Medication approval journey

lithium (Lithobid)

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

page first published · last updated

Also answers to “the oldest rock in the band” — its codename in our videos and posts. The full codebook

FDA approvedMood stabiliserTaper risk: high

How this page reads

The page as written, with the clinical terms

Plain language uses the same facts, the same numbers and the same caveats. It does not leave anything out. Quotes from the FDA label are never reworded in either setting.

Before you stop or change your lithium dose

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.

what the lithium warnings mean

label facts below are read from the lithium carbonate FDA label on DailyMed, set id 59d0e8e3-bc0b-0cc1-e063-6394a90a0a6d, version 1, effective august 24, 2026. the section numbers in brackets are the label’s own. every source is linked at the end of this section. last checked 2026-10-05.

lithium was approved in 1970, before the fda published its reviews, and today’s label is a generic manufacturer’s. how many americans take it is a number this page cannot give: the federal survey this site uses for every other drug (ahrq meps) reports no year from 2014 to 2024 that meets its reliability rule for lithium, so we print no count rather than an estimate [meps]. the label carries one boxed warning, on toxicity, and nine further warnings, and almost all of lithium’s evidence, for and against, was produced after approval and lives outside the label. this section says what each warning means in plain words, what the label’s one controlled trial measured, which side effects the label counts and how often, and what independent research has found, in both directions. every number is from the label or from a study in the library, and each source is linked at the end.

this is information to take to a prescriber. nothing here is a reason to start, stop or change a dose on your own; with lithium, a missed blood test or a stomach bug can matter as much as a dose change.

the boxed warning: toxicity, and why the blood tests exist

the boxed warning is unusual for a psychiatric drug. it says lithium toxicity is closely related to the concentration in the blood and "can occur at doses close to therapeutic concentrations", and that facilities for prompt and accurate blood lithium measurement must be available before treatment starts [label, boxed warning]. the numbers behind it: the therapeutic range is 0.8 to 1.2 meq/l and toxic concentrations begin at 1.5 meq/l or above, so the gap between working and poisoning is narrow, and some people show toxic signs inside the therapeutic range [label 5.1].

that is what the blood draws are for. the label says to draw the level 12 hours after the last dose, when it is relatively stable; to re-check after any dose change, any new medicine (it names diuretics, nsaids, blood-pressure drugs of the renin-angiotensin type, and metronidazole), any big change in exercise, and any illness; and not to rely on the number alone, because the person matters too. older people often need lower doses and can be toxic at levels others tolerate [label 2.3; narrow-window row].

the signs run from mild to fatal: fine tremor, light-headedness, poor coordination and weakness; then giddiness, apathy, drowsiness, muscle twitching, unsteady gait, blurred vision, ringing in the ears and slurred speech; then muscle jerking, confusion, seizures, coma and death. rarely the neurological damage persists after the drug is stopped. the heart, kidneys, lungs and gut can all be involved, and there is no specific antidote. toxicity is more likely with a fever, dehydration, kidney impairment, heart disease, a change in sodium or potassium, or a new drug that raises the level [label 5.1]. because the drug takes up to 24 hours to reach the brain, symptoms can lag the blood level.

the nine other warnings, in plain words

the label’s warnings and precautions run from 5.2 to 5.10. none is boxed. most of them are about the kidneys, salt and water, and the glands, which is why lithium comes with a schedule of blood tests rather than a single warning.

