Index of reports
> Cases with Somnolence (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Invega (Paliperidone) where reactions include somnolence. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Invega side effects in 20 year old female
Reported by a physician from Israel on 2012-08-27
Patient: 20 year old female
Reactions: Menstrual Disorder, Speech Disorder, Blood Prolactin Increased, Lung Disorder, Activities of Daily Living Impaired, Palpitations, Somnolence, Menopause
Drug(s) suspected as cause:
Biperiden Hydrochloride TAB
Indication: Product Used FOR Unknown Indication
Invega
Administration route: Oral
Invega
Administration route: Oral
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Risperidone
Administration route: Oral
Risperidone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Invega side effects in 20 year old female
Reported by a physician from Israel on 2012-08-21
Patient: 20 year old female
Reactions: Somnolence, Menopause, Menstrual Disorder, Speech Disorder, Lung Disorder, Blood Prolactin Increased, Activities of Daily Living Impaired, Palpitations
Drug(s) suspected as cause:
Biperiden Hydrochloride TAB
Indication: Product Used FOR Unknown Indication
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Invega
Administration route: Oral
Invega
Administration route: Oral
Risperidone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Invega side effects in
Reported by a physician from Canada on 2012-08-16
Patient:
Reactions: Hallucination, Auditory, Drug Ineffective, Restlessness, Dizziness, Somnolence
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Invega Sustenna
Indication: Product Used FOR Unknown Indication
Invega Sustenna
Olanzapine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Invega side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Depression, Somnolence
Drug(s) suspected as cause:
Invega
Administration route: Oral
Start date: 2012-05-01
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Invega
Administration route: Oral
Lexapro
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-01
Other drugs received by patient: Abilify; Xanax; Unknown Medication; Gabapentin
Possible Invega side effects in male
Reported by a physician from Japan on 2012-08-06
Patient: male, weighing 57.0 kg (125.4 pounds)
Reactions: Malaise, Insomnia, Abnormal Behaviour, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Schizophrenia, Paranoid Type
Start date: 2011-12-26
End date: 2012-01-18
Invega
Administration route: Oral
Start date: 2012-01-19
End date: 2012-02-06
Other drugs received by patient: Zoloft; Nitrazepam; Alprazolam; Silece; Diazepam; Doral
Possible Invega side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: male, weighing 87.1 kg (191.6 pounds)
Reactions: Dysphagia, DRY Mouth, Dizziness, Somnolence, Cough
Drug(s) suspected as cause:
Invega
Possible Invega side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 58 year old female
Reactions: Depression, Somnolence
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-01
Lexapro
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-01
Other drugs received by patient: Gabapentin; Xanax
Possible Invega side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 95.3 kg (209.6 pounds)
Reactions: Abdominal Pain, Tachycardia, Headache, Palpitations, DRY Mouth, Postmenopausal Haemorrhage, Urinary Retention, Crying, Diabetes Mellitus Inadequate Control, Hypotension, Hyperprolactinaemia, Pituitary Tumour, Panic Disorder, Diabetic Coma, Vision Blurred, Electrocardiogram QT Prolonged, Hypersensitivity, Drug Ineffective, Drug Interaction, Disorientation, Constipation, Somnolence, Mania, Abdominal Distension, Dizziness, Decreased Appetite, Vomiting, Nausea, Retching, Muscular Weakness, Amnesia, Renal Failure Chronic, Anxiety, Blood Glucose Decreased, Bipolar Disorder, Eye Swelling, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-09-01
End date: 2008-09-01
Invega
Administration route: Oral
Start date: 2008-01-01
End date: 2008-01-01
Invega
Administration route: Oral
Indication: Schizophrenia
Start date: 2008-01-01
End date: 2008-01-01
Invega
Administration route: Oral
Start date: 2008-09-01
End date: 2008-09-01
Invega
Administration route: Oral
Start date: 2008-01-01
End date: 2008-01-01
Invega
Administration route: Oral
Start date: 2008-01-01
End date: 2008-01-01
Other drugs received by patient possibly interacting with the suspect drug: Haldol
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-09-26
Haldol
Administration route: Oral
Haldol
