Drug information for FANAPT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 10MG Prescription   ILOPERIDONE iloperidone NOVARTIS 22192
2012-01-31 Letter
2012-01-30 Label
2011-12-22 Other Important Information from FDA
2011-09-12 Label
2011-09-12 Label
2011-09-12 Letter
2011-09-12 Letter
2011-03-28 Label
2011-03-24 Letter
2010-12-06 Letter
2010-12-04 Label
2010-08-27 Label
2010-08-26 Letter
2009-06-12 Review
2009-06-12 Summary Review
2009-05-11 Label
2009-05-11 Letter
TABLET; ORAL 12MG Prescription   ILOPERIDONE iloperidone NOVARTIS   "
TABLET; ORAL 1MG Prescription  (Reference Drug) ILOPERIDONE iloperidone NOVARTIS   "
TABLET; ORAL 2MG Prescription   ILOPERIDONE iloperidone NOVARTIS   "
TABLET; ORAL 4MG Prescription   ILOPERIDONE iloperidone NOVARTIS   "
TABLET; ORAL 6MG Prescription   ILOPERIDONE iloperidone NOVARTIS   "
TABLET; ORAL 8MG Prescription   ILOPERIDONE iloperidone NOVARTIS   "

Drug Adverse Effects information for FANAPT

Role code Indications Reaction # Reports
PS AFFECTIVE DISORDER BLOOD PRESSURE INCREASED 1
PS AFFECTIVE DISORDER CONFUSIONAL STATE 1
PS AFFECTIVE DISORDER DEHYDRATION 1
PS AFFECTIVE DISORDER OVERDOSE 1
PS AFFECTIVE DISORDER PRODUCT LABEL CONFUSION 1
PS AFFECTIVE DISORDER SYNCOPE 1
PS AFFECTIVE DISORDER TACHYCARDIA 1
PS ANXIETY ABDOMINAL PAIN 1
PS ANXIETY BACK PAIN 1
PS ANXIETY FATIGUE 1
PS ANXIETY FEELING HOT 1
PS ANXIETY NECK PAIN 1
PS ANXIETY PAIN IN EXTREMITY 1
PS ANXIETY WEIGHT INCREASED 1
PS BIPOLAR DISORDER DISCOMFORT 3
PS BIPOLAR DISORDER DIZZINESS 2
PS BIPOLAR DISORDER DYSKINESIA 1
PS BIPOLAR DISORDER HEAD DISCOMFORT 1
PS BIPOLAR DISORDER HEADACHE 1
PS BIPOLAR DISORDER INCREASED APPETITE 1
PS BIPOLAR DISORDER INSOMNIA 1
PS BIPOLAR DISORDER MUSCLE CONTRACTIONS INVOLUNTARY 1
PS BIPOLAR DISORDER MUSCULOSKELETAL STIFFNESS 1
PS BIPOLAR DISORDER NAUSEA 1
PS BIPOLAR DISORDER OEDEMA PERIPHERAL 2
PS BIPOLAR DISORDER TACHYCARDIA 2
PS BIPOLAR DISORDER WEIGHT INCREASED 1
PS HYPERTENSION ARTHRALGIA 4
PS HYPERTENSION CONCOMITANT DISEASE PROGRESSION 4
PS HYPERTENSION SYNCOPE 4
PS INSOMNIA CYANOSIS 1
PS INSOMNIA DISORIENTATION 1
PS INSOMNIA DIZZINESS 1
PS INSOMNIA HYPOTENSION 1
PS INSOMNIA HYPOXIA 1
PS INSOMNIA VISION BLURRED 1
PS INSOMNIA WRONG DRUG ADMINISTERED 1
PS MANIA MIGRAINE 2
PS PARANOIA ABDOMINAL PAIN 1
PS PARANOIA ANORGASMIA 2
PS PARANOIA APPETITE DISORDER 2
PS PARANOIA BACK PAIN 1
PS PARANOIA DISTURBANCE IN ATTENTION 2
PS PARANOIA DIZZINESS 4
PS PARANOIA DRY EYE 2
PS PARANOIA DYSKINESIA 2
PS PARANOIA DYSPHONIA 2
PS PARANOIA DYSSTASIA 2
