Alprazolam vs Hydroxyzine: side effects in FDA adverse event reports
At a glance
| Alprazolam | Hydroxyzine | |
|---|---|---|
| Drug class | Benzodiazepine | – |
| Brand names | – | Hydroxyzine Hydrochloride |
| FAERS reports | 204,870 | 47,369 |
| Serious | 71% | 66% |
| Death outcome | 33,446 | 6,790 |
| Boxed warning | Yes RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids ma | No |
Signals both drugs share
| Reaction | Alprazolam | Hydroxyzine | Label screen (A / B) |
|---|---|---|---|
| Poisoning | 1,659 · PRR 15.4 | 259 · PRR 9.2 | Labeled adverse reaction / Not in label — unassessed |
| Suspected suicide | 325 · PRR 7.4 | 250 · PRR 24.4 | Labeled (related wording) / Not in label — unassessed |
| Rebound acid hypersecretion | 252 · PRR 9.1 | 94 · PRR 14.0 | Labeled (related wording) / Not in label — unassessed |
| Nephrogenic anaemia | 450 · PRR 10.8 | 161 · PRR 15.7 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 242 · PRR 10.7 | 85 · PRR 15.3 | Not in label — unassessed / Not in label — unassessed |
| Accidental death | 173 · PRR 10.4 | 45 · PRR 11.0 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 132 · PRR 14.2 | 48 · PRR 20.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Alprazolam
- Suicide attempt — n=3,736, PRR 6.6 Labeled (related wording)
- Coma — n=2,872, PRR 6.5 Labeled — boxed warning
- Drug use disorder — n=951, PRR 13.2 Labeled (related wording)
- Bradyphrenia — n=447, PRR 7.4 Labeled adverse reaction
- Multiple drug overdose intentional — n=312, PRR 10.7 Labeled (related wording)
- Substance use disorder — n=283, PRR 10.3 Labeled adverse reaction
- Anxiety disorder — n=199, PRR 6.4 Labeled (related wording)
Labeled signals distinctive to Hydroxyzine
- Anticholinergic syndrome — n=93, PRR 27.4 Labeled (related wording)
Common questions
Which has more reported side effects, Alprazolam or Hydroxyzine?
Alprazolam has 204,870 FAERS reports and Hydroxyzine 47,369. 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 66%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Alprazolam and Hydroxyzine share?
Both drugs carry disproportionality signals for poisoning, suspected suicide, rebound acid hypersecretion, nephrogenic anaemia, hyperparathyroidism secondary. Shared signals often reflect a shared drug class or the condition both are used for.
Is Alprazolam or Hydroxyzine 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.