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Atarax (Hydroxyzine) - Somnolence - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Somnolence (19)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Atarax (Hydroxyzine) where reactions include somnolence. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Atarax side effects in 81 year old female

Reported by a physician from Japan on 2012-04-05

Patient: 81 year old female

Reactions: Blood Bilirubin Increased, Autoimmune Hepatitis, Hepatic Failure, Blood Albumin Decreased, Prothrombin Time Prolonged, Activated Partial Thromboplastin Time Prolonged, Hepatic Encephalopathy, Blood Immunoglobulin G Increased, Malaise, Dermatitis, Oedema Peripheral, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Blood Cholinesterase Decreased, General Physical Health Deterioration, Chromaturia, Prothrombin Time Ratio Decreased, Faeces Pale, Aspartate Aminotransferase Increased, Bilirubin Conjugated Increased, Jaundice, Somnolence, Hepatitis, Liver Disorder, Blood Fibrinogen Decreased, Gamma-Glutamyltransferase Increased, Hepatic Atrophy, Decreased Appetite, Blood Immunoglobulin A Increased, Alanine Aminotransferase Increased, Protein Total Decreased, Ascites, Oliguria, Epstein-Barr Virus Antibody Positive, Albumin Globulin Ratio Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Celestamine TAB
    Dosage: 2 df, 1x/day
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-14
    End date: 2011-11-20

Atarax
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-21
    End date: 2011-11-27

Olopatadine HCL
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-28
    End date: 2011-11-29

Xyzal
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-10
    End date: 2011-11-13

Other drugs received by patient: Gastrom; Lansoprazole; Bezalip



Possible Atarax side effects in 81 year old female

Reported by a physician from Japan on 2012-04-04

Patient: 81 year old female

Reactions: Blood Bilirubin Increased, Allergic Hepatitis, Autoimmune Hepatitis, Blood Albumin Decreased, Hepatic Failure, Prothrombin Time Prolonged, Activated Partial Thromboplastin Time Prolonged, Malaise, Hepatic Encephalopathy, Blood Immunoglobulin G Increased, Dermatitis, Oedema Peripheral, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, General Physical Health Deterioration, Chromaturia, Blood Cholinesterase Decreased, Prothrombin Time Ratio Decreased, Faeces Pale, Aspartate Aminotransferase Increased, Bilirubin Conjugated Increased, Jaundice, Somnolence, Liver Disorder, Blood Fibrinogen Decreased, Gamma-Glutamyltransferase Increased, Hepatic Atrophy, Decreased Appetite, Blood Immunoglobulin A Increased, Alanine Aminotransferase Increased, Protein Total Decreased, Ascites, Oliguria, Epstein-Barr Virus Antibody Positive, Albumin Globulin Ratio Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atarax
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-21
    End date: 2011-11-27

Xyzal
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-10
    End date: 2011-11-13

Celestamine TAB
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-14
    End date: 2011-11-20

Olopatadine HCL
    Administration route: Oral
    Indication: Erythema
    Start date: 2011-11-28
    End date: 2011-11-29

Other drugs received by patient: Gastrom; Bezalip; Lansoprazole



Possible Atarax side effects in 43 year old female

Reported by a physician from Germany on 2012-03-16

Patient: 43 year old female

Reactions: Blood Pressure Systolic Decreased, Vomiting, Limb Injury, Multiple Drug Overdose Intentional, Suicide Attempt, Bradycardia, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Chlorprothixene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Melperone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Enoxaparin Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Atarax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Lithium Carbonate
    Dosage: 450
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Clopidogrel
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01



Possible Atarax side effects in 43 year old female

Reported by a physician from Germany on 2012-03-15

Patient: 43 year old female

Reactions: Blood Pressure Systolic Decreased, Vomiting, Overdose, Limb Injury, Suicide Attempt, Bradycardia, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorprothixene
    Dosage: 150 mg, single, ingestion not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Lithium Carbonate
    Dosage: quilonom retard tablet 450
    Administration route: Oral

