therapeutic goods administration medicine summary
TRANSCRIPT
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Total DeathOutcome
SoleSuspected
Causality Unclear Excluded
ALL REPORT DATES
- Cases Including Medicine
- Occurrences of Medicine
- Reactions Related to MedicineAgranulocytosis
Anaemia
Anaemia macrocytic
Anaemia neonatal
Anisocytosis
Basophilia
Bone marrow failure
Coagulopathy
Disseminated intravascular coagulation
Eosinopenia
Eosinophilia
Granulocytosis
Haemolysis
Haemolytic anaemia
Hypochromic anaemia
Leukocytosis
Leukopenia
Lymphadenopathy
Lymphocytosis
Lymphopenia
Microcytic anaemia
Microcytosis
Monocytopenia
Monocytosis
Neutropenia
Neutrophilia
Normochromic normocytic anaemia
Pancytopenia
Blood and lymphatic system disorders
3902 248 3388
3930 254 3388
9823 575 8304
112 2 97
33 2 30
1 0 1
1 0 1
3 0 3
1 0 1
2 0 2
2 2 1
2 0 2
4 0 4
145 0 129
3 0 3
1 0 1
1 0 1
1 0 1
132 5 117
272 1 249
4 0 3
8 0 6
21 2 18
2 0 2
1 0 1
1 0 1
1 0 1
578 3 530
22 0 18
1 0 0
14 0 8
Page 1Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Poikilocytosis
Splenomegaly
Thrombocythaemia
Thrombocytopenia
Blood and lymphatic system disorders
Acute myocardial infarction
Angina pectoris
Aortic valve disease
Arrhythmia
Atrial fibrillation
Atrial flutter
Atrial hypertrophy
Atrioventricular block
Atrioventricular block first degree
Atrioventricular block second degree
Bradycardia
Bundle branch block
Bundle branch block left
Bundle branch block right
Cardiac arrest
Cardiac disorder
Cardiac failure
Cardiac failure congestive
Cardiac tamponade
Cardiogenic shock
Cardiomegaly
Cardiomyopathy
Cardio-respiratory arrest
Congestive cardiomyopathy
Coronary artery occlusion
Cyanosis
Diastolic dysfunction
Dilatation atrial
Dilatation ventricular
Extrasystoles
Hypertensive cardiomyopathy
Cardiac disorders
3 0 3
5 1 3
10 0 8
54 1 45
1 0 1
7 0 7
1 0 1
18 3 13
24 2 20
3 1 1
2 0 1
3 0 3
2 0 2
1 0 1
12 0 12
7 0 6
2 0 1
7 0 7
22 18 15
67 1 62
42 7 33
3 0 3
3 0 3
1 0 1
35 3 27
166 6 148
3 3 3
5 0 5
1 1 1
8 2 4
3 0 3
7 0 7
11 0 9
11 0 11
1 0 1
Page 2Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Hypertrophic cardiomyopathy
Left ventricular dysfunction
Left ventricular failure
Left ventricular hypertrophy
Mitral valve disease
Mitral valve incompetence
Myocardial infarction
Myocardial ischaemia
Myocarditis
Nodal arrhythmia
Palpitations
Pericardial effusion
Pericarditis
Right atrial dilatation
Right ventricular failure
Right ventricular hypertrophy
Sinus tachycardia
Supraventricular tachycardia
Tachyarrhythmia
Tachycardia
Tricuspid valve incompetence
Ventricular dysfunction
Ventricular extrasystoles
Ventricular failure
Ventricular fibrillation
Ventricular hyperkinesia
Ventricular hypertrophy
Ventricular hypokinesia
Ventricular tachycardia
Cardiac disorders
Cleft palate
Congenital foot malformation
Deafness congenital
Congenital, familial and genetic disorders
Deafness
Vertigo
