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Invega Sustenna (Paliperidone) - Product Quality Issue - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Product Quality Issue (61)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Invega Sustenna (Paliperidone) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 61   Next >>

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

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient:

Reactions: Product Quality Issue, Akathisia, Fatigue, Sleep Disorder, Panic Disorder

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

Risperdal Consta
    Indication: Product Used FOR Unknown Indication

Cogentin
    Indication: Akathisia

Other drugs received by patient: Wellbutrin XL; Ativan



Possible Invega Sustenna side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 50 year old male, weighing 77.1 kg (169.6 pounds)

Reactions: Product Quality Issue, Incorrect Route of Drug Administration, Weight Increased, Fatigue, Palpitations, Sensory Disturbance, Catatonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Start date: 2011-12-01
    End date: 2012-06-01

Invega Sustenna
    Indication: Bipolar Disorder
    Start date: 2012-07-01
    End date: 2012-07-01

Other drugs received by patient: Lithium Carbonate; Celexa



Possible Invega Sustenna side effects in 45 year old female

Reported by a physician from United States on 2012-08-03

Patient: 45 year old female

Reactions: Product Quality Issue, Condition Aggravated, Hallucination, Delusion

Drug(s) suspected as cause:
Invega Sustenna
    Dosage: day 63 dose given on an unspecified date

Invega Sustenna
    Dosage: day 1 dose given at unspecified date

Risperdal
    Dosage: every bed time
    Administration route: Oral
    Indication: Schizophrenia

Invega Sustenna
    Dosage: day 35 dose given at unspecified date

Invega Sustenna
    Dosage: day 91 dose given on an unspecified date

Invega Sustenna
    Dosage: day 8 dose given at unspecified date
    Indication: Schizophrenia

Other drugs received by patient: Prozac



Possible Invega Sustenna side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female, weighing 61.7 kg (135.7 pounds)

Reactions: Product Quality Issue, Weight Decreased, Dyspnoea, Eye Injury, Vaginal Odour, Feeling Abnormal, Eye Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Vitamin D; Lamotrigine; Unknown Medication; Simvastatin



Possible Invega Sustenna side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: male

Reactions: Product Quality Issue, Malaise, Anger, Abnormal Behaviour, Unevaluable Event, Hormone Level Abnormal, Aggression

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Product Used FOR Unknown Indication

Invega Sustenna



Possible Invega Sustenna side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female

Reactions: Application Site Reaction, Product Quality Issue, Injection Site Erythema, Injection Site Pain

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

Reported by a pharmacist from United States on 2012-07-05

Patient: male

Reactions: Inappropriate Schedule of Drug Administration, Product Quality Issue, Drug Dose Omission, Device Occlusion

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Nexium; Ventolin



Possible Invega Sustenna side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: female, weighing 61.7 kg (135.7 pounds)

Reactions: Weight Decreased, Product Quality Issue, Eye Injury, Dyspnoea, Feeling Abnormal, Eye Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Lamotrigine



Possible Invega Sustenna side effects in

Reported by a physician from United States on 2012-06-25

Patient:

Reactions: Product Quality Issue, Condition Aggravated

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Product Quality Issue

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18

Patient:

Reactions: Product Quality Issue, Underdose

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: female, weighing 61.7 kg (135.7 pounds)

Reactions: Weight Decreased, Product Quality Issue, Eye Injury, Dyspnoea, Eye Disorder, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Lamotrigine



Possible Invega Sustenna side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: male

Reactions: Product Quality Issue, Mania

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

Reported by a physician from United States on 2012-05-11

Patient: male

Reactions: Product Quality Issue, Psychotic Disorder

Drug(s) suspected as cause:
Invega Sustenna
    Dosage: day 1 dose
    Start date: 2012-01-01
    End date: 2012-01-01

Invega Sustenna
    Dosage: day 8 dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Invega Sustenna side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-24

Patient: male

Reactions: Product Quality Issue, Weight Increased, Fear, Stress, Antisocial Behaviour, Aggression

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in

Reported by a physician from United States on 2012-04-20

Patient:

Reactions: Product Quality Issue, Agitation, Paranoia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Product Used FOR Unknown Indication

Invega Sustenna



Possible Invega Sustenna side effects in 20 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-09

Patient: 20 year old male

Reactions: Product Quality Issue, Drug Dose Omission, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in 31 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-09

Patient: 31 year old male

Reactions: Inappropriate Schedule of Drug Administration, Product Quality Issue, DRY Skin, Erythema

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

Invega Sustenna
    Indication: Schizophrenia

Other drugs received by patient: Haldol; Paxil; Zyprexa; Flexeril; Zoloft; Buspar



Possible Invega Sustenna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30

Patient: female

Reactions: Product Quality Issue, Mood Altered

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-28

Patient:

Reactions: Device Leakage, Product Quality Issue, Wrong Technique in Drug Usage Process

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 2012-03-23

Patient: male

Reactions: Product Quality Issue, Device Leakage, Accidental Exposure

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 2012-03-16

Patient: male

Reactions: Product Quality Issue, Pain

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Product Used FOR Unknown Indication

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01



Possible Invega Sustenna side effects in 24 year old male

Reported by a physician from United States on 2012-03-08

Patient: 24 year old male

Reactions: Product Quality Issue, Psychotic Disorder, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-01-25
    End date: 2012-01-29

Invega Sustenna
    Indication: Schizophrenia
    Start date: 2012-02-17
    End date: 2012-02-17

Invega Sustenna

Other drugs received by patient: Ativan



Possible Invega Sustenna side effects in

Reported by a pharmacist from United States on 2012-03-07

Patient:

Reactions: Product Quality Issue, Condition Aggravated

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in male

Reported by a physician from United States on 2012-03-02

Patient: male, weighing 77.1 kg (169.6 pounds)

Reactions: Product Quality Issue, Drug Administered AT Inappropriate Site, Injection Site Cellulitis, Pain in Extremity, Paranoia, Pain, Schizophrenia, Pyrexia, Poor Quality Drug Administered, Fatigue, Injection Site Erythema, Staphylococcal Infection, Regressive Behaviour, Product Container Issue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Start date: 2011-02-15
    End date: 2011-02-01

Invega
    Administration route: Oral
    Indication: Schizophrenia

Invega
    Administration route: Oral

Invega Sustenna
    Indication: Schizophrenia, Disorganised Type
    Start date: 2011-02-08

Other drugs received by patient: Unspecified Generic Drug



Possible Invega Sustenna side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-03-01

Patient: male

Reactions: Product Quality Issue, Exposure To Contaminated Device, Injury Associated With Device

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-27

Patient: female

Reactions: Product Quality Issue, Psychotic Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna

Other drugs received by patient: Lithium Carbonate



Possible Invega Sustenna side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-21

Patient: male

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

Drug(s) suspected as cause:
Invega Sustenna



Possible Invega Sustenna side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-21

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Product Quality Issue, Drug Dose Omission, Maternal Exposure During Pregnancy, Incorrect Dose Administered, Abnormal Behaviour, Aggression, Crying

Drug(s) suspected as cause:
Invega Sustenna
    Start date: 2011-07-01

Invega Sustenna
    Start date: 2010-03-01
    End date: 2010-08-01

Invega Sustenna
    Indication: Bipolar Disorder
    Start date: 2011-10-01

Invega Sustenna
    Start date: 2011-12-04

Invega Sustenna
    Dosage: doctor administered half of 39 mg dose because of pregnancy
    Start date: 2010-11-01
    End date: 2011-04-01

Invega Sustenna

Other drugs received by patient: Lamictal



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