ORAMORPH SR

Oramorph Sr Adverse Events Reported to the FDA Over Time

How are Oramorph Sr adverse event reports trending over time?

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

Most Common Oramorph Sr Adverse Events Reported to the FDA

What are the most common Oramorph Sr adverse events reported to the FDA?

Abdominal Pain	30 (4.45%)
Cardio-respiratory Arrest	26 (3.86%)
Death	18 (2.67%)
Respiratory Arrest	18 (2.67%)
Drug Toxicity	15 (2.23%)
Pain	15 (2.23%)
Completed Suicide	14 (2.08%)
Constipation	14 (2.08%)
Multiple Drug Overdose	14 (2.08%)
Drug Withdrawal Syndrome	12 (1.78%)
Fatigue	11 (1.63%)
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Cardiac Arrest	10 (1.48%)
Confusional State	10 (1.48%)
Dyspnoea	10 (1.48%)
Renal Failure Acute	9 (1.34%)
Respiratory Depression	9 (1.34%)
Drug Ineffective	8 (1.19%)
Overdose	8 (1.19%)
Circulatory Collapse	7 (1.04%)
Diarrhoea	7 (1.04%)
Miosis	7 (1.04%)
Somnolence	7 (1.04%)
Vomiting	7 (1.04%)
Drug Abuse	6 (.89%)
Feeling Abnormal	6 (.89%)
Hyperhidrosis	6 (.89%)
Hypotension	6 (.89%)
Depressed Level Of Consciousness	5 (.74%)
Depression	5 (.74%)
Drug Interaction	5 (.74%)
Emotional Distress	5 (.74%)
Hallucination	5 (.74%)
Intentional Drug Misuse	5 (.74%)
Intestinal Obstruction	5 (.74%)
Lethargy	5 (.74%)
Narcotic Intoxication	5 (.74%)
Nausea	5 (.74%)
Sedation	5 (.74%)
Swollen Tongue	5 (.74%)
Wrong Technique In Drug Usage Proce...	5 (.74%)
Anxiety	4 (.59%)
Blood Alkaline Phosphatase Increase...	4 (.59%)
Breath Sounds Abnormal	4 (.59%)
Condition Aggravated	4 (.59%)
Dizziness	4 (.59%)
Hepatitis	4 (.59%)
Hyperaesthesia	4 (.59%)
Inadequate Analgesia	4 (.59%)
Memory Impairment	4 (.59%)
Procedural Pain	4 (.59%)
Rash	4 (.59%)
Rash Pruritic	4 (.59%)
Renal Failure Chronic	4 (.59%)
Tachycardia	4 (.59%)
Urine Output Decreased	4 (.59%)
White Blood Cell Count Increased	4 (.59%)
Accidental Death	3 (.45%)
Agitation	3 (.45%)
Aspartate Aminotransferase Increase...	3 (.45%)
C-reactive Protein Decreased	3 (.45%)
Drug Administration Error	3 (.45%)
Hospitalisation	3 (.45%)
Insomnia	3 (.45%)
Medication Error	3 (.45%)
Musculoskeletal Stiffness	3 (.45%)
Myoclonus	3 (.45%)
Oedema	3 (.45%)
Oedema Peripheral	3 (.45%)
Oxygen Saturation Decreased	3 (.45%)
Pain In Extremity	3 (.45%)
Product Quality Issue	3 (.45%)
Purulent Discharge	3 (.45%)
Respiratory Acidosis	3 (.45%)
Sickle Cell Anaemia	3 (.45%)
Tremor	3 (.45%)
Unresponsive To Stimuli	3 (.45%)
Abdominal Pain Upper	2 (.3%)
Accidental Overdose	2 (.3%)
Anaemia	2 (.3%)
Bone Pain	2 (.3%)
Bradypnoea	2 (.3%)
C-reactive Protein Increased	2 (.3%)
Convulsion	2 (.3%)
Cytolytic Hepatitis	2 (.3%)
Dehydration	2 (.3%)
Erythema	2 (.3%)
Febrile Bone Marrow Aplasia	2 (.3%)
Gamma-glutamyltransferase Increased	2 (.3%)
Gastric Infection	2 (.3%)
Headache	2 (.3%)
Hyponatraemia	2 (.3%)
Infected Skin Ulcer	2 (.3%)
Joint Arthroplasty	2 (.3%)
Mucosal Inflammation	2 (.3%)
Muscle Spasms	2 (.3%)
Oral Pain	2 (.3%)
Pleural Effusion	2 (.3%)
Pollakiuria	2 (.3%)
Pruritus	2 (.3%)
Renal Failure	2 (.3%)
Sepsis	2 (.3%)

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

What are the most common Oramorph Sr adverse events reported to the FDA?

