Aa Lettergrootte
16

Lareb Database

BUSCOZOL (OMEPRAZOL)

  Attention: The results shown, apply for the ATC-group of drugs to which BUSCOZOL (OMEPRAZOL) belongs. Click here for a complete overview of these drugs.

Click for more information about:

Publications by Lareb

Publications, both in English and in Dutch, by the Netherlands Pharmacovigilance Centre Lareb

# Author(s) Title Magazine Year Volume Download
1 Hunsel, F. van, Jong, L. de, Vries, T.de (Es)omeprazole and discoloration of regurgitated gastric contents in infants: worrying for care-takers and a sign of a reduced bioavailability JPPT 2016 21(3):206-262
2 Natsch S., Vinks M.H.A.M., Meyboom R.H.B. Anaphylactic reactions to proton-pump inhibitors Ann. Pharmacother. 2000 34:474-476
3 Weits, G. Bijwerking belicht: Omeprazol en verkleurd sputum bij zuigelingen Uitsluitend Apotheek (UA) 2017 2017(4):21
4 Natsch S., Vinks M.H.A.M., Meyboom R.H.B. De anafylactische shock. Zeldzame reacties op protonpompremmers PW 2000 135(44):1650-2
5 Heeringa M. Ernstige reacties niet uitgesloten. Bijwerkingen van protonpompremmers PW 2000 135(44):1645-8
6 Ekhart C. Es(omeprazol) en vitamine B12 deficiëntie GeBu 2012 46(10):119
7 Monster M., Grootheest van A.C. Gynaecomastie tijdens gebruik van protonpompremmers PW 2008 27: 38-39
8 Zweers P.G.M.A. omeprazol en erectiele dysfunctie GeBu 2009 42;61
9 Sonnenberg, M., Weits, G. Paars speeksel, spuug of braaksel bij (es)omeprazol Pharmaceutisch Weekblad 2019 154(1/2):16-17
10 Fabius M., Graaf de L., Diemont W., Puijenbroek van E.P. The weber-curve pitfall. Effects of a forced introduction on reporting rates and reported adverse event profiles (abstract) Proceedings of the ISOP conference 17-20 october 2 2001 145
11 Graaf de L., Fabius M.A., Diemont W.L., Puijenbroek van E.P. The Weber-curve pitfall: effects of a forced introduction on reporting rates and reported adverse event profiles Pharm. World Science 2003 25(6):260-263
12 Smeets, T., Härmark, L. Vitamine B12-tekort mogelijk na langdurig slikken PPI’s PW 2015 150(27)18-20
13 Blokpoel R.G.T., Broos N., Jong-van den Berg de L.T.W. Waarde omeprazol bij huilende zuigelingen beperkt NTVG 2010 154:A1850
Signals

Signals as submitted to Lareb to the Dutch Medicines Evaluation Board. Some of the articles are in Dutch only.

# Title Year Download
1 (es) Omeprazole and tinnitus 2013
2 (es) Omeprazole and vitamin B12 deficiency 2011
3 (Es)omeprazole and regurgitated gastric content discoloured - an update 2019
4 Hypomagnesaemia following the concomitant use of proton pump inhibitors and bumetanide 2015
5 Meldingen na substitutie omeprazol naar Omecat 2016
6 Omeprazol and cutaneous lupus erythematosus 2013
7 Omeprazole and coumarine interactions 2009
8 Omeprazole and erectile dysfunction – an update 2015
9 Omeprazole and erectyle dysfunction 2006
10 Omeprazole and gastric content discolouration 2013
11 Omeprazole suspension and regurgitated gastric content discoloured 2017
12 Omeprazole, esomeprazole and hypomagnesaemia 2009
13 Proton pump inhibitors and fundic gland polyps 2015
14 Proton pump inhibitors and tongue discoloration 2009
15 Proton pump inhibitors and tongue discoloration 2009
16 Proton-pump inhibitors and gynecomastia 2005
Overview of reports submitted to Lareb

To ensure a correct interpretation of the results, the data shown may only be used for publications or other media after consulting Lareb. Please read the disclaimer.

The reports shown on this website were received directly by the Netherlands Pharmacovigilance Centre Lareb. If you enter a brand name or generic name, all reports of products will be shown that contain the corresponding active substance. The selection that is shown is based on the ATC classification system of the World Health Organization.

The fact that a possible side effect of a drug or vaccine is reported, does not imply that the reported symptoms are actually caused by the drug or vaccine. Since the aim of a voluntary reporting centre is to detect new adverse drug reactions, we ask healthcare professionals and consumers to report suspicions of ADRs, even if the causal relationship has not been proven.

One single report may refer to multiple ADRs For this reason, the number of reports may be higher than the number of reports shown in the overview.

The number of reports shown does not necessarily reflect the actual change for an ADR to occur. It is therefore not possible to calculate an incidence rate of these ADRs based on these data.

Most recent update: 5/26/2020.

OMEPRAZOL

Number of reports 9,962
Serious 1,716
Gender
Male
Female
Unknown
3,682
(37%)
6,261
(63%)
19
(0%)
Age
 
Year received
Calender year of reporting.
 
Year ADR
Calender year in which the possible ADR occured. If more events have been reported, the year in which the first event occurred is shown. Before 2002 the date, on which the report was received, was noted instead of the date of occurrence of the possible adverse drug reaction. For these reports the year in which the reaction actually occurred is not always known.
 
