Drug Analysis Print Drug name: RIMONABANT

Transcription

1 Jump to first report page Report type: Spontaneous Total number of reactions*: 2123 Total number of ADR reports: 720 Total number of fatal ADR reports: 5 Products included in this print - products (PBGs): ACOMPLIA *It is important to note that one report may contain one or more reactions. Page 1 of 31

2 Report type: Spontaneous System Organ Class All Fatal All Fatal All Fatal Blood disorders Cardiac disorders Ear disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders Hepatic disorders Infections Injuries Investigations Metabolic disorders Muscle & tissue disorders Neoplasms Nervous system disorders Pregnancy conditions Psychiatric disorders Renal & urinary disorders Reproductive & breast disorders Respiratory disorders Skin disorders Social circumstances Vascular disorders TOTAL NUMBER OF REACTIONS TOTAL NUMBER OF FATAL ADR REPORTS* 5 0 5* TOTAL NUMBER OF ADR REPORTS* * *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 2 of 31

3 Report type: Spontaneous Glossary/Abbreviations ADR - Adverse Drug Reaction Age group - lists which age groups are included in the either ALL, Adolescent, Adult, Child, Elderly, Infant or Neonate Data lock date - shows data on the database at this specified date and time - High Level Term - see definition of MedDRA MedDRA - this stands for Medical Dictionary for Regulatory Activities, which is the internationally agreed list of terms used for Medicines Regulation. MedDRA groups related adverse drug reaction terms in a hierarchical structure whereby the 'preferred term' () (e.g. tunnel vision) is grouped under the broader heading the 'high level term' () (e.g. visual field disorders). 'High level terms' are contained within the 'system organ class' () (e.g. eye disorders). The 'preferred term' is the most specific term on the, while the 'system organ class' is the most general Multi active products - contain the drug of interest plus one or more other drug s (e.g. co-codamol contains paracetamol and codeine) NEC - appears in MedDRA and stands for Not Elsewhere Classified NOS - appears in MedDRA and stands for Not Otherwise Specified PBG - Product Brand Generic this means drug brand name e.g. Amoxil is a PBG for the drug substance amoxicillin Products included in this print - this is a list of the products for which at least one suspected Adverse Drug Reaction (ADR) report has been received that specifies that product as a 'suspected drug' (i.e. suspected causal association with the reaction). It does not provide an exhaustive list of the products which contain the named drug substance - Preferred Term - see definition of MedDRA Reaction - defines which ADRs are included in the either ALL, Serious or Non-Serious Reporter type - lists the reporter types which are included in the either Patient, Health Professional or ALL (i.e. both) Report run date - the date the was produced Route of admin - lists the route of administration of the suspect drug for which reports are included in the Drug Analysis Print, e.g. ORAL only includes reports where the suspect drug was specified as having been taken by the oral route, or ALL which includes all routes of administration Spontaneous - suspected ADR reports sent in to the Yellow Card Scheme are called spontaneous reports products - contain only the drug substance of interest System Organ Class () - this is the highest level in MedDRA which groups together reactions that affect similar systems/organs in the body Page 3 of 31

4 Report type: Spontaneous Blood disorders Anaemias NEC Anaemia Eosinophilic disorders Eosinophilia Blood disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 4 of 31

5 Report type: Spontaneous Cardiac disorders Cardiac conduction disorders Atrioventricular block complete Cardiac signs and symptoms NEC Palpitations Ischaemic coronary artery disorders Acute coronary syndrome Angina pectoris Myocardial infarction Myocardial ischaemia Rate and rhythm disorders NEC Cardiac flutter Tachycardia Supraventricular arrhythmias Atrial flutter Ventricular arrhythmias and cardiac arrest Ventricular extrasystoles Ventricular tachycardia Cardiac disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 5 of 31

6 Report type: Spontaneous Ear disorders Hyperacusia Hyperacusis Inner ear signs and symptoms Tinnitus Vertigo Ear disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 6 of 31

7 Report type: Spontaneous Endocrine disorders Thyroid hyperfunction disorders Hyperthyroidism Endocrine disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 7 of 31

8 Report type: Spontaneous Eye disorders Blindness (excl colour blindness) Blindness Cataract conditions Cataract Conjunctival infections, irritations and inflammations Conjunctivitis allergic Eyelid movement disorders Blepharospasm Lid, lash and lacrimal infections, irritations and inflammations Eyelid oedema Ocular disorders NEC Eye pain Eye swelling Ocular sensation disorders Abnormal sensation in eye Asthenopia Photophobia Optic disc abnormalities NEC Papilloedema Retinal structural change, deposit and degeneration Macular degeneration Visual disorders NEC Diplopia Phosphenes Vision blurred Visual brightness Visual disturbance Eye disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 8 of 31

