Drug information for SAPHRIS

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; SUBLINGUAL EQ 10MG BASE Prescription  (Reference Drug) ASENAPINE MALEATE Asenapine ORGANON USA INC 22117
2011-12-20 Other Important Information from FDA

2011-10-13 Letter

2011-10-12 Label

2011-08-11 Letter

2011-08-11 Label

2010-12-07 Letter

2010-12-04 Label

2010-09-21 Letter

2010-09-21 Letter

2010-08-30 Label

2010-08-30 Label

2009-10-02 Review

2009-10-02 Summary Review

2009-08-26 Label

2009-08-26 Letter
TABLET; SUBLINGUAL EQ 5MG BASE Prescription   ASENAPINE MALEATE Asenapine ORGANON USA INC   "

Drug Adverse Effects information for SAPHRIS

Role code Indications Reaction # Reports
PS AFFECTIVE DISORDER ABNORMAL BEHAVIOUR 1
PS AFFECTIVE DISORDER AGGRESSION 1
PS AFFECTIVE DISORDER ANXIETY 1
PS AFFECTIVE DISORDER BLOOD GLUCOSE INCREASED 1
PS AFFECTIVE DISORDER DEPRESSION 1
PS AFFECTIVE DISORDER DROOLING 1
PS AFFECTIVE DISORDER DYSTONIA 2
PS AFFECTIVE DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS AFFECTIVE DISORDER NAUSEA 1
PS AFFECTIVE DISORDER OFF LABEL USE 1
PS AFFECTIVE DISORDER OROPHARYNGEAL BLISTERING 1
PS AFFECTIVE DISORDER PHARYNGEAL OEDEMA 1
PS AFFECTIVE DISORDER SELF-INJURIOUS IDEATION 1
PS AFFECTIVE DISORDER SKIN IRRITATION 1
PS AFFECTIVE DISORDER SOMNOLENCE 1
PS AFFECTIVE DISORDER SUICIDAL IDEATION 1
PS AFFECTIVE DISORDER UNDERDOSE 1
PS AGITATION GALACTORRHOEA 1
PS AGITATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS AGITATION UNDERDOSE 1
PS ANXIETY DEATH 1
PS ANXIETY DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE 1
PS ANXIETY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS ANXIETY RETCHING 1
PS ANXIETY UNDERDOSE 1
PS ANXIETY VOMITING 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER FEAR 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER HALLUCINATION 1
PS BIPOLAR DISORDER ABDOMINAL PAIN UPPER 1
PS BIPOLAR DISORDER ABNORMAL BEHAVIOUR 1
PS BIPOLAR DISORDER ADVERSE EVENT 2
PS BIPOLAR DISORDER AGITATION 3
PS BIPOLAR DISORDER AKATHISIA 6
PS BIPOLAR DISORDER ANGIOEDEMA 4
PS BIPOLAR DISORDER ANXIETY 1
PS BIPOLAR DISORDER ARTHRALGIA 2
PS BIPOLAR DISORDER ARTHROPOD BITE 1
PS BIPOLAR DISORDER BALANCE DISORDER 3
PS BIPOLAR DISORDER BLOOD CHOLESTEROL INCREASED 1
PS BIPOLAR DISORDER BLOOD CREATINE PHOSPHOKINASE 1
PS BIPOLAR DISORDER BLOOD GLUCOSE DECREASED 2
PS BIPOLAR DISORDER BLOOD GLUCOSE INCREASED 3
PS BIPOLAR DISORDER BLOOD POTASSIUM DECREASED 1
PS BIPOLAR DISORDER BLOOD POTASSIUM INCREASED 1
PS BIPOLAR DISORDER BLOOD PRESSURE INCREASED 1
PS BIPOLAR DISORDER BODY TEMPERATURE INCREASED 1
PS BIPOLAR DISORDER CHEILITIS 1
PS BIPOLAR DISORDER CHEST PAIN 2
PS BIPOLAR DISORDER CHILLS 1
PS BIPOLAR DISORDER COGNITIVE DISORDER 1
PS BIPOLAR DISORDER CONDITION AGGRAVATED 2
PS BIPOLAR DISORDER CONFUSIONAL STATE 3
PS BIPOLAR DISORDER CONSTIPATION 1
PS BIPOLAR DISORDER CONVULSION 4
PS BIPOLAR DISORDER COUGH 2
PS BIPOLAR DISORDER DELUSION 1
PS BIPOLAR DISORDER DENTAL CARIES 1
PS BIPOLAR DISORDER DEPRESSION 1
PS BIPOLAR DISORDER DISORIENTATION 1
PS BIPOLAR DISORDER DISTURBANCE IN ATTENTION 1
PS BIPOLAR DISORDER DIZZINESS 7
PS BIPOLAR DISORDER DRUG ABUSE 1
PS BIPOLAR DISORDER DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE 2
PS BIPOLAR DISORDER DRUG DOSE OMISSION 2
PS BIPOLAR DISORDER DRUG HYPERSENSITIVITY 3
PS BIPOLAR DISORDER DRUG WITHDRAWAL HEADACHE 1
PS BIPOLAR DISORDER DRY SKIN 1
