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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125344471 | 12534447 | 1 | I | 201511 | 20160603 | 20160706 | 20160706 | EXP | US-MUNDIPHARMA DS AND PHARMACOVIGILANCE-USA-2016-0131395 | PURDUE | 35.58 | YR | F | Y | 0.00000 | 20160706 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125344471 | 12534447 | 1 | PS | BUTRANS | BUPRENORPHINE | 1 | Transdermal | 15 MCG/HR, WEEKLY | 3040385F | 21306 | TRANSDERMAL PATCH | ||||||||
| 125344471 | 12534447 | 2 | SS | BUTRANS | BUPRENORPHINE | 1 | Transdermal | 10 MCG/HR, WEEKLY | 3040445B | 21306 | TRANSDERMAL PATCH | ||||||||
| 125344471 | 12534447 | 3 | SS | BUTRANS | BUPRENORPHINE | 1 | Transdermal | 7.5 MCG/HR, UNK | UNKNOWN | 21306 | TRANSDERMAL PATCH | ||||||||
| 125344471 | 12534447 | 4 | SS | BUTRANS | BUPRENORPHINE | 1 | Transdermal | 5 MCG/HR, WEEKLY | UNKNOWN | 21306 | TRANSDERMAL PATCH | ||||||||
| 125344471 | 12534447 | 5 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | Oral | 4 MG, UNK | U | U | UNKNOWN | 0 | 4 | MG | |||||
| 125344471 | 12534447 | 6 | SS | PERCOCET /00446701/ | ACETAMINOPHENOXYCODONE HYDROCHLORIDEOXYCODONE TEREPHTHALATE | 1 | Oral | U | U | UNKNOWN | 0 | ||||||||
| 125344471 | 12534447 | 7 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | UNK | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125344471 | 12534447 | 1 | Pain |
| 125344471 | 12534447 | 5 | Product used for unknown indication |
| 125344471 | 12534447 | 6 | Product used for unknown indication |
| 125344471 | 12534447 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125344471 | 12534447 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125344471 | 12534447 | Abdominal pain upper | |
| 125344471 | 12534447 | Application site pruritus | |
| 125344471 | 12534447 | Breakthrough pain | |
| 125344471 | 12534447 | Diarrhoea | |
| 125344471 | 12534447 | Dizziness | |
| 125344471 | 12534447 | Drug dependence | |
| 125344471 | 12534447 | Drug effect decreased | |
| 125344471 | 12534447 | Drug ineffective | |
| 125344471 | 12534447 | Drug withdrawal syndrome | |
| 125344471 | 12534447 | Dyspnoea | |
| 125344471 | 12534447 | Loss of consciousness | |
| 125344471 | 12534447 | Product adhesion issue | |
| 125344471 | 12534447 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125344471 | 12534447 | 1 | 20160603 | 0 | ||
| 125344471 | 12534447 | 2 | 201604 | 20160602 | 0 | |
| 125344471 | 12534447 | 3 | 201601 | 201603 | 0 | |
| 125344471 | 12534447 | 4 | 201511 | 201601 | 0 |