ACETAMINOPHEN 500 MG

N/A

Manufactured by Allegiant Health

253 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETAMINOPHEN 500 MG

ACETAMINOPHEN 500 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegiant Health. The most commonly reported adverse reactions for ACETAMINOPHEN 500 MG include NAUSEA, INFUSION RELATED REACTION, DIZZINESS, PAIN, CHILLS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN 500 MG.

Top Adverse Reactions

NAUSEA12 reports
INFUSION RELATED REACTION11 reports
DIZZINESS9 reports
PAIN9 reports
CHILLS8 reports
DYSPNOEA8 reports
VOMITING7 reports
ALANINE AMINOTRANSFERASE INCREASED6 reports
ASPARTATE AMINOTRANSFERASE INCREASED6 reports
LIVER FUNCTION TEST INCREASED5 reports
PRURITUS5 reports
DRUG INEFFECTIVE4 reports
MENTAL STATUS CHANGES4 reports
TREMOR4 reports
ABDOMINAL PAIN UPPER3 reports
ASTHENIA3 reports
BACK PAIN3 reports
CONFUSIONAL STATE3 reports
CONSTIPATION3 reports
COUGH3 reports
FALL3 reports
FATIGUE3 reports
HAEMOGLOBIN DECREASED3 reports
HEADACHE3 reports
HEPATIC ENZYME INCREASED3 reports
HYPERHIDROSIS3 reports
HYPERSENSITIVITY3 reports
PYREXIA3 reports
THERAPY INTERRUPTED3 reports
UNRESPONSIVE TO STIMULI3 reports
ABDOMINAL PAIN2 reports
ACUTE KIDNEY INJURY2 reports
ADVERSE DRUG REACTION2 reports
BLOOD CREATININE INCREASED2 reports
BLOOD PRESSURE DECREASED2 reports
CHEST DISCOMFORT2 reports
CHEST PAIN2 reports
DEMENTIA2 reports
DEPRESSED LEVEL OF CONSCIOUSNESS2 reports
DIARRHOEA2 reports
ELECTROCARDIOGRAM QT PROLONGED2 reports
FLUSHING2 reports
GAIT DISTURBANCE2 reports
HAEMOLYTIC ANAEMIA2 reports
HYPERTENSION2 reports
HYPOXIA2 reports
LOCAL SWELLING2 reports
LOSS OF CONSCIOUSNESS2 reports
MALAISE2 reports
MELAENA2 reports
MUSCULOSKELETAL STIFFNESS2 reports
NO ADVERSE EVENT2 reports
PAIN IN EXTREMITY2 reports
PARAESTHESIA2 reports
PHARYNGEAL DISORDER2 reports
PNEUMONIA2 reports
PRODUCT LABEL CONFUSION2 reports
PRODUCT QUALITY ISSUE2 reports
RASH2 reports
RECTAL HAEMORRHAGE2 reports
REFUSAL OF TREATMENT BY PATIENT2 reports
SINUSITIS2 reports
SYNCOPE2 reports
TACHYCARDIA2 reports
THERAPY CESSATION2 reports
TRANSAMINASES INCREASED2 reports
VISION BLURRED2 reports
ABASIA1 reports
ABDOMINAL DISCOMFORT1 reports
ABNORMAL BEHAVIOUR1 reports
ABSCESS1 reports
ACCIDENT1 reports
ACCIDENTAL OVERDOSE1 reports
ACUTE LUNG INJURY1 reports
APATHY1 reports
ARRHYTHMIA1 reports
ARTERIOVENOUS MALFORMATION1 reports
ARTHRALGIA1 reports
ATRIAL FIBRILLATION1 reports
BASILAR ARTERY ANEURYSM1 reports
BLADDER OPERATION1 reports
BLINDNESS TRANSIENT1 reports
BLISTER1 reports
BLOOD ALKALINE PHOSPHATASE INCREASED1 reports
BLOOD CREATINE PHOSPHOKINASE DECREASED1 reports
BLOOD GLUCOSE INCREASED1 reports
BLOOD PRESSURE FLUCTUATION1 reports
BLOOD PRESSURE IMMEASURABLE1 reports
BLOOD PRESSURE INCREASED1 reports
BODY TEMPERATURE INCREASED1 reports
BONE DISORDER1 reports
BOWEL MOVEMENT IRREGULARITY1 reports
BRONCHITIS1 reports
BRUXISM1 reports
BURNING SENSATION1 reports
C REACTIVE PROTEIN INCREASED1 reports
CAPILLARY LEAK SYNDROME1 reports
CARDIAC ARREST1 reports
CARDIAC FAILURE CONGESTIVE1 reports
CARDIOVERSION1 reports

Report Outcomes

Out of 120 classified reports for ACETAMINOPHEN 500 MG:

Serious 61.7%Non-Serious 38.3%

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

Female72 (62.1%)
Male44 (37.9%)

Reports by Age

Age 715 reports
Age 654 reports
Age 704 reports
Age 744 reports
Age 774 reports
Age 383 reports
Age 403 reports
Age 493 reports
Age 513 reports
Age 553 reports
Age 643 reports
Age 663 reports
Age 803 reports
Age 192 reports
Age 322 reports
Age 362 reports
Age 392 reports
Age 482 reports
Age 522 reports
Age 562 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 500 MG?

This profile reflects 253 FDA FAERS reports that mention ACETAMINOPHEN 500 MG. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN 500 MG?

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

Who manufactures ACETAMINOPHEN 500 MG?

Labeling and FAERS entries often list Allegiant Health in connection with ACETAMINOPHEN 500 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.