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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113338912 | 11333891 | 2 | F | 2013 | 20160216 | 20150803 | 20160808 | PER | US-IMPAX LABORATORIES, INC-IMP_08238_2014 | IMPAX | 56.46 | YR | F | Y | 63.00000 | KG | 20160808 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113338912 | 11333891 | 1 | PS | OXYMORPHONE HYDROCHLORIDE ER | OXYMORPHONE HYDROCHLORIDE | 1 | Oral | 40 MG, Q8HRS | Y | Y | 79087 | 40 | MG | PROLONGED-RELEASE TABLET | Q8H | ||||
| 113338912 | 11333891 | 2 | SS | OXYMORPHONE HYDROCHLORIDE ER | OXYMORPHONE HYDROCHLORIDE | 1 | Oral | 15 MG, 2 /DAY | Y | Y | 79087 | 15 | MG | PROLONGED-RELEASE TABLET | BID | ||||
| 113338912 | 11333891 | 3 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | Oral | 4 MG, BID | 0 | 4 | MG | BID | |||||||
| 113338912 | 11333891 | 4 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 113338912 | 11333891 | 5 | SS | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 10-325 | 0 | ||||||||||
| 113338912 | 11333891 | 6 | C | MAXALT | RIZATRIPTAN BENZOATE | 1 | Oral | 10 MG, PRN | 0 | 10 | MG | ||||||||
| 113338912 | 11333891 | 7 | C | OXYCODONE | OXYCODONE | 1 | Unknown | 15 MG, UNK | 0 | 15 | MG | ||||||||
| 113338912 | 11333891 | 8 | C | TIZANIDINE. | TIZANIDINE | 1 | Unknown | 4 MG, UNK | 0 | 4 | MG | ||||||||
| 113338912 | 11333891 | 9 | C | TIZANIDINE. | TIZANIDINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113338912 | 11333891 | 1 | Spinal pain |
| 113338912 | 11333891 | 3 | Muscle spasms |
| 113338912 | 11333891 | 4 | Back pain |
| 113338912 | 11333891 | 5 | Breakthrough pain |
| 113338912 | 11333891 | 6 | Migraine |
| 113338912 | 11333891 | 7 | Breakthrough pain |
| 113338912 | 11333891 | 8 | Back pain |
| 113338912 | 11333891 | 9 | Muscle spasms |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113338912 | 11333891 | Confusional state | |
| 113338912 | 11333891 | Disturbance in attention | |
| 113338912 | 11333891 | Feeling abnormal | |
| 113338912 | 11333891 | Mental impairment | |
| 113338912 | 11333891 | Migraine | |
| 113338912 | 11333891 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 113338912 | 11333891 | 1 | 20130814 | 0 | ||
| 113338912 | 11333891 | 2 | 20160129 | 20160213 | 0 | |
| 113338912 | 11333891 | 3 | 201103 | 0 | ||
| 113338912 | 11333891 | 5 | 201105 | 0 | ||
| 113338912 | 11333891 | 6 | 201402 | 0 |