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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127038041 | 12703804 | 1 | I | 201605 | 20160609 | 20160831 | 20160831 | PER | US-MYLANLABS-2016M1024448 | MYLAN | 61.45 | YR | F | Y | 72.56000 | KG | 20160831 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127038041 | 12703804 | 1 | PS | LIDOCAINE PATCH | LIDOCAINE | 1 | Cutaneous | 1 DF, QD 12HR ON 12 HR OFF | 614230 | 202346 | 1 | DF | CUTANEOUS PATCH | QD | |||||
| 127038041 | 12703804 | 2 | SS | LIDOCAINE PATCH | LIDOCAINE | 1 | 202346 | CUTANEOUS PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127038041 | 12703804 | 1 | Back pain |
| 127038041 | 12703804 | 2 | Off label use |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127038041 | 12703804 | Application site pruritus | |
| 127038041 | 12703804 | Application site rash | |
| 127038041 | 12703804 | Product adhesion issue | |
| 127038041 | 12703804 | Product quality 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 |
|---|---|---|---|---|---|---|
| 127038041 | 12703804 | 1 | 201605 | 0 |