TRAMAL

Adverse Events

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Tramal Adverse Events Reported to the FDA Over Time

How are Tramal adverse event reports trending over time?

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

Most Common Tramal Adverse Events Reported to the FDA

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

Drug Interaction	24 (2.37%)
Somnolence	23 (2.27%)
Drug Ineffective	20 (1.97%)
Nausea	20 (1.97%)
Vomiting	20 (1.97%)
Drug Exposure During Pregnancy	19 (1.87%)
Confusional State	18 (1.78%)
Stevens-johnson Syndrome	15 (1.48%)
Suicide Attempt	15 (1.48%)
Pain	14 (1.38%)
Serotonin Syndrome	13 (1.28%)
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Coma	12 (1.18%)
Tremor	12 (1.18%)
Hypotension	10 (.99%)
Intentional Overdose	10 (.99%)
Respiratory Failure	10 (.99%)
Dizziness	9 (.89%)
Drug Dependence	9 (.89%)
Loss Of Consciousness	9 (.89%)
Overdose	9 (.89%)
Tachycardia	9 (.89%)
Blister	8 (.79%)
Headache	8 (.79%)
Hyperhidrosis	8 (.79%)
Toxic Epidermal Necrolysis	8 (.79%)
Agitation	7 (.69%)
Cardio-respiratory Arrest	7 (.69%)
Convulsion	7 (.69%)
Death	7 (.69%)
Diarrhoea	7 (.69%)
Drug Abuse	7 (.69%)
Drug Withdrawal Syndrome Neonatal	7 (.69%)
Epilepsy	7 (.69%)
Euphoric Mood	7 (.69%)
Renal Failure Acute	7 (.69%)
Weight Decreased	7 (.69%)
Withdrawal Syndrome	7 (.69%)
Asthenia	6 (.59%)
Bradycardia	6 (.59%)
Disorientation	6 (.59%)
Drug Abuser	6 (.59%)
Dyspnoea	6 (.59%)
Fall	6 (.59%)
Fatigue	6 (.59%)
Hypothyroidism	6 (.59%)
Malaise	6 (.59%)
Pyrexia	6 (.59%)
Respiratory Acidosis	6 (.59%)
Respiratory Arrest	6 (.59%)
Therapy Regimen Changed	6 (.59%)
Cold Sweat	5 (.49%)
Feeling Abnormal	5 (.49%)
Multiple Drug Overdose Intentional	5 (.49%)
Premature Baby	5 (.49%)
Abdominal Pain	4 (.39%)
Abdominal Pain Upper	4 (.39%)
Alanine Aminotransferase Increased	4 (.39%)
Arthralgia	4 (.39%)
Caesarean Section	4 (.39%)
Cardiac Failure	4 (.39%)
Constipation	4 (.39%)
Diplopia	4 (.39%)
Dyslalia	4 (.39%)
Faecaloma	4 (.39%)
Hypersensitivity	4 (.39%)
Miosis	4 (.39%)
Multiple Drug Overdose	4 (.39%)
Muscular Weakness	4 (.39%)
Pain In Extremity	4 (.39%)
Respiratory Depression	4 (.39%)
Restlessness	4 (.39%)
Subileus	4 (.39%)
Swelling Face	4 (.39%)
Syncope	4 (.39%)
Thrombocytopenia	4 (.39%)
Altered State Of Consciousness	3 (.3%)
Anorexia	3 (.3%)
Blood Alkaline Phosphatase Increase...	3 (.3%)
Blood Pressure Decreased	3 (.3%)
Blood Pressure Increased	3 (.3%)
C-reactive Protein Increased	3 (.3%)
Circulatory Collapse	3 (.3%)
Cognitive Disorder	3 (.3%)
Delirium	3 (.3%)
Depression	3 (.3%)
Enanthema	3 (.3%)
Gamma-glutamyltransferase Increased	3 (.3%)
Haematemesis	3 (.3%)
Haemoglobin Decreased	3 (.3%)
Hallucination, Visual	3 (.3%)
Hepatitis Acute	3 (.3%)
Maternal Drugs Affecting Foetus	3 (.3%)
Motor Dysfunction	3 (.3%)
Muscle Spasms	3 (.3%)
Oedema Peripheral	3 (.3%)
Osteoarthritis	3 (.3%)
Renal Failure	3 (.3%)
Road Traffic Accident	3 (.3%)
Sedation	3 (.3%)
Sepsis	3 (.3%)
Shock	3 (.3%)

