TRICYCLIC ANTIDEPRESSANTS

Tricyclic Antidepressants Adverse Events Reported to the FDA Over Time

How are Tricyclic Antidepressants adverse event reports trending over time?

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

Most Common Tricyclic Antidepressants Adverse Events Reported to the FDA

What are the most common Tricyclic Antidepressants adverse events reported to the FDA?

Completed Suicide	101 (10.5%)
Cardiac Arrest	28 (2.91%)
Respiratory Arrest	28 (2.91%)
Multiple Drug Overdose	25 (2.6%)
Poisoning	24 (2.49%)
Cardio-respiratory Arrest	23 (2.39%)
Coma	20 (2.08%)
Death	20 (2.08%)
Suicide Attempt	20 (2.08%)
Intentional Drug Misuse	16 (1.66%)
Somnolence	14 (1.46%)
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Drug Screen Positive	12 (1.25%)
Agitation	10 (1.04%)
Drug Toxicity	10 (1.04%)
Drug Abuse	9 (.94%)
Multiple Drug Overdose Intentional	9 (.94%)
Ammonia Increased	8 (.83%)
Drug Interaction	8 (.83%)
Heart Rate Increased	8 (.83%)
Lethargy	7 (.73%)
Liver Injury	7 (.73%)
Overdose	7 (.73%)
Blood Potassium Decreased	6 (.62%)
Brain Herniation	6 (.62%)
Brain Oedema	6 (.62%)
Cholestasis	6 (.62%)
Depressed Level Of Consciousness	6 (.62%)
Disorientation	6 (.62%)
Drug Abuser	6 (.62%)
Hypotension	6 (.62%)
Intentional Overdose	6 (.62%)
Sepsis	6 (.62%)
Sinus Tachycardia	6 (.62%)
Tachycardia	6 (.62%)
Blood Pressure Increased	5 (.52%)
Confusional State	5 (.52%)
Drug Ineffective	5 (.52%)
Electrocardiogram Qt Prolonged	5 (.52%)
Hallucination	5 (.52%)
Hepatic Necrosis	5 (.52%)
International Normalised Ratio Incr...	5 (.52%)
Mental Status Changes	5 (.52%)
Tremor	5 (.52%)
Unresponsive To Stimuli	5 (.52%)
White Blood Cell Count Increased	5 (.52%)
Acute Hepatic Failure	4 (.42%)
Aggression	4 (.42%)
Alanine Aminotransferase Increased	4 (.42%)
Aspartate Aminotransferase Increase...	4 (.42%)
Blood Creatine Phosphokinase Increa...	4 (.42%)
Blood Glucose Increased	4 (.42%)
Blood Urea Increased	4 (.42%)
Body Temperature Increased	4 (.42%)
Circulatory Collapse	4 (.42%)
Convulsion	4 (.42%)
Depression	4 (.42%)
Dysarthria	4 (.42%)
Electrocardiogram Qrs Complex Prolo...	4 (.42%)
Haematocrit Decreased	4 (.42%)
Medication Error	4 (.42%)
Multiple Drug Overdose Accidental	4 (.42%)
Pupillary Reflex Impaired	4 (.42%)
Vomiting	4 (.42%)
Accidental Overdose	3 (.31%)
Asthenia	3 (.31%)
Blood Alkaline Phosphatase Increase...	3 (.31%)
Blood Bicarbonate Decreased	3 (.31%)
Blood Bilirubin Increased	3 (.31%)
Blood Ph Decreased	3 (.31%)
Blood Pressure Decreased	3 (.31%)
Blood Pressure Systolic Increased	3 (.31%)
Cyanosis	3 (.31%)
Drug Withdrawal Syndrome	3 (.31%)
Fall	3 (.31%)
Gait Disturbance	3 (.31%)
Haemoglobin Decreased	3 (.31%)
Hyperhidrosis	3 (.31%)
Hypertension	3 (.31%)
Hypothermia	3 (.31%)
Loss Of Consciousness	3 (.31%)
Memory Impairment	3 (.31%)
Metabolic Acidosis	3 (.31%)
Mydriasis	3 (.31%)
Pain	3 (.31%)
Pco2 Decreased	3 (.31%)
Pneumonia Aspiration	3 (.31%)
Prothrombin Time Prolonged	3 (.31%)
Respiratory Rate Decreased	3 (.31%)
Sleep Apnoea Syndrome	3 (.31%)
Unevaluable Event	3 (.31%)
Weight Increased	3 (.31%)
Abasia	2 (.21%)
Abdominal Pain	2 (.21%)
Abnormal Behaviour	2 (.21%)
Acidosis	2 (.21%)
Ankle Fracture	2 (.21%)
Aspiration	2 (.21%)
Atrial Tachycardia	2 (.21%)
Bacteria Urine Identified	2 (.21%)
Base Excess Increased	2 (.21%)
Blood Cholesterol Increased	2 (.21%)

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

What are the most common Tricyclic Antidepressants adverse events reported to the FDA?