9 Report type: Spontaneous Gastrointestinal disorders Abdominal findings abnormal Gastrointestinal sounds abnormal Acute and chronic pancreatitis Pancreatitis acute Diarrhoea (excl infective) Diarrhoea Dyspeptic signs and symptoms Dyspepsia Epigastric discomfort Faecal abnormalities NEC Faeces discoloured Flatulence, bloating and distension Abdominal distension Flatulence Gastritis (excl infective) Gastritis Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain Abdominal pain upper Gastrointestinal atonic and hypomotility disorders NEC Constipation Gastrointestinal disorders NEC Gastrointestinal disorder Gastrointestinal inflammatory disorders NEC Inflammatory bowel disease Gastrointestinal signs and symptoms NEC Abdominal discomfort Dysphagia Faecal incontinence Stomach discomfort Gastrointestinal spastic and hypermotility disorders Defaecation urgency Irritable bowel syndrome Intestinal haemorrhages Rectal haemorrhage Nausea and vomiting symptoms Nausea Retching Vomiting Vomiting in pregnancy Oral dryness and saliva altered *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 9 of 31

10 Report type: Spontaneous Reaction Name Gastrointestinal disorders cont'd All Fatal All Fatal All Fatal Dry mouth Stomatitis and ulceration Mouth ulceration Gastrointestinal disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 10 of 31

11 Report type: Spontaneous General disorders Asthenic conditions Asthenia Fatigue Malaise Body temperature perception Chills Feeling cold Feeling hot Feeling of body temperature change Death and sudden death Sudden death Febrile disorders Pyrexia General signs and symptoms NEC Chest discomfort Condition aggravated Feeling abnormal Feeling drunk Feeling jittery Hunger Influenza like illness Irritability Interactions Alcohol interaction Drug interaction Oedema NEC Oedema Oedema peripheral Pain and discomfort NEC Chest pain Discomfort Pain Tenderness Therapeutic and nontherapeutic responses Drug ineffective General disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 11 of 31

12 Report type: Spontaneous Hepatic disorders Cholecystitis and cholelithiasis Cholecystitis Cholecystitis acute Hepatic disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 12 of 31

13 Report type: Spontaneous Infections Bacterial infections NEC Cellulitis Folliculitis Candida infections Candidiasis Ear infections Ear infection Fungal infections NEC Pneumonia fungal Infections NEC Toxic shock syndrome Lower respiratory tract and lung infections Lower respiratory tract infection Sepsis, bacteraemia, viraemia and fungaemia NEC Septic shock Skin structures and soft tissue infections Furuncle Upper respiratory tract infections Epiglottitis Nasopharyngitis Pharyngitis Rhinitis Sinusitis Upper respiratory tract infection Infections TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 13 of 31

14 Report type: Spontaneous Injuries Limb injuries NEC (incl traumatic amputation) Joint injury Joint sprain Non-site specific injuries NEC Fall Injury Overdoses Intentional overdose Skin injuries NEC Contusion Injuries TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 14 of 31

15 Report type: Spontaneous Investigations Carbohydrate tolerance analyses (incl diabetes) Blood glucose decreased Blood glucose fluctuation Blood glucose increased Cardiac auscultatory investigations Cardiac murmur Coagulation and bleeding analyses International normalised ratio decreased International normalised ratio increased ECG investigations Electrocardiogram T wave inversion Haematological analyses NEC Red blood cell sedimentation rate decreased Heart rate and pulse investigations Heart rate increased Heart rate irregular Liver function analyses Hepatic enzyme increased Liver function test abnormal Transaminases increased Mineral and electrolyte analyses Blood potassium decreased Blood potassium increased Physical examination procedures Body temperature decreased Weight decreased Weight increased Protein analyses NEC C-reactive protein decreased Renal function analyses Blood creatinine increased Glomerular filtration rate decreased Renal function test abnormal Skeletal and cardiac muscle analyses Blood creatine phosphokinase increased Vascular tests NEC (incl blood pressure) Blood pressure increased Investigations TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 15 of 31

16 Report type: Spontaneous Metabolic disorders Appetite disorders Anorexia Appetite disorder Decreased appetite Food craving Hyperphagia Increased appetite Calcium metabolism disorders Hypocalcaemia Diabetes mellitus (incl subtypes) Decreased insulin requirement Diabetes mellitus inadequate control Food malabsorption and intolerance syndromes (excl sugar intolerance) Food intolerance General nutritional disorders NEC Weight loss poor Hyperglycaemic conditions NEC Glucose tolerance impaired Hyperglycaemia Hypoglycaemic conditions NEC Hypoglycaemia Potassium imbalance Hypokalaemia Sodium imbalance Hyponatraemia Total fluid volume decreased Dehydration Total fluid volume increased Fluid retention Metabolic disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 16 of 31

