ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by Bayer HealthCare LLC.

68 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. The most commonly reported adverse reactions for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE include CHOKING, FOREIGN BODY IN THROAT, VOMITING, DYSPNOEA, OROPHARYNGEAL PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

CHOKING12 reports
FOREIGN BODY IN THROAT8 reports
VOMITING4 reports
DYSPNOEA3 reports
OROPHARYNGEAL PAIN3 reports
PRODUCT USE COMPLAINT3 reports
DIZZINESS2 reports
FOREIGN BODY IN RESPIRATORY TRACT2 reports
NAUSEA2 reports
RETCHING2 reports
THROAT IRRITATION2 reports
ABDOMINAL PAIN UPPER1 reports
ANAPHYLACTIC REACTION1 reports
BLINDNESS TRANSIENT1 reports
BRONCHITIS1 reports
BURNING SENSATION1 reports
CHEST PAIN1 reports
CHILLS1 reports
COUGH1 reports
FEELING COLD1 reports
FOREIGN BODY IN GASTROINTESTINAL TRACT1 reports
HEADACHE1 reports
HEART RATE INCREASED1 reports
HYPERHIDROSIS1 reports
HYPERTENSION1 reports
INTENTIONAL PRODUCT USE ISSUE1 reports
MIDDLE INSOMNIA1 reports
PAIN1 reports
PARALYSIS1 reports
PNEUMONIA1 reports
POST TRAUMATIC STRESS DISORDER1 reports
PRODUCT LOT NUMBER ISSUE1 reports
PRURITUS1 reports
PSYCHOMOTOR HYPERACTIVITY1 reports
REGURGITATION1 reports
URTICARIA1 reports

Report Outcomes

Out of 28 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE:

Serious 96.4%Non-Serious 3.6%

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

Female20 (87.0%)
Male3 (13.0%)

Reports by Age

Age 322 reports
Age 392 reports
Age 602 reports
Age 211 reports
Age 241 reports
Age 481 reports
Age 541 reports
Age 571 reports
Age 641 reports
Age 671 reports
Age 711 reports
Age 741 reports
Age 751 reports
Age 771 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 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 68 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include CHOKING, FOREIGN BODY IN THROAT, VOMITING, DYSPNOEA, OROPHARYNGEAL PAIN, PRODUCT USE COMPLAINT. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Bayer HealthCare LLC. in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE 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.