Dosage: 5 mg 1 in the am, 5 mg 1 in the pm and 5 mg as needed
Administration route: Oral
Start date: 1976-01-01
Other drugs received by patient: Other Therapeutic Medications; Depakote; Labetalol HCL; Allopurinol; Ibuprofen; Albuterol; Simvastatin; Depakote ER; Prevacid; Acetaminophen; Cozaar; Serevent; Abilify; Clonazepam; Restoril; Benadryl; Flovent; Zyprexa
Possible Invega side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: male, weighing 81.7 kg (179.6 pounds)
Reactions: Irritability, Agitation, Condition Aggravated, Cognitive Disorder, Somnolence
Drug(s) suspected as cause:
Invega
Dosage: 3 mg
Administration route: Oral
Start date: 2012-05-30
Invega
Administration route: Oral
Indication: Bipolar I Disorder
Start date: 2012-05-01
End date: 2012-05-01
Invega
Dosage: 3 mg tablet
Administration route: Oral
Start date: 2012-05-01
End date: 2012-05-29
Other drugs received by patient: Abilify; Lithium Carbonate; Hydroxyurea
Possible Invega side effects in male
Reported by a physician from Japan on 2012-06-21
Patient: male, weighing 57.0 kg (125.4 pounds)
Reactions: Malaise, Abnormal Behaviour, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Schizophrenia, Paranoid Type
Start date: 2011-12-26
End date: 2012-01-18
Invega
Administration route: Oral
Start date: 2012-01-19
End date: 2012-02-06
Other drugs received by patient: Zoloft; Silece; Diazepam; Alprazolam; Doral; Nitrazepam
Possible Invega side effects in female
Reported by a physician from Japan on 2012-05-30
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Malaise, Hospitalisation, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Schizophrenia, Paranoid Type
Start date: 2011-12-08
Invega
Administration route: Oral
Start date: 2011-10-31
End date: 2011-12-07
Other drugs received by patient: Lansoprazole; Enalapril Maleate; Zyprexa; Nitrazepam; Nitrazepam; Zyprexa; Zyprexa; Amoban
Possible Invega side effects in female
Reported by a consumer/non-health professional from China on 2012-05-24
Patient: female
Reactions: Cardiac Enzymes Increased, Somnolence, Asthenia, Influenza Like Illness
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-03-01
End date: 2011-04-03
Lexapro
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
End date: 2011-04-03
Lexapro
Administration route: Oral
Start date: 2011-04-08
Risperdal
Dosage: 0.5 mg in the morning and 1 mg at night
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-04-08
End date: 2011-04-13
Possible Invega side effects in female
Reported by a physician from Japan on 2012-05-16
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Hospitalisation, Malaise, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Schizophrenia, Paranoid Type
Start date: 2011-12-08
Invega
Administration route: Oral
Start date: 2011-10-31
End date: 2011-12-07
Other drugs received by patient: Zyprexa; Nitrazepam; Nitrazepam; Zyprexa; Amoban; Zyprexa; Lasoprazole; Enalapril Maleate
Possible Invega side effects in female
Reported by a consumer/non-health professional from China on 2012-05-03
Patient: female
Reactions: Cardiac Enzymes Increased, Somnolence, Asthenia, Influenza Like Illness
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-03-01
End date: 2011-04-03
Lexapro
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
End date: 2011-04-03
Lexapro
Administration route: Oral
Start date: 2011-04-08
Risperdal
Dosage: 0.5 mg in the morning and 1 mg at night
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-04-08
End date: 2011-04-13
Possible Invega side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-26
Patient: female, weighing 67.0 kg (147.4 pounds)
Reactions: Fatigue, Depression, Somnolence, Tremor, Delusion
Drug(s) suspected as cause:
Invega
Dosage: 3-6mg qd
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2007-12-01
End date: 2008-03-15
Provigil
Dosage: 100 milligram;
Administration route: Oral
Start date: 2008-03-27
Provigil
Dosage: 25 milligram;
Administration route: Oral
Indication: Somnolence
Start date: 2008-01-30
End date: 2008-02-18
Provigil
Dosage: 50 milligram;
Administration route: Oral
Start date: 2008-02-19
End date: 2008-03-21
Risperdal
Dosage: 3 milligram;
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2008-03-16
Other drugs received by patient: ST. Johns Wort; Deplin; Vitamin E; Multi-Vitamin; Green TEA
Possible Invega side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: male
Reactions: Drug Dose Omission, Hospitalisation, Somnolence, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Invega
Administration route: Oral