Suicidal And Self-injurious Behavio...	124 (12.89%)
Neurological	82 (8.52%)
Cardiac Arrhythmias	72 (7.48%)
Medication Errors	60 (6.24%)
Respiratory	52 (5.41%)
Chemical Injury And Poisoning	39 (4.05%)
Cardiac And Vascular Investigations	37 (3.85%)
Psychiatric	33 (3.43%)
Hematology Investigations	29 (3.01%)
Hepatic And Hepatobiliary	23 (2.39%)
Fatal Outcomes	21 (2.18%)
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Hepatobiliary	21 (2.18%)
Therapeutic And Nontherapeutic Effe...	20 (2.08%)
Metabolic, Nutritional And Blood Ga...	19 (1.98%)
Water, Electrolyte And Mineral	19 (1.98%)
Ocular Neuromuscular	15 (1.56%)
Toxicology And Therapeutic Drug Mon...	15 (1.56%)
Deliria	13 (1.35%)
Physical Examination Topics	13 (1.35%)
Anxiety Disorders	12 (1.25%)
Renal And Urinary Tract Investigati...	12 (1.25%)
Injuries	11 (1.14%)
Decreased And Nonspecific Blood Pre...	10 (1.04%)
Enzyme	10 (1.04%)
Gastrointestinal Signs	10 (1.04%)
Infections - Pathogen Unspecified	9 (.94%)
Lifestyle Issues	9 (.94%)
Movement Disorders	8 (.83%)
Increased Intracranial Pressure And...	7 (.73%)
Muscle	7 (.73%)
Acid-base	6 (.62%)
Depressed Mood Disorders	6 (.62%)
Disturbances In Thinking	5 (.52%)
Electrolyte And Fluid Balance Condi...	5 (.52%)
Lower Respiratory Tract Disorders	5 (.52%)
Personality Disorders	5 (.52%)
Seizures	5 (.52%)
Bacterial Infectious	4 (.42%)
Body Temperature Conditions	4 (.42%)
Mood Disorders	4 (.42%)
Skin Appendage Conditions	4 (.42%)
Cardiac Disorder Signs	3 (.31%)
Mental Impairment	3 (.31%)
Microbiology And Serology	3 (.31%)
Musculoskeletal And Connective Tiss...	3 (.31%)
Vascular Hypertensive	3 (.31%)
Abortions And Stillbirth	2 (.21%)
Appetite And General Nutritional	2 (.21%)
Bone And Joint Injuries	2 (.21%)
Bronchial Disorders	2 (.21%)
Changes In Physical Activity	2 (.21%)
Demyelinating	2 (.21%)
Glucose Metabolism Disorders	2 (.21%)
Lipid Analyses	2 (.21%)
Metabolism	2 (.21%)
Obstetric And Gynecological Therape...	2 (.21%)
Peripheral Neuropathies	2 (.21%)
Pregnancy, Labour, Delivery And Pos...	2 (.21%)
Psychiatric And Behavioural Symptom...	2 (.21%)
Renal Disorders	2 (.21%)
Sleep Disorders	2 (.21%)
Thyroid Gland	2 (.21%)
Urinary Tract Signs	2 (.21%)
White Blood Cell	2 (.21%)
Allergic Conditions	1 (.1%)
Endocrine Investigations	1 (.1%)
Endocrine Neoplasms Malignant And U...	1 (.1%)
Gastrointestinal Motility And Defec...	1 (.1%)
Genitourinary Tract	1 (.1%)
Headaches	1 (.1%)
Heart Failures	1 (.1%)
Hematological And Lymphoid Tissue T...	1 (.1%)
Joint	1 (.1%)
Menstrual Cycle And Uterine Bleedin...	1 (.1%)
Neurological, Special Senses And Ps...	1 (.1%)
Neuromuscular	1 (.1%)
Ocular Infections, Irritations And ...	1 (.1%)
Ovarian And Fallopian Tube	1 (.1%)
Protein And Amino Acid Metabolism	1 (.1%)
Salivary Gland Conditions	1 (.1%)
Synovial And Bursal	1 (.1%)
Tendon, Ligament And Cartilage	1 (.1%)
Therapeutic Procedures And Supporti...	1 (.1%)
Tissue	1 (.1%)
Upper Respiratory Tract Disorders	1 (.1%)
Vascular	1 (.1%)

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