CODEINE

Codeine Adverse Events Reported to the FDA Over Time

How are Codeine adverse event reports trending over time?

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

Most Common Codeine Adverse Events Reported to the FDA

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

Completed Suicide	445 (2.27%)
Vomiting	316 (1.61%)
Drug Hypersensitivity	306 (1.56%)
Overdose	300 (1.53%)
Drug Toxicity	258 (1.31%)
Nausea	227 (1.16%)
Drug Interaction	223 (1.14%)
Dyspnoea	195 (.99%)
Somnolence	180 (.92%)
Malaise	177 (.9%)
Multiple Drug Overdose	170 (.87%)
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Cardiac Arrest	161 (.82%)
Death	158 (.8%)
Headache	156 (.79%)
Loss Of Consciousness	153 (.78%)
Respiratory Arrest	148 (.75%)
Abdominal Pain	147 (.75%)
Dizziness	146 (.74%)
Drug Ineffective	143 (.73%)
Multiple Drug Overdose Intentional	136 (.69%)
Pyrexia	136 (.69%)
Constipation	134 (.68%)
Drug Abuse	134 (.68%)
Confusional State	126 (.64%)
Back Pain	121 (.62%)
Hypotension	115 (.59%)
Pain	110 (.56%)
Cardio-respiratory Arrest	108 (.55%)
Drug Exposure During Pregnancy	105 (.53%)
Suicide Attempt	104 (.53%)
Depression	101 (.51%)
Diarrhoea	99 (.5%)
Fatigue	99 (.5%)
Intentional Overdose	99 (.5%)
Intentional Drug Misuse	97 (.49%)
Hallucination	96 (.49%)
Alanine Aminotransferase Increased	94 (.48%)
Asthenia	93 (.47%)
Serotonin Syndrome	92 (.47%)
Fall	86 (.44%)
Cough	85 (.43%)
Pruritus	85 (.43%)
Respiratory Depression	84 (.43%)
Rash	81 (.41%)
Convulsion	80 (.41%)
Feeling Abnormal	78 (.4%)
Medication Error	76 (.39%)
Hyperhidrosis	75 (.38%)
Hypertension	74 (.38%)
Poisoning	74 (.38%)
Accidental Overdose	73 (.37%)
Hypersensitivity	73 (.37%)
Metabolic Acidosis	72 (.37%)
Dehydration	71 (.36%)
Weight Increased	71 (.36%)
Depressed Level Of Consciousness	68 (.35%)
Agitation	67 (.34%)
Coma	64 (.33%)
Tremor	64 (.33%)
Insomnia	63 (.32%)
Renal Failure	63 (.32%)
Renal Failure Acute	63 (.32%)
Abdominal Pain Upper	62 (.32%)
Pulmonary Oedema	62 (.32%)
Tachycardia	61 (.31%)
Heart Rate Increased	60 (.31%)
Drug Dependence	59 (.3%)
Aspartate Aminotransferase Increase...	58 (.3%)
Atrial Fibrillation	57 (.29%)
Pneumonia	57 (.29%)
Lethargy	56 (.29%)
Unresponsive To Stimuli	54 (.28%)
Arthralgia	53 (.27%)
Blood Creatinine Increased	53 (.27%)
Cerebrovascular Accident	53 (.27%)
Anxiety	52 (.26%)
Chest Pain	52 (.26%)
Decreased Appetite	52 (.26%)
Urticaria	52 (.26%)
Condition Aggravated	51 (.26%)
International Normalised Ratio Incr...	49 (.25%)
Jaundice	48 (.24%)
Oedema Peripheral	48 (.24%)
Abdominal Distension	47 (.24%)
Drug Abuser	47 (.24%)
Pancreatitis Acute	47 (.24%)
Substance Abuse	47 (.24%)
Suicidal Ideation	47 (.24%)
Syncope	47 (.24%)
Weight Decreased	47 (.24%)
Blood Pressure Increased	46 (.23%)
Muscle Spasms	46 (.23%)
Myalgia	46 (.23%)
Hypoxia	45 (.23%)
Musculoskeletal Stiffness	45 (.23%)
Delirium	44 (.22%)
Pain In Extremity	44 (.22%)
Miosis	43 (.22%)
Gamma-glutamyltransferase Increased	42 (.21%)
Hepatic Failure	42 (.21%)
Mental Status Changes	42 (.21%)

