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ETHANOL

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Ethanol Adverse Events Reported to the FDA Over Time

How are Ethanol adverse event reports trending over time?

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

Most Common Ethanol Adverse Events Reported to the FDA

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

Completed Suicide
1880 (10.73%)
Cardiac Arrest
760 (4.34%)
Respiratory Arrest
694 (3.96%)
Cardio-respiratory Arrest
583 (3.33%)
Drug Toxicity
488 (2.78%)
Drug Abuse
376 (2.15%)
Death
371 (2.12%)
Intentional Drug Misuse
351 (2%)
Intentional Overdose
344 (1.96%)
Alcohol Use
339 (1.93%)
Suicide Attempt
336 (1.92%)
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Multiple Drug Overdose
330 (1.88%)
Poisoning
319 (1.82%)
Multiple Drug Overdose Intentional
289 (1.65%)
Overdose
283 (1.62%)
Somnolence
194 (1.11%)
Coma
189 (1.08%)
Hypotension
171 (.98%)
Vomiting
171 (.98%)
Alcohol Poisoning
165 (.94%)
Loss Of Consciousness
152 (.87%)
Tachycardia
139 (.79%)
Convulsion
118 (.67%)
Drug Abuser
111 (.63%)
Agitation
84 (.48%)
Drug Interaction
84 (.48%)
Blood Alcohol Increased
82 (.47%)
Alcohol Interaction
74 (.42%)
Aspartate Aminotransferase Increase...
74 (.42%)
Unresponsive To Stimuli
74 (.42%)
Pulmonary Oedema
73 (.42%)
Aggression
71 (.41%)
Depressed Level Of Consciousness
70 (.4%)
Heart Rate Increased
69 (.39%)
Substance Abuse
69 (.39%)
Accidental Death
68 (.39%)
Metabolic Acidosis
68 (.39%)
Nausea
68 (.39%)
Alanine Aminotransferase Increased
65 (.37%)
Fall
64 (.37%)
Pulmonary Congestion
62 (.35%)
Suicidal Ideation
60 (.34%)
Confusional State
59 (.34%)
Lethargy
59 (.34%)
Multiple Drug Overdose Accidental
57 (.33%)
Drug Screen Positive
54 (.31%)
Electrocardiogram Qt Prolonged
53 (.3%)
Aspiration
51 (.29%)
Depression
50 (.29%)
Sinus Tachycardia
49 (.28%)
Mydriasis
46 (.26%)
Drug Withdrawal Syndrome
45 (.26%)
Rhabdomyolysis
45 (.26%)
Accidental Overdose
44 (.25%)
Amnesia
44 (.25%)
Blood Glucose Increased
43 (.25%)
Drug Ineffective
43 (.25%)
Road Traffic Accident
43 (.25%)
Dyspnoea
42 (.24%)
Hepatic Failure
42 (.24%)
Hyperhidrosis
42 (.24%)
Incorrect Dose Administered
42 (.24%)
Diarrhoea
41 (.23%)
Poisoning Deliberate
41 (.23%)
Oxygen Saturation Decreased
40 (.23%)
Abnormal Behaviour
39 (.22%)
Blood Pressure Decreased
38 (.22%)
Bradycardia
38 (.22%)
Drug Dependence
38 (.22%)
Drug Exposure During Pregnancy
37 (.21%)
Blood Ethanol Increased
36 (.21%)
Fatigue
36 (.21%)
Hypoglycaemia
36 (.21%)
Renal Failure
36 (.21%)
Respiratory Rate Increased
36 (.21%)
Abdominal Pain
35 (.2%)
Medication Error
35 (.2%)
Respiratory Failure
35 (.2%)
Tremor
35 (.2%)
Blood Creatine Phosphokinase Increa...
34 (.19%)
Blood Creatinine Increased
34 (.19%)
Blood Potassium Decreased
34 (.19%)
Dizziness
34 (.19%)
International Normalised Ratio Incr...
34 (.19%)
Respiratory Depression
34 (.19%)
Blood Ph Decreased
33 (.19%)
Dysarthria
33 (.19%)
Hypertension
33 (.19%)
Haemodialysis
32 (.18%)
Hepatic Steatosis
32 (.18%)
Intentional Self-injury
32 (.18%)
Miosis
32 (.18%)
Grand Mal Convulsion
30 (.17%)
Mental Status Changes
30 (.17%)
Feeling Abnormal
29 (.17%)
Acidosis
27 (.15%)
Anxiety
27 (.15%)
Apnoea
27 (.15%)
Condition Aggravated
27 (.15%)
Delirium
27 (.15%)
Hypokalaemia
27 (.15%)

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

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

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

Common Uses of Ethanol According to Those Reporting Adverse Events

Why are people taking Ethanol, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
1172
Product Used For Unknown Indication
910
Ill-defined Disorder
233
Suicide Attempt
189
Alcohol Use
63
Completed Suicide
28
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Intentional Overdose
19
Drug Abuser
14
Alcoholism
12
Intentional Drug Misuse
11
Alcohol Abuse
10
Intentional Misuse
10
Chemical Poisoning
9
Nasopharyngitis
8
Drug Abuse
8
Alcohol Poisoning
5
Overdose
5
Sinus Disorder
4
Poisoning
4
Suicidal Ideation
4
Drug Exposure During Pregnancy
4
Hepatic Neoplasm Malignant
3
Alcoholic
3
Percutaneous Ethanol Injection Ther...
3
Malaise
3
Overgrowth Bacterial
2
Ischaemic Stroke
2
Haemostasis
2
Chest Discomfort
2
Depression
2
Peptic Ulcer Haemorrhage
2
Headache
2
Preoperative Care
2
Back Pain
2
Suicidal Behaviour
1
Infection Prophylaxis
1
Discomfort
1
Feeling Of Relaxation
1
Poisoning Deliberate
1
Influenza
1
Insomnia
1
Depressed Mood
1
Feeling Of Despair
1
Multiple Drug Overdose
1
Euphoric Mood
1
Blood Methanol Increased
1
Cough
1
Vomiting
1
Central Line Infection
1
Blood Ethanol
1
Drug Therapy
1

Ethanol Case Reports

What Ethanol safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Ethanol. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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