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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125657762 | 12565776 | 2 | F | 20160712 | 20160718 | 20160808 | EXP | US-JNJFOC-20160711824 | JANSSEN | ONOFRIO S, VARTAN CM, NAZARIO M, DISCALA S, CUEVAS-TRISAN R, MELENDEZ-BENABE J. THE USE OF TRANSDERMAL BUPRENORPHINE IN COMPLEX REGIONAL PAIN SYNDROME: A REPORT OF TWO CASES.. J PAIN PALLIAT CARE PHARMACOTHER 2016;30:124-127. | 66.00 | YR | E | M | Y | 0.00000 | 20160808 | PH | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125657762 | 12565776 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Unknown | U | U | UNKNOWN | 20281 | UNSPECIFIED | |||||||
125657762 | 12565776 | 2 | SS | LIDOCAINE. | LIDOCAINE | 1 | Topical | U | 0 | 1 | DF | UNSPECIFIED | |||||||
125657762 | 12565776 | 3 | SS | BUPRENORPHINE. | BUPRENORPHINE | 1 | Transdermal | 0 | 10 | UG | PATCH | ||||||||
125657762 | 12565776 | 4 | SS | BUPRENORPHINE. | BUPRENORPHINE | 1 | Transdermal | 0 | 20 | UG | PATCH | /hr | |||||||
125657762 | 12565776 | 5 | SS | BUPRENORPHINE. | BUPRENORPHINE | 1 | Transdermal | 0 | 15 | UG | PATCH | /hr | |||||||
125657762 | 12565776 | 6 | SS | BUPRENORPHINE. | BUPRENORPHINE | 1 | Transdermal | 0 | 10 | UG | PATCH | ||||||||
125657762 | 12565776 | 7 | SS | BUPRENORPHINE. | BUPRENORPHINE | 1 | Transdermal | 0 | 20 | UG | PATCH | ||||||||
125657762 | 12565776 | 8 | SS | BUPRENORPHINE. | BUPRENORPHINE | 1 | Transdermal | 0 | 20 | UG | PATCH | ||||||||
125657762 | 12565776 | 9 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 0 | INJECTION | ||||||||||
125657762 | 12565776 | 10 | C | FENTANYL. | FENTANYL | 1 | Transdermal | U | 0 | 12 | UG | UNSPECIFIED | /hr | ||||||
125657762 | 12565776 | 11 | C | FENTANYL. | FENTANYL | 1 | Transdermal | U | 0 | 25 | UG | UNSPECIFIED | /hr | ||||||
125657762 | 12565776 | 12 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | AS NEEDED | 0 | GEL | |||||||||
125657762 | 12565776 | 13 | C | TROLAMINE | TROLAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 14 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 15 | C | TIZANIDINE. | TIZANIDINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 16 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 17 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 18 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 19 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 20 | C | DULOXETINE. | DULOXETINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125657762 | 12565776 | 21 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 15 | MG | UNSPECIFIED | TID | |||||||
125657762 | 12565776 | 22 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 15 | MG | UNSPECIFIED | QID | |||||||
125657762 | 12565776 | 23 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 15 | MG | UNSPECIFIED | BID | |||||||
125657762 | 12565776 | 24 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 15 | MG | UNSPECIFIED | QD | |||||||
125657762 | 12565776 | 25 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 7.5 | MG | UNSPECIFIED | BID | |||||||
125657762 | 12565776 | 26 | C | POLYETHYLENE GLYCOL | POLYETHYLENE GLYCOLS | 1 | Oral | 0 | 17 | G | UNSPECIFIED | ||||||||
125657762 | 12565776 | 27 | C | MORPHINE | MORPHINE | 1 | Oral | 0 | 30 | MG | UNSPECIFIED | ||||||||
125657762 | 12565776 | 28 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | REDUCED DOSE | 0 | UNSPECIFIED | |||||||||
125657762 | 12565776 | 29 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 0 | 5 | UG | UNSPECIFIED | Q8H | |||||||
125657762 | 12565776 | 30 | C | HYDROCODONE | HYDROCODONE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125657762 | 12565776 | 1 | Pain management |
125657762 | 12565776 | 2 | Pain management |
125657762 | 12565776 | 3 | Pain management |
125657762 | 12565776 | 4 | Pain management |
125657762 | 12565776 | 5 | Pain management |
125657762 | 12565776 | 6 | Pain management |
125657762 | 12565776 | 7 | Pain management |
125657762 | 12565776 | 8 | Pain management |
125657762 | 12565776 | 9 | Pain management |
125657762 | 12565776 | 10 | Pain management |
125657762 | 12565776 | 11 | Pain management |
125657762 | 12565776 | 12 | Pain management |
125657762 | 12565776 | 13 | Pain management |
125657762 | 12565776 | 14 | Pain management |
125657762 | 12565776 | 15 | Pain management |
125657762 | 12565776 | 16 | Pain management |
125657762 | 12565776 | 17 | Pain management |
125657762 | 12565776 | 18 | Pain management |
125657762 | 12565776 | 19 | Pain management |
125657762 | 12565776 | 20 | Pain management |
125657762 | 12565776 | 21 | Breakthrough pain |
125657762 | 12565776 | 22 | Breakthrough pain |
125657762 | 12565776 | 23 | Breakthrough pain |
125657762 | 12565776 | 24 | Breakthrough pain |
125657762 | 12565776 | 25 | Breakthrough pain |
125657762 | 12565776 | 26 | Constipation prophylaxis |
125657762 | 12565776 | 27 | Breakthrough pain |
125657762 | 12565776 | 28 | Pain management |
125657762 | 12565776 | 29 | Pain management |
125657762 | 12565776 | 30 | Pain management |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125657762 | 12565776 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125657762 | 12565776 | Application site irritation | |
125657762 | 12565776 | Application site pruritus | |
125657762 | 12565776 | Drug ineffective | |
125657762 | 12565776 | Dyspnoea | |
125657762 | 12565776 | Incorrect drug administration duration | |
125657762 | 12565776 | Lethargy | |
125657762 | 12565776 | Mental disorder | |
125657762 | 12565776 | Mental impairment | |
125657762 | 12565776 | Product use issue | |
125657762 | 12565776 | Pruritus generalised | |
125657762 | 12565776 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |