OXYCODONE

Oxycodone Adverse Events Reported to the FDA Over Time

How are Oxycodone adverse event reports trending over time?

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

Most Common Oxycodone Adverse Events Reported to the FDA

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

Drug Dependence	3121 (2.57%)
Pain	2195 (1.81%)
Drug Withdrawal Syndrome	2082 (1.72%)
Drug Abuser	1993 (1.64%)
Completed Suicide	1817 (1.5%)
Nausea	1810 (1.49%)
Death	1769 (1.46%)
Drug Ineffective	1625 (1.34%)
Vomiting	1521 (1.25%)
Depression	1491 (1.23%)
Respiratory Arrest	1462 (1.21%)
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Cardiac Arrest	1396 (1.15%)
Overdose	1311 (1.08%)
Anxiety	1296 (1.07%)
Somnolence	1252 (1.03%)
Constipation	1095 (.9%)
Drug Abuse	1045 (.86%)
Headache	987 (.81%)
Insomnia	967 (.8%)
Confusional State	939 (.77%)
Cardio-respiratory Arrest	876 (.72%)
Suicidal Ideation	858 (.71%)
Multiple Drug Overdose	852 (.7%)
Drug Toxicity	835 (.69%)
Inadequate Analgesia	829 (.68%)
Diarrhoea	817 (.67%)
Dyspnoea	791 (.65%)
Hyperhidrosis	789 (.65%)
Malaise	711 (.59%)
Substance Abuse	689 (.57%)
Back Pain	680 (.56%)
Loss Of Consciousness	668 (.55%)
Intentional Drug Misuse	659 (.54%)
Fatigue	645 (.53%)
Fall	633 (.52%)
Tremor	601 (.5%)
Asthenia	591 (.49%)
Weight Decreased	591 (.49%)
Dizziness	590 (.49%)
Coma	572 (.47%)
Pain In Extremity	568 (.47%)
Drug Effect Decreased	560 (.46%)
Feeling Abnormal	555 (.46%)
Arthralgia	531 (.44%)
Pyrexia	520 (.43%)
Agitation	504 (.42%)
Paranoia	482 (.4%)
Abdominal Pain	481 (.4%)
Condition Aggravated	466 (.38%)
Abdominal Pain Upper	454 (.37%)
Medication Error	452 (.37%)
Accidental Overdose	447 (.37%)
Pneumonia	428 (.35%)
Chest Pain	423 (.35%)
Poisoning	408 (.34%)
Pruritus	401 (.33%)
Lethargy	397 (.33%)
Hallucination	393 (.32%)
Muscle Spasms	392 (.32%)
Drug Interaction	391 (.32%)
Road Traffic Accident	385 (.32%)
Convulsion	380 (.31%)
Decreased Appetite	379 (.31%)
Oedema Peripheral	374 (.31%)
Depressed Level Of Consciousness	373 (.31%)
Hypoaesthesia	365 (.3%)
Dehydration	362 (.3%)
Mental Status Changes	362 (.3%)
Suicide Attempt	362 (.3%)
Amnesia	359 (.3%)
Drug Tolerance	357 (.29%)
Obsessive-compulsive Disorder	357 (.29%)
Hypotension	351 (.29%)
Rash	334 (.28%)
Heart Rate Increased	330 (.27%)
Delusional Disorder, Unspecified Ty...	325 (.27%)
Irritability	320 (.26%)
Memory Impairment	320 (.26%)
Aggression	313 (.26%)
Weight Increased	308 (.25%)
Hypertension	305 (.25%)
Disturbance In Attention	302 (.25%)
Respiratory Depression	296 (.24%)
Chills	295 (.24%)
Nervousness	295 (.24%)
Myocardial Infarction	292 (.24%)
Delirium	290 (.24%)
Euphoric Mood	286 (.24%)
Unresponsive To Stimuli	284 (.23%)
Dysarthria	280 (.23%)
Miosis	274 (.23%)
Gait Disturbance	273 (.23%)
General Physical Health Deteriorati...	272 (.22%)
Mental Disorder	272 (.22%)
Intentional Overdose	266 (.22%)
Injury	263 (.22%)
Abdominal Discomfort	256 (.21%)
Blood Pressure Increased	255 (.21%)
Unevaluable Event	255 (.21%)
Sedation	253 (.21%)
Drug Hypersensitivity	251 (.21%)