Melperone Hydrochloride
    Dosage: 15 tablets, oral ingestion not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Ibuprofen Tablets
    Dosage: 1200 mg, single, ingestion not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Atarax
    Dosage: 350 mg, single
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Clopidogrel
    Dosage: 750 mg, single, not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Enoxaparin Sodium
    Dosage: 80 mg, single
    Start date: 2012-02-01
    End date: 2012-02-01



Possible Atarax side effects in 81 year old female

Reported by a physician from Japan on 2012-03-15

Patient: 81 year old female

Reactions: Jaundice, Blood Bilirubin Increased, Blood Albumin Decreased, Hepatic Failure, Prothrombin Time Prolonged, Hepatitis, Somnolence, Liver Disorder, Activated Partial Thromboplastin Time Prolonged, Blood Fibrinogen Decreased, Malaise, Hepatic Encephalopathy, Blood Immunoglobulin G Increased, Gamma-Glutamyltransferase Increased, Hepatic Atrophy, Oedema Peripheral, Decreased Appetite, Blood Immunoglobulin A Increased, Blood Alkaline Phosphatase Increased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, General Physical Health Deterioration, Chromaturia, Blood Cholinesterase Decreased, Protein Total Decreased, Ascites, Prothrombin Time Ratio Decreased, Faeces Pale, Oliguria, Aspartate Aminotransferase Increased, Epstein-Barr Virus Antibody Positive, Bilirubin Conjugated Increased, Albumin Globulin Ratio Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-21
    End date: 2011-11-28

Xyzal
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-10
    End date: 2011-11-14

Celestamine TAB
    Dosage: 2 df, 1x/day
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-14
    End date: 2011-11-21

Olopatadine HCL
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-28
    End date: 2011-12-02



Possible Atarax side effects in 81 year old female

Reported by a physician from Japan on 2012-03-14

Patient: 81 year old female

Reactions: Blood Bilirubin Increased, Jaundice, Allergic Hepatitis, Hepatic Failure, Blood Albumin Decreased, Prothrombin Time Prolonged, Somnolence, Liver Disorder, Activated Partial Thromboplastin Time Prolonged, Blood Immunoglobulin G Increased, Malaise, Hepatic Encephalopathy, Blood Fibrinogen Decreased, Hepatic Atrophy, Gamma-Glutamyltransferase Increased, Oedema Peripheral, Blood Immunoglobulin A Increased, Decreased Appetite, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, General Physical Health Deterioration, Chromaturia, Blood Cholinesterase Decreased, Protein Total Decreased, Ascites, Prothrombin Time Ratio Decreased, Faeces Pale, Aspartate Aminotransferase Increased, Oliguria, Epstein-Barr Virus Antibody Positive, Bilirubin Conjugated Increased, Albumin Globulin Ratio Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xyzal
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-10
    End date: 2011-11-14

Atarax
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-21
    End date: 2011-11-28

Olopatadine HCL
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-28
    End date: 2011-12-02

Celestamine TAB
    Administration route: Oral
    Indication: Pruritus
    Start date: 2011-11-14
    End date: 2011-11-21



Possible Atarax side effects in 54 year old male

Reported by a consumer/non-health professional from France on 2012-03-06

Patient: 54 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Multiple Drug Overdose Intentional, Suicide Attempt, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valdoxan
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2012-02-17

Valdoxan
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2011-10-25
    End date: 2012-02-15

Valdoxan
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Depression
    Start date: 2011-08-16
    End date: 2011-10-24

Valdoxan
    Dosage: 625 mg, daily
    Administration route: Oral
    Start date: 2011-02-16
    End date: 2011-02-16

Atarax
    Dosage: unk ukn, unk
    Start date: 2012-02-16
    End date: 2012-02-16