Ear and labyrinth disorders
Diabetes insipidusEndocrine disorders
3 0 3
14 0 14
15 1 13
3 1 3
1 0 1
6 0 5
33 20 29
12 3 12
227 12 201
1 0 1
37 0 35
23 1 20
30 1 26
1 0 1
2 0 1
1 0 1
30 0 27
6 0 3
2 0 2
426 6 367
3 0 3
10 0 9
1 0 1
4 0 4
2 1 2
2 0 2
10 0 10
7 0 7
2 0 2
1 0 0
1 0 0
1 0 1
1 0 1
1 0 1
1 0 1
Page 3Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Hyperadrenocorticism
Hyperparathyroidism
Hyperprolactinaemia
Hypoparathyroidism
Hypothyroidism
Thyroiditis
Endocrine disorders
Blepharospasm
Cataract
Conjunctivitis
Diplopia
Eyelid ptosis
Glaucoma
Miosis
Mydriasis
Night blindness
Oculogyration
Optic neuropathy
Photophobia
Pupillary reflex impaired
Retinal detachment
Retinal disorder
Vision blurred
Visual disturbance
Eye disorders
Abdominal discomfort
Abdominal distension
Abdominal pain
Abdominal pain upper
Abdominal rigidity
Anorectal disorder
Bowel sounds abnormal
Coeliac disease
Colitis
Colitis ulcerative
Constipation
Crohn's disease
Gastrointestinal disorders
1 0 1
1 0 1
2 0 1
1 0 1
1 0 1
1 0 1
1 0 1
3 0 2
1 0 1
1 0 1
1 0 1
1 0 0
1 0 1
1 0 1
1 0 1
3 0 3
1 0 0
1 0 1
1 0 0
1 0 1
1 0 0
2 0 2
6 0 6
2 0 2
5 0 4
40 1 31
7 0 6
1 0 1
1 0 1
1 0 1
1 0 0
7 0 6
1 0 0
63 6 53
1 0 1
Page 4Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Diarrhoea
Duodenitis
Dyspepsia
Dysphagia
Enteritis
Faecal incontinence
Flatulence
Gastritis
Gastrointestinal disorder
Gastrointestinal haemorrhage
Gastrointestinal necrosis
Gastrooesophageal reflux disease
Haematemesis
Hiatus hernia
Ileus
Ileus paralytic
Inflammatory bowel disease
Intestinal ischaemia
Intestinal obstruction
Intestinal perforation
Large intestine perforation
Megacolon
Melaena
Mouth ulceration
Nausea
Odynophagia
Oesophageal varices haemorrhage
Oesophagitis
Oesophagitis ulcerative
Pancreatitis
Pancreatitis acute
Peptic ulcer
Peritonitis
Proctitis
Rectal haemorrhage
Gastrointestinal disorders 73 0 64
1 0 1
15 1 14
21 0 19
2 0 2
5 0 4
2 1 2
3 0 3
4 1 3
3 2 3
3 2 2
7 0 7
6 0 6
1 0 1
2 1 2
8 1 5
1 0 1
1 1 1
20 4 19
4 2 3
1 0 1
1 0 1
2 0 2
3 0 3
119 2 100
1 0 1
1 0 1
5 0 5
3 0 3
12 0 8
2 0 1
2 0 2
2 0 2
1 0 1
2 0 2
Page 5Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Reflux oesophagitis
Salivary gland enlargement
Salivary hypersecretion
Small intestinal obstruction
Swollen tongue
Tongue oedema
Varices oesophageal
Vomiting
Gastrointestinal disorders
Abasia
Asthenia
Chest discomfort
Chest pain
Chills
Condition aggravated
Crepitations
Death
Disease progression
Drug ineffective
Drug interaction
Drug withdrawal syndrome
Exercise tolerance decreased
Face oedema
Fatigue
Feeling abnormal
Feeling cold
Feeling hot
Feeling hot and cold
Foaming at mouth
Gait disturbance
General physical health deterioration
Generalised oedema
Gravitational oedema
Hunger
Hyperpyrexia
Hyperthermia
General disorders and administration siteconditions
1 0 1
15 0 12
110 1 94
2 0 2
1 0 1
3 0 1
1 0 1
141 7 112
1 0 1
29 0 25
6 1 4
151 1 135