PS BIPOLAR DISORDER DYSGEUSIA 3
PS BIPOLAR DISORDER DYSKINESIA 1
PS BIPOLAR DISORDER DYSPHAGIA 2
PS BIPOLAR DISORDER DYSPHEMIA 2
PS BIPOLAR DISORDER DYSPNOEA 5
PS BIPOLAR DISORDER DYSTONIA 4
PS BIPOLAR DISORDER ENERGY INCREASED 1
PS BIPOLAR DISORDER ENURESIS 1
PS BIPOLAR DISORDER ERYTHEMA 2
PS BIPOLAR DISORDER EUPHORIC MOOD 1
PS BIPOLAR DISORDER EXTRAPYRAMIDAL DISORDER 3
PS BIPOLAR DISORDER EYE MOVEMENT DISORDER 2
PS BIPOLAR DISORDER EYE SWELLING 1
PS BIPOLAR DISORDER FALL 3
PS BIPOLAR DISORDER FATIGUE 1
PS BIPOLAR DISORDER FEELING ABNORMAL 6
PS BIPOLAR DISORDER FEELING COLD 1
PS BIPOLAR DISORDER FEELING JITTERY 1
PS BIPOLAR DISORDER FLUSHING 1
PS BIPOLAR DISORDER GAIT DISTURBANCE 2
PS BIPOLAR DISORDER GLOSSODYNIA 1
PS BIPOLAR DISORDER GYNAECOMASTIA 1
PS BIPOLAR DISORDER HALLUCINATION 1
PS BIPOLAR DISORDER HANGOVER 1
PS BIPOLAR DISORDER HEAD INJURY 1
PS BIPOLAR DISORDER HEADACHE 1
PS BIPOLAR DISORDER HEART RATE IRREGULAR 1
PS BIPOLAR DISORDER HYPERHIDROSIS 3
PS BIPOLAR DISORDER HYPERSENSITIVITY 2
PS BIPOLAR DISORDER HYPERSOMNIA 1
PS BIPOLAR DISORDER HYPOAESTHESIA 3
PS BIPOLAR DISORDER HYPOAESTHESIA ORAL 6
PS BIPOLAR DISORDER HYPOMANIA 3
PS BIPOLAR DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 38
PS BIPOLAR DISORDER INCORRECT ROUTE OF DRUG ADMINISTRATION 6
PS BIPOLAR DISORDER INCREASED APPETITE 3
PS BIPOLAR DISORDER INSOMNIA 5
PS BIPOLAR DISORDER IRRITABILITY 1
PS BIPOLAR DISORDER JAW DISORDER 1
PS BIPOLAR DISORDER JOINT STIFFNESS 1
PS BIPOLAR DISORDER LETHARGY 1
PS BIPOLAR DISORDER LIVER FUNCTION TEST ABNORMAL 1
PS BIPOLAR DISORDER LOCAL SWELLING 1
PS BIPOLAR DISORDER LOSS OF CONSCIOUSNESS 1
PS BIPOLAR DISORDER MANIA 3
PS BIPOLAR DISORDER MEMORY IMPAIRMENT 1
PS BIPOLAR DISORDER MUSCLE SPASMS 1
PS BIPOLAR DISORDER MUSCULOSKELETAL STIFFNESS 1
PS BIPOLAR DISORDER MYALGIA 1
PS BIPOLAR DISORDER MYDRIASIS 1
PS BIPOLAR DISORDER NAUSEA 2
PS BIPOLAR DISORDER NIGHTMARE 1
PS BIPOLAR DISORDER NOCTURNAL DYSPNOEA 1
PS BIPOLAR DISORDER OBSESSIVE-COMPULSIVE DISORDER 1
PS BIPOLAR DISORDER OEDEMA PERIPHERAL 5
PS BIPOLAR DISORDER ORAL DISCOMFORT 1
PS BIPOLAR DISORDER OROPHARYNGEAL BLISTERING 1
PS BIPOLAR DISORDER ORTHOSTATIC HYPOTENSION 1
PS BIPOLAR DISORDER OVERDOSE 3
PS BIPOLAR DISORDER PAIN IN EXTREMITY 2
PS BIPOLAR DISORDER PALPITATIONS 1
PS BIPOLAR DISORDER PANIC ATTACK 2
PS BIPOLAR DISORDER PHARYNGEAL OEDEMA 2
PS BIPOLAR DISORDER PLATELET COUNT DECREASED 1
PS BIPOLAR DISORDER PSYCHOTIC DISORDER 1
PS BIPOLAR DISORDER RABBIT SYNDROME 1
PS BIPOLAR DISORDER RASH 3
PS BIPOLAR DISORDER RASH GENERALISED 5
PS BIPOLAR DISORDER RESTLESS LEGS SYNDROME 2
PS BIPOLAR DISORDER RESTLESSNESS 2
PS BIPOLAR DISORDER SEDATION 4
PS BIPOLAR DISORDER SIMPLE PARTIAL SEIZURES 1
PS BIPOLAR DISORDER SKIN EXFOLIATION 1
PS BIPOLAR DISORDER SLEEP APNOEA SYNDROME 1
PS BIPOLAR DISORDER SLEEP TALKING 1
PS BIPOLAR DISORDER SOMNAMBULISM 2
PS BIPOLAR DISORDER SOMNOLENCE 4
PS BIPOLAR DISORDER SPEECH DISORDER 1
PS BIPOLAR DISORDER STARING 1
PS BIPOLAR DISORDER SUBSTANCE ABUSE 1
PS BIPOLAR DISORDER SUDDEN ONSET OF SLEEP 1
PS BIPOLAR DISORDER SWOLLEN TONGUE 6
PS BIPOLAR DISORDER SYNCOPE 1
PS BIPOLAR DISORDER TARDIVE DYSKINESIA 3
PS BIPOLAR DISORDER THERAPEUTIC PRODUCT INEFFECTIVE 1
PS BIPOLAR DISORDER THINKING ABNORMAL 1
PS BIPOLAR DISORDER THIRST 1
PS BIPOLAR DISORDER THROAT IRRITATION 2
PS BIPOLAR DISORDER THROAT TIGHTNESS 1