Reporter
 

Overview of reported side effects

Click on a side effect for more specific information

Blood and lymphatic system : 187
Leukopenia : 25
Neutropenia : 9
Blood disorder : 1
Autoimmune haemolytic anaemia : 5
Bone marrow failure : 2
Anaemia : 16
Haemolytic anaemia : 4
Iron deficiency anaemia : 5
Microcytic anaemia : 1
Anaemia megaloblastic : 1
Haemorrhagic diathesis : 5
Coagulopathy : 2
Eosinophilia : 7
Febrile neutropenia : 4
Haemolytic uraemic syndrome : 2
Heparin-induced thrombocytopenia : 3
Leukocytosis : 2
Methaemoglobinaemia : 2
Normocytic anaemia : 2
Aplastic anaemia : 4
Pancytopenia : 22
Pernicious anaemia : 1
Spontaneous haematoma : 1
Thrombocytopenia : 32
Disseminated intravascular coagulation : 1
Lymphadenopathy : 15
Increased tendency to bruise : 1
Lymphopenia : 2
Agranulocytosis : 8
Polycythaemia : 1
Anaemia vitamin B12 deficiency : 1
Cardiac : 520
Cor pulmonale acute : 1
Atrioventricular block second degree : 2
Angina unstable : 1
Angina pectoris : 17
Atrial tachycardia : 1
Cyanosis : 6
Congestive cardiomyopathy : 1
Myocardial ischaemia : 1
Acute coronary syndrome : 1
Ventricular extrasystoles : 1
Bundle branch block left : 1
Cardiac disorder : 7
Cardiac failure : 11
Cardiac failure congestive : 2
Left ventricular failure : 2
Cardiac failure acute : 3
Acute myocardial infarction : 5
Myocardial infarction : 17
Palpitations : 258
Atrial fibrillation : 17
Torsade de pointes : 2
Ventricular arrhythmia : 1
Ventricular fibrillation : 5
Cardiomyopathy : 4
Cardiomyopathy acute : 1
Cardiac arrest : 11
Cardiotoxicity : 1
Atrioventricular block first degree : 1
Long QT syndrome : 1
Left ventricular dysfunction : 1
Arrhythmia : 52
Pericarditis : 6
Myocarditis : 2
Right ventricular failure : 1
Pericarditis constrictive : 1
Extrasystoles : 3
Sinus node dysfunction : 1
Tachycardia : 36
Supraventricular tachycardia : 3
Sinus tachycardia : 1
Arteriospasm coronary : 2
Neonatal tachycardia : 1
Bradycardia : 17
Sinus bradycardia : 1
Intracardiac thrombus : 1
Ventricular tachycardia : 5
Atrioventricular block : 1
Atrioventricular block complete : 3
Ear and labyrinth : 212
Ear haemorrhage : 1
Deafness : 15
Deafness unilateral : 4
Vertigo : 27
Vestibular disorder : 3
Ear disorder : 3
Ear discomfort : 2
Ear pain : 8
Ear pruritus : 1
Tinnitus : 113
Ototoxicity : 4
Hyperacusis : 3
Hypoacusis : 27
Meniere's disease : 1
Endocrine system : 44
Adrenocortical insufficiency acute : 1
Addison's disease : 1
Adrenal haemorrhage : 1
Diabetes insipidus : 1
Glucocorticoid deficiency : 1
Hypoparathyroidism : 2
Hyperthyroidism : 11
Thyroid disorder : 2
Thyroiditis : 1
Adrenal insufficiency : 3
Cushingoid : 1
Hyperprolactinaemia : 2
Inappropriate antidiuretic hormone secretion : 7
Hypothyroidism : 10
Eye : 540
Retinal disorder : 1
Accommodation disorder : 6
Retinal vein thrombosis : 1
Chromatopsia : 2
Maculopathy : 1
Eye movement disorder : 4
Asthenopia : 2
Corneal lesion : 1
Myopia : 1
Blindness : 4
Conjunctival haemorrhage : 1
Chorioretinopathy : 1
Corneal disorder : 1
Corneal opacity : 1
Dry eye : 19
Diplopia : 25
Meibomian gland dysfunction : 1
Visual impairment : 113
Vitreous disorder : 1
Vitreous detachment : 2
Vitreous floaters : 2
Glaucoma : 3
Growth of eyelashes : 2
Uveitis : 5
Eye pruritus : 6
Blepharospasm : 5
Photophobia : 5
Retinal detachment : 5
Amblyopia : 1
Macular degeneration : 5
Night blindness : 1
Corneal deposits : 1
Retinal haemorrhage : 1
Retinal pigmentation : 1
Oculogyric crisis : 2
Pupils unequal : 1
Ocular discomfort : 5
Blepharitis : 2
Keratitis : 1
Eye disorder : 10
Eye discharge : 1
Eye haemorrhage : 4
Eye irritation : 25
Eyelids pruritus : 1
Eyelid disorder : 2
Eyelid oedema : 3
Eye oedema : 1
Eye inflammation : 2
Eye pain : 17
Optic neuropathy : 1
Eye swelling : 11
Optic ischaemic neuropathy : 1
Papilloedema : 2
Corneal perforation : 1
Periorbital swelling : 1
Eyelid ptosis : 5
Miosis : 1
Refraction disorder : 1
Ocular hyperaemia : 12
Visual acuity reduced : 5
Cataract : 5
Photopsia : 10
Cataract subcapsular : 1
Blindness transient : 1
Lacrimation increased : 12
Lacrimation disorder : 5
Hypermetropia : 1
Periorbital oedema : 8
Vision blurred : 144
Corneal oedema : 1
Swelling of eyelid : 3
Gastrointestinal : 3075
Haemorrhoids : 5
Gastrointestinal disorder : 26
Oesophageal disorder : 1
Tongue exfoliation : 1
Defaecation urgency : 1
Abnormal faeces : 13
Pancreatitis acute : 9
Acute abdomen : 1
Acute oesophageal mucosal lesion : 1
Aphthous ulcer : 19
Aptyalism : 1
Pancreatitis : 38
Anal haemorrhage : 1
Anal pruritus : 5
Anaesthesia oral : 1
Angular cheilitis : 1
Anorectal discomfort : 4
Salivary duct obstruction : 1
Oral mucosal blistering : 22
Haematemesis : 3
Enterocolitis haemorrhagic : 2
Diarrhoea haemorrhagic : 4
Haematochezia : 8
Diverticulum intestinal haemorrhagic : 1
Rectal haemorrhage : 13
Oesophageal ulcer haemorrhage : 1
Eructation : 43
Upper gastrointestinal haemorrhage : 1
Retching : 5
Vomiting : 204
Glossodynia : 20
Gastric haemorrhage : 3
Abdominal discomfort : 115
Abdominal pain : 174
Burning mouth syndrome : 4
Dental caries : 9
Pancreatitis chronic : 1
Colitis microscopic : 1
Colitis ulcerative : 5
Ileus : 4
Ileus paralytic : 1
Enterocolitis : 2
Intestinal perforation : 4
Intestinal villi atrophy : 1
Diarrhoea : 323
Large intestinal haemorrhage : 1
Discoloured vomit : 3
Diverticular perforation : 1
Subileus : 1
Dry mouth : 181
Dumping syndrome : 1
Dyschezia : 1
Proctitis ulcerative : 1
Enteritis : 1
Epigastric discomfort : 2
Gastritis erosive : 1
Frequent bowel movements : 7
Functional gastrointestinal disorder : 1
Gastrointestinal perforation : 1
Malabsorption : 1
Chapped lips : 1
Dysphagia : 44
Swollen tongue : 37
Gingival discomfort : 1
Gingival pain : 1
Gingival hypertrophy : 3
Faeces hard : 3
Anal incontinence : 15
Infrequent bowel movements : 2
Intestinal ischaemia : 1
Intestinal angioedema : 2
Intestinal haemorrhage : 1
Intra-abdominal haemorrhage : 1
Intrinsic factor deficiency : 1
Colitis ischaemic : 2
Anal fissure : 1
Oesophageal spasm : 4
Tongue geographic : 2
Lip dry : 6
Lip erythema : 1
Lip pain : 1
Lip disorder : 4
Lip blister : 1
Lip haemorrhage : 1
Lip exfoliation : 1
Lip oedema : 1
Lip discolouration : 1
Lip swelling : 31
Loose tooth : 2
Gastric disorder : 7
Gastrointestinal haemorrhage : 14
Gastrointestinal pain : 15
Gastrointestinal sounds abnormal : 2
Gastrointestinal inflammation : 1
Gastrointestinal polyp haemorrhage : 2
Gastrointestinal hypomotility : 1
Dyspepsia : 131
Gastritis : 6
Gastric perforation : 1
Gastric polyps : 5
Gastric ulcer : 3
Peptic ulcer perforation : 1
Gastric ulcer perforation : 1
Mesenteric artery thrombosis : 2
Nausea : 539
Oral disorder : 3
Pancreatitis necrotising : 1
Constipation : 114
Oedema mouth : 5
Oesophageal pain : 13
Lower gastrointestinal haemorrhage : 1
Bowel movement irregularity : 1
Stomatitis : 69
Colitis : 7
Uvulitis : 2
Oesophagitis : 9
Cheilitis : 9
Breath odour : 4
Abdominal distension : 59
Oral discomfort : 9
Oral mucosal eruption : 1
Large intestine perforation : 1
Abdominal pain upper : 163
Proctalgia : 4
Oral pain : 12
Abdominal pain lower : 6
Rectal tenesmus : 2
Irritable bowel syndrome : 1
Regurgitation : 1
Retroperitoneal fibrosis : 2
Retroperitoneal haemorrhage : 1
Mucous stools : 1
Odynophagia : 4
Oesophageal discomfort : 3
Oesophageal stenosis : 2
Salivary gland pain : 1
Salivary gland calculus : 1
Salivary gland enlargement : 1
Tooth disorder : 12
Teeth brittle : 4
Tooth erosion : 1
Dental discomfort : 1
Toothache : 12
Tooth discolouration : 9
Tooth loss : 2
Gingival disorder : 1
Gingival bleeding : 1
Paraesthesia oral : 19
Tongue dry : 3
Tongue disorder : 22
Tongue movement disturbance : 2
Tongue blistering : 1
Tongue oedema : 13
Glossitis : 24
Tongue discomfort : 1
Tongue erythema : 2
Tongue discolouration : 38
Trichoglossia : 4
Mesenteric vein thrombosis : 1
Tongue eruption : 2
Change of bowel habit : 4
Saliva altered : 1
Enlarged uvula : 1
Parotid gland enlargement : 1
Salivary hypersecretion : 15
Faeces discoloured : 18
Hypoaesthesia oral : 5
Gastrointestinal motility disorder : 1
Gingival recession : 4
Steatorrhoea : 2
Ascites : 4
Flatulence : 67
Faeces soft : 1
Gastrooesophageal reflux disease : 25
Melaena : 7
Oesophageal ulcer : 2
Duodenal ulcer : 1
Mouth ulceration : 11
Lip ulceration : 1
Mouth swelling : 2
Gingival swelling : 4
General disorders and administr. Site : 2896
Facial pain : 2
General symptom : 1
General physical health deterioration : 4
Atrophy : 1
Concomitant disease aggravated : 2
Mucosa vesicle : 1
Injection site haemorrhage : 1
Application site burn : 1
Calcinosis : 1
Complication associated with device : 6
Crepitations : 1
Cyst : 1
Thirst : 15
Energy increased : 1
Application site erythema : 3
Generalised oedema : 5
Localised oedema : 2
Drug ineffective : 87
Adverse drug reaction : 2
Drug interaction : 178
Drug withdrawal syndrome : 8
Drug withdrawal syndrome neonatal : 1
Feeling abnormal : 36
Feeling of relaxation : 1
Feeling of body temperature change : 7
Sensation of foreign body : 7
Face oedema : 26
Injection site mass : 2
Influenza like illness : 55
Cardiac death : 3
Application site haemorrhage : 1
Feeling hot : 25
Feeling cold : 35
Hyperpyrexia : 1
Hunger : 2
Crying : 17
Vaccination site induration : 1
Inhibitory drug interaction : 5
Injection site haematoma : 6
Injection site irritation : 1
Injection site oedema : 1
Injection site rash : 5
Injection site urticaria : 1
Injection site induration : 5
Injection site discolouration : 1
Injection site warmth : 28
Injection site pruritus : 23
Hangover : 2
Pyrexia : 153
Fever neonatal : 1
Chills : 43
Moaning : 2
Hypothermia : 10
Asthenia : 44
Gait disturbance : 27
Malaise : 197
Discomfort : 3
Nodule : 1
Injection site nodule : 2
Oedema : 57
Oedema mucosal : 1
Axillary pain : 2
Chest discomfort : 51
Injection site discomfort : 1
Application site discharge : 1
Inflammation : 4
Injection site inflammation : 64
Withdrawal syndrome : 17
Therapeutic response unexpected : 489
Application site hypersensitivity : 1
Paradoxical drug reaction : 1
Oedema peripheral : 147
Peripheral swelling : 34
Pain : 42
Chest pain : 101
Injection site pain : 40
Sudden cardiac death : 1
Potentiating drug interaction : 26
Application site pruritus : 1
Application site rash : 1
Injection site reaction : 16
Application site reaction : 11
Vaccination site reaction : 1
Injection site erythema : 37
Screaming : 2
Foaming at mouth : 2
Mucosal pain : 2
Mucosal dryness : 3
Mucosal inflammation : 6
Gravitational oedema : 3
Systemic inflammatory response syndrome : 1
Rebound effect : 4
Therapeutic product effect incomplete : 2
Therapeutic product effect decreased : 22
Therapeutic product ineffective : 2
Therapeutic response delayed : 1
Extensive swelling of vaccinated limb : 5
Administration site rash : 1
Injection site extravasation : 1
Vaccination site pain : 1
Exercise tolerance decreased : 1
Decreased activity : 1
Therapeutic response decreased : 74
Fatigue : 361
Condition aggravated : 29
Impaired healing : 5
Food interaction : 5
Drug-disease interaction : 1
Xerosis : 2
Feeling drunk : 9
Feeling jittery : 13
Mucosal ulceration : 1
Swelling : 22
Swelling face : 29
Implant site swelling : 1
Vaccination site swelling : 1
Injection site swelling : 32
Hepatobiliary : 165
Acute hepatic failure : 2
Hepatic function abnormal : 29
Biliary colic : 1
Cholelithiasis : 3
Cholestasis : 5
Jaundice : 22
Jaundice cholestatic : 5
Jaundice hepatocellular : 1
Hepatitis toxic : 15
Drug-induced liver injury : 2
Hepatic cirrhosis : 1
Hepatitis : 34
Hepatitis acute : 5
Hepatitis cholestatic : 13
Hepatocellular injury : 3
Ocular icterus : 1
Liver disorder : 4
Hepatic failure : 9
Hepatic pain : 1
Hepatic steatosis : 2
Hepatic necrosis : 1
Cholecystitis : 3
Hepatotoxicity : 2
Hyperbilirubinaemia : 1
Immune system : 163
Serum sickness : 2
Anaphylactic reaction : 41
Anaphylactic shock : 37
Eosinophilic granulomatosis with polyangiitis : 1
Drug hypersensitivity : 3
Type IV hypersensitivity reaction : 1
Immunodeficiency : 1
Immune system disorder : 1
Hypogammaglobulinaemia : 1
Hypersensitivity : 60
Anaphylactoid reaction : 3
