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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116411552 | 11641155 | 2 | F | 20150918 | 20151019 | 20160919 | PER | US-ENDO PHARMACEUTICALS INC.-2015-002316 | ENDO | 0.00 | M | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116411552 | 11641155 | 1 | PS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | Oral | 12 OF THE 25 MG TABLETS DAILY (TOTAL DAILY DOSE OF 300 MG) | C1090215A | 40218 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116411552 | 11641155 | 1 | Depression |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116411552 | 11641155 | Anxiety | |
| 116411552 | 11641155 | Drug ineffective | |
| 116411552 | 11641155 | Feeling abnormal | |
| 116411552 | 11641155 | Overdose | |
| 116411552 | 11641155 | Product quality issue | |
| 116411552 | 11641155 | Unevaluable event |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |