FEXOFENADINE HYDROCHLORIDE

N/A

Manufactured by Chattem, Inc.

32,531 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FEXOFENADINE HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE3,555 reports
HEADACHE878 reports
FATIGUE858 reports
NAUSEA778 reports
PRURITUS765 reports
EXTRA DOSE ADMINISTERED700 reports
DIARRHOEA693 reports
NO ADVERSE EVENT691 reports
DIZZINESS648 reports
RASH605 reports
SOMNOLENCE597 reports
DYSPNOEA589 reports
COUGH555 reports
INSOMNIA530 reports
PAIN488 reports
FEELING ABNORMAL485 reports
OFF LABEL USE478 reports
MALAISE451 reports
CONDITION AGGRAVATED450 reports
PRODUCT DOSE OMISSION ISSUE450 reports
HYPERSENSITIVITY416 reports
VOMITING414 reports
THERAPEUTIC RESPONSE DECREASED408 reports
COVID 19364 reports
ARTHRALGIA363 reports
SINUSITIS356 reports
URTICARIA354 reports
ANXIETY349 reports
PRODUCT USE IN UNAPPROVED INDICATION343 reports
PNEUMONIA342 reports
RHINORRHOEA342 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION319 reports
PRODUCT USE ISSUE317 reports
FALL315 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS308 reports
PYREXIA307 reports
NASOPHARYNGITIS299 reports
ASTHMA270 reports
WEIGHT DECREASED267 reports
ABDOMINAL DISCOMFORT261 reports
CONSTIPATION259 reports
ASTHENIA258 reports
BACK PAIN251 reports
DECREASED APPETITE246 reports
DEPRESSION246 reports
ERYTHEMA241 reports
ILLNESS239 reports
INJECTION SITE PAIN232 reports
PAIN IN EXTREMITY231 reports
ABDOMINAL PAIN UPPER229 reports
HYPERTENSION228 reports
SNEEZING225 reports
BLOOD PRESSURE INCREASED221 reports
WEIGHT INCREASED219 reports
URINARY TRACT INFECTION212 reports
DRY SKIN202 reports
DERMATITIS ATOPIC201 reports
UNEVALUABLE EVENT201 reports
NASAL CONGESTION196 reports
EXPIRED PRODUCT ADMINISTERED193 reports
MUSCLE SPASMS187 reports
DRUG HYPERSENSITIVITY185 reports
MYALGIA179 reports
BRONCHITIS174 reports
SEASONAL ALLERGY174 reports
TREMOR174 reports
DEATH171 reports
INFLUENZA171 reports
OROPHARYNGEAL PAIN171 reports
MIGRAINE170 reports
PERIPHERAL SWELLING169 reports
VISION BLURRED168 reports
SLEEP DISORDER165 reports
CHEST PAIN163 reports
PALPITATIONS162 reports
DRY MOUTH161 reports
SKIN EXFOLIATION157 reports
INFECTION156 reports
GASTROOESOPHAGEAL REFLUX DISEASE153 reports
EYE PRURITUS146 reports
INCORRECT DOSE ADMINISTERED145 reports
LOSS OF CONSCIOUSNESS145 reports
DRY EYE142 reports
HEART RATE INCREASED142 reports
LACRIMATION INCREASED140 reports
HYPERHIDROSIS139 reports
PARAESTHESIA139 reports
HYPOAESTHESIA137 reports
ABDOMINAL PAIN136 reports
DRUG EFFECT INCOMPLETE136 reports
ECZEMA133 reports
EPISTAXIS133 reports
MEMORY IMPAIRMENT133 reports
DEHYDRATION132 reports
INTENTIONAL PRODUCT MISUSE131 reports
UPPER RESPIRATORY TRACT INFECTION130 reports
CHEST DISCOMFORT129 reports
EYE PAIN128 reports
THERAPEUTIC RESPONSE SHORTENED119 reports
INTENTIONAL PRODUCT USE ISSUE118 reports

Report Outcomes

Out of 19,814 classified reports for FEXOFENADINE HYDROCHLORIDE:

Serious 33.3%Non-Serious 66.7%

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

Female10,792 (68.8%)
Male4,893 (31.2%)
Unknown10 (0.1%)

Reports by Age

Age 70230 reports
Age 69213 reports
Age 62203 reports
Age 66201 reports
Age 65197 reports
Age 75194 reports
Age 68191 reports
Age 60187 reports
Age 67186 reports
Age 63183 reports
Age 59180 reports
Age 58179 reports
Age 74178 reports
Age 72177 reports
Age 77176 reports
Age 61174 reports
Age 71174 reports
Age 73173 reports
Age 64169 reports
Age 55167 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 HYDROCHLORIDE?

This profile reflects 32,531 FDA FAERS reports that mention FEXOFENADINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FEXOFENADINE HYDROCHLORIDE?

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

Who manufactures FEXOFENADINE HYDROCHLORIDE?

Labeling and FAERS entries often list Chattem, Inc. in connection with FEXOFENADINE 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.