Reaction to food additive : 1
Reaction to excipient : 9
Sarcoidosis : 1
Food allergy : 1
Infections and infestations : 263
Abscess : 1
Injection site abscess : 1
Abscess oral : 1
Tonsillitis : 1
Appendicitis : 1
Arthritis bacterial : 2
Bacterial infection : 1
Blister infected : 1
Cystitis : 12
Mastitis : 1
Upper respiratory tract infection : 4
Respiratory tract infection : 6
Bronchitis : 3
Abdominal abscess : 1
Gastroenteritis : 2
Peritonitis : 2
Bullous impetigo : 1
Campylobacter gastroenteritis : 1
Oesophageal candidiasis : 4
Candida infection : 2
Cellulitis : 2
Meningitis cryptococcal : 1
Intervertebral discitis : 1
Diverticulitis : 1
Endocarditis : 1
Erysipelas : 1
Pharyngitis : 3
Fournier's gangrene : 1
Localised infection : 1
Genital candidiasis : 2
Herpes zoster : 7
Haemophilus infection : 1
Hepatitis C : 1
Hepatitis E : 1
Herpes virus infection : 1
Skin infection : 4
Fungal skin infection : 2
Infection : 4
Opportunistic infection : 1
Epstein-Barr virus infection : 1
Ear infection : 3
Infection susceptibility increased : 3
Herpes simplex : 1
Pneumonia legionella : 1
Liver abscess : 2
Hepatic amoebiasis : 1
Pneumonia : 20
Otitis media : 1
Nasopharyngitis : 13
Rhinitis : 17
Osteomyelitis : 1
Lymphangitis : 1
Paronychia : 1
Gingivitis : 7
Sialoadenitis : 4
Folliculitis : 4
Conjunctivitis : 12
Onychomycosis : 2
Eye infection : 2
Eyelid infection : 2
Oral candidiasis : 10
Oral herpes : 1
Oral infection : 1
Oral fungal infection : 1
Oropharyngeal candidiasis : 1
Pneumocystis jirovecii pneumonia : 1
Progressive multifocal leukoencephalopathy : 4
Pseudomembranous colitis : 1
Pustule : 2
Rash pustular : 9
Fungal infection : 5
Scrotal abscess : 1
Sepsis : 6
Septic shock : 2
Parotitis : 2
Staphylococcal abscess : 1
Furuncle : 2
Pneumonia streptococcal : 1
Periodontitis : 2
Tonsillitis bacterial : 1
Tuberculosis : 1
Urinary tract infection : 10
Urosepsis : 1
Vaginal infection : 1
Varicella zoster virus infection : 2
Encephalitis viral : 1
Sinusitis : 3
Vulvovaginal candidiasis : 6
Vulvovaginal mycotic infection : 1
Injury and poisoning : 115
Subdural haematoma : 3
Thoracic vertebral fracture : 1
Eye burns : 1
Burn oesophageal : 2
Burns second degree : 1
Fracture : 1
Gastrointestinal stoma complication : 1
Ankle fracture : 1
Epidural haemorrhage : 1
Femur fracture : 4
Wound haemorrhage : 1
Decerebration : 1
Hip fracture : 1
Head injury : 1
Skin wound : 1
Contusion : 2
Maternal exposure during pregnancy : 13
Medication error : 3
Splenic injury : 1
Subcutaneous haematoma : 2
Intercepted medication error : 1
Incorrect route of product administration : 1
Eye contusion : 1
Overdose : 2
Tendon injury : 2
Product administration error : 2
Recall phenomenon : 1
Tendon rupture : 24
Scapula fracture : 1
Sedation complication : 1
Muscle rupture : 3
Stress fracture : 2
Tooth injury : 2
Toxicity to various agents : 11
Traumatic haematoma : 1
Fall : 12
Thermal burn : 1
Spinal fracture : 1
Chillblains : 1
Wound : 1
Wrong technique in product usage process : 1
Nerve injury : 1
Investigations : 547
Respiratory rate decreased : 1
Electrocardiogram QT prolonged : 6
General physical condition : 1
Blood alkaline phosphatase increased : 1
Amylase increased : 1
Antiphospholipid antibodies : 1
Apgar score low : 1
Smear cervix abnormal : 1
Blood bilirubin increased : 3
Blood creatine phosphokinase MB : 1
Blood follicle stimulating hormone decreased : 1
Blood phosphorus abnormal : 1
Blood glucose abnormal : 2
Blood iron decreased : 1
Blood urine present : 2
Blood luteinising hormone decreased : 1
Blood magnesium decreased : 2
Blood sodium increased : 1
Blood parathyroid hormone increased : 1
Blood testosterone increased : 1
Blood thyroid stimulating hormone : 1
Blood urine : 2
Blood uric acid increased : 1
Blood pressure abnormal : 1
Blood pressure diastolic increased : 1
Blood pressure diastolic decreased : 2
Blood pressure systolic increased : 1
Blood pressure increased : 20
Blood pressure decreased : 17
Bleeding time prolonged : 2
Blood test abnormal : 1
Chest X-ray abnormal : 1
Red blood cell sedimentation rate increased : 3
Blood calcium decreased : 1
Blood cholesterol increased : 2
Blood creatine phosphokinase increased : 12
Blood creatinine increased : 4
Electrocardiogram QT interval abnormal : 1
Gamma-glutamyltransferase increased : 6
Activated partial thromboplastin time prolonged : 1
Glycosylated haemoglobin increased : 2
Glycosylated haemoglobin decreased : 1
Drug level above therapeutic : 1
Weight increased : 112
Weight decreased : 36
Blood glucose increased : 23
Blood glucose decreased : 6
Heart rate irregular : 7
Heart rate increased : 21
Heart rate decreased : 3
Haemoglobin decreased : 11
High density lipoprotein decreased : 1
International normalised ratio increased : 31
International normalised ratio decreased : 8
International normalised ratio abnormal : 2
Blood potassium decreased : 3
Blood lactate dehydrogenase increased : 2
Hepatic enzyme abnormal : 7
Hepatic enzyme increased : 22
Liver function test abnormal : 32
Body temperature increased : 16
Body temperature decreased : 4
Liver function test increased : 7
Low density lipoprotein increased : 1
Gastric pH increased : 1
Blood sodium decreased : 2
Renal function test abnormal : 1
Pancreatic enzymes increased : 1
Blood prolactin increased : 1
Prothrombin time prolonged : 4
Thyroid function test abnormal : 1
International normalised ratio fluctuation : 1
Serum ferritin increased : 1
Sputum abnormal : 1
Blood testosterone decreased : 1
Thyroxine increased : 1
Drug level increased : 4
Urine viscosity increased : 1
Blood thyroid stimulating hormone increased : 1
Blood thyroid stimulating hormone decreased : 1
Blood urea increased : 1
Urine analysis abnormal : 4
Transaminases increased : 2
Alanine aminotransferase increased : 8
Aspartate aminotransferase increased : 4
C-reactive protein increased : 3
Intraocular pressure increased : 4
Urine output decreased : 3
Oxygen saturation decreased : 10
Creatinine renal clearance decreased : 1
Coagulation time shortened : 1
Coagulation time prolonged : 3
