DOXEPIN

Doxepin Adverse Events Reported to the FDA Over Time

How are Doxepin adverse event reports trending over time?

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

Most Common Doxepin Adverse Events Reported to the FDA

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

Completed Suicide	293 (5.92%)
Cardiac Arrest	132 (2.67%)
Suicide Attempt	130 (2.63%)
Respiratory Arrest	119 (2.4%)
Drug Toxicity	118 (2.38%)
Somnolence	90 (1.82%)
Cardio-respiratory Arrest	81 (1.64%)
Death	78 (1.58%)
Overdose	78 (1.58%)
Coma	73 (1.48%)
Multiple Drug Overdose	72 (1.45%)
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Multiple Drug Overdose Intentional	67 (1.35%)
Drug Ineffective	64 (1.29%)
Drug Interaction	60 (1.21%)
Intentional Overdose	56 (1.13%)
Insomnia	51 (1.03%)
Tremor	50 (1.01%)
Confusional State	47 (.95%)
Hypotension	46 (.93%)
Loss Of Consciousness	45 (.91%)
Tachycardia	45 (.91%)
Convulsion	41 (.83%)
Fatigue	41 (.83%)
Poisoning	41 (.83%)
Depression	38 (.77%)
Drug Abuse	38 (.77%)
Fall	36 (.73%)
Medication Error	35 (.71%)
Dry Mouth	33 (.67%)
Nausea	31 (.63%)
Agitation	27 (.55%)
Suicidal Ideation	27 (.55%)
Serotonin Syndrome	26 (.53%)
Dizziness	25 (.51%)
Headache	25 (.51%)
Intentional Drug Misuse	25 (.51%)
Pyrexia	25 (.51%)
Drug Abuser	24 (.48%)
Electrocardiogram Qt Prolonged	24 (.48%)
Memory Impairment	24 (.48%)
Syncope	23 (.46%)
Amnesia	22 (.44%)
Anxiety	20 (.4%)
Diarrhoea	20 (.4%)
Drug Effect Decreased	20 (.4%)
Dysarthria	20 (.4%)
Dyskinesia	20 (.4%)
Dyspnoea	19 (.38%)
Weight Increased	19 (.38%)
Chills	18 (.36%)
Drug Withdrawal Syndrome	18 (.36%)
Aggression	17 (.34%)
Bradycardia	17 (.34%)
Cognitive Disorder	17 (.34%)
Constipation	17 (.34%)
Hypertension	17 (.34%)
Vomiting	17 (.34%)
Incorrect Dose Administered	16 (.32%)
Nightmare	16 (.32%)
Rhabdomyolysis	16 (.32%)
Sopor	16 (.32%)
Vision Blurred	16 (.32%)
Abdominal Pain Upper	15 (.3%)
Hallucination	15 (.3%)
Metabolic Acidosis	15 (.3%)
Muscle Twitching	15 (.3%)
Pain	15 (.3%)
Renal Failure	15 (.3%)
Respiratory Failure	15 (.3%)
Decreased Appetite	14 (.28%)
Disorientation	14 (.28%)
Pruritus	14 (.28%)
Aspiration	13 (.26%)
Asthenia	13 (.26%)
Depressed Level Of Consciousness	13 (.26%)
Rash	13 (.26%)
Weight Decreased	13 (.26%)
Blood Pressure Increased	12 (.24%)
Circulatory Collapse	12 (.24%)
Drug Hypersensitivity	12 (.24%)
Gamma-glutamyltransferase Increased	12 (.24%)
Malaise	12 (.24%)
Pneumonia	12 (.24%)
Sleep Disorder	12 (.24%)
Ageusia	11 (.22%)
Blood Creatine Phosphokinase Increa...	11 (.22%)
Dehydration	11 (.22%)
Diabetes Mellitus	11 (.22%)
Disturbance In Attention	11 (.22%)
Gastritis	11 (.22%)
Grand Mal Convulsion	11 (.22%)
Miosis	11 (.22%)
Mydriasis	11 (.22%)
Restlessness	11 (.22%)
Alanine Aminotransferase Increased	10 (.2%)
Alcohol Use	10 (.2%)
Blood Pressure Decreased	10 (.2%)
Burning Sensation	10 (.2%)
Drug Withdrawal Syndrome Neonatal	10 (.2%)
Homicide	10 (.2%)
Hyperhidrosis	10 (.2%)

