ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE

N/A

Manufactured by Haleon US Holdings LLC

29,082 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE

ACETAMINOPHEN, ASPIRIN (NSAID) 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 (NSAID) 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 (NSAID) AND CAFFEINE.

Top Adverse Reactions

DRUG INEFFECTIVE3,777 reports
PRODUCT USE IN UNAPPROVED INDICATION2,038 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION1,566 reports
HEADACHE1,111 reports
NAUSEA1,023 reports
FATIGUE616 reports
DIZZINESS591 reports
MIGRAINE586 reports
PAIN529 reports
VOMITING514 reports
ABDOMINAL PAIN UPPER495 reports
INSOMNIA439 reports
OVERDOSE412 reports
INCORRECT DOSE ADMINISTERED403 reports
DIARRHOEA402 reports
MALAISE385 reports
FEELING ABNORMAL383 reports
ABDOMINAL DISCOMFORT369 reports
OFF LABEL USE367 reports
DYSPNOEA357 reports
ANXIETY356 reports
THERAPEUTIC RESPONSE UNEXPECTED333 reports
PRODUCT QUALITY ISSUE315 reports
DRUG DEPENDENCE296 reports
PRODUCT USE ISSUE270 reports
ARTHRALGIA257 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION255 reports
FALL255 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS252 reports
ASTHENIA245 reports
DEPRESSION238 reports
PAIN IN EXTREMITY236 reports
PRURITUS223 reports
SOMNOLENCE222 reports
DYSPEPSIA214 reports
CONDITION AGGRAVATED213 reports
BACK PAIN212 reports
TREMOR207 reports
HYPOAESTHESIA198 reports
CONSTIPATION197 reports
CHEST PAIN194 reports
MEDICATION OVERUSE HEADACHE192 reports
RASH190 reports
ABDOMINAL PAIN183 reports
PALPITATIONS181 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE179 reports
WEIGHT DECREASED179 reports
HYPERTENSION176 reports
COUGH163 reports
MEDICATION ERROR162 reports
BLOOD PRESSURE INCREASED161 reports
MUSCLE SPASMS161 reports
PARAESTHESIA156 reports
DRUG HYPERSENSITIVITY153 reports
GAIT DISTURBANCE152 reports
UNDERDOSE150 reports
HYPERSENSITIVITY148 reports
LOSS OF CONSCIOUSNESS148 reports
INJECTION SITE PAIN147 reports
FEELING JITTERY144 reports
MEMORY IMPAIRMENT138 reports
HEART RATE INCREASED137 reports
URTICARIA135 reports
GASTRIC DISORDER133 reports
PYREXIA131 reports
WEIGHT INCREASED130 reports
CHRONIC KIDNEY DISEASE129 reports
DECREASED APPETITE127 reports
SINUSITIS124 reports
PNEUMONIA121 reports
PRODUCT DOSE OMISSION ISSUE120 reports
GASTROOESOPHAGEAL REFLUX DISEASE119 reports
VISION BLURRED117 reports
INTENTIONAL PRODUCT MISUSE114 reports
NASOPHARYNGITIS114 reports
URINARY TRACT INFECTION114 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION112 reports
ERYTHEMA111 reports
HYPERHIDROSIS107 reports
GASTRIC ULCER106 reports
RENAL FAILURE106 reports
CHEST DISCOMFORT105 reports
EXPIRED PRODUCT ADMINISTERED105 reports
NERVOUSNESS105 reports
CEREBROVASCULAR ACCIDENT103 reports
CONTUSION103 reports
DRUG EFFECT LESS THAN EXPECTED102 reports
ALOPECIA101 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION97 reports
DYSPHAGIA96 reports
EXTRA DOSE ADMINISTERED96 reports
ILLNESS96 reports
MYALGIA96 reports
PERIPHERAL SWELLING96 reports
CHILLS95 reports
DRUG EFFECT INCOMPLETE95 reports
ULCER94 reports
CONTRAINDICATED PRODUCT ADMINISTERED93 reports
DRUG ADMINISTRATION ERROR92 reports
INJURY91 reports

Report Outcomes

Out of 16,691 classified reports for ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE:

Serious 29.5%Non-Serious 70.5%

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

Female9,412 (78.6%)
Male2,519 (21.0%)
Unknown43 (0.4%)

Reports by Age

Age 56155 reports
Age 49148 reports
Age 59144 reports
Age 54142 reports
Age 63139 reports
Age 58137 reports
Age 53135 reports
Age 61135 reports
Age 60132 reports
Age 57131 reports
Age 50127 reports
Age 55125 reports
Age 66125 reports
Age 44124 reports
Age 45120 reports
Age 52119 reports
Age 47118 reports
Age 48117 reports
Age 43116 reports
Age 64115 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 (NSAID) AND CAFFEINE?

This profile reflects 29,082 FDA FAERS reports that mention ACETAMINOPHEN, ASPIRIN (NSAID) 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 (NSAID) 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 (NSAID) AND CAFFEINE?

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