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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124782809 | 12478280 | 9 | F | 20160226 | 20160916 | 20160617 | 20160921 | EXP | FR-ASTELLAS-2016US022900 | ASTELLAS | 63.23 | YR | M | Y | 64.00000 | KG | 20160921 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124782809 | 12478280 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 4 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 6 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 6.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 1.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 2.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 295 | MG | D | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 124782809 | 12478280 | 10 | SS | PREVISCAN /00789001/ | FLUINDIONE | 1 | Unknown | Y | 0 | 20 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124782809 | 12478280 | 11 | SS | PREVISCAN /00789001/ | FLUINDIONE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | 0 | FORMULATION UNKNOWN | ||||||||
| 124782809 | 12478280 | 12 | C | XANAX | ALPRAZOLAM | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 13 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 14 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 15 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 16 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 17 | C | NORFLOXACIN | NORFLOXACIN | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 18 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 19 | C | DUPHALAC | LACTULOSE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 20 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 21 | C | EUPRESSYL /00631801/ | URAPIDIL | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 22 | C | LASILIX /00032601/ | FUROSEMIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 23 | C | ALDACTONE | SPIRONOLACTONE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 24 | C | ROVALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 25 | C | RISPERDAL | RISPERIDONE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 26 | C | CORTANCYL | PREDNISONE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 27 | C | INSULIN | INSULIN NOS | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 28 | C | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 29 | C | MORPHINE | MORPHINE | 1 | Unknown | UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 30 | C | TAZOCILLINE | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 31 | C | CIFLOX /00697201/ | CIPROFLOXACIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 32 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 124782809 | 12478280 | 33 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124782809 | 12478280 | 1 | Liver transplant |
| 124782809 | 12478280 | 10 | Product used for unknown indication |
| 124782809 | 12478280 | 12 | Product used for unknown indication |
| 124782809 | 12478280 | 13 | Product used for unknown indication |
| 124782809 | 12478280 | 14 | Product used for unknown indication |
| 124782809 | 12478280 | 15 | Product used for unknown indication |
| 124782809 | 12478280 | 16 | Product used for unknown indication |
| 124782809 | 12478280 | 17 | Product used for unknown indication |
| 124782809 | 12478280 | 18 | Product used for unknown indication |
| 124782809 | 12478280 | 19 | Product used for unknown indication |
| 124782809 | 12478280 | 20 | Product used for unknown indication |
| 124782809 | 12478280 | 21 | Product used for unknown indication |
| 124782809 | 12478280 | 22 | Product used for unknown indication |
| 124782809 | 12478280 | 23 | Product used for unknown indication |
| 124782809 | 12478280 | 24 | Product used for unknown indication |
| 124782809 | 12478280 | 25 | Product used for unknown indication |
| 124782809 | 12478280 | 26 | Product used for unknown indication |
| 124782809 | 12478280 | 27 | Product used for unknown indication |
| 124782809 | 12478280 | 28 | Product used for unknown indication |
| 124782809 | 12478280 | 29 | Product used for unknown indication |
| 124782809 | 12478280 | 30 | Product used for unknown indication |
| 124782809 | 12478280 | 31 | Product used for unknown indication |
| 124782809 | 12478280 | 32 | Product used for unknown indication |
| 124782809 | 12478280 | 33 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124782809 | 12478280 | DE |
| 124782809 | 12478280 | LT |
| 124782809 | 12478280 | HO |
| 124782809 | 12478280 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124782809 | 12478280 | Acute kidney injury | |
| 124782809 | 12478280 | Multiple organ dysfunction syndrome | |
| 124782809 | 12478280 | Overdose | |
| 124782809 | 12478280 | Pneumocystis jirovecii pneumonia | |
| 124782809 | 12478280 | Pneumonia | |
| 124782809 | 12478280 | Respiratory distress | |
| 124782809 | 12478280 | Septic shock | |
| 124782809 | 12478280 | Shock haemorrhagic | |
| 124782809 | 12478280 | Soft tissue necrosis |
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 |
|---|---|---|---|---|---|---|
| 124782809 | 12478280 | 1 | 20151027 | 20151029 | 0 | |
| 124782809 | 12478280 | 2 | 20151030 | 20151102 | 0 | |
| 124782809 | 12478280 | 3 | 20151103 | 20151104 | 0 | |
| 124782809 | 12478280 | 4 | 20151105 | 20151109 | 0 | |
| 124782809 | 12478280 | 5 | 20151110 | 20151203 | 0 | |
| 124782809 | 12478280 | 6 | 20151204 | 20151217 | 0 | |
| 124782809 | 12478280 | 7 | 20151218 | 20151227 | 0 | |
| 124782809 | 12478280 | 8 | 20151228 | 20151229 | 0 | |
| 124782809 | 12478280 | 9 | 20151230 | 20160403 | 0 |