Simvastatin
    Dosage: unk ukn, unk

Other drugs received by patient: Allopurinol; Irbesartan; Glucophage; Zolpidem



Possible Atarax side effects in 43 year old female

Reported by a physician from Germany on 2012-03-02

Patient: 43 year old female

Reactions: Vomiting, Suicide Attempt, Multiple Drug Overdose Intentional, Somnolence

Drug(s) suspected as cause:
Melperone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Clopidogrel
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Ibuprofen Tablets
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Enoxaparin Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Chlorprothixene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01

Atarax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-02-01



Possible Atarax side effects in 43 year old female

Reported by a physician from Germany on 2012-02-29

Patient: 43 year old female

Reactions: Overdose, Vomiting, Suicide Attempt, Somnolence

Drug(s) suspected as cause:
Atarax
    Dosage: 350 mg, single, ingestion not assured.
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Chlorprothixene
    Dosage: 150 mg, single, ingestion not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Ibuprofen
    Dosage: 1200 mg, single, ingestion not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Clopidogrel
    Dosage: 750 mg, single, not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01

Enoxaparin Sodium
    Dosage: 80 mg, single
    Start date: 2012-02-01
    End date: 2012-02-01

Melperone
    Dosage: 15 df, single, ingestion not assured
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-02-01



Possible Atarax side effects in 36 year old female

Reported by a physician from France on 2012-02-10

Patient: 36 year old female

Reactions: Injection Site Haematoma, Somnolence, Injection Site Erythema, Fatigue, Skin Ulcer, Balance Disorder, Injection Site Induration, Injection Site Warmth, Heart Rate Irregular, Erythema Multiforme, Nervousness, Staphylococcal Skin Infection, Eye Inflammation, Impetigo, Skin Hypertrophy, Injection Site Pruritus, Systemic Lupus Erythematosus, Vertigo, Neuralgia, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 1 dose on the previous and on the same day as the injection of enbrel
    Indication: Premedication
    Start date: 2009-07-15
    End date: 2009-07-16

Enbrel
    Dosage: 50.0 mg, weekly
    Indication: Ankylosing Spondylitis
    Start date: 2009-07-02

Other drugs received by patient: Aerius / 01398501 /



Possible Atarax side effects in 58 year old female

Reported by a physician on 2012-01-20

Patient: 58 year old female

Reactions: Speech Disorder, Systolic Hypertension, Suicide Attempt, Toxicity To Various Agents, Somnolence, Hallucination

Drug(s) suspected as cause:
Atarax
    Dosage: (1875 mg, total), oral
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2011-12-01

Mirtazapine
    Dosage: (750 mg, total), oral
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2011-12-01

Hypnotics and Sedatives (Hypnotics and Sedatives)
    Dosage: (10 dosage forms), oral
    Administration route: Oral
    Indication: Suicide Attempt



Possible Atarax side effects in 58 year old female

Reported by a physician on 2011-12-22

Patient: 58 year old female

Reactions: Speech Disorder, Systolic Hypertension, Incorrect Dose Administered, Suicide Attempt, Somnolence

Drug(s) suspected as cause:
Atarax
    Dosage: (75 dosage forms,total)
    Indication: Suicide Attempt
    Start date: 2011-12-01

Mirtazapine
    Dosage: (50 dosage forms,total)
    Indication: Suicide Attempt
    Start date: 2011-12-01



Possible Atarax side effects in 58 year old female

Reported by a physician on 2011-12-21

Patient: 58 year old female

Reactions: Speech Disorder, Systolic Hypertension, Incorrect Dose Administered, Suicide Attempt, Somnolence

Drug(s) suspected as cause:
Mirtazapine
    Dosage: (50 dosage forms, total)
    Indication: Suicide Attempt
    Start date: 2011-12-01

Atarax
    Dosage: (75 dosage forms, total)
    Indication: Suicide Attempt
    Start date: 2011-12-01



