Liite 7. Fimealle raportoidut haittavaikutukset v

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1 1 (6) Liite 7. Fimealle raportoidut haittavaikutukset v Fimean haittavaikutusrekisterin tietojen käytössä tulee huomioida, että: ilmoitukset koskevat epäiltyjä yhteyksiä, jotka kuvastavat ilmoittajan havaintoja ja näkemyksiä ilmoitus rekisterissä ei tarkoita, että lääkkeen ja haittavaikutusten välinen mahdollinen yhteys olisi vahvistettu ilmoitusten perusteella ei voi laskea haittojen yleisyyttä ilmoitusten lukumäärän perusteella ei voi vertailla eri lääkkeiden turvallisuutta keskenään ATC-koodi Epäilty valmiste Vaikuttava-aine Haitat A = Ruoansulatuselimistön ja aineenvaihduntasairauksien lääkkeet (n=5) A04AA01 ONDANSETRON FRE- Ondansetroni hydrochloridum dihydricum Red blotches SENIUS KABI A07EC01 SALAZOPYRIN Sulfasalazinum Maternal drug exposure, Cholestasis, Blood bilirubin increased, Total bile acids increased, Jaundice A10BA02 DIFORMIN RETARD Metformini hydrochloridum Lactic acidosis, Renal failure, Diarrhoea, Vomiting A10BK03 JARDIANCE Empagliflozinum Emphysematous pyelonephritis, Multiorgan failure, Sepsis A10BK03 JARDIANCE Empagliflozinum Euglycaemic diabetic ketoacidosis B = Veritautien lääkkeet (n=19) B01AA03 MAREVAN FORTE Warfarinum natricum Paraplegia, Spinal epidural haematoma B01AC06, ASA-RATIOPHARM, Acidum acetylsalicylicum / Ticagrelorum / Enoxaparinum Haemothorax, Epistaxis B01AC24, B01AB05 BRILIQUE, KLEXANE natricum B01AF01 XARELTO Rivaroxabanum Intracerebral, Intraventricular B01AF01 XARELTO Rivaroxabanum Deep vein thrombosis leg B01AF01 XARELTO Rivaroxabanum Intracerebral, Basal ganglia, Intraventricular B01AF01 XARELTO Rivaroxabanum Cerebral, Intraventricular B01AF01 XARELTO Rivaroxabanum Cerebral, Respiratory failure, Infection B01AF01 XARELTO Rivaroxabanum Cerebral, Intraventricular B01AF01 XARELTO Rivaroxabanum Cerebral, Brain herniation, Brain death B01AF01 XARELTO Rivaroxabanum Basal ganglia, Intraventricular

2 2 (6) B01AF01 XARELTO Rivaroxabanum Cerebral B01AF01 XARELTO Rivaroxabanum Basal ganglia B01AF01 XARELTO Rivaroxabanum Basal ganglia, Pneumonia aspiration, Cardiac failure, Retention carbon dioxide, Tracheostomy B01AF02 ELIQUIS Apixabanum Leucocytoclastic vasculitis, Pyrexia, General physical health deterioration, Fatigue, Hepatic enzymes increased, C-reactive protein increased B01AF02 ELIQUIS Apixabanum Thalamus, Hemiparesis, Aphasia B02AA02 CAPRILON Acidum tranexamicum Cerebral infarction B03XA02 ARANESP Darbepoetinum alfa Hepatic lesion, Alkaline phosphatase increased, Gamma-glutamyltransferase increased B05AA01 ALBUREX Albuminum humanum Anaphylactic reaction, Allergic reaction B05AA01, J01FF01, M03AC09 ALBUREX, CLINDAMY- CIN FRESENIUS KABI, ESMERON Albuminum humanum / Clindamycini phosphas / Rocuronii bromidum Anaphylactic reaction C = Sydän- ja verisuonitautien lääkkeet (n=3) C09DX04 ENTRESTO Sacubitrilum, Valsartanum Diarrhoea C10AA05 ATORVASTATIN