ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE

N/A

Manufactured by Bayer HealthCare LLC.

179 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE

ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. The most commonly reported adverse reactions for ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE include CEREBROVASCULAR ACCIDENT, DRUG INEFFECTIVE, DRUG DEPENDENCE, MALAISE, PRODUCT USE ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE.

Top Adverse Reactions

CEREBROVASCULAR ACCIDENT9 reports
DRUG INEFFECTIVE7 reports
DRUG DEPENDENCE5 reports
MALAISE5 reports
PRODUCT USE ISSUE5 reports
CHOKING4 reports
DIZZINESS4 reports
NAUSEA4 reports
PRODUCT USE IN UNAPPROVED INDICATION4 reports
RECTAL HAEMORRHAGE4 reports
ABDOMINAL DISCOMFORT3 reports
ABDOMINAL PAIN UPPER3 reports
DEATH3 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION3 reports
DYSPNOEA3 reports
HAEMATOCHEZIA3 reports
HAEMORRHAGIC STROKE3 reports
SOMNOLENCE3 reports
TINNITUS3 reports
ABDOMINAL PAIN LOWER2 reports
BLOOD GLUCOSE INCREASED2 reports
BLOOD PRESSURE INCREASED2 reports
COUGH2 reports
DIARRHOEA2 reports
EXPIRED PRODUCT ADMINISTERED2 reports
HAEMATEMESIS2 reports
HAEMORRHAGIC DIATHESIS2 reports
HEADACHE2 reports
HYPOAESTHESIA2 reports
INCORRECT DRUG ADMINISTRATION DURATION2 reports
LIP SWELLING2 reports
LOSS OF CONSCIOUSNESS2 reports
OEDEMA PERIPHERAL2 reports
PAIN2 reports
RETCHING2 reports
SEIZURE2 reports
SWELLING FACE2 reports
SWOLLEN TONGUE2 reports
THERAPEUTIC RESPONSE UNEXPECTED2 reports
UNDERDOSE2 reports
VAGINAL HAEMORRHAGE2 reports
VOMITING2 reports
ABDOMINAL DISTENSION1 reports
ABDOMINAL RIGIDITY1 reports
ABNORMAL BEHAVIOUR1 reports
ADVERSE DRUG REACTION1 reports
ADVERSE REACTION1 reports
ALLERGIC REACTION TO EXCIPIENT1 reports
ANEURYSM1 reports
ASTHMA1 reports
BURNING SENSATION1 reports
CARDIAC DISCOMFORT1 reports
CARDIAC DISORDER1 reports
CEREBRAL HAEMORRHAGE1 reports
CHEST DISCOMFORT1 reports
COAGULOPATHY1 reports
DEAFNESS1 reports
DISORIENTATION1 reports
DRY MOUTH1 reports
DYSPEPSIA1 reports
EPISTAXIS1 reports
EXTRA DOSE ADMINISTERED1 reports
FEELING ABNORMAL1 reports
FEELING JITTERY1 reports
GASTRIC DISORDER1 reports
GASTRIC HAEMORRHAGE1 reports
GASTROINTESTINAL HAEMORRHAGE1 reports
GASTROINTESTINAL ULCER HAEMORRHAGE1 reports
HAEMATOSPERMIA1 reports
HAEMOPTYSIS1 reports
HAEMORRHAGE1 reports
HEARING IMPAIRED1 reports
HYPERSENSITIVITY1 reports
HYPERSOMNIA1 reports
INSOMNIA1 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR1 reports
LETHARGY1 reports
MATERNAL EXPOSURE DURING PREGNANCY1 reports
MUSCLE TIGHTNESS1 reports
MYOCARDIAL INFARCTION1 reports
NASOPHARYNGITIS1 reports
NEOPLASM MALIGNANT1 reports
NERVOUSNESS1 reports
OROPHARYNGEAL PAIN1 reports
PALLOR1 reports
PELVIC PAIN1 reports
PRODUCT QUALITY ISSUE1 reports
RESPIRATORY ARREST1 reports
RESPIRATORY TRACT CONGESTION1 reports
SINUSITIS1 reports
SLEEP DISORDER1 reports
SPEECH DISORDER1 reports
THROAT TIGHTNESS1 reports
ULCER1 reports
ULCER HAEMORRHAGE1 reports
VERTIGO1 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS1 reports

Report Outcomes

Out of 71 classified reports for ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE:

Serious 90.1%Non-Serious 9.9%

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

Female41 (63.1%)
Male22 (33.8%)
Unknown2 (3.1%)

Reports by Age

Age 372 reports
Age 472 reports
Age 582 reports
Age 642 reports
Age 662 reports
Age 672 reports
Age 682 reports
Age 752 reports
Age 161 reports
Age 291 reports
Age 351 reports
Age 391 reports
Age 441 reports
Age 501 reports
Age 561 reports
Age 601 reports
Age 611 reports
Age 621 reports
Age 631 reports
Age 691 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 ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE?

This profile reflects 179 FDA FAERS reports that mention ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE?

Frequently reported terms in FAERS include CEREBROVASCULAR ACCIDENT, DRUG INEFFECTIVE, DRUG DEPENDENCE, MALAISE, PRODUCT USE ISSUE, CHOKING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE?

Labeling and FAERS entries often list Bayer HealthCare LLC. in connection with ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE. 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.