ACETAMINOPHEN 325MG

N/A

Manufactured by Allegiant Health

383 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETAMINOPHEN 325MG

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

Top Adverse Reactions

INFUSION RELATED REACTION31 reports
NAUSEA19 reports
HEADACHE15 reports
DEATH13 reports
DYSPNOEA13 reports
VOMITING13 reports
RASH12 reports
DIARRHOEA9 reports
FATIGUE9 reports
CHEST DISCOMFORT7 reports
CHILLS7 reports
COUGH7 reports
ERYTHEMA7 reports
HYPERTENSION7 reports
PRURITUS7 reports
PYREXIA7 reports
BLOOD PRESSURE INCREASED6 reports
THROAT IRRITATION6 reports
DISEASE PROGRESSION5 reports
HYPOAESTHESIA5 reports
LIP SWELLING5 reports
MALAISE5 reports
THERAPY CESSATION5 reports
URTICARIA5 reports
ABDOMINAL DISCOMFORT4 reports
FEELING ABNORMAL4 reports
OCULAR HYPERAEMIA4 reports
PERIPHERAL SWELLING4 reports
THERAPY INTERRUPTED4 reports
ABDOMINAL PAIN UPPER3 reports
BURNING SENSATION3 reports
CARDIAC ARREST3 reports
DIZZINESS3 reports
FALL3 reports
FLUID RETENTION3 reports
FLUSHING3 reports
HOSPICE CARE3 reports
HOSPITALISATION3 reports
MUSCLE SPASMS3 reports
OXYGEN SATURATION DECREASED3 reports
PAIN3 reports
PAIN IN EXTREMITY3 reports
PNEUMONIA3 reports
SKIN DISCOLOURATION3 reports
SKIN EXFOLIATION3 reports
TREMOR3 reports
ABDOMINAL PAIN2 reports
ACUTE KIDNEY INJURY2 reports
ALANINE AMINOTRANSFERASE INCREASED2 reports
ANAPHYLACTIC REACTION2 reports
ANXIETY2 reports
ASPARTATE AMINOTRANSFERASE INCREASED2 reports
ASTHENIA2 reports
BACK PAIN2 reports
BLISTER2 reports
CHEST PAIN2 reports
CONDITION AGGRAVATED2 reports
CYANOSIS2 reports
CYTOKINE RELEASE SYNDROME2 reports
DEHYDRATION2 reports
DRY SKIN2 reports
EAR PRURITUS2 reports
GASTROOESOPHAGEAL REFLUX DISEASE2 reports
HAEMATEMESIS2 reports
HEART RATE DECREASED2 reports
HYPOTENSION2 reports
INFLUENZA LIKE ILLNESS2 reports
MENINGITIS ASEPTIC2 reports
NEUROPATHY PERIPHERAL2 reports
PARAESTHESIA2 reports
PLATELET COUNT DECREASED2 reports
PLEURAL EFFUSION2 reports
RASH ERYTHEMATOUS2 reports
RASH PRURITIC2 reports
RECALLED PRODUCT ADMINISTERED2 reports
SWELLING2 reports
SWELLING FACE2 reports
SWOLLEN TONGUE2 reports
VISION BLURRED2 reports
ABORTION SPONTANEOUS1 reports
ABSCESS LIMB1 reports
ADVERSE DRUG REACTION1 reports
AGITATION1 reports
ANGIOEDEMA1 reports
APNOEA1 reports
ATRIAL FIBRILLATION1 reports
BASAL CELL CARCINOMA1 reports
BEDRIDDEN1 reports
BLOOD CREATINE INCREASED1 reports
BLOOD CREATININE INCREASED1 reports
BLOOD FIBRINOGEN DECREASED1 reports
BLOOD POTASSIUM DECREASED1 reports
BLOOD PRESSURE SYSTOLIC INCREASED1 reports
BODY TEMPERATURE FLUCTUATION1 reports
BRADYCARDIA1 reports
BRAIN OEDEMA1 reports
CELLULITIS1 reports
CEREBROVASCULAR ACCIDENT1 reports
CHROMATURIA1 reports
COAGULOPATHY1 reports

Report Outcomes

Out of 179 classified reports for ACETAMINOPHEN 325MG:

Serious 60.3%Non-Serious 39.7%

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

Female109 (62.6%)
Male65 (37.4%)

Reports by Age

Age 6711 reports
Age 638 reports
Age 727 reports
Age 566 reports
Age 686 reports
Age 715 reports
Age 745 reports
Age 765 reports
Age 184 reports
Age 514 reports
Age 574 reports
Age 584 reports
Age 594 reports
Age 604 reports
Age 654 reports
Age 664 reports
Age 734 reports
Age 774 reports
Age 273 reports
Age 463 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 325MG?

This profile reflects 383 FDA FAERS reports that mention ACETAMINOPHEN 325MG. Reporting is voluntary and does not prove that the drug caused any listed event.

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

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

Who manufactures ACETAMINOPHEN 325MG?

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