17 0 15
3 0 3
1 1 1
48 48 40
1 0 1
63 2 58
13 0 0
35 1 28
1 0 1
5 0 5
72 2 67
4 0 4
1 0 1
1 0 1
4 0 4
1 0 0
11 2 8
1 0 1
1 1 1
5 1 4
1 0 1
3 0 3
1 0 1
Page 6Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Hypothermia
Influenza like illness
Irritability
Malaise
Mucosal inflammation
Multi-organ failure
Oedema
Oedema peripheral
Pain
Pitting oedema
Pyrexia
Rebound effect
Sluggishness
Sudden death
Swelling
Therapeutic response decreased
Therapeutic response increased
Therapeutic response unexpected with drug substitution
Thirst
General disorders and administration siteconditions
Cholangitis
Cholecystitis
Cholelithiasis
Cholestasis
Gallbladder disorder
Hepatic cirrhosis
Hepatic failure
Hepatic function abnormal
Hepatic steatosis
Hepatitis
Hepatitis cholestatic
Hepatomegaly
Hepatosplenomegaly
Hepatosplenomegaly neonatal
Hyperbilirubinaemia
Jaundice
Hepatobiliary disorders
4 0 3
65 4 60
1 0 0
103 3 91
1 0 1
2 1 1
3 0 2
16 0 13
16 0 15
1 0 1
397 8 337
1 0 0
1 0 1
111 111 89
1 0 1
13 0 9
1 0 0
1 0 1
3 0 3
1 0 1
1 0 1
2 0 2
3 0 2
1 0 1
1 1 0
1 1 1
85 1 68
8 0 5
18 1 16
3 0 3
7 0 3
2 0 1
1 0 0
1 0 0
5 1 4
Page 7Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Jaundice cholestaticHepatobiliary disorders
Drug hypersensitivity
Hypersensitivity
Immune system disorders
Abscess
Appendicitis
Bacterial infection
Bronchiectasis
Bronchitis
Bronchopneumonia
Candidiasis
Cellulitis
Clostridial infection
Cytomegalovirus infection
Endocarditis
Gastroenteritis
Haemophilus infection
Helicobacter infection
Hepatitis C
Hepatitis viral
Herpes zoster
Infection
Infection in an immunocompromised host
Infectious mononucleosis
Influenza
Lower respiratory tract infection
Lung infection
Measles
Meningitis
Mycoplasma infection
Nasopharyngitis
Necrotising fasciitis
Otitis media
Parotitis
Perianal abscess
Pharyngitis
Infections and infestations
1 0 1
1 0 1
3 0 3
1 0 1
2 0 2
6 0 6
1 0 1
6 1 5
3 3 3
2 0 2
3 0 2
1 0 1
1 0 1
3 0 3
8 2 7
1 0 1
5 0 5
1 1 1
1 0 0
3 0 2
15 0 13
1 0 1
1 0 1
6 0 5
4 0 4
1 1 1
1 0 1
2 1 2
1 0 1
3 0 1
1 0 1
1 0 1
1 0 1
1 0 1
29 0 25
Page 8Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Pharyngolaryngeal abscess
Pneumonia
Pneumonia primary atypical
Pyelonephritis
Pyothorax
Rash pustular
Respiratory tract infection
Respiratory tract infection viral
Rhinitis
Sepsis
Sinusitis
Streptococcal infection
Streptococcal sepsis
Subcutaneous abscess
Tooth abscess
Upper respiratory tract infection
Urinary tract infection
Varicella
Viral infection
Infections and infestations
Accidental exposure
Accidental overdose
Cardiac function disturbance postoperative
Drug exposure during pregnancy
Drug toxicity
Fall
Heat stroke
Incorrect dose administered
Intentional overdose
Medication error
Overdose
Therapeutic agent toxicity
Wrong drug administered
Injury, poisoning and proceduralcomplications
Alanine aminotransferase increased
Ammonia increased
Antinuclear antibody positive
