Lithium Carbonate side effects: what 16,890 FDA adverse event reports show
Drug class
Mood-stabilizing agent
Who reports
16,890 reports · 80% serious · 1,194 with death outcome · 58% female
Used for
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older • Maintenance treatment in patients 7 years .
Boxed warning
LITHIUM TOXICITY Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )].
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,143 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Antipsychotic drug level below therapeutic | 216 | 562.7 479.3–660.6ROR 570.0 · χ² 82,598 / p <1e-300 | 373.1 EB05 333.1 · IC025 +7.4 3/3 methods agree | Lab value / disease marker | serious n=197 · ♀ 22% (drug 58%) | not reported in cached trials |
| Dystonic tremor | 16 | 279.9 162.6–481.7ROR 280.1 · χ² 3,395 / p <1e-300 | 179.5 EB05 117.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Nephrogenic diabetes insipidus | 187 | 241.3 206.4–282.0ROR 244.0 · χ² 37,181 / p <1e-300 | 197.7 EB05 175.0 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=181 · 94% clinician | not reported in cached trials |
| Therapeutic agent toxicity | 441 | 186.5 168.9–205.9ROR 191.4 · χ² 70,447 / p <1e-300 | 160.8 EB05 148.6 · IC025 +6.9 3/3 methods agree | Labeled (related wording) related wording | serious n=425 | not reported in cached trials |
| Antipsychotic drug level above therapeutic | 109 | 171.8 140.6–209.8ROR 172.9 · χ² 16,080 / p <1e-300 | 146.9 EB05 125.2 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=105 · 94% clinician | not reported in cached trials |
| Parathyroid gland enlargement | 15 | 143.5 84.1–244.9ROR 143.6 · χ² 1,774 / p <1e-300 | 110.8 EB05 71.3 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Disinhibition | 163 | 139.8 118.9–164.2ROR 141.1 · χ² 20,033 / p <1e-300 | 123.8 EB05 108.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 6% (drug 58%) | not reported in cached trials |
| Hyperparathyroidism primary | 35 | 131.1 92.5–185.7ROR 131.3 · χ² 3,964 / p <1e-300 | 111.4 EB05 83.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=34 | not reported in cached trials |
| Cytotoxic lesions of corpus callosum | 12 | 127.8 70.5–231.5ROR 127.9 · χ² 1,254 / p 5e-275 | 98.2 EB05 59.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Body tinea | 52 | 126.1 94.8–167.7ROR 126.5 · χ² 5,737 / p <1e-300 | 109.9 EB05 87.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 100% (drug 58%) · 94% clinician | not reported in cached trials |
| Antipsychotic drug level increased | 239 | 115.2 101.0–131.4ROR 116.9 · χ² 24,632 / p <1e-300 | 104.5 EB05 93.9 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=230 | not reported in cached trials |
| Parathyroid tumour benign | 42 | 74.2 54.4–101.3ROR 74.4 · χ² 2,791 / p <1e-300 | 68.0 EB05 52.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 78% (drug 58%) | not reported in cached trials |
| Hyperparathyroidism | 116 | 74.1 61.4–89.3ROR 74.6 · χ² 7,815 / p <1e-300 | 69.1 EB05 59.2 · IC025 +5.4 3/3 methods agree | Labeled — boxed warning exact term | serious n=115 · 100% clinician | not reported in cached trials |
| Schizoaffective disorder bipolar type | 12 | 68.0 38.0–121.6ROR 68.1 · χ² 689 / p 5e-152 | 58.8 EB05 35.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | not reported in cached trials |
| Radial nerve palsy | 18 | 65.8 41.0–105.7ROR 65.9 · χ² 1,029 / p 4e-226 | 58.8 EB05 39.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Insulin-requiring type 2 diabetes mellitus | 14 | 58.3 34.1–99.6ROR 58.4 · χ² 699 / p 3e-154 | 52.0 EB05 32.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Diabetes insipidus | 104 | 55.7 45.8–67.8ROR 56.0 · χ² 5,292 / p <1e-300 | 52.8 EB05 44.8 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=101 | not reported in cached trials |
