Lithium carbonate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Lithium carbonate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Mood stabilizer
Also reported as: Lithium Carbonate Cap, Lithium Carbonate Capsules, Lithium Carbonate Tablets Usp 300mg

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 7,307 adverse event reports that name Lithium carbonate. In these reports the drug is a suspect or interacting product.

In the same period, 9,218 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 266 reports in the 12 months to June 2026 and 230 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Lithium carbonate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 46 reports that name Lithium carbonate.
In January to March 2026, FDA received 94.
In April to June 2025, FDA received 49.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 706 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 7,196 of the 7,307 reports (98.5%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 706 terms.

Reaction terms in the reports that name Lithium carbonate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 7,307 reports
Toxicity to various agentspoisoning or toxic effect of one or more substances	1,114	15.2%
Drug interactionan interaction between medicines	752	10.3%
Tremorshaking	698	9.6%
Drug ineffectivethe medicine did not work as expected	668	9.1%
Confusional stateconfusion	408	5.6%
Weight increasedweight gain	408	5.6%
Therapeutic agent toxicity	397	5.4%
Suicide attempta suicide attempt	381	5.2%
Vomitingbeing sick	309	4.2%
Somnolencedrowsiness	304	4.2%
Completed suicidedeath by suicide	274	3.7%
Fatiguetiredness	271	3.7%
Nauseafeeling sick	265	3.6%
Diarrhoealoose or frequent stools	255	3.5%
Overdosea dose above the recommended amount	243	3.3%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	238	3.3%
Insomniadifficulty sleeping	230	3.1%
Depressionlow mood	227	3.1%
Agitationrestlessness	226	3.1%
Dizzinesslight-headedness or unsteadiness	221	3%
Acute kidney injurysudden loss of kidney function	220	3%
Dehydration	211	2.9%
Akathisiainner restlessness and an urge to move	208	2.8%
Dysarthria	206	2.8%
Antipsychotic drug level below therapeutic	205	2.8%
Off label useused for a purpose or in a way not on the label	203	2.8%
Hypotensionlow blood pressure	196	2.7%
Antipsychotic drug level increased	195	2.7%
Gait disturbancedifficulty walking	193	2.6%
Hypertensionhigh blood pressure	192	2.6%
Nephrogenic diabetes insipidus	184	2.5%
Mania	183	2.5%
Astheniaweakness or lack of energy	182	2.5%
Blood creatinine increasedraised creatinine, a kidney test	179	2.4%
Renal failure acute	176	2.4%
Falla fall	175	2.4%
Product use in unapproved indicationused for a purpose not on the label	173	2.4%
Therapeutic product effect incomplete	173	2.4%
Renal failurekidney failure	171	2.3%
Obsessive-compulsive disorder	169	2.3%
Mental status changes	165	2.3%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	164	2.2%
Euphoric mood	162	2.2%
Increased appetite	160	2.2%
Leukopenialow white blood cells	160	2.2%
Ataxia	158	2.2%
Hypothyroidismunderactive thyroid	152	2.1%
Renal impairmentreduced kidney function	152	2.1%
Disorientation	150	2.1%
Intentional overdosea deliberate overdose	148	2%

Download all 706 terms of Lithium carbonate (CSV)

The counts add to more than 7,307 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Lithium carbonate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	238	217	37	26	139	9	0	62	21
2005	243	213	21	11	131	10	4	79	30
2006	324	285	30	14	166	9	2	117	39
2007	351	325	30	26	213	9	2	131	26
2008	325	305	47	34	177	12	0	119	20
2009	358	322	56	19	167	24	5	169	36
2010	317	267	38	22	164	6	1	139	50
2011	423	348	53	31	189	12	0	156	75
2012	491	455	66	55	180	16	11	279	36
2013	329	301	28	32	143	7	7	192	28
2014	252	217	33	26	120	5	14	107	35
2015	338	304	24	20	137	5	5	211	34
2016	238	215	23	10	98	4	7	145	23
2017	273	239	51	13	123	13	8	165	34
2018	312	260	10	19	168	4	1	180	52
2019	301	254	30	13	149	11	4	193	47
2020	311	270	15	8	166	9	2	198	41
2021	357	320	23	29	230	6	1	241	37
2022	405	383	29	37	248	7	0	269	22
2023	357	343	6	25	226	4	10	270	14
2024	293	278	3	17	194	2	7	202	15
2025	311	293	13	39	197	7	2	222	18
2026	160	146	2	22	106	3	0	109	14

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Lithium carbonate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Lithium carbonate, by the year in which FDA received them
Year	Reports
2004	213
2005	236
2006	308
2007	390
2008	317
2009	364
2010	314
2011	423
2012	535
2013	324
2014	251
2015	342
2016	256
2017	298
2018	326
2019	326
2020	336
2021	405
2022	362
2023	318
2024	271
2025	252
2026	140

Reports that name Lithium carbonate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Lithium carbonate
Age	Reports	Share
Under 2	64	0.9%
2 to 11	59	0.8%
12 to 17	206	2.8%
18 to 44	1,817	24.9%
45 to 64	2,213	30.3%
65 to 74	714	9.8%
75 and over	287	3.9%
Age not given	1,947	26.6%

Sex of the patient in the reports that name Lithium carbonate
Sex	Reports	Share
Female	3,543	48.5%
Male	2,863	39.2%
Unknown or not given	901	12.3%

Type of reporter in the reports that name Lithium carbonate
Reporter	Reports	Share
Physician	2,050	28.1%
Pharmacist	785	10.7%
Other health professional	2,369	32.4%
Lawyer	11	0.2%
Consumer or non-health professional	1,270	17.4%
Not given	822	11.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 41% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lithium carbonate record
Indication as recorded (MedDRA)	Reports	Share
Bipolar disorder	1,805	24.7%
Bipolar i disorder	376	5.1%
Depression	312	4.3%
Schizophrenia	229	3.1%
Schizoaffective disorder	189	2.6%
Affective disorder	121	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 7,307 reports.

Drugs in the same reports

Other drugs that the reports of Lithium carbonate name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	501
Clonazepam	424
Clozapine	485
Haloperidol	475
Lorazepam	387
Olanzapine	877
Quetiapine	740
Quetiapine fumarate	477
Risperidone	642
Valproate sodium	340

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Lithium same class
Tegretol same class
Carbatrol same class
Carbamazepine same class
Livalo next in the A to Z list
Litfulo next in the A to Z list
Livdelzi next in the A to Z list
Listerine Original next in the A to Z list
Livmarli next in the A to Z list
Listerine next in the A to Z list
Livtencity next in the A to Z list
Lisocabtagene maraleucel next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Lithium carbonateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Lithium carbonate: adverse event reports that FDA received. https://reportedreactions.com/drug/lithium-carbonate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Lithium carbonate as a suspect or interacting product. The 9,218 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Lithium carbonate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Lithium carbonate?

No. It is a count of what people reported to FDA: 7,307 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (32.4%), physician (28.1%) and consumer or non-health professional (17.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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