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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125310621 | 12531062 | 1 | I | 20160623 | 20160706 | 20160706 | EXP | NL-IMPAX LABORATORIES, INC-2016-IPXL-00680 | IMPAX | 63.00 | YR | F | Y | 0.00000 | 20160706 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125310621 | 12531062 | 1 | PS | CLINDAMYCIN HYDROCHLORIDE. | CLINDAMYCIN HYDROCHLORIDE | 1 | Unknown | UNK, TID | N | 65194 | CAPSULE | ||||||||
| 125310621 | 12531062 | 2 | SS | Morphine Sulfate Extended-Release | MORPHINE SULFATE | 1 | Intrathecal | 3.5 MG,PER DAY | N | 0 | 3.5 | MG | QD | ||||||
| 125310621 | 12531062 | 3 | SS | Morphine Sulfate Extended-Release | MORPHINE SULFATE | 1 | 0.5 MG, 1 /DAY | N | 0 | .5 | MG | QD | |||||||
| 125310621 | 12531062 | 4 | SS | CLONIDINE HYDROCHLORIDE. | CLONIDINE HYDROCHLORIDE | 1 | Oral | 0.15 MG, UNK | N | 0 | .15 | MG | TABLET | TID | |||||
| 125310621 | 12531062 | 5 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 20 MG, QID | N | 0 | 20 | MG | QID | ||||||
| 125310621 | 12531062 | 6 | SS | AMOXICILLIN/CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Intravenous (not otherwise specified) | 500/125 MG, 4 /DAY | N | 0 | QID | ||||||||
| 125310621 | 12531062 | 7 | SS | AMOXICILLIN/CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | 1,000/200 MG QID | N | 0 | QID | ||||||||
| 125310621 | 12531062 | 8 | SS | DUROGESIC | FENTANYL | 1 | Unknown | 100 ?G/H, UNK | 0 | ||||||||||
| 125310621 | 12531062 | 9 | SS | SEVOFLURANE. | SEVOFLURANE | 1 | Unknown | 0 | |||||||||||
| 125310621 | 12531062 | 10 | SS | PROPOFOL. | PROPOFOL | 1 | Unknown | 0 | |||||||||||
| 125310621 | 12531062 | 11 | SS | SUFENTANIL | SUFENTANIL | 1 | Unknown | 0 | |||||||||||
| 125310621 | 12531062 | 12 | SS | ROCURONIUM | ROCURONIUM BROMIDE | 1 | Unknown | 0 | |||||||||||
| 125310621 | 12531062 | 13 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 25 MG, 1 /DAY | 0 | 25 | MG | QD | |||||||
| 125310621 | 12531062 | 14 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | 5 MG, TID | 0 | 5 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125310621 | 12531062 | 1 | Product used for unknown indication |
| 125310621 | 12531062 | 2 | Amputation stump pain |
| 125310621 | 12531062 | 4 | Pain |
| 125310621 | 12531062 | 5 | Pain |
| 125310621 | 12531062 | 6 | Pain |
| 125310621 | 12531062 | 8 | Pain |
| 125310621 | 12531062 | 9 | General anaesthesia |
| 125310621 | 12531062 | 10 | General anaesthesia |
| 125310621 | 12531062 | 11 | General anaesthesia |
| 125310621 | 12531062 | 12 | General anaesthesia |
| 125310621 | 12531062 | 13 | Pain |
| 125310621 | 12531062 | 14 | Muscle spasms |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125310621 | 12531062 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125310621 | 12531062 | Endothelial dysfunction | |
| 125310621 | 12531062 | 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 |