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What the label lists and what reports show

Hydroxyzine side effects

Hydroxyzine's FDA label lists its adverse reactions in its own words. FAERS holds 50,844 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (3,066 reports).

  • Generic listed

Check it at the source: the hydroxyzine FDA label on DailyMed (effective March 3, 2026, Aurobindo Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes. In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: Allergic reaction. Nervous System: Headache. Psychiatric: Hallucination. …

Source: FDA drug label, Aurobindo Pharma Limited, effective March 3, 2026 (SPL set 9de2de56-614f-4294-8794-d30758cf5f70), via openFDA; the full label on DailyMed

What do FAERS reports show?

50,844 reports list hydroxyzine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,463 are coded as a death and 15,632 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)3,485
  • Pruritus (a use or a product term, not a reaction)3,383
  • Nausea3,066
  • Fatigue2,960
  • Off Label Use (a use or a product term, not a reaction)2,620
  • Toxicity To Various Agents2,567
  • Completed Suicide (an outcome recorded in the report)2,543
  • Pain2,509
  • Headache (named in the label)2,452
  • Rash (named in the label)2,274
  • Diarrhoea2,144
  • Dyspnoea2,074
  • Anxiety (a use or a product term, not a reaction)2,067
  • Vomiting1,919
  • Dizziness1,788
  • Urticaria (a use or a product term, not a reaction)1,573
  • Product Dose Omission Issue (a use or a product term, not a reaction)1,539
  • Arthralgia1,515
  • Fall1,493
  • Insomnia1,491
  • Malaise1,426
  • Death (an outcome recorded in the report)1,397
  • Depression1,379
  • Pyrexia1,269
  • Asthenia1,245

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Hydroxyzine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions