Person who experienced the adverse event (patient)
Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
116670193 | 11667019 | 3 | F | 20070927 | 20160714 | 20151027 | 20160721 | EXP | JP-ASTELLAS-2009JP004097 | ASTELLAS | 40.00 | YR | F | Y | 0.00000 | 20160721 | MD | JP | JP |
Drug(s) used by person
Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
116670193 | 11667019 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 237 | MG | 50708 | 3 | MG | CAPSULE | QD | |||||
116670193 | 11667019 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 10 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 20 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 15 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 12.5 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 10 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 20 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 8 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 17.5 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 15 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 10 | C | CEFZON | CEFDINIR | 1 | Oral | U | 0 | 100 | MG | CAPSULE | QD | ||||||
116670193 | 11667019 | 11 | C | Astomin | DIMEMORFAN | 1 | Oral | U | 0 | 30 | MG | FORMULATION UNKNOWN | QD | ||||||
116670193 | 11667019 | 12 | C | MUCOSTA | REBAMIPIDE | 1 | Oral | U | 0 | 300 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 13 | C | BLOPRESS | CANDESARTAN CILEXETIL | 1 | Oral | U | 0 | 2 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 14 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | 0.25 ?G, ONCE DAILY | U | 0 | .25 | UG | PER ORAL NOS | QD | |||||
116670193 | 11667019 | 15 | C | FERROMIA | FERROUS CITRATE | 1 | Oral | U | 0 | 100 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 16 | C | FERROMIA | FERROUS CITRATE | 1 | Oral | U | 0 | 100 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 17 | C | CHLOMY | CHLORAMPHENICOL | 1 | Vaginal | U | 0 | 100 | MG | QD | |||||||
116670193 | 11667019 | 18 | C | OKINAZOLE | 2 | Vaginal | U | 0 | 600 | MG | QD | ||||||||
116670193 | 11667019 | 19 | C | HYALEIN | HYALURONATE SODIUM | 1 | Ophthalmic | UNK UNK, UNKNOWN FREQ. | U | 0 | EYE DROPS | ||||||||
116670193 | 11667019 | 20 | C | PL | ACETAMINOPHENCAFFEINEPROMETHAZINESALICYLAMIDE | 1 | Oral | U | 0 | 3 | G | GRANULES | QD | ||||||
116670193 | 11667019 | 21 | C | PL | ACETAMINOPHENCAFFEINEPROMETHAZINESALICYLAMIDE | 1 | Oral | U | 0 | 3 | G | GRANULES | QD | ||||||
116670193 | 11667019 | 22 | C | MUCODYNE | CARBOCYSTEINE | 1 | Oral | U | 0 | 1500 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 23 | C | COCARL | ACETAMINOPHEN | 1 | Oral | U | 0 | 400 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 24 | C | NERISONA | DIFLUCORTOLONE VALERATE | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | CUTANEOUS SOLUTION | ||||||||
116670193 | 11667019 | 25 | C | RESTAMIN | DIPHENHYDRAMINE | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | ||||||||
116670193 | 11667019 | 26 | C | LIDOMEX:SOL. | 2 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | LOTION (EXCEPT LOTION FOR EYE) | |||||||||
116670193 | 11667019 | 27 | C | LIDOMEX:CREAM | 2 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | |||||||||
116670193 | 11667019 | 28 | C | CLARITH | CLARITHROMYCIN | 1 | Oral | U | 0 | 100 | MG | PER ORAL NOS | QD | ||||||
116670193 | 11667019 | 29 | C | CLARITH | CLARITHROMYCIN | 1 | Oral | U | 0 | 400 | MG | PER ORAL NOS | QD | ||||||
