Prescription medicine
Lithium Brand names: Lithobid; first approved as Lithonate
Lithium (Lithobid) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $0.104 per lithium carbonate 300 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the lithium FDA label on DailyMed (effective December 23, 2025, Glenmark Pharmaceuticals Inc., USA); the NDA 16782 record on Drugs@FDA; every lithium label on DailyMed.
Highlights of the record
FDA label of December 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LITHIUM TOXICITY.
Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )]. WARNING: LITHIUM TOXICITY See full prescribing information for complete boxed warning. Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy ( 2.3 , 5.1 ).
Used for
From the label: indications and usageLithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )]
Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic a
Forms and strengths
- 150 mg
- 300 mg
- 450 mg
- 600 mg
- 8 meq/5ml
Capsule; extended-release tablet; gelatin-coated capsule; tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- April 6, 1970 Lithonate, Solvay; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first May 21, 1986; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 24 under generic applications, 5 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.104 per capsule Lithium carbonate 300 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest January 26, 2022
- FAERS reports
- 41,678 through July 30, 2026
What is lithium used for?
From the label: indications and usageLithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )]
Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 )
Maintenance treatment in patients 7 years and older
Conditions named in the indications of lithium's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Mood Stabilizer.
Source: FDA drug label (Lithium Carbonate), Glenmark Pharmaceuticals Inc., USA, effective December 23, 2025 (SPL set 63b3790f-a9b5-47f4-bae1-ddf8b43c13c1), via openFDA; the full label on DailyMed
What does the patient leaflet for lithium say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about lithium carbonate capsules?Lithium carbonate capsules can cause serious side effects, including: • too much lithium in your blood (lithium toxicity). Lithium toxicity that can cause death may happen even if the lithium level in your blood is close to the right level for you. Your healthcare provider will need to monitor your blood levels of lithium to find the best dose for you. Take your lithium carbonate capsules exactly as your healthcare provider tells you to take it. Stop taking lithium carbonate capsules and call your healthcare provider right away if you have any symptoms of lithium toxicity including: • abnormal heartbeat • vomiting • diarrhea • drowsiness • weak muscles • blurred vision • clumsiness • ringing in your ears • muscle twitching Other symptoms may include: • lightheadedness • confusion • bloating • mood changes • slurred speech • breathing problems • seizure • coma
From the patient leaflet: What should I avoid while taking lithium carbonate capsules?Do not drive, operate heavy machinery, or do other dangerous activities when you start taking lithium carbonate capsules, when your dose is changed, or until you know how lithium carbonate capsules affects you. Lithium carbonate capsules can make you sleepy. Talk to your healthcare provider about these activities. • Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your healthcare provider instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough. • Do not change the amount of salt in your diet. Changing the amount of salt in your diet could change the amount of lithium carbonate in your blood.
From the patient leaflet: How should I store lithium carbonate capsules?Store lithium carbonate capsules at room temperature, between 68°F to 77°F (20°C to 25°C). Keep capsules dry and keep in a tightly closed container. Keep lithium carbonate capsules, and all medicines out of the reach of children.
Source: FDA drug label (Lithium Carbonate), Glenmark Pharmaceuticals Inc., USA, effective December 23, 2025 (SPL set 63b3790f-a9b5-47f4-bae1-ddf8b43c13c1), via openFDA; the full label on DailyMed
Is there a generic for lithium (Lithobid)?
The FDA approved the first generic lithium on May 21, 1986. 27 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lithium from 24 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lithium (Lithobid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.104 per Lithium carbonate 300 mg capsule, down 6% from $0.111 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lithium carbonate 300 mg capsule (generic)
- Lithobid ER 300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lithium 8 mEq/5 mL solution | Generic | $0.453 per mL | n/a | -4% |
| Lithium carbonate 150 mg capsule | Generic | $0.0963 per capsule | $2.89 | +12% |
| Lithium carbonate 300 mg capsule | Generic | $0.104 per capsule | $3.12 | -6% |
| Lithium carbonate 300 mg tablet | Generic | $0.191 per tablet | $5.73 | +0.4% |
| Lithium carbonate 600 mg capsule | Generic | $0.243 per capsule | $7.28 | -3% |
| Lithium carbonate ER 300 mg tablet | Generic | $0.196 per tablet | $5.89 | -1% |
| Lithium carbonate ER 450 mg tablet | Generic | $0.259 per tablet | $7.77 | +2% |
| Lithobid ER 300 mg tablet | Brand | $12.02 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $360.58 | -0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lithium been recalled?
The FDA's Enforcement Report lists 4 recalls naming lithium since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lithium label say about other medicines?
