Lithium Carbonate
According to the FDA label: 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 [see Clinical Studies (14)] Maintenance treatment in patients 7 years and older [see Clinical Studies (14)].
16,130 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lithium Carbonate in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Toxicity to Various Agents 1,181 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Drug Ineffective 1,099 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Tremor 1,056 reports
Involuntary shaking or trembling, often in the hands.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 968 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Nausea 787 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Weight Increased 786 reports
Insomnia 691 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Depression 680 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Fatigue 664 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Vomiting 646 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Confusional State 626 reports
A state of being confused, disoriented, or unable to think clearly.
Full definition in the glossary →Somnolence 613 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Anxiety 587 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Suicide Attempt 575 reports
A report that a person attempted suicide. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Off Label Use 562 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 8,538 |
| Male | 6,301 |
| Unknown | 83 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 625 |
| 18-34 | 2,111 |
| 35-49 | 3,101 |
| 50-64 | 3,420 |
| 65-74 | 1,272 |
| 75+ | 498 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Lithium Carbonate. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 8,121 |
| Hospitalization | 6,880 |
| Non-Serious | 3,157 |
| Death | 1,165 |
| Life-Threatening | 952 |
| Disability | 505 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Lithium Carbonate. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 530 |
| 2005 | 451 |
| 2006 | 746 |
| 2007 | 1,023 |
| 2008 | 723 |
| 2009 | 826 |
| 2010 | 798 |
| 2011 | 1,114 |
| 2012 | 1,406 |
| 2013 | 499 |
| 2014 | 398 |
| 2015 | 615 |
| 2016 | 694 |
| 2017 | 584 |
| 2018 | 716 |
| 2019 | 678 |
| 2020 | 687 |
| 2021 | 762 |
| 2022 | 740 |
| 2023 | 723 |
| 2024 | 654 |
| 2025 | 587 |
| 2026 (partial) | 176 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Lithium Carbonate
In FDA adverse event reports that mention Lithium Carbonate, these medications appeared most often in the same report.
- Quetiapine (3,802 reports)
- Olanzapine (2,407 reports)
- Lamotrigine (1,931 reports)
- Clonazepam (1,823 reports)
- Aripiprazole (1,810 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026