Investigations
1 0 1
100 16 89
3 0 2
2 0 1
1 0 1
5 0 5
3 0 3
1 1 1
4 0 4
18 6 13
2 0 2
1 0 1
2 1 2
1 1 1
2 0 2
11 1 10
8 1 7
3 0 2
16 0 16
2 0 2
7 1 6
2 0 2
1 0 1
4 0 2
12 2 9
1 1 0
2 0 2
8 1 7
6 0 5
10 0 8
1 0 0
1 0 1
10 0 8
1 0 0
1 0 1
Page 9Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Antipsychotic drug level below therapeutic
Antipsychotic drug level increased
Aspartate aminotransferase increased
Blood albumin increased
Blood alkaline phosphatase increased
Blood amylase increased
Blood bilirubin increased
Blood calcium decreased
Blood cholesterol increased
Blood creatine increased
Blood creatine phosphokinase increased
Blood creatine phosphokinase MB increased
Blood creatinine decreased
Blood creatinine increased
Blood glucose increased
Blood homocysteine increased
Blood insulin abnormal
Blood lactate dehydrogenase increased
Blood lactic acid increased
Blood osmolarity decreased
Blood osmolarity increased
Blood phosphorus decreased
Blood potassium abnormal
Blood pressure decreased
Blood pressure diastolic increased
Blood pressure increased
Blood prolactin increased
Blood sodium abnormal
Blood sodium decreased
Blood test abnormal
Blood triglycerides increased
Blood urea decreased
Blood urea increased
Blood urea nitrogen/creatinine ratio decreased
Blood uric acid increased
Investigations 1 0 1
6 0 3
10 0 8
1 0 1
8 0 5
2 0 1
2 0 2
1 0 0
11 1 11
2 0 2
164 4 138
2 0 2
1 0 1
4 0 3
21 1 18
1 0 1
1 0 1
3 0 2
1 0 1
2 0 2
1 0 1
1 0 1
1 0 1
6 0 5
2 0 2
13 0 11
4 0 3
1 0 1
1 0 1
1 0 1
12 0 12
1 0 1
1 0 0
1 0 1
2 0 2
Page 10Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Body temperature increased
Cardiac enzymes increased
Cardiac murmur
Cardiac output decreased
C-reactive protein increased
Creatinine urine increased
Drug level above therapeutic
Drug level below therapeutic
Drug level changed
Drug level decreased
Drug level fluctuating
Drug level increased
ECG signs of ventricular hypertrophy
Echocardiogram abnormal
Echography abnormal
Ejection fraction
Ejection fraction abnormal
Ejection fraction decreased
Electrocardiogram abnormal
Electrocardiogram change
Electrocardiogram normal
Electrocardiogram P wave biphasic
Electrocardiogram QT prolonged
Electrocardiogram QT shortened
Electrocardiogram repolarisation abnormality
Electrocardiogram ST segment abnormal
Electrocardiogram ST segment depression
Electrocardiogram ST segment elevation
Electrocardiogram ST-T change
Electrocardiogram ST-T segment abnormal
Electrocardiogram T wave abnormal
Electrocardiogram T wave amplitude decreased
Electrocardiogram T wave inversion
Electroencephalogram abnormal
Eosinophil count decreased
Investigations 19 0 17
6 0 5
2 0 2
1 0 1
59 0 51
1 0 0
7 0 3
2 0 2
4 0 4
23 0 17
2 0 0
84 4 51
1 0 1
49 0 49
1 0 1
1 0 1
2 0 2
57 1 51
120 1 108
1 0 1
1 0 1
1 0 1
18 0 16
1 0 1
1 0 1
2 0 2
1 0 0
4 0 4
2 0 2
1 0 1
5 0 5
2 0 2
24 0 20
7 0 5
1 0 1
