Aa Lettergrootte
16

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.

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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: 9/10/2019.

OMEPRAZOL

Number of reports 2,185
Serious 222
Gender
Male
Female
Unknown
876
(40%)
1,303
(60%)
6
(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 : 22
Leukopenia : 6
Neutropenia : 1
Autoimmune haemolytic anaemia : 1
Anaemia : 2
Iron deficiency anaemia : 2
Coagulopathy : 1
Pernicious anaemia : 1
Thrombocytopenia : 5
Lymphadenopathy : 1
Agranulocytosis : 1
Polycythaemia : 1
Cardiac : 81
Angina pectoris : 1
Cyanosis : 1
Cardiac disorder : 4
Palpitations : 32
Atrial fibrillation : 4
Arrhythmia : 1
Oedema peripheral : 33
Tachycardia : 3
Bradycardia : 2
Ear and labyrinth : 44
Deafness : 3
Vertigo : 8
Tinnitus : 25
Hypoacusis : 8
Endocrine system : 5
Hypoparathyroidism : 2
Thyroid disorder : 1
Inappropriate antidiuretic hormone secretion : 1
Hypothyroidism : 1
Eye : 128
Retinal disorder : 1
Blindness : 1
Dry eye : 2
Diplopia : 6
Visual impairment : 31
Uveitis : 1
Blepharospasm : 1
Photophobia : 2
Retinal detachment : 1
Amblyopia : 1
Macular degeneration : 1
Optic neuritis : 1
Conjunctivitis : 5
Eye disorder : 2
Eye haemorrhage : 1
Eye irritation : 5
Eye inflammation : 1
Eye pain : 3
Eye swelling : 3
Eyelid ptosis : 1
Ocular hyperaemia : 1
Visual acuity reduced : 1
Photopsia : 2
Lacrimation increased : 1
Lacrimation disorder : 2
Vision blurred : 50
Swelling of eyelid : 1
Gastrointestinal : 922
Haemorrhoids : 1
Gastrointestinal disorder : 9
Oesophageal disorder : 1
Abnormal faeces : 5
Aphthous ulcer : 7
Pancreatitis : 4
Anal pruritus : 2
Salivary duct obstruction : 1
Oral mucosal blistering : 7
Haematemesis : 1
Haematochezia : 5
Rectal haemorrhage : 1
Oesophageal ulcer haemorrhage : 1
Eructation : 30
Vomiting : 41
Glossodynia : 8
Gastric haemorrhage : 1
Abdominal discomfort : 41
Abdominal pain : 60
Burning mouth syndrome : 1
Diarrhoea : 88
Discoloured vomit : 1
Dry throat : 5
Dry mouth : 50
Epigastric discomfort : 2
Frequent bowel movements : 2
Dysphagia : 8
Swollen tongue : 9
Hiccups : 4
Anal incontinence : 1
Infrequent bowel movements : 2
Intrinsic factor deficiency : 1
Throat irritation : 2
Anal fissure : 1
Oesophageal spasm : 2
Tongue geographic : 1
Lip dry : 2
Lip disorder : 2
Lip haemorrhage : 1
Lip swelling : 10
Gastric disorder : 4
Gastrointestinal pain : 6
Gastrointestinal sounds abnormal : 2
Dyspepsia : 77
Gastritis : 2
Gastric polyps : 5
Nausea : 140
Oral disorder : 1
Constipation : 29
Oesophageal pain : 2
Stomatitis : 20
Colitis : 1
Oesophagitis : 2
Cheilitis : 2
Breath odour : 2
Abdominal distension : 29
Oral discomfort : 2
Oral mucosal eruption : 1
Abdominal pain upper : 65
Proctalgia : 1
Oral pain : 2
Abdominal pain lower : 1
Odynophagia : 2
Oesophageal discomfort : 1
Salivary gland calculus : 1
Tooth disorder : 4
Toothache : 3
Tongue dry : 1
Tongue disorder : 4
Tongue movement disturbance : 2
Glossitis : 5
Tongue erythema : 1
Tongue discolouration : 9
Change of bowel habit : 2
Saliva altered : 1
Salivary hypersecretion : 2
Faeces discoloured : 4
Gastrointestinal motility disorder : 1
Steatorrhoea : 2
Flatulence : 44
Gastrooesophageal reflux disease : 14
Melaena : 1
Mouth ulceration : 1
General disorders and administr. Site : 615
Atrophy : 1
Thirst : 3
Localised oedema : 1
Drug ineffective : 51
Adverse drug reaction : 1
Drug interaction : 28
Drug withdrawal syndrome : 2
Feeling abnormal : 6
Sensation of foreign body : 1
Influenza like illness : 3
Feeling hot : 2
Feeling cold : 2
Inhibitory drug interaction : 3