  • passing a lot of urine [5.2]: lithium can reduce the kidney’s ability to concentrate urine, sometimes to the point of nephrogenic diabetes insipidus, with heavy urination and thirst, within weeks of starting. the danger is dehydration, which raises the lithium level. it is usually reversible on stopping, but after long-term use may be only partly reversible. the label names amiloride as a possible treatment.
  • low sodium [5.3]: lithium makes the kidneys lose sodium, so the label says to keep a normal salted diet and drink enough (2.5 to 3 litres a day during stabilisation). heavy sweating, diarrhea, vomiting or a fever can lower tolerance to the drug; the label says fluid and salt should be replaced under medical supervision and the dose reduced or paused until the illness passes. below a sodium of 120 the signs are confusion and lethargy; below 115, seizures, coma and death can follow.
  • chronic kidney disease [5.4]: long-term lithium is associated with a chronic scarring of the kidney’s tubules and, in post-marketing reports, nephrotic syndrome. the label says kidney function should be checked before and during treatment, and that a progressive or sudden change, even within the normal range, is a reason to re-evaluate.
  • brain syndrome with antipsychotics [5.5]: weakness, lethargy, fever, tremor and confusion with movement problems has occurred in people on lithium plus an antipsychotic, in some cases followed by irreversible brain damage. the label says the combination needs close monitoring and prompt stopping if signs appear, and that the syndrome may be the same as neuroleptic malignant syndrome.
  • serotonin syndrome [5.6]: lithium can trigger it, and the risk rises with ssris, snris, triptans, tricyclics, fentanyl, tramadol, buspirone and st john’s wort, and with maois. signs are agitation or confusion, racing heart, sweating, fever, tremor, muscle jerking and overactive reflexes.
  • thyroid [5.7]: lithium concentrates in the thyroid and can suppress it, causing hypothyroidism; paradoxically, cases of overactive thyroid have also been reported. the label says to test thyroid function before starting, at three months, and every six to twelve months after.
  • calcium and parathyroid [5.8]: long-term lithium is associated with persistent overactivity of the parathyroid glands and high calcium, which may not resolve on stopping and may need surgery. the label says to check calcium regularly.
  • brugada syndrome [5.9]: post-marketing reports link lithium to unmasking this inherited heart-rhythm disorder, which carries a risk of sudden death. the label says to avoid lithium in anyone with it or suspected of it, and to involve a cardiologist if there is unexplained fainting or a family history of sudden death before 45.
  • pressure in the head [5.10]: pseudotumor cerebri, raised pressure inside the skull with swelling of the optic nerve, has been reported; undetected it can damage vision. the label says to consider stopping if it occurs.
  • drug interactions [7]: the label’s interaction table says diuretics, nsaids such as ibuprofen and naproxen, renin-angiotensin drugs such as ace inhibitors, and metronidazole can raise the lithium level, and asks for more frequent levels and dose adjustment when they are started [interactions].

what the label’s trial measured, and what it does not cover

the only controlled trial the current label describes is recent and in children. eighty-one patients aged 7 to 17 with an acute manic or mixed episode were randomised two to one to lithium or placebo for 8 weeks; on the young mania rating scale lithium beat placebo by 5.5 points (a 12.9-point fall against 7.3). then 31 who had stabilised on lithium were randomised to continue or switch to placebo for 28 weeks: 41.2% of those kept on lithium discontinued for any reason, against 78.6% on placebo [label 14, table 5]. mean blood level in the acute trial was 0.98 meq/l.

what the label does not carry: how lithium’s efficacy in adults was established. the fda approved it in 1970 and never published its review, and the label lists adult adverse reactions from voluntary reports with no frequencies attached [dossier approval record on this page]. for an adult on long-term lithium, none of the label’s trial data describes them. the independent research below is where the adult evidence lives.

the most common side effects, with the label’s numbers

the label’s only incidence table comes from the pediatric trial, 53 children on lithium against 28 on placebo over 8 weeks: nausea or vomiting 57% vs 29%, passing a lot of urine (including bed-wetting) 38% vs 14%, tremor 32% vs 7%, thirst 28% vs 11%, fatigue 26% vs 4%, raised thyroid-stimulating hormone 25% vs 0%, dizziness 23% vs 7%, unsteady gait 13% vs 0%, rash 13% vs 0%, decreased appetite 9% vs 4%, blurry vision 9% vs 0%, disorientation 6% vs 0% [label 6.1]. the full list is in the side-effects section lower on this page.

for adults the label gives a list without rates, headed by fine hand tremor, frequent urination, mild thirst and nausea during early treatment, and then the longer voluntary-report list: muscle twitching, unsteadiness, slurred speech, dizziness, confusion, slow heart rhythms, qt prolongation, reduced kidney clearance, hair thinning, and more [label 6]. the reason there are no adult percentages is the reason above: the adult trials predate the modern label.

the independent synthesis fills the gap. pooling 385 studies, long-term lithium went with a modest fall in kidney filtration, reduced ability to concentrate urine, about six-fold higher odds of hypothyroidism, and weight gain, while end-stage kidney failure was rare: 18 of 3,369 patients, 0.5% [mcknight-2012].

