ALCOHOL

Alcohol Adverse Events Reported to the FDA Over Time

How are Alcohol adverse event reports trending over time?

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

Most Common Alcohol Adverse Events Reported to the FDA

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

Suicide Attempt	759 (2.75%)
Overdose	606 (2.19%)
Intentional Overdose	545 (1.97%)
Completed Suicide	486 (1.76%)
Drug Toxicity	371 (1.34%)
Vomiting	357 (1.29%)
Alcohol Use	349 (1.26%)
Somnolence	340 (1.23%)
Multiple Drug Overdose Intentional	325 (1.18%)
Loss Of Consciousness	311 (1.13%)
Drug Abuse	274 (.99%)
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Alcohol Poisoning	260 (.94%)
Aggression	258 (.93%)
Tachycardia	249 (.9%)
Drug Interaction	243 (.88%)
Multiple Drug Overdose	233 (.84%)
Convulsion	229 (.83%)
Agitation	221 (.8%)
Intentional Drug Misuse	217 (.79%)
Nausea	213 (.77%)
Coma	205 (.74%)
Substance Abuse	198 (.72%)
Suicidal Ideation	198 (.72%)
Cardiac Arrest	195 (.71%)
Depression	187 (.68%)
Amnesia	185 (.67%)
Death	183 (.66%)
Fatigue	180 (.65%)
Confusional State	174 (.63%)
Dysarthria	168 (.61%)
Hypotension	159 (.58%)
Road Traffic Accident	150 (.54%)
Dizziness	142 (.51%)
Respiratory Arrest	141 (.51%)
Abnormal Behaviour	139 (.5%)
Alcohol Interaction	138 (.5%)
Dyspnoea	131 (.47%)
Fall	131 (.47%)
Malaise	129 (.47%)
Cardio-respiratory Arrest	127 (.46%)
Drug Dependence	127 (.46%)
Product Quality Issue	126 (.46%)
Anxiety	123 (.45%)
Insomnia	119 (.43%)
Headache	118 (.43%)
Pain	117 (.42%)
Tremor	113 (.41%)
Diarrhoea	110 (.4%)
Depressed Level Of Consciousness	108 (.39%)
Blood Alcohol Increased	105 (.38%)
Psychotic Disorder	103 (.37%)
Drug Abuser	102 (.37%)
Incorrect Dose Administered	101 (.37%)
Pyrexia	98 (.35%)
Mydriasis	97 (.35%)
Poisoning	94 (.34%)
Blood Pressure Increased	91 (.33%)
Hyperhidrosis	90 (.33%)
Accidental Overdose	89 (.32%)
Hallucination	89 (.32%)
Metabolic Acidosis	89 (.32%)
Memory Impairment	86 (.31%)
Serotonin Syndrome	86 (.31%)
Heart Rate Increased	84 (.3%)
Asthenia	82 (.3%)
Feeling Abnormal	82 (.3%)
Drug Withdrawal Syndrome	80 (.29%)
Unresponsive To Stimuli	80 (.29%)
Nystagmus	79 (.29%)
Disturbance In Attention	78 (.28%)
Drug Exposure During Pregnancy	76 (.28%)
Impaired Driving Ability	76 (.28%)
Palpitations	76 (.28%)
Sinus Tachycardia	76 (.28%)
Alanine Aminotransferase Increased	75 (.27%)
Drug Ineffective	75 (.27%)
Lethargy	74 (.27%)
Rhabdomyolysis	74 (.27%)
Electrocardiogram Qt Prolonged	70 (.25%)
Hepatotoxicity	69 (.25%)
Pneumonia	69 (.25%)
Abdominal Pain	68 (.25%)
Disorientation	68 (.25%)
Euphoric Mood	64 (.23%)
Aspartate Aminotransferase Increase...	63 (.23%)
Cardiac Disorder	63 (.23%)
Dehydration	63 (.23%)
Hypertension	62 (.22%)
Somnambulism	62 (.22%)
Blood Creatine Phosphokinase Increa...	61 (.22%)
Alcoholism	60 (.22%)
Liver Function Test Abnormal	60 (.22%)
Weight Decreased	60 (.22%)
Gait Disturbance	59 (.21%)
Condition Aggravated	58 (.21%)
Renal Failure Acute	58 (.21%)
Alcohol Abuse	57 (.21%)
Restlessness	57 (.21%)
Sopor	56 (.2%)
Drug Screen Positive	55 (.2%)
Blood Bilirubin Increased	54 (.2%)

