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Etizolam Side Effects

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Common Etizolam Side Effects


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

Aspartate Aminotransferase Increased (3)
Suicide Attempt (3)
Chest Pain (3)
Alanine Aminotransferase Increased (2)
Acute Myocardial Infarction (2)
Altered State Of Consciousness (2)
Cerebral Haemorrhage (2)
Delirium (2)
Convulsion (2)
Dizziness (2)
Body Temperature Increased (2)
Thinking Abnormal (2)
Liver Disorder (2)
Gait Disturbance (2)
Mydriasis (2)
Respiratory Disorder (2)
Serotonin Syndrome (2)
Schizophrenia (2)
Dyspnoea (2)
Loss Of Consciousness (1)

➢ 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.

Etizolam Side Effects Reported to FDA



Etizolam Side Effect Report#8411143-X
Thirst, Decreased Appetite, Hyperkalaemia, Diarrhoea
This is a report of a male patient (weight: NA) from Denmark, suffering from the following health symptoms/conditions: NA, who was treated with Etizolam (dosage: 2 Mg, start time:
Mar 03, 2012), combined with:
  • Mirtazapine
  • Escitalopram (10 Mg)
  • Flunitrazepam (1 Mg)
and developed a serious reaction and side effect(s): Thirst, Decreased Appetite, Hyperkalaemia, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in male patients, resulting in Thirst side effect.
Etizolam Side Effect Report#8319547-0
Diabetes Mellitus, Blood Potassium Decreased, Electrocardiogram Qt Prolonged
This report suggests a potential Etizolam Diabetes Mellitus side effect(s) that can have serious consequences. A male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Etizolam (dosage: 0.5 Mg, Unk) starting
Sep 12, 2009. After starting Etizolam the patient began experiencing various side effects, including: Diabetes Mellitus, Blood Potassium Decreased, Electrocardiogram Qt ProlongedAdditional drugs used concurrently:
  • Tasigna (800 Mg, Qd)
  • Allorine (100 Mg, Unk)
  • Amaryl (1 Mg, Unk)
  • Voglibose (0.9 Mg, Unk)
  • Amaryl (3 Mg, Unk)
  • Amaryl (2.5 Mg, Unk)
  • Basen (0.6 Mg, Unk)
  • Zolpidem (5 Mg, Unk)
Although Etizolam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diabetes Mellitus, may still occur.
Etizolam Side Effect Report#8278089
Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased
This Alanine Aminotransferase Increased problem was reported by a physician from JP. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 10, 2011 this consumer started treatment with Etizolam (dosage: NA). The following drugs were being taken at the same time:
  • Peginterferon Alfa-2a
  • Peginterferon Alfa-2a
When using Etizolam, the patient experienced the following unwanted symptoms/side effects: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin IncreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Alanine Aminotransferase Increased, may become evident only after a product is in use by the general population.
Etizolam Side Effect Report#8256515-1
Dysarthria, Serotonin Syndrome, Tremor, Facial Spasm
This Dysarthria side effect was reported by a pharmacist from Japan. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Etizolam (drug dosage: NA), which was initiated on
Aug 01, 2011. Concurrently used drugs:
  • Lansoprazole
  • Luvox (Po)
  • Tramadol Hydrohloride (25 Mg;qid;po)
  • Prochlorperazine Maleate
  • Mirtazapine (Po)
  • Magnesium Oxide
.After starting to take Etizolam the consumer reported adverse symptoms, such as: Dysarthria, Serotonin Syndrome, Tremor, Facial SpasmThese side effects may potentially be related to Etizolam. The patient was hospitalized.
Etizolam Side Effect Report#8243041-9
Blepharospasm
This is a report of a 36-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Etizolam (dosage: Unk, start time: NS), combined with:
  • Sulpiride (Unk)
  • Diazepam (Unk)
  • Alprazolam (Unk)
  • Paroxetine Hcl (Unk)
and developed a serious reaction and side effect(s): Blepharospasm after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in male patients, resulting in Blepharospasm side effect.
