Medication approval journey

lithium (Lithobid)

Approved for Acute manic or mixed episodes of bipolar I disorder in patients aged 7 to 17

FDA approvedMood stabiliserTaper risk: high

Before changing anything

Stopping abruptly can be dangerous — never do it without medical supervision

Do not stop abruptly. Stopping lithium suddenly is associated with rebound mania and increased suicide risk. Several drugs in this group are also anticonvulsants, and stopping them abruptly can trigger seizures. Any change should be prescriber-supervised.

How long the trials actually ran

The longest trial behind the lithium approval ran 8 weeks.

The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.

The boxed warning

The strongest warning the FDA puts on a label, reproduced word for word — not our summary of it.

WARNING: 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 ).

FDA label effective August 24, 2026 — read the full label on DailyMed

How many Americans take lithium

Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.

3,301,040
prescriptions in the United States (2024)
501,291
people filling them (2024)

Prescriptions are down 19% since 2014. Whatever you decide about lithium, you are deciding alongside about 501,291 other people this year.

Source: ClinCalc DrugStats (Medical Expenditure Panel Survey (MEPS), Agency for Healthcare Research and Quality), CC BY-SA 4.0, release 2026.08.

What people report to the FDA about lithium

Read this before the numbers.

Anyone can file an adverse event report — patients, doctors, manufacturers — and nobody verifies that the drug caused what was reported. There is no denominator: tens of millions of prescriptions generate reports at an unknowable rate, and reporting rises with news coverage, not necessarily with harm. Counts below are report volumes, not rates, and cannot be compared between drugs. The FDA itself says not to use this data to make medical decisions — we show it because you deserve to see what is in the public record, with its limits stated plainly.

42,306
reports mentioning lithium, all time
33,069
filed as serious (a report-level flag covering every drug and outcome in the report)

Most-reported reactions

  • Toxicity to various agents3,427
  • Drug ineffective3,385
  • Tremor2,597
  • Drug interaction2,576
  • Nausea2,252
  • Off label use2,172
  • Weight increased1,960
  • Fatigue1,792
  • Vomiting1,739
  • Depression1,734

“Drug ineffective” ranking this high is worth noticing: a report of not being helped counts as an adverse event too, and people file them in large numbers.

Source: FDA Adverse Event Reporting System (FAERS), via openFDA, data through 2026-07-30.

Known interactions, from the label

The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.

Read the label’s interactions section

7 DRUG INTERACTIONS Diuretics, NSAID, renin-angiotensin system antagonists, or metronidazole may increase lithium serum concentrations. Recommend frequent monitoring of serum lithium concentration and adjust dosage when necessary. ( 2.3 , 7.1 ) Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium. ( 5.6 , 7.1 ) Antipsychotics: There have been reports of neurologic adverse reactions in patients treated with lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome. ( 5.5 , 7.1 )

7.1 Drugs Having Clinically Important Interactions with Lithium Table 4: Clinically Important Drug Interactions with Lithium Diuretics Clinical Impact: Diuretic-induced sodium loss may reduce lithium clearance and increase serum lithium concentrations. Intervention: More frequent monitoring of serum electrolyte and lithium concentrations. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 ), Warning and Precautions ( 5.3 )]. Non-Steroidal Anti-inflammatory Drugs (NSAID) Clinical Impact: NSAID decrease renal blood flow, resulting in decreased renal clearance and increased serum lithium concentrations. Intervention: More frequent serum lithium concentration monitoring. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )] . Renin-Angiotensin System Antagonists Clinical Impact: Concomitant use increase steady-state serum lithium concentrations. Intervention: More frequent monitoring of serum lithium concentration. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )] . Serotonergic Drugs Clinical Impact: Concomitant use can precipitate serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during lithium initiation. If serotonin syndrome occurs, consider discontinuation of lithium and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.6 )]. Nitroimidazole Antibiotics Clinical Impact: Concomitant use may increase serum lithium concentrations due to reduced renal clearance. Intervention: More frequent monitoring of serum lithium concentration. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )]. Acetazolamide, Urea, Xanthine Preparations, Alkalinizing Agents Clinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion. Intervention: More frequent serum lithium concentration monitoring. Increase lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )] . Methyldopa, Phenytoin and Carbamazepine Clinical Impact: Concomitant use may increase risk of adverse reactions of these drugs. Intervention: Monitor patients closely for adverse reactions of methyldopa, phenytoin, and carbamazepine. Iodide Preparations Clinical Impact: Concomitant use may produce hypothyroidism. Intervention: Monitor patients for signs or symptoms of hypothyroidism [see Warnings and Precautions ( 5.7 )] . Calcium Channel Blocking Agents (CCB) Clinical Impact: Concomitant use may increase the risk of neurologic adverse reactions in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus. Intervention: Monitor for neurologic adverse reactions. Atypical and Typical Antipsychotic Drugs Clinical Impact: Reports of neurotoxic reactions in patients treated with both lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome, as well as reports of an encephalopathic syndrome in few patients treated with concomitant therapy [see Warnings and Precautions ( 5.5 )]. Intervention: Monitor for neurologic adverse reactions. Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor Clinical Impact: Concomitant use of lithium with an SGLT2 inhibitor may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during SGLT2 inhibitor initiation and dosage changes. Neuromuscular Blocking Agents Clinical Impact: Lithium may prolong the effects of neuromuscular blocking agents. Intervention: Monitor for prolonged paralysis.