| Schizoaffective disorder | 74 | 53.4 42.4–67.4ROR 53.7 · χ² 3,598 / p <1e-300 | 50.6 EB05 41.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 31% (drug 58%) | not reported in cached trials |
| Grandiosity | 15 | 53.4 31.8–89.5ROR 53.4 · χ² 690 / p 3e-152 | 48.3 EB05 31.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Antidepressant drug level increased | 14 | 50.7 29.7–86.5ROR 50.8 · χ² 608 / p 1e-134 | 45.9 EB05 29.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Cogwheel rigidity | 41 | 50.3 36.8–68.6ROR 50.4 · χ² 1,854 / p <1e-300 | 47.3 EB05 36.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=41 | not reported in cached trials |
| Persistent depressive disorder | 15 | 48.2 28.8–80.7ROR 48.2 · χ² 622 / p 1e-137 | 44.0 EB05 28.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Brugada syndrome | 38 | 47.9 34.6–66.2ROR 48.0 · χ² 1,633 / p <1e-300 | 45.1 EB05 34.3 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=38 · ♀ 24% (drug 58%) · 100% clinician | not reported in cached trials |
| Therapeutic product effect variable | 140 | 47.2 39.9–55.9ROR 47.6 · χ² 6,059 / p <1e-300 | 45.3 EB05 39.3 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=138 · ♀ 0% (drug 58%) | not reported in cached trials |
| Bipolar ii disorder | 13 | 46.5 26.8–81.0ROR 46.6 · χ² 515 / p 2e-114 | 42.3 EB05 26.3 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=13 | not reported in cached trials |
| Inhibitory drug interaction | 55 | 44.5 34.0–58.1ROR 44.6 · χ² 2,213 / p <1e-300 | 42.3 EB05 33.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 100% (drug 58%) · 91% clinician | not reported in cached trials |
| Hypomania | 127 | 44.3 37.1–52.8ROR 44.6 · χ² 5,142 / p <1e-300 | 42.5 EB05 36.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=122 | not reported in cached trials |
| Bone abscess | 14 | 44.2 25.9–75.3ROR 44.2 · χ² 529 / p 2e-117 | 40.5 EB05 25.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Elevated mood | 15 | 43.5 26.0–72.8ROR 43.6 · χ² 561 / p 2e-124 | 40.1 EB05 25.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | not reported in cached trials |
| Neuroleptic malignant syndrome | 354 | 38.1 34.3–42.3ROR 38.9 · χ² 12,368 / p <1e-300 | 36.9 EB05 33.8 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 · 91% clinician | not reported in cached trials |
| Pressure of speech | 18 | 35.3 22.1–56.4ROR 35.4 · χ² 551 / p 5e-122 | 33.3 EB05 22.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | not reported in cached trials |
| Abulia | 25 | 35.0 23.5–52.1ROR 35.1 · χ² 771 / p 7e-170 | 33.3 EB05 23.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Pitting oedema | 17 | 35.0 21.6–56.6ROR 35.0 · χ² 513 / p 7e-114 | 32.9 EB05 21.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pleurothotonus | 25 | 35.0 23.5–52.0ROR 35.0 · χ² 770 / p 1e-169 | 33.3 EB05 23.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Bipolar i disorder | 59 | 34.4 26.5–44.5ROR 34.5 · χ² 1,827 / p <1e-300 | 33.1 EB05 26.6 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=56 | not reported in cached trials |
| Obsessive-compulsive disorder | 217 | 34.3 30.0–39.2ROR 34.7 · χ² 6,793 / p <1e-300 | 33.3 EB05 29.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=214 · ♀ 16% (drug 58%) | not reported in cached trials |
| Tachycardia foetal | 13 | 33.4 19.3–58.0ROR 33.5 · χ² 367 / p 4e-82 | 31.2 EB05 19.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Cerebellar atrophy | 23 | 33.1 21.9–50.1ROR 33.2 · χ² 667 / p 2e-147 | 31.5 EB05 22.1 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious n=23 | not reported in cached trials |
| Bipolar disorder | 282 | 32.8 29.2–36.9ROR 33.4 · χ² 8,443 / p <1e-300 | 31.9 EB05 28.9 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.6 | not reported in cached trials |