PS BIPOLAR DISORDER TONGUE BLISTERING 2
PS BIPOLAR DISORDER TONGUE DISCOLOURATION 2
PS BIPOLAR DISORDER TONGUE DISORDER 1
PS BIPOLAR DISORDER TONGUE EXFOLIATION 1
PS BIPOLAR DISORDER TONGUE ULCERATION 1
PS BIPOLAR DISORDER TOOTH DISCOLOURATION 2
PS BIPOLAR DISORDER TREMOR 6
PS BIPOLAR DISORDER UNDERDOSE 20
PS BIPOLAR DISORDER URTICARIA 2
PS BIPOLAR DISORDER VISION BLURRED 1
PS BIPOLAR DISORDER VOMITING 1
PS BIPOLAR DISORDER WEIGHT INCREASED 10
PS BIPOLAR DISORDER WOUND 1
PS BIPOLAR DISORDER WRONG TECHNIQUE IN DRUG USAGE PROCESS 2
PS BIPOLAR I DISORDER ARTHRALGIA 1
PS BIPOLAR I DISORDER ASTHMA 1
PS BIPOLAR I DISORDER BALANCE DISORDER 1
PS BIPOLAR I DISORDER BLISTER 1
PS BIPOLAR I DISORDER BRADYPHRENIA 1
PS BIPOLAR I DISORDER BREAST TENDERNESS 1
PS BIPOLAR I DISORDER COUGH 2
PS BIPOLAR I DISORDER DEATH 1
PS BIPOLAR I DISORDER DISORIENTATION 2
PS BIPOLAR I DISORDER DIZZINESS 2
PS BIPOLAR I DISORDER EAR DISORDER 1
PS BIPOLAR I DISORDER EXCORIATION 1
PS BIPOLAR I DISORDER FALL 1
PS BIPOLAR I DISORDER HYPERSEXUALITY 1
PS BIPOLAR I DISORDER HYPERTENSION 1
PS BIPOLAR I DISORDER HYPOAESTHESIA 1
PS BIPOLAR I DISORDER HYPOTENSION 1
PS BIPOLAR I DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 3
PS BIPOLAR I DISORDER INCORRECT ROUTE OF DRUG ADMINISTRATION 1
PS BIPOLAR I DISORDER INFLUENZA 1
PS BIPOLAR I DISORDER INFLUENZA LIKE ILLNESS 1
PS BIPOLAR I DISORDER LACRIMATION INCREASED 2
PS BIPOLAR I DISORDER MALAISE 1
PS BIPOLAR I DISORDER MOUTH ULCERATION 1
PS BIPOLAR I DISORDER MUSCLE TIGHTNESS 1
PS BIPOLAR I DISORDER MYALGIA 2
PS BIPOLAR I DISORDER NAUSEA 2
PS BIPOLAR I DISORDER PANIC ATTACK 1
PS BIPOLAR I DISORDER PARAESTHESIA 1
PS BIPOLAR I DISORDER RASH 1
PS BIPOLAR I DISORDER SCAR 1
PS BIPOLAR I DISORDER SEDATION 1
PS BIPOLAR I DISORDER SOMNOLENCE 1
PS BIPOLAR I DISORDER SUICIDAL IDEATION 1
PS BIPOLAR I DISORDER SYNCOPE 1
PS BIPOLAR I DISORDER TARDIVE DYSKINESIA 2
PS BIPOLAR I DISORDER UNDERDOSE 3
PS BIPOLAR I DISORDER WRIST FRACTURE 1
PS BIPOLAR I DISORDER WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
PS BIPOLAR II DISORDER OROMANDIBULAR DYSTONIA 1
PS BIPOLAR II DISORDER RASH GENERALISED 1
PS BIPOLAR II DISORDER RASH PRURITIC 2
PS BIPOLAR II DISORDER TORTICOLLIS 1
PS DEPRESSION ADVERSE EVENT 1
PS DEPRESSION AKATHISIA 2
PS DEPRESSION ANXIETY 1
PS DEPRESSION DEPRESSION 1
PS DEPRESSION DRUG EFFECT DECREASED 1
PS DEPRESSION DYSPNOEA 1
PS DEPRESSION FEELING ABNORMAL 1
PS DEPRESSION HOT FLUSH 1
PS DEPRESSION HYPERHIDROSIS 1
PS DEPRESSION HYPOMANIA 1
PS DEPRESSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 5
PS DEPRESSION INCORRECT ROUTE OF DRUG ADMINISTRATION 1
PS DEPRESSION LETHARGY 1
PS DEPRESSION MANIA 2
PS DEPRESSION OEDEMA PERIPHERAL 1
PS DEPRESSION OFF LABEL USE 1
PS DEPRESSION RESTLESSNESS 2
PS DEPRESSION SOMNOLENCE 1
PS DEPRESSION SURGERY 1
PS DEPRESSION SWOLLEN TONGUE 1
PS DEPRESSION THROAT TIGHTNESS 1
PS DEPRESSION TREMOR 1
PS DEPRESSION UNDERDOSE 3
PS DEPRESSION VOMITING 1
PS DEPRESSION WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
PS GENERALISED ANXIETY DISORDER DRUG EFFECT DECREASED 1
PS GENERALISED ANXIETY DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS GENERALISED ANXIETY DISORDER LETHARGY 1
PS GENERALISED ANXIETY DISORDER SURGERY 1
PS HALLUCINATION CHILLS 1
PS HALLUCINATION DYSPNOEA 1
PS HALLUCINATION HAEMOPTYSIS 1
PS HALLUCINATION LOBAR PNEUMONIA 1
PS HALLUCINATION PULMONARY HAEMORRHAGE 1