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

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

Neurological	7223 (5.96%)
Psychiatric	6644 (5.48%)
Therapeutic And Nontherapeutic Effe...	5835 (4.81%)
Gastrointestinal Signs	5590 (4.61%)
Medication Errors	5058 (4.17%)
Respiratory	4574 (3.77%)
Suicidal And Self-injurious Behavio...	3157 (2.6%)
Cardiac Arrhythmias	3028 (2.5%)
Anxiety Disorders	2996 (2.47%)
Lifestyle Issues	2879 (2.38%)
Injuries	2448 (2.02%)
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Gastrointestinal Motility And Defec...	2223 (1.83%)
Infections - Pathogen Unspecified	2051 (1.69%)
Fatal Outcomes	2045 (1.69%)
Depressed Mood Disorders	2044 (1.69%)
Musculoskeletal And Connective Tiss...	1924 (1.59%)
Epidermal And Dermal Conditions	1803 (1.49%)
Chemical Injury And Poisoning	1678 (1.38%)
Sleep Disorders	1584 (1.31%)
Deliria	1474 (1.22%)
Mood Disorders	1436 (1.18%)
Mental Impairment	1324 (1.09%)
Physical Examination Topics	1317 (1.09%)
Cardiac And Vascular Investigations	1253 (1.03%)
Skin Appendage Conditions	1203 (.99%)
Headaches	1168 (.96%)
Personality Disorders	1150 (.95%)
Muscle	1122 (.93%)
Procedural And Device Related Injur...	1106 (.91%)
Joint	1093 (.9%)
Movement Disorders	1015 (.84%)
Urinary Tract Signs	961 (.79%)
Disturbances In Thinking	882 (.73%)
Appetite And General Nutritional	869 (.72%)
Product Quality Issues	848 (.7%)
Electrolyte And Fluid Balance Condi...	776 (.64%)
Metabolic, Nutritional And Blood Ga...	771 (.64%)
Hepatic And Hepatobiliary	761 (.63%)
Hepatobiliary	750 (.62%)
Lower Respiratory Tract Disorders	746 (.62%)
Hematology Investigations	718 (.59%)
Renal Disorders	715 (.59%)
Bone And Joint Injuries	640 (.53%)
Body Temperature Conditions	577 (.48%)
Therapeutic Procedures And Supporti...	572 (.47%)
Coronary Artery	562 (.46%)
Ocular Neuromuscular	512 (.42%)
Allergic Conditions	488 (.4%)
Dental And Gingival Conditions	484 (.4%)
Toxicology And Therapeutic Drug Mon...	479 (.4%)
Vision	475 (.39%)
Seizures	474 (.39%)
Decreased And Nonspecific Blood Pre...	448 (.37%)
Schizophrenia And Other Psychotic	448 (.37%)
Cardiac Disorder Signs	446 (.37%)
Enzyme	440 (.36%)
Central Nervous System Vascular	425 (.35%)
Water, Electrolyte And Mineral	415 (.34%)
Miscellaneous And Site Unspecified ...	377 (.31%)
Renal And Urinary Tract Investigati...	376 (.31%)
Bronchial Disorders	375 (.31%)
Bacterial Infectious	371 (.31%)
Legal Issues	360 (.3%)
Vascular Hypertensive	326 (.27%)
Gastrointestinal Hemorrhages	318 (.26%)
Myocardial	290 (.24%)
Upper Respiratory Tract Disorders	288 (.24%)
Gastrointestinal Stenosis And Obstr...	287 (.24%)
Psychiatric And Behavioural Symptom...	287 (.24%)
Viral Infectious	281 (.23%)
Vascular	279 (.23%)
Changes In Physical Activity	237 (.2%)
Gastrointestinal Conditions	231 (.19%)
Embolism And Thrombosis	225 (.19%)
Anemias Nonhemolytic And Marrow Dep...	215 (.18%)
Oral Soft Tissue Conditions	215 (.18%)
Bone Disorders	212 (.17%)
Encephalopathies	207 (.17%)
Heart Failures	205 (.17%)
Neuromuscular	200 (.16%)
Salivary Gland Conditions	199 (.16%)
Eye	194 (.16%)
Gastrointestinal Inflammatory Condi...	193 (.16%)
Musculoskeletal And Connective Tiss...	187 (.15%)
Angiedema And Urticaria	186 (.15%)
Respiratory And Mediastinal Neoplas...	179 (.15%)
Inner Ear And Viiith Cranial Nerve	178 (.15%)
Arteriosclerosis, Stenosis, Vascula...	170 (.14%)
Sleep Disturbances	170 (.14%)
Peripheral Neuropathies	168 (.14%)
Gastrointestinal Ulceration And Per...	167 (.14%)
Tissue	162 (.13%)
Spinal Cord And Nerve Root	161 (.13%)
Hearing	160 (.13%)
Sexual Function And Fertility	159 (.13%)
Glucose Metabolism Disorders	158 (.13%)
Pleural	157 (.13%)
Bone And Joint Therapeutic Procedur...	150 (.12%)
Exocrine Pancreas Conditions	136 (.11%)
Menstrual Cycle And Uterine Bleedin...	126 (.1%)
Communication Disorders	125 (.1%)

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