Atorvastatinum calcicum Necrotising myositis, Autoimmune myositis C10AX14 PRALUENT Alirocumabum Back pain, Pain in hip D = Ihotautilääkkeet (n=2) D10BA01 ISOTRETINOIN Isotretinoinum Idiopathic intracranial hypertension, Loss of consciousness, Headache D11AH05 DUPIXENT Dupilumabum Atopic eczema G = Sukupuoli- ja virtsaelinsairauksien lääkkeet, sukupuolihormonit (n=23) G02BA03 KYLEENA Levonorgestrelum Pregnancy with intrauterine device, Abortion spontaneous G02BA03 JAYDESS Levonorgestrelum Pregnancy with intrauterine device G02BA03 JAYDESS Levonorgestrelum Pregnancy with intrauterine device G02BA03 JAYDESS Levonorgestrelum Pregnancy with intrauterine device, Skin symptom G02BA03 KYLEENA Levonorgestrelum Ectopic pregnancy with intrauterine device G02BA03 KYLEENA Levonorgestrelum Ectopic pregnancy with intrauterine device G02BA03 JAYDESS Levonorgestrelum Ectopic pregnancy with intrauterine device G02BA03 KYLEENA Levonorgestrelum Pregnancy with intrauterine device G02BB01 NUVARING Etonogestrelum, Ethinylestradiolum Pregnancy with vaginal contraceptive device G03AA12 STEFAMINELLE Drospirenonum, Ethinylestradiolum Pregnancy on oral contraceptive G03AA12 TASMINETTA Ethinylestradiolum, Drospirenonum Pregnancy on oral contraceptive G03AA13 EVRA Ethinylestradiolum, Norelgestrominum Pregnancy with contraceptive patch G03AA14 ZOELY Nomegestroli acetas, Estradiolum hemihydricum Pregnancy on oral contraceptive G03AC01 MINI-PILL Norethisteronum Pregnancy on oral contraceptive G03AC03 MICROLUTON Levonorgestrelum Pregnancy on oral contraceptive G03AC09 DESOGESTREL Desogestrelum Pregnancy on oral contraceptive G03AC09 AZALIA Desogestrelum Pregnancy on oral contraceptive G03AC09 AZALIA Desogestrelum Pregnancy on oral contraceptive G03AC09 DESOGESTREL Desogestrelum Pregnancy on oral contraceptive G03AC09 AZALIA Desogestrelum Pregnancy on oral contraceptive G03BA03 NEBIDO Testosteroni undecanoas Cerebral infarction, Paradoxical embolism

3 3 (6) G04BD12 BETMIGA Mirabegronum Abdominal pain upper, Nausea G04BD12 BETMIGA Mirabegronum Urinary retention H = Systeemisesti käytettävät hormonivalmisteet (n=2) H03BB01 TYRAZOL Carbimazolum Pneumonia pseudomonal, Neutropenia H03BB01 TYRAZOL Carbimazolum Neutropenic infection, Agranulocytosis, Haemoglobin decreased J = Systeemisesti käytettävät infektiolääkkeet (n=21) J01DC02 CEFUROXIM MIP PHARMA Cefuroximum natricum Oedema, Urticaria, Generalised erythema, Palpitation J01EE01 COTRIM FORTE Trimethoprimum, Sulfamethoxazolum Neutropenia J01FA10 AZITHROMYCIN KRKA Azithromycinum dihydricum Drug-induced liver injury, Hepatitis cholestatic, Hepatic necrosis J01MA02 CIPROFLOXACIN RA- TIOPHARM Ciprofloxacini hydrochloridum anhydricum J01XE01 NITROFUR-C Nitrofurantoinum, Acidum ascorbicum Pulmonary fibrosis Tubulointerstitial nephritis, Acute kidney injury, Dehydration J04BA02 DAPSON Dapsonum Cholestatic liver injury J07AM51 DITEBOOSTER Corynebacterium diphtheriae toxoid, adsorbed, Clostridium