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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125821361 | 12582136 | 1 | I | 20160629 | 20160708 | 20160722 | 20160722 | EXP | GB-AUROBINDO-AUR-APL-2016-09029 | AUROBINDO | 65.00 | YR | M | Y | 117.00000 | KG | 20160722 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125821361 | 12582136 | 1 | PS | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | Unknown | U | U | 65489 | |||||||||
| 125821361 | 12582136 | 2 | C | ADALAT | NIFEDIPINE | 1 | Unknown | 1 DF, ONCE A DAY | 420 | DF | U | 0 | 1 | DF | QD | ||||
| 125821361 | 12582136 | 3 | C | ALPHOSYL /01514901/ | 2 | Unknown | 1 DF, ONCE A DAY | 420 | DF | U | 0 | 1 | DF | QD | |||||
| 125821361 | 12582136 | 4 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | INTRA-AURAL | 1 GTT, 3 TIMES A DAY FOR 2 WEEKS | 165 | Gtt | U | 0 | 1 | GTT | EAR DROPS | TID | |||
| 125821361 | 12582136 | 5 | C | FYBOGEL | PLANTAGO OVATA SEED | 1 | Unknown | USE AS DIRECTED. | U | 0 | |||||||||
| 125821361 | 12582136 | 6 | C | GENTAMICIN. | GENTAMICIN | 1 | Unknown | 2 GTT, FOUR TIMES/DAY APPLY DROPS BILATERAL. | 496 | Gtt | U | 0 | 2 | GTT | QID | ||||
| 125821361 | 12582136 | 7 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Topical | 1 DF, TWO TIMES A DAY (APPLY THINLY TO THE AFFECTED AREA(S).) | 124 | DF | U | 0 | 1 | DF | BID | ||||
| 125821361 | 12582136 | 8 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 1 DF, ONCE A DAY | 420 | DF | U | 0 | 1 | DF | QD | ||||
| 125821361 | 12582136 | 9 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 1 DF, ONCE A DAY HAVE ROUTINE BLOOD TESTS | 420 | DF | U | 0 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125821361 | 12582136 | 1 | Product used for unknown indication |
| 125821361 | 12582136 | 2 | Product used for unknown indication |
| 125821361 | 12582136 | 3 | Product used for unknown indication |
| 125821361 | 12582136 | 4 | Product used for unknown indication |
| 125821361 | 12582136 | 5 | Product used for unknown indication |
| 125821361 | 12582136 | 6 | Product used for unknown indication |
| 125821361 | 12582136 | 7 | Product used for unknown indication |
| 125821361 | 12582136 | 8 | Product used for unknown indication |
| 125821361 | 12582136 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125821361 | 12582136 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125821361 | 12582136 | Lethargy | |
| 125821361 | 12582136 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125821361 | 12582136 | 1 | 20160317 | 0 | ||
| 125821361 | 12582136 | 2 | 20150506 | 0 | ||
| 125821361 | 12582136 | 3 | 20150506 | 0 | ||
| 125821361 | 12582136 | 4 | 20160505 | 20160519 | 0 | |
| 125821361 | 12582136 | 5 | 20150907 | 0 | ||
| 125821361 | 12582136 | 6 | 20160428 | 20160505 | 0 | |
| 125821361 | 12582136 | 7 | 20160428 | 20160526 | 0 | |
| 125821361 | 12582136 | 8 | 20150506 | 0 | ||
| 125821361 | 12582136 | 9 | 20150506 | 0 |