Vitamin B12 decreased : 1
Vitamin B6 : 1
Vitamin B6 increased : 2
Blood glucose fluctuation : 7
Metabolism and nutrition : 504
Tetany : 3
Abnormal loss of weight : 1
Abnormal weight gain : 1
Food aversion : 2
Diabetes mellitus : 15
Dyslipidaemia : 1
Folate deficiency : 1
Lack of satiety : 1
Vitamin B12 deficiency : 12
Weight fluctuation : 2
Hyperglycaemia : 27
Hyperlactacidaemia : 1
Alkalosis hypochloraemic : 1
Hypophagia : 1
Gout : 12
Hypoalbuminaemia : 1
Hypoglycaemia : 41
Hypoglycaemia neonatal : 2
Hypocalcaemia : 38
Hypochloraemia : 1
Hypophosphataemia : 8
Hypokalaemia : 33
Hypomagnesaemia : 70
Hyponatraemia : 34
Metabolic acidosis : 4
Malnutrition : 1
Diabetes mellitus inadequate control : 1
Lactic acidosis : 7
Poor feeding infant : 1
Hyperlipidaemia : 1
Increased appetite : 19
Tumour lysis syndrome : 1
Type 2 diabetes mellitus : 2
Dehydration : 10
Hyperammonaemia : 1
Hypercalcaemia : 1
Hyperphosphataemia : 2
Hyperkalaemia : 10
Polydipsia : 2
Hypertriglyceridaemia : 2
Oligodipsia : 1
Decreased appetite : 85
Appetite disorder : 4
Electrolyte imbalance : 2
Diabetic ketoacidosis : 3
Ketoacidosis : 2
Vitamin B1 deficiency : 1
Vitamin D deficiency : 5
Fluid retention : 24
Food intolerance : 1
Zinc deficiency : 1
Obesity : 1
Musculoskeletal and connective tissue : 1448
Muscle atrophy : 4
Osteoarthritis : 3
Connective tissue disorder : 1
Haemarthrosis : 2
Bone disorder : 3
Pathological fracture : 3
Bone hypertrophy : 1
Bone pain : 24
Osteomalacia : 3
Bone swelling : 1
Compartment syndrome : 1
Torticollis : 3
Hypotonia neonatal : 1
Rhabdomyolysis : 15
Muscle tightness : 3
Arthropathy : 10
Gouty arthritis : 2
Arthritis : 23
Polyarthritis : 1
Arthralgia : 204
Joint stiffness : 7
Joint swelling : 11
Jaw disorder : 1
Trismus : 6
Musculoskeletal discomfort : 13
Groin pain : 2
Lupus-like syndrome : 1
Metatarsalgia : 1
Mobility decreased : 1
Myopathy : 8
Myopathy toxic : 1
Myositis-like syndrome : 1
Neck pain : 10
Systemic lupus erythematosus : 4
Osteitis : 3
Osteoarthropathy : 1
Osteonecrosis of jaw : 9
Osteonecrosis of external auditory canal : 1
Osteoporosis : 7
Tendon pain : 13
Tendon disorder : 6
Tendon discomfort : 1
Tendonitis : 38
Pain in extremity : 87
Flank pain : 7
Pain in jaw : 13
Coccydynia : 1
Polymyalgia rheumatica : 1
Limb discomfort : 13
Rheumatic disorder : 2
Rheumatoid arthritis : 7
Back disorder : 1
Back pain : 44
Musculoskeletal chest pain : 4
Musculoskeletal disorder : 1
Musculoskeletal pain : 26
Musculoskeletal stiffness : 43
Bursitis : 5
Muscle discomfort : 11
Muscle disorder : 4
Muscle haemorrhage : 2
Muscle contracture : 2
Myositis : 3
Myalgia : 392
Muscle spasms : 206
Muscle rigidity : 5
Muscle twitching : 3
Muscle fatigue : 2
Muscular weakness : 101
Spinal pain : 1
Deformity thorax : 1
Osteopenia : 1
Osteonecrosis : 4
Joint effusion : 1
Neoplasms : 61
Acute leukaemia : 1
Cervix carcinoma : 1
Basal cell carcinoma : 1
B-cell lymphoma : 2
B-cell lymphoma stage IV : 1
Bladder cancer : 1
Breast cancer : 2
Colon cancer : 1
Colorectal cancer : 1
Cutaneous T-cell lymphoma : 1
Diffuse large B-cell lymphoma : 1
Ovarian cancer : 1
Gallbladder cancer : 1
Gastrointestinal carcinoma : 1
Skin papilloma : 4
Lipoma : 3
Pituitary tumour benign : 1
Squamous cell carcinoma : 1
Skin cancer : 3
Invasive ductal breast carcinoma : 1
Rectal cancer : 1
Neoplasm malignant : 1
Lung neoplasm malignant : 3
Langerhans' cell histiocytosis : 1
Laryngeal cancer : 1
Lymphoproliferative disorder : 1
Gastric cancer : 1
Malignant melanoma : 3
Myeloid leukaemia : 1
Neuroendocrine carcinoma of the skin : 2
Renal cell carcinoma : 1
Renal neoplasm : 1
Non-Hodgkin's lymphoma : 7
Transitional cell carcinoma : 2
Plasma cell myeloma : 1
Thyroid cancer : 1
Oesophageal adenocarcinoma : 1
Testis cancer : 1
Lymphoma : 1
Bowen's disease : 1
Nervous system : 2616
Disturbance in attention : 38
Trigeminal neuralgia : 1
Facial paralysis : 5
Acute disseminated encephalomyelitis : 1
Areflexia : 1
Coordination abnormal : 11
Ataxia : 5
Aura : 1
Autonomic nervous system imbalance : 1
Axonal neuropathy : 1
Cerebrovascular accident : 7
Cerebrovascular disorder : 1
Intention tremor : 3
Chorea : 2
Choreoathetosis : 1
Movement disorder : 5
Consciousness fluctuating : 1
Loss of consciousness : 19
Haemorrhage intracranial : 4
Subarachnoid haemorrhage : 1
Burning sensation : 17
Burning sensation mucosal : 5
Cauda equina syndrome : 1
Cerebellar haemorrhage : 1
Cerebral venous sinus thrombosis : 1
Clonus : 1
Cluster headache : 3
Cognitive disorder : 9
Hypotonic-hyporesponsive episode : 1
Coma : 6
Apallic syndrome : 1
Complex regional pain syndrome : 1
Apraxia : 2
Decerebrate posture : 1
Dementia : 3
Vascular dementia : 1
Dementia Alzheimer's type : 2
Demyelination : 2
Demyelinating polyneuropathy : 1
Head discomfort : 25
Diplegia : 1
Drop attacks : 1
Dizziness : 476
Dyskinesia : 19
Epilepsy : 25
Serotonin syndrome : 5
Balance disorder : 24
Extrapyramidal disorder : 5
Facial spasm : 1
Facial neuralgia : 3
Syncope : 72
Formication : 1
Hemiparesis : 4
Paresis : 2
Generalised tonic-clonic seizure : 5
Memory impairment : 37
Amnesia : 17
Facial paresis : 2
Visual field defect : 3
Guillain-Barre syndrome : 1
Hemianopia : 1
Encephalopathy : 2
Cerebral haemorrhage : 10
Cerebral haemorrhage neonatal : 1
Cerebral infarction : 9
Pachymeningitis : 1
Metabolic encephalopathy : 1
Headache : 535
Drug withdrawal headache : 2
Dizziness postural : 4
Hypersomnia : 8
Ischaemic cerebral infarction : 3
Tunnel vision : 1
Transient ischaemic attack : 10
Drooling : 1
Lacunar infarction : 1
Migraine : 44
Migraine with aura : 2
Hypogeusia : 5
Monoparesis : 1
Multiple sclerosis : 4
Myasthenia gravis : 3
Myelopathy : 1
Neurological symptom : 2
Anosmia : 15
Unresponsive to stimuli : 2
Optic neuritis : 3
Muscle contractions involuntary : 15
Psychomotor hyperactivity : 9
Hyperaesthesia : 7
Peripheral motor neuropathy : 1
Peripheral sensorimotor neuropathy : 1
Neuropathy peripheral : 20
Peroneal nerve palsy : 1
Petit mal epilepsy : 1
Sciatica : 2
Sudden onset of sleep : 2
Polyneuropathy : 15
Polyneuropathy chronic : 1