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

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

Medication Errors	2231 (8.08%)
Neurological	2096 (7.59%)
Suicidal And Self-injurious Behavio...	1565 (5.67%)
Psychiatric	1106 (4.01%)
Cardiac Arrhythmias	1021 (3.7%)
Chemical Injury And Poisoning	882 (3.19%)
Gastrointestinal Signs	836 (3.03%)
Respiratory	720 (2.61%)
Therapeutic And Nontherapeutic Effe...	639 (2.31%)
Lifestyle Issues	613 (2.22%)
Injuries	603 (2.18%)
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Hepatic And Hepatobiliary	524 (1.9%)
Cardiac And Vascular Investigations	510 (1.85%)
Anxiety Disorders	477 (1.73%)
Mental Impairment	407 (1.47%)
Infections - Pathogen Unspecified	403 (1.46%)
Epidermal And Dermal Conditions	397 (1.44%)
Personality Disorders	397 (1.44%)
Disturbances In Thinking	374 (1.35%)
Hepatobiliary	368 (1.33%)
Sleep Disorders	360 (1.3%)
Seizures	329 (1.19%)
Toxicology And Therapeutic Drug Mon...	317 (1.15%)
Deliria	298 (1.08%)
Fatal Outcomes	286 (1.04%)
Depressed Mood Disorders	276 (1%)
Mood Disorders	253 (.92%)
Decreased And Nonspecific Blood Pre...	243 (.88%)
Cardiac Disorder Signs	239 (.87%)
Hematology Investigations	231 (.84%)
Muscle	223 (.81%)
Movement Disorders	218 (.79%)
Administration Site Reactions	201 (.73%)
Lower Respiratory Tract Disorders	194 (.7%)
Product Quality Issues	191 (.69%)
Metabolic, Nutritional And Blood Ga...	189 (.68%)
Ocular Neuromuscular	184 (.67%)
Legal Issues	183 (.66%)
Physical Examination Topics	180 (.65%)
Gastrointestinal Motility And Defec...	168 (.61%)
Electrolyte And Fluid Balance Condi...	165 (.6%)
Renal Disorders	157 (.57%)
Psychiatric And Behavioural Symptom...	152 (.55%)
Acid-base	148 (.54%)
Water, Electrolyte And Mineral	142 (.51%)
Neuromuscular	141 (.51%)
Musculoskeletal And Connective Tiss...	139 (.5%)
Body Temperature Conditions	137 (.5%)
Schizophrenia And Other Psychotic	132 (.48%)
Skin Appendage Conditions	131 (.47%)
Headaches	127 (.46%)
Bone And Joint Injuries	125 (.45%)
Vascular	119 (.43%)
Enzyme	117 (.42%)
Bacterial Infectious	112 (.41%)
Appetite And General Nutritional	106 (.38%)
Allergic Conditions	103 (.37%)
Renal And Urinary Tract Investigati...	84 (.3%)
Urinary Tract Signs	82 (.3%)
Therapeutic Procedures And Supporti...	80 (.29%)
Coronary Artery	79 (.29%)
Changes In Physical Activity	78 (.28%)
Gastrointestinal Hemorrhages	75 (.27%)
Encephalopathies	74 (.27%)
Vision	68 (.25%)
Glucose Metabolism Disorders	67 (.24%)
Vascular Hypertensive	66 (.24%)
Upper Respiratory Tract Disorders	65 (.24%)
Ocular Infections, Irritations And ...	60 (.22%)
Bronchial Disorders	58 (.21%)
Heart Failures	55 (.2%)
Myocardial	54 (.2%)
Central Nervous System Vascular	50 (.18%)
Joint	50 (.18%)
Anemias Nonhemolytic And Marrow Dep...	47 (.17%)
Eye	45 (.16%)
Viral Infectious	45 (.16%)
Angiedema And Urticaria	44 (.16%)
Exocrine Pancreas Conditions	41 (.15%)
Oral Soft Tissue Conditions	40 (.14%)
Bile Duct	38 (.14%)
Hematological And Lymphoid Tissue T...	37 (.13%)
Platelet	35 (.13%)
Increased Intracranial Pressure And...	33 (.12%)
Skin Vascular Abnormalities	33 (.12%)
Manic And Bipolar Mood Disorders	32 (.12%)
Gastrointestinal Inflammatory Condi...	31 (.11%)
Neonatal And Perinatal Conditions	31 (.11%)
Peripheral Neuropathies	31 (.11%)
Sexual Function And Fertility	30 (.11%)
Spleen, Lymphatic And Reticulendoth...	30 (.11%)
Protein And Chemistry Analyses	29 (.11%)
Salivary Gland Conditions	29 (.11%)
Tongue Conditions	28 (.1%)
White Blood Cell	28 (.1%)
Lipid Analyses	27 (.1%)
Communication Disorders	26 (.09%)
Inner Ear And Viiith Cranial Nerve	26 (.09%)
Procedural And Device Related Injur...	26 (.09%)
Cardiac And Vascular Disorders Cong...	25 (.09%)
Dental And Gingival Conditions	25 (.09%)

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