ACETAMINOPHEN, CAFFEINE

N/A

Manufactured by Haleon US Holdings LLC

12,550 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, CAFFEINE

ACETAMINOPHEN, 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, CAFFEINE include DRUG INEFFECTIVE, HEADACHE, NAUSEA, FATIGUE, PRODUCT USE IN UNAPPROVED INDICATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, CAFFEINE.

Top Adverse Reactions

DRUG INEFFECTIVE2,042 reports
HEADACHE564 reports
NAUSEA411 reports
FATIGUE356 reports
PRODUCT USE IN UNAPPROVED INDICATION300 reports
MIGRAINE280 reports
PAIN237 reports
DIZZINESS223 reports
INSOMNIA209 reports
VOMITING204 reports
DIARRHOEA200 reports
ABDOMINAL PAIN UPPER192 reports
ABDOMINAL DISCOMFORT187 reports
MALAISE183 reports
OFF LABEL USE163 reports
ANXIETY162 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION156 reports
FEELING ABNORMAL149 reports
PRODUCT QUALITY ISSUE149 reports
MEDICATION OVERUSE HEADACHE148 reports
ARTHRALGIA143 reports
DYSPNOEA143 reports
DRUG DEPENDENCE141 reports
FALL135 reports
INCORRECT DOSE ADMINISTERED127 reports
ASTHENIA119 reports
BACK PAIN118 reports
THERAPEUTIC RESPONSE UNEXPECTED117 reports
PAIN IN EXTREMITY116 reports
CONSTIPATION114 reports
CHRONIC KIDNEY DISEASE111 reports
DEPRESSION111 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS108 reports
PRODUCT USE ISSUE107 reports
DRUG HYPERSENSITIVITY106 reports
CONDITION AGGRAVATED101 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION96 reports
PRURITUS96 reports
RASH93 reports
OVERDOSE90 reports
SOMNOLENCE89 reports
RENAL FAILURE88 reports
GAIT DISTURBANCE87 reports
TREMOR87 reports
MUSCLE SPASMS83 reports
WEIGHT DECREASED83 reports
COUGH82 reports
GASTRIC DISORDER81 reports
HYPOAESTHESIA79 reports
CHEST PAIN77 reports
DYSPEPSIA77 reports
PALPITATIONS77 reports
PARAESTHESIA77 reports
INJECTION SITE PAIN76 reports
DECREASED APPETITE74 reports
MEMORY IMPAIRMENT74 reports
ACUTE KIDNEY INJURY71 reports
HYPERTENSION71 reports
PYREXIA70 reports
MYALGIA68 reports
PRODUCT DOSE OMISSION ISSUE68 reports
INTENTIONAL PRODUCT MISUSE67 reports
GASTROOESOPHAGEAL REFLUX DISEASE65 reports
PERIPHERAL SWELLING65 reports
ABDOMINAL PAIN64 reports
BLOOD PRESSURE INCREASED64 reports
WEIGHT INCREASED62 reports
ALOPECIA61 reports
PNEUMONIA61 reports
UNDERDOSE61 reports
ULCER59 reports
URTICARIA59 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE58 reports
NASOPHARYNGITIS57 reports
DRUG EFFECT INCOMPLETE56 reports
DRUG DOSE OMISSION55 reports
HEART RATE INCREASED55 reports
HYPERSENSITIVITY55 reports
SINUSITIS55 reports
CONTUSION54 reports
DEATH53 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION52 reports
URINARY TRACT INFECTION52 reports
ERYTHEMA51 reports
VISION BLURRED51 reports
CHILLS50 reports
DRUG EFFECT VARIABLE50 reports
INCORRECT DRUG ADMINISTRATION DURATION50 reports
CEREBROVASCULAR ACCIDENT49 reports
BALANCE DISORDER48 reports
CONTRAINDICATED PRODUCT ADMINISTERED48 reports
LOSS OF CONSCIOUSNESS48 reports
ULCER HAEMORRHAGE48 reports
ARTHRITIS47 reports
ILLNESS47 reports
OROPHARYNGEAL PAIN47 reports
DRUG ADMINISTRATION ERROR46 reports
GASTRIC ULCER46 reports
ANAEMIA44 reports
CHEST DISCOMFORT44 reports

Report Outcomes

Out of 7,381 classified reports for ACETAMINOPHEN, CAFFEINE:

Serious 30.5%Non-Serious 69.5%

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

Female4,187 (79.2%)
Male1,088 (20.6%)
Unknown13 (0.2%)

Reports by Age

Age 5671 reports
Age 4964 reports
Age 5461 reports
Age 6059 reports
Age 6159 reports
Age 6358 reports
Age 6658 reports
Age 5956 reports
Age 6756 reports
Age 4555 reports
Age 5354 reports
Age 7052 reports
Age 5850 reports
Age 6550 reports
Age 6249 reports
Age 6849 reports
Age 6448 reports
Age 4347 reports
Age 5746 reports
Age 7446 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, CAFFEINE?

This profile reflects 12,550 FDA FAERS reports that mention ACETAMINOPHEN, CAFFEINE. Reporting is voluntary and does not prove that the drug caused any listed event.

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

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

Who manufactures ACETAMINOPHEN, CAFFEINE?

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