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Invega Side Effects

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Common Invega Side Effects

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The most commonly reported Invega side effects (click to view or check a box to report):

Weight Increased (259)
Galactorrhoea (163)
Blood Prolactin Increased (125)
Psychotic Disorder (115)
Extrapyramidal Disorder (113)
Tremor (109)
Insomnia (109)
Anxiety (106)
Dizziness (99)
Somnolence (95)
Dystonia (92)
Aggression (89)
Akathisia (85)
Off Label Use (85)
Agitation (84)
Injection Site Nodule (83)
Dyspnoea (83)
Product Quality Issue (80)
Dyskinesia (77)
Tardive Dyskinesia (77)

➢ More

If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Invega Side Effects Reported to FDA



Invega Side Effect Report#9994856
Lacrimation Increased, Eye Pruritus
This is a report of a 43-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bipolar disorder, who was treated with Invega Sustenna (dosage: NA, start time:
Feb 05, 2014), combined with: NA. and developed a serious reaction and side effect(s): Lacrimation Increased, Eye Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega Sustenna treatment in female patients, resulting in Lacrimation Increased side effect.
Invega Side Effect Report#9994808
Investigation, Injection Site Nodule, Treatment Noncompliance
This report suggests a potential Invega Sustenna Investigation side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Invega Sustenna (dosage: NA) starting NS. After starting Invega Sustenna the patient began experiencing various side effects, including: Investigation, Injection Site Nodule, Treatment NoncomplianceAdditional drugs used concurrently: NA.The patient was hospitalized. Although Invega Sustenna demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Investigation, may still occur.
Invega Side Effect Report#9994807
Chest Discomfort, Nervousness, Muscle Rigidity, Anxiety, Blood Pressure Increased, Injection Site Pain
This Chest Discomfort problem was reported by a consumer or non-health professional from CN. A 35-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia. On 2013 this consumer started treatment with Invega Sustenna (dosage: NA). The following drugs were being taken at the same time: NA. When using Invega Sustenna, the patient experienced the following unwanted symptoms/side effects: Chest Discomfort, Nervousness, Muscle Rigidity, Anxiety, Blood Pressure Increased, Injection Site PainThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chest Discomfort, may become evident only after a product is in use by the general population.
Invega Side Effect Report#9991988
Delusion, Treatment Noncompliance
This Delusion side effect was reported by a health professional from US. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: schizophrenia.The patient was prescribed Invega (drug dosage: NA), which was initiated on 201312. Concurrently used drugs: NA..After starting to take Invega the consumer reported adverse symptoms, such as: Delusion, Treatment NoncomplianceThese side effects may potentially be related to Invega.
Invega Side Effect Report#9991987
Depression
This is a report of a 19-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Invega (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega treatment in male patients, resulting in Depression side effect.
Invega Side Effect Report#9991757
Injection Site Nodule
This report suggests a potential Invega Sustenna Injection Site Nodule side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: schizophrenia and used Invega Sustenna (dosage: NA) starting 2014. After starting Invega Sustenna the patient began experiencing various side effects, including: Injection Site NoduleAdditional drugs used concurrently: NA. Although Invega Sustenna demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Nodule, may still occur.
Invega Side Effect Report#9980763
Akathisia
This Akathisia problem was reported by a health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia. On 201402 this consumer started treatment with Invega Sustenna (dosage: NA). The following drugs were being taken at the same time: NA. When using Invega Sustenna, the patient experienced the following unwanted symptoms/side effects: AkathisiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Akathisia, may become evident only after a product is in use by the general population.
Invega Side Effect Report#9969838
Adverse Event
This Adverse Event side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: schizophrenia.The patient was prescribed Invega (drug dosage: NA), which was initiated on 201312. Concurrently used drugs: NA..After starting to take Invega the consumer reported adverse symptoms, such as: Adverse EventThese side effects may potentially be related to Invega.
Invega Side Effect Report#9969836
Sedation, Mental Impairment
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: schizoaffective disorder, who was treated with Invega Sustenna (dosage: NA, start time: 201310), combined with: NA. and developed a serious reaction and side effect(s): Sedation, Mental Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega Sustenna treatment in male patients, resulting in Sedation side effect. The patient was hospitalized.
