MEDICINE SUMMARY. Atomoxetine Hydrochloride Layer 1 of 8 ALL REPORT DATES. Tachycardia. Supraventricular tachycardia. Palpitations.

Transcription

1 Atomoxetine Hydrochloride Layer 1 of 8 ALL REPORT DATES Causality Unclear Exclud Total Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Blood and lymphatic system disorders Cardiac disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Infections and infestations Injury, poisoning and procedural complications Investigations Coagulopathy Tachycardia Supraventricular tachycardia Palpitations Eyelid ptosis Strabismus Visual disturbance Pancreatitis Gastrointestinal disorder Diarrhoea Dyspepsia Abdominal pain Abdominal pain upper Faecal incontinence Nausea Vomiting Feeling cold Feeling hot Condition aggravated Irritability Chest pain Pain Drug interaction Drug ineffective Hepatitis Orchitis Fall Heart rate increased Page 1

2 Atomoxetine Hydrochloride Layer 1 of 8 Investigations Blood pressure increased Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Nervous system disorders Psychiatric disorders Visual acuity tests abnormal Weight decreased Anorexia Arthralgia Joint swelling Muscle rigidity Growth retardation Facial spasm Headache Intracranial pressure increased Disturbance in attention Psychomotor hyperactivity Syncope Motor dysfunction Dizziness Paraesthesia Hypoaesthesia Convulsion Obsessive-compulsive disorder Agitation Anxiety Nervousness Panic attack Restlessness Tic Paramnesia Depression Major depression Depressed mood Tearfulness Hallucination, auditory Thinking abnormal Affect lability Anger Page 2

3 Atomoxetine Hydrochloride Layer 1 of 8 Psychiatric disorders Emotional disorder Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social circumstances Surgical and medical procedures Vascular disorders Mood altered Mood swings Aggression Attention-seeking behaviour Homicidal ideation Hostility Social avoidant behaviour Abnormal behaviour Regressive behaviour Mental disorder Psychotic disorder Insomnia Sleep disorder Intentional self-injury Self injurious behaviour Self-injurious ideation Suicidal ideation Suicide attempt Urinary incontinence Balanitis Cough Throat tightness Periorbital oedema Rash Educational problem Therapy regimen changed Pallor Hypertension Page 3

4 DEXAMPHETAMINE SULPHATE Layer 2 of 8 ALL REPORT DATES Causality Unclear Exclud Total Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Investigations Metabolism and nutrition disorders Neutropenia Tachycardia Palpitations Cardiomyopathy Multiple congenital abnormalitie Hearing impaired Tinnitus Mydriasis Photophobia Retinal pigmentation Vision blurred Abdominal pain Vomiting Cheilitis Stomatitis Dry mouth Chills Asthenia Fatigue Abasia Irritability Face oedema Drug effect decreased Drug ineffective Therapeutic response decrease Electroencephalogram abnorma Weight decreased Anorexia Page 4

5 DEXAMPHETAMINE SULPHATE Layer 2 of 8 Metabolism and nutrition disorders Hyponatraemia Musculoskeletal and connective tissue disorders Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Hypoglycaemia Myalgia Muscle spasms Muscle twitching Subarachnoid haemorrhage Headache Disturbance in attention Judgement impaired Dyskinesia Hyperkinesia Dystonia Tremor Hyperreflexia Hyporeflexia Dizziness Burning sensation mucosal Paraesthesia Neuralgia Dysarthria Speech disorder Hypertonia Hypotonia Serotonin syndrome Muscle contractions involuntary Convulsion Neonatal disorder Neurosis Obsessive-compulsive disorder Agitation Anxiety Nervousness Restlessness Confusional state Disorientation Page 5

6 DEXAMPHETAMINE SULPHATE Layer 2 of 8 Psychiatric disorders Depression Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Depressed mood Delusion Hallucination Hallucination, auditory Hallucination, visual Thinking abnormal Anger Crying Mood swings Apathy Aggression Homicidal ideation Paranoia Abnormal behaviour Neglect of personal appearance Psychotic disorder Insomnia Suicidal ideation Renal pain Testicular disorder Bronchospasm Dyspnoea Hyperventilation Periorbital oedema Urticaria Erythema Rash erythematous Pruritus Rash Skin ulcer Alopecia Hyperhidrosis Nail discolouration Purpura Page 6

7 DEXAMPHETAMINE SULPHATE Layer 2 of 8 Surgical and medical procedures Therapy regimen changed Vascular disorders Peripheral ischaemia Orthostatic hypotension Page 7

8 METHYLPHENIDATE HYDROCHLORIDE Layer 3 of 8 ALL REPORT DATES Causality Unclear Excluded Total Death Outcome Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Endocrine disorders Eye disorders Gastrointestinal disorders Anaemia Aplastic anaemia Pancytopenia Arrhythmia Tachycardia Cardiac arrest Ventricular fibrillation Palpitations Myocardial infarction Cardiomyopathy Tourette's disorder Hypothyroidism Eye oedema Eye pain Conjunctivitis Oculogyric crisis Photophobia Optic atrophy Retinal pigmentation Vision blurred Visual disturbance Tooth discolouration Gingival hyperplasia Pancreatitis Gastrointestinal inflammation Diarrhoea Abdominal pain Abdominal pain upper Page 8

9 METHYLPHENIDATE HYDROCHLORIDE Layer 3 of 8 Gastrointestinal disorders Abdominal discomfort 1 General disorders and administration site conditions Infections and infestations Injury, poisoning and procedural complications Investigations Nausea Vomiting Duodenal scarring Lip swelling Mouth ulceration Dry mouth Pyrexia Sudden death Fatigue Malaise Abasia Chest discomfort Condition aggravated Feeling abnormal Influenza like illness Irritability Swelling Face oedema Oedema peripheral Chest pain Pain Drug interaction Drug effect decreased Drug ineffective Drug withdrawal syndrome Mass Otitis media Infection Pharyngitis Rhinitis Viral infection Fall Wrong drug administered Electrocardiogram abnormal Page 9

10 METHYLPHENIDATE HYDROCHLORIDE Layer 3 of 8 Investigations Heart rate increased Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders Heart rate irregular Blood pressure increased Androgens increased Bleeding time prolonged Prothrombin level decreased Corneal reflex decreased Intraocular pressure increased Weight decreased Weight increased Anorexia Decreased appetite Increased appetite Obesity Polydipsia Pain in jaw Myalgia Muscle twitching Muscle rigidity Growth retardation Sensation of heaviness Pseudolymphoma Neoplasm malignant Optic neuritis Headache Migraine Dementia Amnesia Choreoathetosis Dyskinesia Extrapyramidal disorder Hyperkinesia Psychomotor hyperactivity Tardive dyskinesia Dystonia Page 10

11 METHYLPHENIDATE HYDROCHLORIDE Layer 3 of 8 Nervous system disorders Tremor Psychiatric disorders Ataxia Coma Lethargy Somnolence Dizziness Formication Hyperaesthesia Paraesthesia Dysgeusia Dysarthria Visual field defect Hypertonia Neuroleptic malignant syndrom Poor quality sleep Neurosis Obsessive-compulsive disorder Agitation Anxiety Nervousness Obsessive thoughts Fear Panic attack Restlessness Head banging Tic Distractibility Logorrhoea Lack of spontaneous speech Confusional state Disorientation Depression Tearfulness Hallucination Hallucination, auditory Page 11