Pyrexia : 12
Chills : 6
Moaning : 1
Asthenia : 9
Groin pain : 1
Gait disturbance : 6
Malaise : 37
Oedema : 8
Axillary pain : 1
Chest discomfort : 6
Inflammation : 1
Uvulitis : 1
Therapeutic response unexpected : 216
Pain : 7
Chest pain : 19
Potentiating drug interaction : 12
Product blister packaging issue : 2
Product colour issue : 1
Product quality issue : 1
Product counterfeit : 1
Application site reaction : 1
Mucosal pain : 1
Mucosal dryness : 1
Rebound effect : 3
Therapeutic product effect incomplete : 1
Therapeutic product effect decreased : 18
Therapeutic product ineffective : 1
Fall : 1
Therapeutic response decreased : 61
Fatigue : 64
Condition aggravated : 4
Food interaction : 1
Feeling drunk : 1
Feeling jittery : 2
Swelling : 3
Hepatobiliary : 30
Hepatic function abnormal : 6
Jaundice : 3
Jaundice cholestatic : 2
Hepatitis toxic : 3
Hepatitis : 7
Hepatitis cholestatic : 2
Hepatocellular injury : 1
Liver disorder : 2
Hepatic failure : 2
Hepatic pain : 1
Hepatotoxicity : 1
Immune system : 28
Serum sickness : 1
Anaphylactic reaction : 7
Anaphylactic shock : 10
Drug hypersensitivity : 1
Hypersensitivity : 7
Anaphylactoid reaction : 2
Infections and infestations : 20
Tonsillitis : 1
Cystitis : 1
Respiratory tract infection : 1
Campylobacter gastroenteritis : 1
Oesophageal candidiasis : 1
Candida infection : 1
Dental caries : 1
Herpes zoster : 1
Infection : 1
Infection susceptibility increased : 1
Sialoadenitis : 2
Oral candidiasis : 3
Pseudomembranous colitis : 1
Fungal infection : 2
Parotitis : 1
Urinary tract infection : 1
Injury and poisoning : 11
Blister : 6
Subdural haematoma : 1
Hip fracture : 1
Eye contusion : 1
Overdose : 1
Toxicity to various agents : 1
Investigations : 103
Blood iron decreased : 1
Blood urine present : 1
Blood magnesium decreased : 2
Blood pressure diastolic increased : 1
Blood pressure increased : 3
Blood pressure decreased : 5
Bleeding time prolonged : 1
Blood calcium decreased : 1
Weight increased : 29
Weight decreased : 7
Weight fluctuation : 1
Blood glucose increased : 2
Heart rate irregular : 1
Heart rate increased : 4
Heart rate decreased : 1
Haemoglobin decreased : 4
International normalised ratio increased : 9
Blood potassium decreased : 2
Hepatic enzyme increased : 4
Liver function test abnormal : 6
Body temperature increased : 1
Body temperature decreased : 2
Gastric pH increased : 1
Drug level increased : 2
Urine analysis abnormal : 1
Transaminases increased : 1
Alanine aminotransferase increased : 3
Urine output decreased : 1
Oxygen saturation decreased : 1
Coagulation time shortened : 1
Vitamin B12 decreased : 1
Vitamin B6 increased : 1
Blood glucose fluctuation : 2
Metabolism and nutrition : 171
Tetany : 3
Abnormal loss of weight : 1
Diabetes mellitus : 3
Folate deficiency : 1
Lack of satiety : 1
Vitamin B12 deficiency : 9
Hunger : 2
Hyperglycaemia : 6
Hyperlactacidaemia : 1
Alkalosis hypochloraemic : 1
Gout : 4
Hypoglycaemia : 3
Hypocalcaemia : 21
Hypophosphataemia : 1
Hypokalaemia : 17
Hypomagnesaemia : 59
Hyponatraemia : 3
Increased appetite : 8
Hyperphosphataemia : 1
Decreased appetite : 17
Appetite disorder : 3
Electrolyte imbalance : 1
Ketoacidosis : 1
Vitamin D deficiency : 2
Zinc deficiency : 1
Obesity : 1
Musculoskeletal and connective tissue : 253
Muscle atrophy : 1
Osteoarthritis : 1
Bone pain : 3
Bone swelling : 1
Rhabdomyolysis : 1
Arthropathy : 1
Arthritis : 3
Polyarthritis : 1
Arthralgia : 42
Joint swelling : 1
Musculoskeletal discomfort : 1
Myopathy : 2
Neck pain : 1
Osteoporosis : 4
Tendon pain : 2
Peripheral swelling : 4
Pain in extremity : 10
Flank pain : 3
