TRAMADOL

Tramadol Adverse Events Reported to the FDA Over Time

How are Tramadol adverse event reports trending over time?

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

Most Common Tramadol Adverse Events Reported to the FDA

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

Convulsion	956 (1.95%)
Drug Interaction	932 (1.9%)
Completed Suicide	808 (1.65%)
Nausea	806 (1.65%)
Vomiting	735 (1.5%)
Dizziness	663 (1.36%)
Confusional State	645 (1.32%)
Somnolence	628 (1.28%)
Overdose	625 (1.28%)
Serotonin Syndrome	443 (.91%)
Drug Ineffective	439 (.9%)
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Loss Of Consciousness	428 (.87%)
Fall	426 (.87%)
Headache	411 (.84%)
Dyspnoea	402 (.82%)
Drug Toxicity	401 (.82%)
Hyperhidrosis	385 (.79%)
Pain	370 (.76%)
Death	356 (.73%)
Cardiac Arrest	349 (.71%)
Multiple Drug Overdose	335 (.68%)
Suicide Attempt	326 (.67%)
Hallucination	319 (.65%)
Tachycardia	319 (.65%)
Insomnia	318 (.65%)
Tremor	315 (.64%)
Cardio-respiratory Arrest	312 (.64%)
Hypotension	308 (.63%)
Respiratory Arrest	301 (.62%)
Asthenia	282 (.58%)
Malaise	281 (.57%)
Fatigue	278 (.57%)
Drug Abuser	271 (.55%)
Agitation	270 (.55%)
Constipation	268 (.55%)
Intentional Overdose	261 (.53%)
Drug Withdrawal Syndrome	257 (.53%)
Drug Abuse	256 (.52%)
Anxiety	240 (.49%)
Pyrexia	239 (.49%)
Coma	234 (.48%)
Drug Dependence	228 (.47%)
Grand Mal Convulsion	225 (.46%)
Feeling Abnormal	220 (.45%)
Depression	219 (.45%)
Depressed Level Of Consciousness	212 (.43%)
Renal Failure Acute	206 (.42%)
Diarrhoea	201 (.41%)
Unresponsive To Stimuli	199 (.41%)
Hypertension	197 (.4%)
Respiratory Depression	193 (.39%)
Multiple Drug Overdose Intentional	192 (.39%)
Delirium	191 (.39%)
Withdrawal Syndrome	188 (.38%)
Abdominal Pain	186 (.38%)
Disorientation	183 (.37%)
Intentional Drug Misuse	177 (.36%)
Hyponatraemia	174 (.36%)
Hypoglycaemia	172 (.35%)
Pruritus	172 (.35%)
Suicidal Ideation	165 (.34%)
Back Pain	160 (.33%)
Condition Aggravated	153 (.31%)
Chest Pain	149 (.3%)
Syncope	143 (.29%)
Weight Decreased	143 (.29%)
Bradycardia	142 (.29%)
Dehydration	137 (.28%)
Arthralgia	132 (.27%)
Heart Rate Increased	132 (.27%)
Decreased Appetite	130 (.27%)
Rhabdomyolysis	130 (.27%)
Abnormal Behaviour	129 (.26%)
Aggression	129 (.26%)
Gait Disturbance	129 (.26%)
Hallucination, Visual	129 (.26%)
Pneumonia	129 (.26%)
Dyskinesia	126 (.26%)
Rash	125 (.26%)
Myoclonus	124 (.25%)
Muscle Spasms	123 (.25%)
Drug Exposure During Pregnancy	122 (.25%)
Pain In Extremity	118 (.24%)
Speech Disorder	118 (.24%)
Oedema Peripheral	117 (.24%)
Renal Failure	115 (.24%)
International Normalised Ratio Incr...	114 (.23%)
Psychotic Disorder	114 (.23%)
Road Traffic Accident	114 (.23%)
Amnesia	113 (.23%)
Myocardial Infarction	111 (.23%)
Palpitations	111 (.23%)
Dysarthria	110 (.22%)
Medication Error	107 (.22%)
Miosis	107 (.22%)
Vision Blurred	107 (.22%)
Blood Pressure Increased	104 (.21%)
Lethargy	104 (.21%)
Abdominal Pain Upper	102 (.21%)
Cytolytic Hepatitis	102 (.21%)
Hallucination, Auditory	101 (.21%)

