Drug information for LATUDA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 40MG Prescription   LURASIDONE HYDROCHLORIDE N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide SUNOVION 200603
2012-05-01 Label
2012-05-01 Label
2012-04-27 Letter
2012-04-27 Letter
2011-12-22 Other Important Information from FDA
2011-12-13 Letter
2011-12-13 Letter
2011-12-13 Label
2011-12-13 Label
2011-02-17 Summary Review
2010-12-28 Letter
2010-12-23 Label
2010-12-03 Review
2010-11-03 Letter
2010-10-29 Label
TABLET; ORAL 80MG Prescription  (Reference Drug) LURASIDONE HYDROCHLORIDE N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide SUNOVION   "

Drug Adverse Effects information for LATUDA

Role code Indications Reaction # Reports
PS DELUSION CATATONIA 1
PS HALLUCINATION, AUDITORY CONFUSIONAL STATE 1
PS HALLUCINATION, AUDITORY DISORIENTATION 1
PS HALLUCINATION, AUDITORY HALLUCINATION 1
PS HALLUCINATION, AUDITORY IMPAIRED DRIVING ABILITY 1
PS HALLUCINATION, AUDITORY OVERDOSE 1
PS HALLUCINATION, AUDITORY PARANOIA 1
PS HALLUCINATION, AUDITORY WEIGHT INCREASED 1
PS OBSESSIVE-COMPULSIVE DISORDER AGGRESSION 1
PS OBSESSIVE-COMPULSIVE DISORDER AGITATION 1
PS OBSESSIVE-COMPULSIVE DISORDER INSOMNIA 1
PS POST-TRAUMATIC STRESS DISORDER CONFUSIONAL STATE 1
PS POST-TRAUMATIC STRESS DISORDER DISORIENTATION 1
PS POST-TRAUMATIC STRESS DISORDER HALLUCINATION 1
PS POST-TRAUMATIC STRESS DISORDER IMPAIRED DRIVING ABILITY 1
PS POST-TRAUMATIC STRESS DISORDER OVERDOSE 1
PS POST-TRAUMATIC STRESS DISORDER PARANOIA 1
PS POST-TRAUMATIC STRESS DISORDER WEIGHT INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION ABASIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION CATATONIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION MOVEMENT DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION PLATELET COUNT DECREASED 13
PS PSYCHOTIC DISORDER ALANINE AMINOTRANSFERASE INCREASED 1
PS PSYCHOTIC DISORDER ASPARTATE AMINOTRANSFERASE INCREASED 1
PS PSYCHOTIC DISORDER CONDITION AGGRAVATED 1
PS PSYCHOTIC DISORDER MOOD ALTERED 1
PS PSYCHOTIC DISORDER PSYCHOTIC DISORDER 1
PS SCHIZOAFFECTIVE DISORDER CONFUSIONAL STATE 1
PS SCHIZOAFFECTIVE DISORDER CONVULSION 2
PS SCHIZOAFFECTIVE DISORDER DISORIENTATION 1
PS SCHIZOAFFECTIVE DISORDER HALLUCINATION 1
PS SCHIZOAFFECTIVE DISORDER HYPERVENTILATION 2
PS SCHIZOAFFECTIVE DISORDER IMPAIRED DRIVING ABILITY 1
PS SCHIZOAFFECTIVE DISORDER LOSS OF CONSCIOUSNESS 1
PS SCHIZOAFFECTIVE DISORDER OVERDOSE 1
PS SCHIZOAFFECTIVE DISORDER PANIC ATTACK 2
PS SCHIZOAFFECTIVE DISORDER PARANOIA 1
PS SCHIZOAFFECTIVE DISORDER TREATMENT NONCOMPLIANCE 2
PS SCHIZOAFFECTIVE DISORDER WEIGHT INCREASED 1
PS SCHIZOPHRENIA AGGRESSION 1
PS SCHIZOPHRENIA AGITATION 1
PS SCHIZOPHRENIA ANTICONVULSANT DRUG LEVEL INCREASED 2
PS SCHIZOPHRENIA ANXIETY 4
PS SCHIZOPHRENIA CONDITION AGGRAVATED 2
PS SCHIZOPHRENIA DYSTONIA 4
PS SCHIZOPHRENIA FEELING ABNORMAL 2
PS SCHIZOPHRENIA GUN SHOT WOUND 2
PS SCHIZOPHRENIA HYPERSENSITIVITY 1