Invega Side Effect Report#9969835
Pollakiuria, Restless Legs Syndrome, Dyskinesia
This report suggests a potential Invega Sustenna Pollakiuria side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: schizophrenia and used Invega Sustenna (dosage: NA) starting 2012. After starting Invega Sustenna the patient began experiencing various side effects, including: Pollakiuria, Restless Legs Syndrome, DyskinesiaAdditional drugs used concurrently: NA. Although Invega Sustenna demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pollakiuria, may still occur.
Invega Side Effect Report#9963988
Gynaecomastia
This Gynaecomastia problem was reported by a health professional from US. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Invega Sustenna (dosage: NA). The following drugs were being taken at the same time: NA. When using Invega Sustenna, the patient experienced the following unwanted symptoms/side effects: GynaecomastiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gynaecomastia, may become evident only after a product is in use by the general population.
Invega Side Effect Report#9960710
Condition Aggravated
This Condition Aggravated side effect was reported by a physician from US. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: schizoaffective disorder.The patient was prescribed Invega Sustenna (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Invega Sustenna the consumer reported adverse symptoms, such as: Condition AggravatedThese side effects may potentially be related to Invega Sustenna.
Invega Side Effect Report#9938602
Hyponatraemia
This is a report of a 54-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: NA, who was treated with Invega (dosage: NA, start time:
Dec 11, 2013), combined with:
  • Nexium
  • Seroquel
  • Barnetil
  • Mucosta
  • Akineton
  • Magmitt
and developed a serious reaction and side effect(s): Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega treatment in male patients, resulting in Hyponatraemia side effect. The patient was hospitalized.
Invega Side Effect Report#9938097
Gynaecomastia
This report suggests a potential Invega Sustenna Gynaecomastia side effect(s) that can have serious consequences. A 27-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Invega Sustenna (dosage: NA) starting NS. After starting Invega Sustenna the patient began experiencing various side effects, including: GynaecomastiaAdditional drugs used concurrently: NA. Although Invega Sustenna demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gynaecomastia, may still occur.
Invega Side Effect Report#9938089
Neuroleptic Malignant Syndrome, Aggression, Confusional State, Cogwheel Rigidity, Tremor, Hyperhidrosis
This Neuroleptic Malignant Syndrome problem was reported by a physician from CH. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia, paranoid type. On
Aug 12, 2013 this consumer started treatment with Invega (dosage: NA). The following drugs were being taken at the same time:
  • Clozapine
  • Clozapine
  • Clozapine
  • Clozapine
  • Clopixol
  • Clopixol
  • Temesta
  • Depakin
When using Invega, the patient experienced the following unwanted symptoms/side effects: Neuroleptic Malignant Syndrome, Aggression, Confusional State, Cogwheel Rigidity, Tremor, HyperhidrosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neuroleptic Malignant Syndrome, may become evident only after a product is in use by the general population.
Invega Side Effect Report#9931710
Sedation, Accidental Overdose
This Sedation side effect was reported by a health professional from US. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Invega Sustenna (drug dosage: Two Days In A Row), which was initiated on NS. Concurrently used drugs: NA..After starting to take Invega Sustenna the consumer reported adverse symptoms, such as: Sedation, Accidental OverdoseThese side effects may potentially be related to Invega Sustenna.
Invega Side Effect Report#9925397
Paranoia, Adverse Event
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: schizoaffective disorder, who was treated with Invega Sustenna (dosage: NA, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Paranoia, Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega Sustenna treatment in female patients, resulting in Paranoia side effect.
Invega Side Effect Report#9921402
Incorrect Dose Administered
This report suggests a potential Invega Sustenna Incorrect Dose Administered side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: schizophrenia and used Invega Sustenna (dosage: NA) starting
Jan 31, 2014. After starting Invega Sustenna the patient began experiencing various side effects, including: Incorrect Dose AdministeredAdditional drugs used concurrently:
  • Cogentin
  • Wellbutrin
  • Klonopin
  • Haldol
  • Ativan
  • Risperidone
  • Altace
Although Invega Sustenna demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Incorrect Dose Administered, may still occur.
Invega Side Effect Report#9919218
Treatment Noncompliance, Product Outer Packaging Issue