Etizolam Side Effect Report#8207683-9
Adult T-cell Lymphoma/leukaemia
This report suggests a potential Etizolam Adult T-cell Lymphoma/leukaemia side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: anxiety disorder,prophylaxis,constipation,hypercholesterolaemia and used Etizolam (dosage: Unk) starting
Jul 12, 2011. After starting Etizolam the patient began experiencing various side effects, including: Adult T-cell Lymphoma/leukaemiaAdditional drugs used concurrently:
  • Aspirin (Unk)
  • Yodel (Unk)
  • Lipitor (10 Mg, 1x/day)
The patient was hospitalized. Although Etizolam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adult T-cell Lymphoma/leukaemia, may still occur.
Etizolam Side Effect Report#8189535-6
Dizziness, Schizophrenia, Delusion, Somnolence
This Dizziness problem was reported by a physician from Japan. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 26, 2012 this consumer started treatment with Etizolam (etizolam) (dosage: 0.5 Mg;unk;po). The following drugs were being taken at the same time:
  • Flunitrazepam (flunitrazepam) (2 Mg;unk;po)
  • Ethyl Loflazepate (ethyl Loflazepate) (1 Mg;qd;po)
  • Mirtazapine (15 Mg;once;po, 7.5 Mg;once;po)
  • Mirtazapine (15 Mg;once;po, 7.5 Mg;once;po)
When using Etizolam (etizolam), the patient experienced the following unwanted symptoms/side effects: Dizziness, Schizophrenia, Delusion, SomnolenceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Etizolam Side Effect Report#8179978-9
Suicide Attempt, Mydriasis, Thinking Abnormal, Blood Creatine Phosphokinase Increased, Heart Rate Increased, Cognitive Disorder, Asthenia, Body Temperature Increased, Delirium
This Suicide Attempt side effect was reported by a health professional from Japan. A 17-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Etizolam (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Diphenhydramine Hcl (72 Tabs.)
  • Abilify
  • Nitrazepam
.After starting to take Etizolam the consumer reported adverse symptoms, such as: Suicide Attempt, Mydriasis, Thinking Abnormal, Blood Creatine Phosphokinase Increased, Heart Rate Increased, Cognitive Disorder, Asthenia, Body Temperature Increased, DeliriumThese side effects may potentially be related to Etizolam. The patient was hospitalized.
Etizolam Side Effect Report#8158786-9
Completed Suicide, Asphyxia
This is a report of a 59-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Etizolam (dosage: NA, start time:
Oct 20, 2010), combined with:
  • Paroxetine
  • Mirtazapine (15 Mg;qd;po;7.5 Mg;qd;po;15 Mg;qd;po)
  • Mirtazapine (15 Mg;qd;po;7.5 Mg;qd;po;15 Mg;qd;po)
  • Mirtazapine (15 Mg;qd;po;7.5 Mg;qd;po;15 Mg;qd;po)
  • Sulpiride
  • Hydrochoride
and developed a serious reaction and side effect(s): Completed Suicide, Asphyxia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in male patients, resulting in Completed Suicide side effect.
Etizolam Side Effect Report#8110540-X
Thinking Abnormal, White Blood Cell Count Increased, Suicide Attempt, Mydriasis, Body Temperature Increased, Muscle Tightness, Serotonin Syndrome, Delirium, Soliloquy
This report suggests a potential Etizolam Thinking Abnormal side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Etizolam (dosage: NA) starting NS. After starting Etizolam the patient began experiencing various side effects, including: Thinking Abnormal, White Blood Cell Count Increased, Suicide Attempt, Mydriasis, Body Temperature Increased, Muscle Tightness, Serotonin Syndrome, Delirium, SoliloquyAdditional drugs used concurrently:
  • Abilify
  • Diphenhydramine Hcl (72 Tabs.)
  • Nitrazepam
The patient was hospitalized. Although Etizolam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thinking Abnormal, may still occur.
Etizolam Side Effect Report#8076175-2
Stevens-johnson Syndrome, Loss Of Consciousness, Hallucination, Dizziness, Toxic Epidermal Necrolysis, Parkinson's Disease
