ACETAMINOPHEN 325 MG

N/A

Manufactured by Ulai Health LLC

211 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETAMINOPHEN 325 MG

ACETAMINOPHEN 325 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ulai Health LLC. The most commonly reported adverse reactions for ACETAMINOPHEN 325 MG include INFUSION RELATED REACTION, CHILLS, DYSPNOEA, NAUSEA, ALANINE AMINOTRANSFERASE INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN 325 MG.

Top Adverse Reactions

INFUSION RELATED REACTION11 reports
CHILLS7 reports
DYSPNOEA7 reports
NAUSEA7 reports
ALANINE AMINOTRANSFERASE INCREASED5 reports
ASPARTATE AMINOTRANSFERASE INCREASED5 reports
DIZZINESS5 reports
LIVER FUNCTION TEST INCREASED5 reports
PRURITUS5 reports
VOMITING5 reports
MENTAL STATUS CHANGES4 reports
PAIN4 reports
ABDOMINAL PAIN UPPER3 reports
CHEST PAIN3 reports
CONFUSIONAL STATE3 reports
COUGH3 reports
FALL3 reports
HAEMOGLOBIN DECREASED3 reports
HEADACHE3 reports
HEPATIC ENZYME INCREASED3 reports
HYPERHIDROSIS3 reports
PAIN IN EXTREMITY3 reports
PYREXIA3 reports
SYNCOPE3 reports
THERAPY INTERRUPTED3 reports
TREMOR3 reports
UNRESPONSIVE TO STIMULI3 reports
ABDOMINAL PAIN2 reports
ACUTE KIDNEY INJURY2 reports
ADVERSE DRUG REACTION2 reports
ASTHENIA2 reports
BLOOD CREATININE INCREASED2 reports
BLOOD PRESSURE DECREASED2 reports
CHEST DISCOMFORT2 reports
CONSTIPATION2 reports
DEPRESSED LEVEL OF CONSCIOUSNESS2 reports
DRUG INEFFECTIVE2 reports
ELECTROCARDIOGRAM QT PROLONGED2 reports
HAEMOLYTIC ANAEMIA2 reports
HYPERSENSITIVITY2 reports
HYPOXIA2 reports
MELAENA2 reports
MUSCULOSKELETAL STIFFNESS2 reports
RASH2 reports
RECTAL HAEMORRHAGE2 reports
REFUSAL OF TREATMENT BY PATIENT2 reports
TACHYCARDIA2 reports
THERAPY CESSATION2 reports
TRANSAMINASES INCREASED2 reports
VISION BLURRED2 reports
ABDOMINAL DISTENSION1 reports
ABNORMAL BEHAVIOUR1 reports
ACUTE LUNG INJURY1 reports
ANHEDONIA1 reports
ANXIETY1 reports
APPETITE DISORDER1 reports
ARTERIOVENOUS MALFORMATION1 reports
ARTHRALGIA1 reports
ATRIAL FIBRILLATION1 reports
BACK PAIN1 reports
BASILAR ARTERY ANEURYSM1 reports
BLISTER1 reports
BLOOD ALKALINE PHOSPHATASE INCREASED1 reports
BLOOD CREATINE PHOSPHOKINASE DECREASED1 reports
BLOOD GLUCOSE INCREASED1 reports
BLOOD PRESSURE FLUCTUATION1 reports
BLOOD PRESSURE INCREASED1 reports
BODY TEMPERATURE INCREASED1 reports
BRONCHITIS1 reports
BRUXISM1 reports
BURKHOLDERIA TEST POSITIVE1 reports
BURNING SENSATION1 reports
C REACTIVE PROTEIN INCREASED1 reports
CAPILLARY LEAK SYNDROME1 reports
CARDIAC ARREST1 reports
CARDIOVERSION1 reports
CEREBRAL ARTERY STENOSIS1 reports
CLOSTRIDIUM DIFFICILE INFECTION1 reports
COLITIS1 reports
COLITIS ULCERATIVE1 reports
CONTUSION1 reports
COVID 191 reports
CREATININE RENAL CLEARANCE DECREASED1 reports
DECREASED ACTIVITY1 reports
DEEP VEIN THROMBOSIS1 reports
DEMENTIA1 reports
DEPRESSION1 reports
DIARRHOEA1 reports
DIZZINESS POSTURAL1 reports
DROOLING1 reports
DRUG DISPENSING ERROR1 reports
DRUG INDUCED LIVER INJURY1 reports
ECCHYMOSIS1 reports
ECONOMIC PROBLEM1 reports
EMOTIONAL DISTRESS1 reports
EPISTAXIS1 reports
FATIGUE1 reports
FEAR1 reports
FEELING ABNORMAL1 reports
FEELING COLD1 reports

Report Outcomes

Out of 95 classified reports for ACETAMINOPHEN 325 MG:

Serious 69.5%Non-Serious 30.5%

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

Female55 (61.1%)
Male35 (38.9%)

Reports by Age

Age 644 reports
Age 714 reports
Age 744 reports
Age 774 reports
Age 383 reports
Age 403 reports
Age 493 reports
Age 653 reports
Age 663 reports
Age 673 reports
Age 703 reports
Age 803 reports
Age 192 reports
Age 362 reports
Age 392 reports
Age 482 reports
Age 552 reports
Age 562 reports
Age 572 reports
Age 762 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 325 MG?

This profile reflects 211 FDA FAERS reports that mention ACETAMINOPHEN 325 MG. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN 325 MG?

Frequently reported terms in FAERS include INFUSION RELATED REACTION, CHILLS, DYSPNOEA, NAUSEA, ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN 325 MG?

Labeling and FAERS entries often list Ulai Health LLC in connection with ACETAMINOPHEN 325 MG. 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.