PS HALLUCINATION PYREXIA 1
PS HALLUCINATION, AUDITORY BLOOD GLUCOSE INCREASED 1
PS HALLUCINATION, VISUAL DYSPHAGIA 1
PS HALLUCINATION, VISUAL OESOPHAGEAL STENOSIS 1
PS HALLUCINATION, VISUAL VOMITING 1
PS HALLUCINATION, VISUAL WEIGHT DECREASED 1
PS HYPERTHYROIDISM HEPATIC FAILURE 1
PS HYPERTHYROIDISM MENTAL STATUS CHANGES 1
PS HYPERTHYROIDISM RENAL FAILURE ACUTE 1
PS HYPERTHYROIDISM STEVENS-JOHNSON SYNDROME 1
PS INSOMNIA HOT FLUSH 1
PS INSOMNIA HYPERHIDROSIS 1
PS INSOMNIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
PS INSOMNIA INCORRECT ROUTE OF DRUG ADMINISTRATION 1
PS INSOMNIA SOMNOLENCE 1
PS MAJOR DEPRESSION BALANCE DISORDER 1
PS MANIA DRUG HYPERSENSITIVITY 1
PS MANIA DYSPHAGIA 1
PS MANIA HYPOAESTHESIA ORAL 1
PS MANIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
PS MANIA INFLUENZA 1
PS MANIA OFF LABEL USE 1
PS MANIA OROPHARYNGEAL BLISTERING 1
PS MANIA PRURITUS 2
PS MANIA PYREXIA 2
PS MANIA SOMNAMBULISM 1
PS MANIA UNDERDOSE 2
PS MENTAL DISORDER DYSGEUSIA 1
PS MENTAL DISORDER DYSPNOEA 1
PS MENTAL DISORDER HYPOAESTHESIA 1
PS MENTAL DISORDER JOINT SWELLING 1
PS MENTAL DISORDER OEDEMA PERIPHERAL 1
PS MENTAL DISORDER OFF LABEL USE 1
PS MENTAL DISORDER UNDERDOSE 1
PS OBSESSIVE-COMPULSIVE DISORDER DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE 1
PS OBSESSIVE-COMPULSIVE DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS OBSESSIVE-COMPULSIVE DISORDER RETCHING 1
PS OBSESSIVE-COMPULSIVE DISORDER UNDERDOSE 1
PS OBSESSIVE-COMPULSIVE DISORDER VOMITING 1
PS POST-TRAUMATIC STRESS DISORDER NAUSEA 1
PS POST-TRAUMATIC STRESS DISORDER VOMITING 1
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISCOMFORT 1
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 2
PS PRODUCT USED FOR UNKNOWN INDICATION ACCIDENTAL OVERDOSE 1
PS PRODUCT USED FOR UNKNOWN INDICATION AGEUSIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION AGITATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION AKATHISIA 8
PS PRODUCT USED FOR UNKNOWN INDICATION AKINESIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION AMENORRHOEA 2
PS PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTIC REACTION 7
PS PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTOID REACTION 2
PS PRODUCT USED FOR UNKNOWN INDICATION ANGER 3
PS PRODUCT USED FOR UNKNOWN INDICATION ANGIOEDEMA 2
PS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 2
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD GLUCOSE INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD POTASSIUM DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD PRESSURE DECREASED 2
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD PROLACTIN INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BRADYCARDIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION BREATH ALCOHOL TEST POSITIVE 1
PS PRODUCT USED FOR UNKNOWN INDICATION CEREBROVASCULAR ACCIDENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION CHEMICAL BURN OF GASTROINTESTINAL TRACT 1
PS PRODUCT USED FOR UNKNOWN INDICATION COELIAC DISEASE 1
PS PRODUCT USED FOR UNKNOWN INDICATION COMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION COMA SCALE ABNORMAL 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONFUSIONAL STATE 2
PS PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION COUGH 6
PS PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION DENTAL CARIES 1
PS PRODUCT USED FOR UNKNOWN INDICATION DEPRESSIVE SYMPTOM 2
