HYDROXYZINE PAMOATE

N/A

Manufactured by Amneal Pharmaceuticals of New York LLC

7,494 FDA adverse event reports analyzed

Last updated: 2026-04-15

About HYDROXYZINE PAMOATE

HYDROXYZINE PAMOATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals of New York LLC. The most commonly reported adverse reactions for HYDROXYZINE PAMOATE include COMPLETED SUICIDE, DRUG INEFFECTIVE, NAUSEA, FATIGUE, DRUG HYPERSENSITIVITY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROXYZINE PAMOATE.

Top Adverse Reactions

COMPLETED SUICIDE273 reports
DRUG INEFFECTIVE271 reports
NAUSEA208 reports
FATIGUE205 reports
DRUG HYPERSENSITIVITY196 reports
PAIN182 reports
ANXIETY165 reports
HEADACHE163 reports
PRURITUS153 reports
RASH144 reports
OFF LABEL USE140 reports
DIARRHOEA137 reports
DRUG ABUSE126 reports
DIZZINESS125 reports
VOMITING121 reports
CARDIAC ARREST117 reports
URTICARIA113 reports
DEPRESSION112 reports
FALL109 reports
RESPIRATORY ARREST109 reports
CHRONIC KIDNEY DISEASE106 reports
INSOMNIA104 reports
ARTHRALGIA103 reports
DEATH100 reports
PRODUCT DOSE OMISSION ISSUE100 reports
DYSPNOEA95 reports
MALAISE93 reports
ACUTE KIDNEY INJURY92 reports
ASTHENIA91 reports
WEIGHT DECREASED89 reports
RENAL FAILURE87 reports
PYREXIA84 reports
SOMNOLENCE77 reports
CONSTIPATION76 reports
PAIN IN EXTREMITY74 reports
CONDITION AGGRAVATED71 reports
FEELING ABNORMAL71 reports
COUGH70 reports
DECREASED APPETITE70 reports
BACK PAIN67 reports
PNEUMONIA66 reports
TOXICITY TO VARIOUS AGENTS66 reports
WEIGHT INCREASED65 reports
ABDOMINAL PAIN62 reports
HYPERTENSION62 reports
TREMOR59 reports
ABDOMINAL DISCOMFORT58 reports
OVERDOSE57 reports
ILLNESS56 reports
PRODUCT USE IN UNAPPROVED INDICATION56 reports
NASOPHARYNGITIS54 reports
ABDOMINAL PAIN UPPER53 reports
ASTHMA53 reports
EMOTIONAL DISTRESS53 reports
GAIT DISTURBANCE53 reports
CHEST PAIN51 reports
MIGRAINE51 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION48 reports
URINARY TRACT INFECTION47 reports
HYPERSENSITIVITY46 reports
HYPOTENSION46 reports
SLEEP DISORDER46 reports
GASTROOESOPHAGEAL REFLUX DISEASE45 reports
MUSCLE SPASMS45 reports
SUICIDAL IDEATION44 reports
BLOOD PRESSURE INCREASED43 reports
SEIZURE43 reports
PERIPHERAL SWELLING41 reports
INJECTION SITE PAIN40 reports
PARAESTHESIA40 reports
PRODUCT USE ISSUE40 reports
STRESS40 reports
COVID 1939 reports
INFECTION39 reports
SINUSITIS39 reports
ANAEMIA38 reports
DRUG INTERACTION38 reports
LOSS OF CONSCIOUSNESS38 reports
DIABETES MELLITUS37 reports
PSORIASIS37 reports
CONFUSIONAL STATE36 reports
DEHYDRATION36 reports
DRUG DEPENDENCE36 reports
MENTAL DISORDER36 reports
HYPOAESTHESIA35 reports
NEUROPATHY PERIPHERAL35 reports
CONTUSION34 reports
DYSPEPSIA34 reports
DYSPHAGIA34 reports
ERYTHEMA34 reports
HOSPITALISATION34 reports
MUSCULAR WEAKNESS34 reports
HERPES ZOSTER33 reports
HYPERHIDROSIS33 reports
SUICIDE ATTEMPT33 reports
SWELLING33 reports
INCORRECT DOSE ADMINISTERED31 reports
NASAL CONGESTION31 reports
DISCOMFORT30 reports
ANHEDONIA29 reports

Report Outcomes

Out of 3,416 classified reports for HYDROXYZINE PAMOATE:

Serious 63.7%Non-Serious 36.3%

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

Female2,105 (65.7%)
Male1,096 (34.2%)
Unknown3 (0.1%)

Reports by Age

Age 6163 reports
Age 5660 reports
Age 4957 reports
Age 3452 reports
Age 5352 reports
Age 5552 reports
Age 5050 reports
Age 6250 reports
Age 4349 reports
Age 5949 reports
Age 6549 reports
Age 4248 reports
Age 4848 reports
Age 5847 reports
Age 6047 reports
Age 5146 reports
Age 5246 reports
Age 4645 reports
Age 5445 reports
Age 4544 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 PAMOATE?

This profile reflects 7,494 FDA FAERS reports that mention HYDROXYZINE PAMOATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HYDROXYZINE PAMOATE?

Frequently reported terms in FAERS include COMPLETED SUICIDE, DRUG INEFFECTIVE, NAUSEA, FATIGUE, DRUG HYPERSENSITIVITY, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures HYDROXYZINE PAMOATE?

Labeling and FAERS entries often list Amneal Pharmaceuticals of New York LLC in connection with HYDROXYZINE PAMOATE. 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.