This Stevens-johnson Syndrome problem was reported by a health professional from Japan. A 86-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: autonomic nervous system imbalance. On
Jul 26, 2011 this consumer started treatment with Etizolam (dosage: Daily Dose .5 Mg). The following drugs were being taken at the same time:
  • Aspirin (Daily Dose 100 Mg)
  • Ebrantil (Unk)
  • Zonisamide (Daily Dose 100 Mg)
  • Asnamin Z (aspirin Aluminium)
  • Tamsulosin Hcl (Daily Dose .2 Mg)
  • Paxil (Daily Dose 10 Mg)
  • Mucosta
  • Risedronate Sodium
When using Etizolam, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson Syndrome, Loss Of Consciousness, Hallucination, Dizziness, Toxic Epidermal Necrolysis, Parkinson's DiseaseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Etizolam Side Effect Report#8018863-X
Pyelonephritis, Dyskinesia, Septic Shock, Teratoma
This Pyelonephritis side effect was reported by a physician from Japan. A 37-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Etizolam (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Rilmazafone Hydrochloride
  • Flunitrazepam
  • Risperdal
  • Vegetamin-a
  • Bromazepam
  • Brotizolam
  • Levomepromazine Maleate
  • Trihexyphenidyl Hcl
.After starting to take Etizolam the consumer reported adverse symptoms, such as: Pyelonephritis, Dyskinesia, Septic Shock, TeratomaThese side effects may potentially be related to Etizolam. The patient was hospitalized.
Etizolam Side Effect Report#7913904-X
Altered State Of Consciousness, Intentional Overdose, Dyspnoea
This is a report of a 30-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: depression, who was treated with Etizolam (dosage: NA, start time: NS), combined with:
  • Cloxazolam
  • Tandospirone Citrate
  • Phenobarbital Tab
  • Phenobarbital Tab
  • Estazolam
  • Flunitrazepam
  • Quazepam
  • Oxazolam
and developed a serious reaction and side effect(s): Altered State Of Consciousness, Intentional Overdose, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in female patients, resulting in Altered State Of Consciousness side effect. The patient was hospitalized.
Etizolam Side Effect Report#7807714-1
Aspartate Aminotransferase Increased, Respiratory Disorder, Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased, Cardiac Failure, Liver Disorder, Oedema Peripheral
This report suggests a potential Etizolam Aspartate Aminotransferase Increased side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Etizolam (dosage: NA) starting
Feb 10, 2010. After starting Etizolam the patient began experiencing various side effects, including: Aspartate Aminotransferase Increased, Respiratory Disorder, Blood Alkaline Phosphatase Increased, Gamma-glutamyltransferase Increased, Cardiac Failure, Liver Disorder, Oedema PeripheralAdditional drugs used concurrently:
  • Serrapeptase
  • Nifedipine
  • Tracleer (62.5 Mg, Bid)
  • Nizatidine
  • Beraprost Sodium
  • Temisartan
  • Terbinafine Hcl
  • Mosapride Citrate
The patient was hospitalized. Although Etizolam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aspartate Aminotransferase Increased, may still occur.
Etizolam Side Effect Report#7794672-1
Hypoglycaemia
This Hypoglycaemia problem was reported by a physician from Japan. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 12, 2011 this consumer started treatment with Etizolam (dosage: NA). The following drugs were being taken at the same time:
  • Alprazolam
  • Mirtazapine (7.5 Mg;qd;po)
  • Loperamide Hcl
When using Etizolam, the patient experienced the following unwanted symptoms/side effects: HypoglycaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemia, may become evident only after a product is in use by the general population.
Etizolam Side Effect Report#7761835-0
Overdose, Logorrhoea, Bipolar I Disorder, Agitated Depression, Chest Pain, Dyspnoea, Alcoholism, Insomnia, Suicidal Ideation
This Overdose side effect was reported by a physician from Japan. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Etizolam (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Amoxapine (Unk)