Possible Atarax side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-16

Patient: 58 year old male

Reactions: Electroencephalogram Abnormal, Hypokinesia, Phlebotomy, HIV Test Positive, Major Depression, Somnolence, Craniocerebral Injury, Fall, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xanax
    Dosage: 0.5 mg x 2 df (1 mg), daily
    Administration route: Oral

Havlane
    Dosage: 0.5 df, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-06

Paroxetine HCL
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-10

Gardenale
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    End date: 2011-10-13

Tiapridal
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-06

Xanax
    Dosage: 0.25 mg, 2x/day
    Administration route: Oral
    End date: 2011-10-12

Atarax
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-06

Xanax
    Dosage: 0.5 mg x 5 df (2.5 mg), daily
    Administration route: Oral
    Start date: 2010-06-25

Gardenale
    Dosage: 180 mg, 1x/day
    Administration route: Oral
    Start date: 2011-10-14
    End date: 2011-10-14

Other drugs received by patient: Norvir; Insulin Detemir; Abacavir Sulfate and Lamivudine; Maraviroc; Maraviroc; Lamictal; Novorapid; Reyataz



Possible Atarax side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-16

Patient: male

Reactions: Suicide Attempt, Toxicity To Various Agents, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-05

Methocarbamol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-05

Alcohol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-05

Atarax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-05

Naproxen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-05

Ibuprofen
    Administration route: Oral

Ciprofloxacin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-05



Possible Atarax side effects in 15 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-16

Patient: 15 year old male

Reactions: Suicide Attempt, Toxicity To Various Agents, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methocarbamol
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2011-09-05

Ibuprofen
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2011-09-05

Naproxen
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2011-09-05

Ciprofloxacin HCL
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2011-09-05

Atarax
    Dosage: unk
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2011-09-05



Possible Atarax side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-14

Patient: 58 year old male

Reactions: Electroencephalogram Abnormal, Phlebotomy, Hypokinesia, HIV Test Positive, Major Depression, Somnolence, Craniocerebral Injury, Fall, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xanax
    Dosage: 0.25 mg, 2x/day
    Administration route: Oral
    End date: 2011-10-12

Atarax
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-06

Tiapridal
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-06

Gardenale
    Dosage: 180 mg, 1x/day
    Administration route: Oral
    Start date: 2011-10-14
    End date: 2011-10-14

Havlane
    Dosage: 0.5 df, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-06

Paroxetine HCL
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Start date: 2010-06-25
    End date: 2011-10-10

Xanax
    Dosage: 0.5 mg x 5 df (2.5 mg), daily
    Administration route: Oral
    Start date: 2010-06-25

Xanax
    Dosage: 0.5 mg x 2 df (1 mg), daily
    Administration route: Oral

Gardenale
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    End date: 2011-10-13

Other drugs received by patient: Reyataz; Maraviroc; Abacavir Sulfate; Norvir



Possible Atarax side effects in 62 year old male

Reported by a physician from France on 2011-12-12

Patient: 62 year old male

Reactions: Fatigue, Somnolence, Suicidal Ideation

Drug(s) suspected as cause:
Atarax
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Anxiety

Keppra
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Lamictal



Possible Atarax side effects in male

Reported by a physician from France on 2011-12-07

Patient: male

Reactions: Fall, Somnolence, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paroxetine HCL
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-25

Tiapridal
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-25
    End date: 2011-10-06

Phenobarbital TAB
    Dosage: 200mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-14

Atarax
    Dosage: 25mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-25
    End date: 2011-10-06

Havlane
    Dosage: .5unit per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-25
    End date: 2011-10-06

Xanax
    Dosage: 2.5mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-06-25
    End date: 2011-10-12

Other drugs received by patient: Maraviroc; Norvir; Novorapid; Levemir; Urbanyl; Imovane; Abacavir Sulfate; Reyataz; Lamictal

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