Page 11Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Eosinophil count increased
Exercise electrocardiogram abnormal
Gamma-glutamyltransferase increased
Glasgow coma scale abnormal
Globulins increased
Glucose tolerance test abnormal
Haematocrit decreased
Haemoglobin decreased
Heart rate increased
Heart rate irregular
Hepatic enzyme abnormal
Hepatic enzyme increased
High density lipoprotein decreased
Lipase increased
Lipids abnormal
Lipids increased
Liver function test abnormal
Low density lipoprotein increased
Lymphocyte count decreased
Lymphocyte count increased
Lymphocyte morphology abnormal
Mean cell volume decreased
Monocyte count decreased
Monocyte count increased
Myoglobin blood increased
Myoglobin urine present
Neutrophil count decreased
Neutrophil count increased
Oxygen saturation decreased
Platelet count decreased
Platelet count increased
Protein total increased
Prothrombin level decreased
Prothrombin time prolonged
Pulse abnormal
Investigations 28 1 25
1 0 1
15 0 13
1 0 0
1 0 1
1 0 1
2 0 2
9 1 7
13 0 12
3 0 2
1 0 0
6 0 5
3 0 3
4 0 3
1 0 1
1 0 1
34 0 28
1 0 1
6 0 4
1 0 1
2 0 2
2 0 2
1 0 1
3 0 3
1 0 1
1 0 1
30 0 29
35 0 33
4 0 1
13 0 9
6 0 4
1 0 1
1 0 1
1 0 0
1 0 1
Page 12Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
QRS axis abnormal
Red blood cell count decreased
Red blood cell count increased
Red blood cell elliptocytes present
Red blood cell sedimentation rate abnormal
Red blood cell sedimentation rate increased
Red cell distribution width increased
Respiratory rate increased
Scan myocardial perfusion abnormal
Thyroid function test abnormal
Transaminases increased
Troponin I increased
Troponin increased
Troponin T increased
Ultrasound liver abnormal
Urine osmolarity decreased
Weight decreased
Weight increased
White blood cell count decreased
White blood cell count increased
Investigations
Acidosis
Anorexia
Decreased appetite
Dehydration
Diabetes mellitus
Diabetes mellitus inadequate control
Diabetes mellitus insulin-dependent
Diabetes mellitus non-insulin-dependent
Diabetic ketoacidosis
Electrolyte imbalance
Glucose tolerance impaired
Hyperammonaemia
Hypercalcaemia
Hypercholesterolaemia
Hyperglycaemia
Metabolism and nutrition disorders
2 0 1
2 0 2
2 0 1
1 0 1
1 0 1
35 1 23
1 0 0
1 0 0
1 0 1
1 0 1
1 0 0
22 0 20
119 1 111
1 0 1
1 0 1
1 0 1
18 0 17
94 2 81
31 0 29
46 1 38
2 2 1
23 2 17
1 0 1
16 0 13
93 2 86
2 0 1
5 1 5
8 2 7
4 0 3
2 1 2
4 0 3
1 0 0
4 0 3
3 0 3
64 1 61
Page 13Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Hyperkalaemia
Hyperlipidaemia
Hypernatraemia
Hyperphosphataemia
Hypertriglyceridaemia
Hyperuricaemia
Hypocalcaemia
Hypochloraemia
Hypoglycaemia
Hypokalaemia
Hyponatraemia
Hypophosphataemia
Hypoproteinaemia
Increased appetite
Insulin resistance
Ketoacidosis
Ketosis
Metabolic syndrome
Obesity
Polydipsia
Vitamin B12 deficiency
Metabolism and nutrition disorders
Arthralgia
Back pain
Joint stiffness
Mobility decreased
Muscle atrophy
