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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121694254 | 12169425 | 4 | F | 20160212 | 20160914 | 20160310 | 20160919 | EXP | US-OTSUKA-2016_003965 | OTSUKA | 49.74 | YR | F | Y | 51.88000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121694254 | 12169425 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, QM | Y | ACS0914A | 202971 | 400 | MG | SUSPENSION FOR INJECTION | /month | ||||
| 121694254 | 12169425 | 2 | SS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, QM | Y | 4J90YKAA | 202971 | 400 | MG | SUSPENSION FOR INJECTION | /month | ||||
| 121694254 | 12169425 | 3 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 500 MG, BID | 0 | 500 | MG | TABLET | BID | ||||||
| 121694254 | 12169425 | 4 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 250 MG, BID | 0 | 250 | MG | TABLET | BID | ||||||
| 121694254 | 12169425 | 5 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 500 MG, BID | 0 | 500 | MG | TABLET | BID | ||||||
| 121694254 | 12169425 | 6 | C | HYDROXYZINE PAMOATE. | HYDROXYZINE PAMOATE | 1 | Oral | 100 MG, TID | 0 | 100 | MG | CAPSULE | TID | ||||||
| 121694254 | 12169425 | 7 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 121694254 | 12169425 | 8 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 100 MG, TID | 0 | 100 | MG | TID | |||||||
| 121694254 | 12169425 | 9 | C | MORPHINE | MORPHINE | 1 | Unknown | 30 MG, BID | 0 | 30 | MG | BID | |||||||
| 121694254 | 12169425 | 10 | C | MORPHINE | MORPHINE | 1 | 0 | ||||||||||||
| 121694254 | 12169425 | 11 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 7.5/325 TID PRN | 0 | TID | |||||||||
| 121694254 | 12169425 | 12 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 121694254 | 12169425 | 13 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | TAPERING DOSE | 0 | ||||||||||
| 121694254 | 12169425 | 14 | C | SUMATRIPTAN. | SUMATRIPTAN | 1 | Oral | 4 TABS DAILY PRN | 0 | 25 | MG | TABLET | |||||||
| 121694254 | 12169425 | 15 | C | TAMOXIFEN | TAMOXIFEN | 1 | Unknown | 20 MG, ONE DAILY | 0 | 20 | MG | QD | |||||||
| 121694254 | 12169425 | 16 | C | XARELTO | RIVAROXABAN | 1 | Unknown | 20 MG, AT BEDTIME | 0 | 20 | MG | ||||||||
| 121694254 | 12169425 | 17 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Unknown | 5 MG, AT BEDTIME | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121694254 | 12169425 | 1 | Schizoaffective disorder |
| 121694254 | 12169425 | 3 | Product used for unknown indication |
| 121694254 | 12169425 | 6 | Product used for unknown indication |
| 121694254 | 12169425 | 7 | Prophylaxis |
| 121694254 | 12169425 | 8 | Product used for unknown indication |
| 121694254 | 12169425 | 9 | Back pain |
| 121694254 | 12169425 | 10 | Arthralgia |
| 121694254 | 12169425 | 11 | Back pain |
| 121694254 | 12169425 | 12 | Arthralgia |
| 121694254 | 12169425 | 13 | Product used for unknown indication |
| 121694254 | 12169425 | 14 | Migraine |
| 121694254 | 12169425 | 15 | Breast cancer |
| 121694254 | 12169425 | 16 | Product used for unknown indication |
| 121694254 | 12169425 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121694254 | 12169425 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121694254 | 12169425 | Alopecia | |
| 121694254 | 12169425 | Decreased appetite | |
| 121694254 | 12169425 | Hospitalisation | |
| 121694254 | 12169425 | Injection site pain | |
| 121694254 | 12169425 | Malaise | |
| 121694254 | 12169425 | Off label use | |
| 121694254 | 12169425 | Product label issue | |
| 121694254 | 12169425 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 121694254 | 12169425 | 1 | 20151130 | 0 | ||
| 121694254 | 12169425 | 2 | 20160209 | 20160229 | 0 | |
| 121694254 | 12169425 | 3 | 20151130 | 0 | ||
| 121694254 | 12169425 | 4 | 20151130 | 20160229 | 0 | |
| 121694254 | 12169425 | 6 | 20151130 | 0 |