ACETAMINOPHEN

Acetaminophen Adverse Events Reported to the FDA Over Time

How are Acetaminophen adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Acetaminophen, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Acetaminophen is flagged as the suspect drug causing the adverse event.

Most Common Acetaminophen Adverse Events Reported to the FDA

What are the most common Acetaminophen adverse events reported to the FDA?

Completed Suicide	7503 (7.53%)
Drug Toxicity	2434 (2.44%)
Overdose	2393 (2.4%)
Cardio-respiratory Arrest	2389 (2.4%)
Cardiac Arrest	1922 (1.93%)
Respiratory Arrest	1703 (1.71%)
Intentional Drug Misuse	1504 (1.51%)
Intentional Overdose	1464 (1.47%)
Death	1360 (1.37%)
Vomiting	1226 (1.23%)
Multiple Drug Overdose	1134 (1.14%)
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Hepatic Failure	934 (.94%)
Nausea	920 (.92%)
Multiple Drug Overdose Intentional	854 (.86%)
Acute Hepatic Failure	853 (.86%)
Drug Abuse	841 (.84%)
Myocardial Infarction	825 (.83%)
Arrhythmia	798 (.8%)
Hypotension	773 (.78%)
Alanine Aminotransferase Increased	755 (.76%)
Cardiac Disorder	745 (.75%)
Somnolence	731 (.73%)
Cardiovascular Disorder	723 (.73%)
Drug Ineffective	721 (.72%)
Poisoning	671 (.67%)
Suicide Attempt	669 (.67%)
Aspartate Aminotransferase Increase...	662 (.66%)
Loss Of Consciousness	597 (.6%)
Coma	583 (.59%)
Pyrexia	577 (.58%)
Drug Interaction	563 (.57%)
Liver Injury	548 (.55%)
Medication Error	520 (.52%)
Confusional State	517 (.52%)
Metabolic Acidosis	511 (.51%)
Dyspnoea	497 (.5%)
Hepatic Necrosis	494 (.5%)
Renal Failure	480 (.48%)
Dizziness	460 (.46%)
Renal Failure Acute	435 (.44%)
Accidental Overdose	431 (.43%)
Headache	406 (.41%)
International Normalised Ratio Incr...	406 (.41%)
Abdominal Pain	404 (.41%)
Tachycardia	397 (.4%)
Hepatotoxicity	388 (.39%)
Malaise	388 (.39%)
Convulsion	375 (.38%)
Pain	362 (.36%)
Depressed Level Of Consciousness	360 (.36%)
Fall	349 (.35%)
Drug Exposure During Pregnancy	343 (.34%)
Diarrhoea	339 (.34%)
Pruritus	308 (.31%)
Multi-organ Failure	297 (.3%)
Sudden Cardiac Death	297 (.3%)
Rash	294 (.3%)
Agitation	287 (.29%)
Asthenia	261 (.26%)
Liver Function Test Abnormal	261 (.26%)
Cytolytic Hepatitis	260 (.26%)
Transaminases Increased	257 (.26%)
Hepatic Function Abnormal	256 (.26%)
Hypertension	254 (.26%)
Heart Rate Increased	253 (.25%)
Blood Creatinine Increased	252 (.25%)
Abdominal Pain Upper	251 (.25%)
Lethargy	243 (.24%)
Incorrect Dose Administered	241 (.24%)
Unresponsive To Stimuli	237 (.24%)
Encephalopathy	234 (.23%)
Blood Bilirubin Increased	233 (.23%)
Hallucination	232 (.23%)
Sepsis	232 (.23%)
Mental Status Changes	231 (.23%)
Constipation	226 (.23%)
Bradycardia	221 (.22%)
Thrombocytopenia	221 (.22%)
Coagulopathy	215 (.22%)
Condition Aggravated	212 (.21%)
Renal Impairment	211 (.21%)
Hyperhidrosis	210 (.21%)
Product Quality Issue	210 (.21%)
Rhabdomyolysis	210 (.21%)
Toxic Epidermal Necrolysis	210 (.21%)
Pneumonia	209 (.21%)
Drug Administration Error	208 (.21%)
Fatigue	206 (.21%)
Pulmonary Oedema	201 (.2%)
Acidosis	199 (.2%)
Chest Pain	199 (.2%)
Prothrombin Time Prolonged	198 (.2%)
General Physical Health Deteriorati...	195 (.2%)
Jaundice	195 (.2%)
Feeling Abnormal	194 (.19%)
Respiratory Depression	194 (.19%)
Urticaria	191 (.19%)
Hepatic Encephalopathy	190 (.19%)
Gamma-glutamyltransferase Increased	189 (.19%)
Blood Alkaline Phosphatase Increase...	188 (.19%)
Insomnia	187 (.19%)

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This graph shows the top adverse events submitted to the FDA for Acetaminophen, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Acetaminophen is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Acetaminophen

What are the most common Acetaminophen adverse events reported to the FDA?