116670193 | 11667019 | 30 | C | PATANOL | OLOPATADINE HYDROCHLORIDE | 1 | Ophthalmic | UNK UNK, UNKNOWN FREQ. | U | 0 | EYE DROPS | ||||||||
116670193 | 11667019 | 31 | C | FLUNASE | FLUTICASONE PROPIONATE | 1 | Nasal | UNK UNK, UNKNOWN FREQ. | U | 0 | NASAL DROPS | ||||||||
116670193 | 11667019 | 32 | C | UREPEARL | UREA | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | ||||||||
116670193 | 11667019 | 33 | C | UREPEARL | UREA | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | ||||||||
116670193 | 11667019 | 34 | C | FLUMETHOLON | FLUOROMETHOLONE | 1 | Ophthalmic | UNK UNK, UNKNOWN FREQ. | U | 0 | EYE DROPS | ||||||||
116670193 | 11667019 | 35 | C | MOHRUS TAPE L | 2 | Topical | U | 0 | 1 | DF | TAPE (INCLUDING POULTICE) | QD | |||||||
116670193 | 11667019 | 36 | C | MOHRUS TAPE L | 2 | Topical | U | 0 | 1 | DF | TAPE (INCLUDING POULTICE) | QD | |||||||
116670193 | 11667019 | 37 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | U | 0 | 60 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 38 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | U | 0 | 120 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 39 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | U | 0 | 60 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 40 | C | LOCOID | HYDROCORTISONE BUTYRATE | 1 | Transdermal | UNK UNK, UNKNOWN FREQ. | U | 0 | CREAM | ||||||||
116670193 | 11667019 | 41 | C | LOXONIN | LOXOPROFEN SODIUM | 1 | Oral | U | 0 | 180 | MG | PER ORAL NOS | QD | ||||||
116670193 | 11667019 | 42 | C | VITAMINS NOS | VITAMINS | 1 | Oral | U | 0 | 10 | UG | TABLET | QD | ||||||
116670193 | 11667019 | 43 | C | PLETAAL | CILOSTAZOL | 1 | Oral | U | 0 | 50 | MG | ORODISPERSIBLE TABLET | QD | ||||||
116670193 | 11667019 | 44 | C | NITROPEN | NITROGLYCERIN | 1 | Oral | 0.3 MG, ONCE DAILY | U | 0 | .3 | MG | PER ORAL NOS | QD | |||||
116670193 | 11667019 | 45 | C | HOKUNALIN /00654901/ | TULOBUTEROL | 1 | Transdermal | 0.5 MG, ONCE DAILY | U | 0 | .5 | MG | TAPE (INCLUDING POULTICE) | QD | |||||
116670193 | 11667019 | 46 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||||
116670193 | 11667019 | 47 | C | TRANSAMIN | TRANEXAMIC ACID | 1 | Oral | U | 0 | 250 | MG | CAPSULE | QD | ||||||
116670193 | 11667019 | 48 | C | AZUNOL /00620101/ | 2 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | |||||||||
116670193 | 11667019 | 49 | C | AZUNOL /00620101/ | 2 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | MOUTHWASH | |||||||||
116670193 | 11667019 | 50 | C | AZUNOL /00620101/ | 2 | U | 0 | MOUTHWASH | |||||||||||
116670193 | 11667019 | 51 | C | DEXALTIN | DEXAMETHASONE | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | OINTMENT | ||||||||
116670193 | 11667019 | 52 | C | TRAMCET | ACETAMINOPHENTRAMADOL | 1 | Oral | U | 0 | 2 | DF | TABLET | QD | ||||||
116670193 | 11667019 | 53 | C | TRAMCET | ACETAMINOPHENTRAMADOL | 1 | Oral | U | 0 | 3 | DF | TABLET | QD | ||||||
116670193 | 11667019 | 54 | C | NOVAMIN /00013303/ | 2 | Oral | U | 0 | 15 | MG | PER ORAL NOS | QD | |||||||
116670193 | 11667019 | 55 | C | LYRICA | PREGABALIN | 1 | Oral | U | 0 | 150 | MG | CAPSULE | QD | ||||||
116670193 | 11667019 | 56 | C | KEISHIBUKURYOGAN | HERBALS | 1 | Oral | U | 0 | 7.5 | G | PER ORAL NOS | QD | ||||||
116670193 | 11667019 | 57 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | U | 0 | 300 | MG | PER ORAL NOS | QD | ||||||
116670193 | 11667019 | 58 | C | OXICONAZOLE NITRATE. | OXICONAZOLE NITRATE | 1 | Unknown | U | 0 | 600 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 59 | C | CANDESARTAN /01349502/ | CANDESARTAN | 1 | Oral | U | 0 | 2 | MG | TABLET | QD | ||||||
