NORTRIPTYLINE

Nortriptyline Adverse Events Reported to the FDA Over Time

How are Nortriptyline adverse event reports trending over time?

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

Most Common Nortriptyline Adverse Events Reported to the FDA

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

Completed Suicide	205 (4.24%)
Drug Ineffective	92 (1.9%)
Suicidal Ideation	89 (1.84%)
Drug Toxicity	76 (1.57%)
Convulsion	56 (1.16%)
Cardiac Arrest	51 (1.06%)
Constipation	48 (.99%)
Insomnia	48 (.99%)
Drug Interaction	47 (.97%)
Hypotension	47 (.97%)
Headache	45 (.93%)
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Somnolence	45 (.93%)
Cardio-respiratory Arrest	44 (.91%)
Multiple Drug Overdose	44 (.91%)
Overdose	44 (.91%)
Vomiting	44 (.91%)
Death	42 (.87%)
Dizziness	42 (.87%)
Weight Increased	42 (.87%)
Confusional State	39 (.81%)
Weight Decreased	37 (.77%)
Depression	35 (.72%)
Dyspnoea	35 (.72%)
Intentional Overdose	35 (.72%)
Loss Of Consciousness	35 (.72%)
Suicide Attempt	34 (.7%)
Nausea	33 (.68%)
Respiratory Arrest	33 (.68%)
Tremor	33 (.68%)
Dyspepsia	30 (.62%)
Agitation	29 (.6%)
Diarrhoea	29 (.6%)
Fall	29 (.6%)
Gastrointestinal Disorder	28 (.58%)
Syncope	27 (.56%)
Gastrooesophageal Reflux Disease	25 (.52%)
Pain	25 (.52%)
Intentional Drug Misuse	24 (.5%)
Paraesthesia	24 (.5%)
Dry Mouth	23 (.48%)
Heart Rate Increased	23 (.48%)
Malaise	23 (.48%)
Multiple Drug Overdose Intentional	23 (.48%)
Oedema	23 (.48%)
Oedema Peripheral	23 (.48%)
Ventricular Tachycardia	23 (.48%)
Coma	22 (.46%)
Duodenal Ulcer	22 (.46%)
Rectal Haemorrhage	22 (.46%)
Abdominal Distension	21 (.43%)
Fatigue	21 (.43%)
Gastritis	21 (.43%)
Blood Pressure Increased	19 (.39%)
Drug Abuse	19 (.39%)
Reflux Oesophagitis	19 (.39%)
Accidental Overdose	18 (.37%)
Anxiety	18 (.37%)
Arrhythmia	18 (.37%)
Faeces Hard	18 (.37%)
Haemorrhoids	18 (.37%)
Palpitations	18 (.37%)
Condition Aggravated	17 (.35%)
Migraine	17 (.35%)
Poisoning	17 (.35%)
Pulmonary Embolism	17 (.35%)
Respiratory Depression	17 (.35%)
Feeling Abnormal	16 (.33%)
Long Qt Syndrome	16 (.33%)
Nightmare	16 (.33%)
Tachycardia	16 (.33%)
Abdominal Pain	15 (.31%)
Aggression	15 (.31%)
Anger	15 (.31%)
Asthenia	15 (.31%)
Dyskinesia	15 (.31%)
Hyperprolactinaemia	15 (.31%)
Vision Blurred	15 (.31%)
Abnormal Behaviour	14 (.29%)
Amnesia	14 (.29%)
Back Pain	14 (.29%)
Brugada Syndrome	14 (.29%)
Chest Pain	14 (.29%)
Delirium	14 (.29%)
Disorientation	14 (.29%)
Hypertension	14 (.29%)
Mental Status Changes	14 (.29%)
Mydriasis	14 (.29%)
Pneumonia	14 (.29%)
Accidental Death	13 (.27%)
Electrocardiogram Qrs Complex Prolo...	13 (.27%)
Hallucination	13 (.27%)
Muscle Spasms	13 (.27%)
Neck Pain	13 (.27%)
Off Label Use	13 (.27%)
Pain In Extremity	13 (.27%)
Blood Pressure Decreased	12 (.25%)
Bradycardia	12 (.25%)
Drug Level Increased	12 (.25%)
Dysgeusia	12 (.25%)
Hyperhidrosis	12 (.25%)
Multiple Drug Overdose Accidental	12 (.25%)