17 Report type: Spontaneous Muscle & tissue disorders Arthropathies NEC Arthritis Joint related signs and symptoms Arthralgia Joint swelling Muscle pains Myalgia Muscle related signs and symptoms NEC Muscle spasms Muscle twitching Muscle tone abnormalities Muscle rigidity Muscle weakness conditions Muscular weakness Musculoskeletal and connective tissue signs and symptoms NEC Back pain Limb discomfort Musculoskeletal discomfort Musculoskeletal stiffness Neck pain Pain in extremity Sensation of heaviness Myopathies Rhabdomyolysis Tendon disorders Tendon pain Tendonitis Muscle & tissue disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 17 of 31

18 Report type: Spontaneous Neoplasms Bladder neoplasms malignant Bladder cancer Breast and nipple neoplasms malignant Breast cancer Breast neoplasms unspecified malignancy Breast neoplasm Neoplasms TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 18 of 31

19 Report type: Spontaneous Nervous system disorders Central nervous system haemorrhages and cerebrovascular accidents Cerebral infarction Cerebrovascular accident Thrombotic stroke Cerebellar coordination and balance disturbances Balance disorder Coordination abnormal Chronic polyneuropathies Diabetic neuropathy Disturbances in consciousness NEC Altered state of consciousness Lethargy Loss of consciousness Somnolence Syncope Syncope vasovagal Dyskinesias and movement disorders NEC Dyskinesia Facial cranial nerve disorders Facial palsy Headaches NEC Headache Memory loss (excl dementia) Amnesia Memory impairment Mental impairment (excl dementia and memory loss) Disturbance in attention Mental impairment Mental retardations Mental retardation Migraine headaches Migraine Neurological signs and symptoms NEC Dizziness Olfactory nerve disorders Anosmia Optic nerve disorders NEC Optic neuritis Paraesthesias and dysaesthesias Burning sensation Paraesthesia *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 19 of 31

20 Report type: Spontaneous Reaction Name Nervous system disorders cont'd All Fatal All Fatal All Fatal Seizures and seizure disorders NEC Convulsion Epilepsy Sensory abnormalities NEC Ageusia Dysgeusia Hypoaesthesia Sensory disturbance Sensory loss Sleep disturbances NEC Poor quality sleep Speech and language abnormalities Dysarthria Speech disorder Transient cerebrovascular events Transient ischaemic attack Tremor (excl congenital) Tremor Nervous system disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 20 of 31

21 Report type: Spontaneous Pregnancy conditions Abortions spontaneous Abortion spontaneous Pregnancy conditions TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 21 of 31

22 Report type: Spontaneous Psychiatric disorders Abnormal behaviour NEC Abnormal behaviour Affect alterations NEC Affect lability Inappropriate affect Anxiety disorders NEC (incl obsessive compulsive disorder) Obsessive-compulsive disorder Anxiety symptoms Agitation Anxiety Nervousness Stress Tension Behaviour and socialisation disturbances Aggression Disinhibition Homicidal ideation Paranoia Personality change Social avoidant behaviour Bipolar disorders Bipolar I disorder Confusion and disorientation Confusional state Delusional symptoms Delusion Persecutory delusion Depressive disorders Depression Depression suicidal Disturbances in initiating and maintaining sleep Insomnia Eating disorders NEC Binge eating Emotional and mood disturbances NEC Anger Crying Dysphoria Emotional disorder Euphoric mood Mood altered *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 22 of 31

23 Report type: Spontaneous Reaction Name Psychiatric disorders cont'd All Fatal All Fatal All Fatal Fear symptoms and phobic disorders (incl social phobia) Claustrophobia Fear Fear of disease Fluctuating mood symptoms Mood swings Increased physical activity levels Restlessness Mental disorders NEC Mental disorder Mood alterations with depressive symptoms Anhedonia Decreased interest Depressed mood Depressive symptom Feeling guilty Feeling of despair Feelings of worthlessness Psychomotor retardation Tearfulness Mood alterations with manic symptoms Hypomania Mania Mood disorders NEC Affective disorder Apathy Panic attacks and disorders Panic attack Panic disorder Panic reaction Parasomnias Abnormal dreams Nightmare Parasomnia Sleep talking Sleep terror Somnambulism Perception disturbances Derealisation Hallucination Hallucination, visual Hallucinations, mixed *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 23 of 31