Pain in jaw : 3
Limb discomfort : 3
Rheumatic disorder : 1
Rheumatoid arthritis : 1
Back pain : 10
Musculoskeletal chest pain : 1
Musculoskeletal pain : 9
Musculoskeletal stiffness : 3
Muscle discomfort : 1
Myalgia : 82
Muscle spasms : 34
Muscle twitching : 2
Muscular weakness : 20
Osteonecrosis : 1
Neoplasms : 4
Bladder cancer : 1
Rectal cancer : 1
Gastric cancer : 1
Renal neoplasm : 1
Nervous system : 513
Disturbance in attention : 5
Cerebrovascular accident : 1
Loss of consciousness : 3
Burning sensation : 2
Burning sensation mucosal : 2
Dementia : 2
Head discomfort : 4
Dizziness : 129
Epilepsy : 1
Serotonin syndrome : 1
Balance disorder : 7
Facial spasm : 1
Syncope : 9
Memory impairment : 5
Amnesia : 1
Facial paresis : 1
Visual field defect : 1
Headache : 122
Dizziness postural : 1
Trismus : 1
Migraine : 12
Monoparesis : 1
Anosmia : 3
Muscle contractions involuntary : 3
Hyperaesthesia : 2
Peripheral motor neuropathy : 1
Neuropathy peripheral : 3
Polyneuropathy : 1
Presyncope : 2
Restless legs syndrome : 4
Sedation : 2
Poor quality sleep : 3
Somnolence : 30
Taste disorder : 10
Ageusia : 13
Speech disorder : 4
Dysarthria : 1
Aphasia : 1
Dysphonia : 3
Sensory disturbance : 2
Paraesthesia : 48
Paraesthesia oral : 2
Stupor : 1
Seizure : 6
Tremor : 11
Parosmia : 6
Convulsive threshold lowered : 1
Hypertonia : 2
Paralysis : 1
Depressed level of consciousness : 1
Hypoaesthesia : 2
Dysaesthesia : 1
Dysgeusia : 27
Neuralgia : 3
Parkinson's disease : 1
Pregnancy and perinatal conditions : 4
Apgar score low : 1
Haemorrhage in pregnancy : 1
Foetal growth restriction : 1
Abortion spontaneous : 1
Product issues : 7
Product complaint : 7
Psychiatric : 185
Adjustment disorder with depressed mood : 1
Abnormal behaviour : 1
Abnormal dreams : 5
Paranoia : 1
Food aversion : 1
Aggression : 10
Alcoholism : 1
Anxiety : 9
Apathy : 3
Compulsive lip biting : 1
Compulsive cheek biting : 1
Depersonalisation/derealisation disorder : 1
Depression : 12
Depressed mood : 19
Derealisation : 2
Disorientation : 1
Self-injurious ideation : 1
Hallucination : 10
Anorgasmia : 1
Hallucination, auditory : 2
Delirium : 2
Reading disorder : 1
Listless : 4
Nightmare : 2
Obsessive-compulsive disorder : 1
Agitation : 5
Withdrawal syndrome : 2
Panic attack : 2
Panic reaction : 1
Personality change : 1
Irritability : 1
Mental disorder : 2
Psychomotor retardation : 1
Restlessness : 6
Sleep attacks : 1
Sleep disorder : 13
Insomnia : 36
Mood swings : 3
Dysphemia : 1
Depressive symptom : 1
Bruxism : 1
Libido decreased : 3
Confusional state : 7
Delusion : 1
Suicidal ideation : 3
Nervousness : 1
Renal and urinary tracts : 63
Micturition disorder : 3
Renal disorder : 1
Acute kidney injury : 1
Enuresis : 2
Bladder pain : 1
Haematuria : 2
Nocturia : 1
Renal failure : 4
Renal impairment : 8
Renal colic : 1
Nephritis : 2
Dysuria : 2
Tubulointerstitial nephritis : 21
Urine odour abnormal : 1
Urinary incontinence : 3
Urge incontinence : 1
Urinary retention : 1
Calculus urinary : 1
Polyuria : 1
Pollakiuria : 2
Chromaturia : 1
Fluid retention : 3
Reproductive system and breasts : 99
Vulval disorder : 1
Vulvovaginal discomfort : 1
Haematospermia : 1
Postmenopausal haemorrhage : 1
Breast cyst : 1
Breast hyperplasia : 1
Mastitis : 1
Breast pain : 2
Breast enlargement : 4
Genital rash : 1
Genital haemorrhage : 1
Breast swelling : 1
Menorrhagia : 1
Erectile dysfunction : 21
Pruritus genital : 1
Menstrual disorder : 3
Menstruation irregular : 1
Penis disorder : 2
Nipple pain : 1
Endometrial hyperplasia : 1
Ejaculation failure : 2
Vaginal discharge : 1
Vulvovaginal dryness : 1