The lithium label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 43 other medicines name lithium. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | Clinical Impact: Concomitant use may increase serum lithium concentrations due to reduced renal clearance. … concentration and clinical response [see Dosage and Administration ( 2.3 )]. Acetazolamide, Urea, Xanthine Preparations, Alkalinizing Agents |
| Amiloride | warnings and precautions | Amiloride may be considered as a therapeutic agent for lithium-induced nephrogenic diabetes insipidus. |
| Buspirone | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, and St. … |
| Carbamazepine | drug interactions | Clinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion. … response [see Dosage and Administration ( 2.3 )]. Methyldopa, Phenytoin and Carbamazepine |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, and St. … |
| Methyldopa | drug interactions | Clinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion. … concentration and clinical response [see Dosage and Administration ( 2.3 )]. Methyldopa, Phenytoin and Carbamazepine |
| Metronidazole | drug interactions | Diuretics, NSAID, renin-angiotensin system antagonists, or metronidazole may increase lithium serum concentrations. |
| Phenytoin | drug interactions | Clinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion. … and clinical response [see Dosage and Administration ( 2.3 )]. Methyldopa, Phenytoin and Carbamazepine |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, and St. … |
Other labels that name lithium
- Amiodarone
- Amitriptyline
- Amphetamine
- Azilsartan
- Benazepril
- Bexagliflozin
- Bumetanide
- Calcitonin salmon
- Calcium chloride
- Canagliflozin
- Candesartan
- Captopril
- Celecoxib
- Chlorothiazide
- Chlorpromazine
- Chlorthalidone
- Cisatracurium
- Citalopram
- Clomipramine
- Dapagliflozin
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Diclofenac
- Diflunisal
- Dronabinol
- Duloxetine
- Empagliflozin
- Enalapril
- Enalaprilat
- Eplerenone
- Ertugliflozin
- Escitalopram
- Ethacrynic acid
- Etodolac
- Fenfluramine
- Fenoprofen
- Fluoxetine
- Fluvoxamine
- Furosemide
- Haloperidol
- Hydrochlorothiazide
- Ibuprofen
- Indapamide
- Indomethacin
- Insulin aspart
- Insulin degludec
- Insulin detemir
- Insulin glargine
- Insulin glulisine
- Insulin human
- Insulin lispro
- Irbesartan
- Ketoprofen
- Ketorolac
- Levomilnacipran
- Lisdexamfetamine
- Lisinopril
- Losartan
- Mannitol
- Meclofenamate
- Mefenamic acid
- Meloxicam
- Methamphetamine
- Metolazone
- Milnacipran
- Mirtazapine
- Moexipril
- Nabumetone
- Naproxen
- Nortriptyline
- Olanzapine
- Olmesartan
- Oxaprozin
- Paroxetine
- Perindopril
- Piroxicam
- Potassium iodide
- Prochlorperazine
- Ramipril
- Rocuronium
- Sargramostim
- Sertraline
- Sodium chloride
- Sodium polystyrene sulfonate
- Sotagliflozin
- Spironolactone
- Succinylcholine
- Sulindac
- Telmisartan
- Thalidomide
- Theophylline
- Tinidazole
- Topiramate
- Torsemide
- Trandolapril
- Trazodone
- Triamterene
- Trifluoperazine
- Trimipramine
- Valproic acid
- Valsartan
- Vasopressin
- Venlafaxine
- Verapamil
- Vilazodone
- Vortioxetine
- Ziprasidone
Source: FDA drug label (Lithium Carbonate), Glenmark Pharmaceuticals Inc., USA, effective December 23, 2025 (SPL set 63b3790f-a9b5-47f4-bae1-ddf8b43c13c1), via openFDA; the full label on DailyMed
What do FAERS reports show for lithium?
The FDA Adverse Event Reporting System holds 41,678 reports that list lithium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,280 are coded as a death and 16,962 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lithium?
5 other medicines are given the same way (oral) and in the same FDA class as lithium or labeled mainly for the same use (bipolar disorder), the same class first. Bipolar disorder lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lamotrigine | Bipolar disorder | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Divalproex | Bipolar disorder | 44 labelers | $0.194 per tablet 500 mg tablet | No current entry |
| Carbamazepine | Bipolar disorder | 42 labelers | $0.119 per tablet 200 mg tablet | A presentation being discontinued |
| Risperidone | Bipolar disorder | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lithium compare with medicines for the same use?
7 side-by-side pages set lithium beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lithium
- 5 medicines for the same use
- Other mood stabilizers
- the pharmacologic class, with prices and generics
- Lithium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other