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

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

Neurological	4134 (8.45%)
Gastrointestinal Signs	2258 (4.62%)
Medication Errors	2096 (4.28%)
Therapeutic And Nontherapeutic Effe...	2009 (4.11%)
Respiratory	1713 (3.5%)
Cardiac Arrhythmias	1458 (2.98%)
Seizures	1360 (2.78%)
Suicidal And Self-injurious Behavio...	1353 (2.77%)
Epidermal And Dermal Conditions	1125 (2.3%)
Psychiatric	1047 (2.14%)
Deliria	1021 (2.09%)
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Injuries	938 (1.92%)
Movement Disorders	794 (1.62%)
Chemical Injury And Poisoning	751 (1.53%)
Disturbances In Thinking	745 (1.52%)
Muscle	678 (1.39%)
Anxiety Disorders	654 (1.34%)
Infections - Pathogen Unspecified	654 (1.34%)
Cardiac And Vascular Investigations	601 (1.23%)
Hepatic And Hepatobiliary	592 (1.21%)
Neuromuscular	586 (1.2%)
Gastrointestinal Motility And Defec...	581 (1.19%)
Sleep Disorders	569 (1.16%)
Musculoskeletal And Connective Tiss...	541 (1.11%)
Skin Appendage Conditions	507 (1.04%)
Lifestyle Issues	495 (1.01%)
Decreased And Nonspecific Blood Pre...	483 (.99%)
Hematology Investigations	475 (.97%)
Headaches	474 (.97%)
Renal Disorders	449 (.92%)
Electrolyte And Fluid Balance Condi...	441 (.9%)
Fatal Outcomes	434 (.89%)
Hepatobiliary	401 (.82%)
Urinary Tract Signs	396 (.81%)
Joint	381 (.78%)
Mental Impairment	378 (.77%)
Lower Respiratory Tract Disorders	344 (.7%)
Physical Examination Topics	337 (.69%)
Body Temperature Conditions	301 (.62%)
Vision	300 (.61%)
Ocular Neuromuscular	292 (.6%)
Cardiac Disorder Signs	288 (.59%)
Depressed Mood Disorders	278 (.57%)
Appetite And General Nutritional	268 (.55%)
Allergic Conditions	265 (.54%)
Bone And Joint Injuries	258 (.53%)
Toxicology And Therapeutic Drug Mon...	251 (.51%)
Personality Disorders	249 (.51%)
Glucose Metabolism Disorders	245 (.5%)
Gastrointestinal Hemorrhages	243 (.5%)
Mood Disorders	243 (.5%)
Central Nervous System Vascular	242 (.49%)
Metabolic, Nutritional And Blood Ga...	234 (.48%)
Coronary Artery	224 (.46%)
Water, Electrolyte And Mineral	221 (.45%)
Vascular Hypertensive	211 (.43%)
White Blood Cell	209 (.43%)
Renal And Urinary Tract Investigati...	185 (.38%)
Enzyme	180 (.37%)
Anemias Nonhemolytic And Marrow Dep...	167 (.34%)
Vascular	154 (.31%)
Procedural And Device Related Injur...	150 (.31%)
Schizophrenia And Other Psychotic	149 (.3%)
Therapeutic Procedures And Supporti...	143 (.29%)
Changes In Physical Activity	136 (.28%)
Psychiatric And Behavioural Symptom...	135 (.28%)
Gastrointestinal Ulceration And Per...	134 (.27%)
Oral Soft Tissue Conditions	134 (.27%)
Bronchial Disorders	130 (.27%)
Heart Failures	129 (.26%)
Hypothalamus And Pituitary Gland	129 (.26%)
Inner Ear And Viiith Cranial Nerve	129 (.26%)
Acid-base	127 (.26%)
Angiedema And Urticaria	126 (.26%)
Tongue Conditions	124 (.25%)
Bacterial Infectious	107 (.22%)
Platelet	101 (.21%)
Upper Respiratory Tract Disorders	101 (.21%)
Gastrointestinal Inflammatory Condi...	98 (.2%)
Vascular Hemorrhagic	97 (.2%)
Encephalopathies	96 (.2%)
Salivary Gland Conditions	96 (.2%)
Gastrointestinal Stenosis And Obstr...	95 (.19%)
Myocardial	93 (.19%)
Product Quality Issues	93 (.19%)
Skin Vascular Abnormalities	89 (.18%)
Eye	87 (.18%)
Protein And Chemistry Analyses	87 (.18%)
Bone Disorders	82 (.17%)
Pulmonary Vascular	80 (.16%)
Gastrointestinal Conditions	79 (.16%)
Musculoskeletal And Connective Tiss...	77 (.16%)
Arteriosclerosis, Stenosis, Vascula...	76 (.16%)
Exocrine Pancreas Conditions	71 (.15%)
Legal Issues	67 (.14%)
Embolism And Thrombosis	66 (.13%)
Viral Infectious	57 (.12%)
Manic And Bipolar Mood Disorders	55 (.11%)
Neurological, Special Senses And Ps...	55 (.11%)
Cranial Nerve Disorders	54 (.11%)
Peripheral Neuropathies	52 (.11%)

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