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

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

Neurological	340 (7.03%)
Suicidal And Self-injurious Behavio...	333 (6.89%)
Cardiac Arrhythmias	284 (5.88%)
Medication Errors	214 (4.43%)
Gastrointestinal Signs	182 (3.77%)
Therapeutic And Nontherapeutic Effe...	180 (3.72%)
Respiratory	162 (3.35%)
Cardiac And Vascular Investigations	121 (2.5%)
Chemical Injury And Poisoning	121 (2.5%)
Gastrointestinal Motility And Defec...	111 (2.3%)
Physical Examination Topics	97 (2.01%)
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Sleep Disorders	89 (1.84%)
Anxiety Disorders	87 (1.8%)
Seizures	79 (1.63%)
Epidermal And Dermal Conditions	76 (1.57%)
Psychiatric	72 (1.49%)
Deliria	67 (1.39%)
Injuries	66 (1.37%)
Decreased And Nonspecific Blood Pre...	65 (1.34%)
Movement Disorders	65 (1.34%)
Headaches	63 (1.3%)
Fatal Outcomes	59 (1.22%)
Muscle	58 (1.2%)
Musculoskeletal And Connective Tiss...	54 (1.12%)
Depressed Mood Disorders	47 (.97%)
Gastrointestinal Inflammatory Condi...	47 (.97%)
Infections - Pathogen Unspecified	47 (.97%)
Mood Disorders	41 (.85%)
Gastrointestinal Ulceration And Per...	40 (.83%)
Mental Impairment	39 (.81%)
Lower Respiratory Tract Disorders	37 (.77%)
Gastrointestinal Hemorrhages	36 (.74%)
Disturbances In Thinking	35 (.72%)
Toxicology And Therapeutic Drug Mon...	34 (.7%)
Cardiac Disorder Signs	30 (.62%)
Gastrointestinal Conditions	30 (.62%)
Lifestyle Issues	30 (.62%)
Salivary Gland Conditions	29 (.6%)
Water, Electrolyte And Mineral	29 (.6%)
Skin Appendage Conditions	28 (.58%)
Hypothalamus And Pituitary Gland	26 (.54%)
Bone And Joint Injuries	24 (.5%)
Personality Disorders	24 (.5%)
Vision	23 (.48%)
Gastrointestinal Vascular Condition...	22 (.46%)
Ocular Neuromuscular	22 (.46%)
Therapeutic Procedures And Supporti...	22 (.46%)
Renal And Urinary Tract Investigati...	21 (.43%)
Coronary Artery	20 (.41%)
Hepatic And Hepatobiliary	20 (.41%)
Renal Disorders	20 (.41%)
Metabolic, Nutritional And Blood Ga...	19 (.39%)
Neuromuscular	19 (.39%)
Pulmonary Vascular	17 (.35%)
Urinary Tract Signs	17 (.35%)
Psychiatric And Behavioural Symptom...	15 (.31%)
Appetite And General Nutritional	14 (.29%)
Electrolyte And Fluid Balance Condi...	14 (.29%)
Hearing	14 (.29%)
Hematology Investigations	14 (.29%)
Vascular Hypertensive	14 (.29%)
Hepatobiliary	13 (.27%)
Myocardial	13 (.27%)
Embolism And Thrombosis	12 (.25%)
Acid-base	11 (.23%)
Anemias Nonhemolytic And Marrow Dep...	11 (.23%)
Body Temperature Conditions	11 (.23%)
Joint	11 (.23%)
Procedural And Device Related Injur...	11 (.23%)
Central Nervous System Vascular	10 (.21%)
Changes In Physical Activity	10 (.21%)
Musculoskeletal And Connective Tiss...	10 (.21%)
Tissue	10 (.21%)
Vascular	10 (.21%)
Allergic Conditions	9 (.19%)
Eye	9 (.19%)
Gastrointestinal Stenosis And Obstr...	9 (.19%)
Gastrointestinal Therapeutic Proced...	9 (.19%)
Glucose Metabolism Disorders	9 (.19%)
Menstrual Cycle And Uterine Bleedin...	9 (.19%)
Neurological, Special Senses And Ps...	9 (.19%)
Oral Soft Tissue Conditions	9 (.19%)
Sexual Function And Fertility	9 (.19%)
Tongue Conditions	9 (.19%)
Viral Infectious	9 (.19%)
Manic And Bipolar Mood Disorders	8 (.17%)
Product Quality Issues	8 (.17%)
Sleep Disturbances	8 (.17%)
Arteriosclerosis, Stenosis, Vascula...	7 (.14%)
Breast	7 (.14%)
Cognitive And Attention Disorders	7 (.14%)
Dental And Gingival Conditions	7 (.14%)
Enzyme	7 (.14%)
Heart Failures	7 (.14%)
Inner Ear And Viiith Cranial Nerve	7 (.14%)
Lipid Analyses	7 (.14%)
Peripheral Neuropathies	7 (.14%)
White Blood Cell	7 (.14%)
Bronchial Disorders	6 (.12%)
Hematological And Lymphoid Tissue T...	6 (.12%)
Nephropathies	6 (.12%)

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