Prescription medication · Mood Stabilizer
lithium
Also sold as Lithobid, Eskalith. Lithium is used to treat bipolar disorder.
Data updated 2026-05-15
- 24,367
- FDA reportsModerately reported
- 90
- InteractionsMany interactions
- 1
- Recall record
What the data shows
lithium (Lithobid) is a prescription Mood Stabilizer, reported at a middle-of-the-pack volume (24,367 FDA reports), with 90 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
lithium (Lithobid) is a prescription Mood Stabilizer. Lithium is used to treat bipolar disorder.
Lithium is a mood stabilizer medicine. It helps to balance mood swings.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.08/unit
Generic Available
Yes (14 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Lithium is used to treat bipolar disorder.
Common side effects
Tremor (shaking), Nausea, Increased weight
Key warnings
Lithium levels in your blood need to be monitored closely by your doctor.
The sections below are summarized in plain English from lithium's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Lithium affects the flow of sodium in nerve and muscle cells in the body. This helps to stabilize your mood. It may also affect other chemical messenger systems in the brain.
How to Take It
Take lithium exactly as your doctor tells you. Swallow the tablets whole. Do not crush or chew them. You can take lithium with food or on an empty stomach.
This is a plain-language summary of lithium's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Lithium can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Lithium can pass into breast milk and may harm a nursing infant. Talk to your doctor about the best way to feed your baby if you are taking lithium.
This is a plain-language summary of lithium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of lithium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store lithium at room temperature, away from moisture and heat.
Side Effects (from patient reports)
Based on 24,367 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for lithium, by number of reports
- Poisoning from different substances
Poisoning from different substances
2,179 reports
- The drug is reacting with another medicine
The drug is reacting with another medicine
1,526 reports
- Shaking
Shaking
1,463 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,344 reports
- Gaining weight
Gaining weight
1,153 reports
- Feeling tired
Feeling tired
1,065 reports
- Throwing up
Throwing up
1,016 reports
- Feeling very sad
Feeling very sad
986 reports
- Feeling worried or nervous
Feeling worried or nervous
961 reports
- Feeling sleepy
Feeling sleepy
914 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for lithium each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where lithium sits
lithium has more FDA adverse-event reports than 59% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is lithium; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 24,367 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
24,367
Reports Mentioning Death
2,021
8.3% of reports — not proof of cause
Hospitalization Reports
9,664
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | TOXICITY TO VARIOUS AGENTS | 2,179 |
| 4 | DRUG INTERACTION | 1,526 |
| 5 | TREMOR | 1,462 |
| 6 | NAUSEA | 1,344 |
| 7 | WEIGHT INCREASED | 1,153 |
| 8 | FATIGUE | 1,065 |
| 9 | VOMITING | 1,016 |
| 10 | DEPRESSION | 986 |
| 11 | ANXIETY | 961 |
| 12 | SOMNOLENCE | 914 |
| 13 | INSOMNIA | 899 |
| 14 | SUICIDAL IDEATION | 891 |
| 15 | DIZZINESS | 819 |
| 16 | CONFUSIONAL STATE | 800 |
| 17 | CONDITION AGGRAVATED | 795 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Lithium levels in your blood need to be monitored closely by your doctor. Too much lithium can be toxic and cause serious side effects. Make sure to attend all scheduled blood tests.
Known Drug Interactions
7 DRUG INTERACTIONS • Potassium supplements/potassium-sparing diuretics: hyperkalemia ( 7.1 ) • Lithium: Increased serum lithium levels; toxicity symptoms ( 7.1 ) • Injectable gold: facial flushing, nausea, vomiting, hypotension ( 7.1 ) • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect ( 7.1 ) • Do not exceed doses greater than 20 mg daily of simvastatin ( 7.1 ) • mTOR inhibitors: increased risk of angioedema ( 7.1 ) • Dual inhibition of the RAS: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.1 ) • Neprilysin...
Mechanism: Benazepril can make it harder for the kidneys to remove lithium from the body, causing lithium levels to rise. This increase can lead to lithium poisoning or other serious side effects.
What to do: Your doctor should check your lithium blood levels often to make sure they stay in a safe range. They may need to change your lithium dose while you take this medicine.
Do not exceed twice the patient’s usual dose Enzyme (CYP3A) inhibitors Ranitidine 150 mg twice daily 1 mg single dose 1.2 1.4 Dose adjustment not needed Cimetidine 400 mg twice daily 1 mg single dose 1.1 1.3 Dose adjustment not needed Erythromycin 500 mg four times daily 1 mg single dose 1.1 0.94 Dose adjustment not needed Other Drugs Amitriptyline 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose adjustment not Needed *Change relative to reference Effect of Risperidone on other drugs Lithium Repeated oral doses of risperidone tablets (3 mg twice daily) did not affect the exposure (AUC) or...
Mechanism: Taking risperidone does not change the amount of lithium that stays in your bloodstream or how your body handles it.
What to do: No dose changes are necessary for lithium when it is used at the same time as risperidone.
Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy.
Mechanism: Amiloride makes it harder for your kidneys to get rid of lithium. This can cause lithium to reach toxic levels in your body.
What to do: These drugs should generally not be used together because of the high risk of lithium poisoning.
Table 1: Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment Pharmacodynamic Interactions QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents Increased risk of Torsade de Pointes.
Mechanism: Both drugs can affect the electrical rhythm of your heart. Taking them together increases the risk of a dangerous and irregular heartbeat.
What to do: Your doctor should monitor your heart rhythm closely if you must take these medications together.
Valsartan – Hydrochlorothiazide Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. Monitor lithium levels in patients taking Exforge HCT. ( 12.3 ) Lithium: Increased risk of lithium toxicity.
Mechanism: Valsartan can make it harder for your kidneys to clear lithium from your body. This can cause lithium to build up to levels that are poisonous to your system.
What to do: Your doctor should monitor your lithium levels closely to prevent toxicity while you are taking these drugs together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I avoid while taking lithium?
Can I drink alcohol while taking lithium?
How long does it take for lithium to work?
Will I need blood tests while taking lithium?
What should I do if I experience side effects?
Can I stop taking lithium suddenly?
Does lithium interact with other medications?
What are the symptoms of lithium toxicity?
Can lithium affect my kidneys?
Can lithium affect my thyroid?
What are the common side effects of lithium?
Does lithium interact with other medications?
What drug class is lithium?
Is lithium safe during pregnancy?
Has lithium been recalled?
Active Recalls
Lack of Assurance of Sterility
Tri-Coast Pharmacy
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for lithium
The FDA label for lithium (sold under brand names such as Lithobid, Eskalith) classifies it as a prescription-only medication in the Mood Stabilizer class. Lithium is used to treat bipolar disorder. Official labeling lists 6 commonly reported side effects, including Tremor (shaking), Nausea, Increased weight.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 24,367 voluntary reports. The database also lists 90 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.08.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: August 17, 2023
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages