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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127606261 | 12760626 | 1 | I | 201510 | 20151019 | 20160919 | 20160919 | PER | US-ENDO PHARMACEUTICALS INC.-2015-003523 | ENDO | 83.46 | YR | M | Y | 89.89000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127606261 | 12760626 | 1 | PS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | Unknown | 40218 | 25 | MG | TABLETS | QD | |||||||
| 127606261 | 12760626 | 2 | SS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | 40218 | ||||||||||||
| 127606261 | 12760626 | 3 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127606261 | 12760626 | 1 | Pain |
| 127606261 | 12760626 | 2 | Sleep disorder |
| 127606261 | 12760626 | 3 | Pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127606261 | 12760626 | Drug ineffective for unapproved indication | |
| 127606261 | 12760626 | Insomnia | |
| 127606261 | 12760626 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 127606261 | 12760626 | 1 | 201510 | 0 |