  • Triazolam (Unk)
  • Sertraline Hydrochloride (Unk)
  • Alprazolam (Unk)
.After starting to take Etizolam the consumer reported adverse symptoms, such as: Overdose, Logorrhoea, Bipolar I Disorder, Agitated Depression, Chest Pain, Dyspnoea, Alcoholism, Insomnia, Suicidal IdeationThese side effects may potentially be related to Etizolam. The patient was hospitalized.
Etizolam Side Effect Report#7757389-5
Respiratory Disorder, Gastrointestinal Haemorrhage, Endotracheal Intubation, Traumatic Intracranial Haemorrhage, Subarachnoid Haemorrhage, Convulsion, Brain Oedema, Fall, Surgery
This is a report of a female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Etizolam (dosage: NA, start time:
Dec 02, 2007), combined with:
  • Sulpiride
  • Carbocisteine
  • Furosemide
  • Famotidine
  • Isosorbide Dinitrate
  • Carvedilol
  • Chlorpromazine
  • Magnesium Oxide
and developed a serious reaction and side effect(s): Respiratory Disorder, Gastrointestinal Haemorrhage, Endotracheal Intubation, Traumatic Intracranial Haemorrhage, Subarachnoid Haemorrhage, Convulsion, Brain Oedema, Fall, Surgery after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in female patients, resulting in Respiratory Disorder side effect.
Etizolam Side Effect Report#7738138-3
Lymphocyte Count Decreased, Dysuria, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Liver Disorder, Pain In Extremity, White Blood Cell Count Decreased
This report suggests a potential Etizolam Lymphocyte Count Decreased side effect(s) that can have serious consequences. A male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Etizolam (dosage: NA) starting
Jan 27, 2011. After starting Etizolam the patient began experiencing various side effects, including: Lymphocyte Count Decreased, Dysuria, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Liver Disorder, Pain In Extremity, White Blood Cell Count DecreasedAdditional drugs used concurrently:
  • Rebamipide
  • Sulfamethoxazole And Trimethoprim
  • Brotizolam
  • Miglitol
  • Isotonic Sodium Chloride
  • Rituximab
  • Triamcinolone Acetonide
  • Meropenem Hydrate
The patient was hospitalized. Although Etizolam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lymphocyte Count Decreased, may still occur.
Etizolam Side Effect Report#7725422-2
Deep Vein Thrombosis
This Deep Vein Thrombosis problem was reported by a consumer or non-health professional from Japan. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 09, 2011 this consumer started treatment with Etizolam (dosage: NA). The following drugs were being taken at the same time:
  • Risedronate Sodium
  • Fareston (40 Mg)
When using Etizolam, the patient experienced the following unwanted symptoms/side effects: Deep Vein ThrombosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deep Vein Thrombosis, may become evident only after a product is in use by the general population.
Etizolam Side Effect Report#7630919-X
Suicide Attempt, Schizophrenia
This Suicide Attempt side effect was reported by a health professional from Japan. A 29-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Etizolam (drug dosage: Upto 19jan2011.also 1 Mg/day), which was initiated on
Jan 20, 2011. Concurrently used drugs:
  • Risperdal (Tabs)
  • Abilify (12mg:27jan11-09feb11.10feb11-23feb11 14 Days.24mg 05mar11-mar11 6 Mg:20jan11-26jan11.7 Days)
  • Lendormin (Tabs)
  • Sennal (Tab,)
.After starting to take Etizolam the consumer reported adverse symptoms, such as: Suicide Attempt, SchizophreniaThese side effects may potentially be related to Etizolam. The patient was hospitalized.
Etizolam Side Effect Report#7594148-0
Convulsion, Road Traffic Accident
This is a report of a 27-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Etizolam (dosage: Unk, start time:
Jan 01, 2011), combined with:
  • Hirnamin (Unk)
  • Halcion (0.25 Mg, 1x/day)
  • Zolpidem (Unk)
