OXYCODONE AND ACETAMINOPHEN

Oxycodone And Acetaminophen Adverse Events Reported to the FDA Over Time

How are Oxycodone And Acetaminophen adverse event reports trending over time?

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

Most Common Oxycodone And Acetaminophen Adverse Events Reported to the FDA

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

Completed Suicide	452 (8.36%)
Cardiac Arrest	189 (3.49%)
Respiratory Arrest	185 (3.42%)
Cardio-respiratory Arrest	157 (2.9%)
Drug Ineffective	140 (2.59%)
Death	125 (2.31%)
Drug Toxicity	109 (2.02%)
Multiple Drug Overdose	77 (1.42%)
Intentional Drug Misuse	73 (1.35%)
Drug Abuse	68 (1.26%)
Somnolence	67 (1.24%)
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Confusional State	61 (1.13%)
Poisoning	61 (1.13%)
Nausea	60 (1.11%)
Overdose	56 (1.04%)
Loss Of Consciousness	52 (.96%)
Vomiting	52 (.96%)
Headache	43 (.79%)
Multiple Drug Overdose Intentional	43 (.79%)
Hypotension	40 (.74%)
Agitation	38 (.7%)
Lethargy	37 (.68%)
Coma	36 (.67%)
Mental Status Changes	34 (.63%)
Drug Effect Decreased	33 (.61%)
Dyspnoea	31 (.57%)
Medication Error	31 (.57%)
Pain	30 (.55%)
Feeling Abnormal	29 (.54%)
Incorrect Dose Administered	28 (.52%)
Aspartate Aminotransferase Increase...	26 (.48%)
Depressed Level Of Consciousness	25 (.46%)
Tachycardia	24 (.44%)
Unresponsive To Stimuli	24 (.44%)
Alanine Aminotransferase Increased	23 (.43%)
Drug Abuser	23 (.43%)
Insomnia	23 (.43%)
Malaise	23 (.43%)
Road Traffic Accident	23 (.43%)
Product Substitution Issue	21 (.39%)
Pruritus	21 (.39%)
Delirium	20 (.37%)
Diarrhoea	20 (.37%)
Respiratory Depression	20 (.37%)
Suicide Attempt	20 (.37%)
Accidental Overdose	19 (.35%)
Constipation	19 (.35%)
Contusion	19 (.35%)
Oxygen Saturation Decreased	19 (.35%)
Product Quality Issue	19 (.35%)
Dizziness	18 (.33%)
Drug Interaction	18 (.33%)
Hallucination	18 (.33%)
Drug Screen Positive	17 (.31%)
Heart Rate Increased	17 (.31%)
Rash	17 (.31%)
Withdrawal Syndrome	17 (.31%)
Abdominal Pain	16 (.3%)
Drug Withdrawal Syndrome	16 (.3%)
Miosis	16 (.3%)
Pyrexia	16 (.3%)
Sinus Tachycardia	16 (.3%)
Convulsion	15 (.28%)
Facial Bones Fracture	15 (.28%)
Haemoptysis	15 (.28%)
Hyperhidrosis	15 (.28%)
Hypertension	15 (.28%)
International Normalised Ratio Incr...	15 (.28%)
Periorbital Haematoma	15 (.28%)
Renal Failure	15 (.28%)
Aggression	14 (.26%)
Sedation	14 (.26%)
Blood Potassium Decreased	13 (.24%)
Depression	13 (.24%)
Disorientation	13 (.24%)
Drug Screen Negative	13 (.24%)
Thinking Abnormal	13 (.24%)
Abdominal Discomfort	12 (.22%)
Abdominal Pain Upper	12 (.22%)
Acidosis	12 (.22%)
Drug Administration Error	12 (.22%)
Fall	12 (.22%)
Hypersomnia	12 (.22%)
Myocardial Infarction	12 (.22%)
Pupillary Reflex Impaired	12 (.22%)
Skin Laceration	12 (.22%)
Anger	11 (.2%)
Blood Glucose Increased	11 (.2%)
Delusion	11 (.2%)
Dysarthria	11 (.2%)
Dyskinesia	11 (.2%)
Hepatic Failure	11 (.2%)
Inadequate Analgesia	11 (.2%)
Pruritus Generalised	11 (.2%)
Pulmonary Oedema	11 (.2%)
Urticaria	11 (.2%)
Anxiety	10 (.18%)
Apnoea	10 (.18%)
Blood Pressure Increased	10 (.18%)
Drug Hypersensitivity	10 (.18%)
Electrocardiogram Qt Prolonged	10 (.18%)

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This graph shows the top adverse events submitted to the FDA for Oxycodone And 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 Oxycodone And 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 Oxycodone And Acetaminophen