Posterior reversible encephalopathy syndrome : 1
Post-injection delirium sedation syndrome : 1
Presyncope : 23
Psychomotor skills impaired : 2
Reduced facial expression : 1
Nystagmus : 3
Akathisia : 8
Restless legs syndrome : 17
Sedation : 4
Poor quality sleep : 22
Lethargy : 1
Somnolence : 135
Taste disorder : 39
Ageusia : 54
Tension headache : 2
Tardive dyskinesia : 6
Myoclonus : 17
Speech disorder : 20
Dysarthria : 14
Aphasia : 14
Vocal cord paralysis : 1
Sensory disturbance : 5
Dysgraphia : 1
Parkinsonism : 9
Paraesthesia : 191
Paraesthesia mucosal : 4
Head titubation : 1
Dystonia : 7
Stupor : 3
Seizure : 41
Toxic encephalopathy : 1
Slow response to stimuli : 1
Tremor : 94
Cerebral artery thrombosis : 1
Altered state of consciousness : 1
Parosmia : 18
Intracranial pressure increased : 2
Convulsive threshold lowered : 1
Hypertonia : 10
Paralysis : 2
Pyramidal tract syndrome : 1
Radial nerve palsy : 1
Depressed level of consciousness : 14
Mental impairment : 3
Hypoaesthesia : 30
Hyperreflexia : 1
Dysaesthesia : 2
Dysgeusia : 116
Dyspraxia : 1
Transient global amnesia : 3
Anticholinergic syndrome : 1
Neuritis : 2
Neuralgia : 15
Peripheral sensory neuropathy : 1
Nervous system disorder : 2
Parkinson's disease : 1
Pregnancy and perinatal conditions : 10
Haemorrhage in pregnancy : 1
Foetal death : 2
Foetal growth restriction : 2
Normal newborn : 1
Unintended pregnancy : 1
Premature baby : 1
Abortion spontaneous : 1
Pregnancy on oral contraceptive : 1
Product issues : 104
Product adhesion issue : 2
Device breakage : 1
Product complaint : 88
Device colour issue : 2
Product blister packaging issue : 2
Product lot number issue : 1
Product physical issue : 1
Product colour issue : 1
Product quality issue : 4
Product counterfeit : 1
Product deposit : 1
Psychiatric : 1213
Attention deficit hyperactivity disorder : 1
Adjustment disorder with depressed mood : 3
Abnormal behaviour : 6
Abnormal dreams : 42
Suspiciousness : 1
Paranoia : 8
Drug dependence : 2
Aggression : 33
Alcoholism : 2
Anxiety : 67
Fear of death : 1
Apathy : 12
Enuresis : 5
Binge eating : 2
Compulsive lip biting : 1
Compulsive cheek biting : 1
Daydreaming : 1
Depersonalisation/derealisation disorder : 7
Depression : 67
Depression suicidal : 1
Depressed mood : 102
Derealisation : 4
Disorientation : 11
Dissociation : 7
Dissociative disorder : 1
Compulsions : 1
Emotional poverty : 4
Emotional distress : 1
Affect lability : 19
Emotional disorder : 5
Self-injurious ideation : 2
Thought blocking : 1
Behaviour disorder : 1
Flat affect : 1
Thinking abnormal : 7
Gambling disorder : 1
Hallucination, visual : 22
Hallucination : 72
Anorgasmia : 4
Hallucination, auditory : 12
Hypomania : 1
Delirium : 20
Impulse-control disorder : 2
Initial insomnia : 4
Reading disorder : 1
Libido disorder : 1
Loss of libido : 4
Conversion disorder : 1
Listless : 22
Mania : 4
Inappropriate affect : 1
Homicidal ideation : 1
Nightmare : 50
Negative thoughts : 2
Negativism : 1
Obsessive-compulsive disorder : 1
Agitation : 36
Disinhibition : 2
Mutism : 1
Indifference : 1
Oppositional defiant disorder : 1
Intentional self-injury : 2
Hypervigilance : 1
Panic attack : 9
Panic reaction : 7
Panic disorder : 1
Parasomnia : 1
Personality change : 1
Sleep talking : 1
Irritability : 10
Mental disorder : 2
Psychomotor retardation : 1
Psychotic disorder : 15
Restlessness : 62
Schizophrenia : 1
Disturbance in sexual arousal : 1
Sleep attacks : 2
Sleep disorder : 54
Insomnia : 134
Somnambulism : 3
Tension : 3
Logorrhoea : 1
Mood altered : 4
Affective disorder : 4
Mood swings : 15
Dysphemia : 5
Stress : 2
Suicidal behaviour : 2
Depressive symptom : 3
Bruxism : 4
Euphoric mood : 1
Libido increased : 2
Libido decreased : 17
Bradyphrenia : 2
Confusional state : 69
Hostility : 1
Delusion : 13
Anger : 2
Completed suicide : 1
Suicidal ideation : 30
Suicide attempt : 4
Nervousness : 22
Renal and urinary tracts : 343
Urethral disorder : 1
Micturition disorder : 14
Renal disorder : 2
Acute kidney injury : 27
Bladder discomfort : 2
Bladder pain : 3
Haematuria : 15
End stage renal disease : 1
Incontinence : 3
Micturition frequency decreased : 3
Nocturia : 18
Terminal dribbling : 1
Nephrotic syndrome : 4
Renal failure : 18
Renal impairment : 24
Renal colic : 4
Nephritis : 3
Glomerulonephritis : 1
Renal pain : 5
Nephrolithiasis : 2
Dysuria : 17
Postrenal failure : 1
Atonic urinary bladder : 1
Tubulointerstitial nephritis : 32
Anuria : 4
Ureterolithiasis : 1
Urine abnormality : 1
Urine odour abnormal : 4
Urinary incontinence : 26
Urge incontinence : 2
Urinary retention : 35
Calculus urinary : 1
Polyuria : 14
Pollakiuria : 25
Chromaturia : 18
Oliguria : 2
Renal tubular acidosis : 1
Micturition urgency : 7
Reproductive system and breasts : 322
Vulval disorder : 3
Vulvovaginal discomfort : 4
Perineal pain : 1
Pelvic discomfort : 1
Pelvic pain : 1
Haematospermia : 1
Postmenopausal haemorrhage : 7
Breast cyst : 1
Breast hyperplasia : 1
Breast pain : 12
Breast enlargement : 9
Ovarian cyst : 1
Genital rash : 3
Genital swelling : 2
Genital haemorrhage : 1
Genital pain : 1
Breast discomfort : 1
Breast swelling : 1
Menorrhagia : 5
Erectile dysfunction : 69
Pruritus genital : 6
Priapism : 3
Galactorrhoea : 8
Oligomenorrhoea : 1
Menstrual disorder : 7
Vulval oedema : 1
Menstruation irregular : 5
Metrorrhagia : 7
Balanoposthitis : 3
Penis disorder : 3
Penile exfoliation : 1
Scrotal pain : 2
Testicular pain : 1
Breast tenderness : 1
Dysmenorrhoea : 2
Prostatitis : 2
Scrotal oedema : 1
Sexual dysfunction : 2
Spontaneous penile erection : 2
Ejaculation disorder : 6
Menopausal symptoms : 1
Nipple disorder : 3
Nipple pain : 5
Breast discharge : 1
Nipple swelling : 1
Erection increased : 1
Endometrial hyperplasia : 1
Ejaculation failure : 8
Uterine inflammation : 1
Vaginal discharge : 6
Vaginal haemorrhage : 8
Vulvovaginal dryness : 2
Vaginal odour : 1
Gynaecomastia : 63
Acquired phimosis : 1
Vulvovaginal burning sensation : 7
Vulvovaginal inflammation : 1
Vulvovaginal pain : 1
Vulvovaginal pruritus : 8
Vulvovaginal erythema : 2
Vulvovaginal swelling : 1
