OPANA ER

Opana Er Adverse Events Reported to the FDA Over Time

How are Opana Er adverse event reports trending over time?

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

Most Common Opana Er Adverse Events Reported to the FDA

What are the most common Opana Er adverse events reported to the FDA?

Drug Abuse	223 (6.14%)
Drug Ineffective	211 (5.81%)
Intentional Drug Misuse	158 (4.35%)
Wrong Technique In Drug Usage Proce...	122 (3.36%)
Drug Effect Decreased	76 (2.09%)
Incorrect Route Of Drug Administrat...	74 (2.04%)
Inappropriate Schedule Of Drug Admi...	73 (2.01%)
Nausea	70 (1.93%)
Overdose	68 (1.87%)
Withdrawal Syndrome	66 (1.82%)
Drug Toxicity	53 (1.46%)
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Vomiting	53 (1.46%)
Drug Diversion	51 (1.4%)
Drug Dependence	46 (1.27%)
Medication Residue	46 (1.27%)
Death	42 (1.16%)
Headache	40 (1.1%)
Malaise	35 (.96%)
Unresponsive To Stimuli	34 (.94%)
Diarrhoea	33 (.91%)
Drug Screen Positive	30 (.83%)
Drug Withdrawal Syndrome	30 (.83%)
Constipation	28 (.77%)
Dizziness	27 (.74%)
Drug Dispensing Error	27 (.74%)
Feeling Abnormal	27 (.74%)
Loss Of Consciousness	27 (.74%)
Abdominal Discomfort	26 (.72%)
Abdominal Pain Upper	26 (.72%)
Accidental Death	26 (.72%)
Confusional State	25 (.69%)
Pain	25 (.69%)
Drug Screen Negative	24 (.66%)
Insomnia	22 (.61%)
Accidental Overdose	21 (.58%)
Convulsion	21 (.58%)
Inadequate Analgesia	20 (.55%)
Dyspnoea	19 (.52%)
Chest Pain	17 (.47%)
Dysphagia	17 (.47%)
Road Traffic Accident	17 (.47%)
Somnolence	16 (.44%)
Contusion	15 (.41%)
Hyperhidrosis	15 (.41%)
Abdominal Pain	14 (.39%)
Depression	14 (.39%)
Incorrect Dose Administered	14 (.39%)
Pulmonary Congestion	14 (.39%)
Pulmonary Oedema	14 (.39%)
Euphoric Mood	13 (.36%)
Drug Effect Delayed	12 (.33%)
Drug Interaction	12 (.33%)
Oedema Peripheral	12 (.33%)
Agitation	11 (.3%)
Anxiety	11 (.3%)
Cardiac Arrest	11 (.3%)
Facial Bones Fracture	11 (.3%)
Hypoaesthesia	11 (.3%)
Intestinal Obstruction	11 (.3%)
Periorbital Haematoma	11 (.3%)
Urticaria	11 (.3%)
Asthenia	10 (.28%)
Disorientation	10 (.28%)
Fall	10 (.28%)
Fatigue	10 (.28%)
Hallucination	10 (.28%)
Medication Error	10 (.28%)
Product Formulation Issue	10 (.28%)
Pruritus	10 (.28%)
Self-medication	10 (.28%)
Skin Laceration	10 (.28%)
Suicidal Ideation	10 (.28%)
Chest Discomfort	9 (.25%)
Completed Suicide	9 (.25%)
Condition Aggravated	9 (.25%)
Dehydration	9 (.25%)
Haemoptysis	9 (.25%)
Migraine	9 (.25%)
Multiple Drug Overdose	9 (.25%)
Pain In Extremity	9 (.25%)
Palpitations	9 (.25%)
Tremor	9 (.25%)
Abnormal Behaviour	8 (.22%)
Blood Pressure Increased	8 (.22%)
Cardiac Failure Congestive	8 (.22%)
Hepatic Congestion	8 (.22%)
Hypersensitivity	8 (.22%)
Prescription Form Tampering	8 (.22%)
Therapeutic Response Decreased	8 (.22%)
Tinnitus	8 (.22%)
Treatment Noncompliance	8 (.22%)
Alcohol Poisoning	7 (.19%)
Anger	7 (.19%)
Breakthrough Pain	7 (.19%)
Drug Abuser	7 (.19%)
Dyspepsia	7 (.19%)
Epistaxis	7 (.19%)
Hepatic Steatosis	7 (.19%)
Nervousness	7 (.19%)
No Therapeutic Response	7 (.19%)
Pneumonia	7 (.19%)

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

What are the most common Opana Er adverse events reported to the FDA?

