BAYER GENUINE ASPIRIN

N/A

Manufactured by Bayer HealthCare LLC.

1,811 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BAYER GENUINE ASPIRIN

BAYER GENUINE ASPIRIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. The most commonly reported adverse reactions for BAYER GENUINE ASPIRIN include PRODUCT USE ISSUE, DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, MYOCARDIAL INFARCTION, HAEMORRHAGE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BAYER GENUINE ASPIRIN.

Top Adverse Reactions

PRODUCT USE ISSUE221 reports
DRUG HYPERSENSITIVITY151 reports
DRUG INEFFECTIVE87 reports
MYOCARDIAL INFARCTION51 reports
HAEMORRHAGE49 reports
DEATH40 reports
INCORRECT DRUG ADMINISTRATION DURATION37 reports
MEDICATION ERROR37 reports
INTENTIONAL PRODUCT MISUSE36 reports
OFF LABEL USE36 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR35 reports
DYSPNOEA34 reports
NAUSEA32 reports
THERAPEUTIC RESPONSE UNEXPECTED31 reports
ABDOMINAL PAIN UPPER30 reports
GASTROINTESTINAL HAEMORRHAGE27 reports
CEREBROVASCULAR ACCIDENT26 reports
EXPIRED PRODUCT ADMINISTERED25 reports
GASTRIC HAEMORRHAGE25 reports
ABDOMINAL DISCOMFORT22 reports
GASTRIC ULCER22 reports
URTICARIA22 reports
DIARRHOEA20 reports
EXTRA DOSE ADMINISTERED20 reports
EPISTAXIS19 reports
HEADACHE19 reports
RECTAL HAEMORRHAGE18 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS17 reports
DIZZINESS16 reports
BLOOD PRESSURE INCREASED15 reports
FATIGUE15 reports
DRUG ADMINISTRATION ERROR14 reports
HAEMATEMESIS14 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE13 reports
GASTRIC ULCER HAEMORRHAGE13 reports
VOMITING13 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS13 reports
DYSPEPSIA12 reports
HAEMATOCHEZIA12 reports
LOSS OF CONSCIOUSNESS12 reports
ANAPHYLACTIC REACTION11 reports
ASTHENIA11 reports
HYPERTENSION11 reports
MALAISE11 reports
PAIN IN EXTREMITY11 reports
ULCER11 reports
UNEVALUABLE EVENT11 reports
BLOOD URINE PRESENT10 reports
CONTUSION10 reports
FALL10 reports
INSOMNIA10 reports
LIP SWELLING10 reports
MELAENA10 reports
ULCER HAEMORRHAGE10 reports
ANAPHYLACTIC SHOCK9 reports
DRUG EFFECT INCOMPLETE9 reports
FEELING ABNORMAL9 reports
PAIN9 reports
PRURITUS9 reports
SWELLING FACE9 reports
WEIGHT DECREASED9 reports
ARTHRALGIA8 reports
CONSTIPATION8 reports
FAECES DISCOLOURED8 reports
INTERNAL HAEMORRHAGE8 reports
SWOLLEN TONGUE8 reports
ANAEMIA7 reports
ANGINA PECTORIS7 reports
BACK PAIN7 reports
CHOKING7 reports
DRUG DEPENDENCE7 reports
GASTRIC DISORDER7 reports
GASTROOESOPHAGEAL REFLUX DISEASE7 reports
HAEMOPTYSIS7 reports
INCORRECT DOSE ADMINISTERED7 reports
OVERDOSE7 reports
PALPITATIONS7 reports
PERIPHERAL SWELLING7 reports
RASH7 reports
COMA6 reports
CORONARY ARTERY OCCLUSION6 reports
HEART RATE INCREASED6 reports
HYPERSENSITIVITY6 reports
MUSCLE SPASMS6 reports
PHARYNGEAL OEDEMA6 reports
PNEUMONIA6 reports
SOMNOLENCE6 reports
SWELLING6 reports
SYNCOPE6 reports
TINNITUS6 reports
TRANSIENT ISCHAEMIC ATTACK6 reports
UPPER GASTROINTESTINAL HAEMORRHAGE6 reports
WHEEZING6 reports
ABDOMINAL PAIN5 reports
ACUTE MYOCARDIAL INFARCTION5 reports
ADVERSE DRUG REACTION5 reports
CARDIAC ARREST5 reports
CARDIAC FAILURE CONGESTIVE5 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION5 reports
DRUG INTERACTION5 reports

Report Outcomes

Out of 833 classified reports for BAYER GENUINE ASPIRIN:

Serious 71.3%Non-Serious 28.7%

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

Female466 (63.1%)
Male273 (36.9%)

Reports by Age

Age 6623 reports
Age 8220 reports
Age 6919 reports
Age 7017 reports
Age 7316 reports
Age 7915 reports
Age 7514 reports
Age 5813 reports
Age 6813 reports
Age 7113 reports
Age 6312 reports
Age 7812 reports
Age 8012 reports
Age 5411 reports
Age 7211 reports
Age 6510 reports
Age 609 reports
Age 619 reports
Age 649 reports
Age 749 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 BAYER GENUINE ASPIRIN?

This profile reflects 1,811 FDA FAERS reports that mention BAYER GENUINE ASPIRIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BAYER GENUINE ASPIRIN?

Frequently reported terms in FAERS include PRODUCT USE ISSUE, DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, MYOCARDIAL INFARCTION, HAEMORRHAGE, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BAYER GENUINE ASPIRIN?

Labeling and FAERS entries often list Bayer HealthCare LLC. in connection with BAYER GENUINE ASPIRIN. 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.