what independent research says, in both directions

in favour. across 48 randomised trials with 6,674 people with mood disorders, those on lithium were far less likely to die by suicide than those on placebo (odds ratio 0.13) and less likely to die from any cause (odds ratio 0.38) [cipriani-2013]. among 18,018 finnish patients with bipolar disorder followed about seven years, periods on lithium carried the lowest risk of psychiatric rehospitalisation of any oral treatment, about 33% lower than periods off it [lahteenvuo-2018]. among 6,671 uk patients on maintenance treatment, self-harm rates were roughly 40 to 50% higher on valproate, olanzapine or quetiapine than on lithium [hayes-2016]. and in 330 people with bipolar i disorder followed up to two years, lithium alone or with valproate prevented relapse better than valproate alone, with no clear extra benefit from adding valproate to lithium [balance-2010]. lithium has more independent long-term evidence behind it than most drugs on this site.

against, or narrower than the headline. the suicide-prevention finding met its test in 2022: a double-blind trial at 29 veterans affairs centres added extended-release lithium or placebo to usual care in 519 veterans with bipolar disorder or depression who had recently attempted suicide or been admitted to prevent one. it was stopped for futility: no difference in repeat suicide-related events (hazard ratio 1.10), 24.5% of participants having an event, 65 on lithium and 62 on placebo [katz-2022]. the two results can both be true. the meta-analysis pooled smaller trials with deaths as the outcome; the va trial asked whether adding lithium to existing care, at modest levels (mean 0.54 meq/l in bipolar disorder, 0.46 in depression), in a group that was 84% men, cut a broad set of repeat events; deaths were too few to compare. "simply adding lithium to existing medication regimens is unlikely to be effective for preventing a broad range of suicide-related events", the authors wrote, and that is the honest reading of both studies side by side.

where the warnings have been measured. among 10,615 ontario residents aged 66 and over on lithium, 3.9% were admitted at least once for lithium toxicity over ten years; starting a loop diuretic raised the risk 5.5-fold and an ace inhibitor 7.6-fold in the following month, while thiazide diuretics and nsaids were not independently associated with admission in that population, a null that does not license regular ibuprofen on lithium and that the label still monitors [juurlink-2004]. and one acute signal from the weakest kind of evidence: of 62 online reports of a classic psychedelic taken with lithium, 47% involved seizures and 39% medical attention, against none of 34 reports on lamotrigine; trip reports are self-selected and 47% is not a rate, but the contrast is hard to explain away and the trials excluded people with bipolar disorder for a reason [nayak-2021].

questions to ask your prescriber about lithium

each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.

  • what is my target lithium level, how often is it checked, and when was the last one drawn 12 hours after a dose?
  • what should i do about my lithium if i get a vomiting or diarrhoea illness, a fever, or become dehydrated in hot weather?
  • which painkiller is safe for me? the label lists ibuprofen and naproxen among the drugs that raise the level.
  • if a new blood-pressure or heart drug is started, is a lithium level booked for the weeks after it?
  • how often are my kidney function, thyroid and calcium being checked, and what result would change the plan?
  • if lithium was suggested for me partly for suicide prevention, what does the evidence show for someone in my situation?
  • do i have any unexplained fainting or a family history of sudden death before 45? the label says that is a reason to involve a cardiologist.

questions people ask

does lithium have a black box warning?
yes, on toxicity. the fda label says lithium toxicity is closely related to blood concentration and can occur at doses close to therapeutic ones, and that facilities for prompt blood lithium measurement must be available before treatment starts. the therapeutic range is 0.8 to 1.2 meq/l and toxicity begins at 1.5 or above, which is why the blood tests are not optional.
what are the signs of lithium toxicity?
the label describes a range: mild, with fine tremor, light-headedness, poor coordination and weakness; moderate, with giddiness, drowsiness, muscle twitching, unsteady gait, blurred vision, ringing in the ears and slurred speech; and severe, with muscle jerking, confusion, seizures, coma and death. nausea, vomiting and diarrhea are also listed, and because the drug takes up to 24 hours to reach the brain, symptoms can lag the blood level. there is no specific antidote; a prescriber or emergency service is the call.
does lithium prevent suicide?
the evidence points both ways and the honest answer is: in some settings, apparently yes, and when simply added to existing care, apparently not. a meta-analysis of 48 randomised trials (6,674 people) found far fewer suicides on lithium than placebo (odds ratio 0.13). a 2022 double-blind trial in 519 veterans who had recently attempted suicide added lithium or placebo to their usual care and was stopped for futility, with no difference in repeat suicide-related events (hazard ratio 1.10), at modest blood levels and in a mostly male group. neither cancels the other.
what does lithium do to the kidneys and thyroid?
the label warns of heavy urination and thirst from reduced urine-concentrating ability, chronic kidney scarring with long-term use, hypothyroidism, and high calcium from overactive parathyroid glands, and asks for kidney, thyroid and calcium monitoring. pooling 385 studies, long-term lithium went with a modest fall in kidney filtration, about six-fold higher odds of hypothyroidism and weight gain; end-stage kidney failure was rare, 18 of 3,369 patients (0.5%).
what are the most common lithium side effects?
for adults the label lists fine hand tremor, frequent urination, mild thirst and nausea during early treatment, without rates, because the adult trials predate the modern label. its only incidence table is from an 8-week trial in 53 children against 28 on placebo: nausea or vomiting 57% vs 29%, frequent urination 38% vs 14%, tremor 32% vs 7%, thirst 28% vs 11%, fatigue 26% vs 4%, raised thyroid-stimulating hormone 25% vs 0%, dizziness 23% vs 7%.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

