Generic name
Lithium carbonate: adverse event reports filed with FDA
7,307 reports list it as a suspect or interacting product, 2004–2026. Class: Mood stabilizer. Also reported as Lithium Carbonate Cap, Lithium Carbonate Capsules, Lithium Carbonate Tablets Usp 300mg.
- 7,307
- reports as suspect product
- 0% of all reports · about 325 a year
- 266
- reports, 12 months to June 2026
- 230 in the 12 months before
- 89.8%
- marked serious by the reporter
- 91.4% across the class
- 9.1%
- record death among outcomes, as reported
- 668 reports · not verified by FDA
Between January 2004 and June 2026, 7,307 adverse event reports received by FDA list lithium carbonate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (9,218) are left out of every figure here.
In the 12 months to June 2026, 266 reports listed it, up 16% from 230 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 325 reports a year and 0% of the 20,646,523 reports in the database, and 12.8% of the reports for the mood stabilizer class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are toxicity to various agents (15.2%), drug interaction (10.3%) and tremor (9.6%). A report can list several reactions, so shares add to more than 100%; 1,242 different terms appear across these reports. Toxicity to various agents is recorded in 15.2% of these reports, about the same share as in the median mood stabilizer drug (12.5%).
89.8% of the reports are marked serious by the reporter (91.4% across the class); 9.1% record death among the outcomes and 52.4% record hospitalisation, as reported. 32.4% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (30.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lithium carbonate reports recording the termmedian drug in mood stabilizer
- Toxicity to various agentspoisoning or toxic effect of one or more substances15.2%1,114
- Drug interactionan interaction between medicines10.3%752
- Tremorshaking9.6%698
- Drug ineffectivethe medicine did not work as expected9.1%668
- Confusional stateconfusion5.6%408
- Weight increasedweight gain5.6%408
- Therapeutic agent toxicity5.4%397
- Suicide attempta suicide attempt5.2%381
- Vomitingbeing sick4.2%309
- Somnolencedrowsiness4.2%304
- Completed suicidedeath by suicide3.7%274
- Fatiguetiredness3.7%271
- Nauseafeeling sick3.6%265
- Diarrhoealoose or frequent stools3.5%255
- Overdosea dose above the recommended amount3.3%243
- Neuroleptic malignant syndromea rare severe reaction with fever and rigidity3.3%238
- Insomniadifficulty sleeping3.1%230
- Depressionlow mood3.1%227
- Agitationrestlessness3.1%226
- Dizzinesslight-headedness or unsteadiness3%221
- Acute kidney injurysudden loss of kidney function3%220
- Dehydrationdehydration2.9%211
- Akathisiainner restlessness and an urge to move2.8%208
- Dysarthria2.8%206
- Antipsychotic drug level below therapeutic2.8%205
- Off label useused for a purpose or in a way not on the label2.8%203
- Hypotensionlow blood pressure2.7%196
- Antipsychotic drug level increased2.7%195
- Gait disturbancedifficulty walking2.6%193
- Hypertensionhigh blood pressure2.6%192
Top 30 of 1,242 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the mood stabilizer class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 57,019 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 41% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| 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 indication field is filled in by the reporter and is often blank; shares are of all 7,307 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Lithium carbonate reports |
|---|---|---|
| Olanzapine | 877 | 12% |
| Quetiapine | 740 | 10.1% |
| Risperidone | 642 | 8.8% |
| Aripiprazole | 501 | 6.9% |
| Clozapine | 485 | 6.6% |
| Quetiapine fumarate | 477 | 6.5% |
| Haloperidol | 475 | 6.5% |
| Clonazepam | 424 | 5.8% |
| Lorazepam | 387 | 5.3% |
| Valproate sodium | 340 | 4.7% |
Other products listed in reports where Lithium carbonate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Lithium carbonate | Mood stabilizer | All reports |
|---|---|---|---|
| Reports as suspect product | 7,307 | 57,019 | 20,646,523 |
| Share of that pool | — | 12.8% | 0% |
| Reports, latest 12 months | 266 | — | 1,332,454 |
| Marked serious | 89.8% | 91.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 91 | 100 | 91 |
| Hospitalisation recorded, per 1,000 reports | 524 | 433 | 213 |
| Consumer-filed share | 17.4% | 20.2% | 45.8% |
| Top term, share of reports | Toxicity to various agents 15.2% | median 12.5% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the mood stabilizer class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Carbamazepine | generic | 22,081 | 1,516 | 93.6% |
| Tegretol | brand | 16,844 | 477 | 89.7% |
| Lithium | generic | 10,787 | 720 | 90.8% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lithium carbonate reports
How many adverse event reports has FDA received for Lithium carbonate?
7,307 reports list Lithium carbonate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 266 of them arrived in the latest 12 months. Another 9,218 list it only as a concomitant medication.
What reactions are recorded in Lithium carbonate reports?
toxicity to various agents (15.2%), drug interaction (10.3%), tremor (9.6%), drug ineffective (9.1%) and confusional state (5.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lithium carbonate was responsible.
How serious are the reports?
89.8% are marked serious by the reporter. Among the outcomes recorded, 9.1% of reports include death and 52.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (32.4%), physician (28.1%) and consumer or non-health professional (17.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lithium carbonate rising?
266 reports in the 12 months to June 2026, up 16% from 230 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lithium carbonate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lithium carbonate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lithium carbonate as a suspect or interacting product; reports listing it only as a concomitant medication (9,218) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.