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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