Antipsychotics raise the risk of death in older people with dementia
Pooled across 17 trials, mortality was about 4.5% on drug against 2.6% on placebo.
Top of the evidence hierarchy, independently funded. how we score evidence
This is one of the clearest harm signals in psychiatric medicine, and it applies to a specific group: older adults with dementia-related psychosis. Pooling 17 placebo-controlled trials covering 5,106 patients over roughly 10 weeks, the risk of death was 1.6 to 1.7 times higher on an antipsychotic than on placebo — about 4.5% against 2.6%. Most deaths were cardiovascular or infectious, chiefly heart failure, sudden death and pneumonia.
The FDA first applied this warning to the newer antipsychotics in 2005 and extended it to the older ones in 2008. No antipsychotic is approved for dementia-related psychosis.
If this is being prescribed for an older relative with dementia, worth asking: what specific behaviour are we treating, what have we tried that is not a drug, what is the shortest time we can plan for, and when will we review stopping.
Source
RISPERDAL (risperidone) prescribing information — Boxed Warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis — U.S. Food and Drug Administration (approved labelling)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- No external funding
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- No
- Conflicts disclosed
- Yes
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 5, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "gold standard". Top of the evidence hierarchy, independently funded. It scores 86 out of 100 on our published rubric. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
RISPERDAL (risperidone) prescribing information — Boxed Warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis — U.S. Food and Drug Administration (approved labelling). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: No external funding. The researchers were independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is antipsychotic FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.