24 Report type: Spontaneous Reaction Name Psychiatric disorders cont'd All Fatal All Fatal All Fatal Personality disorders NEC Personality disorder Psychiatric symptoms NEC Hypervigilance Psychiatric symptom Psychotic disorder NEC Psychotic disorder Sexual desire disorders Libido decreased Libido increased Loss of libido Sleep disorders NEC Sleep disorder Somatoform disorders Psychosomatic disease Speech articulation and rhythm disturbances Pressure of speech Screaming Substance-related disorders Alcoholism Withdrawal syndrome Suicidal and self-injurious behaviour Completed suicide Intentional self-injury Self injurious behaviour Self-injurious ideation Suicidal behaviour Suicidal ideation Suicide attempt Thinking disturbances Bradyphrenia Flight of ideas Morbid thoughts Thinking abnormal Psychiatric disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 24 of 31

25 Report type: Spontaneous Renal & urinary disorders Bladder and urethral symptoms Bladder pain Dysuria Pollakiuria Strangury Urinary incontinence Renal failure and impairment Renal failure Renal failure acute Renal impairment Urinary abnormalities Haematuria Urinary tract signs and symptoms NEC Nocturia Polyuria Renal pain Renal & urinary disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 25 of 31

26 Report type: Spontaneous Reproductive & breast disorders Breast disorders NEC Breast enlargement Breast signs and symptoms Breast pain Breast tenderness Erection and ejaculation conditions and disorders Erectile dysfunction Menstruation and uterine bleeding NEC Menstruation irregular Menstruation with increased bleeding Metrorrhagia Prostatic signs, symptoms and disorders NEC Prostatic pain Vulvovaginal signs and symptoms Vaginal discharge Vulvovaginal pruritus Reproductive & breast disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 26 of 31

27 Report type: Spontaneous Respiratory disorders Breathing abnormalities Dyspnoea Sleep apnoea syndrome Bronchospasm and obstruction Asthma Wheezing Coughing and associated symptoms Cough Laryngeal spasm, oedema and obstruction Laryngeal oedema Lower respiratory tract signs and symptoms Hiccups Nasal disorders NEC Epistaxis Paranasal sinus disorders (excl infections and neoplasms) Sinus disorder Pharyngeal disorders (excl infections and neoplasms) Tonsillar disorder Pulmonary oedemas Acute pulmonary oedema Respiratory tract disorders NEC Respiratory tract irritation Upper respiratory tract signs and symptoms Choking sensation Nasal discomfort Pharyngolaryngeal pain Rhinorrhoea Throat tightness Respiratory disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 27 of 31

28 Report type: Spontaneous Skin disorders Acnes Acne Alopecias Alopecia Angioedemas Angioedema Apocrine and eccrine gland disorders Hyperhidrosis Night sweats Sweat gland disorder Bullous conditions Blister Erythema multiforme Stevens-Johnson syndrome Connective tissue disorders Dermatomyositis Dermal and epidermal conditions NEC Skin discolouration Swelling face Dermatitis and eczema Skin irritation Dermatitis ascribed to specific agent Drug rash with eosinophilia and systemic symptoms Erythemas Erythema Panniculitides Erythema nodosum Papulosquamous conditions Rash papular Pilar disorders NEC Hair growth abnormal Pruritus NEC Pruritus Pruritus generalised Rash pruritic Purpura and related conditions Petechiae Rashes, eruptions and exanthems NEC Rash Rash macular Skin and subcutaneous tissue ulcerations *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 28 of 31

29 Report type: Spontaneous Reaction Name Skin disorders cont'd All Fatal All Fatal All Fatal Skin ulcer Urticarias Urticaria Skin disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 29 of 31

30 Report type: Spontaneous Social circumstances Criminal activity Physical assault Disability issues Activities of daily living impaired Impaired work ability Employment issues Job dissatisfaction Social issues Social problem Tobacco use Ex-smoker Social circumstances TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 30 of 31

31 Report type: Spontaneous Vascular disorders Peripheral embolism and thrombosis Deep vein thrombosis Peripheral vascular disorders NEC Flushing Hot flush Peripheral vasoconstriction, necrosis and vascular insufficiency Raynaud's phenomenon Site specific vascular disorders NEC Pallor Vascular hypertensive disorders NEC Hypertension Vascular hypotensive disorders Hypotension Orthostatic hypotension Vascular disorders TOTAL TOTAL NUMBER OF REACTIONS TOTAL NUMBER OF FATAL ADR REPORTS* 5 0 5* TOTAL NUMBER OF ADR REPORTS* * *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 31 of 31