Share/Embed Graph Export Data

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

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

Neurological	95 (9.37%)
Gastrointestinal Signs	57 (5.62%)
Therapeutic And Nontherapeutic Effe...	53 (5.23%)
Epidermal And Dermal Conditions	49 (4.83%)
Respiratory	42 (4.14%)
Medication Errors	34 (3.35%)
Cardiac Arrhythmias	27 (2.66%)
Deliria	27 (2.66%)
Chemical Injury And Poisoning	24 (2.37%)
Psychiatric	24 (2.37%)
Movement Disorders	20 (1.97%)
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Decreased And Nonspecific Blood Pre...	17 (1.68%)
Hepatic And Hepatobiliary	16 (1.58%)
Hepatobiliary	16 (1.58%)
Neuromuscular	16 (1.58%)
Suicidal And Self-injurious Behavio...	16 (1.58%)
Cardiac And Vascular Investigations	15 (1.48%)
Seizures	15 (1.48%)
Hematology Investigations	14 (1.38%)
Renal Disorders	13 (1.28%)
Skin Appendage Conditions	13 (1.28%)
Infections - Pathogen Unspecified	12 (1.18%)
Gastrointestinal Motility And Defec...	11 (1.08%)
Injuries	11 (1.08%)
Joint	11 (1.08%)
Disturbances In Thinking	10 (.99%)
Enzyme	10 (.99%)
Mood Disorders	9 (.89%)
Physical Examination Topics	9 (.89%)
Vision	9 (.89%)
Anxiety Disorders	8 (.79%)
Fatal Outcomes	8 (.79%)
Headaches	8 (.79%)
Lifestyle Issues	8 (.79%)
Muscle	8 (.79%)
Body Temperature Conditions	7 (.69%)
Mental Impairment	7 (.69%)
Platelet	7 (.69%)
Therapeutic Procedures And Supporti...	7 (.69%)
Ocular Neuromuscular	6 (.59%)
Oral Soft Tissue Conditions	6 (.59%)
Thyroid Gland	6 (.59%)
Changes In Physical Activity	5 (.49%)
Depressed Mood Disorders	5 (.49%)
Gastrointestinal Hemorrhages	5 (.49%)
Heart Failures	5 (.49%)
Neonatal And Perinatal Conditions	5 (.49%)
Sleep Disorders	5 (.49%)
Urinary Tract Signs	5 (.49%)
Allergic Conditions	4 (.39%)
Anemias Nonhemolytic And Marrow Dep...	4 (.39%)
Appetite And General Nutritional	4 (.39%)
Central Nervous System Vascular	4 (.39%)
Gastrointestinal Stenosis And Obstr...	4 (.39%)
Musculoskeletal And Connective Tiss...	4 (.39%)
Obstetric And Gynecological Therape...	4 (.39%)
Abortions And Stillbirth	3 (.3%)
Bone And Joint Injuries	3 (.3%)
Cardiac Disorder Signs	3 (.3%)
Electrolyte And Fluid Balance Condi...	3 (.3%)
Nervous System, Skull And Spine The...	3 (.3%)
Ocular Infections, Irritations And ...	3 (.3%)
Ocular Sensory Symptoms	3 (.3%)
Protein And Chemistry Analyses	3 (.3%)
White Blood Cell	3 (.3%)
Autoimmune	2 (.2%)
Bile Duct	2 (.2%)
Bone Disorders	2 (.2%)
Breast	2 (.2%)
Coagulopathies And Bleeding Diathes...	2 (.2%)
Embolism And Thrombosis	2 (.2%)
Encephalopathies	2 (.2%)
Gastrointestinal Conditions	2 (.2%)
Gastrointestinal Inflammatory Condi...	2 (.2%)
Gastrointestinal Ulceration And Per...	2 (.2%)
Maternal Complications Of Labour An...	2 (.2%)
Metabolic, Nutritional And Blood Ga...	2 (.2%)
Myocardial	2 (.2%)
Peripheral Neuropathies	2 (.2%)
Product Quality Issues	2 (.2%)
Renal And Urinary Tract Neoplasms M...	2 (.2%)
Skin Vascular Abnormalities	2 (.2%)
Sleep Disturbances	2 (.2%)
Toxicology And Therapeutic Drug Mon...	2 (.2%)
Upper Respiratory Tract Disorders	2 (.2%)
Vascular Inflammations	2 (.2%)
Water, Electrolyte And Mineral	2 (.2%)
Acid-base	1 (.1%)
Administration Site Reactions	1 (.1%)
Aneurysms And Artery Dissections	1 (.1%)
Angiedema And Urticaria	1 (.1%)
Arteriosclerosis, Stenosis, Vascula...	1 (.1%)
Bacterial Infectious	1 (.1%)
Bone And Joint Therapeutic Procedur...	1 (.1%)
Cardiac Valve	1 (.1%)
Coronary Artery	1 (.1%)
Dental And Gingival Conditions	1 (.1%)
Diverticular	1 (.1%)
Eye	1 (.1%)
Fungal Infectious	1 (.1%)
Gallbladder	1 (.1%)

Share/Embed Graph Export Data

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

Common Uses of Tramal According to Those Reporting Adverse Events

Why are people taking Tramal, according to those reporting adverse events to the FDA?

Pain	192
Drug Use For Unknown Indication	94
Product Used For Unknown Indication	48
Back Pain	40
Abdominal Pain	12
Analgesic Therapy	12
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Rheumatoid Arthritis	9
Fracture	8
Bone Pain	7
General Symptom	5
Headache	5
Osteoarthritis	5
Arthralgia	5
Pain Prophylaxis	4
Drug Exposure During Pregnancy	4
Neck Pain	4
Hip Fracture	4
Wound Complication	3
Ankylosing Spondylitis	3
Proctalgia	3
Abdominal Pain Upper	3
Tension	3
Muscle Spasms	3
Parkinsonism	2
Tonsillectomy	2
Intervertebral Disc Protrusion	2
Gastritis	2
Gout	2
Neoplasm Malignant	2
Musculoskeletal Pain	2
Bursitis	2
Biliary Colic	2
Tumour Pain	2
Postoperative Analgesia	1
Procedural Pain	1
Trigeminal Neuralgia	1
Suicide Attempt	1
Herpes Zoster	1
Peripheral Sensory Neuropathy	1
Cerebrovascular Accident	1
Radicular Syndrome	1
Vomiting	1
Sensory Disturbance	1
Renal Colic	1
Cancer Pain	1
Sciatica	1
Convalescent	1
Osteoporosis	1
Contusion	1
Myopathy	1
Analgesia	1

Tramal Case Reports

What Tramal safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Tramal. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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