PS PARANOIA EJACULATION DISORDER 2
PS PARANOIA ERECTILE DYSFUNCTION 2
PS PARANOIA FATIGUE 3
PS PARANOIA FEELING ABNORMAL 2
PS PARANOIA FEELING HOT 1
PS PARANOIA HEART RATE IRREGULAR 2
PS PARANOIA HYPOAESTHESIA 2
PS PARANOIA HYPOTENSION 2
PS PARANOIA LEUKOPLAKIA ORAL 2
PS PARANOIA NECK PAIN 1
PS PARANOIA NEURALGIA 2
PS PARANOIA PAIN IN EXTREMITY 1
PS PARANOIA PRIAPISM 2
PS PARANOIA PROSTATIC DISORDER 2
PS PARANOIA PROSTATITIS 2
PS PARANOIA PROSTATOMEGALY 2
PS PARANOIA SEDATION 2
PS PARANOIA THIRST 2
PS PARANOIA TINNITUS 2
PS PARANOIA WEIGHT INCREASED 1
PS PSYCHOTIC DISORDER CYANOSIS 1
PS PSYCHOTIC DISORDER DISORIENTATION 1
PS PSYCHOTIC DISORDER DIZZINESS 1
PS PSYCHOTIC DISORDER HYPOTENSION 1
PS PSYCHOTIC DISORDER HYPOXIA 1
PS PSYCHOTIC DISORDER TACHYCARDIA 1
PS PSYCHOTIC DISORDER VISION BLURRED 1
PS PSYCHOTIC DISORDER WRONG DRUG ADMINISTERED 1
PS SCHIZOAFFECTIVE DISORDER BALLISMUS 1
PS SCHIZOAFFECTIVE DISORDER CHOREOATHETOSIS 1
PS SCHIZOAFFECTIVE DISORDER COGNITIVE DISORDER 2
PS SCHIZOAFFECTIVE DISORDER DRUG INEFFECTIVE 2
PS SCHIZOAFFECTIVE DISORDER DYSARTHRIA 1
PS SCHIZOAFFECTIVE DISORDER DYSKINESIA 1
PS SCHIZOAFFECTIVE DISORDER DYSTONIA 1
PS SCHIZOAFFECTIVE DISORDER GAIT DISTURBANCE 1
PS SCHIZOAFFECTIVE DISORDER GRIMACING 1
PS SCHIZOAFFECTIVE DISORDER HYPOTENSION 2
PS SCHIZOAFFECTIVE DISORDER LETHARGY 2
PS SCHIZOAFFECTIVE DISORDER LEUKOPENIA 2
PS SCHIZOAFFECTIVE DISORDER MENTAL DISORDER 1
PS SCHIZOAFFECTIVE DISORDER MOTOR DYSFUNCTION 2
PS SCHIZOAFFECTIVE DISORDER MUSCULOSKELETAL DISCOMFORT 1
PS SCHIZOAFFECTIVE DISORDER OXYGEN SATURATION DECREASED 2
PS SCHIZOAFFECTIVE DISORDER PROTRUSION TONGUE 1
PS SCHIZOAFFECTIVE DISORDER TARDIVE DYSKINESIA 1
PS SCHIZOAFFECTIVE DISORDER THROMBOCYTOPENIA 2
PS SCHIZOAFFECTIVE DISORDER TONGUE DISORDER 1
PS SCHIZOAFFECTIVE DISORDER URINARY INCONTINENCE 2
PS SCHIZOAFFECTIVE DISORDER WEIGHT DECREASED 2
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE COGNITIVE DISORDER 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE DIET REFUSAL 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE DRUG INEFFECTIVE 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE LETHARGY 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE MASTICATION DISORDER 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE MUSCLE RIGIDITY 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE URINARY TRACT INFECTION 1
PS SCHIZOPHRENIA ARTHRALGIA 4
PS SCHIZOPHRENIA BALLISMUS 1
PS SCHIZOPHRENIA BLOOD PRESSURE DECREASED 1
PS SCHIZOPHRENIA CHOREOATHETOSIS 1
PS SCHIZOPHRENIA CONCOMITANT DISEASE PROGRESSION 4
