- Design
- Case-control disproportionality analysis of VigiBase reports
- Population
- About 29,900 lithium adverse reaction reports compared with antipsychotic reports
- Primary outcome
- Proportional reporting ratios by organ system and age
- Effect
- Children: more renal, endocrine, GI, skin and cardiac reports with lithium
A case-control analysis in the British Journal of Clinical Pharmacology, published on 4 October 2026, used VigiBase, the WHO global database of individual case safety reports, from 1968 to October 2023. It compared the pattern of adverse reactions reported with lithium, nearly 30,000 reports, with second-generation antipsychotics, across age groups.
In children, lithium reports carried a higher proportion of renal, endocrine, gastrointestinal, skin and cardiac reactions than antipsychotic reports. Thyroid reactions with lithium, and weight-related reactions with antipsychotics, were proportionally more common in children than in adults. Renal impairment made up a larger share of lithium reports in older adults than in children.
Disproportionality analysis shows what is reported relatively often, not how often it happens, and reporting is shaped by awareness and severity. The clinical value is in confirming which organ systems to watch when lithium is used in a child, and that the profile differs from the metabolic burden of antipsychotics.
- Check thyroid function and renal function before starting lithium in a child and at regular intervals.
- Ask about gastrointestinal symptoms and tremor at each review, which may herald toxicity.
- Weigh lithium's renal and thyroid profile against the weight and metabolic effects of antipsychotics when choosing.
- Report suspected adverse reactions in children; paediatric data remain thin.
Why it matters
Choosing between lithium and an antipsychotic in a child is often framed as safe versus unsafe; the reality is two different harm profiles.
Don't overread it
Spontaneous reports measure reporting patterns, not incidence — it cannot say which drug is safer.
The statistics, in plain English
Proportional reporting ratios compare how often a reaction appears among one drug's reports relative to another's. A higher ratio means it is reported proportionally more, which can reflect real risk, reporting habits or both.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for clinical pharmacology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free