This Treatment Noncompliance problem was reported by a health professional from US. A 23-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia. On 201303 this consumer started treatment with Invega Sustenna (dosage: NA). The following drugs were being taken at the same time: NA. When using Invega Sustenna, the patient experienced the following unwanted symptoms/side effects: Treatment Noncompliance, Product Outer Packaging IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Treatment Noncompliance, may become evident only after a product is in use by the general population.
Invega Side Effect Report#9919217
Galactorrhoea, Blood Prolactin Increased
This Galactorrhoea side effect was reported by a health professional from US. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Invega Sustenna (drug dosage: NA), which was initiated on 2012. Concurrently used drugs: NA..After starting to take Invega Sustenna the consumer reported adverse symptoms, such as: Galactorrhoea, Blood Prolactin IncreasedThese side effects may potentially be related to Invega Sustenna.
Invega Side Effect Report#9919215
Eye Disorder, Dysarthria, Dyspnoea, Dyskinesia, Extrapyramidal Disorder, Vision Blurred, Off Label Use
This is a report of a 14-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: affective disorder, who was treated with Invega Sustenna (dosage: Day 1 Dose, start time:
Jan 24, 2014), combined with: NA. and developed a serious reaction and side effect(s): Eye Disorder, Dysarthria, Dyspnoea, Dyskinesia, Extrapyramidal Disorder, Vision Blurred, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega Sustenna treatment in female patients, resulting in Eye Disorder side effect.
Invega Side Effect Report#9919211
Weight Increased
This report suggests a potential Invega Sustenna Weight Increased side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: schizophrenia and used Invega Sustenna (dosage: NA) starting NS. After starting Invega Sustenna the patient began experiencing various side effects, including: Weight IncreasedAdditional drugs used concurrently: NA. Although Invega Sustenna demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Weight Increased, may still occur.
Invega Side Effect Report#9919210
Injection Site Pain
This Injection Site Pain problem was reported by a pharmacist from US. A 20-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: schizophrenia. On 2013 this consumer started treatment with Invega Sustenna (dosage: NA). The following drugs were being taken at the same time: NA. When using Invega Sustenna, the patient experienced the following unwanted symptoms/side effects: Injection Site PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Injection Site Pain, may become evident only after a product is in use by the general population.
Invega Side Effect Report#9919209
Off Label Use
This Off Label Use side effect was reported by a consumer or non-health professional from US. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: schizoaffective disorder.The patient was prescribed Invega Sustenna (drug dosage: In Between (tricep And Bicep)), which was initiated on 2013. Concurrently used drugs: NA..After starting to take Invega Sustenna the consumer reported adverse symptoms, such as: Off Label UseThese side effects may potentially be related to Invega Sustenna.
Invega Side Effect Report#9916258
Psychotic Disorder, Memory Impairment
This is a report of a 22-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: schizophrenia, who was treated with Invega Sustenna (dosage: NA, start time: 201312), combined with: NA. and developed a serious reaction and side effect(s): Psychotic Disorder, Memory Impairment after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Invega Sustenna treatment in male patients, resulting in Psychotic Disorder side effect.


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The appearance of Invega on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Invega Side Effects for Women?

Women Side EffectsReports
Galactorrhoea 159
Weight Increased 126
Blood Prolactin Increased 100
Amenorrhoea 67
Insomnia 61
Tremor 57
Injection Site Nodule 55
Dyspnoea 51
Anxiety 48
Somnolence 47

What are common Invega Side Effects for Men?

Men Side EffectsReports
Weight Increased 131
Psychotic Disorder 75
Aggression 70
Extrapyramidal Disorder 64
Dizziness 58
Dystonia 58
Anxiety 57
Agitation 55
Off Label Use 54
Tremor 52

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

    • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Invega reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Invega Safety Alerts, Active Ingredients, Usage Information

    NDC21695-455
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameINVEGA
    Namepaliperidone
    Dosage FormTABLET, EXTENDED RELEASE
    RouteORAL
    On market since20061219
    LabelerRebel Distributors Corp
    Active Ingredient(s)PALIPERIDONE
    Strength(s)6
    Unit(s)mg/1
    Pharma ClassAtypical Antipsychotic [EPC]

    Invega Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3857

    Invega safety alerts: No

    Reported deaths: 113

    Reported hospitalizations: 490

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