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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118563892 | 11856389 | 2 | F | 20160829 | 20151221 | 20160912 | EXP | JP-ASTELLAS-2015JP025136 | ASTELLAS | 45.00 | YR | F | Y | 0.00000 | 20160912 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118563892 | 11856389 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | Y | N | 50708 | 12 | MG | CAPSULE | QD | |||||
| 118563892 | 11856389 | 2 | I | TACROLIMUS. | TACROLIMUS | 1 | Oral | N | 50708 | 8 | MG | CAPSULE | QD | ||||||
| 118563892 | 11856389 | 3 | I | TACROLIMUS. | TACROLIMUS | 1 | N | 50708 | CAPSULE | ||||||||||
| 118563892 | 11856389 | 4 | I | FLORID /00310801/ | MICONAZOLE | 1 | Oral | Y | 0 | 300 | MG | GEL | QD | ||||||
| 118563892 | 11856389 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 8 | C | ALFACALCIDOL | ALFACALCIDOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 9 | C | MENATETRENONE | MENATETRENONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 10 | C | RABEPRAZOLE SODIUM. | RABEPRAZOLE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 11 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 12 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 13 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 14 | C | CLOTIAZEPAM | CLOTIAZEPAM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 15 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 16 | C | ROSUVASTATIN CALCIUM. | ROSUVASTATIN CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 17 | C | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 118563892 | 11856389 | 18 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118563892 | 11856389 | 1 | Dermatomyositis |
| 118563892 | 11856389 | 2 | Interstitial lung disease |
| 118563892 | 11856389 | 3 | Immunosuppressant drug therapy |
| 118563892 | 11856389 | 4 | Oral candidiasis |
| 118563892 | 11856389 | 5 | Immunosuppressant drug therapy |
| 118563892 | 11856389 | 6 | Product used for unknown indication |
| 118563892 | 11856389 | 7 | Product used for unknown indication |
| 118563892 | 11856389 | 8 | Product used for unknown indication |
| 118563892 | 11856389 | 9 | Product used for unknown indication |
| 118563892 | 11856389 | 10 | Product used for unknown indication |
| 118563892 | 11856389 | 11 | Product used for unknown indication |
| 118563892 | 11856389 | 12 | Product used for unknown indication |
| 118563892 | 11856389 | 13 | Product used for unknown indication |
| 118563892 | 11856389 | 14 | Product used for unknown indication |
| 118563892 | 11856389 | 15 | Product used for unknown indication |
| 118563892 | 11856389 | 16 | Product used for unknown indication |
| 118563892 | 11856389 | 17 | Product used for unknown indication |
| 118563892 | 11856389 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118563892 | 11856389 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118563892 | 11856389 | Drug interaction | |
| 118563892 | 11856389 | Headache | |
| 118563892 | 11856389 | Hypertension | |
| 118563892 | 11856389 | Oral candidiasis | |
| 118563892 | 11856389 | Platelet count decreased | |
| 118563892 | 11856389 | Renal disorder | |
| 118563892 | 11856389 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 118563892 | 11856389 | 1 | 20151219 | 0 | ||
| 118563892 | 11856389 | 2 | 20151224 | 0 | ||
| 118563892 | 11856389 | 4 | 20151214 | 20151219 | 0 |