HYDROXYZINE HYDROCHLORIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

26,851 FDA adverse event reports analyzed

Last updated: 2026-04-14

About HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for HYDROXYZINE HYDROCHLORIDE include PRURITUS, DRUG INEFFECTIVE, FATIGUE, NAUSEA, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROXYZINE HYDROCHLORIDE.

Top Adverse Reactions

PRURITUS945 reports
DRUG INEFFECTIVE853 reports
FATIGUE753 reports
NAUSEA740 reports
RASH711 reports
PRODUCT DOSE OMISSION ISSUE703 reports
HEADACHE700 reports
PAIN637 reports
OFF LABEL USE591 reports
TOXICITY TO VARIOUS AGENTS577 reports
DIARRHOEA527 reports
DYSPNOEA514 reports
VOMITING468 reports
DERMATITIS ATOPIC451 reports
DIZZINESS432 reports
PRODUCT USE IN UNAPPROVED INDICATION395 reports
COMPLETED SUICIDE386 reports
ANXIETY376 reports
PYREXIA364 reports
FALL362 reports
ARTHRALGIA360 reports
MALAISE360 reports
COUGH339 reports
PNEUMONIA332 reports
COVID 19323 reports
URTICARIA314 reports
CONDITION AGGRAVATED306 reports
INJECTION SITE PAIN286 reports
DRY SKIN277 reports
INSOMNIA277 reports
ASTHENIA271 reports
WEIGHT DECREASED269 reports
ILLNESS264 reports
SOMNOLENCE262 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION254 reports
DEPRESSION253 reports
BACK PAIN250 reports
ASTHMA247 reports
DEATH247 reports
HYPOTENSION246 reports
SLEEP DISORDER245 reports
PAIN IN EXTREMITY244 reports
URINARY TRACT INFECTION242 reports
DRUG ABUSE239 reports
NASOPHARYNGITIS231 reports
SINUSITIS225 reports
DISCOMFORT223 reports
ERYTHEMA217 reports
DECREASED APPETITE211 reports
INFECTION210 reports
WEIGHT INCREASED210 reports
CONSTIPATION203 reports
FEELING ABNORMAL202 reports
ABDOMINAL PAIN196 reports
HYPERTENSION196 reports
ABDOMINAL PAIN UPPER187 reports
ECZEMA187 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION187 reports
PRODUCT USE ISSUE186 reports
ACUTE KIDNEY INJURY185 reports
CHEST PAIN185 reports
SKIN EXFOLIATION184 reports
PERIPHERAL SWELLING182 reports
HYPERSENSITIVITY179 reports
CHRONIC KIDNEY DISEASE175 reports
INFLUENZA173 reports
ABDOMINAL DISCOMFORT163 reports
TREMOR162 reports
MIGRAINE156 reports
BLOOD PRESSURE INCREASED154 reports
CARDIO RESPIRATORY ARREST150 reports
MUSCLE SPASMS149 reports
BRONCHITIS148 reports
DRUG INTERACTION144 reports
ANAEMIA141 reports
RENAL FAILURE141 reports
DRUG HYPERSENSITIVITY139 reports
OVERDOSE128 reports
SEPSIS128 reports
ALOPECIA125 reports
MEMORY IMPAIRMENT125 reports
MYALGIA125 reports
PSORIASIS125 reports
GAIT DISTURBANCE124 reports
DEHYDRATION120 reports
HYPOAESTHESIA120 reports
SUICIDAL IDEATION120 reports
VISION BLURRED119 reports
GASTROOESOPHAGEAL REFLUX DISEASE116 reports
INCORRECT DOSE ADMINISTERED116 reports
CONFUSIONAL STATE113 reports
HOSPITALISATION113 reports
HYPERHIDROSIS113 reports
EYE PAIN112 reports
INFUSION SITE PAIN109 reports
SWELLING107 reports
SEIZURE106 reports
UPPER RESPIRATORY TRACT INFECTION106 reports
SURGERY105 reports
THERAPY INTERRUPTED103 reports

Report Outcomes

Out of 11,638 classified reports for HYDROXYZINE HYDROCHLORIDE:

Serious 55.9%Non-Serious 44.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female7,328 (68.6%)
Male3,343 (31.3%)
Unknown12 (0.1%)

Reports by Age

Age 51175 reports
Age 59167 reports
Age 58150 reports
Age 62149 reports
Age 57148 reports
Age 60146 reports
Age 48144 reports
Age 61143 reports
Age 52142 reports
Age 53142 reports
Age 55139 reports
Age 64135 reports
Age 66134 reports
Age 63133 reports
Age 50131 reports
Age 56129 reports
Age 47128 reports
Age 54128 reports
Age 65125 reports
Age 44123 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with HYDROXYZINE HYDROCHLORIDE?

This profile reflects 26,851 FDA FAERS reports that mention HYDROXYZINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HYDROXYZINE HYDROCHLORIDE?

Frequently reported terms in FAERS include PRURITUS, DRUG INEFFECTIVE, FATIGUE, NAUSEA, RASH, PRODUCT DOSE OMISSION ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures HYDROXYZINE HYDROCHLORIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with HYDROXYZINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.