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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125614111 | 12561411 | 1 | I | 20151206 | 20151207 | 20160715 | 20160715 | PER | US-ENDO PHARMACEUTICALS INC-2015SCPR014538 | PAR | 0.00 | Y | 0.00000 | 20160715 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125614111 | 12561411 | 1 | PS | CORTISPORIN | BACITRACIN ZINCHYDROCORTISONENEOMYCIN SULFATEPOLYMYXIN B SULFATE | 1 | INTRA-AURAL | 3 GTT, OD, ON BOTH EARS | Y | 804340 | 50356 | 3 | GTT | SUSPENSION | |||||
| 125614111 | 12561411 | 2 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 1 DF, SIX TIMES A DAY | U | U | 0 | 1 | DF | ||||||
| 125614111 | 12561411 | 3 | C | DICLOPHEN /00171701/ | 2 | Oral | 1 DF, TID | 0 | 1 | DF | TABLET | TID | |||||||
| 125614111 | 12561411 | 4 | C | FLUPHENAZINE | FLUPHENAZINE | 1 | Oral | 1 DF, SIX TIMES A DAY | 0 | 1 | DF | TABLET | |||||||
| 125614111 | 12561411 | 5 | C | ALTACE | RAMIPRIL | 1 | Oral | UNK, BID | 0 | BID | |||||||||
| 125614111 | 12561411 | 6 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 1 DF, BID | 0 | 1 | DF | TABLET | BID | ||||||
| 125614111 | 12561411 | 7 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 1 DF, BID | 0 | 1 | DF | TABLET | BID | ||||||
| 125614111 | 12561411 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 1 DF, OD | 0 | 1 | DF | TABLET | |||||||
| 125614111 | 12561411 | 9 | C | PREVACID | LANSOPRAZOLE | 1 | Oral | UNK, BID | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125614111 | 12561411 | 1 | Ear infection |
| 125614111 | 12561411 | 2 | Tardive dyskinesia |
| 125614111 | 12561411 | 3 | Tardive dyskinesia |
| 125614111 | 12561411 | 4 | Tardive dyskinesia |
| 125614111 | 12561411 | 5 | Cardiac failure congestive |
| 125614111 | 12561411 | 6 | Cardiac failure congestive |
| 125614111 | 12561411 | 7 | Cardiac failure congestive |
| 125614111 | 12561411 | 8 | Blood cholesterol abnormal |
| 125614111 | 12561411 | 9 | Gastrooesophageal reflux disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125614111 | 12561411 | Ear discomfort | |
| 125614111 | 12561411 | Ear pain | |
| 125614111 | 12561411 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125614111 | 12561411 | 1 | 20151206 | 20151206 | 0 |