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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125593632 | 12559363 | 2 | F | 20160317 | 20160728 | 20160715 | 20160811 | EXP | GB-AUROBINDO-AUR-APL-2016-08718 | AUROBINDO | 65.00 | YR | F | Y | 0.00000 | 20160811 | PH | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125593632 | 12559363 | 1 | PS | Clarithromycin 500mg | CLARITHROMYCIN | 1 | Oral | 500 MG, TWO TIMES A DAY | 7000 | MG | Y | U | 65489 | 500 | MG | BID | |||
| 125593632 | 12559363 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, TWO TIMES A DAY | 42 | MG | Y | U | 0 | 3 | MG | BID | |||
| 125593632 | 12559363 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 1.5 MG, TWO TIMES A DAY, LOWER DOSE | 42 | MG | Y | U | 0 | 1.5 | MG | BID | |||
| 125593632 | 12559363 | 4 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 5 | C | BUMETANIDE. | BUMETANIDE | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 6 | C | BUTRANS | BUPRENORPHINE | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 7 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 8 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 9 | C | EPREX | ERYTHROPOIETIN | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 11 | C | LEVEMIR | INSULIN DETEMIR | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 12 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 13 | C | NOVORAPID | INSULIN ASPART | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 14 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 15 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 16 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 17 | C | DOXYCYCLINE. | DOXYCYCLINE | 1 | Unknown | U | 0 | ||||||||||
| 125593632 | 12559363 | 18 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125593632 | 12559363 | 1 | Lower respiratory tract infection |
| 125593632 | 12559363 | 2 | Prophylaxis against transplant rejection |
| 125593632 | 12559363 | 4 | Product used for unknown indication |
| 125593632 | 12559363 | 5 | Product used for unknown indication |
| 125593632 | 12559363 | 6 | Product used for unknown indication |
| 125593632 | 12559363 | 7 | Product used for unknown indication |
| 125593632 | 12559363 | 8 | Product used for unknown indication |
| 125593632 | 12559363 | 9 | Product used for unknown indication |
| 125593632 | 12559363 | 10 | Product used for unknown indication |
| 125593632 | 12559363 | 11 | Product used for unknown indication |
| 125593632 | 12559363 | 12 | Product used for unknown indication |
| 125593632 | 12559363 | 13 | Product used for unknown indication |
| 125593632 | 12559363 | 14 | Product used for unknown indication |
| 125593632 | 12559363 | 15 | Product used for unknown indication |
| 125593632 | 12559363 | 16 | Product used for unknown indication |
| 125593632 | 12559363 | 17 | Lower respiratory tract infection |
| 125593632 | 12559363 | 18 | Lower respiratory tract infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125593632 | 12559363 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125593632 | 12559363 | Immunosuppressant drug level increased | |
| 125593632 | 12559363 | Labelled drug-drug interaction medication error | |
| 125593632 | 12559363 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 125593632 | 12559363 | 1 | 20160310 | 20160315 | 0 | |
| 125593632 | 12559363 | 2 | 20160310 | 0 | ||
| 125593632 | 12559363 | 3 | 20160322 | 0 |