PS PRODUCT USED FOR UNKNOWN INDICATION DIABETIC KETOACIDOSIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION DROOLING 3
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE 2
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG DOSE OMISSION 2
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG HYPERSENSITIVITY 8
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 1
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INTOLERANCE 2
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG PRESCRIBING ERROR 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 5
PS PRODUCT USED FOR UNKNOWN INDICATION DYSTONIA 3
PS PRODUCT USED FOR UNKNOWN INDICATION ENURESIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION EXERCISE TOLERANCE DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION EXTRAPYRAMIDAL DISORDER 2
PS PRODUCT USED FOR UNKNOWN INDICATION EYE DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION FAECAL INCONTINENCE 2
PS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 1
PS PRODUCT USED FOR UNKNOWN INDICATION FEELING ABNORMAL 3
PS PRODUCT USED FOR UNKNOWN INDICATION FEELING HOT 1
PS PRODUCT USED FOR UNKNOWN INDICATION FEELING JITTERY 1
PS PRODUCT USED FOR UNKNOWN INDICATION GALACTORRHOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION GINGIVAL EROSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION GLOSSODYNIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION GRAND MAL CONVULSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 2
PS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEPATIC FAILURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HOMICIDAL IDEATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERSENSITIVITY 6
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOAESTHESIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOAESTHESIA ORAL 4
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOMANIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOTENSION 2
PS PRODUCT USED FOR UNKNOWN INDICATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 13
PS PRODUCT USED FOR UNKNOWN INDICATION INCORRECT ROUTE OF DRUG ADMINISTRATION 3
PS PRODUCT USED FOR UNKNOWN INDICATION INJURY 1
PS PRODUCT USED FOR UNKNOWN INDICATION INSOMNIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION JOINT SWELLING 1
PS PRODUCT USED FOR UNKNOWN INDICATION LACERATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION LARYNGOSPASM 4
PS PRODUCT USED FOR UNKNOWN INDICATION LIP BLISTER 1
PS PRODUCT USED FOR UNKNOWN INDICATION LIP SWELLING 4
PS PRODUCT USED FOR UNKNOWN INDICATION LOCAL SWELLING 2
PS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 1
PS PRODUCT USED FOR UNKNOWN INDICATION MENSTRUAL DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION MENTAL STATUS CHANGES 1
PS PRODUCT USED FOR UNKNOWN INDICATION MOVEMENT DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCLE TWITCHING 1
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 6
PS PRODUCT USED FOR UNKNOWN INDICATION NECK PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION NIGHT SWEATS 1
PS PRODUCT USED FOR UNKNOWN INDICATION OEDEMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION OEDEMA PERIPHERAL 3
PS PRODUCT USED FOR UNKNOWN INDICATION OESOPHAGEAL STENOSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION ORAL DISCOMFORT 1
