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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125623072 | 12562307 | 2 | F | 20160804 | 20160715 | 20160815 | EXP | US-MUNDIPHARMA DS AND PHARMACOVIGILANCE-GBR-2016-0039149 | PURDUE | ONOFRIO S, VARTAN CM, NAZARIO M, DISCALA S, CUEVAS-TRISAN R, ET AL. THE USE OF TRANSDERMAL BUPRENORPHINE IN COMPLEX REGIONAL PAIN SYNDROME. A REPORT OF TWO CASES. J PAIN PALLIATIVE CARE PHARMACOTHERAPY. 2016;30:124-127 | 66.00 | YR | M | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125623072 | 12562307 | 1 | SS | LIDOCAINE. | LIDOCAINE | 1 | Topical | 1 DF, UNK | U | 0 | 1 | DF | MEDICATED PLASTER | ||||||
| 125623072 | 12562307 | 2 | PS | Buprenorphine (similar to NDA 21-306) | BUPRENORPHINE | 1 | Transdermal | 20 MCG, UNK | U | 21306 | 20 | UG | |||||||
| 125623072 | 12562307 | 3 | SS | Non-PMN Tramadol | TRAMADOL | 1 | Unknown | U | U | 0 | OTHER | ||||||||
| 125623072 | 12562307 | 4 | C | Morphine Sulfate (similar to NDA 19-516) | MORPHINE SULFATE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 5 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 6 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 7 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 8 | C | MACROGOL | POLYETHYLENE GLYCOLS | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 9 | C | FENTANYL. | FENTANYL | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 10 | C | HYDROCODONE | HYDROCODONE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 11 | C | DULOXETINE. | DULOXETINE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 12 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 13 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 14 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 15 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 16 | C | TIZANIDINE. | TIZANIDINE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 17 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 18 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | U | 0 | |||||||||||
| 125623072 | 12562307 | 19 | C | TROLAMINE | TROLAMINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125623072 | 12562307 | 1 | Pain management |
| 125623072 | 12562307 | 2 | Pain management |
| 125623072 | 12562307 | 3 | Pain management |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125623072 | 12562307 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125623072 | 12562307 | Application site irritation | |
| 125623072 | 12562307 | Application site pruritus | |
| 125623072 | 12562307 | Drug ineffective | |
| 125623072 | 12562307 | Dyspnoea | |
| 125623072 | 12562307 | Incorrect drug administration duration | |
| 125623072 | 12562307 | Lethargy | |
| 125623072 | 12562307 | Mental disorder | |
| 125623072 | 12562307 | Mental impairment | |
| 125623072 | 12562307 | Product use issue | |
| 125623072 | 12562307 | Pruritus generalised | |
| 125623072 | 12562307 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |