therapeutic goods administration medicine summary

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

Report run on 5 June 2007

THERAPEUTIC GOODS ADMINISTRATIONTHERAPEUTIC GOODS ADMINISTRATIONMEDICINE SUMMARY


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




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




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




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




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




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




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




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




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




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


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




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


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




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




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




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




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




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




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




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




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




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


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




Respiratory arrest

Respiratory depression

Respiratory disorder

Respiratory distress

Respiratory failure

Rhinorrhoea

Sinus disorder

Sleep apnoea syndrome

Tachypnoea

Tonsillar disorder

Wheezing


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




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


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