Muscle disorder
Muscle rigidity
Muscle spasms
Muscle twitching
Muscular weakness
Musculoskeletal chest pain
Musculoskeletal stiffness
Myalgia
Myopathy
Musculoskeletal and connective tissuedisorders
2 2 0
7 1 6
2 0 2
2 0 2
2 0 2
1 0 1
3 1 1
1 0 1
3 1 3
6 1 5
21 4 15
1 0 1
1 0 1
2 0 2
2 0 1
1 0 1
11 2 11
1 0 1
3 2 3
15 0 12
1 0 1
14 0 12
2 0 1
2 0 1
2 0 2
1 0 1
1 0 1
3 0 2
3 0 3
8 0 7
3 0 2
1 0 1
2 0 2
26 0 21
4 0 4
Page 14Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Myositis
Neck mass
Pathological fracture
Posture abnormal
Rhabdomyolysis
Tendonitis
Torticollis
Trismus
Musculoskeletal and connective tissuedisorders
Adrenal carcinoma
Angiocentric lymphoma
Basal cell carcinoma
Brain neoplasm malignant
Breast cancer female
Chronic lymphocytic leukaemia
Hepatic neoplasm malignant
Leukaemia
Lung neoplasm malignant
Lymphocytic leukaemia
Lymphoma
Malignant melanoma
Metastatic neoplasm
Multiple myeloma
Neoplasm malignant
Pituitary tumour
Pituitary tumour benign
Pseudolymphoma
Testis cancer
Neoplasms benign, malignant andunspecified (incl cysts and polyps)
Akathisia
Amnesia
Anticholinergic syndrome
Aphasia
Aura
Balance disorder
Cataplexy
Cerebral atrophy
Nervous system disorders
4 0 4
1 0 1
1 0 1
2 0 2
6 1 5
1 0 1
1 0 1
1 0 1
1 0 1
1 1 0
1 0 1
2 2 2
3 1 1
1 0 1
2 0 2
4 2 3
1 0 1
1 0 1
5 0 3
1 0 1
1 1 1
3 0 2
2 2 2
1 0 0
1 0 1
4 1 3
1 0 1
4 0 3
3 0 2
2 0 2
5 0 4
1 0 0
5 0 5
1 0 1
1 0 0
Page 15Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Cerebral haemorrhage
Cerebral haemorrhage neonatal
Cerebral infarction
Cerebrovascular accident
Cerebrovascular disorder
Cholinergic syndrome
Choreoathetosis
Circadian rhythm sleep disorder
Cogwheel rigidity
Coma
Consciousness fluctuating
Convulsion
Coordination abnormal
Cranial nerve disorder
Dementia
Depressed level of consciousness
Disturbance in attention
Dizziness
Dizziness postural
Drooling
Dysarthria
Dysgeusia
Dyskinesia
Dysstasia
Dystonia
Encephalopathy
Epilepsy
Extrapyramidal disorder
Facial palsy
Grand mal convulsion
Haemorrhage intracranial
Headache
Hemiparesis
Hemiplegia
Hyperkinesia
Nervous system disorders 1 0 1
1 0 0
2 1 2
2 2 2
7 3 6
2 0 2
2 0 2
1 0 1
2 0 2
19 4 12
9 0 7
206 8 155
25 0 20
1 0 1
1 0 1
7 1 4
1 0 1
86 1 81
1 0 1
6 0 6
19 0 15
3 0 3
10 0 6
1 0 1
19 0 13
4 0 3
4 0 3
7 0 4
1 0 1
51 0 35
1 0 1
46 1 38
2 0 1
1 0 1
3 0 2
Page 16Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Hyperreflexia
Hypersomnia
Hypertonia
Hypoaesthesia
Hypokinesia
Hyporeflexia
Hypotonia
Incoherent
Lethargy
Loss of consciousness
Memory impairment
Meningism
Mental impairment
Migraine
Movement disorder
Muscle contractions involuntary
Myoclonic epilepsy
Myoclonus
Neuroleptic malignant syndrome
Neuropathy
Neuropathy peripheral
Nystagmus
Opisthotonus
Paraesthesia
Paresis
Parkinsonian gait
Parkinsonism
Parkinson's disease
Partial seizures
Petit mal epilepsy
Reflexes abnormal
Restless legs syndrome
Sedation
Sensory disturbance