PS PRODUCT USED FOR UNKNOWN INDICATION OROPHARYNGEAL BLISTERING 1
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEOPENIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION OVERDOSE 1
PS PRODUCT USED FOR UNKNOWN INDICATION PAIN IN EXTREMITY 3
PS PRODUCT USED FOR UNKNOWN INDICATION PANIC ATTACK 2
PS PRODUCT USED FOR UNKNOWN INDICATION PARAESTHESIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION PHARYNGEAL OEDEMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION POST PROCEDURAL COMPLICATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION PRIAPISM 2
PS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 2
PS PRODUCT USED FOR UNKNOWN INDICATION PSYCHOTIC DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 2
PS PRODUCT USED FOR UNKNOWN INDICATION RASH 6
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 1
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION RESTLESS LEGS SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION RESTLESSNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION SALIVARY HYPERSECRETION 1
PS PRODUCT USED FOR UNKNOWN INDICATION SEDATION 5
PS PRODUCT USED FOR UNKNOWN INDICATION SENSORY LOSS 1
PS PRODUCT USED FOR UNKNOWN INDICATION SKIN LESION 2
PS PRODUCT USED FOR UNKNOWN INDICATION SNEEZING 2
PS PRODUCT USED FOR UNKNOWN INDICATION SOMNOLENCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION STEVENS-JOHNSON SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION STOMATITIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION STRESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION SUICIDAL IDEATION 2
PS PRODUCT USED FOR UNKNOWN INDICATION SUICIDE ATTEMPT 1
PS PRODUCT USED FOR UNKNOWN INDICATION SURGERY 1
PS PRODUCT USED FOR UNKNOWN INDICATION SWELLING 1
PS PRODUCT USED FOR UNKNOWN INDICATION SWELLING FACE 1
PS PRODUCT USED FOR UNKNOWN INDICATION SWOLLEN TONGUE 6
PS PRODUCT USED FOR UNKNOWN INDICATION TARDIVE DYSKINESIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION TENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION TOOTH DISCOLOURATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION TREMOR 1
PS PRODUCT USED FOR UNKNOWN INDICATION UNDERDOSE 7
PS PRODUCT USED FOR UNKNOWN INDICATION VOMITING 4
PS PRODUCT USED FOR UNKNOWN INDICATION WEIGHT INCREASED 7
PS PRODUCT USED FOR UNKNOWN INDICATION WHEEZING 2
PS PRODUCT USED FOR UNKNOWN INDICATION WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
PS PSYCHOTIC DISORDER ARTHRALGIA 1
PS PSYCHOTIC DISORDER BLOOD PRESSURE INCREASED 1
PS PSYCHOTIC DISORDER BLOOD UREA DECREASED 1
PS PSYCHOTIC DISORDER CONDITION AGGRAVATED 1
PS PSYCHOTIC DISORDER DRUG HYPERSENSITIVITY 1
PS PSYCHOTIC DISORDER DYSARTHRIA 1
PS PSYCHOTIC DISORDER DYSPNOEA 3
PS PSYCHOTIC DISORDER ENLARGED UVULA 1
PS PSYCHOTIC DISORDER EYE MOVEMENT DISORDER 1
PS PSYCHOTIC DISORDER HEART RATE INCREASED 1
PS PSYCHOTIC DISORDER HEPATIC ENZYME INCREASED 1
PS PSYCHOTIC DISORDER HYPERHIDROSIS 1
PS PSYCHOTIC DISORDER HYPERTENSION 1
PS PSYCHOTIC DISORDER HYPOAESTHESIA ORAL 3
PS PSYCHOTIC DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS PSYCHOTIC DISORDER INCORRECT ROUTE OF DRUG ADMINISTRATION 2
PS PSYCHOTIC DISORDER MONOCYTE COUNT INCREASED 1
PS PSYCHOTIC DISORDER MUSCULOSKELETAL STIFFNESS 1
PS PSYCHOTIC DISORDER OFF LABEL USE 1
PS PSYCHOTIC DISORDER PSYCHOTIC DISORDER 1
PS PSYCHOTIC DISORDER RASH 2
PS PSYCHOTIC DISORDER RESPIRATORY DISORDER 1