116670193 | 11667019 | 60 | C | ALFACALCIDOL | ALFACALCIDOL | 1 | Oral | 0.25 ?G, ONCE DAILY | U | 0 | .25 | UG | CAPSULE | QD | |||||
116670193 | 11667019 | 61 | C | PRECIPITATED CALCIUM CARBONATE | CALCIUM CARBONATE | 1 | Oral | U | 0 | 1500 | MG | TABLET | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
116670193 | 11667019 | 1 | Lupus nephritis |
116670193 | 11667019 | 2 | Lupus nephritis |
116670193 | 11667019 | 10 | Upper respiratory tract inflammation |
116670193 | 11667019 | 11 | Upper respiratory tract inflammation |
116670193 | 11667019 | 12 | Prophylaxis |
116670193 | 11667019 | 13 | Lupus nephritis |
116670193 | 11667019 | 14 | Prophylaxis |
116670193 | 11667019 | 15 | Product used for unknown indication |
116670193 | 11667019 | 17 | Vaginitis bacterial |
116670193 | 11667019 | 18 | Vaginitis bacterial |
116670193 | 11667019 | 19 | Sjogren's syndrome |
116670193 | 11667019 | 20 | Upper respiratory tract inflammation |
116670193 | 11667019 | 21 | Nasopharyngitis |
116670193 | 11667019 | 22 | Upper respiratory tract inflammation |
116670193 | 11667019 | 23 | Upper respiratory tract inflammation |
116670193 | 11667019 | 24 | Seborrhoeic dermatitis |
116670193 | 11667019 | 25 | Seborrhoeic dermatitis |
116670193 | 11667019 | 26 | Seborrhoeic dermatitis |
116670193 | 11667019 | 27 | Seborrhoeic dermatitis |
116670193 | 11667019 | 28 | Bronchitis |
116670193 | 11667019 | 30 | Seasonal allergy |
116670193 | 11667019 | 31 | Seasonal allergy |
116670193 | 11667019 | 32 | Hyperkeratosis |
116670193 | 11667019 | 34 | Dry eye |
116670193 | 11667019 | 35 | Periarthritis |
116670193 | 11667019 | 36 | Costochondritis |
116670193 | 11667019 | 37 | Urticaria |
116670193 | 11667019 | 40 | Urticaria |
116670193 | 11667019 | 41 | Headache |
116670193 | 11667019 | 42 | Raynaud's phenomenon |
116670193 | 11667019 | 43 | Raynaud's phenomenon |
116670193 | 11667019 | 44 | Angina pectoris |
116670193 | 11667019 | 45 | Upper respiratory tract inflammation |
116670193 | 11667019 | 46 | Gastric ulcer |
116670193 | 11667019 | 47 | Stomatitis |
116670193 | 11667019 | 48 | Stomatitis |
116670193 | 11667019 | 49 | Prophylaxis |
116670193 | 11667019 | 50 | Stomatitis |
116670193 | 11667019 | 51 | Stomatitis |
116670193 | 11667019 | 52 | Neuralgia |
116670193 | 11667019 | 54 | Neuralgia |
116670193 | 11667019 | 55 | Neuralgia |
116670193 | 11667019 | 56 | Dysmenorrhoea |
116670193 | 11667019 | 57 | Prophylaxis |
116670193 | 11667019 | 58 | Vaginal infection |
116670193 | 11667019 | 59 | Lupus nephritis |
116670193 | 11667019 | 60 | Prophylaxis |
116670193 | 11667019 | 61 | Hypocalcaemia |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
116670193 | 11667019 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
116670193 | 11667019 | Angina pectoris | |
116670193 | 11667019 | Bronchitis | |
116670193 | 11667019 | Costochondritis | |
116670193 | 11667019 | Dermatitis atopic | |
116670193 | 11667019 | Dry eye | |
116670193 | 11667019 | Dysmenorrhoea | |
116670193 | 11667019 | Gastric ulcer | |
116670193 | 11667019 | Headache | |
116670193 | 11667019 | Hyperkeratosis | |
116670193 | 11667019 | Hypocalcaemia | |
116670193 | 11667019 | Nasopharyngitis | |
116670193 | 11667019 | Neuralgia | |
116670193 | 11667019 | Periarthritis | |
116670193 | 11667019 | Raynaud's phenomenon | |
116670193 | 11667019 | Seasonal allergy | |
116670193 | 11667019 | Seborrhoeic dermatitis | |
116670193 | 11667019 | Stomatitis | |
