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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127754351 | 12775435 | 1 | I | 201511 | 20160915 | 20160923 | 20160923 | EXP | US-INDIVIOR LIMITED-INDV-094972-2016 | INDIVIOR | 60.00 | YR | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127754351 | 12775435 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 12 MG, ONE TIME DOSE | UNKNOWN | 22410 | 12 | MG | |||||||
| 127754351 | 12775435 | 2 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 6 MG, TWICE A DAY | UNKNOWN | 22410 | |||||||||
| 127754351 | 12775435 | 3 | SS | FENTANYL /00174602/ | FENTANYL | 1 | Transdermal | UNKNOWN | Y | U | 0 | ||||||||
| 127754351 | 12775435 | 4 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127754351 | 12775435 | 1 | Drug dependence |
| 127754351 | 12775435 | 3 | Pain |
| 127754351 | 12775435 | 4 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127754351 | 12775435 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127754351 | 12775435 | Dyspraxia | |
| 127754351 | 12775435 | Hallucination | |
| 127754351 | 12775435 | Hyperhidrosis | |
| 127754351 | 12775435 | Intentional product misuse | |
| 127754351 | 12775435 | Muscular weakness | |
| 127754351 | 12775435 | Oral administration complication | |
| 127754351 | 12775435 | Oral discomfort | |
| 127754351 | 12775435 | Product preparation error | |
| 127754351 | 12775435 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 127754351 | 12775435 | 1 | 201511 | 201511 | 0 | |
| 127754351 | 12775435 | 2 | 20160909 | 0 | ||
| 127754351 | 12775435 | 3 | 201511 | 0 |