Amenorrhoea : 7
Retrograde ejaculation : 3
Respiratory and thoracic : 981
Apnoea : 4
Acute respiratory distress syndrome : 1
Respiration abnormal : 1
Apnoeic attack : 1
Asthma : 7
Throat tightness : 12
Epistaxis : 49
Bronchial irritation : 1
Bronchiectasis : 1
Bronchospasm : 10
Chronic obstructive pulmonary disease : 8
Diaphragmatic disorder : 2
Dry throat : 7
Nasal dryness : 4
Dysaesthesia pharynx : 1
Dyspnoea at rest : 2
Emphysema : 1
Respiratory failure : 8
Pharyngeal swelling : 17
Pharyngeal haemorrhage : 1
Yawning : 5
Suffocation feeling : 1
Hiccups : 17
Cough : 136
Stridor : 3
Hyperventilation : 20
Increased viscosity of upper respiratory secretion : 1
Interstitial lung disease : 21
Throat irritation : 19
Throat lesion : 1
Nasal crusting : 1
Dyspnoea : 310
Dyspnoea exertional : 6
Oropharyngeal spasm : 1
Lung disorder : 10
Pulmonary haemorrhage : 3
Pulmonary embolism : 29
Pulmonary fibrosis : 8
Pulmonary infarction : 1
Lung infiltration : 3
Pneumonitis : 15
Pleurisy : 1
Rhinorrhoea : 12
Respiratory disorder : 5
Neonatal respiratory failure : 1
Nasal discomfort : 1
Nasal inflammation : 1
Nasal polyps : 2
Nasal congestion : 17
Sneezing : 7
Obstructive airways disorder : 1
Laryngeal oedema : 3
Respiratory depression : 1
Laryngospasm : 3
Haemoptysis : 4
Organising pneumonia : 2
Oropharyngeal discomfort : 1
Oropharyngeal blistering : 1
Oropharyngeal pain : 57
Orthopnoea : 2
Hypersensitivity pneumonitis : 1
Pharyngeal disorder : 1
Wheezing : 7
Pleural effusion : 4
Productive cough : 8
Respiratory symptom : 1
Rhonchi : 1
Pulmonary toxicity : 4
Sleep apnoea syndrome : 1
Tachypnoea : 2
Snoring : 4
Sputum increased : 5
Sputum discoloured : 18
Aphonia : 2
Dysphonia : 28
Hypercapnia : 1
Throat clearing : 1
Increased bronchial secretion : 5
Increased upper airway secretion : 1
Tonsillar hypertrophy : 1
Increased viscosity of bronchial secretion : 1
Neonatal respiratory depression : 1
Aspiration : 1
Choking : 2
Choking sensation : 4
Pulmonary oedema : 2
Pharyngeal oedema : 3
Skin and subcutaneous tissue : 2348
Lichenoid keratosis : 2
Acne : 10
Acute febrile neutrophilic dermatosis : 2
Umbilical discharge : 1
Skin necrosis : 1
Dermatitis allergic : 8
Angioedema : 140
Blister : 30
Pemphigoid : 3
Pemphigus : 1
Skin burning sensation : 19
Dermatitis atopic : 1
Dermatitis contact : 4
Dermatitis psoriasiform : 5
Dermatomyositis : 1
Skin hypertrophy : 1
Dry skin : 18
Skin atrophy : 4
Dyshidrotic eczema : 1
Eczema : 31
Eczema asteatotic : 1
Ecchymosis : 11
Acute generalised exanthematous pustulosis : 5
Erythema multiforme : 12
Dermatitis exfoliative : 4
Exfoliative rash : 2
Photodermatosis : 1
Urticaria : 138
Dermatitis exfoliative generalised : 1
Drug reaction with eosinophilia and systemic symptoms : 5
Sensitive skin : 2
Granuloma skin : 1
Hair disorder : 6
Hair growth abnormal : 3
Alopecia : 245
Palmar-plantar erythrodysaesthesia syndrome : 2
Henoch-Schonlein purpura : 2
Dandruff : 1
Skin warm : 4
Skin disorder : 15
Granuloma annulare : 2
Lichen planus : 13
Seborrhoeic dermatitis : 1
Toxic epidermal necrolysis : 9
Fixed eruption : 2
Drug eruption : 1
Skin haemorrhage : 3
Skin odour abnormal : 6
Skin mass : 7
Skin hypopigmentation : 1
Skin irritation : 7
Skin fissures : 3
Skin lesion : 1
Dermatitis : 10
Dermatitis bullous : 27
Skin reaction : 14
Skin striae : 1
Skin toxicity : 1
Rash : 270
Rash maculo-papular : 29
Rash papular : 13
Toxic skin eruption : 16
Rash vesicular : 13
Cutaneous lupus erythematosus : 2
Skin discolouration : 17
Vitiligo : 2
Skin swelling : 2
Pruritus : 316
Prurigo : 1
Rash pruritic : 89
Piloerection : 1
Sticky skin : 1
Scab : 1
Scar pain : 1
Purpura : 27
Hypotrichosis : 2
Night sweats : 20
Nail disorder : 16
Nail growth abnormal : 1
Onycholysis : 4
Nail discolouration : 4
Cutaneous vasculitis : 1
Nodular vasculitis : 2
Onychoclasis : 9
Dermatitis acneiform : 3
Hypersensitivity vasculitis : 9
Hirsutism : 6
Hypertrichosis : 3
Hyperhidrosis : 233
Seborrhoea : 2
Hyperkeratosis : 4
Palmar erythema : 1
Papule : 2
Perivascular dermatitis : 1
Pain of skin : 2
Alopecia areata : 7
Psoriasis : 42
Petechiae : 16
Pustular psoriasis : 1
Photosensitivity reaction : 39
Rash erythematous : 43
Erythema nodosum : 5
Erythema : 91
Rosacea : 4
Stevens-Johnson syndrome : 7
Skin tightness : 3
Actinic keratosis : 1
Subacute cutaneous lupus erythematosus : 4
Skin hyperpigmentation : 11
Trichorrhexis : 3
Hair colour changes : 1
Hair texture abnormal : 9
Madarosis : 2
Fingerprint loss : 1
Skin depigmentation : 6
Skin exfoliation : 42
Telangiectasia : 2
Rash macular : 12
Alopecia totalis : 1
Xanthelasma : 1
Chloasma : 1
Skin ulcer : 5
Sweat discolouration : 3
Cold sweat : 6
Social circumstances : 3
Bedridden : 1
Walking disability : 1
Impaired driving ability : 1
Surgical and medical procedures : 3
Cardiac pacemaker insertion : 1
Toe amputation : 1
Medical device change : 1
Vascular : 397
Peripheral vascular disorder : 2
Phlebitis : 3
Thrombophlebitis : 3
Necrosis ischaemic : 1
Aortic dissection : 1
Arterial occlusive disease : 1
Arterial thrombosis : 1
Atheroembolism : 1
Blue toe syndrome : 1
Pallor : 9
Bloody discharge : 1
Haemorrhage : 9
Haematoma : 60
Vascular occlusion : 1
Peripheral ischaemia : 2
Embolism : 2
Intermittent claudication : 2
Extremity necrosis : 2
Raynaud's phenomenon : 9
Circulatory collapse : 9
Haemodynamic instability : 2
Blood pressure inadequately controlled : 1
Peripheral coldness : 26
Hypotension : 49
Orthostatic hypotension : 8
Capillary leak syndrome : 1
Malignant hypertension : 2
Nitritoid reaction : 1
Polyarteritis nodosa : 1
Hot flush : 44
Flushing : 45
Peripheral artery thrombosis : 3
Peripheral arterial occlusive disease : 1
Shock haemorrhagic : 1
Poor peripheral circulation : 1
Varicose vein : 2
Shock : 6
Temporal arteritis : 2
Thrombosis : 6
Deep vein thrombosis : 6
Vasculitis : 11
Vasoconstriction : 2
Vasodilatation : 3
Hypertension : 52
Blood pressure fluctuation : 1
Overview of reports submitted to EMA
All reports submitted to EMA can be found here.
Overview of reports submitted to World Health Organization

