AMITRIPTYLINE

Amitriptyline Adverse Events Reported to the FDA Over Time

How are Amitriptyline adverse event reports trending over time?

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

Most Common Amitriptyline Adverse Events Reported to the FDA

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

Completed Suicide	741 (3.38%)
Cardiac Arrest	392 (1.79%)
Drug Toxicity	326 (1.49%)
Respiratory Arrest	326 (1.49%)
Drug Interaction	316 (1.44%)
Cardio-respiratory Arrest	252 (1.15%)
Somnolence	248 (1.13%)
Overdose	244 (1.11%)
Multiple Drug Overdose	229 (1.04%)
Confusional State	226 (1.03%)
Suicide Attempt	196 (.89%)
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Death	184 (.84%)
Agitation	179 (.82%)
Loss Of Consciousness	178 (.81%)
Drug Ineffective	177 (.81%)
Coma	174 (.79%)
Intentional Overdose	165 (.75%)
Convulsion	158 (.72%)
Serotonin Syndrome	158 (.72%)
Multiple Drug Overdose Intentional	157 (.72%)
Vomiting	149 (.68%)
Pain	148 (.68%)
Hypotension	147 (.67%)
Dizziness	136 (.62%)
Depression	130 (.59%)
Fall	130 (.59%)
Tremor	125 (.57%)
Hallucination	123 (.56%)
Tachycardia	123 (.56%)
Headache	122 (.56%)
Insomnia	119 (.54%)
Fatigue	116 (.53%)
Delirium	112 (.51%)
Suicidal Ideation	112 (.51%)
Anxiety	110 (.5%)
Pyrexia	108 (.49%)
Depressed Level Of Consciousness	107 (.49%)
Poisoning	106 (.48%)
Intentional Drug Misuse	103 (.47%)
Malaise	102 (.47%)
Asthenia	98 (.45%)
Dyspnoea	97 (.44%)
Feeling Abnormal	95 (.43%)
Nausea	94 (.43%)
Diarrhoea	93 (.42%)
Aggression	91 (.42%)
Arthralgia	89 (.41%)
Electrocardiogram Qt Prolonged	89 (.41%)
Weight Increased	89 (.41%)
Heart Rate Increased	86 (.39%)
Disorientation	79 (.36%)
Drug Abuse	78 (.36%)
Condition Aggravated	72 (.33%)
Grand Mal Convulsion	70 (.32%)
Hyperhidrosis	70 (.32%)
Pulmonary Oedema	70 (.32%)
Memory Impairment	69 (.31%)
Syncope	69 (.31%)
Hypertension	68 (.31%)
Amnesia	67 (.31%)
Drug Withdrawal Syndrome	67 (.31%)
Metabolic Acidosis	67 (.31%)
Drug Exposure During Pregnancy	66 (.3%)
Dry Mouth	66 (.3%)
Electrocardiogram Qrs Complex Prolo...	66 (.3%)
Renal Failure Acute	66 (.3%)
Dyskinesia	65 (.3%)
Pain In Extremity	65 (.3%)
Urinary Retention	64 (.29%)
Asthma	63 (.29%)
Multi-organ Failure	61 (.28%)
Abnormal Behaviour	60 (.27%)
Hypoaesthesia	60 (.27%)
Mydriasis	60 (.27%)
Gait Disturbance	59 (.27%)
Unresponsive To Stimuli	59 (.27%)
Constipation	58 (.26%)
Acute Respiratory Distress Syndrome	57 (.26%)
Paraesthesia	57 (.26%)
Speech Disorder	57 (.26%)
Mental Status Changes	56 (.26%)
Myalgia	56 (.26%)
Oedema Peripheral	56 (.26%)
Disturbance In Attention	55 (.25%)
Pneumonia	55 (.25%)
Medication Error	54 (.25%)
Alanine Aminotransferase Increased	53 (.24%)
Irritability	53 (.24%)
Restlessness	53 (.24%)
Hypoglycaemia	52 (.24%)
Blood Pressure Increased	51 (.23%)
Dysarthria	51 (.23%)
Rhabdomyolysis	51 (.23%)
Blood Sodium Decreased	50 (.23%)
Respiratory Depression	49 (.22%)
Shock	49 (.22%)
Weight Decreased	49 (.22%)
Anaemia	48 (.22%)
Balance Disorder	48 (.22%)
Ventricular Tachycardia	48 (.22%)
Rheumatoid Arthritis	46 (.21%)