  1. lithium carbonate prescribing information, fda label on dailymed (set id 59d0e8e3-bc0b-0cc1-e063-6394a90a0a6d, version 1, effective august 24, 2026): boxed warning; sections 2.3, 5.1 to 5.10, 6, 6.1, 7, 14 table 5
  2. ahrq medical expenditure panel survey, prescribed medicines public-use files 2014 to 2024: no year meets ahrq’s reliability rule (fewer than 60 respondents or relative standard error over 50%) for lithium, so no count is printed; computed by veisund, method on the usage section of this page
  3. lithium works in a narrow window, which is why the blood tests are not optional (fda boxed warning and dosing section, read off the label) (library row)
  4. lithium’s label names the everyday drugs that push its level up: water pills, nsaids, blood pressure drugs (lithium carbonate prescribing information, drug interactions, september 2026) (library row)
  5. cipriani a, et al. lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis. bmj 2013 (library row)
  6. katz ir, et al. lithium treatment in the prevention of repeat suicide-related outcomes in veterans with major depression or bipolar disorder: a randomized clinical trial. jama psychiatry 2022 (library row)
  7. lähteenvuo m, et al. real-world effectiveness of pharmacologic treatments for the prevention of rehospitalization in a finnish nationwide cohort of patients with bipolar disorder. jama psychiatry 2018 (library row)
  8. hayes jf, et al. self-harm, unintentional injury, and suicide in bipolar disorder during maintenance mood stabilizer treatment: a uk population-based electronic health records study. jama psychiatry 2016 (library row)
  9. geddes jr, et al. lithium plus valproate combination therapy versus monotherapy for relapse prevention in bipolar i disorder (balance). lancet 2010 (library row)
  10. mcknight rf, et al. lithium toxicity profile: a systematic review and meta-analysis. lancet 2012 (library row)
  11. nayak sm, et al. classic psychedelic coadministration with lithium, but not lamotrigine, is associated with seizures: an analysis of online psychedelic experience reports. pharmacopsychiatry 2021 (case series; contested) (library row)

How long the lithium 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.

People often stay on these drugs for far longer than the trials ran. The one trial the label describes ran 8 weeks.

That does not mean longer use is unsafe. It does not mean the drug stops working either. It means longer use was never the thing that got tested.

If you have been on it a long time, that is a fair thing to ask your prescriber about.

Boxed warning: lithium toxicity

The strongest warning the FDA puts on a label, often called a black box warning. It is reproduced below word for word, not summarised.

This is the strongest warning the FDA can put on a drug label. Some people call it a black box warning. We copied it word for word. We did not shorten it and we did not soften it.

The warning below is about lithium poisoning (lithium toxicity). How much lithium is in the blood decides the risk. Poisoning can happen at doses close to the ones that treat the illness. The label says a lab must be available before treatment starts. It has to measure blood lithium quickly and correctly.

The FDA’s own words follow, copied exactly.

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

What lithium is FDA approved for, and the trials behind it

Approved for acute manic and mixed episodes of bipolar I disorder, and maintenance treatment, in patients 7 years and older; the 1970 approval predates by decades the pediatric trial that today's label describes in 1970, under application NDA 016782. Source: FDA Drugs@FDA.

The FDA approved lithium in 1970 and never published its review of that approval; the modern label's only controlled-trial data come from a pediatric study conducted decades later. How lithium's efficacy in adults was established is not documented anywhere on the label, which lists adult adverse reactions from voluntary reports without frequencies.