PS PSYCHOTIC DISORDER SOMNOLENCE 1
PS PSYCHOTIC DISORDER SWELLING FACE 1
PS PSYCHOTIC DISORDER SWOLLEN TONGUE 4
PS PSYCHOTIC DISORDER TACHYCARDIA 1
PS PSYCHOTIC DISORDER THROAT TIGHTNESS 1
PS PSYCHOTIC DISORDER UNDERDOSE 1
PS PSYCHOTIC DISORDER UNRESPONSIVE TO STIMULI 1
PS PSYCHOTIC DISORDER WEIGHT INCREASED 1
PS SCHIZOAFFECTIVE DISORDER ARTHRALGIA 1
PS SCHIZOAFFECTIVE DISORDER BLOOD GLUCOSE INCREASED 1
PS SCHIZOAFFECTIVE DISORDER BLOOD UREA DECREASED 1
PS SCHIZOAFFECTIVE DISORDER CONDITION AGGRAVATED 2
PS SCHIZOAFFECTIVE DISORDER CYSTITIS 1
PS SCHIZOAFFECTIVE DISORDER DYSPHAGIA 1
PS SCHIZOAFFECTIVE DISORDER GRAND MAL CONVULSION 1
PS SCHIZOAFFECTIVE DISORDER HEPATIC ENZYME INCREASED 1
PS SCHIZOAFFECTIVE DISORDER HYPOAESTHESIA ORAL 2
PS SCHIZOAFFECTIVE DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 3
PS SCHIZOAFFECTIVE DISORDER INCORRECT ROUTE OF DRUG ADMINISTRATION 2
PS SCHIZOAFFECTIVE DISORDER MATERNAL EXPOSURE DURING PREGNANCY 1
PS SCHIZOAFFECTIVE DISORDER MENSTRUAL DISORDER 1
PS SCHIZOAFFECTIVE DISORDER MONOCYTE COUNT INCREASED 1
PS SCHIZOAFFECTIVE DISORDER OESOPHAGEAL STENOSIS 2
PS SCHIZOAFFECTIVE DISORDER OFF LABEL USE 1
PS SCHIZOAFFECTIVE DISORDER ORAL DISORDER 1
PS SCHIZOAFFECTIVE DISORDER OVERDOSE 1
PS SCHIZOAFFECTIVE DISORDER PSYCHIATRIC SYMPTOM 1
PS SCHIZOAFFECTIVE DISORDER PSYCHOTIC DISORDER 1
PS SCHIZOAFFECTIVE DISORDER SOMNOLENCE 1
PS SCHIZOAFFECTIVE DISORDER UNDERDOSE 1
PS SCHIZOAFFECTIVE DISORDER VOMITING 1
PS SCHIZOAFFECTIVE DISORDER WEIGHT DECREASED 1
PS SCHIZOAFFECTIVE DISORDER WEIGHT INCREASED 2
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE ANGIOEDEMA 1
PS SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE URTICARIA 1
PS SCHIZOPHRENIA AGGRESSION 1
PS SCHIZOPHRENIA AKATHISIA 3
PS SCHIZOPHRENIA ANGER 1
PS SCHIZOPHRENIA ANGIOEDEMA 2
PS SCHIZOPHRENIA ANXIETY 1
PS SCHIZOPHRENIA ASTHENIA 2
PS SCHIZOPHRENIA BALANCE DISORDER 1
PS SCHIZOPHRENIA BLOOD PROLACTIN ABNORMAL 1
PS SCHIZOPHRENIA CHEST PAIN 1
PS SCHIZOPHRENIA CHILLS 1
PS SCHIZOPHRENIA CONDITION AGGRAVATED 1
PS SCHIZOPHRENIA CONVULSION 2
PS SCHIZOPHRENIA DELUSION 1
PS SCHIZOPHRENIA DEPRESSION 1
PS SCHIZOPHRENIA DIZZINESS 2
PS SCHIZOPHRENIA DROOLING 3
PS SCHIZOPHRENIA DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE 3
PS SCHIZOPHRENIA DRUG DOSE OMISSION 1
PS SCHIZOPHRENIA DYSKINESIA 1
PS SCHIZOPHRENIA DYSPHAGIA 2
PS SCHIZOPHRENIA DYSPNOEA 2
PS SCHIZOPHRENIA DYSTONIA 2
PS SCHIZOPHRENIA EMOTIONAL DISORDER 1
PS SCHIZOPHRENIA EUPHORIC MOOD 1
PS SCHIZOPHRENIA EXTRAPYRAMIDAL DISORDER 1
PS SCHIZOPHRENIA FATIGUE 1
PS SCHIZOPHRENIA FEELING ABNORMAL 2
PS SCHIZOPHRENIA FLUSHING 1
PS SCHIZOPHRENIA GAIT DISTURBANCE 1
PS SCHIZOPHRENIA GASTROINTESTINAL MOTILITY DISORDER 1
PS SCHIZOPHRENIA GENERALISED OEDEMA 1
PS SCHIZOPHRENIA GYNAECOMASTIA 1
PS SCHIZOPHRENIA HAEMOPTYSIS 1
PS SCHIZOPHRENIA HEADACHE 1
PS SCHIZOPHRENIA HYPERPHAGIA 1
PS SCHIZOPHRENIA HYPOAESTHESIA 2
PS SCHIZOPHRENIA HYPOAESTHESIA ORAL 4
PS SCHIZOPHRENIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 7
PS SCHIZOPHRENIA INCORRECT ROUTE OF DRUG ADMINISTRATION 1
PS SCHIZOPHRENIA INSOMNIA 1
PS SCHIZOPHRENIA LIP SWELLING 3
PS SCHIZOPHRENIA LOBAR PNEUMONIA 1
PS SCHIZOPHRENIA LOSS OF LIBIDO 1
PS SCHIZOPHRENIA NEUTROPHIL COUNT DECREASED 1
PS SCHIZOPHRENIA OESOPHAGEAL HYPOMOTILITY 1
PS SCHIZOPHRENIA PALLOR 1
PS SCHIZOPHRENIA PARAESTHESIA 1
PS SCHIZOPHRENIA PLATELET COUNT DECREASED 1
