CETIRIZINE HCL

N/A

Manufactured by Rite Aid Corporation

16,420 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CETIRIZINE HCL

CETIRIZINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rite Aid Corporation. The most commonly reported adverse reactions for CETIRIZINE HCL include FATIGUE, NAUSEA, HEADACHE, DIARRHOEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CETIRIZINE HCL.

Top Adverse Reactions

FATIGUE601 reports
NAUSEA525 reports
HEADACHE464 reports
DIARRHOEA453 reports
DYSPNOEA430 reports
PRURITUS408 reports
PAIN384 reports
DRUG INEFFECTIVE370 reports
COUGH345 reports
PRODUCT DOSE OMISSION ISSUE343 reports
DIZZINESS329 reports
RASH325 reports
OFF LABEL USE295 reports
PNEUMONIA271 reports
VOMITING271 reports
ARTHRALGIA265 reports
ASTHENIA251 reports
PYREXIA251 reports
MALAISE248 reports
FALL245 reports
WEIGHT DECREASED219 reports
SINUSITIS211 reports
CONDITION AGGRAVATED208 reports
ANXIETY192 reports
COVID 19189 reports
NASOPHARYNGITIS188 reports
DEPRESSION187 reports
ASTHMA180 reports
URTICARIA178 reports
SOMNOLENCE174 reports
FEELING ABNORMAL170 reports
PAIN IN EXTREMITY169 reports
DEATH167 reports
INSOMNIA162 reports
CONSTIPATION160 reports
BACK PAIN158 reports
PRODUCT USE IN UNAPPROVED INDICATION157 reports
ABDOMINAL PAIN UPPER153 reports
WEIGHT INCREASED151 reports
DECREASED APPETITE147 reports
HYPERSENSITIVITY144 reports
URINARY TRACT INFECTION144 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION135 reports
ERYTHEMA132 reports
PERIPHERAL SWELLING131 reports
DRUG HYPERSENSITIVITY129 reports
HYPERTENSION125 reports
ABDOMINAL DISCOMFORT124 reports
ABDOMINAL PAIN123 reports
INFECTION123 reports
MUSCLE SPASMS122 reports
ILLNESS121 reports
CHEST PAIN119 reports
INJECTION SITE PAIN118 reports
INFLUENZA117 reports
TREMOR117 reports
DRY SKIN112 reports
HYPOTENSION109 reports
GAIT DISTURBANCE105 reports
BRONCHITIS101 reports
PRODUCT USE ISSUE99 reports
MYALGIA97 reports
SEASONAL ALLERGY97 reports
DEHYDRATION95 reports
MEMORY IMPAIRMENT95 reports
CHEST DISCOMFORT93 reports
FLUSHING93 reports
UPPER RESPIRATORY TRACT INFECTION92 reports
HYPOAESTHESIA91 reports
PRODUCTIVE COUGH91 reports
BLOOD PRESSURE INCREASED90 reports
DERMATITIS ATOPIC90 reports
LOSS OF CONSCIOUSNESS90 reports
MIGRAINE90 reports
RHINORRHOEA90 reports
ANAEMIA87 reports
HYPERHIDROSIS87 reports
PARAESTHESIA87 reports
ARTHRITIS85 reports
GASTROOESOPHAGEAL REFLUX DISEASE84 reports
INFUSION SITE PAIN84 reports
HOSPITALISATION83 reports
OEDEMA PERIPHERAL83 reports
CONTUSION81 reports
EYE PAIN81 reports
INCORRECT DOSE ADMINISTERED81 reports
CONFUSIONAL STATE80 reports
ALOPECIA78 reports
CHILLS78 reports
SWELLING77 reports
DRUG INTERACTION76 reports
OROPHARYNGEAL PAIN76 reports
SKIN EXFOLIATION76 reports
NEUROPATHY PERIPHERAL75 reports
OXYGEN SATURATION DECREASED75 reports
VISION BLURRED75 reports
HEART RATE INCREASED74 reports
VIRAL INFECTION74 reports
PALPITATIONS73 reports
ABDOMINAL DISTENSION72 reports

Report Outcomes

Out of 8,298 classified reports for CETIRIZINE HCL:

Serious 56.9%Non-Serious 43.1%

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

Female4,995 (64.9%)
Male2,698 (35.0%)
Unknown7 (0.1%)

Reports by Age

Age 62101 reports
Age 67100 reports
Age 7199 reports
Age 6497 reports
Age 6096 reports
Age 7396 reports
Age 6595 reports
Age 7095 reports
Age 6393 reports
Age 6893 reports
Age 7693 reports
Age 5989 reports
Age 5688 reports
Age 5884 reports
Age 7283 reports
Age 6982 reports
Age 6681 reports
Age 5579 reports
Age 6179 reports
Age 7579 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 CETIRIZINE HCL?

This profile reflects 16,420 FDA FAERS reports that mention CETIRIZINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CETIRIZINE HCL?

Frequently reported terms in FAERS include FATIGUE, NAUSEA, HEADACHE, DIARRHOEA, DYSPNOEA, PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CETIRIZINE HCL?

Labeling and FAERS entries often list Rite Aid Corporation in connection with CETIRIZINE HCL. 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.