HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Hydrocodone Bitartrate And Acetaminophen Adverse Events Reported to the FDA Over Time

How are Hydrocodone Bitartrate And Acetaminophen adverse event reports trending over time?

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

Most Common Hydrocodone Bitartrate And Acetaminophen Adverse Events Reported to the FDA

What are the most common Hydrocodone Bitartrate And Acetaminophen adverse events reported to the FDA?

Completed Suicide	2485 (17.16%)
Cardio-respiratory Arrest	805 (5.56%)
Cardiac Arrest	741 (5.12%)
Respiratory Arrest	725 (5.01%)
Intentional Drug Misuse	547 (3.78%)
Death	427 (2.95%)
Drug Abuse	401 (2.77%)
Multiple Drug Overdose	231 (1.6%)
Poisoning	216 (1.49%)
Nausea	182 (1.26%)
Drug Ineffective	179 (1.24%)
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Drug Toxicity	169 (1.17%)
Vomiting	142 (.98%)
Overdose	138 (.95%)
Somnolence	110 (.76%)
Multiple Drug Overdose Intentional	104 (.72%)
Confusional State	96 (.66%)
Medication Error	90 (.62%)
Fall	86 (.59%)
Coma	80 (.55%)
Dizziness	77 (.53%)
Pain	76 (.52%)
Hypotension	75 (.52%)
Constipation	72 (.5%)
Headache	69 (.48%)
Mental Status Changes	68 (.47%)
Malaise	66 (.46%)
Intentional Overdose	61 (.42%)
Pruritus	58 (.4%)
Aspartate Aminotransferase Increase...	57 (.39%)
Dyspnoea	55 (.38%)
Loss Of Consciousness	55 (.38%)
Lethargy	54 (.37%)
Agitation	53 (.37%)
Product Substitution Issue	53 (.37%)
Abdominal Pain	52 (.36%)
Drug Effect Decreased	52 (.36%)
Insomnia	51 (.35%)
Alanine Aminotransferase Increased	50 (.35%)
Anxiety	49 (.34%)
Depressed Level Of Consciousness	49 (.34%)
Incorrect Dose Administered	47 (.32%)
Diarrhoea	44 (.3%)
Feeling Abnormal	44 (.3%)
Convulsion	43 (.3%)
Drug Abuser	43 (.3%)
Abdominal Pain Upper	41 (.28%)
Hallucination	41 (.28%)
Asthenia	40 (.28%)
Drug Screen Positive	40 (.28%)
Hypertension	40 (.28%)
Unresponsive To Stimuli	40 (.28%)
Heart Rate Increased	39 (.27%)
Hyperhidrosis	39 (.27%)
Product Quality Issue	39 (.27%)
Drug Interaction	38 (.26%)
Chest Pain	37 (.26%)
Rash	34 (.23%)
Pneumonia	33 (.23%)
Sinus Tachycardia	33 (.23%)
Tremor	33 (.23%)
Blood Pressure Decreased	32 (.22%)
Fatigue	32 (.22%)
Blood Glucose Increased	31 (.21%)
Nervousness	30 (.21%)
Tachycardia	30 (.21%)
Memory Impairment	29 (.2%)
Respiratory Depression	29 (.2%)
Urinary Tract Infection	29 (.2%)
Dysuria	28 (.19%)
Sedation	28 (.19%)
Hepatic Failure	27 (.19%)
Miosis	27 (.19%)
Oxygen Saturation Decreased	26 (.18%)
Vision Blurred	26 (.18%)
Aggression	24 (.17%)
Apnoea	24 (.17%)
Dehydration	24 (.17%)
Delirium	24 (.17%)
Poisoning Deliberate	24 (.17%)
Blood Creatine Phosphokinase Increa...	23 (.16%)
Blood Creatinine Increased	23 (.16%)
Blood Potassium Decreased	23 (.16%)
Urticaria	23 (.16%)
Abdominal Discomfort	22 (.15%)
Abnormal Dreams	22 (.15%)
Depression	22 (.15%)
Dry Mouth	22 (.15%)
Hyponatraemia	22 (.15%)
Multi-organ Failure	22 (.15%)
Cold Sweat	21 (.15%)
No Therapeutic Response	21 (.15%)
Accidental Overdose	20 (.14%)
Blood Pressure Increased	20 (.14%)
Decreased Appetite	20 (.14%)
Excoriation	20 (.14%)
Hypophagia	20 (.14%)
Respiratory Rate Increased	20 (.14%)
Suicide Attempt	20 (.14%)
Withdrawal Syndrome	20 (.14%)
Amnesia	19 (.13%)

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This graph shows the top adverse events submitted to the FDA for Hydrocodone Bitartrate And Acetaminophen, 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 Hydrocodone Bitartrate And Acetaminophen 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 Hydrocodone Bitartrate And Acetaminophen

What are the most common Hydrocodone Bitartrate And Acetaminophen adverse events reported to the FDA?

