Lithium Side Effects

Brand Names: Eskalith, Lithobid

Please note - some side effects for Lithium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lithium - for the Consumer

Lithium

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lithium:

Mild hand tremor; mild thirst; temporary, mild nausea and general discomfort at the beginning of treatment.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; excessive weight gain; fainting; giddiness; inability to control the bladder or bowels; increased thirst; increased or decreased urination; involuntary twitching or muscle movements; loss of consciousness; loss of coordination; muscle weakness; persistent headache; persistent or severe nausea; ringing in the ears; seizures; slow or irregular heartbeat; slurred speech; swelling of the ankles or wrists; unsteadiness; vision changes; vomiting.

Lithium Controlled-Release and Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lithium Controlled-Release and Extended-Release Tablets:

Mild hand tremor; mild thirst; temporary, mild nausea and general discomfort at the beginning of treatment.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; excessive weight gain; fainting; giddiness; inability to control the bladder or bowels; increased thirst; increased or decreased urination; involuntary twitching or muscle movements; loss of consciousness; loss of coordination; muscle weakness; persistent headache; persistent or severe nausea; ringing in the ears; seizures; slow or irregular heartbeat; slurred speech; swelling of the ankles or wrists; unsteadiness; vision changes; vomiting.

Lithium Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lithium Syrup:

Mild hand tremor; mild thirst; temporary, mild nausea and general discomfort at the beginning of treatment.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; excessive weight gain; fainting; giddiness; inability to control the bladder or bowels; increased thirst; increased or decreased urination; involuntary twitching or muscle movements; loss of consciousness; loss of coordination; muscle weakness; persistent headache; persistent or severe nausea; ringing in the ears; seizures; slow or irregular heartbeat; slurred speech; swelling of the ankles or wrists; unsteadiness; vision changes; vomiting.

Lithium Side Effects - for the Professional

Lithium

The occurrence and severity of adverse reactions are generally directly related to serum Lithium concentrations as well as to individual patient sensitivity to Lithium, and generally occur more frequently and with greater severity at higher concentrations.

Adverse reactions may be encountered at serum Lithium levels below 1.5 mEq/L. Mild to moderate adverse reactions may occur at levels from 1.5 to 2.5 mEq/L, and moderate to severe reactions may be seen at levels of 2.0 mEq/L and above.

Fine hand tremor, polyuna and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of Lithium administration.

These side effects usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, cessation of Lithium therapy may be required.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of Lithium intoxication, and can occur at Lithium levels below 2.0 mEq/L. At higher levels, ataxia, giddiness, tinnitus, blurred vision and a large output of dilute urine may be seen. Serum Lithium levels above 3.0 mEq/L may produce a complex clinical picture, involving multiple organs and organ systems. Serum Lithium levels should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.

The following reactions have been reported and appear to be related to serum Lithium levels, including levels within the therapeutic range:

Neuromuscular/Central Nervous System - tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreoathetotic movements, hyperactive deep tendon reflex, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus; hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes, myasthenia gravis (rarely);

Cardiovascular – cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction with severe bradycardia (which may result in syncope);

Gastrointestinal - anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion;

Genitourinary - glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst and polydipsia;

Dermatologic - drying and thinning of hair, alopecia, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with or without, rash, cutaneous ulcers, angioedema;

Autonomic - blurred vision, dry mouth, impotence/sexual dysfunction;

Thyroid Abnormalities - euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. I131 uptake may be elevated. Paradoxically, rare cases of hyperthyroidism have been reported;

EEG Changes - diffuse slowing, widening of the frequency spectrum, potentiation and disorganization of background rhythm;

EKG Changes -reversible flattening, isoelectricity or inversion of T-waves;

Miscellaneous - fatigue, lethargy, transient scotomata, exophthalmos, dehydration, weight loss, leukocytosis, headache, transient hyperglycemia, hypercalcemia, hyperparathyroidism, excessive weight gain, edematous swelling of ankles or wrists, metallic taste, dysgeusia/taste distortion, salty taste, thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, dental caries.

Some reports of nephrogenic diabetes insipidus, hyperparathyroidism and hypothyroidism which persist after Lithium discontinuation have been received.

A few reports have been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment with Lithium. The mechanism through which these symptoms (resembling Raynaud's syndrome) developed is not known. Recovery followed discontinuance.

Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with Lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs.

Side Effects by Body System

Nervous system

The hand tremor associated with lithium therapy is usually a fine rapid intentional tremor. Coarsening of the tremor or occurrence of tremor in a new part of the body may suggest lithium toxicity.