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

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

Neurological	1787 (8.15%)
Cardiac Arrhythmias	1209 (5.52%)
Suicidal And Self-injurious Behavio...	1082 (4.94%)
Medication Errors	1025 (4.68%)
Respiratory	753 (3.44%)
Therapeutic And Nontherapeutic Effe...	715 (3.26%)
Chemical Injury And Poisoning	599 (2.73%)
Cardiac And Vascular Investigations	493 (2.25%)
Gastrointestinal Signs	437 (1.99%)
Deliria	418 (1.91%)
Anxiety Disorders	401 (1.83%)
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Epidermal And Dermal Conditions	378 (1.72%)
Movement Disorders	352 (1.61%)
Psychiatric	335 (1.53%)
Injuries	304 (1.39%)
Hepatic And Hepatobiliary	293 (1.34%)
Seizures	291 (1.33%)
Lower Respiratory Tract Disorders	284 (1.3%)
Sleep Disorders	282 (1.29%)
Muscle	268 (1.22%)
Decreased And Nonspecific Blood Pre...	256 (1.17%)
Fatal Outcomes	251 (1.15%)
Gastrointestinal Motility And Defec...	251 (1.15%)
Infections - Pathogen Unspecified	250 (1.14%)
Physical Examination Topics	241 (1.1%)
Mental Impairment	230 (1.05%)
Neuromuscular	230 (1.05%)
Hepatobiliary	206 (.94%)
Depressed Mood Disorders	205 (.94%)
Joint	205 (.94%)
Musculoskeletal And Connective Tiss...	205 (.94%)
Disturbances In Thinking	200 (.91%)
Hematology Investigations	178 (.81%)
Urinary Tract Signs	172 (.78%)
Lifestyle Issues	158 (.72%)
Personality Disorders	149 (.68%)
Metabolic, Nutritional And Blood Ga...	148 (.68%)
Electrolyte And Fluid Balance Condi...	147 (.67%)
Water, Electrolyte And Mineral	144 (.66%)
Headaches	143 (.65%)
Mood Disorders	140 (.64%)
Renal Disorders	139 (.63%)
Ocular Neuromuscular	134 (.61%)
Body Temperature Conditions	133 (.61%)
Toxicology And Therapeutic Drug Mon...	129 (.59%)
Central Nervous System Vascular	115 (.52%)
Vision	113 (.52%)
Cardiac Disorder Signs	111 (.51%)
Appetite And General Nutritional	110 (.5%)
Acid-base	101 (.46%)
Renal And Urinary Tract Investigati...	100 (.46%)
Glucose Metabolism Disorders	98 (.45%)
Bronchial Disorders	95 (.43%)
Skin Appendage Conditions	95 (.43%)
Anemias Nonhemolytic And Marrow Dep...	84 (.38%)
Salivary Gland Conditions	81 (.37%)
Bacterial Infectious	77 (.35%)
Changes In Physical Activity	77 (.35%)
Platelet	75 (.34%)
Bone And Joint Injuries	72 (.33%)
Vascular Hypertensive	72 (.33%)
Psychiatric And Behavioural Symptom...	71 (.32%)
Enzyme	68 (.31%)
Coagulopathies And Bleeding Diathes...	67 (.31%)
Schizophrenia And Other Psychotic	64 (.29%)
White Blood Cell	64 (.29%)
Myocardial	62 (.28%)
Allergic Conditions	60 (.27%)
Coronary Artery	58 (.26%)
Pulmonary Vascular	56 (.26%)
Procedural And Device Related Injur...	51 (.23%)
Therapeutic Procedures And Supporti...	51 (.23%)
Abortions And Stillbirth	49 (.22%)
Sleep Disturbances	48 (.22%)
Eye	46 (.21%)
Inner Ear And Viiith Cranial Nerve	46 (.21%)
Vascular	46 (.21%)
Manic And Bipolar Mood Disorders	45 (.21%)
Heart Failures	44 (.2%)
Tongue Conditions	44 (.2%)
Gastrointestinal Inflammatory Condi...	42 (.19%)
Pregnancy, Labour, Delivery And Pos...	42 (.19%)
Vascular Hemorrhagic	41 (.19%)
Gastrointestinal Conditions	40 (.18%)
Encephalopathies	39 (.18%)
Oral Soft Tissue Conditions	39 (.18%)
Peripheral Neuropathies	39 (.18%)
Pleural	39 (.18%)
Neurological, Special Senses And Ps...	37 (.17%)
Gastrointestinal Ulceration And Per...	35 (.16%)
Cranial Nerve Disorders	34 (.16%)
Legal Issues	32 (.15%)
Musculoskeletal And Connective Tiss...	32 (.15%)
Dissociative	30 (.14%)
Lipid Analyses	29 (.13%)
Gastrointestinal Hemorrhages	28 (.13%)
Cardiac Valve	27 (.12%)
Embolism And Thrombosis	27 (.12%)
Tissue	27 (.12%)
Gastrointestinal Stenosis And Obstr...	26 (.12%)
Protein And Chemistry Analyses	26 (.12%)

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