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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126197252 | 12619725 | 2 | F | 201512 | 20160810 | 20160803 | 20160818 | EXP | US-INDIVIOR LIMITED-INDV-092615-2016 | INDIVIOR | 57.00 | YR | F | Y | 0.00000 | 20160818 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126197252 | 12619725 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 8 MG, TID | Y | U | UNKNOWN | 22410 | 8 | MG | TID | ||||
| 126197252 | 12619725 | 2 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Sublingual | 8MG, VARIOUS DOSES | Y | U | UNKNOWN | 22410 | |||||||
| 126197252 | 12619725 | 3 | SS | Buprenorphine/Naloxone Generic | BUPRENORPHINENALOXONE | 1 | Sublingual | UNK | UNKNOWN | 0 | |||||||||
| 126197252 | 12619725 | 4 | SS | CRACK COCAINE | COCAINE | 1 | Unknown | UNK | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126197252 | 12619725 | 1 | Drug dependence |
| 126197252 | 12619725 | 2 | Pain |
| 126197252 | 12619725 | 3 | Drug dependence |
| 126197252 | 12619725 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126197252 | 12619725 | HO |
| 126197252 | 12619725 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126197252 | 12619725 | Disturbance in attention | |
| 126197252 | 12619725 | Drug abuse | |
| 126197252 | 12619725 | Drug detoxification | |
| 126197252 | 12619725 | Drug withdrawal syndrome | |
| 126197252 | 12619725 | Dysarthria | |
| 126197252 | 12619725 | Feeling jittery | |
| 126197252 | 12619725 | Hallucination | |
| 126197252 | 12619725 | Hyperhidrosis | |
| 126197252 | 12619725 | Product use issue | |
| 126197252 | 12619725 | Psychomotor hyperactivity | |
| 126197252 | 12619725 | Restlessness | |
| 126197252 | 12619725 | Tremor | |
| 126197252 | 12619725 | Yawning |
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 |
|---|---|---|---|---|---|---|
| 126197252 | 12619725 | 1 | 201512 | 201607 | 0 | |
| 126197252 | 12619725 | 2 | 201607 | 201607 | 0 | |
| 126197252 | 12619725 | 3 | 201607 | 0 | ||
| 126197252 | 12619725 | 4 | 2016 | 2016 | 0 |