FDA label for lithium, effective August 24, 2026 — DailyMed.

Who pays for lithium

Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.

Medicare Part D · claims · 2024Medicaid · claims floor · 2024All-payer · survey · 2024Commercially insured adults · not publishedChildren · no per-drug data
Medicare Part D
Read the under-65 group correctly before the numbers: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error. The beneficiary total sums brand-level rows, so treat it as an upper bound on distinct people. 163,602 beneficiaries filled 1,140,044 claims in 2024 — 63,904 aged 65 and over, and 99,698 under 65.
Medicaid
At least 1,125,775 prescriptions in 2024 — a floor, because 60 of 349 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.
All payers (survey estimate)
The MEPS-based estimate above puts the whole country at 3,301,040 prescriptions and 501,291 people in 2024. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.
The population nobody counts
The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of lithium specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.

Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.

The approval, step by step

  1. Step 1

    What the approval was actually based on

    Which studies did the FDA rely on, how long did they run, and who was in them?

    The safety and efficacy of lithium as a treatment for acute manic or mixed episodes of bipolar I disorder in pediatric patients (ages 7 to <=18 years) was demonstrated in an 8-week, randomized, placebo-controlled, parallel group study (NCT01166425). In this study, 81 patients with a Young Mania Rating Scale (YMRS) score of 20 or more were randomized to receive lithium or placebo in a 2:1 ratio.

    FDA-approved labelling, 14 CLINICAL STUDIES (from a generic manufacturer's label — the brand application has no current label on file, so this text is FDA-cleared but is not the original approval document) — read the label on DailyMed

    Our reading

    This is the strangest entry in the directory and the most important to read carefully. Lithium was approved in 1970 and is the oldest and best-established drug in psychiatry. The only trial on its label is an eight-week study in eighty-one children, registered in 2010 and run because a paediatric indication was being sought — forty years after approval. So the label carries a modern, preregistered, placebo-controlled trial that describes almost none of the actual use: lithium is prescribed overwhelmingly to adults, for maintenance, often for decades. The evidence for that use is real and it is substantial. It is simply not on the label, because in 1970 nothing required it to be.

  2. Step 2

    The approval

    When was it approved, under what application, and by whose review?

    Approved
    April 6, 1970
    Application
    NDA016782
    Review
    PRIORITY
    Holds it now
    Solvay
    Label submissions since
    22

    Drug applications are bought and sold. The company that holds this one today is often not the company that ran the trials, and where we cannot state the original sponsor from a source we leave it blank rather than guess.

    Source: openFDA Drugs@FDA, original application ORIG-1

  3. Step 3

    What was added after it was on the market

    Which warnings arrived only after millions of people were already taking it?

    • Lithium works in a narrow window, which is why the blood tests are not optional

      Lithium's boxed warning says something unusual for a psychiatric medication. Toxicity is closely tied to the concentration in your blood, and it can occur at doses close to therapeutic ones. The label instructs that facilities for prompt and accurate lithium measurement must be available before treatment is even started.

      That is why the blood draws exist. They are not administrative. The label directs a level drawn 12 hours after a dose, repeated regularly until you are stable, targeting roughly 0.8 to 1.2 mEq/L for an acute episode and 0.8 to 1 for maintenance.

      Things that shift your level without your dose changing: dehydration, a stomach bug, heavy sweating, a low-salt diet, and several common drugs including ibuprofen and some blood-pressure medications.

      Worth asking

      How often am I getting levels checked, what is my target range, and what should I do about my lithium if I get a vomiting illness or become dehydrated.

      Lithium carbonate prescribing information — Boxed Warning: Lithium Toxicity — U.S. Food and Drug Administration (approved labelling)

  4. Step 4

    What independent research has found since

    What has been learned by people who were not selling it?

  5. Step 5

    What still is not known

    Which questions you might reasonably have has nobody answered yet?

    • The only trial the label shows is in children and ran eight weeks. If you are an adult on long-term lithium, none of it describes you.
    • Lithium has more independent long-term evidence behind it than most drugs here — including on suicide reduction — and almost all of it postdates approval and lives outside the label.
    • Narrow therapeutic index, and kidney and thyroid monitoring for as long as you take it. Which of those is being checked, and how often?

Deciding about lithium?

Open lithium (Lithobid) in Resolv

The app has the full approval journey, the resources behind it, and people working through the same questions.

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