Low back pain tetani toxoid, adsorbed J07AN01 BCG VACCINE AJVAC- CINES Mycobacterium bovis BCG (Danish strain 1331), live attenuated Vaccination site reaction, Vaccination site discharge Pain in arm, Pyrexia, Myalgia J07BB02 PANDEMRIX Influenza virus (H1N1)v, split virion, inactivated Narcolepsy, Cataplexy Choking sensation, Paraesthesia Burning in throat, Dizziness, Tingling lips, Erythema facial Localised erythema, Blood pressure increased Myalgia Urticaria generalised, Pruritus Vaccination site pain, Pain in arm Vertigo

4 4 (6) J07BD52 M-M-RVAXPRO Measles virus (Enders' Edmonston), live attenuated, Mumps virus (Jeryl Lynn level B), live attenuated, Rubella virus (Wistar RA 27/3), live attenuated Rash generalised Rotatory vertigo Pain in arm, Vaccination site movement impairment Malaise, Headache, Dizziness, Blood pressure increased L = Syöpälääkkeet ja immuunisvasteen muuntajat (n=17) L01BA01 METHOTREXATE Methotrexatum Hepatic failure, Renal failure, Drug level increased L01CD02, L03AA14 DOCETAXEL, LON- QUEX Docetaxelum / Lipegfilgrastimum Splenic rupture, Splenic, Abdominal pain, Constipation, Haemoglobin decreased, Malaise, Rigidity, Muscular weakness, Oedema L01XC02 RITEMVIA Rituximabum Febrile reaction, Neck pain, Back pain, Headache, Red blotches, Skin burning sensation, Itching papule L01XC05 MYLOTARG Gemtuzumabum ozogamicinum Haemolysis, Haemoglobin increased, Blood lactate dehydrogenase increased, Neutrophil count decreased, Monocytopenia, Macrophages decreased, Haptoglobin increased, Plasmapheresis L01XC06 ERBITUX Cetuximabum Interstitial pneumonia L01XC07 AVASTIN Bevacizumabum Cardio-respiratory arrest, Uncontrolled, Epistaxis, Depressed level of consciousness, Nasal septum perforation L01XC07 AVASTIN Bevacizumabum Cerebral infarction L01XC15 GAZYVARO Obinutuzumabum Oesophagitis, Cytomegalovirus infection reactivation, Neutropenia L01XC18 KEYTRUDA Pembrolizumabum Immune-mediated hepatic disorder, Hepatic enzymes increased L01XE05 NEXAVAR Sorafenibum tosylatum micronisatum Thrombocytopenia, Blood product transfusion, Melaena L01XE11 VOTRIENT Pazopanibi hydrochloridum Posterior reversible encephalopathy syndrome, Subarachnoid, Hypothyroidism, Blood pressure increased, Blood bilirubin increased, Transaminases increased L01XE27 IMBRUVICA Ibrutinibum Cellulitis, Infected skin ulcer, Rash, Staphylococcus test positive, Streptococcus test positive L03AB13 PLEGRIDY Peginterferonum beta-1a Pulmonary arterial pressure increased, Chest discomfort, Palpitations L03AB13 PLEGRIDY Peginterferonum beta-1a Condition aggravated, Pyrexia, Thrombocytopenia, Leukopenia, Injection site reaction L04AA36 OCREVUS Ocrelizumab Agranulocytosis, Oral herpes, Herpes pharyngitis, Pyrexia, Common cold, Diarrhoea, Nausea, Fatigue

