GUAIFENESIN AND PSEUDOEPHEDRINE HCL

N/A

Manufactured by H E B

92 FDA adverse event reports analyzed

Last updated: 2026-04-15

About GUAIFENESIN AND PSEUDOEPHEDRINE HCL

GUAIFENESIN AND PSEUDOEPHEDRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H E B. The most commonly reported adverse reactions for GUAIFENESIN AND PSEUDOEPHEDRINE HCL include DYSPNOEA, INFUSION SITE ERYTHEMA, RENAL FAILURE, SWELLING FACE, ABNORMAL WEIGHT GAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GUAIFENESIN AND PSEUDOEPHEDRINE HCL.

Top Adverse Reactions

DYSPNOEA2 reports
INFUSION SITE ERYTHEMA2 reports
RENAL FAILURE2 reports
SWELLING FACE2 reports
ABNORMAL WEIGHT GAIN1 reports
ACUTE KIDNEY INJURY1 reports
ALANINE AMINOTRANSFERASE INCREASED1 reports
ANAEMIA1 reports
ANHEDONIA1 reports
ANXIETY1 reports
ARTHRITIS1 reports
ASPARTATE AMINOTRANSFERASE INCREASED1 reports
ASTHMA1 reports
BLADDER DISORDER1 reports
BLOOD ALKALINE PHOSPHATASE INCREASED1 reports
BLOOD CHLORIDE DECREASED1 reports
BLOOD CHOLESTEROL INCREASED1 reports
BLOOD SODIUM DECREASED1 reports
BRONCHITIS1 reports
CHOLELITHIASIS1 reports
CONDITION AGGRAVATED1 reports
CONTRAINDICATED PRODUCT ADMINISTERED1 reports
DEEP VEIN THROMBOSIS1 reports
DEPRESSION1 reports
DEVICE ALARM ISSUE1 reports
DEVICE INFORMATION OUTPUT ISSUE1 reports
DEVICE INFUSION ISSUE1 reports
DEVICE MALFUNCTION1 reports
DEVICE OCCLUSION1 reports
DEVICE POWER SOURCE ISSUE1 reports
DEVICE USE ISSUE1 reports
DIZZINESS1 reports
DRUG INEFFECTIVE1 reports
DRUG INTERACTION1 reports
DRY THROAT1 reports
DYSGEUSIA1 reports
ECONOMIC PROBLEM1 reports
EMOTIONAL DISTRESS1 reports
END STAGE RENAL DISEASE1 reports
ERYTHEMA1 reports
FATIGUE1 reports
GLAUCOMA1 reports
GOUT1 reports
HAEMOPTYSIS1 reports
HYPERHIDROSIS1 reports
INCORRECT DOSE ADMINISTERED1 reports
INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION1 reports
INFLUENZA LIKE ILLNESS1 reports
INFUSION SITE DISCOMFORT1 reports
INFUSION SITE INDURATION1 reports
INFUSION SITE IRRITATION1 reports
INFUSION SITE PAIN1 reports
INFUSION SITE STREAKING1 reports
INFUSION SITE SWELLING1 reports
LABORATORY TEST ABNORMAL1 reports
MALAISE1 reports
MEMORY IMPAIRMENT1 reports
MYDRIASIS1 reports
NASAL CONGESTION1 reports
NASAL ULCER1 reports
NAUSEA1 reports
NEOPLASM MALIGNANT1 reports
NEUROPATHY PERIPHERAL1 reports
OROPHARYNGEAL DISCOMFORT1 reports
OSTEOARTHRITIS1 reports
OSTEOPENIA1 reports
OSTEOPOROSIS1 reports
PAIN1 reports
PERIPHERAL SWELLING1 reports
PHLEBITIS1 reports
PLASMA CELL MYELOMA1 reports
PRODUCT DOSE OMISSION ISSUE1 reports
PURPURA SENILE1 reports
RESORPTION BONE INCREASED1 reports
RESPIRATORY TRACT CONGESTION1 reports
SECRETION DISCHARGE1 reports
TARSAL TUNNEL SYNDROME1 reports
THROAT IRRITATION1 reports
THROMBOPHLEBITIS SUPERFICIAL1 reports
TRANSFUSION1 reports
VASCULITIS1 reports
VERTIGO POSITIONAL1 reports
VESTIBULAR DISORDER1 reports
VISION BLURRED1 reports
VOMITING1 reports
WEIGHT DECREASED1 reports
WRIST FRACTURE1 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS1 reports

Report Outcomes

Out of 16 classified reports for GUAIFENESIN AND PSEUDOEPHEDRINE HCL:

Serious 50.0%Non-Serious 50.0%

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 (62.5%)
Male6 (37.5%)

Reports by Age

Age 351 reports
Age 411 reports
Age 521 reports
Age 551 reports
Age 581 reports
Age 621 reports
Age 701 reports
Age 711 reports
Age 741 reports
Age 881 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 GUAIFENESIN AND PSEUDOEPHEDRINE HCL?

This profile reflects 92 FDA FAERS reports that mention GUAIFENESIN AND PSEUDOEPHEDRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GUAIFENESIN AND PSEUDOEPHEDRINE HCL?

Frequently reported terms in FAERS include DYSPNOEA, INFUSION SITE ERYTHEMA, RENAL FAILURE, SWELLING FACE, ABNORMAL WEIGHT GAIN, ACUTE KIDNEY INJURY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GUAIFENESIN AND PSEUDOEPHEDRINE HCL?

Labeling and FAERS entries often list H E B in connection with GUAIFENESIN AND PSEUDOEPHEDRINE 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.