Suicidal And Self-injurious Behavio...	2524 (17.43%)
Cardiac Arrhythmias	1679 (11.6%)
Psychiatric	1063 (7.34%)
Respiratory	968 (6.69%)
Medication Errors	795 (5.49%)
Neurological	659 (4.55%)
Gastrointestinal Signs	488 (3.37%)
Fatal Outcomes	453 (3.13%)
Chemical Injury And Poisoning	441 (3.05%)
Therapeutic And Nontherapeutic Effe...	371 (2.56%)
Injuries	169 (1.17%)
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Cardiac And Vascular Investigations	166 (1.15%)
Hepatobiliary	161 (1.11%)
Epidermal And Dermal Conditions	144 (.99%)
Anxiety Disorders	143 (.99%)
Deliria	137 (.95%)
Metabolic, Nutritional And Blood Ga...	128 (.88%)
Gastrointestinal Motility And Defec...	126 (.87%)
Infections - Pathogen Unspecified	124 (.86%)
Product Quality Issues	120 (.83%)
Lifestyle Issues	97 (.67%)
Sleep Disorders	96 (.66%)
Hematology Investigations	89 (.61%)
Decreased And Nonspecific Blood Pre...	87 (.6%)
Toxicology And Therapeutic Drug Mon...	86 (.59%)
Urinary Tract Signs	83 (.57%)
Water, Electrolyte And Mineral	83 (.57%)
Physical Examination Topics	78 (.54%)
Headaches	77 (.53%)
Hepatic And Hepatobiliary	77 (.53%)
Disturbances In Thinking	75 (.52%)
Renal And Urinary Tract Investigati...	73 (.5%)
Electrolyte And Fluid Balance Condi...	69 (.48%)
Skin Appendage Conditions	67 (.46%)
Mental Impairment	64 (.44%)
Lower Respiratory Tract Disorders	63 (.44%)
Muscle	60 (.41%)
Ocular Neuromuscular	59 (.41%)
Appetite And General Nutritional	58 (.4%)
Musculoskeletal And Connective Tiss...	58 (.4%)
Renal Disorders	55 (.38%)
Central Nervous System Vascular	53 (.37%)
Enzyme	52 (.36%)
Seizures	51 (.35%)
Movement Disorders	50 (.35%)
Procedural And Device Related Injur...	49 (.34%)
Allergic Conditions	45 (.31%)
Vision	44 (.3%)
Vascular Hypertensive	40 (.28%)
Personality Disorders	39 (.27%)
Angiedema And Urticaria	38 (.26%)
Acid-base	36 (.25%)
Cardiac Disorder Signs	36 (.25%)
Bone And Joint Injuries	34 (.23%)
Joint	30 (.21%)
Coronary Artery	29 (.2%)
Gastrointestinal Hemorrhages	29 (.2%)
Mood Disorders	29 (.2%)
Depressed Mood Disorders	28 (.19%)
Coagulopathies And Bleeding Diathes...	27 (.19%)
Encephalopathies	27 (.19%)
Gastrointestinal Stenosis And Obstr...	24 (.17%)
Salivary Gland Conditions	22 (.15%)
Upper Respiratory Tract Disorders	22 (.15%)
Bronchial Disorders	20 (.14%)
Glucose Metabolism Disorders	20 (.14%)
Legal Issues	20 (.14%)
Body Temperature Conditions	18 (.12%)
Hearing	18 (.12%)
Psychiatric And Behavioural Symptom...	18 (.12%)
Ocular Infections, Irritations And ...	17 (.12%)
Oral Soft Tissue Conditions	17 (.12%)
Pulmonary Vascular	17 (.12%)
Adrenal Gland	16 (.11%)
Inner Ear And Viiith Cranial Nerve	16 (.11%)
Protein And Chemistry Analyses	16 (.11%)
Sleep Disturbances	16 (.11%)
Musculoskeletal And Connective Tiss...	15 (.1%)
Changes In Physical Activity	14 (.1%)
Demyelinating	14 (.1%)
Embolism And Thrombosis	14 (.1%)
Heart Failures	14 (.1%)
Hematological And Lymphoid Tissue T...	14 (.1%)
Myocardial	14 (.1%)
Gastrointestinal Conditions	13 (.09%)
Therapeutic Procedures And Supporti...	13 (.09%)
Bacterial Infectious	12 (.08%)
Gastrointestinal Ulceration And Per...	12 (.08%)
Neuromuscular	12 (.08%)
Arteriosclerosis, Stenosis, Vascula...	11 (.08%)
Fungal Infectious	11 (.08%)
Schizophrenia And Other Psychotic	11 (.08%)
Vascular Hemorrhagic	11 (.08%)
Viral Infectious	11 (.08%)
Gastrointestinal	10 (.07%)
Exocrine Pancreas Conditions	9 (.06%)
Eye	9 (.06%)
Increased Intracranial Pressure And...	9 (.06%)
Musculoskeletal And Connective Tiss...	9 (.06%)
Structural Brain	9 (.06%)
Tongue Conditions	9 (.06%)

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This graph shows the top categories of adverse events submitted to the FDA for Hydrocodone Bitartrate And Acetaminophen, 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 Hydrocodone Bitartrate And Acetaminophen 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.