5 5 (6) L04AA36 OCREVUS Ocrelizumab Pneumonia mycoplasmal, Viral infection, Pulmonary infiltration, Bronchial secretion retention, Pyrexia, Cough, Dyspnoea exertional, Suspected COVID-19, SARS-CoV-2 test negative L04AX04 REVLIMID Lenalidomidum Pulmonary infiltration, Miliary tuberculosis, Pneumonia, Pyrexia, Lymphocytosis, Eosinophilia M = Tuki- ja liikuntaelinsairauksien lääkkeet (n=2) M01AE17 KETESSE Dexketoprofenum trometamolum Bronchial obstruction M03AX01 BOTOX Clostridium botulinum type A neurotoxin complex (900 kd) Off label use, Neck pain, Upper back pain, Shoulder blade pain, Pain in arm, Mobility decreased, Dysphagia, Pyrexia N = Hermostoon vaikuttavat lääkkeet (n=16) N02CD01 AIMOVIG Erenumabum Choroidal, Nausea, Vomiting N02CD03 AJOVY Fremanezumabum Flushing, Pyrexia, Urticaria, Malaise N02CD03 AJOVY Fremanezumabum Migraine aggravated, Cluster headache, Dry eye, Alopecia, Abdominal discomfort, Diarrhoea, Constipation, Photosensitivity, Hyperacusis, Malaise, Fatigue, Asthenia, Infection reactivation, Oral fungal infection N03AF02 APYDAN Oxcarbazepinum Cough N03AX09 LAMICTAL Lamotriginum Generalised maculopapular rash, Pyrexia, Mouth ulceration, Genital irritation, Pruritus N03AX09 LAMICTAL Lamotriginum Stevens-Johnson syndrome N03AX18, C07AA05 N05AX08, N06BA12 N05AX08, N06BA12 VIMPAT, PROPRAL Lacosamidum / Propranololi hydrochloridum Drug interaction, Nodal rhythm, Hypotension, Acute kidney injury, Hyperkalaemia RISPERIDONE, EL- VANSE RISPERIDONE, EL- VANSE Risperidonum / Lisdexamfetamini dimesylas Risperidonum / Lisdexamfetamini dimesylas Pharmacokinetic interaction, Dystonia Pharmacokinetic interaction, Tardive dyskinesia, Akathisia N05AX12 ABILIFY MAINTENA Aripiprazolum Maternal exposure during pregnancy, Abortion spontaneous N05AX12 ABILIFY Aripiprazolum Salivary hypersecretion, Visual acuity reduced N05AX13 TREVICTA Paliperidoni palmitas Tardive dyskinesia, Tremor, Tooth erosion N05AX16 RXULTI Brexpiprazolum Venous thrombosis limb N06AA12 DOXAL Doxepini hydrochloridum Tinnitus N06AX16 VENLAFAXIN RA- TIOPHARM Venlafaxini hydrochloridum Alanine aminotransferase increased N06BA04 MEDIKINET CR Methylphenidati hydrochloridum Mouth ulceration, Oral mucosa pain, Glossodynia R = Hengityselinten sairauksien lääkkeet (n=3) R03DC03 MONTELUKAST Montelukastum natricum Crying, Nightmare, Anxiety ORION R03DX05 XOLAIR Omalizumabum Urosepsis, Escherichia urinary tract infection, Suspected COVID-19 R03DX10 FASENRA Benralizumabum Pulmonary embolism S = Silmä- ja korvatautien lääkkeet (n=1) S01BC10 NEVANAC Nepafenacum Visual disturbances V = Muut (n=11) V01AA02 GRAZAX Phleum pratense (timotei) Eosinophilic oesophagitis, Oesophageal irritation, Throat irritation

6 6 (6) V08AB02 OMNIPAQUE Iohexolum Anaphylactoid reaction V08AB02 OMNIPAQUE Iohexolum Urticaria V08AB02 OMNIPAQUE Iohexolum Urticaria generalised, Blood pressure increased V08CA02 DOTAREM Acidum gadotericum Respiratory symptom, Cough, Rhinitis V08CA02 DOTAREM Acidum gadotericum Eye irritation, Eyelid oedema, Urticaria localised, Localised erythema, Face oedema V08DA05 SONOVUE Sulfur hexafluoridum Anaphylactic reaction