Diphenhydramine vs Doxylamine: side effects in FDA adverse event reports
At a glance
| Diphenhydramine | Doxylamine | |
|---|---|---|
| Drug class | – | – |
| Brand names | Nightime Sleep Aid | – |
| FAERS reports | 164,753 | 5,981 |
| Serious | 71% | 37% |
| Death outcome | 22,785 | 443 |
| Boxed warning | No | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Diphenhydramine
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Doxylamine
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Diphenhydramine or Doxylamine?
Diphenhydramine has 164,753 FAERS reports and Doxylamine 5,981. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (71% vs 37%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Diphenhydramine and Doxylamine share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Diphenhydramine or Doxylamine safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.