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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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