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.
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
- Toxicity To Various Agents
Toxicity To Various Agents
2,179 reports
- Drug Interaction
Drug Interaction
1,526 reports
- Tremor
Tremor
1,462 reports
- Nausea
Nausea
1,344 reports
- Weight Increased
Weight Increased
1,153 reports
- Fatigue
Fatigue
1,065 reports
- Vomiting
Vomiting
1,016 reports
- Depression
Depression
986 reports
- Anxiety
Anxiety
961 reports
- Somnolence
Somnolence
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for lithium?
Has lithium been recalled?
Active Recalls
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Related Medications in Mood Stabilizer
Other drugs grouped near lithium - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with lithium →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with lithium →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with lithium →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with lithium →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with lithium →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for lithium: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 24,367.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.29%.
- acarbose Δ 0.00 pts · 3,736 reports · Alpha-Glucosidase Inhibitor 8.30%death share
- methimazole Δ 0.00 pts · 7,411 reports · Anti-Thyroid Agent 8.30%death share
- levomilnacipran Δ 0.01 pts · 1,858 reports · Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 8.29%death share
- leflunomide Δ 0.01 pts · 102,095 reports · Disease-Modifying Antirheumatic Drug (DMARD) 8.28%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: August 17, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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