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

Suicidal And Self-injurious Behavio...	481 (8.89%)
Cardiac Arrhythmias	421 (7.78%)
Neurological	350 (6.47%)
Medication Errors	335 (6.19%)
Respiratory	335 (6.19%)
Therapeutic And Nontherapeutic Effe...	242 (4.47%)
Psychiatric	211 (3.9%)
Chemical Injury And Poisoning	184 (3.4%)
Gastrointestinal Signs	177 (3.27%)
Fatal Outcomes	140 (2.59%)
Injuries	113 (2.09%)
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Deliria	94 (1.74%)
Epidermal And Dermal Conditions	94 (1.74%)
Cardiac And Vascular Investigations	86 (1.59%)
Hepatobiliary	81 (1.5%)
Hematology Investigations	70 (1.29%)
Anxiety Disorders	62 (1.15%)
Metabolic, Nutritional And Blood Ga...	60 (1.11%)
Infections - Pathogen Unspecified	53 (.98%)
Disturbances In Thinking	52 (.96%)
Hepatic And Hepatobiliary	51 (.94%)
Product Quality Issues	51 (.94%)
Toxicology And Therapeutic Drug Mon...	50 (.92%)
Gastrointestinal Motility And Defec...	46 (.85%)
Decreased And Nonspecific Blood Pre...	44 (.81%)
Lifestyle Issues	44 (.81%)
Physical Examination Topics	44 (.81%)
Headaches	43 (.79%)
Water, Electrolyte And Mineral	43 (.79%)
Ocular Neuromuscular	40 (.74%)
Movement Disorders	38 (.7%)
Sleep Disorders	35 (.65%)
Renal Disorders	31 (.57%)
Musculoskeletal And Connective Tiss...	30 (.55%)
Lower Respiratory Tract Disorders	29 (.54%)
Muscle	28 (.52%)
Renal And Urinary Tract Investigati...	28 (.52%)
Procedural And Device Related Injur...	24 (.44%)
Acid-base	23 (.43%)
Body Temperature Conditions	23 (.43%)
Coronary Artery	22 (.41%)
Depressed Mood Disorders	22 (.41%)
Skin Appendage Conditions	22 (.41%)
Bone And Joint Injuries	21 (.39%)
Enzyme	21 (.39%)
Mood Disorders	21 (.39%)
Allergic Conditions	20 (.37%)
Personality Disorders	20 (.37%)
Urinary Tract Signs	20 (.37%)
Mental Impairment	19 (.35%)
Cardiac Disorder Signs	18 (.33%)
Seizures	18 (.33%)
Electrolyte And Fluid Balance Condi...	17 (.31%)
Gastrointestinal Hemorrhages	17 (.31%)
Myocardial	17 (.31%)
Angiedema And Urticaria	15 (.28%)
Vascular Hypertensive	15 (.28%)
Encephalopathies	14 (.26%)
Neuromuscular	14 (.26%)
Appetite And General Nutritional	13 (.24%)
Glucose Metabolism Disorders	13 (.24%)
Sleep Disturbances	12 (.22%)
Vision	12 (.22%)
Increased Intracranial Pressure And...	11 (.2%)
Upper Respiratory Tract Disorders	11 (.2%)
Changes In Physical Activity	10 (.18%)
Inner Ear And Viiith Cranial Nerve	10 (.18%)
Spinal Cord And Nerve Root	10 (.18%)
Vascular	10 (.18%)
Anemias Nonhemolytic And Marrow Dep...	9 (.17%)
Arteriosclerosis, Stenosis, Vascula...	9 (.17%)
Gastrointestinal	9 (.17%)
Gastrointestinal Ulceration And Per...	9 (.17%)
Hematological And Lymphoid Tissue T...	9 (.17%)
Joint	9 (.17%)
Legal Issues	9 (.17%)
Tissue	9 (.17%)
White Blood Cell	9 (.17%)
Coagulopathies And Bleeding Diathes...	8 (.15%)
Embolism And Thrombosis	8 (.15%)
Exocrine Pancreas Conditions	8 (.15%)
Eye	8 (.15%)
Gastrointestinal Stenosis And Obstr...	8 (.15%)
Investigations, Imaging And Histopa...	8 (.15%)
Vascular Hemorrhagic	8 (.15%)
Bacterial Infectious	7 (.13%)
Hearing	7 (.13%)
Oral Soft Tissue Conditions	7 (.13%)
Central Nervous System Vascular	6 (.11%)
Gastrointestinal Conditions	6 (.11%)
Musculoskeletal And Connective Tiss...	6 (.11%)
Protein And Chemistry Analyses	6 (.11%)
Therapeutic Procedures And Supporti...	6 (.11%)
Tongue Conditions	6 (.11%)
Anal And Rectal Conditions	5 (.09%)
Manic And Bipolar Mood Disorders	5 (.09%)
Peritoneal And Retroperitoneal Cond...	5 (.09%)
Reproductive Tract And Breast Disor...	5 (.09%)
Spleen, Lymphatic And Reticulendoth...	5 (.09%)
Structural Brain	5 (.09%)
Fungal Infectious	4 (.07%)

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This graph shows the top categories of adverse events submitted to the FDA for Oxycodone And 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 Oxycodone And 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.