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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126683652 | 12668365 | 2 | F | 20160725 | 20160816 | 20160819 | 20160824 | EXP | US-FRI-1000086908 | FOREST | 34.48 | YR | M | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126683652 | 12668365 | 1 | PS | SAPHRIS | ASENAPINE MALEATE | 1 | Sublingual | 10 MG TWICE DAILY, ONE 10 MG PRN | Y | 22117 | 10 | MG | TABLET | ||||||
| 126683652 | 12668365 | 2 | SS | ZYPREXA | OLANZAPINE | 1 | 0 | 30 | MG | ||||||||||
| 126683652 | 12668365 | 3 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126683652 | 12668365 | 4 | C | THORAZINE | CHLORPROMAZINE | 1 | 0 | 200 | MG | ||||||||||
| 126683652 | 12668365 | 5 | C | LITHIUM. | LITHIUM | 1 | 0 | 2400 | MG | ||||||||||
| 126683652 | 12668365 | 6 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | 0 | 20 | MG | ||||||||||
| 126683652 | 12668365 | 7 | C | VALIUM | DIAZEPAM | 1 | 5 MG | 0 | 2.5 | MG | BID | ||||||||
| 126683652 | 12668365 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | 0 | ||||||||||||
| 126683652 | 12668365 | 9 | C | GEMFIBROZIL. | GEMFIBROZIL | 1 | 0 | 1200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126683652 | 12668365 | 1 | Schizoaffective disorder |
| 126683652 | 12668365 | 2 | Schizoaffective disorder |
| 126683652 | 12668365 | 3 | Schizoaffective disorder |
| 126683652 | 12668365 | 4 | Schizoaffective disorder |
| 126683652 | 12668365 | 5 | Schizoaffective disorder |
| 126683652 | 12668365 | 6 | Schizoaffective disorder |
| 126683652 | 12668365 | 7 | Schizoaffective disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126683652 | 12668365 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126683652 | 12668365 | Alanine aminotransferase increased | |
| 126683652 | 12668365 | Aspartate aminotransferase increased | |
| 126683652 | 12668365 | Blood creatine phosphokinase increased | |
| 126683652 | 12668365 | Chromaturia | |
| 126683652 | 12668365 | Distractibility | |
| 126683652 | 12668365 | Enuresis | |
| 126683652 | 12668365 | Inappropriate affect | |
| 126683652 | 12668365 | Incoherent | |
| 126683652 | 12668365 | Insomnia | |
| 126683652 | 12668365 | Off label use | |
| 126683652 | 12668365 | Rhabdomyolysis |
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 |
|---|---|---|---|---|---|---|
| 126683652 | 12668365 | 1 | 20160725 | 20160812 | 0 | |
| 126683652 | 12668365 | 2 | 20160730 | 0 |