PS SCHIZOPHRENIA COUGH 2
PS SCHIZOPHRENIA DIZZINESS 3
PS SCHIZOPHRENIA DYSARTHRIA 1
PS SCHIZOPHRENIA DYSKINESIA 1
PS SCHIZOPHRENIA DYSPNOEA 2
PS SCHIZOPHRENIA DYSTONIA 1
PS SCHIZOPHRENIA FAECAL INCONTINENCE 2
PS SCHIZOPHRENIA FALL 2
PS SCHIZOPHRENIA FEELING ABNORMAL 1
PS SCHIZOPHRENIA GAIT DISTURBANCE 1
PS SCHIZOPHRENIA GRIMACING 1
PS SCHIZOPHRENIA INCREASED APPETITE 1
PS SCHIZOPHRENIA INSOMNIA 2
PS SCHIZOPHRENIA MENTAL DISORDER 1
PS SCHIZOPHRENIA MUSCULOSKELETAL DISCOMFORT 1
PS SCHIZOPHRENIA NAUSEA 1
PS SCHIZOPHRENIA PRIAPISM 2
PS SCHIZOPHRENIA PROTRUSION TONGUE 1
PS SCHIZOPHRENIA PSYCHOMOTOR HYPERACTIVITY 2
PS SCHIZOPHRENIA RETROGRADE EJACULATION 1
PS SCHIZOPHRENIA SEDATION 1
PS SCHIZOPHRENIA SYNCOPE 4
PS SCHIZOPHRENIA TACHYCARDIA 2
PS SCHIZOPHRENIA TARDIVE DYSKINESIA 1
PS SCHIZOPHRENIA TONGUE DISORDER 1
PS SCHIZOPHRENIA URINARY INCONTINENCE 2
PS SCHIZOPHRENIA VOMITING 1
PS SCHIZOPHRENIA WEIGHT INCREASED 1
PS TYPE 1 DIABETES MELLITUS ARTHRALGIA 2
PS TYPE 1 DIABETES MELLITUS CONCOMITANT DISEASE PROGRESSION 2
PS TYPE 1 DIABETES MELLITUS SYNCOPE 2
SS AFFECTIVE DISORDER BLOOD PRESSURE INCREASED 1
SS AFFECTIVE DISORDER CONFUSIONAL STATE 1
SS AFFECTIVE DISORDER DEHYDRATION 1
SS AFFECTIVE DISORDER OVERDOSE 1
SS AFFECTIVE DISORDER PRODUCT LABEL CONFUSION 1
SS AFFECTIVE DISORDER SYNCOPE 1
SS AFFECTIVE DISORDER TACHYCARDIA 1
SS HYPERTENSION ARTHRALGIA 12
SS HYPERTENSION CONCOMITANT DISEASE PROGRESSION 12
SS HYPERTENSION SYNCOPE 12
SS PRODUCT USED FOR UNKNOWN INDICATION PRIAPISM 3
SS PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 3
SS SCHIZOPHRENIA ARTHRALGIA 28
SS SCHIZOPHRENIA CONCOMITANT DISEASE PROGRESSION 28
SS SCHIZOPHRENIA DIABETES MELLITUS 16
SS SCHIZOPHRENIA SYNCOPE 28
SS TYPE 1 DIABETES MELLITUS ARTHRALGIA 14
SS TYPE 1 DIABETES MELLITUS CONCOMITANT DISEASE PROGRESSION 14
SS TYPE 1 DIABETES MELLITUS DIABETES MELLITUS 8
SS TYPE 1 DIABETES MELLITUS SYNCOPE 14
C BIPOLAR I DISORDER ANXIETY 1
C BIPOLAR I DISORDER ASTHENIA 1
C BIPOLAR I DISORDER BIPOLAR DISORDER 1
C BIPOLAR I DISORDER CONDITION AGGRAVATED 1
C BIPOLAR I DISORDER DEPRESSION 1
C BIPOLAR I DISORDER FLASHBACK 1
C BIPOLAR I DISORDER PNEUMONIA 1
C BIPOLAR I DISORDER RESPIRATORY FAILURE 1
C BIPOLAR I DISORDER SOMNOLENCE 1
C DEPRESSION ANXIETY 1
C DEPRESSION ASTHENIA 1
C DEPRESSION BIPOLAR DISORDER 1
C DEPRESSION CONDITION AGGRAVATED 1
C DEPRESSION DEPRESSION 1
C DEPRESSION FLASHBACK 1
C DEPRESSION PNEUMONIA 1
C DEPRESSION RESPIRATORY FAILURE 1
C DEPRESSION SOMNOLENCE 1
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