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

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

Suicidal And Self-injurious Behavio...	459 (9.27%)
Neurological	408 (8.24%)
Medication Errors	384 (7.76%)
Cardiac Arrhythmias	334 (6.75%)
Respiratory	207 (4.18%)
Therapeutic And Nontherapeutic Effe...	195 (3.94%)
Chemical Injury And Poisoning	187 (3.78%)
Gastrointestinal Signs	106 (2.14%)
Movement Disorders	99 (2%)
Sleep Disorders	98 (1.98%)
Psychiatric	93 (1.88%)
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Fatal Outcomes	87 (1.76%)
Mental Impairment	86 (1.74%)
Cardiac And Vascular Investigations	80 (1.62%)
Injuries	77 (1.56%)
Epidermal And Dermal Conditions	76 (1.54%)
Decreased And Nonspecific Blood Pre...	65 (1.31%)
Deliria	65 (1.31%)
Seizures	61 (1.23%)
Anxiety Disorders	60 (1.21%)
Muscle	55 (1.11%)
Depressed Mood Disorders	51 (1.03%)
Lifestyle Issues	51 (1.03%)
Gastrointestinal Motility And Defec...	50 (1.01%)
Hepatobiliary	45 (.91%)
Physical Examination Topics	43 (.87%)
Toxicology And Therapeutic Drug Mon...	42 (.85%)
Body Temperature Conditions	40 (.81%)
Hepatic And Hepatobiliary	38 (.77%)
Salivary Gland Conditions	36 (.73%)
Neuromuscular	35 (.71%)
Ocular Neuromuscular	31 (.63%)
Headaches	28 (.57%)
Vision	27 (.55%)
Enzyme	26 (.53%)
Infections - Pathogen Unspecified	26 (.53%)
Metabolic, Nutritional And Blood Ga...	26 (.53%)
Musculoskeletal And Connective Tiss...	26 (.53%)
Electrolyte And Fluid Balance Condi...	25 (.51%)
Disturbances In Thinking	24 (.48%)
Encephalopathies	24 (.48%)
Renal Disorders	24 (.48%)
Myocardial	23 (.46%)
Personality Disorders	23 (.46%)
Allergic Conditions	22 (.44%)
Mood Disorders	22 (.44%)
Coronary Artery	21 (.42%)
Legal Issues	20 (.4%)
Vascular Hypertensive	18 (.36%)
Appetite And General Nutritional	17 (.34%)
Hematology Investigations	17 (.34%)
Skin Appendage Conditions	17 (.34%)
Acid-base	16 (.32%)
Glucose Metabolism Disorders	16 (.32%)
Joint	16 (.32%)
Bone And Joint Injuries	15 (.3%)
Viral Infectious	15 (.3%)
Gastrointestinal Ulceration And Per...	14 (.28%)
Lower Respiratory Tract Disorders	14 (.28%)
Microbiology And Serology	14 (.28%)
Urinary Tract Signs	14 (.28%)
Changes In Physical Activity	13 (.26%)
Eye	13 (.26%)
Vascular	13 (.26%)
Gastrointestinal Inflammatory Condi...	12 (.24%)
Water, Electrolyte And Mineral	12 (.24%)
Neurological, Special Senses And Ps...	11 (.22%)
Cardiac Disorder Signs	10 (.2%)
Gastrointestinal	9 (.18%)
Hematological And Lymphoid Tissue T...	9 (.18%)
Breast	8 (.16%)
Somatoform And Factitious	8 (.16%)
White Blood Cell	8 (.16%)
Angiedema And Urticaria	7 (.14%)
Cardiac And Vascular Disorders Cong...	7 (.14%)
Communication Disorders	7 (.14%)
Gastrointestinal Conditions	7 (.14%)
Neonatal And Perinatal Conditions	7 (.14%)
Pulmonary Vascular	7 (.14%)
Tongue Conditions	7 (.14%)
Gallbladder	6 (.12%)
Heart Failures	6 (.12%)
Manic And Bipolar Mood Disorders	6 (.12%)
Ocular Sensory Symptoms	6 (.12%)
Ocular Structural Change, Deposit A...	6 (.12%)
Oral Soft Tissue Conditions	6 (.12%)
Renal And Urinary Tract Investigati...	6 (.12%)
Respiratory Tract Therapeutic Proce...	6 (.12%)
Schizophrenia And Other Psychotic	6 (.12%)
Therapeutic Procedures And Supporti...	6 (.12%)
Coagulopathies And Bleeding Diathes...	5 (.1%)
Musculoskeletal And Connective Tiss...	5 (.1%)
Prostatic Disorders	5 (.1%)
Psychiatric And Behavioural Symptom...	5 (.1%)
Sexual Function And Fertility	5 (.1%)
Upper Respiratory Tract Disorders	5 (.1%)
Bacterial Infectious	4 (.08%)
Cardiac Valve	4 (.08%)
Central Nervous System Vascular	4 (.08%)
Immune	4 (.08%)
Inner Ear And Viiith Cranial Nerve	4 (.08%)

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