End date: 2012-02-01
Invega Sustenna
Indication: Product Used FOR Unknown Indication
Start date: 2012-02-11
End date: 2012-02-11
Invega Sustenna
Start date: 2012-02-04
End date: 2012-02-04
Possible Invega side effects in male
Reported by a physician from Japan on 2012-03-22
Patient: male
Reactions: Psychomotor Hyperactivity, Somnolence
Drug(s) suspected as cause:
Invega
Possible Invega side effects in 40 year old male
Reported by a consumer/non-health professional from Brazil on 2012-01-30
Patient: 40 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Product Quality Issue, Rash, Fall, Somnolence, Drug Prescribing Error, Post-Traumatic Stress Disorder, Medication Error, Dizziness, Blood Pressure Decreased, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Haldol
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2005-01-01
Invega
Administration route: Oral
Indication: Bipolar Disorder
Invega
Administration route: Oral
Invega
Administration route: Oral
Start date: 2005-01-01
Invega
Administration route: Oral
Other drugs received by patient: Abilify; Slow-K; Retinol; Seroquel; Lithium Carbonate; Trileptal; Wellbutrin XL; Amplictil; Clonazepam; Diazepam; Cialis; Diamox SR
Possible Invega side effects in female
Reported by a physician from United States on 2011-12-28
Patient: female, weighing 95.3 kg (209.6 pounds)
Reactions: Abdominal Pain, Tachycardia, Headache, Palpitations, DRY Mouth, Postmenopausal Haemorrhage, Urinary Retention, Diabetes Mellitus Inadequate Control, Crying, Hypotension, Hyperprolactinaemia, Pituitary Tumour, Panic Disorder, Diabetic Coma, Vision Blurred, Electrocardiogram QT Prolonged, Hypersensitivity, Drug Ineffective, Drug Interaction, Disorientation, Constipation, Somnolence, Mania, Abdominal Distension, Dizziness, Decreased Appetite, Vomiting, Nausea, Retching, Muscular Weakness, Renal Failure Chronic, Amnesia, Blood Glucose Decreased, Anxiety, Bipolar Disorder, Eye Swelling, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Start date: 2008-01-01
End date: 2008-01-01
Invega
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-09-01
End date: 2008-09-01
Invega
Administration route: Oral
Start date: 2008-01-01
End date: 2008-01-01
Invega
Administration route: Oral
Indication: Schizophrenia
Start date: 2008-01-01
End date: 2008-01-01
Invega
Administration route: Oral
Start date: 2008-09-01
End date: 2008-09-01
Invega
Administration route: Oral
Start date: 2008-01-01
End date: 2008-01-01
Other drugs received by patient possibly interacting with the suspect drug: Haldol
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-09-26
Haldol
Administration route: Oral
Haldol
Dosage: 5 mg 1 in the am, 5 mg 1 in the pm and 5 mg as needed
Administration route: Oral
Start date: 1976-01-01
Other drugs received by patient: Restoril; Allopurinol; Acetaminophen; Albuterol; Depakote ER; Ibuprofen; Cozaar; Prevacid; Serevent; Abilify; Zyprexa; Other Therapeutic Medications; Benadryl; Depakote; Flovent; Labetalol HCL; Clonazepam; Simvastatin
Possible Invega side effects in 40 year old male
Reported by a consumer/non-health professional from Brazil on 2011-11-14
Patient: 40 year old male, weighing 92.0 kg (202.4 pounds)
Reactions: Product Quality Issue, Rash, Drug Prescribing Error, Fall, Somnolence, Post-Traumatic Stress Disorder, Medication Error, Dizziness, Asthenia, Blood Pressure Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Haldol
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2005-01-01
Invega
Administration route: Oral
Invega
Administration route: Oral
Start date: 2005-01-01
Invega
Administration route: Oral
Invega
Administration route: Oral
Indication: Bipolar Disorder
Other drugs received by patient: Wellbutrin XL; Cialis; Trileptal; Seroquel; Diamox SR; Amplictil; Slow-K; Retinol; Abilify; Carbolitium; Diazepam; Clonazepam
Possible Invega side effects in 93 year old female
Reported by a pharmacist from Spain on 2011-10-20
Patient: 93 year old female
Reactions: Stupor, Somnolence, Loss of Consciousness
Drug(s) suspected as cause:
Invega
Other drugs received by patient: Omeprazole; Amlodipine Besylate; Losartan Potassium; Allopurinol; Insulin; Aspirin; Diazepam; Citicoline Sodium
Possible Invega side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14
Patient: male
Reactions: Weight Increased, Depression, Somnolence, Suicidal Ideation
Drug(s) suspected as cause:
Invega
Dosage: oral
Administration route: Oral
Lexapro
Indication: Oral Disorder
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