PS SCHIZOPHRENIA PRODUCT FORMULATION ISSUE 1
PS SCHIZOPHRENIA PSYCHOTIC DISORDER 1
PS SCHIZOPHRENIA PULMONARY HAEMORRHAGE 1
PS SCHIZOPHRENIA PYREXIA 1
PS SCHIZOPHRENIA SALIVARY HYPERSECRETION 2
PS SCHIZOPHRENIA SEDATION 3
PS SCHIZOPHRENIA SOMNOLENCE 1
PS SCHIZOPHRENIA SPEECH DISORDER 3
PS SCHIZOPHRENIA SWOLLEN TONGUE 2
PS SCHIZOPHRENIA TARDIVE DYSKINESIA 1
PS SCHIZOPHRENIA THERAPEUTIC PRODUCT INEFFECTIVE 1
PS SCHIZOPHRENIA TREMOR 3
PS SCHIZOPHRENIA UNDERDOSE 3
PS SCHIZOPHRENIA WEIGHT INCREASED 4
PS SCHIZOPHRENIA WRONG TECHNIQUE IN DRUG USAGE PROCESS 2
PS SCHIZOPHRENIA, PARANOID TYPE ANGIOEDEMA 1
PS SCHIZOPHRENIFORM DISORDER BLOOD PRESSURE INCREASED 1
PS SCHIZOPHRENIFORM DISORDER GLOSSODYNIA 1
PS SCHIZOPHRENIFORM DISORDER HEART RATE INCREASED 1
PS SCHIZOPHRENIFORM DISORDER HYPOAESTHESIA 1
PS SCHIZOPHRENIFORM DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS SCHIZOPHRENIFORM DISORDER UNDERDOSE 1
PS SCHIZOPHRENIFORM DISORDER WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
SS AFFECTIVE DISORDER ABNORMAL BEHAVIOUR 1
SS AFFECTIVE DISORDER AGGRESSION 1
SS AFFECTIVE DISORDER DROOLING 1
SS AFFECTIVE DISORDER NAUSEA 1
SS AFFECTIVE DISORDER OROPHARYNGEAL BLISTERING 1
SS AFFECTIVE DISORDER SELF-INJURIOUS IDEATION 1
SS AFFECTIVE DISORDER SKIN IRRITATION 1
SS AFFECTIVE DISORDER SOMNOLENCE 1
SS AFFECTIVE DISORDER SUICIDAL IDEATION 1
SS BIPOLAR DISORDER BLOOD GLUCOSE INCREASED 1
SS BIPOLAR DISORDER BLOOD PRESSURE INCREASED 1
SS BIPOLAR DISORDER BODY TEMPERATURE INCREASED 1
SS BIPOLAR DISORDER DRY SKIN 1
SS BIPOLAR DISORDER DYSTONIA 1
SS BIPOLAR DISORDER FLUSHING 1
SS BIPOLAR DISORDER HYPERHIDROSIS 1
SS BIPOLAR DISORDER HYPOMANIA 1
SS BIPOLAR DISORDER JAW DISORDER 1
SS BIPOLAR DISORDER LOCAL SWELLING 1
SS BIPOLAR DISORDER TARDIVE DYSKINESIA 1
SS BIPOLAR DISORDER THROAT TIGHTNESS 1
SS BIPOLAR DISORDER TREMOR 1
SS BIPOLAR DISORDER WEIGHT INCREASED 1
SS BIPOLAR I DISORDER AGITATION 2
SS BIPOLAR I DISORDER BLISTER 2
SS BIPOLAR I DISORDER DEPRESSION 2
SS BIPOLAR I DISORDER DRUG INEFFECTIVE 2
SS BIPOLAR I DISORDER EAR DISORDER 2
SS BIPOLAR I DISORDER INAPPROPRIATE AFFECT 2
SS BIPOLAR I DISORDER MOOD ALTERED 2
SS BIPOLAR I DISORDER PANIC ATTACK 2
SS BIPOLAR I DISORDER PARANOIA 2
SS BIPOLAR I DISORDER SOMNOLENCE 2
SS PRODUCT USED FOR UNKNOWN INDICATION AGGRESSION 4
SS PRODUCT USED FOR UNKNOWN INDICATION DRUG DOSE OMISSION 5
SS PRODUCT USED FOR UNKNOWN INDICATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 5
SS PRODUCT USED FOR UNKNOWN INDICATION INJURY 5
SS PRODUCT USED FOR UNKNOWN INDICATION LACERATION 2
SS PRODUCT USED FOR UNKNOWN INDICATION PRIAPISM 6
SS PRODUCT USED FOR UNKNOWN INDICATION PSYCHOTIC DISORDER 4
SS PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 3
SS PRODUCT USED FOR UNKNOWN INDICATION TARDIVE DYSKINESIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION WEIGHT INCREASED 1
SS SCHIZOPHRENIA PRIAPISM 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DEPRESSION 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE HOMICIDAL IDEATION 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE SUICIDAL IDEATION 1
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD PROLACTIN INCREASED 2
C SCHIZOPHRENIA CARDIAC FAILURE CONGESTIVE 2
C SCHIZOPHRENIA EXTRAPYRAMIDAL DISORDER 1
C SCHIZOPHRENIA FLAT AFFECT 1
C SCHIZOPHRENIA MYOCARDITIS 2
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