lithium Side Effects
Also known as: Lithobid, Eskalith
Analysis of 24,367 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
24,367
Death-Related
2,021
8.3% of reports
Hospitalizations
9,664
39.7% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 2,021 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 714 |
| TOXICITY TO VARIOUS AGENTS | 428 |
| DEATH | 325 |
| OVERDOSE | 141 |
| CARDIO-RESPIRATORY ARREST | 140 |
| CARDIAC ARREST | 134 |
| OFF LABEL USE | 95 |
| SEIZURE | 87 |
| DIARRHOEA | 85 |
| PSYCHOTIC DISORDER | 85 |
| FATIGUE | 83 |
| PLATELET COUNT DECREASED | 82 |
| LEUKOPENIA | 79 |
| NAUSEA | 78 |
| NEUTROPENIA | 77 |
| PNEUMONIA | 77 |
| COVID-19 | 75 |
| EXTRAPYRAMIDAL DISORDER | 72 |
| SCHIZOPHRENIA | 72 |
| SUSPECTED SUICIDE | 72 |
Reactions in Hospitalization Reports
Top reactions in 9,664 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 1,479 |
| DRUG INTERACTION | 849 |
| DRUG INEFFECTIVE | 844 |
| OFF LABEL USE | 691 |
| NAUSEA | 664 |
| TREMOR | 654 |
| VOMITING | 629 |
| CONFUSIONAL STATE | 521 |
| PSYCHOTIC DISORDER | 480 |
| SUICIDE ATTEMPT | 475 |
| OVERDOSE | 467 |
| PNEUMONIA | 463 |
| NEUROLEPTIC MALIGNANT SYNDROME | 457 |
| SUICIDAL IDEATION | 453 |
| CONDITION AGGRAVATED | 450 |
| WEIGHT INCREASED | 437 |
| SCHIZOPHRENIA | 433 |
| MANIA | 428 |
| DIARRHOEA | 419 |
| ACUTE KIDNEY INJURY | 413 |
Nearby — Related Medications
What the FAERS Data Reveals About lithium Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 24,367 voluntary reports linked to lithium and its brand equivalents (Lithobid, Eskalith), spanning 2004 through 2025. Of those, 2,021 (8.3%) listed death as an outcome and 9,664 (39.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 58% were female and 42% male; age distribution skews toward 18-44, with 6,806 reports in that bracket. The single most reported reaction is drug ineffective with 2,243 submissions, followed by toxicity to various agents and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.