PS SCHIZOPHRENIA INSOMNIA 3
PS SCHIZOPHRENIA INTENTIONAL SELF-INJURY 2
PS SCHIZOPHRENIA PANIC ATTACK 4
PS SCHIZOPHRENIA PHYSICAL ASSAULT 2
PS SCHIZOPHRENIA PSYCHIATRIC DECOMPENSATION 2
PS SCHIZOPHRENIA SUICIDE ATTEMPT 2
PS SCHIZOPHRENIA TREATMENT FAILURE 2
PS SCHIZOPHRENIA, PARANOID TYPE CONVULSION 1
PS SCHIZOPHRENIA, PARANOID TYPE GRAND MAL CONVULSION 1
PS SCHIZOPHRENIA, PARANOID TYPE MEDICATION ERROR 1
PS SCHIZOPHRENIA, PARANOID TYPE RESUSCITATION 1
SS BIPOLAR DISORDER OEDEMA PERIPHERAL 1
SS BIPOLAR DISORDER SWELLING FACE 1
SS DELUSION CATATONIA 1
SS DEPRESSION ANXIETY 1
SS PRODUCT USED FOR UNKNOWN INDICATION AGGRESSION 4
SS PRODUCT USED FOR UNKNOWN INDICATION CATATONIA 2
SS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 2
SS PRODUCT USED FOR UNKNOWN INDICATION PLATELET COUNT DECREASED 13
SS PRODUCT USED FOR UNKNOWN INDICATION PSYCHOTIC DISORDER 4
C ANXIETY DEPRESSION 2
C ANXIETY FATIGUE 2
C ANXIETY GENERAL SYMPTOM 2
C ANXIETY INFLUENZA LIKE ILLNESS 2
C ANXIETY MOBILITY DECREASED 2
C BACK PAIN DEPRESSION 1
C BACK PAIN FATIGUE 1
C BACK PAIN GENERAL SYMPTOM 1
C BACK PAIN INFLUENZA LIKE ILLNESS 1
C BACK PAIN MOBILITY DECREASED 1
C BIPOLAR DISORDER DEPRESSION 2
C BIPOLAR DISORDER FATIGUE 2
C BIPOLAR DISORDER GENERAL SYMPTOM 2
C BIPOLAR DISORDER INFLUENZA LIKE ILLNESS 2
C BIPOLAR DISORDER MOBILITY DECREASED 2
C DEPRESSION DEPRESSION 2
C DEPRESSION FATIGUE 2
C DEPRESSION GENERAL SYMPTOM 2
C DEPRESSION INFLUENZA LIKE ILLNESS 2
C DEPRESSION MOBILITY DECREASED 2
C HYPERTENSION DEPRESSION 1
C HYPERTENSION FATIGUE 1
C HYPERTENSION GENERAL SYMPTOM 1
C HYPERTENSION INFLUENZA LIKE ILLNESS 1
C HYPERTENSION MOBILITY DECREASED 1
C INSOMNIA DEPRESSION 1
C INSOMNIA FATIGUE 1
C INSOMNIA GENERAL SYMPTOM 1
C INSOMNIA INFLUENZA LIKE ILLNESS 1
C INSOMNIA MOBILITY DECREASED 1
C INTERVERTEBRAL DISC DEGENERATION DEPRESSION 2
C INTERVERTEBRAL DISC DEGENERATION FATIGUE 2
C INTERVERTEBRAL DISC DEGENERATION GENERAL SYMPTOM 2
C INTERVERTEBRAL DISC DEGENERATION INFLUENZA LIKE ILLNESS 2
C INTERVERTEBRAL DISC DEGENERATION MOBILITY DECREASED 2
C INTERVERTEBRAL DISC PROTRUSION DEPRESSION 1
C INTERVERTEBRAL DISC PROTRUSION FATIGUE 1
C INTERVERTEBRAL DISC PROTRUSION GENERAL SYMPTOM 1
C INTERVERTEBRAL DISC PROTRUSION INFLUENZA LIKE ILLNESS 1
C INTERVERTEBRAL DISC PROTRUSION MOBILITY DECREASED 1
C MULTIPLE SCLEROSIS DEPRESSION 1
C MULTIPLE SCLEROSIS FATIGUE 1
C MULTIPLE SCLEROSIS GENERAL SYMPTOM 1
C MULTIPLE SCLEROSIS INFLUENZA LIKE ILLNESS 1
C MULTIPLE SCLEROSIS MOBILITY DECREASED 1
C PRODUCT USED FOR UNKNOWN INDICATION AMENORRHOEA 2
C PRODUCT USED FOR UNKNOWN INDICATION WEIGHT INCREASED 2
C SCHIZOPHRENIA FAECAL INCONTINENCE 2
C SCHIZOPHRENIA URINARY INCONTINENCE 2
C SLEEP DISORDER AMENORRHOEA 2
C SLEEP DISORDER WEIGHT INCREASED 2
C SMOKING CESSATION THERAPY BLISTER 1
C SMOKING CESSATION THERAPY ERYTHEMA 1
C SMOKING CESSATION THERAPY SUICIDE ATTEMPT 1
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