A wide variety of other nervous system effects have been reported and include ataxia, dysarthria, hyperreflexia, other movement disorders, EEG changes, blackouts, stupor, coma, central incontinence, sleep disturbances, dizziness, vertigo, pseudotumor cerebri, seizures, and worsening of organic brain syndrome.

One study (n=34) has concluded that chronic maintenance treatment with lithium affects the peripheral nerves even if the impairment rarely leads to discontinuation of therapy. This study suggests that monitoring of electroneuronographic results could be useful for the early detection of neurotoxicity of lithium.

Nervous system side effects most commonly have included nervous system effects include tremor, lethargy, lassitude, and muscle weakness. Headache, decreased concentration and confusion also have been reported less frequently. Most of these effects resolve during continuing therapy.

Gastrointestinal

Taking lithium with meals or dividing doses may ameliorate some of the gastrointestinal effects of lithium.

Gastrointestinal side effects including nausea, vomiting, diarrhea, anorexia, abdominal pain, and dry mouth have been reported frequently.

Renal

Renal side effects including nephrogenic diabetes insipidus have been reported in as many as 50% of patients started on lithium. As a consequence, many patients experience polydipsia and polyuria. Rarely, some patients may show serum electrolyte abnormalities and clinical evidence of dehydration.

The nephrogenic diabetes insipidus associated with lithium therapy is generally reversible after discontinuation of lithium but may take up to a year or more to resolve.

Some investigators have suggested that indomethacin may be useful in the treatment of lithium-induced nephrogenic diabetes insipidus. The mechanism of action of indomethacin's favorable effects may be related to its antiprostaglandin activity or to the prevention of sodium loss in the ascending loop of Henle. Other investigators have recommended amiloride as a useful drug in the medical management of lithium-induced nephrogenic diabetes insipidus.

Moderate reversible increases in blood urea nitrogen and serum creatinine as well as proteinuria have been observed in patients with lithium toxicity. Rarely the decreases in glomerular filtration have been persistent. A variety of renal effects have been reported and include glomerular sclerosis, interstitial fibrosis, chronic interstitial nephritis, nephrotic syndrome, renal tubular acidosis and tubular atrophy.

Endocrine

Endocrine side effects including clinically evident hypothyroidism (1% to 4%) have been reported. Therefore some clinicians recommend baseline thyroid function tests and yearly thyroid function tests while patients are on lithium. Goiter occurs in approximately 5% of patients. Myxedema coma and hyperglycemia have also been reported.

Lithium exerts multiple effects on the thyroid gland. Most importantly it inhibits the release of thyroxine and triiodothyronine and can lead to enhanced thyrotropin activity resulting in goiter.

Cardiovascular

The EKG manifestations of lithium are similar to those seen in hypokalemia and include reversible flattening and inversion of the T wave.

In addition to the effects noted above, interstitial myocarditis has been reported in one patient who experienced lithium overdose.

Cases of sinus node dysfunction have also been reported (often in association with concomitant carbamazepine therapy).

Cardiovascular side effects including a variety of arrhythmias, hypotension, peripheral circulatory collapse and EKG changes have been reported.

Dermatologic

Dermatologic side effects including alopecia have been reported fairly commonly. Folliculitis, maculopapular rash, acneform eruptions, exacerbations of psoriasis, and lower extremity ulcers have also been reported. One case of mycosis fungoides has been reported.

Lithium-induced alopecia has generally been reported to occur within the first six months of treatment. Although the scalp is the most common site for lithium-associated hair loss, rare reports of body hair loss also exist. The alopecia appears to be reversible upon discontinuation of therapy.

Excessive lithium concentration has been determined not to be a contributing factor to hair loss. An increase in the telogen shedding rate has been determined to be the most likely mechanism for lithium-associated hair loss.

Hematologic

Hematologic side effects including reversible leukocytosis (with leukocyte counts in the range of 8,000 to 15,000 cells/mm3) have been reported to occur in most patients on lithium. Erythrocytosis and thrombocytosis have been reported to occur much more rarely.

General

General side effects including weight gain and, less frequently, weight loss as well as edema have been reported. Metallic taste in the mouth, fever and pruritus have also been reported.

Hypersensitivity

Hypersensitivity side effects including allergic vasculitis have been reported rarely.

Metabolic

Metabolic side effects including a decrease in thyroid hormone secretion have been reported.

Genitourinary

Genitourinary side effects may include a significant decrease sperm motility as suggested by one in vitro study.

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