Lithium: adverse event reports filed with FDA

10,787

reports as suspect product

0.1% of all reports · about 480 a year

720

reports, 12 months to June 2026

741 in the 12 months before

90.8%

marked serious by the reporter

91.4% across the class

13.8%

record death among outcomes, as reported

1,493 reports · not verified by FDA

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 reports recording the termmedian drug in mood stabilizer

1. Toxicity to various agentspoisoning or toxic effect of one or more substances19.3%2,082
2. Drug ineffectivethe medicine did not work as expected10.6%1,145
3. Drug interactionan interaction between medicines10.2%1,105
4. Tremorshaking7.8%841
5. Completed suicidedeath by suicide6.3%677
6. Off label useused for a purpose or in a way not on the label5%542
7. Confusional stateconfusion4.6%497
8. Acute kidney injurysudden loss of kidney function4.4%477
9. Weight increasedweight gain4.4%475
10. Overdosea dose above the recommended amount4%429
11. Fatiguetiredness3.9%417
12. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity3.8%412
13. Nauseafeeling sick3.8%408
14. Diarrhoealoose or frequent stools3.8%405
15. Somnolencedrowsiness3.6%392
16. Suicide attempta suicide attempt3.6%388
17. Suicidal ideationthoughts of suicide3.6%385
18. Anxietyanxiety3.2%340
19. Depressionlow mood3.1%330
20. Condition aggravatedthe condition being treated got worse3%328
21. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3%326
22. Vomitingbeing sick3%326
23. Mania3%323
24. Nephrogenic diabetes insipidus2.8%299
25. Intentional overdosea deliberate overdose2.5%275
26. Dizzinesslight-headedness or unsteadiness2.5%271
27. Agitationrestlessness2.4%263
28. Insomniadifficulty sleeping2.4%262
29. Extrapyramidal disordermovement problems such as stiffness or tremor2.4%256
30. Psychotic disordera loss of contact with reality2.3%247

Top 30 of 1,483 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 48.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 10,787 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lithium 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

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

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.

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 as a suspect or interacting product; reports listing it only as a concomitant medication (14,607) 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.