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Alcohol Side Effects

Common Alcohol Side Effects


The most commonly reported Alcohol side effects (click to view or check a box to report):

Product Quality Issue (36)
Suicide Attempt (26)
Intentional Overdose (26)
Vomiting (22)
Toxicity To Various Agents (22)
Road Traffic Accident (22)
Overdose (20)
Coma (17)
Fall (17)
Somnolence (16)
Alcohol Poisoning (16)
Amnesia (16)
Nausea (14)
Diarrhoea (13)
Loss Of Consciousness (13)
Pain (13)
Somnambulism (13)
Completed Suicide (11)
Substance Abuse (11)
Malaise (11)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Alcohol Side Effects Reported to FDA

The following Alcohol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Alcohol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Toxicity To Various Agents
This is a report of a 27-year-old male patient (weight: NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Alcohol (dosage: NA, start time: NS), combined with:
  • Flunitrazepam
  • Cocaine
  • Morphine
  • Diacetylmorphine
  • Clorazepate Dipotassium
  • Valium
  • Cannabis
  • Nordazepam
and developed a serious reaction and side effect(s). The consumer presented with:
  • Toxicity To Various Agents
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alcohol treatment in male patients, resulting in toxicity to various agents side effect.

Hypersensitivity, Dyspnoea, Throat Tightness, Glossitis
This report suggests a potential Alcohol Hypersensitivity, Dyspnoea, Throat Tightness, Glossitis side effect(s) that can have serious consequences. A 25-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: skin papilloma,urinary tract disorder and used Alcohol (dosage: 1 Drop In 6 Ozs Water) starting NS. Soon after starting Alcohol the patient began experiencing various side effects, including:
  • Hypersensitivity
  • Dyspnoea
  • Throat Tightness
  • Glossitis
Drugs used concurrently: NA. Although Alcohol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypersensitivity, may still occur.

Product Quality Issue, Product Contamination
This Product Quality Issue, Product Contamination problem was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201303 this consumer started treatment with Alcohol (dosage: Individual Swab Once Eveyr 2-3 Days, Topical). The following drugs were being taken at the same time: NA. When commencing Alcohol, the patient experienced the following unwanted symptoms/side effects:
  • Product Quality Issue
  • Product Contamination
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as product quality issue, may become evident only after a product is in use by the general population.

Occupational Asthma
This is a report of a 43-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Alcohol\chlorhexidine Gluconate (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Occupational Asthma
This opens a possibility that Alcohol\chlorhexidine Gluconate treatment could cause the above reactions, including occupational asthma, and some female subjects may be more susceptible.


Anaphylactic Shock, Local Swelling, Blister
A 25-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Alcohol treatment (dosage: NA) on Feb 18, 2013. Soon after starting Alcohol treatment, the subject experienced various side effects, including:
  • Anaphylactic Shock
  • Local Swelling
  • Blister
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Alcohol.

Overdose, Coma, Delirium
A 35-year-old male patient from AUSTRALIA (weight: NA) experienced symptoms, such as: NA and was treated with Alcohol(dosage: Unk). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Overdose
  • Coma
  • Delirium
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Alcohol efficacy:
  • Baclofen (2500 Mg, Single)
The patient was hospitalized.

Bradycardia, Delirium, Coma, Hypertension, Overdose
In this report, Alcohol was administered for the following condition: NA.A 33-year-old male consumer from AUSTRALIA (weight: NA) started Alcohol treatment (dosage: Unk) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Bradycardia
  • Delirium
  • Coma
  • Hypertension
  • Overdose
A possible interaction with other drugs could have contributed to this reaction:
  • Baclofen (375 Mg, Single)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Alcohol treatment could be related to the listed above side effect(s).

Coma, Hypertension, Tachycardia, Overdose
This is a report of the following Alcohol side effect(s):
  • Coma
  • Hypertension
  • Tachycardia
  • Overdose
A 33-year-old male patient from AUSTRALIA (weight: NA) presented with the following condition: NA and received a treatment with Alcohol (dosage: Unk) starting: NS.The following concurrently used drugs could have generated interactions:
  • Baclofen (375 Mg, Single)
The patient was hospitalized.This report suggests that a Alcohol treatment could be associated with the listed above side effect(s).