Psychiatric	503 (13.86%)
Medication Errors	446 (12.29%)
Therapeutic And Nontherapeutic Effe...	375 (10.33%)
Gastrointestinal Signs	232 (6.39%)
Neurological	180 (4.96%)
Injuries	81 (2.23%)
Respiratory	78 (2.15%)
Chemical Injury And Poisoning	76 (2.09%)
Gastrointestinal Motility And Defec...	71 (1.96%)
Product Quality Issues	69 (1.9%)
Fatal Outcomes	68 (1.87%)
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Legal Issues	67 (1.85%)
Toxicology And Therapeutic Drug Mon...	61 (1.68%)
Headaches	49 (1.35%)
Anxiety Disorders	35 (.96%)
Deliria	35 (.96%)
Infections - Pathogen Unspecified	34 (.94%)
Lower Respiratory Tract Disorders	32 (.88%)
Mood Disorders	30 (.83%)
Sleep Disorders	28 (.77%)
Lifestyle Issues	27 (.74%)
Epidermal And Dermal Conditions	26 (.72%)
Suicidal And Self-injurious Behavio...	26 (.72%)
Hepatic And Hepatobiliary	25 (.69%)
Cardiac Arrhythmias	24 (.66%)
Cardiac And Vascular Investigations	23 (.63%)
Disturbances In Thinking	23 (.63%)
Procedural And Device Related Injur...	21 (.58%)
Seizures	21 (.58%)
Depressed Mood Disorders	20 (.55%)
Musculoskeletal And Connective Tiss...	19 (.52%)
Cardiac Disorder Signs	18 (.5%)
Movement Disorders	18 (.5%)
Coronary Artery	17 (.47%)
Upper Respiratory Tract Disorders	17 (.47%)
Muscle	16 (.44%)
Renal Disorders	16 (.44%)
Skin Appendage Conditions	16 (.44%)
Urinary Tract Signs	16 (.44%)
Mental Impairment	15 (.41%)
Bone And Joint Injuries	14 (.39%)
Gastrointestinal Hemorrhages	14 (.39%)
Bronchial Disorders	13 (.36%)
Angiedema And Urticaria	12 (.33%)
Gastrointestinal Stenosis And Obstr...	12 (.33%)
Myocardial	12 (.33%)
Physical Examination Topics	12 (.33%)
Therapeutic Procedures And Supporti...	12 (.33%)
Allergic Conditions	11 (.3%)
Arteriosclerosis, Stenosis, Vascula...	11 (.3%)
Dental And Gingival Conditions	10 (.28%)
Gastrointestinal Conditions	10 (.28%)
Inner Ear And Viiith Cranial Nerve	10 (.28%)
Personality Disorders	10 (.28%)
Appetite And General Nutritional	9 (.25%)
Electrolyte And Fluid Balance Condi...	9 (.25%)
Exocrine Pancreas Conditions	9 (.25%)
Gastrointestinal Ulceration And Per...	9 (.25%)
Joint	9 (.25%)
Vision	9 (.25%)
Heart Failures	8 (.22%)
Psychiatric And Behavioural Symptom...	8 (.22%)
Viral Infectious	8 (.22%)
Fungal Infectious	7 (.19%)
Oral Soft Tissue Conditions	7 (.19%)
Sleep Disturbances	7 (.19%)
Bacterial Infectious	6 (.17%)
Changes In Physical Activity	6 (.17%)
Decreased And Nonspecific Blood Pre...	6 (.17%)
Glucose Metabolism Disorders	6 (.17%)
Increased Intracranial Pressure And...	6 (.17%)
Platelet	6 (.17%)
Body Temperature Conditions	5 (.14%)
Central Nervous System Vascular	5 (.14%)
Hemolyses And Related Conditions	5 (.14%)
Hepatobiliary	5 (.14%)
Spleen, Lymphatic And Reticulendoth...	5 (.14%)
Impulse Control	4 (.11%)
Manic And Bipolar Mood Disorders	4 (.11%)
Neonatal And Perinatal Conditions	4 (.11%)
Ocular Infections, Irritations And ...	4 (.11%)
Renal And Urinary Tract Investigati...	4 (.11%)
Salivary Gland Conditions	4 (.11%)
Sexual Function And Fertility	4 (.11%)
Water, Electrolyte And Mineral	4 (.11%)
White Blood Cell	4 (.11%)
Bone Disorders	3 (.08%)
Investigations, Imaging And Histopa...	3 (.08%)
Metabolic, Nutritional And Blood Ga...	3 (.08%)
Nephropathies	3 (.08%)
Neuromuscular	3 (.08%)
Ocular Neuromuscular	3 (.08%)
Peripheral Neuropathies	3 (.08%)
Peritoneal And Retroperitoneal Cond...	3 (.08%)
Pleural	3 (.08%)
Vascular Hemorrhagic	3 (.08%)
Abortions And Stillbirth	2 (.06%)
Aural	2 (.06%)
Breast	2 (.06%)
Cranial Nerve Disorders	2 (.06%)
Embolism And Thrombosis	2 (.06%)

Share/Embed Graph Export Data

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