METHADONE

Methadone Adverse Events Reported to the FDA Over Time

How are Methadone adverse event reports trending over time?

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

Most Common Methadone Adverse Events Reported to the FDA

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

Cardiac Arrest	1061 (4.02%)
Respiratory Arrest	1021 (3.87%)
Completed Suicide	1019 (3.86%)
Cardio-respiratory Arrest	603 (2.29%)
Drug Withdrawal Syndrome Neonatal	589 (2.23%)
Overdose	588 (2.23%)
Drug Toxicity	581 (2.2%)
Death	475 (1.8%)
Drug Interaction	398 (1.51%)
Drug Abuse	385 (1.46%)
Multiple Drug Overdose	339 (1.29%)
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Electrocardiogram Qt Prolonged	296 (1.12%)
Drug Exposure During Pregnancy	291 (1.1%)
Somnolence	280 (1.06%)
Respiratory Depression	239 (.91%)
Drug Ineffective	229 (.87%)
Intentional Drug Misuse	229 (.87%)
Poisoning	225 (.85%)
Torsade De Pointes	209 (.79%)
Accidental Overdose	203 (.77%)
Vomiting	197 (.75%)
Loss Of Consciousness	180 (.68%)
Drug Abuser	172 (.65%)
Premature Baby	172 (.65%)
Drug Withdrawal Syndrome	165 (.63%)
Nausea	163 (.62%)
Pulmonary Oedema	151 (.57%)
Convulsion	147 (.56%)
Multiple Drug Overdose Intentional	145 (.55%)
Pain	141 (.53%)
Nystagmus	139 (.53%)
Coma	133 (.5%)
Confusional State	124 (.47%)
Premature Labour	116 (.44%)
Hypotension	115 (.44%)
Dyspnoea	109 (.41%)
Headache	109 (.41%)
Intentional Overdose	109 (.41%)
Pneumonia	109 (.41%)
Strabismus	108 (.41%)
Fall	106 (.4%)
Unresponsive To Stimuli	106 (.4%)
Dizziness	105 (.4%)
Hyperhidrosis	105 (.4%)
Fatigue	104 (.39%)
Malaise	104 (.39%)
Developmental Delay	101 (.38%)
Syncope	100 (.38%)
Pulmonary Congestion	98 (.37%)
Depressed Level Of Consciousness	97 (.37%)
Serotonin Syndrome	95 (.36%)
Agitation	94 (.36%)
Visual Acuity Reduced	94 (.36%)
Congenital Nystagmus	92 (.35%)
Drug Screen Positive	91 (.34%)
Sedation	89 (.34%)
Drug Dependence	87 (.33%)
Constipation	85 (.32%)
Mental Status Changes	84 (.32%)
Respiratory Failure	82 (.31%)
Withdrawal Syndrome	82 (.31%)
Insomnia	80 (.3%)
Ventricular Tachycardia	80 (.3%)
Lethargy	77 (.29%)
Multiple Drug Overdose Accidental	77 (.29%)
Therapeutic Agent Toxicity	76 (.29%)
Anxiety	75 (.28%)
Medication Error	75 (.28%)
Substance Abuse	75 (.28%)
Feeling Abnormal	73 (.28%)
Asthenia	71 (.27%)
Drug Diversion	71 (.27%)
Maternal Drugs Affecting Foetus	70 (.27%)
Arrhythmia	69 (.26%)
Aspiration	69 (.26%)
Miosis	68 (.26%)
Oedema Peripheral	68 (.26%)
Tremor	64 (.24%)
Accidental Poisoning	63 (.24%)
Pneumonia Aspiration	61 (.23%)
Depression	60 (.23%)
Pain In Extremity	60 (.23%)
Diarrhoea	58 (.22%)
Pyrexia	58 (.22%)
Rhabdomyolysis	56 (.21%)
Blood Potassium Decreased	55 (.21%)
Heart Rate Increased	55 (.21%)
Accidental Death	54 (.2%)
Bronchopneumonia	54 (.2%)
Abnormal Behaviour	53 (.2%)
Brain Oedema	52 (.2%)
Chest Pain	52 (.2%)
Disorientation	52 (.2%)
Delirium	50 (.19%)
Hypokalaemia	50 (.19%)
Self-medication	50 (.19%)
Weight Decreased	50 (.19%)
Abdominal Pain	49 (.19%)
Hallucination	49 (.19%)
Cardiomegaly	48 (.18%)
Dysarthria	47 (.18%)

