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Invega Sustenna (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 Sustenna (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 (1420)
Death (19)
Life Threatening Events (29)
Disability (20)

Reports by Reaction Type

Drug Dose Omission (179)Device Leakage (78)Drug Ineffective (77)Weight Increased (72)Product Quality Issue (61)Condition Aggravated (53)Psychotic Disorder (48)Inappropriate Schedule of Drug Administration (47)Injection Site Pain (47)Hospitalisation (44)Incorrect Dose Administered (40)Accidental Exposure (40)

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

Possible Invega Sustenna side effects in female

Reported by a pharmacist from United States on 2012-08-27

Patient: female

Reactions: Injection Site Extravasation, Underdose

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Blood Prolactin Increased

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Lithium Carbonate



Possible Invega Sustenna side effects in male

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

Patient: male

Reactions: Condition Aggravated, Drug Abuse

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Schizophrenia

Olanzapine
    Indication: Schizophrenia



Possible Invega Sustenna side effects in 59 year old male

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

Patient: 59 year old male, weighing 87.5 kg (192.6 pounds)

Reactions: Mass

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

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

Patient: male

Reactions: Feeling Abnormal, Sluggishness

Drug(s) suspected as cause:
Invega Sustenna

Invega Sustenna

Invega Sustenna
    Indication: Product Used FOR Unknown Indication



Possible Invega Sustenna side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Wrong Technique in Drug Usage Process, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Psychotic Disorder
    Start date: 2012-07-19

Invega Sustenna
    Indication: Bipolar Disorder
    Start date: 2012-07-19

Other drugs received by patient: Saphris; Wellbutrin; AN Unknown Medication; Sertraline Hydrochloride



Possible Invega Sustenna side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Galactorrhoea, Breast Tenderness

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Lithium Carbonate



Possible Invega Sustenna side effects in

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

Patient:

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Invega Sustenna

Invega Sustenna
    Indication: Psychotic Disorder



Possible Invega Sustenna side effects in

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

Patient:

Reactions: Injection Site Nodule

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 122.0 kg (268.4 pounds)

Reactions: Hospitalisation, Drug Ineffective, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Bipolar Disorder
    Start date: 2012-07-01

Invega Sustenna
    Indication: Psychotic Disorder
    Start date: 2012-07-01

Saphris
    Dosage: 5-10 mg
    Indication: Bipolar Disorder
    Start date: 2012-07-01

Saphris
    Dosage: 5-10 mg
    Indication: Psychotic Disorder
    Start date: 2012-07-01

Sertraline Hydrochloride
    Indication: Bipolar Disorder
    Start date: 2012-01-01

Sertraline Hydrochloride
    Indication: Psychotic Disorder
    Start date: 2012-01-01

Topamax
    Indication: Psychotic Disorder
    Start date: 2012-01-01

Topamax
    Indication: Bipolar Disorder
    Start date: 2012-01-01

Wellbutrin
    Dosage: 300-450 mg
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2010-11-01

Wellbutrin
    Dosage: 300-450 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2010-11-01



Possible Invega Sustenna side effects in

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

Patient:

Reactions: Adverse Event

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in 22 year old male

Reported by a physician from United States on 2012-08-27

Patient: 22 year old male

Reactions: Weight Increased, Gynaecomastia

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

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

Patient: male

Reactions: Drug Dose Omission, Device Leakage

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

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

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Alcohol Use

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Drug Dose Omission

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Schizophrenia
    Start date: 2012-07-16

Invega Sustenna
    Start date: 2012-05-29

Other drugs received by patient: Zyprexa; Lexapro; Depakote



Possible Invega Sustenna side effects in female

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

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Hallucination, Auditory, Hypoaesthesia, Loss of Libido

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

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

Patient: male

Reactions: Device Leakage, Drug Dose Omission

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Tegretol; Cymbalta; Trihexyphenidyl HCL; Neurontin; Restoril; Vistaril



Possible Invega Sustenna side effects in 20 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 20 year old female

Reactions: Device Leakage, Accidental Exposure

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male

Reactions: Hallucination, Auditory

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01

Invega Sustenna
    Start date: 2012-08-02

Invega Sustenna
    Start date: 2011-09-01
    End date: 2012-06-01



Possible Invega Sustenna side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Inappropriate Schedule of Drug Administration, Delusion

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Zyprexa



Possible Invega Sustenna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Device Leakage, Underdose

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Albuterol; Hydroxyzine; Albuterol; Fluticasone Propionate; Paxil; Trazodone Hydrochloride



Possible Invega Sustenna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Delusion

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in

Reported by a pharmacist from United States on 2012-08-24

Patient:

Reactions: Drug Dose Omission, Device Leakage, Device Occlusion

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in female

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

Patient: female

Reactions: Condition Aggravated

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

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

Patient: male

Reactions: Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Schizophrenia
    Start date: 2012-08-01

Risperdal
    Administration route: Oral
    Indication: Schizophrenia



Possible Invega Sustenna side effects in male

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

Patient: male

Reactions: Drug Dose Omission, Product Quality Issue, Needle Issue

Drug(s) suspected as cause:
Invega Sustenna
    Start date: 2010-10-01

Invega Sustenna
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-11-01



Possible Invega Sustenna side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 40 year old male

Reactions: Akathisia, Drug Ineffective

Drug(s) suspected as cause:
Invega Sustenna

Invega Sustenna
    Indication: Schizophrenia



Possible Invega Sustenna side effects in female

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

Patient: female

Reactions: Weight Decreased, Decreased Appetite

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Zoloft; Saphris



Possible Invega Sustenna side effects in 50 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 50 year old

Reactions: Pharyngeal Oedema, Swollen Tongue

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Schizophrenia

Invega Sustenna

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