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Lithium Side Effects

The most commonly reported side effects of lithium include toxicity to various agents, off label use, and tremor, based on 42,285 FDA adverse event reports from 2004 to 2025. 6.6% of reports found the drug to be ineffective.

#1 Reported: Toxicity To Various AgentsAll side effects ↓Top Co-Medication: Quetiapine-fumarateDrug interactions ↓79% of Reports Are AdultDemographics ↓

Lithium side effects

Percentages show how often each reaction appears relative to total reports for lithium.

1
Toxicity To Various Agents7.6%3,210
2
Drug Ineffective6.6%2,807
3
Off Label Use4.8%2,034
4
Tremor4.4%1,860
5
Drug Interaction4.4%1,854
6
Nausea3.7%1,575
7
Fatigue3.3%1,378
8
Weight Increased3.2%1,368
9
Vomiting2.8%1,200
10
Depression2.7%1,140
11
Anxiety2.7%1,131
12
Insomnia2.7%1,122
13
Somnolence2.6%1,113
14
Dizziness2.4%1,007
15
Confusional State2.4%1,001

These are voluntary reports and do not establish that lithium caused these reactions.

Report severity

78.4%Serious33,134 reports
40.4%Hospitalizations17,091 reports
7.9%Fatal3,349 reports

Seriousness is determined by the reporter, not by OpenClaim.

Lithium drug interactions

Other drugs that appear in adverse event reports alongside lithium. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Quetiapine-fumarate15.1%6,390
2
Olanzapine10.4%4,402
3
Clozapine8.8%3,711
4
Aripiprazole8.4%3,558
5
Risperidone6.9%2,906
6
Lamotrigine6.0%2,535
7
Venlafaxine3.5%1,483
8
Haloperidol3.3%1,389
9
Clonazepam3.2%1,359
10
Sertraline-hydrochloride2.8%1,202
11
Lorazepam2.8%1,168
12
Bupropion2.6%1,113
13
Valproic-acid2.4%1,033
14
Fluoxetine-hydrochloride2.4%1,001
15
Carbamazepine2.2%940

Taken alongside

1
Levothyroxine-sodium9.5%4,000
2
Quetiapine-fumarate8.5%3,600
3
Clonazepam8.3%3,518
4
Lamotrigine6.8%2,866
5
Lorazepam6.1%2,592
6
Acetaminophen5.8%2,436
7
Trazodone-hydrochloride5.4%2,263
8
Olanzapine5.3%2,227
9
Risperidone4.9%2,082
10
Bupropion4.8%2,043
11
Gabapentin4.8%2,042
12
Aripiprazole4.8%2,032
13
Sertraline-hydrochloride4.3%1,828
14
Omeprazole4.1%1,746
15
Aspirin4.1%1,722

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports lithium side effects

53.0% of lithium adverse event reports involve female patients and 38.5% involve male patients. The largest age group is adult at 79%. These figures reflect who reports side effects, not underlying risk.

Sex

Female53.0%
Male38.5%
Unknown8.5%

Age group

< 21.0%
2–110.9%
12–174.0%
18–6478.8%
65+15.2%

What is lithium used for

Conditions and purposes for which patients were taking lithium when the adverse event was reported.

22q11.2 Deletion SyndromeAbnormal BehaviourAccidental ExposureAcute Graft Versus Host DiseaseAcute Myeloid LeukaemiaAcute PsychosisAdjustment DisorderAdjustment Disorder With Mixed Disturbance Of Emotion And ConductAdjuvant TherapyAdverse Drug ReactionAffect LabilityAffective DisorderAggressionAggressive BehaviourAgitation

Showing 15 of 551 indications

Lithium brand names and reporting trend

Lithium is sold under brand names including Lithotabs, Lithium Citrate.

Brand names

Lithotabs48,549
Lithium Citrate347

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking lithium with another medication?

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