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Invega (Paliperidone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Invega (Paliperidone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (554)
Death (29)
Life Threatening Events (18)
Disability (11)

Reports by Reaction Type

Extrapyramidal Disorder (31)Drug Ineffective (30)Depression (28)Weight Increased (27)Dystonia (24)Insomnia (23)Pain (22)Somnolence (22)Abnormal Behaviour (22)Tardive Dyskinesia (22)Blood Prolactin Increased (21)Weight Decreased (20)

Below are a few examples of reports where side effects / adverse reactions may be related to Invega (Paliperidone). For a complete list or a specific selection of reports, please use the links above.

Possible Invega side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Drug Ineffective, Suicide Attempt, Albumin Urine Present, Medication Residue

Drug(s) suspected as cause:
Invega

Other drugs received by patient: Bupropion HCL; Clonazepam



Possible Invega side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 31 year old female, weighing 57.5 kg (126.5 pounds)

Reactions: Weight Increased

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Bipolar Disorder

Invega
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-01-01

Other drugs received by patient: Klonopin; Depo-Provera; Effexor; Loratadine



Possible Invega side effects in 40 year old female

Reported by a physician from Italy on 2012-08-27

Patient: 40 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Self Injurious Behaviour, Sluggishness

Drug(s) suspected as cause:
Adepril
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Atorvastatin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Clonazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Depakin Chrono
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Flurazepam Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Lorazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19

Sertraline Hydrochloride
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-19
    End date: 2012-08-19



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 male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Weight Increased, Phobia, Haemorrhoids, Hyperhidrosis

Drug(s) suspected as cause:
Invega



Possible Invega side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Phobia, Weight Increased, Haemorrhoids, Hyperhidrosis

Drug(s) suspected as cause:
Invega



Possible Invega side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Leukopenia

Drug(s) suspected as cause:
Invega



Possible Invega side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-22

Patient: 45 year old male, weighing 95.0 kg (209.0 pounds)

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Fluvoxamine Maleate
    Dosage: 100 mg
    Administration route: Oral
    Indication: Schizophrenia
    End date: 2012-07-27

Invega
    Dosage: 6 mg
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-07-01
    End date: 2012-07-27

Nebivolol
    Dosage: 5 mg
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2012-07-27

Olanzapine
    Dosage: 10 mg
    Administration route: Oral
    End date: 2012-07-27

Olanzapine
    Dosage: 30 mg
    Administration route: Oral
    Indication: Schizophrenia

Other drugs received by patient: Gliclazide; Ezetimibe; Aspirin; Zocor



Possible Invega side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 61 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Product Label Issue, Tardive Dyskinesia, Tremor

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Invega

Invega
    Dosage: invega 1 x day
    Indication: Bipolar Disorder



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 male

Reported by a pharmacist from Canada on 2012-08-20

Patient: male

Reactions: Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega



Possible Invega side effects in 37 year old male

Reported by a physician from Ukraine on 2012-08-20

Patient: 37 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Consciousness Fluctuating, Tachycardia, Asthenia, Myocarditis, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2011-07-01
    End date: 2012-08-07

Invega
    Administration route: Oral
    Indication: Schizoaffective Disorder
    Start date: 2011-07-01
    End date: 2012-08-07



Possible Invega side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female

Reactions: Tardive Dyskinesia

Drug(s) suspected as cause:
Invega



Possible Invega side effects in 46 year old female

Reported by a physician from Italy on 2012-08-20

Patient: 46 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Pain, Tachycardia, Coma, Multiple Drug Overdose Intentional, Self Injurious Behaviour

Drug(s) suspected as cause:
Ferrous Sulfate TAB
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-08
    End date: 2012-08-08

Flurazepam Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-08
    End date: 2012-08-08

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-08
    End date: 2012-08-08

Levothyroxine Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-08
    End date: 2012-08-08

Seroquel
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-08
    End date: 2012-08-08



Possible Invega side effects in

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient:

Reactions: Adverse Event

Drug(s) suspected as cause:
Invega



Possible Invega side effects in female

Reported by a physician from South Africa on 2012-08-20

Patient: female

Reactions: Maternal Exposure During Pregnancy, Drug Dispensing Error

Drug(s) suspected as cause:
Invega



Possible Invega side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female, weighing 78.9 kg (173.6 pounds)

Reactions: Tooth Extraction, Headache, Hyperhidrosis, Muscle Twitching, Treatment Noncompliance, Hospitalisation, Overdose, Toothache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-04-01