12 METHYLPHENIDATE HYDROCHLORIDE Layer 3 of 8 Psychiatric disorders Hallucination, visual 1 Renal and urinary disorders Respiratory, thoracic and mediastinal disorders Thinking abnormal Mania Affect lability Inappropriate affect Anger Crying Emotional disorder Emotional distress Mood altered Mood swings Apathy Aggression Asocial behaviour Disturbance in social behaviour Paranoia Social avoidant behaviour Abnormal behaviour Psychiatric symptom Drug dependence Withdrawal syndrome Psychotic disorder Insomnia Abnormal sleep-related event Nightmare Sleep disorder Intentional self-injury Self injurious behaviour Suicidal ideation Suicide attempt Renal failure acute Pollakiuria Polyuria Wheezing Pulmonary embolism Page 12

13 METHYLPHENIDATE HYDROCHLORIDE Layer 3 of 8 Respiratory, thoracic and mediastinal disorders Dyspnoea Skin and subcutaneous tissue disorders Social circumstances Surgical and medical procedures Vascular disorders Cough Pharyngolaryngeal pain Stridor Epistaxis Angioedema Urticaria Erythema multiforme Stevens-Johnson syndrome Skin lesion Swelling face Rash erythematous Pruritus Rash Rash maculo-papular Alopecia Cold sweat Hyperhidrosis Henoch-Schonlein purpura Physical assault Pharmaceutical product compla Therapy regimen changed Peripheral ischaemia Hypotension Flushing Pallor Hypertension Page 13

14 ATTENTA Layer 4 of 8 ALL REPORT DATES Causality Unclear Exclud Total Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Cardiac disorders Gastrointestinal disorders General disorders and administration site conditions Investigations Metabolism and nutrition disorders Nervous system disorders Psychiatric disorders Renal and urinary disorders Skin and subcutaneous tissue disorders Tachycardia Gastrointestinal inflammation Abdominal pain Vomiting Chest discomfort Pain Drug ineffective Blood pressure increased Polydipsia Migraine Agitation Depression Aggression Abnormal behaviour Polyuria Angioedema Hyperhidrosis Page 14

15 Concerta Layer 5 of 8 ALL REPORT DATES Causality Unclear Exclud Total Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Congenital, familial and genetic disorders General disorders and administration site conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Nervous system disorders Psychiatric disorders Skin and subcutaneous tissue disorders Tourette's disorder Condition aggravated Drug ineffective Weight increased Anorexia Muscle twitching Headache Dyskinesia Dystonia Hyperaesthesia Obsessive thoughts Fear Head banging Tic Logorrhoea Hallucination Anger Emotional disorder Mood swings Aggression Disturbance in social behaviour Paranoia Insomnia Self injurious behaviour Skin lesion Hyperhidrosis Henoch-Schonlein purpura Page 15

16 METHYLPHENIDATE HYDROCHLORIDE Layer 6 of 8 ALL REPORT DATES Causality Unclear Exclud Total Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Eye disorders General disorders and administration site conditions Injury, poisoning and procedural complications Investigations Musculoskeletal and connective tissue disorders Nervous system disorders Psychiatric disorders Respiratory, thoracic and mediastinal disorders Photophobia Abasia Drug interaction Drug ineffective Wrong drug administered Bleeding time prolonged Corneal reflex decreased Muscle twitching Muscle rigidity Headache Dyskinesia Extrapyramidal disorder Dystonia Tremor Hyperaesthesia Paraesthesia Dysarthria Hypertonia Anxiety Tic Depression Hallucination, auditory Anger Emotional distress Paranoia Pulmonary embolism Dyspnoea Page 16

17 RITALIN Layer 7 of 8 ALL REPORT DATES Causality Unclear Excluded Total Death Outcome Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Blood and lymphatic system disorders Cardiac disorders Eye disorders Gastrointestinal disorders Anaemia Aplastic anaemia Pancytopenia Tachycardia Cardiac arrest Ventricular fibrillation Palpitations Myocardial infarction Cardiomyopathy Eye oedema Eye pain Conjunctivitis Oculogyric crisis Photophobia Optic atrophy Retinal pigmentation Vision blurred Tooth discolouration Gingival hyperplasia Pancreatitis Diarrhoea Abdominal pain Abdominal pain upper Abdominal discomfort Nausea Vomiting Duodenal scarring Lip swelling Page 17