Suicidal And Self-injurious Behavio...	8473 (8.51%)
Medication Errors	7939 (7.97%)
Cardiac Arrhythmias	6499 (6.52%)
Hepatic And Hepatobiliary	5329 (5.35%)
Neurological	4476 (4.49%)
Respiratory	3870 (3.89%)
Chemical Injury And Poisoning	3770 (3.79%)
Gastrointestinal Signs	3386 (3.4%)
Psychiatric	2957 (2.97%)
Hepatobiliary	2684 (2.69%)
Epidermal And Dermal Conditions	2540 (2.55%)
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Fatal Outcomes	1853 (1.86%)
Therapeutic And Nontherapeutic Effe...	1824 (1.83%)
Cardiac Disorder Signs	1700 (1.71%)
Hematology Investigations	1666 (1.67%)
Renal Disorders	1518 (1.52%)
Infections - Pathogen Unspecified	1349 (1.35%)
Cardiac And Vascular Investigations	1207 (1.21%)
Decreased And Nonspecific Blood Pre...	1027 (1.03%)
Coronary Artery	979 (.98%)
Injuries	954 (.96%)
Metabolic, Nutritional And Blood Ga...	813 (.82%)
Body Temperature Conditions	789 (.79%)
Acid-base	787 (.79%)
Deliria	774 (.78%)
Lower Respiratory Tract Disorders	727 (.73%)
Gastrointestinal Motility And Defec...	660 (.66%)
Toxicology And Therapeutic Drug Mon...	618 (.62%)
Electrolyte And Fluid Balance Condi...	616 (.62%)
Anxiety Disorders	602 (.6%)
Renal And Urinary Tract Investigati...	576 (.58%)
Muscle	573 (.58%)
Seizures	540 (.54%)
Gastrointestinal Hemorrhages	538 (.54%)
Water, Electrolyte And Mineral	525 (.53%)
Urinary Tract Signs	523 (.53%)
Enzyme	510 (.51%)
Musculoskeletal And Connective Tiss...	498 (.5%)
Physical Examination Topics	495 (.5%)
Encephalopathies	489 (.49%)
Headaches	483 (.48%)
Lifestyle Issues	482 (.48%)
Movement Disorders	472 (.47%)
Allergic Conditions	459 (.46%)
White Blood Cell	441 (.44%)
Disturbances In Thinking	396 (.4%)
Product Quality Issues	394 (.4%)
Coagulopathies And Bleeding Diathes...	374 (.38%)
Appetite And General Nutritional	364 (.37%)
Bacterial Infectious	351 (.35%)
Central Nervous System Vascular	339 (.34%)
Sleep Disorders	338 (.34%)
Anemias Nonhemolytic And Marrow Dep...	335 (.34%)
Ocular Neuromuscular	326 (.33%)
Skin Appendage Conditions	324 (.33%)
Angiedema And Urticaria	322 (.32%)
Mental Impairment	304 (.31%)
Platelet	302 (.3%)
Joint	297 (.3%)
Procedural And Device Related Injur...	283 (.28%)
Oral Soft Tissue Conditions	279 (.28%)
Depressed Mood Disorders	260 (.26%)
Vascular Hypertensive	259 (.26%)
Bronchial Disorders	237 (.24%)
Glucose Metabolism Disorders	231 (.23%)
Increased Intracranial Pressure And...	231 (.23%)
Gastrointestinal Ulceration And Per...	224 (.22%)
Vascular	220 (.22%)
Protein And Chemistry Analyses	219 (.22%)
Exocrine Pancreas Conditions	217 (.22%)
Vision	214 (.21%)
Hematological And Lymphoid Tissue T...	213 (.21%)
Upper Respiratory Tract Disorders	197 (.2%)
Personality Disorders	194 (.19%)
Gastrointestinal Inflammatory Condi...	191 (.19%)
Bone And Joint Injuries	190 (.19%)
Viral Infectious	188 (.19%)
Skin Vascular Abnormalities	187 (.19%)
Mood Disorders	175 (.18%)
Therapeutic Procedures And Supporti...	164 (.16%)
Fungal Infectious	162 (.16%)
Neuromuscular	157 (.16%)
Psychiatric And Behavioural Symptom...	157 (.16%)
Gastrointestinal Conditions	153 (.15%)
Ocular Infections, Irritations And ...	140 (.14%)
Nephropathies	139 (.14%)
Heart Failures	138 (.14%)
Abortions And Stillbirth	136 (.14%)
Pleural	127 (.13%)
Changes In Physical Activity	125 (.13%)
Inner Ear And Viiith Cranial Nerve	125 (.13%)
Musculoskeletal And Connective Tiss...	122 (.12%)
Myocardial	120 (.12%)
Vascular Hemorrhagic	120 (.12%)
Gastrointestinal	117 (.12%)
Tissue	117 (.12%)
Hepatobiliary Therapeutic Procedure...	108 (.11%)
Eye	106 (.11%)
Embolism And Thrombosis	103 (.1%)
Arteriosclerosis, Stenosis, Vascula...	101 (.1%)
Bone Disorders	97 (.1%)

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This graph shows the top categories of adverse events submitted to the FDA for Acetaminophen, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Acetaminophen is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.