Invega Sustenna
    Indication: Bipolar Disorder
    Start date: 2012-04-01

Invega Sustenna
    Start date: 2012-06-13

Invega Sustenna
    Start date: 2011-07-01
    End date: 2012-04-01

Invega Sustenna
    Start date: 2011-09-01
    End date: 2012-03-01

Other drugs received by patient: Tegretol



Possible Invega side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female

Reactions: Schizophrenia

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2010-05-14

Invega
    Administration route: Oral
    Start date: 2010-07-17

Invega Sustenna
    Indication: Schizophrenia
    Start date: 2010-05-14



Possible Invega side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 55 year old female

Reactions: Dyskinesia

Drug(s) suspected as cause:
Invega

Other drugs received by patient: Colace; Trazodone Hydrochloride; Effexor



Possible Invega side effects in male

Reported by a physician from Sweden on 2012-08-17

Patient: male, weighing 73.4 kg (161.5 pounds)

Reactions: Cerebral Palsy, Psychotic Behaviour

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Paliperidone
    Dosage: 07-oct (unspecified year)
    Indication: Product Used FOR Unknown Indication

Paliperidone
    Dosage: 02-aug (unspecified year)



Possible Invega side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 122.6 kg (269.7 pounds)

Reactions: Congestive Cardiomyopathy, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel
    Indication: Psoriasis

Humira
    Indication: Psoriasis
    Start date: 2012-01-26
    End date: 2012-05-07

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Sertraline Hydrochloride; Symbicort; Clonidine; Vimpat; Felbatol; Atenolol; Hydroxyzine; Tricor; Lorazepam; Levoxyl; Lovaza; Finasteride; Lipitor; Norvasc; Benztropine Mesylate



Possible Invega side effects in male

Reported by a physician from Japan on 2012-08-16

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Irritability, Malaise, Hyperprolactinaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Start date: 2011-06-19
    End date: 2011-07-08

Invega
    Administration route: Oral
    Start date: 2012-04-08
    End date: 2012-04-21

Invega
    Administration route: Oral
    Start date: 2011-05-22
    End date: 2011-06-18

Invega
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2012-04-07

Invega
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2012-04-22
    End date: 2012-05-02

Other drugs received by patient: Sennoside; Zyprexa; Promethazine HCL; Amaryl; Magnesium Oxide; Lorazepam; Abilify; Flunitrazepam; Abilify; Voglibose; Metformin HCL



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 28 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 28 year old female

Reactions: Akathisia, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-02-03
    End date: 2011-02-22

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01
    End date: 2011-01-11

Other drugs received by patient: Biperiden Hydrochloride TAB; Abilify; Phenobarbital TAB; Zolpidem



Possible Invega side effects in female

Reported by a physician from Japan on 2012-08-13

Patient: female

Reactions: Dermatitis Infected

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega

Other drugs received by patient: Sediel; Sorentmin; Rohypnol; Trichlormethiazide; Clonazepam; Seroquel; Amlodipine; Depakene



Possible Invega side effects in 45 year old male

Reported by a physician from Switzerland on 2012-08-13

Patient: 45 year old male, weighing 95.0 kg (209.0 pounds)

Reactions: Sudden Cardiac Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Fluvoxamine Maleate
    Indication: Product Used FOR Unknown Indication

Invega
    Indication: Schizophrenia
    End date: 2012-07-27

Zyprexa
    Indication: Product Used FOR Unknown Indication

Zyprexa

Other drugs received by patient: Nebivolol HCL; Simvastatin; Aspirin; Gliclazide; Ezetimibe



Possible Invega side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: Galactorrhoea

Drug(s) suspected as cause:
Invega



Possible Invega side effects in 58 year old female

Reported by a physician from Israel on 2012-08-10

Patient: 58 year old female

Reactions: Psychotic Disorder, Nocturia

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Paliperidone
    Indication: Product Used FOR Unknown Indication



Possible Invega side effects in 36 year old male

Reported by a physician from Sweden on 2012-08-10

Patient: 36 year old male

Reactions: Intraocular Pressure Increased, Gaze Palsy

Drug(s) suspected as cause:
Invega

Other drugs received by patient: Imovane; Atarax



Possible Invega side effects in

Reported by a physician from Sweden on 2012-08-10

Patient:

Reactions: Psychotic Behaviour

Drug(s) suspected as cause:
Invega

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