Gynaecomastia : 45
Vulvovaginal burning sensation : 1
Vulvovaginal pruritus : 1
Amenorrhoea : 1
Respiratory and thoracic : 138
Asthma : 1
Throat tightness : 1
Epistaxis : 9
Diaphragmatic disorder : 2
Nasal dryness : 1
Pharyngeal swelling : 6
Yawning : 1
Cough : 18
Hyperventilation : 3
Interstitial lung disease : 1
Dyspnoea : 40
Dyspnoea exertional : 2
Respiratory disorder : 3
Nasal congestion : 1
Laryngospasm : 1
Rhinitis : 1
Oropharyngeal blistering : 1
Oropharyngeal pain : 16
Wheezing : 2
Productive cough : 2
Snoring : 2
Sputum increased : 1
Sputum discoloured : 16
Increased bronchial secretion : 3
Increased upper airway secretion : 1
Aspiration : 1
Choking : 1
Choking sensation : 1
Skin and subcutaneous tissue : 524
Lichenoid keratosis : 1
Acne : 2
Umbilical discharge : 1
Dermatitis allergic : 1
Angioedema : 24
Pemphigus : 1
Dermatitis contact : 1
Dry skin : 5
Eczema : 6
Ecchymosis : 2
Erythema multiforme : 4
Urticaria : 44
Face oedema : 3
Hair disorder : 1
Alopecia : 83
Dandruff : 1
Lichen planus : 2
Toxic epidermal necrolysis : 4
Fixed eruption : 1
Drug eruption : 1
Skin odour abnormal : 1
Skin mass : 1
Dermatitis : 1
Dermatitis bullous : 3
Skin reaction : 2
Rash : 66
Rash maculo-papular : 5
Rash papular : 1
Toxic skin eruption : 2
Cutaneous lupus erythematosus : 1
Pruritus : 81
Rash pruritic : 25
Purpura : 6
Hypotrichosis : 1
Night sweats : 7
Nail disorder : 4
Nail growth abnormal : 1
Nail discolouration : 1
Oedema mouth : 1
Nodular vasculitis : 1
Onychoclasis : 2
Eyelid oedema : 1
Dermatitis acneiform : 1
Hypersensitivity vasculitis : 2
Hyperhidrosis : 34
Seborrhoea : 2
Hyperkeratosis : 1
Papule : 2
Alopecia areata : 3
Pruritus generalised : 5
Psoriasis : 6
Petechiae : 2
Rash pustular : 2
Rash generalised : 2
Photosensitivity reaction : 9
Rash erythematous : 7
Erythema nodosum : 2
Erythema : 12
Rosacea : 1
Stevens-Johnson syndrome : 1
Subacute cutaneous lupus erythematosus : 2
Skin hyperpigmentation : 1
Tongue oedema : 5
Trichorrhexis : 1
Hair texture abnormal : 3
Skin depigmentation : 1
Skin exfoliation : 7
Periorbital oedema : 1
Chloasma : 1
Sweat discolouration : 1
Swelling face : 4
Cold sweat : 1
Surgical and medical procedures : 1
Cardiac pacemaker insertion : 1
Vascular : 52
Peripheral vascular disorder : 1
Phlebitis : 1
Pallor : 1
Haematoma : 14
Peripheral ischaemia : 1
Embolism : 1
Circulatory collapse : 2
Cerebral haemorrhage : 1
Peripheral coldness : 2
Hypotension : 4
Hot flush : 6
Flushing : 9
Vasculitis : 1
Hypertension : 8
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 103,194
Gender
Female
Male
Unknown
49,321
(48%)
34,367
(33%)
19,506
(19%)
Age
 
Year received
 
Region
Africa
Americas
Asia
Europe
Oceania
455
(0%)
61,135
(59%)
15,269
(15%)
23,173
(22%)
3,162
(3%)

Overview of reported side effects



Blood and lymphatic system : 4,455
Cardiac : 3,851
Congenital and genetic disorders : 252
Ear and labyrinth : 1,070
Endocrine system : 1,040
Eye : 2,626
Gastrointestinal : 25,734
General disorders and administr. Site : 24,852
Hepatobiliary : 2,090
Immune system : 2,817
Infections and infestations : 3,031
Injury and poisoning : 9,115
Investigations : 6,392
Metabolism and nutrition : 4,516
Musculoskeletal and connective tissue : 6,524
Neoplasms : 2,061
Nervous system : 12,675
Pregnancy and perinatal conditions : 151
Product issues : 2,030
Psychiatric : 6,453
Renal and urinary tracts : 31,371
Reproductive system and breasts : 1,411
Respiratory and thoracic : 6,715
Skin and subcutaneous tissue : 15,783
Social circumstances : 343
Surgical and medical procedures : 618
Vascular : 2,961
Related drugs and vaccines