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

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

Neurological	1143 (5.82%)
Medication Errors	1078 (5.49%)
Gastrointestinal Signs	938 (4.78%)
Respiratory	901 (4.59%)
Suicidal And Self-injurious Behavio...	618 (3.15%)
Epidermal And Dermal Conditions	566 (2.88%)
Chemical Injury And Poisoning	561 (2.86%)
Cardiac Arrhythmias	508 (2.59%)
Therapeutic And Nontherapeutic Effe...	507 (2.58%)
Allergic Conditions	456 (2.32%)
Hepatic And Hepatobiliary	453 (2.31%)
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Psychiatric	426 (2.17%)
Infections - Pathogen Unspecified	329 (1.68%)
Gastrointestinal Motility And Defec...	303 (1.54%)
Hepatobiliary	286 (1.46%)
Cardiac And Vascular Investigations	265 (1.35%)
Musculoskeletal And Connective Tiss...	255 (1.3%)
Injuries	238 (1.21%)
Hematology Investigations	225 (1.15%)
Headaches	207 (1.05%)
Renal Disorders	207 (1.05%)
Lower Respiratory Tract Disorders	201 (1.02%)
Fatal Outcomes	200 (1.02%)
Anxiety Disorders	198 (1.01%)
Deliria	196 (1%)
Movement Disorders	193 (.98%)
Muscle	175 (.89%)
Physical Examination Topics	175 (.89%)
Decreased And Nonspecific Blood Pre...	168 (.86%)
Electrolyte And Fluid Balance Condi...	166 (.85%)
Urinary Tract Signs	164 (.84%)
Disturbances In Thinking	163 (.83%)
Body Temperature Conditions	148 (.75%)
Sleep Disorders	146 (.74%)
Appetite And General Nutritional	138 (.7%)
Neuromuscular	132 (.67%)
Depressed Mood Disorders	130 (.66%)
Lifestyle Issues	127 (.65%)
Central Nervous System Vascular	121 (.62%)
Joint	121 (.62%)
Musculoskeletal And Connective Tiss...	120 (.61%)
Acid-base	114 (.58%)
Metabolic, Nutritional And Blood Ga...	114 (.58%)
Seizures	111 (.57%)
Toxicology And Therapeutic Drug Mon...	110 (.56%)
Renal And Urinary Tract Investigati...	109 (.56%)
Water, Electrolyte And Mineral	109 (.56%)
Bronchial Disorders	107 (.54%)
Skin Appendage Conditions	99 (.5%)
Ocular Neuromuscular	98 (.5%)
Gastrointestinal Hemorrhages	93 (.47%)
Vision	88 (.45%)
Enzyme	86 (.44%)
Mental Impairment	84 (.43%)
White Blood Cell	80 (.41%)
Angiedema And Urticaria	78 (.4%)
Exocrine Pancreas Conditions	78 (.4%)
Oral Soft Tissue Conditions	78 (.4%)
Mood Disorders	77 (.39%)
Vascular Hypertensive	75 (.38%)
Hearing	73 (.37%)
Viral Infectious	69 (.35%)
Upper Respiratory Tract Disorders	68 (.35%)
Vascular	68 (.35%)
Abortions And Stillbirth	66 (.34%)
Coronary Artery	64 (.33%)
Cardiac Disorder Signs	63 (.32%)
Bone And Joint Injuries	59 (.3%)
Gastrointestinal Ulceration And Per...	58 (.3%)
Encephalopathies	56 (.29%)
Bacterial Infectious	50 (.25%)
Procedural And Device Related Injur...	49 (.25%)
Red Blood Cell	49 (.25%)
Inner Ear And Viiith Cranial Nerve	48 (.24%)
Tongue Conditions	48 (.24%)
Glucose Metabolism Disorders	44 (.22%)
Personality Disorders	43 (.22%)
Gastrointestinal Inflammatory Condi...	42 (.21%)
Gastrointestinal Neoplasms Malignan...	42 (.21%)
Product Quality Issues	41 (.21%)
Pregnancy, Labour, Delivery And Pos...	39 (.2%)
Schizophrenia And Other Psychotic	39 (.2%)
Changes In Physical Activity	38 (.19%)
Gastrointestinal Stenosis And Obstr...	38 (.19%)
Anemias Nonhemolytic And Marrow Dep...	37 (.19%)
Protein And Chemistry Analyses	37 (.19%)
Gastrointestinal Tract Disorders Co...	36 (.18%)
Heart Failures	36 (.18%)
Menstrual Cycle And Uterine Bleedin...	36 (.18%)
Peritoneal And Retroperitoneal Cond...	36 (.18%)
Therapeutic Procedures And Supporti...	35 (.18%)
Coagulopathies And Bleeding Diathes...	34 (.17%)
Cardiac And Vascular Disorders Cong...	33 (.17%)
Gastrointestinal Vascular Condition...	33 (.17%)
Platelet	33 (.17%)
Salivary Gland Conditions	33 (.17%)
Embolism And Thrombosis	32 (.16%)
Eye	32 (.16%)
Gastrointestinal	30 (.15%)
Cranial Nerve Disorders	28 (.14%)
Manic And Bipolar Mood Disorders	28 (.14%)

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