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
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 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 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 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 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
Possible Invega Sustenna side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-23
Patient: male
Reactions: Pneumonia, Abnormal Behaviour, Eye Movement Disorder, Asthenia, Paraesthesia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alcohol
Administration route: Oral
Indication: Alcohol Abuse
Cocaine
Indication: Drug Abuse
Invega Sustenna
Indication: Schizophrenia
Start date: 2012-07-26
NON Therapeutic Product
Indication: Drug Abuse
Unknown Medication
Indication: Pneumonia
Possible Invega Sustenna side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: male
Reactions: Condition Aggravated
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
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