18 RITALIN Layer 7 of 8 Gastrointestinal disorders Mouth ulceration 0 General disorders and administration site conditions Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Pyrexia Sudden death Fatigue Chest discomfort Feeling abnormal Influenza like illness Irritability Swelling Face oedema Oedema peripheral Chest pain Pain Drug interaction Drug effect decreased Drug ineffective Mass Otitis media Infection Pharyngitis Rhinitis Viral infection Fall Electrocardiogram abnormal Heart rate increased Androgens increased Prothrombin level decreased Weight decreased Anorexia Decreased appetite Polydipsia Pain in jaw Myalgia Muscle twitching Growth retardation Page 18

19 RITALIN Layer 7 of 8 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pseudolymphoma Neoplasm malignant 0 1 Nervous system disorders Psychiatric disorders Optic neuritis Headache Dementia Amnesia Dyskinesia Extrapyramidal disorder Hyperkinesia Tardive dyskinesia Dystonia Tremor Ataxia Coma Lethargy Somnolence Dizziness Formication Dysgeusia Visual field defect Hypertonia Neuroleptic malignant syndrom Poor quality sleep Neurosis Obsessive-compulsive disorder Agitation Anxiety Nervousness Restlessness Tic Distractibility Confusional state Depression Tearfulness Hallucination Page 19

20 RITALIN Layer 7 of 8 Psychiatric disorders Thinking abnormal 1 Renal and urinary disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Mania Inappropriate affect Crying Apathy Aggression Asocial behaviour Paranoia Social avoidant behaviour Drug dependence Withdrawal syndrome Psychotic disorder Insomnia Abnormal sleep-related event Nightmare Sleep disorder Suicidal ideation Suicide attempt Renal failure acute Pollakiuria Polyuria Dyspnoea Cough Pharyngolaryngeal pain Stridor Angioedema Urticaria Erythema multiforme Stevens-Johnson syndrome Swelling face Rash erythematous Pruritus Rash Rash maculo-papular Alopecia Page 20

21 RITALIN Layer 7 of 8 Skin and subcutaneous tissue disorders Cold sweat 1 Social circumstances Vascular disorders Hyperhidrosis Physical assault Peripheral ischaemia Hypotension Flushing Pallor Hypertension Page 21

22 Ritalin LA Layer 8 of 8 ALL REPORT DATES Causality Unclear Exclud Total Sole Suspected - Cases Including Medicine - Occurrences of Medicine - Reactions Related to Medicine Blood and lymphatic system disorders Cardiac disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Anaemia Arrhythmia Tachycardia Palpitations Hypothyroidism Vision blurred Visual disturbance Diarrhoea Abdominal pain upper Nausea Vomiting Dry mouth Fatigue Malaise Feeling abnormal Pain Drug ineffective Drug withdrawal syndrome Electrocardiogram abnormal Heart rate increased Heart rate irregular Intraocular pressure increased Weight increased Anorexia Increased appetite Obesity Muscle twitching Sensation of heaviness Page 22

23 Ritalin LA Layer 8 of 8 Nervous system disorders Headache 4 4 Psychiatric disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Choreoathetosis Psychomotor hyperactivity Tremor Lethargy Somnolence Dizziness Agitation Anxiety Nervousness Panic attack Tic Lack of spontaneous speech Confusional state Disorientation Depression Hallucination Hallucination, visual Affect lability Anger Crying Mood altered Abnormal behaviour Psychiatric symptom Withdrawal syndrome Psychotic disorder Intentional self-injury Wheezing Epistaxis Urticaria Pruritus Rash Rash maculo-papular Cold sweat Hyperhidrosis Page 23

24 Ritalin LA Layer 8 of 8 Social circumstances Pharmaceutical product compla Surgical and medical procedures Therapy regimen changed Page 24