The only controlled trial the current label describes is recent and pediatric: an 8-week, randomized, placebo-controlled, parallel-group study in 81 patients aged 7 to 17 with acute manic or mixed episodes, randomized 2:1 to lithium or placebo, followed by a 28-week randomized-withdrawal analysis in 31 patients who had stabilized on lithium.

The largest gap on this page. The FDA approved lithium in 1970 and never published its review.

The only trial data on the modern label come from a study in children run decades later. How lithium was shown to work in adults is written down nowhere on the label. The label lists adult side effects from voluntary reports, with no rates.

The FDA approved lithium in 1970. There were two approved uses. One is sudden manic and mixed episodes of bipolar I disorder. The other is long-term treatment. Both cover people aged 7 and older. The 1970 approval came decades before the trial in children that today’s label describes. The file number is NDA 016782. The source is Drugs@FDA, the FDA's own database.

That one trial ran 8 weeks. People were sorted by chance. The groups ran side by side. It was compared with a placebo.

It held 81 patients aged 7 to 17 having a sudden manic or mixed episode. Two went on the drug for every one on a placebo.

After that came a 28-week look at 31 patients who had become stable. Some of them were moved off the drug by chance.

Trials
1 placebo-controlled trial (pediatric)
Duration
8 weeks
Participants
81 patients aged 7 to 17
Compared against
Placebo
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.

Verbatim from the lithium FDA label, Clinical Studies section, effective August 24, 2026 — read the full label on DailyMed.

Side effects of lithium in the approval trials

Incidence among 53 pediatric patients (7 to 17 years) on lithium versus 28 on placebo in the 8-week acute bipolar trial — the label's only incidence table; adult adverse reactions on the label come from voluntary reports with no frequencies attached. The label cautions that rates observed in clinical trials cannot be directly compared with other trials and may not reflect the rates observed in clinical practice.

Read the limits first. These numbers come from the 8-week trial in patients aged 7 to 17. It is the label’s only rate table. 53 took the drug and 28 took a placebo.

Adult side effects on the label come from voluntary reports with no rates attached.

The label warns that you cannot line these rates up against other trials. It warns that real life may not match them either.

  • Nausea/vomiting (57% vs 29% on placebo)
  • Polyuria, including enuresis (38% vs 14%)
  • Tremor (32% vs 7%)
  • Thirst/polydipsia (28% vs 11%)
  • Fatigue (26% vs 4%)
  • Increased TSH (25% vs 0%)
  • Dizziness (23% vs 7%)
  • Ataxia/gait disturbance (13% vs 0%)
  • Rash/dermatitis (13% vs 0%)
  • Decreased appetite (9% vs 4%)
  • Blurry vision (9% vs 0%)
  • Disorientation (6% vs 0%)
Common Adverse Reactions (incidence ≥ 5% and at least twice the rate of placebo ): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision.

From the lithium FDA label, Adverse Reactions section, effective August 24, 2026 — DailyMed.

More from the lithium label: warnings and precautions

  • Kidney effects with long-term use

    The predominant form of chronic renal disease associated with long-term lithium treatment is a chronic tubulointerstitial nephropathy; the label directs monitoring of kidney function during treatment.

    FDA label, Warnings and Precautions section.

  • Thyroid monitoring

    Lithium is concentrated within the thyroid and can inhibit thyroid hormone synthesis and release, which can lead to hypothyroidism; some paradoxical cases of hyperthyroidism have been reported. The label directs monitoring thyroid function before starting treatment, at three months, and every six to twelve months thereafter.

    FDA label, Warnings and Precautions section.

How many Americans take lithium

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

These are federal survey numbers. They come out about two years late. They count prescriptions filled. They do not tell you if the drug helped.

No year from 2014 to 2024 meets AHRQ’s reliability rule for this drug, so we print no count. Years not shown, under AHRQ’s reliability rule: 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2022, 2023, 2024 (fewer than 60 survey respondents); 2021 (AHRQ masks the name in the public file).

Correction (29 September 2026). An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves. It showed 501,291 people and 3,301,040 prescriptions for 2024. No year meets AHRQ’s reliability rule for this drug, so that count is removed. It said prescriptions were down 19% since 2014; too few years meet the rule to show a trend, so that line is removed.