Self Injurious Behaviour, Sluggishness, Sopor
This Alcohol report was submitted by a 29-year-old female consumer from ITALY (weight: NA). The patient was diagnosed with: NA and Alcohol was administered (dosage: NA) starting: Jun 08, 2012. The consumer developed a set of symptoms:
  • Self Injurious Behaviour
  • Sluggishness
  • Sopor
Other drugs used simultaneously:
  • Risperdal
Those unexpected symptoms could be linked to a Alcohol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Intentional Overdose
This is a report of a possible correlation between Alcohol use and the following symptoms/side effect(s):
  • Intentional Overdose
which could contribute to an assessment of Alcohol risk profile.A 53-year-old female consumer from JAPAN (weight: NA) was suffering from NA and was treated with Alcohol (dosage: NA) starting Jan 08, 2012.Other concurrent medications:
  • Risperdal (82 Tablets Of 1 Mg Tablet)


Unresponsive To Stimuli, Accidental Overdose, Toxicity To Various Agents, Pulmonary Oedema, Alcohol Poisoning, Pulmonary Congestion
A 35-year-old male patient from UNITED STATES (weight: NA) presented with the following symptoms: NA and after a treatment with Alcohol (ethanol) (dosage: NA) experienced the following side effect(s):
  • Unresponsive To Stimuli
  • Accidental Overdose
  • Toxicity To Various Agents
  • Pulmonary Oedema
  • Alcohol Poisoning
  • Pulmonary Congestion
The treatment was started on NS. Alcohol (ethanol) was used in combination with the following drugs:
  • Opana (Oral)
This report could alert potential Alcohol (ethanol) consumers.

Suicidal Ideation, Weight Decreased, Pain Of Skin, Headache, Injection Site Mass, Viral Infection, Abdominal Pain Upper, Nasopharyngitis
In this report, a male patient from UNITED STATES (weight: NA) was affected by a possible Alcohol side effect.The patient was diagnosed with NA. After a treatment with Alcohol (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Suicidal Ideation
  • Weight Decreased
  • Pain Of Skin
  • Headache
  • Injection Site Mass
  • Viral Infection
  • Abdominal Pain Upper
  • Nasopharyngitis
The following simultaneously used drugs could have led to this reaction:
  • Ribavirin
  • Abilify
  • Pegasys
  • Cymbalta
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Alcohol treatment.

Hepatic Enzyme Increased
This is a report of a male patient from UNITED STATES (weight: NA), who used Alcohol (dosage: NA) for a treatment of NA. After starting a treatment on May 20, 2009, the patient experienced the following side effect(s):
  • Hepatic Enzyme Increased
The following drugs could possibly have interacted with the Alcohol treatment
  • Medrol
  • Trazodone Hcl
  • Medrol
  • Protonix
  • Simponi
  • Simponi
  • Celexa
  • Lortab (7.5/500)
Taken together, these observations suggest that a Alcohol treatment could be related to side effect(s), such as Hepatic Enzyme Increased.

Somnolence, Coma, Acidosis, Respiratory Failure
This somnolence side effect was reported by a health professional from GERMANY. A male patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Alcohol (dosage: NA), which was started on NS. Concurrently used drugs:
  • Zyban
When starting to take Alcohol the consumer reported the following symptoms:
  • Somnolence
  • Coma
  • Acidosis
  • Respiratory Failure
The patient was hospitalized. These side effects may potentially be related to Alcohol.

Overdose, Suicide Attempt
This is a Alcohol side effect report of a 46-year-old male patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Alcohol (dosage:NA, start time: NS), combined with:
  • Barbiturates
  • Seroquel Xr
  • Paxil
, and developed a serious reaction and a overdose side effect. The patient presented with:
  • Overdose
  • Suicide Attempt
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Alcohol treatment in male patients suffering from NA, resulting in overdose.

Overdose
This report suggests a potential Alcohol overdose side effect(s) that can have serious consequences. A 46-year-old male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): NA and used Alcohol (dosage: NA) starting NS. Soon after starting Alcohol the patient began experiencing various side effects, including:
  • Overdose
Drugs used concurrently:
  • Barbiturates
  • Paxil
  • Seroquel Xr
The patient was hospitalized. Although Alcohol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as overdose, may still occur.

