ACETAMINOPHEN, ASPIRIN, CAFFEINE

N/A

Manufactured by H E B

765 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, ASPIRIN, CAFFEINE

ACETAMINOPHEN, ASPIRIN, CAFFEINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H E B. The most commonly reported adverse reactions for ACETAMINOPHEN, ASPIRIN, CAFFEINE include DRUG INEFFECTIVE, EXPIRED PRODUCT ADMINISTERED, OFF LABEL USE, NAUSEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, ASPIRIN, CAFFEINE.

Top Adverse Reactions

DRUG INEFFECTIVE71 reports
EXPIRED PRODUCT ADMINISTERED33 reports
OFF LABEL USE32 reports
NAUSEA24 reports
DIZZINESS19 reports
UNDERDOSE19 reports
HEADACHE17 reports
ARTHRALGIA16 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION16 reports
EXPOSURE TO TOXIC AGENT16 reports
INCORRECT DOSE ADMINISTERED16 reports
PAIN16 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS15 reports
ABDOMINAL PAIN UPPER13 reports
FATIGUE12 reports
INFLUENZA11 reports
PRURITUS11 reports
ABDOMINAL DISCOMFORT10 reports
DIARRHOEA10 reports
BACK PAIN9 reports
CHEST PAIN9 reports
FEELING ABNORMAL9 reports
HYPERSENSITIVITY9 reports
ILLNESS9 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION9 reports
MALAISE9 reports
OVERDOSE9 reports
PAIN IN EXTREMITY9 reports
PYREXIA8 reports
VOMITING8 reports
ABDOMINAL PAIN7 reports
ANXIETY7 reports
GAIT DISTURBANCE7 reports
RASH7 reports
ASTHENIA6 reports
COMPLETED SUICIDE6 reports
COUGH6 reports
DEATH6 reports
HYPERTENSION6 reports
INFLAMMATION6 reports
INSOMNIA6 reports
PNEUMONIA6 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE6 reports
BLOOD PRESSURE INCREASED5 reports
DYSPNOEA5 reports
DYSSTASIA5 reports
FALL5 reports
MIGRAINE5 reports
MOBILITY DECREASED5 reports
MUSCULOSKELETAL STIFFNESS5 reports
PRODUCT ODOUR ABNORMAL5 reports
PRODUCT QUALITY ISSUE5 reports
ARTHRITIS4 reports
CHILLS4 reports
CONDITION AGGRAVATED4 reports
COVID 194 reports
DRUG EFFECT DECREASED4 reports
DRUG HYPERSENSITIVITY4 reports
DYSPEPSIA4 reports
ERYTHEMA4 reports
GASTROINTESTINAL DISORDER4 reports
GENERAL PHYSICAL HEALTH DETERIORATION4 reports
MYALGIA4 reports
NECK PAIN4 reports
PRODUCT AVAILABILITY ISSUE4 reports
SINUSITIS4 reports
STOMATITIS4 reports
SWELLING FACE4 reports
THROAT IRRITATION4 reports
TREATMENT NONCOMPLIANCE4 reports
URINARY TRACT INFECTION4 reports
WEIGHT INCREASED4 reports
ANGINA UNSTABLE3 reports
BLOOD URINE PRESENT3 reports
CELLULITIS3 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE3 reports
COLD SWEAT3 reports
DECREASED APPETITE3 reports
DEPRESSED MOOD3 reports
DISCOMFORT3 reports
DRUG EFFECT INCOMPLETE3 reports
DRY SKIN3 reports
DYSGEUSIA3 reports
DYSPHONIA3 reports
EYE IRRITATION3 reports
FIBROMYALGIA3 reports
GASTRIC ULCER3 reports
HORDEOLUM3 reports
HOT FLUSH3 reports
INCORRECT PRODUCT ADMINISTRATION DURATION3 reports
INFECTION3 reports
INJECTION SITE PAIN3 reports
JOINT SWELLING3 reports
NASOPHARYNGITIS3 reports
OROPHARYNGEAL PAIN3 reports
PALPITATIONS3 reports
PLATELET COUNT DECREASED3 reports
PRODUCT DOSE OMISSION ISSUE3 reports
PRODUCT LABEL ISSUE3 reports
PRODUCT TASTE ABNORMAL3 reports

Report Outcomes

Out of 343 classified reports for ACETAMINOPHEN, ASPIRIN, CAFFEINE:

Serious 32.1%Non-Serious 67.9%

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

Female211 (71.8%)
Male83 (28.2%)

Reports by Age

Age 5110 reports
Age 719 reports
Age 618 reports
Age 426 reports
Age 456 reports
Age 505 reports
Age 525 reports
Age 545 reports
Age 585 reports
Age 625 reports
Age 665 reports
Age 474 reports
Age 534 reports
Age 564 reports
Age 594 reports
Age 674 reports
Age 694 reports
Age 724 reports
Age 253 reports
Age 263 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, ASPIRIN, CAFFEINE?

This profile reflects 765 FDA FAERS reports that mention ACETAMINOPHEN, ASPIRIN, CAFFEINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, ASPIRIN, CAFFEINE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, EXPIRED PRODUCT ADMINISTERED, OFF LABEL USE, NAUSEA, DIZZINESS, UNDERDOSE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, ASPIRIN, CAFFEINE?

Labeling and FAERS entries often list H E B in connection with ACETAMINOPHEN, ASPIRIN, CAFFEINE. 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.