ACETAMINOPHEN AND TRAMADOL

Acetaminophen And Tramadol Adverse Events Reported to the FDA Over Time

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

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

Most Common Acetaminophen And Tramadol Adverse Events Reported to the FDA

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

Nausea	124 (2.82%)
Drug Interaction	95 (2.16%)
Somnolence	87 (1.98%)
Vomiting	86 (1.95%)
Dizziness	85 (1.93%)
Loss Of Consciousness	84 (1.91%)
Fall	76 (1.73%)
Malaise	57 (1.29%)
Confusional State	56 (1.27%)
Dyspnoea	55 (1.25%)
Multiple Drug Overdose Intentional	52 (1.18%)
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Hyperhidrosis	43 (.98%)
Completed Suicide	42 (.95%)
Renal Failure Acute	41 (.93%)
Constipation	38 (.86%)
Pyrexia	38 (.86%)
Rhabdomyolysis	38 (.86%)
Drug Ineffective	35 (.79%)
Bradycardia	34 (.77%)
Withdrawal Syndrome	34 (.77%)
Convulsion	29 (.66%)
Headache	29 (.66%)
Suicide Attempt	29 (.66%)
Depressed Level Of Consciousness	28 (.64%)
Overdose	28 (.64%)
Abnormal Behaviour	27 (.61%)
Cytolytic Hepatitis	27 (.61%)
Syncope	27 (.61%)
Decreased Appetite	26 (.59%)
Coma	25 (.57%)
Hyponatraemia	25 (.57%)
Drug Eruption	24 (.54%)
Fatigue	24 (.54%)
Gastric Ulcer	24 (.54%)
Inadequate Analgesia	24 (.54%)
Feeling Abnormal	23 (.52%)
Asthenia	22 (.5%)
Hypoglycaemia	22 (.5%)
Pain	22 (.5%)
Vertigo	20 (.45%)
Gastritis	19 (.43%)
Hallucination	19 (.43%)
Urinary Retention	19 (.43%)
Agranulocytosis	18 (.41%)
Intentional Overdose	18 (.41%)
Multiple Drug Overdose	18 (.41%)
Palpitations	18 (.41%)
Pollakiuria	18 (.41%)
Respiratory Acidosis	18 (.41%)
Alanine Aminotransferase Increased	17 (.39%)
Aspartate Aminotransferase Increase...	17 (.39%)
Insomnia	17 (.39%)
Liver Function Test Abnormal	17 (.39%)
Altered State Of Consciousness	16 (.36%)
Hypokalaemia	16 (.36%)
Hypotension	16 (.36%)
Liver Injury	16 (.36%)
Tremor	16 (.36%)
Cardiac Arrest	15 (.34%)
Chest Discomfort	15 (.34%)
Death	15 (.34%)
Disorientation	15 (.34%)
Dysuria	15 (.34%)
Renal Failure	15 (.34%)
Speech Disorder	15 (.34%)
Visual Acuity Reduced	15 (.34%)
Anxiety	14 (.32%)
Delirium	14 (.32%)
Dyskinesia	14 (.32%)
Hepatitis	14 (.32%)
International Normalised Ratio Incr...	14 (.32%)
Miosis	14 (.32%)
Pruritus	14 (.32%)
Tachycardia	14 (.32%)
Abdominal Discomfort	13 (.3%)
Agitation	13 (.3%)
Drug Prescribing Error	13 (.3%)
Haemorrhage Subcutaneous	13 (.3%)
Hospitalisation	13 (.3%)
Incorrect Dose Administered	13 (.3%)
Anaphylactic Reaction	12 (.27%)
Bradypnoea	12 (.27%)
Dementia	12 (.27%)
Drug Level Increased	12 (.27%)
Hot Flush	12 (.27%)
Myoclonus	12 (.27%)
Pneumonia	12 (.27%)
Serotonin Syndrome	12 (.27%)
Visual Impairment	12 (.27%)
Abdominal Pain	11 (.25%)
Acute Respiratory Failure	11 (.25%)
Anaemia	11 (.25%)
Arthralgia	11 (.25%)
Cholestasis	11 (.25%)
Diarrhoea	11 (.25%)
Drug Dependence	11 (.25%)
Drug Toxicity	11 (.25%)
Gamma-glutamyltransferase Increased	11 (.25%)
Hyperglycaemia	11 (.25%)
Hypertension	11 (.25%)
Muscle Rigidity	11 (.25%)

