Journal of affective disorders · 2026
Real-world pharmacovigilance insights and clinical safety signal characterization of the classic mood stabilizer‑lithium carbonate: A disproportionality analysis based on FAERS data.
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Zeng Yining, Wu Hao, Tan Xiyue, Wang Ruixia, Liu Yuxia, Wang Xueting, Duan Junguo
Аннотация
OBJECTIVE: Lithium carbonate is a classic mood stabilizer for bipolar disorder, yet real-world pharmacovigilance of its safety signals (especially underrecognized systems/populations) is lacking. This study detected disproportional ADR signals via FAERS to clarify its multi-system safety profile and gender/age-specific patterns.
METHODS: FAERS data (Q1 2004-Q3 2025) for lithium carbonate as the primary suspected drug were extracted. Duplicate reports were processed per FDA guidelines; ADRs were coded by MedDRA (PTs/SOCs). Disproportionality analysis used ROR, PRR, BCPNN and EBGM algorithms, with N ≥ 10 threshold and Bonferroni correction for false positive reduction. Sensitivity (excluding concomitant medications) and subgroup (gender: male/female; age: 12-20/>20 years) analyses were conducted.
RESULTS: 3769 reports (16,976 events) involved 27 SOCs, with Nervous (n = 3072) and Psychiatric (n = 2194) disorders top-ranked. Strong signals included Renal/urinary (ROR = 4.25) and Endocrine (ROR = 11.72) disorders; notable Cardiac signals covered nodal rhythm, sinus bradycardia, prolonged QT interval and Brugada syndrome. After rigorous screening, 161 consistent positive PT signals were identified. Top PTs by EBGM: neonatal toxicity (762.20), nephrogenic diabetes insipidus (486.42), parathyroid gland enlargement (425.61). Therapeutic agent toxicity (n = 336) was the most reported, matching lithium carbonate's narrow therapeutic window. Subgroup differences: males had higher tremor/TSH elevation risks; females, nephrogenic diabetes insipidus/hypercalcemia; adolescents, more thyroid disorders; adults, higher multi-agent toxicity.
CONCLUSION: Key ADR signals focus on the nervous, psychiatric, renal-urinary, endocrine and cardiac systems, with distinct gender/age-specific patterns. Clinicians should control dosage, monitor serum lithium/organ function (electrocardiography) and individualize assessments for high-risk groups. This study provides real-world pharmacovigilance evidence for safe lithium carbonate use.
METHODS: FAERS data (Q1 2004-Q3 2025) for lithium carbonate as the primary suspected drug were extracted. Duplicate reports were processed per FDA guidelines; ADRs were coded by MedDRA (PTs/SOCs). Disproportionality analysis used ROR, PRR, BCPNN and EBGM algorithms, with N ≥ 10 threshold and Bonferroni correction for false positive reduction. Sensitivity (excluding concomitant medications) and subgroup (gender: male/female; age: 12-20/>20 years) analyses were conducted.
RESULTS: 3769 reports (16,976 events) involved 27 SOCs, with Nervous (n = 3072) and Psychiatric (n = 2194) disorders top-ranked. Strong signals included Renal/urinary (ROR = 4.25) and Endocrine (ROR = 11.72) disorders; notable Cardiac signals covered nodal rhythm, sinus bradycardia, prolonged QT interval and Brugada syndrome. After rigorous screening, 161 consistent positive PT signals were identified. Top PTs by EBGM: neonatal toxicity (762.20), nephrogenic diabetes insipidus (486.42), parathyroid gland enlargement (425.61). Therapeutic agent toxicity (n = 336) was the most reported, matching lithium carbonate's narrow therapeutic window. Subgroup differences: males had higher tremor/TSH elevation risks; females, nephrogenic diabetes insipidus/hypercalcemia; adolescents, more thyroid disorders; adults, higher multi-agent toxicity.
CONCLUSION: Key ADR signals focus on the nervous, psychiatric, renal-urinary, endocrine and cardiac systems, with distinct gender/age-specific patterns. Clinicians should control dosage, monitor serum lithium/organ function (electrocardiography) and individualize assessments for high-risk groups. This study provides real-world pharmacovigilance evidence for safe lithium carbonate use.