myxedema), iodine 131 uptake increased, lower T3 and T4 levels, thyrotoxicosis^[Ref]

Musculoskeletal

Muscular weakness develops early in lithium toxicity, and may occur at lithium levels below 2 mEq/L.

Muscle hyperirritability includes fasciculations, twitching, clonic movements of whole limbs.

The development of swollen/painful joints and polyarthralgia were unrelated to dosage.^[Ref]

Frequency not reported: Arthralgia/polyarthralgia, muscle hyperirritability, muscular weakness, myalgia, myasthenia gravis, myoclony, rhabdomyolysis, swollen/painful joints, twitching^[Ref]

Renal

Frequency not reported: Decreased creatinine clearance, glycosuria, histological renal changes with interstitial fibrosis, lithium-induced chronic kidney disease, microcysts, nephrogenic diabetes insipidus, nephrotic syndrome, oliguria, renal dysfunction^[Ref]

Diabetes insipidus may persist after discontinuation of treatment.

Histological renal changes with interstitial fibrosis occurred in patients on prolonged treatment, and was usually reversible upon discontinuation. Long-term treatment may cause permanent kidney changes and impairment of renal function; high serum concentrations and/or acute lithium toxicity may worsen these changes.^[Ref]

Metabolic

Frequency not reported: Anorexia, dehydration, excessive weight gain, hypercalcemia, hypermagnesemia, hyponatremia, polydipsia, thirst/mild thirst, transient hyperglycemia/hyperglycemia, weight loss^[Ref]

The development of transient hyperglycemia, hypercalcemia, and excessive weight gain were unrelated to dosage.^[Ref]

Other

Frequency not reported: Fall, fasciculations, fatigue, feeling dazed, fever, general discomfort, lithium toxicity, tinnitus^[Ref]

Tinnitus occurred at levels above 2 mEq/L.

Mild thirst may occur during initial therapy for the acute manic phase, and may persist during therapy; in some cases, thirst resembled diabetes insipidus. The development of thirst was unrelated to dosage.

General discomfort may also appear within the first few days of therapy.

The development of fever was unrelated to dosage.^[Ref]

Genitourinary

Frequency not reported: Albuminuria, impotence/sexual dysfunction, incontinence of urine, large output of dilute urine, lithium-induced polyuria/polyuria^[Ref]

At levels above 2 mEq/L, patients excreted a large output of dilute urine.

Polyuria may occur during initial therapy for the acute manic phase, and may persist during therapy; in some cases, polyuria resembled diabetes insipidus. The development of polyuria was unrelated to dosage.

The development of albuminuria was unrelated to dosage.^[Ref]

Psychiatric

The worsening of organic brain syndromes was unrelated to dosage.^[Ref]

Frequency not reported: Confusion, delirium, hallucinations, restlessness, tics, worsening of organic brain syndromes^[Ref]

Hypersensitivity

Frequency not reported: Allergic rashes, angioedema^[Ref]

Ocular

Blurred vision occurred at levels above 2 mEq/L.^[Ref]

Frequency not reported: Blindness, blurred vision, enlargement of the blind spot, exophthalmos, optic atrophy, transient scotomata/scotoma, visual field constriction^[Ref]

Oncologic

Frequency not reported: Collecting duct renal carcinoma, oncocytoma^[Ref]

Collecting duct renal carcinoma occurred in patients on long-term therapy.^[Ref]

Hematologic

Frequency not reported: Leukocytosis^[Ref]

The development of leukocytosis was unrelated to dosage.^[Ref]