Respiratory	47 (6.97%)
Gastrointestinal Signs	46 (6.82%)
Medication Errors	43 (6.38%)
Cardiac Arrhythmias	40 (5.93%)
Neurological	39 (5.79%)
Therapeutic And Nontherapeutic Effe...	31 (4.6%)
Gastrointestinal Motility And Defec...	22 (3.26%)
Chemical Injury And Poisoning	21 (3.12%)
Fatal Outcomes	21 (3.12%)
Epidermal And Dermal Conditions	19 (2.82%)
Renal Disorders	18 (2.67%)
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Suicidal And Self-injurious Behavio...	15 (2.23%)
Infections - Pathogen Unspecified	14 (2.08%)
Psychiatric	14 (2.08%)
Decreased And Nonspecific Blood Pre...	13 (1.93%)
Deliria	12 (1.78%)
Procedural And Device Related Injur...	11 (1.63%)
Anxiety Disorders	8 (1.19%)
Gastrointestinal Stenosis And Obstr...	7 (1.04%)
Hepatic And Hepatobiliary	7 (1.04%)
Hepatobiliary	7 (1.04%)
Mental Impairment	7 (1.04%)
Musculoskeletal And Connective Tiss...	7 (1.04%)
Ocular Neuromuscular	7 (1.04%)
Protein And Chemistry Analyses	6 (.89%)
Skin Appendage Conditions	6 (.89%)
Depressed Mood Disorders	5 (.74%)
Disturbances In Thinking	5 (.74%)
Hematology Investigations	5 (.74%)
Mood Disorders	5 (.74%)
Movement Disorders	5 (.74%)
Physical Examination Topics	5 (.74%)
Tongue Conditions	5 (.74%)
Anemias Nonhemolytic And Marrow Dep...	4 (.59%)
Electrolyte And Fluid Balance Condi...	4 (.59%)
Enzyme	4 (.59%)
Metabolic, Nutritional And Blood Ga...	4 (.59%)
Product Quality Issues	4 (.59%)
Renal And Urinary Tract Investigati...	4 (.59%)
Therapeutic Procedures And Supporti...	4 (.59%)
Allergic Conditions	3 (.45%)
Blood And Lymphatic System Disorder...	3 (.45%)
Gastrointestinal Ulceration And Per...	3 (.45%)
Seizures	3 (.45%)
Sleep Disorders	3 (.45%)
Urinary Tract Signs	3 (.45%)
Administration Site Reactions	2 (.3%)
Bacterial Infectious	2 (.3%)
Bile Duct	2 (.3%)
Bone And Joint Therapeutic Procedur...	2 (.3%)
Bone Disorders	2 (.3%)
Cardiac And Vascular Investigations	2 (.3%)
Cardiac Disorder Signs	2 (.3%)
Central Nervous System Vascular	2 (.3%)
Gastrointestinal Hemorrhages	2 (.3%)
Headaches	2 (.3%)
Injuries	2 (.3%)
Lower Respiratory Tract Disorders	2 (.3%)
Metastases	2 (.3%)
Muscle	2 (.3%)
Neuromuscular	2 (.3%)
Oral Soft Tissue Conditions	2 (.3%)
Pleural	2 (.3%)
Sleep Disturbances	2 (.3%)
Appetite And General Nutritional	1 (.15%)
Bladder And Bladder Neck Disorders	1 (.15%)
Body Temperature Conditions	1 (.15%)
Bronchial Disorders	1 (.15%)
Exocrine Pancreas Conditions	1 (.15%)
Fungal Infectious	1 (.15%)
Gastrointestinal Conditions	1 (.15%)
Hearing	1 (.15%)
Hematological And Lymphoid Tissue T...	1 (.15%)
Increased Intracranial Pressure And...	1 (.15%)
Joint	1 (.15%)
Lifestyle Issues	1 (.15%)
Miscellaneous And Site Unspecified ...	1 (.15%)
Peritoneal And Retroperitoneal Cond...	1 (.15%)
Psychiatric And Behavioural Symptom...	1 (.15%)
Renal And Urinary Tract Neoplasms M...	1 (.15%)
Respiratory And Mediastinal Neoplas...	1 (.15%)
Upper Respiratory Tract Disorders	1 (.15%)
Vascular	1 (.15%)
Vascular Hypertensive	1 (.15%)
Vulvovaginal Disorders	1 (.15%)

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