Drug Analysis Print Drug name: LIOTHYRONINE

Transcription

1 Jump to first report page Total number of reactions*: 532 Total number of ADR reports: 107 Total number of fatal ADR reports: 0 Products included in this print - products (PBGs): MERCURY PHARMS LIOTHYRONINE Products included in this print - Multi active products (PBGs): ARMOUR THYROID TERTROXIN *It is important to note that one report may contain one or more reactions. Page 1 of 27

2 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 Immune system disorders Infections Injuries Investigations Metabolic disorders Muscle & tissue disorders Nervous system disorders Pregnancy conditions Psychiatric disorders Renal & urinary disorders Reproductive & breast disorders Respiratory disorders Skin disorders Social circumstances Surgical & medical procedures Vascular disorders TOTAL NUMBER OF REACTIONS TOTAL NUMBER OF FATAL ADR REPORTS* 0 0 0* 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 27

3 Glossary/Abbreviations ADR - Adverse Drug Reaction Age group - lists which age groups are included in the Drug Analysis Print 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 Drug Analysis Print, 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 Group 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 Drug Analysis Print either ALL, Serious or Non-Serious Reporter type - lists the reporter types which are included in the Drug Analysis Print either Patient, Health Professional or ALL (i.e. both) Report run date - the date the Drug Analysis Print 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 products - contain only the drug substance of interest Spontaneous - suspected ADR reports sent in to the Yellow Card Scheme are called spontaneous reports Substance - is an active ingredient in a product Substance Variant - is a more specific substance term. A substance may have zero, one or many linked variants. For example LITHIUM is linked to the variant LITHUM CARBONATE and LITHIUM CITRATE. 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 27

4 Blood disorders Lymphatic system disorders NEC Lymphadenopathy 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 27

5 Cardiac disorders Cardiac disorders NEC Cardiac disorder Cardiac signs and symptoms NEC Palpitations Ischaemic coronary artery disorders Angina pectoris Rate and rhythm disorders NEC Tachycardia Ventricular arrhythmias and cardiac arrest Cardiac arrest Ventricular fibrillation 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 27

6 Ear disorders Ear disorders NEC Ear pain Hearing losses Deafness Hearing impaired Inner ear signs and symptoms Motion sickness Tinnitus 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 27

7 Endocrine disorders Acute and chronic thyroiditis Autoimmune thyroiditis Thyroid disorders NEC Goitre Thyroid hyperfunction disorders Hyperthyroidism Thyroid hypofunction disorders Hypothyroidism Myxoedema 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 27

8 Eye disorders Lacrimation disorders Dry eye Ocular disorders NEC Dark circles under eyes Eye pain Ocular infections, inflammations and associated manifestations Ocular hyperaemia Ocular sensation disorders Asthenopia Partial vision loss Visual acuity reduced Visual disorders NEC Visual impairment 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 27

9 Gastrointestinal disorders Dental pain and sensation disorders Toothache Dyspeptic signs and symptoms Dyspepsia Flatulence, bloating and distension Abdominal distension Gastrointestinal atonic and hypomotility disorders NEC Constipation Gastrointestinal signs and symptoms NEC Dysphagia Gastrointestinal spastic and hypermotility disorders Irritable bowel syndrome Nausea and vomiting symptoms Nausea Tongue signs and symptoms Swollen tongue 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 9 of 27

10 General disorders Asthenic conditions Asthenia Fatigue Malaise Sluggishness Body temperature altered Hypothermia Feelings and sensations NEC Feeling abnormal Feeling cold Feeling hot Thirst General signs and symptoms NEC Condition aggravated Crying Fat tissue increased Influenza like illness Local swelling Nonspecific reaction Swelling Inflammations Inflammation Interactions Inhibitory drug interaction Oedema NEC Oedema Oedema peripheral Pain and discomfort NEC Chest discomfort Chest pain Pain Product quality issues NEC Product quality issue Product substitution issue Therapeutic and nontherapeutic responses Drug effect decreased Drug ineffective Therapeutic response decreased 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 10 of 27

11 Hepatic disorders Hepatic and hepatobiliary disorders NEC Liver disorder 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 11 of 27

12 Immune system disorders Allergic conditions NEC Hypersensitivity Allergies to foods, food additives, drugs and other chemicals Drug hypersensitivity Reaction to drug excipients Anaphylactic responses Anaphylactic reaction Immune 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 12 of 27

13 Infections Abdominal and gastrointestinal infections Diverticulitis Influenza viral infections Influenza Viral infections NEC Viral 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 27

14 Injuries Exposures associated with pregnancy, delivery and lactation Exposure during pregnancy Maladministrations Wrong technique in drug usage process Overdoses Overdose 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 27

15 Investigations Carbohydrate tolerance analyses (incl diabetes) Blood glucose increased Heart rate and pulse investigations Heart rate decreased Heart rate increased Heart rate irregular Physical examination procedures and organ system status Body temperature decreased Weight increased Pituitary analyses anterior Blood thyroid stimulating hormone abnormal Blood thyroid stimulating hormone decreased Blood thyroid stimulating hormone increased Thyroid analyses Anti-thyroid antibody positive Tri-iodothyronine 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 27

16 Metabolic disorders Appetite disorders Hyperphagia Increased appetite 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 27

17 Muscle & tissue disorders Bone related signs and symptoms Bone pain Joint related signs and symptoms Arthralgia Muscle pains Myalgia Muscle related signs and symptoms NEC Muscle spasms Muscle weakness conditions Muscular weakness Musculoskeletal and connective tissue infections and inflammations NEC Plantar fasciitis Musculoskeletal and connective tissue pain and discomfort Back pain Musculoskeletal pain Neck pain Pain in extremity Musculoskeletal and connective tissue signs and symptoms NEC Musculoskeletal stiffness Osteoarthropathies Osteoarthritis 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 27

18 Nervous system disorders Alzheimer's disease (incl subtypes) Dementia Alzheimer's type Cortical dysfunction NEC Aphasia Disturbances in consciousness NEC Lethargy Somnolence Syncope Dyskinesias and movement disorders NEC Psychomotor hyperactivity Headaches NEC Headache Memory loss (excl dementia) Amnesia Memory impairment Mental impairment (excl dementia and memory loss) Cognitive disorder Disturbance in attention Mental impairment Migraine headaches Migraine Mononeuropathies Carpal tunnel syndrome Neurological signs and symptoms NEC Dizziness Paraesthesias and dysaesthesias Burning sensation Paraesthesia Paralysis and paresis (excl cranial nerve) Monoplegia Sensory abnormalities NEC Neuralgia Speech and language abnormalities Speech disorder 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 18 of 27

19 Pregnancy conditions Normal pregnancy, labour and delivery Live birth 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 19 of 27

20 Psychiatric disorders Anxiety symptoms Agitation Anxiety Nervousness Tension Confusion and disorientation Confusional state Disorientation Depressive disorders Depression Disturbances in initiating and maintaining sleep Insomnia Emotional and mood disturbances NEC Emotional disorder Irritability Mood altered Fluctuating mood symptoms Mood swings Mood alterations with depressive symptoms Depressed mood Tearfulness Mood disorders NEC Apathy Psychiatric symptoms NEC Abulia Sexual desire disorders Loss of libido Sleep disorders NEC Sleep disorder Stress disorders Burnout syndrome Suicidal and self-injurious behaviour Suicidal ideation Thinking disturbances Tachyphrenia Tic disorders Tic 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 20 of 27

21 Renal & urinary disorders Bladder and urethral symptoms Pollakiuria Bladder disorders NEC Bladder disorder Urinary tract signs and symptoms NEC 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 21 of 27

22 Reproductive & breast disorders Breast disorders NEC Breast enlargement Breast signs and symptoms Breast tenderness Erection and ejaculation conditions and disorders Erectile dysfunction Menopausal effects NEC Menopausal symptoms Menstruation and uterine bleeding NEC Menstrual disorder Menstruation with increased bleeding Menorrhagia Polymenorrhoea 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 22 of 27

23 Respiratory disorders Breathing abnormalities Dyspnoea Bronchospasm and obstruction Asthma Coughing and associated symptoms Cough Nasal disorders NEC Epistaxis Upper respiratory tract signs and symptoms Dysphonia Oropharyngeal pain 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 23 of 27

24 Skin disorders Acnes Acne Alopecias Alopecia Angioedemas Swelling face Apocrine and eccrine gland disorders Hyperhidrosis Miliaria Night sweats Dermal and epidermal conditions NEC Dry skin Dermatitis and eczema Eczema Erythemas Erythema Exfoliative conditions Skin exfoliation Nail and nail bed conditions (excl infections and infestations) Onychoclasis Panniculitides Erythema nodosum Pilar disorders NEC Hair texture abnormal Pruritus NEC Pruritus Rashes, eruptions and exanthems NEC Rash Scaly conditions Dandruff 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 24 of 27

25 Social circumstances Disability issues Activities of daily living impaired Bedridden 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 25 of 27

26 Surgical & medical procedures Therapeutic procedures NEC Off label use Surgical & medical procedures 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 27

27 Vascular disorders Peripheral vascular disorders NEC Flushing Hot flush Vascular disorders TOTAL TOTAL NUMBER OF REACTIONS TOTAL NUMBER OF FATAL ADR REPORTS* 0 0 0* 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 27 of 27