and developed a serious reaction and side effect(s): Convulsion, Road Traffic Accident after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in male patients, resulting in Convulsion side effect. The patient was hospitalized.
Etizolam Side Effect Report#7505323-5
Adjustment Disorder, Memory Impairment, Communication Disorder, Anxiety, Judgement Impaired, Activation Syndrome, Depressed Mood, Altered State Of Consciousness
This report suggests a potential Etizolam Adjustment Disorder side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Etizolam (dosage: NA) starting
Feb 28, 2011. After starting Etizolam the patient began experiencing various side effects, including: Adjustment Disorder, Memory Impairment, Communication Disorder, Anxiety, Judgement Impaired, Activation Syndrome, Depressed Mood, Altered State Of ConsciousnessAdditional drugs used concurrently:
  • Estradiol
  • Fluvoxamine Maleate
  • Alprazolam
  • Mirtazapine (15 Mg;qd;po)
  • Mirtazapine (15 Mg;qd;po)
  • Mirtazapine (15 Mg;qd;po)
Although Etizolam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adjustment Disorder, may still occur.
Etizolam Side Effect Report#7479063-5
Chronic Myeloid Leukaemia Transformation
This Chronic Myeloid Leukaemia Transformation problem was reported by a physician from Japan. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 01, 1995 this consumer started treatment with Etizolam (dosage: NA). The following drugs were being taken at the same time:
  • Mosapride Citrate Hydrate
  • Humira
  • Ascorbic Acid/calcium Pantothenate
  • Sodium Risedronate Hydrate
  • Amlodipine Besylate
  • Folic Acid
  • Methotrexate
  • Sertraline Hydrochloride
When using Etizolam, the patient experienced the following unwanted symptoms/side effects: Chronic Myeloid Leukaemia TransformationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chronic Myeloid Leukaemia Transformation, may become evident only after a product is in use by the general population.
Etizolam Side Effect Report#7450966-0
Weight Increased, Liver Function Test Abnormal
This Weight Increased side effect was reported by a physician from Japan. A 34-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Etizolam (drug dosage: NA), which was initiated on
Jun 01, 2010. Concurrently used drugs:
  • Meilax
  • Paroxetine Hydrochloride
  • Ethyl Loflazepate
  • Zoloft
  • Mirtazapine (15 Mg;qd;po)
.After starting to take Etizolam the consumer reported adverse symptoms, such as: Weight Increased, Liver Function Test AbnormalThese side effects may potentially be related to Etizolam.
Etizolam Side Effect Report#7375379-1
Chest Pain, Cerebral Haemorrhage, Gait Disturbance, Acute Myocardial Infarction
This is a report of a female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: insomnia,hypertension,rheumatoid arthritis, who was treated with Etizolam (dosage: 0.5 Daily, start time:
May 06, 2010), combined with:
  • Amlodipine Besylate
  • Humira
  • Prednisolone (5mg Daily)
  • Celecoxib (200mg Daily)
  • Rebamipide (200mg Daily)
  • Bucillamine
  • Raloxifene Hydrochloride (60mg Daily)
and developed a serious reaction and side effect(s): Chest Pain, Cerebral Haemorrhage, Gait Disturbance, Acute Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Etizolam treatment in female patients, resulting in Chest Pain side effect. The patient was hospitalized and became disabled.

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The appearance of Etizolam 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.


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

    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.

    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.

    Etizolam 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.

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    Side Effects reported to FDA: 27

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    Reported deaths: 4

    Reported hospitalizations: 16

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