Serotonin syndrome
Nervous system disorders 2 0 0
1 0 1
15 0 10
5 0 4
6 0 5
1 0 0
2 0 2
1 0 0
15 0 13
14 1 11
4 0 3
1 0 1
2 0 2
1 0 1
3 0 3
3 0 3
1 0 1
16 0 11
87 2 60
1 0 1
1 0 1
1 0 1
2 0 2
6 0 5
1 0 1
1 0 1
4 0 2
2 0 2
1 0 1
1 0 1
1 0 1
1 0 1
38 1 31
1 0 1
1 0 0
Page 17Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Somnolence
Speech disorder
Stupor
Syncope
Syncope vasovagal
Tardive dyskinesia
Tongue biting
Transient ischaemic attack
Tremor
Upper motor neurone lesion
Visual field defect
Nervous system disorders
Abortion spontaneous
Foetal distress syndrome
Intra-uterine death
Weight decrease neonatal
Pregnancy, puerperium and perinatalconditions
Abnormal behaviour
Acute psychosis
Affect lability
Aggression
Agitation
Alcohol withdrawal syndrome
Anxiety
Apathy
Catatonia
Completed suicide
Confusional state
Crying
Delirium
Delusion
Delusional disorder, mixed type
Depersonalisation
Depression
Disorientation
Disturbance in social behaviour
Elevated mood
Psychiatric disorders
106 3 84
15 0 14
3 0 1
69 8 51
1 0 1
12 0 4
1 0 1
2 0 2
35 0 29
1 0 0
2 0 2
1 0 1
2 0 1
1 0 1
1 0 0
6 1 2
1 0 1
1 0 1
8 0 7
24 1 14
1 0 1
20 1 17
4 0 4
6 0 4
9 9 8
74 2 60
1 0 0
35 2 23
5 0 4
1 0 1
2 0 2
8 1 5
4 1 2
1 0 1
1 0 1
Page 18Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Emotional distress
Hallucination
Hallucination, auditory
Hallucination, visual
Illusion
Impulsive behaviour
Inappropriate affect
Insomnia
Libido increased
Mania
Mental disorder
Neurosis
Nightmare
Obsessive-compulsive disorder
Panic attack
Paranoia
Polydipsia psychogenic
Psychotic disorder
Restlessness
Schizophrenia
Schizophreniform disorder
Sleep disorder
Social avoidant behaviour
Suicidal ideation
Suicide attempt
Tension
Thinking abnormal
Violent ideation
Psychiatric disorders
Albuminuria
Dysuria
Enuresis
Glycosuria
Haematuria
Hydronephrosis
Myoglobinuria
Renal and urinary disorders
2 0 2
12 1 11
6 0 4
2 0 2
1 0 1
1 0 0
1 0 1
4 1 4
1 0 1
4 0 4
6 0 6
15 0 14
1 0 1
7 0 5
1 1 1
3 0 2
1 0 0
41 0 31
4 0 4
3 0 3
2 0 2
2 0 2
1 0 1
2 0 1
55 18 50
1 0 0
5 1 4
1 0 0
2 1 0
4 0 3
8 0 7
2 0 2
2 1 0
1 0 1
2 0 1
Page 19Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Nephritis
Nephritis interstitial
Nephrolithiasis
Nocturia
Oliguria
Pollakiuria
Polyuria
Renal failure
Renal failure acute
Renal impairment
Tubulointerstitial nephritis
Urinary incontinence
Urinary retention
Renal and urinary disorders
Amenorrhoea
Benign prostatic hyperplasia
Breast tenderness
Dysmenorrhoea
Ejaculation disorder
Ejaculation failure
Erectile dysfunction
Galactorrhoea
Gynaecomastia
Menorrhagia
Oligomenorrhoea
Ovarian cyst
Penis disorder
Polycystic ovaries
Priapism
Prostatism
Sexual dysfunction
Testicular disorder
Reproductive system and breast disorders
Alveolitis
Alveolitis allergic
Apnoea
Asphyxia
Respiratory, thoracic and mediastinaldisorders
1 0 0
5 0 5
1 0 1
4 0 4
1 0 1
5 0 5
11 0 9
7 0 6
19 3 15
19 1 16
1 0 1
59 0 49
