FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

N/A

Manufactured by Chattem, Inc.

137 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE 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 AND PSEUDOEPHEDRINE HYDROCHLORIDE include PRODUCT QUALITY ISSUE, DRUG INEFFECTIVE, DIARRHOEA, DIZZINESS, EXTRA DOSE ADMINISTERED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE.

Top Adverse Reactions

PRODUCT QUALITY ISSUE8 reports
DRUG INEFFECTIVE7 reports
DIARRHOEA4 reports
DIZZINESS4 reports
EXTRA DOSE ADMINISTERED4 reports
HEADACHE4 reports
NAUSEA4 reports
CHEST DISCOMFORT2 reports
CONSTIPATION2 reports
EAR PAIN2 reports
FATIGUE2 reports
GASTROINTESTINAL DISORDER2 reports
INSOMNIA2 reports
MALAISE2 reports
NO ADVERSE EVENT2 reports
OVERDOSE2 reports
PAIN2 reports
PRURITUS2 reports
RASH2 reports
RHINITIS2 reports
SOMNOLENCE2 reports
TOXICITY TO VARIOUS AGENTS2 reports
URTICARIA2 reports
WEIGHT INCREASED2 reports
ABDOMINAL DISCOMFORT1 reports
ABDOMINAL PAIN1 reports
ABDOMINAL PAIN UPPER1 reports
ANXIETY1 reports
BLOOD PRESSURE INCREASED1 reports
BODY TEMPERATURE INCREASED1 reports
BRAIN FOG1 reports
CHALAZION1 reports
CLOSTRIDIUM DIFFICILE INFECTION1 reports
COMPLETED SUICIDE1 reports
COVID 191 reports
DEATH1 reports
DEHYDRATION1 reports
DRUG ABUSE1 reports
DRUG ADMINISTRATION ERROR1 reports
DYSGEUSIA1 reports
DYSPHAGIA1 reports
DYSPNOEA1 reports
DYSURIA1 reports
EPISTAXIS1 reports
FAECES DISCOLOURED1 reports
FEELING HOT1 reports
FLUSHING1 reports
FOOT DEFORMITY1 reports
FOREIGN BODY1 reports
GAIT DISTURBANCE1 reports
GASTROINTESTINAL INFECTION1 reports
GASTROOESOPHAGEAL REFLUX DISEASE1 reports
HEART RATE INCREASED1 reports
HYPERPHAGIA1 reports
HYPERSENSITIVITY1 reports
HYPERTENSION1 reports
HYPOKALAEMIA1 reports
HYPONATRAEMIA1 reports
INFECTION1 reports
INJECTION SITE ERYTHEMA1 reports
INJECTION SITE INFECTION1 reports
INJECTION SITE PAIN1 reports
INJECTION SITE PRURITUS1 reports
INJECTION SITE RASH1 reports
INJECTION SITE VESICLES1 reports
LABELLED DRUG FOOD INTERACTION MEDICATION ERROR1 reports
LIMB DISCOMFORT1 reports
MEDICATION RESIDUE PRESENT1 reports
MUSCLE SPASMS1 reports
NASAL CONGESTION1 reports
NASOPHARYNGITIS1 reports
OFF LABEL USE1 reports
PARAESTHESIA1 reports
PARANASAL SINUS HYPERSECRETION1 reports
PNEUMONIA1 reports
PRODUCT PHYSICAL ISSUE1 reports
PRODUCTIVE COUGH1 reports
PULMONARY ARTERIAL HYPERTENSION1 reports
PYREXIA1 reports
RASH MACULAR1 reports
SEASONAL ALLERGY1 reports
SINUSITIS1 reports
SKIN EXFOLIATION1 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION1 reports
SPEECH DISORDER1 reports
STRESS1 reports
SUBRETINAL FLUID1 reports
VERTIGO1 reports
VOMITING1 reports
WEIGHT DECREASED1 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS1 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS1 reports

Report Outcomes

Out of 46 classified reports for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE:

Serious 23.9%Non-Serious 76.1%

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

Female32 (69.6%)
Male14 (30.4%)

Reports by Age

Age 412 reports
Age 482 reports
Age 502 reports
Age 852 reports
Age 31 reports
Age 161 reports
Age 171 reports
Age 271 reports
Age 291 reports
Age 311 reports
Age 331 reports
Age 371 reports
Age 421 reports
Age 511 reports
Age 541 reports
Age 561 reports
Age 601 reports
Age 611 reports
Age 631 reports
Age 651 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 AND PSEUDOEPHEDRINE HYDROCHLORIDE?

This profile reflects 137 FDA FAERS reports that mention FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE 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 AND PSEUDOEPHEDRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include PRODUCT QUALITY ISSUE, DRUG INEFFECTIVE, DIARRHOEA, DIZZINESS, EXTRA DOSE ADMINISTERED, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE?

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