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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: lithium (LITH ee um)
Brand name(s): LITHOBID
GENERIC: available FAMILY: Drugs for Mania
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

There are reported cases of heart problems in infants born to women taking lithium. Use during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

Breast-feeding Warning

Lithium is excreted in human breast milk. Infants should not be nursed during drug treatment with lithium.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy.

Heat Stress Alert

This drug can affect your body’s ability to adjust to heat, putting you at risk of “heat stress.” If you live alone, ask a friend to check on you several times during the day. Early signs of heat stress are dizziness, lightheadedness, faintness, and slightly high temperature. Call your doctor if you have any of these signs. Drink more fluids (water, fruit and vegetable juices) than usual—even if you’re not thirsty—unless your doctor has told you otherwise. Do not drink alcohol.

Facts About This Drug [top]

Lithium (LITHOBID) is used to treat manic episodes of manic depression, a condition in which a person’s mood swings severely from normal to elated to depressed. Lithium also is used to prevent or decrease the intensity of future manic episodes.  

In general, patients over age 60 need to take less than the usual adult dose.In such cases, physicians should frequently measure the levels of lithium in the patient's blood. 

Side effects

Effects on the central nervous system

Even when...

Lithium (LITHOBID) is used to treat manic episodes of manic depression, a condition in which a person’s mood swings severely from normal to elated to depressed. Lithium also is used to prevent or decrease the intensity of future manic episodes.  

In general, patients over age 60 need to take less than the usual adult dose.In such cases, physicians should frequently measure the levels of lithium in the patient's blood. 

Side effects

Effects on the central nervous system

Even when the amount of lithium in an older person’s body is within the recommended range, the drug may cause harm to the central nervous system. Ideally, only patients with normal salt (sodium) intakes and normal heart and kidney functions should use lithium.[1]

Lithium toxicity 

Lithium can interact with some drugs used for cardiovascular diseases. These combinations may result in a dangerous condition known as lithium toxicity, which occurs when lithium blood levels are increased. In severe cases, it can cause seizures, coma and even death.

The risk of lithium toxicity is increased in patients with significant kidney or cardiovascular disease, severe debilitation or dehydration, or sodium depletion and for patients taking medications that may affect kidney function, such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, loop and thiazide diuretics, and nonsteroidal anti-inflammatory drugs.[2]

Symptoms of lithium toxicity are nonspecific gastrointestinal symptoms, such as nausea, vomiting, diarrhea and loss of appetite. These symptoms often are accompanied by other warning signs such as lethargy, slurred speech, tremors and disorientation.[3]

Neuroleptic malignant syndrome

Lithium carbonate taken in combination with antipsychotic drugs may increase the risk of neuroleptic malignant syndrome (NMS). It has been suggested that lithium toxicity may contribute to an increased risk of permanent brain damage following an NMS episode. NMS is a life-threatening neurological disorder most often caused by an adverse reaction to neuroleptic drugs (tranquilizers used to treat psychotic conditions).[4]

The symptoms of NMS include:

  • high fever
  • increased sweat
  • unstable blood pressure
  • stupor
  • muscular rigidity
  • autonomic dysfunction (the autonomic nervous system regulates unconscious body functions including heart rate, blood pressure, breathing, temperature regulation, gastrointestinal secretion, and metabolic and endocrine responses to stress)

Serotonin syndrome

Lithium can cause serotonin syndrome, a potentially life-threatening adverse drug reaction that happens when a patient has an excess of serotonin, a naturally occurring nerve transmitter in the brain. The risk of this adverse effect is increased when taking lithium with other drugs that can increase serotonin levels.

The symptoms of serotonin syndrome are:

  • Restlessness
  • Hallucinations
  • Loss of coordination
  • Fast heartbeat
  • Increased body temperature
  • Rapid changes in blood pressure
  • Overactive reflexes
  • Diarrhea
  • Coma
  • Nausea
  • Vomiting

Read more: Worst Pills, Best Pills News article January 2010. In February 2014, Health Canada (an agency similar to the Food and Drug Administration [FDA]) issued safety information reporting that there is a risk of hypercalcemia (high levels of calcium in the blood) in patients taking lithium. Some patients taking lithium who developed hypercalcemia also were found to have hyperparathyroidism (high levels of parathyroid hormone in the blood), which is a common cause of hypercalciemia.[5]

In July 2014, the American Journal of Psychiatry published a study that found that treatment of women with lithium during pregnancy was associated with a higher risk of fetal cardiovascular defects. The authors recommended that decisions to continue treatment with lithium during pregnancy be made on a case-by-case basis after weighing the risks and benefits.[6]

Regulatory actions surrounding lithium

2011: In August, the FDA issued a warning concerning combination therapy with haloperidol (HALDOL) and lithium. The advisory stated that a few patients taking both lithium and haloperidol had experienced weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, blood urea nitrogen and fasting blood sugar (encephalopathic syndrome) followed by irreversible brain damage. The FDA stated that a causal relationship has not been established between these events and the combined drug therapy. However, the agency recommends that patients taking this combined therapy be monitored closely for early evidence of neurological toxicity.[7]

