PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines
Do I have any heart-rhythm risk factors or other QT-prolonging medications that make hydroxyzine a poor fit — and is my dose within the 100 mg daily cap European regulators set?
Well-supported by good-quality research. how we score evidence
Caveat on this rating: This is an EU regulatory action; the US FDA label does not impose the same 100 mg daily cap.
Europe's medicines regulator concluded hydroxyzine carries a small but definite risk of dangerous heart-rhythm changes (QT prolongation and torsade de pointes) and capped doses at 100 mg per day in adults and 50 mg in the elderly, advising against use in people with heart-rhythm risk factors or on other QT-prolonging drugs.
Worth asking
Do I have any heart-rhythm risk factors or other QT-prolonging medications that make hydroxyzine a poor fit — and is my dose within the 100 mg daily cap European regulators set?
What it is FDA approved for
Read off the label. Trial duration and approval year are shown only where they were recorded — never inferred.
- Symptomatic relief of anxiety and tension associated with psychoneurosis, and as an adjunct in organic disease states in which anxiety is manifested
- Management of pruritus due to allergic conditions (chronic urticaria, atopic and contact dermatoses) and histamine-mediated pruritus
- Sedation as premedication and following general anesthesia
Source
PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines — European Medicines Agency (PRAC) (2015)
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
- No
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "strong evidence". Well-supported by good-quality research. It scores 82 out of 100 on our published rubric. One caveat travels with that badge: This is an EU regulatory action; the US FDA label does not impose the same 100 mg daily cap. 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?
PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines — European Medicines Agency (PRAC) (2015). 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 hydroxyzine (Vistaril, Atarax), vistaril, atarax FDA approved?
Yes — FDA approved for Symptomatic relief of anxiety and tension associated with psychoneurosis, and as an adjunct in organic disease states in which anxiety is manifested, Management of pruritus due to allergic conditions (chronic urticaria, atopic and contact dermatoses) and histamine-mediated pruritus, Sedation as premedication and following general anesthesia. Approval is for a specific indication, not for everything the drug 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.