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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116411572 | 11641157 | 2 | F | 20141218 | 20160216 | 20151019 | 20160919 | PER | US-ENDO PHARMACEUTICALS INC.-2015-002551 | ENDO | 64.92 | YR | F | Y | 52.21000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116411572 | 11641157 | 1 | PS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | Oral | Y | 40218 | 25 | MG | TABLETS | QD | ||||||
| 116411572 | 11641157 | 2 | SS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | Oral | Y | 40218 | 25 | MG | TABLETS | BID | ||||||
| 116411572 | 11641157 | 3 | SS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | Oral | Y | 40218 | 25 | MG | TABLETS | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116411572 | 11641157 | 1 | Toothache |
| 116411572 | 11641157 | 2 | Trigeminal neuralgia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116411572 | 11641157 | Condition aggravated | |
| 116411572 | 11641157 | Dry mouth | |
| 116411572 | 11641157 | Dysphonia | |
| 116411572 | 11641157 | Expired product administered | |
| 116411572 | 11641157 | Product quality issue | |
| 116411572 | 11641157 | Product use issue | |
| 116411572 | 11641157 | Trigeminal neuralgia |
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 |
|---|---|---|---|---|---|---|
| 116411572 | 11641157 | 1 | 20141218 | 20150216 | 0 | |
| 116411572 | 11641157 | 2 | 20150217 | 20150403 | 0 | |
| 116411572 | 11641157 | 3 | 2015 | 0 |