VigiBase® data

This data is sourced from VigiBase, the World Health Organization’s (the “WHO”) global database for suspected adverse drug reactions “ADRs”, maintained by Uppsala Monitoring Centre (“UMC”). UMC is the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden providing scientific leadership and operative support to the WHO Program for International Drug Monitoring (www.who-umc.org).

The data contains reports of suspected ADRs, so called Individual Case Safety Reports (ICSRs), collected by national drug authorities in over 120 countries and span over more than 100 000 different medicinal products. Thus, this database is only a repository of ICSRs provided for VigiBase, and shall not be considered as a systematic register of ADRs that have occurred or may occur.

The volume of ICSRs for a particular medicinal product may be influenced by many different factors, including but not limited to the extent of use of the product, publicity and the nature of the reactions. No information is provided on the number of patients exposed to a particular product, and it is therefore, based on the ICSRs, not possible to calculate frequency of any ADR. Moreover, collection of data is, due to e.g. differing national legislation and policies, heterogeneous between different countries. For these reasons, any interpretation of ADR data, and particularly those based on comparisons between various medicinal products, may be misleading.

Information on a suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use. Any robust conclusion with regard to benefits and risks of a specific medicinal product always requires detailed evaluation and scientific assessment of all available data. The balance between benefit and risk of a specific medicinal product also varies between individual patients.

If you think that you may be experiencing a side-effect from a medicinal product, please seek advice from a health professional as soon as possible. Never stop or change the dose for prescription medicines without consulting your physician.

About the release of this data:
UMC takes great care to ensure that the data contained herein is an accurate record of data collected by the national drug authorities and transmitted to UMC. UMC does, however, not guarantee, warrant or make any representation whatsoever regarding the data contained herein, including but not limited to guarantees, warranties or representations of accuracy, reliability, completeness, currency, suitability, fitness or usefulness for any particular purpose or with respect to non-infringement of any third-party rights. In no event shall UMC be liable for any loss, damage, cost or other expense whatsoever (whether direct, indirect, punitive, incidental, special or consequential) arising out of or in any way connected with the use of or reference to any data contained herein. In no event shall UMC be liable other than i) under Swedish substantive law and ii) subject to the courts of Sweden with the district court of Uppsala as first instance.

OMEPRAZOL

Number of reports 109,005
Gender
Female
Male
Unknown
52,827
(48%)
36,694
(34%)
19,484
(18%)
Age
 
Year received
 
Region
Africa
Americas
Asia
Europe
Oceania
563
(1%)
64,520
(59%)
16,553
(15%)
24,209
(22%)
3,160
(3%)

Overview of reported side effects



Blood and lymphatic system : 4,842
Cardiac : 4,139
Congenital and genetic disorders : 270
Ear and labyrinth : 1,107
Endocrine system : 1,236
Eye : 2,744
Gastrointestinal : 27,617
General disorders and administr. Site : 26,196
Hepatobiliary : 2,159
Immune system : 3,008
Infections and infestations : 3,214
Injury and poisoning : 9,517
Investigations : 6,674
Metabolism and nutrition : 4,826
Musculoskeletal and connective tissue : 6,823
Neoplasms : 2,206
Nervous system : 13,273
Pregnancy and perinatal conditions : 162
Product issues : 2,169
Psychiatric : 6,966
Renal and urinary tracts : 34,006
Reproductive system and breasts : 1,445
Respiratory and thoracic : 7,107
Skin and subcutaneous tissue : 16,545
Social circumstances : 363
Surgical and medical procedures : 746
Vascular : 3,168
Related drugs and vaccines