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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125275082 | 12527508 | 2 | F | 20160623 | 20160705 | 20160705 | EXP | NL-WATSON-2016-14535 | ACTAVIS | VAN AALST J, TEERNSTRA OP, WEBER WE, RIJKERS K. AN UNUSUAL CASE OF POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME IN A PATIENT BEING WEANED FROM INTRATHECAL MORPHINE. INT MED CASE REP J. 2016;9:117-20. | 63.00 | YR | F | Y | 0.00000 | 20160705 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125275082 | 12527508 | 1 | SS | Amoxicillin-Clavulanic acid (Unknown) | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | 500/125 MG 4 TIMES DAILY | Y | UNCONFIRMED | 0 | UNK | |||||||
| 125275082 | 12527508 | 2 | SS | Amoxicillin-Clavulanic acid (Unknown) | AMOXICILLINCLAVULANIC ACID | 1 | Intravenous (not otherwise specified) | 1000/200 MG 4 TIMES DAILY | Y | UNCONFIRMED | 0 | UNK | |||||||
| 125275082 | 12527508 | 3 | SS | Clindamycin (Unknown) | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Unknown | 300 MG, 4 TIMES DAILY | Y | UNCONFIRMED | 0 | 300 | MG | UNK | |||||
| 125275082 | 12527508 | 4 | PS | Morphine (Unknown) | MORPHINE | 1 | Intrathecal | 3.5 MG, DAILY | Y | UNCONFIRMED | 20616 | 3.5 | MG | UNK | QD | ||||
| 125275082 | 12527508 | 5 | SS | Morphine (Unknown) | MORPHINE | 1 | Intrathecal | 0.5 MG, DAILY | Y | UNCONFIRMED | 20616 | .5 | MG | UNK | QD | ||||
| 125275082 | 12527508 | 6 | SS | CLONIDINE. | CLONIDINE | 1 | Oral | Y | 0 | .15 | MG | UNK | TID | ||||||
| 125275082 | 12527508 | 7 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 20 MG, 4 TIMES DAILY | Y | UNCONFIRMED | 0 | 20 | MG | ||||||
| 125275082 | 12527508 | 8 | SS | DUROGESIC | FENTANYL | 1 | Transdermal | 100 ?G/HR | Y | 0 | 100 | UG | |||||||
| 125275082 | 12527508 | 9 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | Y | UNCONFIRMED | 0 | 5 | MG | EMULSION FOR INJECTION | TID | |||||
| 125275082 | 12527508 | 10 | SS | Amitriptyline | AMITRIPTYLINE | 1 | Unknown | Y | UNCONFIRMED | 0 | 25 | MG | QD | ||||||
| 125275082 | 12527508 | 11 | SS | Amitriptyline | AMITRIPTYLINE | 1 | Unknown | 10 MG, | Y | UNCONFIRMED | 0 | 10 | MG | QD | |||||
| 125275082 | 12527508 | 12 | C | SEVOFLURANE. | SEVOFLURANE | 1 | Unknown | UNK | 0 | ||||||||||
| 125275082 | 12527508 | 13 | C | PROPOFOL. | PROPOFOL | 1 | Unknown | UNK | 0 | ||||||||||
| 125275082 | 12527508 | 14 | C | SUFENTANIL | SUFENTANIL | 1 | Unknown | UNK | 0 | ||||||||||
| 125275082 | 12527508 | 15 | C | ROCURONIUM | ROCURONIUM BROMIDE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125275082 | 12527508 | 4 | Amputation stump pain |
| 125275082 | 12527508 | 6 | Pain |
| 125275082 | 12527508 | 7 | Pain |
| 125275082 | 12527508 | 8 | Pain |
| 125275082 | 12527508 | 9 | Muscle spasms |
| 125275082 | 12527508 | 10 | Amputation stump pain |
| 125275082 | 12527508 | 12 | General anaesthesia |
| 125275082 | 12527508 | 13 | General anaesthesia |
| 125275082 | 12527508 | 14 | General anaesthesia |
| 125275082 | 12527508 | 15 | General anaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125275082 | 12527508 | HO |
| 125275082 | 12527508 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125275082 | 12527508 | Drug withdrawal syndrome | |
| 125275082 | 12527508 | Hemiparesis | |
| 125275082 | 12527508 | Posterior reversible encephalopathy syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |