ACETAMINOPHEN, ASPIRIN, AND CAFFEINE

N/A

Manufactured by Haleon US Holdings LLC

37,042 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETAMINOPHEN, ASPIRIN, AND CAFFEINE

ACETAMINOPHEN, ASPIRIN, AND CAFFEINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE include DRUG INEFFECTIVE, PRODUCT USE IN UNAPPROVED INDICATION, DRUG EFFECTIVE FOR UNAPPROVED INDICATION, HEADACHE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE.

Top Adverse Reactions

DRUG INEFFECTIVE3,984 reports
PRODUCT USE IN UNAPPROVED INDICATION3,833 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION3,307 reports
HEADACHE1,305 reports
NAUSEA1,181 reports
FATIGUE735 reports
DIZZINESS672 reports
PAIN642 reports
MIGRAINE641 reports
VOMITING575 reports
ABDOMINAL PAIN UPPER555 reports
INCORRECT DOSE ADMINISTERED519 reports
INSOMNIA516 reports
OFF LABEL USE496 reports
DIARRHOEA492 reports
FEELING ABNORMAL453 reports
ABDOMINAL DISCOMFORT451 reports
MALAISE450 reports
OVERDOSE447 reports
THERAPEUTIC RESPONSE UNEXPECTED447 reports
DYSPNOEA444 reports
ANXIETY404 reports
PRODUCT QUALITY ISSUE340 reports
DRUG DEPENDENCE339 reports
FALL322 reports
ARTHRALGIA316 reports
PRODUCT USE ISSUE308 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION299 reports
ASTHENIA286 reports
PAIN IN EXTREMITY283 reports
DEPRESSION280 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS276 reports
SOMNOLENCE274 reports
PRURITUS268 reports
BACK PAIN265 reports
CONDITION AGGRAVATED262 reports
HYPERTENSION262 reports
UNDERDOSE251 reports
TREMOR239 reports
DYSPEPSIA236 reports
CHEST PAIN234 reports
WEIGHT DECREASED231 reports
CONSTIPATION230 reports
RASH230 reports
COUGH227 reports
HYPOAESTHESIA218 reports
ABDOMINAL PAIN212 reports
PALPITATIONS205 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE203 reports
MEDICATION OVERUSE HEADACHE200 reports
BLOOD PRESSURE INCREASED192 reports
HYPERSENSITIVITY186 reports
MUSCLE SPASMS185 reports
GAIT DISTURBANCE184 reports
LOSS OF CONSCIOUSNESS184 reports
DRUG HYPERSENSITIVITY180 reports
INJECTION SITE PAIN176 reports
PARAESTHESIA176 reports
SINUSITIS175 reports
FEELING JITTERY172 reports
PRODUCT DOSE OMISSION ISSUE167 reports
MEDICATION ERROR166 reports
PNEUMONIA164 reports
DECREASED APPETITE162 reports
MEMORY IMPAIRMENT161 reports
INCORRECT DRUG ADMINISTRATION DURATION160 reports
PYREXIA159 reports
HEART RATE INCREASED157 reports
WEIGHT INCREASED156 reports
URTICARIA154 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION148 reports
URINARY TRACT INFECTION148 reports
GASTRIC DISORDER144 reports
GASTROOESOPHAGEAL REFLUX DISEASE143 reports
NASOPHARYNGITIS140 reports
CHRONIC KIDNEY DISEASE139 reports
DRUG EFFECT LESS THAN EXPECTED136 reports
GASTRIC ULCER135 reports
HYPERHIDROSIS133 reports
CEREBROVASCULAR ACCIDENT132 reports
CHEST DISCOMFORT131 reports
ARTHRITIS129 reports
ERYTHEMA129 reports
VISION BLURRED129 reports
CONTUSION123 reports
INTENTIONAL PRODUCT MISUSE123 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION122 reports
MYALGIA122 reports
COVID 19120 reports
NERVOUSNESS120 reports
ILLNESS119 reports
PERIPHERAL SWELLING119 reports
ALOPECIA116 reports
RENAL FAILURE116 reports
EXPIRED PRODUCT ADMINISTERED115 reports
DEATH114 reports
CHILLS111 reports
ULCER110 reports
DYSPHAGIA109 reports
ANAEMIA106 reports

Report Outcomes

Out of 20,674 classified reports for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE:

Serious 29.7%Non-Serious 70.3%

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

Female10,931 (78.0%)
Male3,019 (21.6%)
Unknown56 (0.4%)

Reports by Age

Age 49182 reports
Age 56173 reports
Age 60169 reports
Age 63169 reports
Age 59166 reports
Age 53163 reports
Age 54161 reports
Age 65161 reports
Age 58159 reports
Age 61157 reports
Age 66154 reports
Age 62150 reports
Age 55149 reports
Age 50146 reports
Age 64146 reports
Age 57144 reports
Age 67143 reports
Age 47142 reports
Age 44136 reports
Age 45136 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, AND CAFFEINE?

This profile reflects 37,042 FDA FAERS reports that mention ACETAMINOPHEN, ASPIRIN, AND 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, AND CAFFEINE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PRODUCT USE IN UNAPPROVED INDICATION, DRUG EFFECTIVE FOR UNAPPROVED INDICATION, HEADACHE, NAUSEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, ASPIRIN, AND CAFFEINE?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with ACETAMINOPHEN, ASPIRIN, AND 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.