116670193 | 11667019 | Upper respiratory tract inflammation | |
116670193 | 11667019 | Urticaria | |
116670193 | 11667019 | Vaginal infection | |
116670193 | 11667019 | Vaginitis bacterial |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|---|
116670193 | 11667019 | 1 | 20070711 | 20160329 | 0 | |
116670193 | 11667019 | 2 | 20071012 | 0 | ||
116670193 | 11667019 | 3 | 20071013 | 20080929 | 0 | |
116670193 | 11667019 | 4 | 20080930 | 20090302 | 0 | |
116670193 | 11667019 | 5 | 20090303 | 20090819 | 0 | |
116670193 | 11667019 | 6 | 20090820 | 20111128 | 0 | |
116670193 | 11667019 | 7 | 20111129 | 20140303 | 0 | |
116670193 | 11667019 | 8 | 20140304 | 20141117 | 0 | |
116670193 | 11667019 | 9 | 20141118 | 20160329 | 0 | |
116670193 | 11667019 | 10 | 20090122 | 20090129 | 0 | |
116670193 | 11667019 | 11 | 20130408 | 20130415 | 0 | |
116670193 | 11667019 | 12 | 20141117 | 0 | ||
116670193 | 11667019 | 13 | 20150608 | 0 | ||
116670193 | 11667019 | 14 | 20150608 | 0 | ||
116670193 | 11667019 | 15 | 20070927 | 20071010 | 0 | |
116670193 | 11667019 | 16 | 20071025 | 20080414 | 0 | |
116670193 | 11667019 | 17 | 20080902 | 20081111 | 0 | |
116670193 | 11667019 | 18 | 20080909 | 20081111 | 0 | |
116670193 | 11667019 | 19 | 20080812 | 20101011 | 0 | |
116670193 | 11667019 | 20 | 20090122 | 20090129 | 0 | |
116670193 | 11667019 | 21 | 20110411 | 20110415 | 0 | |
116670193 | 11667019 | 22 | 20090122 | 20090129 | 0 | |
116670193 | 11667019 | 23 | 20090122 | 20090131 | 0 | |
116670193 | 11667019 | 24 | 20100201 | 20100222 | 0 | |
116670193 | 11667019 | 25 | 20100201 | 20100222 | 0 | |
116670193 | 11667019 | 26 | 20100223 | 20160329 | 0 | |
116670193 | 11667019 | 27 | 20100223 | 20100816 | 0 | |
116670193 | 11667019 | 28 | 20070927 | 20071010 | 0 | |
116670193 | 11667019 | 29 | 20130408 | 20130411 | 0 | |
116670193 | 11667019 | 30 | 20090303 | 20090414 | 0 | |
116670193 | 11667019 | 31 | 20090303 | 20090414 | 0 | |
116670193 | 11667019 | 32 | 20100323 | 20110509 | 0 | |
116670193 | 11667019 | 33 | 20111129 | 20140707 | 0 | |
116670193 | 11667019 | 34 | 20100818 | 20101011 | 0 | |
116670193 | 11667019 | 35 | 20100914 | 20130218 | 0 | |
116670193 | 11667019 | 36 | 20140415 | 20140818 | 0 | |
116670193 | 11667019 | 37 | 20120110 | 20120220 | 0 | |
116670193 | 11667019 | 38 | 20120221 | 20130407 | 0 | |
116670193 | 11667019 | 39 | 20130408 | 20140818 | 0 | |
116670193 | 11667019 | 40 | 20120417 | 20120604 | 0 | |
116670193 | 11667019 | 41 | 20120605 | 20140707 | 0 | |
116670193 | 11667019 | 42 | 20121030 | 20121113 | 0 | |
116670193 | 11667019 | 43 | 20121030 | 20121113 | 0 | |
116670193 | 11667019 | 44 | 20130130 | 20130213 | 0 | |
116670193 | 11667019 | 45 | 20130408 | 20130415 | 0 | |
116670193 | 11667019 | 46 | 20130408 | 20150112 | 0 | |
116670193 | 11667019 | 47 | 20130422 | 20130606 | 0 | |
116670193 | 11667019 | 48 | 20130422 | 20130606 | 0 | |
116670193 | 11667019 | 49 | 20130507 | 20160329 | 0 | |
116670193 | 11667019 | 51 | 20130520 | 20130606 | 0 | |
116670193 | 11667019 | 52 | 20130926 | 20131009 | 0 | |
116670193 | 11667019 | 53 | 20131010 | 20131031 | 0 | |
116670193 | 11667019 | 54 | 20130926 | 20131009 | 0 | |
116670193 | 11667019 | 55 | 20131101 | 20140324 | 0 | |
116670193 | 11667019 | 56 | 20140121 | 20140526 | 0 | |
116670193 | 11667019 | 57 | 20141118 | 20160329 | 0 | |
116670193 | 11667019 | 58 | 20150113 | 20160329 | 0 | |
116670193 | 11667019 | 59 | 20150609 | 20160329 | 0 | |
116670193 | 11667019 | 60 | 20150609 | 20160329 | 0 | |
116670193 | 11667019 | 61 | 20150609 | 20160329 | 0 |