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

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

Neurological	468 (10.63%)
Gastrointestinal Signs	260 (5.9%)
Therapeutic And Nontherapeutic Effe...	175 (3.97%)
Respiratory	163 (3.7%)
Medication Errors	159 (3.61%)
Epidermal And Dermal Conditions	134 (3.04%)
Hepatic And Hepatobiliary	111 (2.52%)
Cardiac Arrhythmias	107 (2.43%)
Injuries	102 (2.32%)
Deliria	85 (1.93%)
Hepatobiliary	79 (1.79%)
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Suicidal And Self-injurious Behavio...	77 (1.75%)
Urinary Tract Signs	77 (1.75%)
Renal Disorders	69 (1.57%)
Hematology Investigations	67 (1.52%)
Psychiatric	67 (1.52%)
Muscle	62 (1.41%)
Electrolyte And Fluid Balance Condi...	61 (1.39%)
Infections - Pathogen Unspecified	58 (1.32%)
Movement Disorders	55 (1.25%)
Gastrointestinal Motility And Defec...	53 (1.2%)
Skin Appendage Conditions	50 (1.14%)
Body Temperature Conditions	48 (1.09%)
Cardiac And Vascular Investigations	47 (1.07%)
Disturbances In Thinking	44 (1%)
Mental Impairment	44 (1%)
Glucose Metabolism Disorders	43 (.98%)
Seizures	43 (.98%)
Vision	43 (.98%)
White Blood Cell	43 (.98%)
Anxiety Disorders	41 (.93%)
Gastrointestinal Ulceration And Per...	35 (.79%)
Headaches	33 (.75%)
Chemical Injury And Poisoning	32 (.73%)
Gastrointestinal Hemorrhages	32 (.73%)
Gastrointestinal Inflammatory Condi...	30 (.68%)
Bone And Joint Injuries	29 (.66%)
Allergic Conditions	28 (.64%)
Appetite And General Nutritional	28 (.64%)
Neuromuscular	28 (.64%)
Ocular Neuromuscular	28 (.64%)
Oral Soft Tissue Conditions	28 (.64%)
Decreased And Nonspecific Blood Pre...	27 (.61%)
Psychiatric And Behavioural Symptom...	27 (.61%)
Vascular	26 (.59%)
Cardiac Disorder Signs	25 (.57%)
Musculoskeletal And Connective Tiss...	25 (.57%)
Procedural And Device Related Injur...	25 (.57%)
Anemias Nonhemolytic And Marrow Dep...	24 (.54%)
Inner Ear And Viiith Cranial Nerve	24 (.54%)
Physical Examination Topics	24 (.54%)
Lower Respiratory Tract Disorders	23 (.52%)
Sleep Disorders	23 (.52%)
Therapeutic Procedures And Supporti...	23 (.52%)
Lifestyle Issues	22 (.5%)
Renal And Urinary Tract Investigati...	22 (.5%)
Skin Vascular Abnormalities	22 (.5%)
Water, Electrolyte And Mineral	22 (.5%)
Toxicology And Therapeutic Drug Mon...	21 (.48%)
Joint	20 (.45%)
Fatal Outcomes	18 (.41%)
Exocrine Pancreas Conditions	17 (.39%)
Bacterial Infectious	16 (.36%)
Coronary Artery	16 (.36%)
Depressed Mood Disorders	16 (.36%)
Central Nervous System Vascular	15 (.34%)
Gastrointestinal Neoplasms Malignan...	15 (.34%)
Gastrointestinal Conditions	14 (.32%)
Enzyme	13 (.3%)
Salivary Gland Conditions	13 (.3%)
Tongue Conditions	13 (.3%)
Angiedema And Urticaria	12 (.27%)
Gastrointestinal Stenosis And Obstr...	12 (.27%)
Vascular Hypertensive	12 (.27%)
Bone Disorders	11 (.25%)
Bronchial Disorders	10 (.23%)
Metabolic, Nutritional And Blood Ga...	10 (.23%)
Protein And Chemistry Analyses	10 (.23%)
Encephalopathies	9 (.2%)
Mood Disorders	9 (.2%)
Ocular Infections, Irritations And ...	9 (.2%)
Hypothalamus And Pituitary Gland	8 (.18%)
Platelet	8 (.18%)
Vascular Hemorrhagic	8 (.18%)
Nephropathies	7 (.16%)
Personality Disorders	7 (.16%)
Upper Respiratory Tract Disorders	7 (.16%)
Musculoskeletal And Connective Tiss...	6 (.14%)
Schizophrenia And Other Psychotic	6 (.14%)
Bladder And Bladder Neck Disorders	5 (.11%)
Changes In Physical Activity	5 (.11%)
Gallbladder	5 (.11%)
Pleural	5 (.11%)
Adjustment Disorders	4 (.09%)
Communication Disorders	4 (.09%)
Cranial Nerve Disorders	4 (.09%)
Eye	4 (.09%)
Heart Failures	4 (.09%)
Thyroid Gland	4 (.09%)
Arteriosclerosis, Stenosis, Vascula...	3 (.07%)
Aural	3 (.07%)

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This graph shows the top categories of adverse events submitted to the FDA for Acetaminophen And Tramadol, 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 And Tramadol 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.