Source: AHRQ Medical Expenditure Panel Survey (MEPS), Prescribed Medicines public-use files, 2014 (HC-168A) through 2024 (HC-254A), computed by veisund. People with at least one purchase where the Multum generic name (RXDRGNAM) equals the drug, weighted by the year’s person weight; purchases include refills. Standard errors by Taylor linearization on VARSTR/VARPSU. AHRQ’s reliability rule: a year is not shown when fewer than 60 survey respondents reported the drug or the relative standard error is over 50%. AHRQ cautions that its 2018 questionnaire redesign and the 2020–2022 pandemic years make year-to-year comparisons less certain.

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.

Read this before the numbers.

Anyone can send a report to the FDA. Patients can. Doctors can. Drug makers can. Nobody checks that the drug caused what the report describes.

There is also no bottom number. Tens of millions of prescriptions turn into reports at a rate nobody knows. Reports go up when a drug is in the news, and that is not the same as more harm.

So these are counts of reports. They are not rates. You cannot use them to compare one drug with another. The FDA itself says not to use this data to make medical choices.

We show it because it is on the public record, and you should get to see it with its limits named.

42,306
reports mentioning lithium, all time
33,069
filed as serious (a report-level flag covering every drug and outcome in the report)
filed as serious. That flag covers the whole report, and one report can name more than one drug and more than one outcome.

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.

It is worth noticing how high “drug ineffective” ranks. A report that the drug did not help counts as an adverse event too. People file a lot of them.

Source: FDA Adverse Event Reporting System (FAERS), via openFDA, openFDA dataset refreshed 2026-07-30 (the refresh date of the query endpoint, not the date reports run through).

Drug interactions listed on the lithium label

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

Below is the part of the FDA label that lists other drugs. It is copied word for word.

No list on the web can see what else you take. A pharmacist can. Ask one to check your full list.

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.

Label history: when this label changes, it is recorded in What changed.

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 · 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)
No figure. In AHRQ’s MEPS 2024 Prescribed Medicines file, only 30 survey respondents reported it, under the 60 AHRQ requires before it publishes an estimate, so we do not print one.
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.

Who has been paying for lithium, 2019–2024

Medicare Part D

Claims, all ages — the one payer with a public per-drug series.

20192024

1,308,367 → 1,140,044 claims

Medicare under 65

Beneficiaries, not ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population. A gap is a suppressed split, not zero.

20192024

130,879 → 99,698 beneficiaries

Medicaid

A floor each year — small-cell rows are suppressed federally and excluded from the sum.

20192024

1,169,622 → 1,125,775 prescriptions (floor)

Commercially insured adults

No public dataset publishes per-drug commercial claims for any year — the absence is the finding, and it is rendered, not interpolated. The population this library most wants to inform is the one with no public per-drug series, in any year — insurers and PBMs hold that data privately. What the federal surveys do measure — how many adults take these medications at all — is on the adult-usage page.

Sources: Medicare Part D Prescribers by Geography and Drug (data.cms.gov, national rows, per data year); Medicaid State Drug Utilization Data (data.medicaid.gov, national rows). Claims, fills and beneficiaries are different units — compare each series only with itself.

The lithium 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's label names the everyday drugs that push its level up: water pills, NSAIDs, blood pressure drugs

      56 years after approval

      Lithium has a narrow window between the level that works and the level that poisons, and the label says the window can be crossed by an ibuprofen or a blood pressure tablet.

      Significant findings

      Lithium carbonate prescribing information (Hikma, September 2026), 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 treatment".

      Drug Interactions summary: "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." The mechanisms, from Table 4: diuretics because "Diuretic-induced sodium loss may reduce lithium clearance and increase serum lithium concentrations"; NSAIDs because they "decrease renal blood flow, resulting in decreased renal clearance and increased serum lithium concentrations." For both, the intervention is "More frequent serum lithium concentration monitoring. Reduce lithium dosage based on serum lithium concentration and clinical response".

      Two psychiatric interactions on the same list: "Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium." And: "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."

      Worth asking

      The drugs on this list are the ones people buy without asking: ibuprofen and naproxen for a headache, a water pill or an ACE inhibitor started by a cardiologist who may not know about the lithium. If you take lithium, the question is what painkiller is safe for you, and whether a lithium level is due after any new prescription. The Juurlink 2004 row in this wave measured which of these actually sent older patients to hospital.

      Lithium carbonate tablets and capsules: FDA-approved prescribing information, Boxed Warning and Drug Interactions 7.1 — Hikma Pharmaceuticals USA Inc.; US Food and Drug Administration (2026)

    • 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 veisund

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