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

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

Cardiac Arrhythmias	2329 (8.83%)
Respiratory	1991 (7.55%)
Medication Errors	1813 (6.87%)
Neurological	1786 (6.77%)
Therapeutic And Nontherapeutic Effe...	1553 (5.89%)
Chemical Injury And Poisoning	1383 (5.24%)
Suicidal And Self-injurious Behavio...	1114 (4.22%)
Psychiatric	1003 (3.8%)
Fatal Outcomes	624 (2.37%)
Cardiac And Vascular Investigations	568 (2.15%)
Gastrointestinal Signs	563 (2.13%)
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Infections - Pathogen Unspecified	393 (1.49%)
Lower Respiratory Tract Disorders	385 (1.46%)
Lifestyle Issues	349 (1.32%)
Injuries	341 (1.29%)
Ocular Neuromuscular	247 (.94%)
Toxicology And Therapeutic Drug Mon...	240 (.91%)
Deliria	229 (.87%)
Seizures	226 (.86%)
Anxiety Disorders	223 (.85%)
Vision	223 (.85%)
Epidermal And Dermal Conditions	214 (.81%)
Muscle	207 (.78%)
Neonatal And Perinatal Conditions	205 (.78%)
Physical Examination Topics	200 (.76%)
Hepatic And Hepatobiliary	197 (.75%)
Hepatobiliary	180 (.68%)
Decreased And Nonspecific Blood Pre...	169 (.64%)
Musculoskeletal And Connective Tiss...	168 (.64%)
Movement Disorders	167 (.63%)
Gastrointestinal Motility And Defec...	160 (.61%)
Sleep Disorders	152 (.58%)
Headaches	149 (.56%)
Water, Electrolyte And Mineral	143 (.54%)
Skin Appendage Conditions	141 (.53%)
Encephalopathies	139 (.53%)
Mental Impairment	135 (.51%)
Myocardial	127 (.48%)
Hematology Investigations	126 (.48%)
Neuromuscular	126 (.48%)
Metabolic, Nutritional And Blood Ga...	124 (.47%)
Coronary Artery	121 (.46%)
Electrolyte And Fluid Balance Condi...	121 (.46%)
Maternal Complications Of Labour An...	121 (.46%)
Legal Issues	116 (.44%)
Renal Disorders	110 (.42%)
Eye Disorders Congenital	107 (.41%)
Cardiac Disorder Signs	102 (.39%)
Bacterial Infectious	101 (.38%)
Therapeutic Procedures And Supporti...	100 (.38%)
Disturbances In Thinking	99 (.38%)
Appetite And General Nutritional	97 (.37%)
Neurological Disorders Congenital	96 (.36%)
Enzyme	88 (.33%)
Depressed Mood Disorders	84 (.32%)
Mood Disorders	84 (.32%)
Renal And Urinary Tract Investigati...	83 (.31%)
Personality Disorders	80 (.3%)
Body Temperature Conditions	70 (.27%)
Increased Intracranial Pressure And...	68 (.26%)
Joint	68 (.26%)
Psychiatric And Behavioural Symptom...	68 (.26%)
Viral Infectious	67 (.25%)
Central Nervous System Vascular	66 (.25%)
Dental And Gingival Conditions	63 (.24%)
Musculoskeletal And Connective Tiss...	62 (.24%)
Urinary Tract Signs	60 (.23%)
Product Quality Issues	56 (.21%)
Changes In Physical Activity	54 (.2%)
Vascular	51 (.19%)
Procedural And Device Related Injur...	50 (.19%)
Allergic Conditions	49 (.19%)
Bronchial Disorders	46 (.17%)
Sleep Disturbances	46 (.17%)
Vascular Hypertensive	46 (.17%)
Acid-base	45 (.17%)
Glucose Metabolism Disorders	42 (.16%)
Upper Respiratory Tract Disorders	42 (.16%)
Spleen, Lymphatic And Reticulendoth...	40 (.15%)
Arteriosclerosis, Stenosis, Vascula...	38 (.14%)
Bone And Joint Injuries	36 (.14%)
White Blood Cell	35 (.13%)
Cardiac And Vascular Disorders Cong...	33 (.13%)
Abortions And Stillbirth	32 (.12%)
Bone Disorders	32 (.12%)
Bone, Calcium, Magnesium And Phosph...	32 (.12%)
Pleural	30 (.11%)
Gallbladder	29 (.11%)
Ocular Infections, Irritations And ...	29 (.11%)
Schizophrenia And Other Psychotic	29 (.11%)
Cardiac Valve	28 (.11%)
Gastrointestinal Conditions	28 (.11%)
Neurological, Special Senses And Ps...	27 (.1%)
Metastases	26 (.1%)
Anemias Nonhemolytic And Marrow Dep...	24 (.09%)
Heart Failures	24 (.09%)
Protein And Chemistry Analyses	24 (.09%)
Salivary Gland Conditions	24 (.09%)
Miscellaneous And Site Unspecified ...	22 (.08%)
Musculoskeletal And Connective Tiss...	22 (.08%)
Congenital And Hereditary	21 (.08%)

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