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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125777581 | 12577758 | 1 | I | 20160706 | 20160721 | 20160721 | EXP | US-MACLEODS PHARMACEUTICALS US LTD-MAC2016002915 | MACLEODS | 0.00 | Y | 0.00000 | 20160721 | OT | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125777581 | 12577758 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 125777581 | 12577758 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Y | U | 0 | ||||||||||
| 125777581 | 12577758 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 125777581 | 12577758 | 4 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Y | U | 0 | ||||||||||
| 125777581 | 12577758 | 5 | SS | ZIPRASIDONE. | ZIPRASIDONE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 125777581 | 12577758 | 6 | SS | ZIPRASIDONE. | ZIPRASIDONE | 1 | Y | U | 0 | ||||||||||
| 125777581 | 12577758 | 7 | C | BUPROPION. | BUPROPION | 1 | Unknown | UNK | Y | 0 | |||||||||
| 125777581 | 12577758 | 8 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 125777581 | 12577758 | 9 | C | LITHIUM. | LITHIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 125777581 | 12577758 | 10 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 14 MG, QD | U | 0 | 14 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125777581 | 12577758 | 1 | Major depression |
| 125777581 | 12577758 | 2 | Catatonia |
| 125777581 | 12577758 | 3 | Major depression |
| 125777581 | 12577758 | 4 | Catatonia |
| 125777581 | 12577758 | 5 | Catatonia |
| 125777581 | 12577758 | 6 | Major depression |
| 125777581 | 12577758 | 7 | Sleep disorder |
| 125777581 | 12577758 | 8 | Sleep disorder |
| 125777581 | 12577758 | 9 | Product used for unknown indication |
| 125777581 | 12577758 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125777581 | 12577758 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125777581 | 12577758 | Abnormal behaviour | |
| 125777581 | 12577758 | Activities of daily living impaired | |
| 125777581 | 12577758 | Aphasia | |
| 125777581 | 12577758 | Catatonia | |
| 125777581 | 12577758 | Condition aggravated | |
| 125777581 | 12577758 | Decreased appetite | |
| 125777581 | 12577758 | Depressed mood | |
| 125777581 | 12577758 | Disturbance in attention | |
| 125777581 | 12577758 | Dysgraphia | |
| 125777581 | 12577758 | Feeling guilty | |
| 125777581 | 12577758 | Incoherent | |
| 125777581 | 12577758 | Insomnia | |
| 125777581 | 12577758 | Intrusive thoughts | |
| 125777581 | 12577758 | Movement disorder | |
| 125777581 | 12577758 | Psychotic disorder | |
| 125777581 | 12577758 | Soliloquy | |
| 125777581 | 12577758 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |