Hydroxyzine

Common brands: Hydroxyzine Hydrochloride, Acid Reducer, Neurontin, Pain Relief, Gralise

Top reporter: Amneal Pharmaceuticals Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]Loop Diuretic [EPC]
45,845
Total Reports
26,221
Serious Reports
6,698
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.61%)

Patient Demographics

Male
14,037
Female
27,620

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Hydroxyzine.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 3,099
5.9%
2 PRURITUS 3,069
5.9%
3 NAUSEA 2,725
5.2%
4 FATIGUE 2,672
5.1%
5 TOXICITY TO VARIOUS AGENTS 2,455
4.7%
6 OFF LABEL USE 2,354
4.5%
7 PAIN 2,254
4.3%
8 COMPLETED SUICIDE 2,226
4.2%
9 HEADACHE 2,210
4.2%
10 RASH 2,049
3.9%
11 DIARRHOEA 1,932
3.7%
12 DYSPNOEA 1,904
3.6%
13 ANXIETY 1,870
3.6%
14 VOMITING 1,716
3.3%
15 DIZZINESS 1,604
3.1%
16 URTICARIA 1,425
2.7%
17 FALL 1,368
2.6%
18 ARTHRALGIA 1,363
2.6%
19 PRODUCT DOSE OMISSION ISSUE 1,359
2.6%
20 INSOMNIA 1,346
2.6%
21 MALAISE 1,298
2.5%
22 DEATH 1,256
2.4%
23 DEPRESSION 1,234
2.4%
24 PYREXIA 1,162
2.2%
25 CONDITION AGGRAVATED 1,117
2.1%
26 ASTHENIA 1,112
2.1%
27 SOMNOLENCE 1,097
2.1%
28 PRODUCT USE IN UNAPPROVED INDICATION 1,091
2.1%
29 PNEUMONIA 1,041
2.0%
30 CHRONIC KIDNEY DISEASE 1,026
2.0%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.