FEXOFENADINE HCL

N/A

Manufactured by CVS Pharmacy

15,768 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FEXOFENADINE HCL

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

Top Adverse Reactions

DRUG INEFFECTIVE766 reports
NAUSEA475 reports
FATIGUE457 reports
DIARRHOEA439 reports
HEADACHE434 reports
DIZZINESS387 reports
DYSPNOEA365 reports
PRURITUS359 reports
PRODUCT QUALITY ISSUE358 reports
RASH312 reports
PAIN276 reports
MALAISE272 reports
PYREXIA259 reports
VOMITING256 reports
INSOMNIA247 reports
PNEUMONIA247 reports
COUGH243 reports
OFF LABEL USE235 reports
ANXIETY216 reports
ARTHRALGIA215 reports
CONDITION AGGRAVATED209 reports
FALL209 reports
EXTRA DOSE ADMINISTERED189 reports
SOMNOLENCE187 reports
FEELING ABNORMAL174 reports
ASTHENIA173 reports
CONSTIPATION170 reports
URTICARIA170 reports
PAIN IN EXTREMITY162 reports
WEIGHT DECREASED161 reports
DECREASED APPETITE157 reports
DEPRESSION157 reports
PRODUCT DOSE OMISSION ISSUE156 reports
ERYTHEMA155 reports
BACK PAIN150 reports
HYPERTENSION144 reports
NO ADVERSE EVENT144 reports
HYPERSENSITIVITY143 reports
ABDOMINAL PAIN UPPER140 reports
ASTHMA138 reports
COVID 19138 reports
SINUSITIS132 reports
MYALGIA131 reports
URINARY TRACT INFECTION129 reports
WEIGHT INCREASED129 reports
NASOPHARYNGITIS124 reports
CHEST PAIN118 reports
TREMOR118 reports
MUSCLE SPASMS117 reports
ANAEMIA115 reports
PRODUCT USE IN UNAPPROVED INDICATION115 reports
ABDOMINAL PAIN113 reports
DEATH110 reports
LOSS OF CONSCIOUSNESS110 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION109 reports
ABDOMINAL DISCOMFORT107 reports
BLOOD PRESSURE INCREASED105 reports
VISION BLURRED105 reports
ACUTE KIDNEY INJURY102 reports
PARAESTHESIA102 reports
HYPOAESTHESIA101 reports
PALPITATIONS98 reports
PERIPHERAL SWELLING97 reports
OVERDOSE93 reports
INFLUENZA91 reports
OEDEMA PERIPHERAL91 reports
HYPERHIDROSIS90 reports
INFECTION90 reports
PLATELET COUNT DECREASED90 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS90 reports
BRONCHITIS89 reports
CHEST DISCOMFORT89 reports
DEHYDRATION89 reports
CHRONIC KIDNEY DISEASE87 reports
INJECTION SITE PAIN87 reports
INTERSTITIAL LUNG DISEASE87 reports
CONFUSIONAL STATE85 reports
OROPHARYNGEAL PAIN85 reports
MUSCULAR WEAKNESS84 reports
SKIN EXFOLIATION83 reports
SYNCOPE83 reports
HYPOTENSION82 reports
GASTROOESOPHAGEAL REFLUX DISEASE80 reports
INCORRECT DOSE ADMINISTERED80 reports
PRODUCT USE ISSUE80 reports
DRUG INTERACTION79 reports
ILLNESS79 reports
WHITE BLOOD CELL COUNT DECREASED79 reports
ABDOMINAL DISTENSION78 reports
DRUG HYPERSENSITIVITY78 reports
HEPATIC FUNCTION ABNORMAL78 reports
ALOPECIA77 reports
GAIT DISTURBANCE76 reports
RHINORRHOEA76 reports
RENAL FAILURE75 reports
HEART RATE INCREASED74 reports
NEUROPATHY PERIPHERAL72 reports
WHEEZING71 reports
EPISTAXIS70 reports
UPPER RESPIRATORY TRACT INFECTION70 reports

Report Outcomes

Out of 8,661 classified reports for FEXOFENADINE HCL:

Serious 62.7%Non-Serious 37.3%

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

Female5,121 (63.7%)
Male2,909 (36.2%)
Unknown15 (0.2%)

Reports by Age

Age 62143 reports
Age 66143 reports
Age 70140 reports
Age 75140 reports
Age 59130 reports
Age 69130 reports
Age 60127 reports
Age 63126 reports
Age 65122 reports
Age 55117 reports
Age 67115 reports
Age 68114 reports
Age 58113 reports
Age 73113 reports
Age 78112 reports
Age 61111 reports
Age 71111 reports
Age 52109 reports
Age 72109 reports
Age 74109 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 FEXOFENADINE HCL?

This profile reflects 15,768 FDA FAERS reports that mention FEXOFENADINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FEXOFENADINE HCL?

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

Who manufactures FEXOFENADINE HCL?

Labeling and FAERS entries often list CVS Pharmacy in connection with FEXOFENADINE 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.