2016:In May, the FDA updated the product label of lithium to state that nephrotic syndrome, a type of kidney disease, has been reported in patients using lithium.[2]

Before You Use This Drug [top]

Do not use if you have or have had:

  • history of leukemia
  • are breast-feeding

Tell your doctor if you have or have had:

  • allergies to drugs
  • pregnancy
  • heart or blood vessel disease
  • Parkinson’s disease
  • epilepsy, seizures
  • severe dehydration from vomiting, diarrhea, or profuse sweating
  • enlarged prostate or difficulty urinating
  • kidney disease
  • diabetes
  • goiter or thyroid disease
  • overactive parathyroid glands
  • recent severe infection
  • organic brain disease
  • schizophrenia
  • psoriasis
  • a current low-salt diet
  • leukemia

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • It may take one to three weeks before you can tell that this drug is working.
  • Do not stop taking this drug suddenly. Your doctor must give you a schedule to lower your dose gradually, to prevent withdrawal symptoms such as nausea, vomiting, and stomach upset.
  • See your doctor regularly to make sure that the drug is working and that you are not developing adverse effects. Your doctor should regularly measure the amount of drug in your body.
  • Follow the diet recommended by your doctor to avoid weight gain, but use caution in dieting.
  • Drink plenty of fluids and use an average amount of salt.
  • Until you know how you react to this drug, do not drive or perform other activities requiring alertness. Lithium may cause blurred vision, drowsiness, fainting, or slow your reaction time.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.
  • Use caution during exercise, saunas, and hot weather so you don’t become dehydrated. The same is true during illness if high fever occurs.
  • Be sure your family knows the early symptoms of overdose.
  • Use caution in drinking large amounts of caffeinated tea, coffee, or colas because of diuretic effect.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is less than four hours until your next scheduled dose. If you are taking extended-release tablets, skip the missed dose if it is less than six hours until your next scheduled dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with food, juice, or milk.
  • Do not break, chew, or crush long-acting forms of this drug.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Do not freeze the liquid form. Keep out of reach of children.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

acetazolamide, ACHROMYCIN, ADVIL, ALDOMET, ALEVE, ANAPROX, CALAN SR, carbamazepine, CELEBREX, celecoxib, chlorothiazide, chlorpromazine, COVERA-HS, DIAMOX, DIURIL, ELIXOPHYLLIN, enalapril, FLAGYL, fluoxetine, HALDOL, haloperidol, ibuprofen, imipramine, IMITREX, INDOCIN, indomethacin, ISOPTIN SR, LOPRESSOR, MAZANOR, mazindol, MELLARIL, MERIDIA, metoprolol, methyldopa, metronidazole, MOTRIN, NAPROSYN, naproxen, ORAP, PANMYCIN, PIMA, pimozide, potassium iodide, PROZAC, rofecoxib, SANOREX, sertraline, sibutramine, SLO-BID, sumatriptan, SUMYCIN, TEGRETOL, TERRAMYCIN, tetracycline, THEO-24, THEOLAIR, theophylline, thioridazine, THORAZINE, TOFRANIL, VASOTEC, verapamil, VERELAN, VIOXX, ZOLOFT.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • signs of parkinsonism: difficulty speaking or swallowing, loss of balance, masklike face or other muscle spasms, stiffness of arms or legs, trembling and shaking, unusual twisting movements of body
  • signs of low thyroid hormone levels: dry, rough skin, hair loss, hoarseness, swelling of feet or lower legs, swelling of neck (goiter), increased sensitivity to cold, fatigue, depression, unusual excitement
  • increased urination
  • increased thirst
  • confusion, poor memory
  • dizziness
  • fainting
  • difficulty breathing on exertion
  • fast or slow heartbeat, irregular pulse
  • weight gain
  • blue color and pain in fingers or toes
  • cold limbs
  • headache
  • eye pain, visual problems
  • nausea, vomiting
  • unusual tiredness or weakness
  • noises in ear

Call your doctor if these symptoms continue:

  • diarrhea
  • increased thirst
  • mild nausea
  • slight trembling of hands
  • slight muscle twitching
  • skin rash, acne
  • bloated feeling
  • fatigue
  • loss of bladder control or increased urination

Signs of overdose (early signs):

  • diarrhea
  • drowsiness
  • loss of appetite
  • muscle weakness
  • nausea or vomiting
  • slurred speech
  • trembling

Signs of overdose (late signs):

  • blurred vision
  • ringing in the ears
  • clumsiness
  • confusion
  • dizziness
  • seizures
  • trembling
  • increased amount of urine

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • white blood cell counts
  • blood levels of lithium (more often if taking other drugs)
  • blood levels of calcium and phosphate
  • electrocardiogram (ECG, EKG)
  • kidney function tests
  • thyroid function tests
  • height and weight evaluation

last reviewed January 31, 2024