Hypersensitivity, Liver Injury, Hepatocellular Injury, Eosinophilia
This hypersensitivity problem was reported by a health professional from SPAIN. A 25-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Alcohol (dosage: 24 G, Daily). The following drugs/medications were being taken at the same time:
  • Acetaminophen (3250 Mg, Daily)
  • Bisacodyl
  • Metoclopramide
When commencing Alcohol, the patient experienced the following unwanted symptoms /side effects:
  • Hypersensitivity
  • Liver Injury
  • Hepatocellular Injury
  • Eosinophilia
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hypersensitivity, may become evident only after a product is in use by the general population.

Coma, Cytolytic Hepatitis, Cerebral Ischaemia, Suicide Attempt, Hyperkalaemia, Metabolic Acidosis
This is a Alcohol side effect report of a 25-year-old male patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: NA and was treated with Alcohol (dosage: Unk) starting Mar 07, 2012. Concurrently used drugs:
  • Lyrica (Daily Intake-single Dose)
  • Acetaminophen (Daily Dose-single Intake)
  • Clonazepam (Daily Dose-single Intake)
  • Atarax (Daily Dose-single Intake)
Soon after that, the consumer experienced the following of symptoms:
  • Coma
  • Cytolytic Hepatitis
  • Cerebral Ischaemia
  • Suicide Attempt
  • Hyperkalaemia
  • Metabolic Acidosis
The patient was hospitalized. This opens a possibility that Alcohol could cause coma and that some male patients may be more susceptible.

Road Traffic Accident, Imprisonment, Incoherent, Automatism, Alcohol Use, Somnambulism, Amnesia
A 34-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: NA started Alcohol treatment (dosage: 10 Mg, Hs) on NS. Soon after starting Alcohol treatment, the consumer experienced several side effects, including:
  • Road Traffic Accident
  • Imprisonment
  • Incoherent
  • Automatism
  • Alcohol Use
  • Somnambulism
  • Amnesia
. Concurrently used drugs:
  • Zolpidem Tartrate (10 Mg, Hs)
This finding indicates that some patients can be more vulnerable to developing Alcohol side effects, such as road traffic accident.

Withdrawal Syndrome, Delusion, Suicide Attempt, Intentional Overdose, Aggression
This withdrawal syndrome side effect was reported by a physician from FRANCE. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Alcohol (dosage: Unk), which was started on NS. Concurrently used drugs:
  • Lyrica (500-600 Mg Daily)
.When starting to take Alcohol the consumer reported symptoms, such as:
  • Withdrawal Syndrome
  • Delusion
  • Suicide Attempt
  • Intentional Overdose
  • Aggression
These side effects may potentially be related to Alcohol. The patient was hospitalized.

Suicide Attempt, Toxicity To Various Agents, Nervous System Disorder
This is a report of a 28-year-old female patient (weight: NA) from SWAZILAND, suffering from the following symptoms/conditions: NA, who was treated with Alcohol (ethanol) (dosage: NA, start time: Jun 09, 2011), combined with:
  • Remeron (30 Mg; Once; Po)
  • Gamma Hydroxy Butarate (gamma-hydroxybutarate)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Suicide Attempt
  • Toxicity To Various Agents
  • Nervous System Disorder
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Alcohol (ethanol) treatment in female patients, resulting in suicide attempt side effect. The patient was hospitalized.

Self Injurious Behaviour
This report suggests a potential Alcohol Self Injurious Behaviour side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from ITALY was diagnosed with the following symptoms/conditions: self injurious behaviour and used Alcohol (dosage: NA) starting Mar 27, 2012. Soon after starting Alcohol the patient began experiencing various side effects, including:
  • Self Injurious Behaviour
Drugs used concurrently:
  • Risperdal
  • Acetaminophen
  • Zoloft
  • Risperdal
Although Alcohol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as self injurious behaviour, may still occur.

Road Traffic Accident, Head Injury, Spinal Fracture, Rib Fracture, Skull Fracture, Sternal Fracture, Chest Injury, Contusion, Subdural Haemorrhage
This Road Traffic Accident, Head Injury, Spinal Fracture, Rib Fracture, Skull Fracture, Sternal Fracture, Chest Injury, Contusion, Subdural Haemorrhage problem was reported by a health professional from UNITED STATES. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Alcohol (ethanol) (dosage: NA). The following drugs were being taken at the same time:
  • Oxycodone Hcl
  • Soma
  • Temazepam
When commencing Alcohol (ethanol), the patient experienced the following unwanted symptoms/side effects:
  • Road Traffic Accident
  • Head Injury
  • Spinal Fracture
  • Rib Fracture
  • Skull Fracture
  • Sternal Fracture
  • Chest Injury
  • Contusion
  • Subdural Haemorrhage
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as road traffic accident, may become evident only after a product is in use by the general population.