6 0 5
2 0 1
1 0 1
1 0 1
1 0 0
2 0 2
16 0 13
6 0 5
3 0 1
1 0 1
1 0 0
1 0 0
2 0 2
1 0 1
1 0 1
6 0 6
1 0 1
2 0 2
2 0 2
1 0 1
3 0 2
6 1 6
4 4 4
Page 20Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Aspiration
Asthma
Bronchospasm
Choking
Choking sensation
Chronic obstructive pulmonary disease
Cough
Dry throat
Dyspnoea
Dyspnoea exertional
Eosinophilic pneumonia
Epistaxis
Haemoptysis
Hiccups
Hyperventilation
Hypoventilation
Hypoxia
Infantile apnoeic attack
Interstitial lung disease
Lung consolidation
Lung infiltration
Obstructive airways disorder
Orthopnoea
Pharyngeal oedema
Pharyngolaryngeal pain
Pleural effusion
Pleurisy
Pleuritic pain
Pneumonia aspiration
Pneumonitis
Productive cough
Pulmonary embolism
Pulmonary fibrosis
Pulmonary hypertension
Pulmonary oedema
Respiratory, thoracic and mediastinaldisorders
5 4 5
6 2 6
14 1 13
7 0 6
1 0 1
1 1 1
29 1 24
1 0 1
137 4 114
2 0 2
1 0 1
2 0 2
1 0 1
1 0 1
5 0 2
2 0 2
17 2 10
1 0 0
1 0 1
1 0 1
2 0 2
1 0 1
2 0 2
1 0 1
7 0 7
11 0 9
2 0 1
13 0 10
4 2 4
2 0 2
5 0 4
17 3 13
2 0 2
2 0 1
13 5 9
Page 21Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Respiratory arrest
Respiratory depression
Respiratory disorder
Respiratory distress
Respiratory failure
Rhinorrhoea
Sinus disorder
Sleep apnoea syndrome
Tachypnoea
Tonsillar disorder
Wheezing
Respiratory, thoracic and mediastinaldisorders
Acne
Alopecia
Angioedema
Cold sweat
Dermatitis exfoliative generalised
Drug eruption
Eczema
Erythema
Erythema nodosum
Hyperhidrosis
Lichenoid keratosis
Night sweats
Periorbital oedema
Photosensitivity reaction
Pruritus
Psoriasis
Purpura
Rash
Rash erythematous
Rash generalised
Rash maculo-papular
Rash morbilliform
Rash papular
Rash vesicular
Skin and subcutaneous tissue disorders
1 1 1
7 1 5
10 1 7
1 0 0
9 7 8
1 0 1
1 0 1
2 0 2
1 0 1
1 0 1
5 0 4
3 0 2
6 0 5
1 0 0
4 0 3
1 0 1
1 0 1
2 0 2
2 0 0
1 0 1
86 1 69
1 0 1
2 0 2
4 0 3
2 0 1
14 0 14
1 0 1
2 0 2
32 0 26
6 0 6
1 1 0
17 0 13
1 0 0
1 0 1
1 0 1
Page 22Report run on 5 June 2007
THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY
CLOZAPINE Layer 1 of 1
Skin discolouration
Skin disorder
Skin odour abnormal
Sweat gland disorder
Swelling face
Systemic lupus erythematosus rash
Urticaria
Skin and subcutaneous tissue disorders
Activities of daily living impaired
Treatment noncompliance
Social circumstances
Drug therapy changed
Therapy regimen changed
Surgical and medical procedures
Aortic stenosis
Arteritis
Blood pressure fluctuation
Circulatory collapse
Deep vein thrombosis
Embolism
Flushing
Haemorrhage
Hypertension
Hypotension
Necrosis ischaemic
Orthostatic hypotension
Pallor
Peripheral ischaemia
Shock
Thrombophlebitis
Thrombosis
Venous thrombosis
Vascular disorders
1 0 1
1 0 0
2 0 2
1 0 1
3 0 2
1 0 1
6 0 4
1 0 1
8 0 8
2 0 2
6 0 4
2 0 2
1 0 0
12 0 12
13 2 11
6 4 4
6 1 5
5 0 5
3 1 2
81 1 74
109 4 88
2 1 2
61 0 52
17 0 15
2 0 2
7 3 4
3 0 2
1 0 1
1 1 1
Page 23Report run on 5 June 2007