| Mania | 423 | 32.8 29.8–36.1ROR 33.6 · χ² 12,676 / p <1e-300 | 31.9 EB05 29.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.3 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lithium Carbonate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT02960763 — Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (N=742, PHASE4; 23 AE terms posted; arms: Aripiprazole Augmentation; Bupropion Augmentation; Switch to Bupropion; Lithium Augmentation)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 1,223 | 9.1 8.6–9.6ROR 9.7 · χ² 8,826 / p <1e-300 | 9.0 EB05 8.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 92% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,151 | 1.1 1.0–1.1ROR 1.1 · χ² 8 / p 0.002 | 1.1 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Tremor (shaking) | 1,090 | 8.2 7.7–8.7ROR 8.7 · χ² 6,882 / p <1e-300 | 8.1 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.9 | NCT02960763: 34/127 (26.8%) on Lithium Carbonate |
| Drug interaction | 1,009 | 7.9 7.5–8.4ROR 8.4 · χ² 6,122 / p <1e-300 | 7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | not reported in cached trials |
| Nausea | 843 | 1.3 1.2–1.4ROR 1.3 · χ² 70 / p 3e-17 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT02960763: 12/127 (9.4%) on Lithium Carbonate |
| Weight increased (weight gain) | 823 | 4.6 4.3–4.9ROR 4.8 · χ² 2,332 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | NCT02960763: 8/127 (6.3%) on Lithium Carbonate |
| Depression | 724 | 3.9 3.7–4.2ROR 4.1 · χ² 1,600 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | not reported in cached trials |
| Insomnia (trouble sleeping) | 723 | 3.4 3.1–3.6ROR 3.5 · χ² 1,216 / p 9e-267 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| Fatigue (tiredness) | 700 | 1.1 1.0–1.2ROR 1.1 · χ² 9 / p 0.001 | 1.1 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.2 | not reported in cached trials |
| Vomiting | 675 | 1.8 1.7–1.9ROR 1.8 · χ² 239 / p 3e-54 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT02960763: 12/127 (9.4%) on Lithium Carbonate |
| Confusional state (confusion) | 648 | 5.0 4.6–5.4ROR 5.1 · χ² 2,069 / p <1e-300 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.2 | not reported in cached trials |
| Somnolence (drowsiness) | 637 | 3.9 3.7–4.3ROR 4.1 · χ² 1,406 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.9 | not reported in cached trials |
| Anxiety | 621 | 2.7 2.5–2.9ROR 2.8 · χ² 674 / p 6e-149 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | not reported in cached trials |
| Off label use (used outside approved label) | 595 | 0.9 0.8–0.9ROR 0.8 · χ² 16 / p 3e-5 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Suicide attempt | 591 | 12.2 11.3–13.2ROR 12.6 · χ² 6,016 / p <1e-300 | 12.1 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Disinhibition — n=163, PRR 139.8
- Body tinea — n=52, PRR 126.1
- Parathyroid tumour benign — n=42, PRR 74.2
- Schizoaffective disorder — n=74, PRR 53.4
- Inhibitory drug interaction — n=55, PRR 44.5
- Hypomania — n=127, PRR 44.3
- Abulia — n=25, PRR 35.0
- Pleurothotonus — n=25, PRR 35.0
- Obsessive-compulsive disorder — n=217, PRR 34.3
- Mania — n=423, PRR 32.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Lithium ↔ Nephrogenic diabetes insipidus.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Lithium Carbonate?
In FDA FAERS, the most frequently co-reported reaction terms for Lithium Carbonate are toxicity to various agents, tremor, nausea, weight increased, depression, insomnia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Lithium Carbonate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: LITHIUM TOXICITY Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )].
Do FAERS signals prove that Lithium Carbonate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 01c4facd-ed79-4078-ba33-2044de372d0f, effective 20260427; matched on
openfda.generic_name.exact:"LITHIUM CARBONATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,183 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
LITHIUM CARBONATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.