Blood Alcohol Increased, Contusion, Eyelid Oedema, Road Traffic Accident, Skull Fracture, Basal Ganglia Haemorrhage, Arteriosclerosis, Aspiration, Excoriation
This is a report of a 49-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Alcohol (dosage: NA) starting NS. Concurrently used drugs:
  • Oxycodone Hcl
  • Soma
  • Meprobamate
  • Tenazepam Capsules, 30 Mg (purepac)
Soon after that, the consumer experienced the following side effects:
  • Blood Alcohol Increased
  • Contusion
  • Eyelid Oedema
  • Road Traffic Accident
  • Skull Fracture
  • Basal Ganglia Haemorrhage
  • Arteriosclerosis
  • Aspiration
  • Excoriation
This opens a possibility that Alcohol treatment could cause the above reactions, including blood alcohol increased, and some male subjects may be more susceptible.

Suicidal Ideation, Vomiting, Weight Decreased, Injection Site Ulcer, Back Pain, Pain Of Skin, Myalgia, Ill-defined Disorder, Fractured Coccyx
A male patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Alcohol treatment (dosage: NA) on NS. Soon after starting Alcohol treatment, the subject experienced various side effects, including:
  • Suicidal Ideation
  • Vomiting
  • Weight Decreased
  • Injection Site Ulcer
  • Back Pain
  • Pain Of Skin
  • Myalgia
  • Ill-defined Disorder
  • Fractured Coccyx
Concurrently used drugs:
  • Pegasys
  • Ribavirin
  • Abilify
  • Cymbalta
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Alcohol.

1 of 13 



Top 10 Alcohol Side Effects for Men

Men Side EffectsReports
Road Traffic Accident 19
Product Quality Issue 17
Fall 15
Amnesia 12
Intentional Overdose 12
Overdose 12
Suicide Attempt 12
Coma 11
Vomiting 11
Nausea 10

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Alcohol Side Effects

    Did You Have a Alcohol Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Alcohol for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Alcohol Safety Alerts, Active Ingredients, Usage Information

    NDC0219-0203
    TypeHUMAN OTC DRUG
    Proprietary NameHumphreys Bendito Alcoholado
    Namementhol
    Dosage FormLIQUID
    RouteTOPICAL
    On market since19720111
    LabelerHumphreys Pharmacal, Incorporated
    Active Ingredient(s)MENTHOL
    Strength(s)12.5
    Unit(s)mg/mL
    Pharma Class

    More About Alcohol

    Side Effects reported to FDA: 325

    Alcohol safety alerts: 2013 2012 2011 2008 2005

    Reported deaths: 47

    Reported hospitalizations: 77

    Xyrem (sodium oxybate): Drug Safety Communication - Warning Against Use With Alcohol or Drugs Causing Respiratory Depression

     

    [Posted 12/17/2012]

    AUDIENCE: Neurology, Internal Medicine, Patient

    ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided.

    The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.

    BACKGROUND: Xyrem (sodium oxybate) is FDA-approved to reduce attacks of muscle weakness (cataplexy) and treat daytime sleepiness in patients with narcolepsy. Sodium oxybate, the active ingredient of Xyrem, is also known as gamma-hydroxybutyrate (GHB). GHB is a known drug of abuse that has been associated with central nervous system (CNS) adverse events, including death. Even at recommended doses, Xyrem can cause confusion, depression, and other neuropsychiatric events.

    RECOMMENDATION: Healthcare professionals are urged to follow the dosing recommendations, contraindications, and boxed warning in the updated Xyrem drug label and to avoid drug combinations that raise the risk of respiratory depression and death. Patients taking Xyrem should not drink alcohol or take insomnia drugs. See the FDA Drug Safety Communication for a Data Summary.


    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [12/17/2012 - Drug Safety Communication - FDA]
    [12/17/2012 - Xyrem (sodium oxybate) Prescribing Information, December 2012]

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