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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127853962 | 12785396 | 2 | F | 20160605 | 20160923 | 20160927 | 20160929 | EXP | IT-MINISAL02-375261 | IT-MYLANLABS-2016M1041058 | MYLAN | 0.00 | Y | 0.00000 | 20160929 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127853962 | 12785396 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 DF, TOTAL | D | 75755 | 20 | DF | TABLET | ||||||
| 127853962 | 12785396 | 2 | SS | LORAZEPAM. | LORAZEPAM | 1 | Oral | 50 MG, TOTAL | U | U | 0 | 50 | MG | TABLET | |||||
| 127853962 | 12785396 | 3 | SS | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1 DF, TID | U | U | 0 | 1 | DF | TABLET | TID | ||||
| 127853962 | 12785396 | 4 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 30 DF TOTAL | U | U | 0 | 30 | DF | ||||||
| 127853962 | 12785396 | 5 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | U | 0 | 1 | DF | QD | |||||
| 127853962 | 12785396 | 6 | C | TRITTICO | TRAZODONE HYDROCHLORIDE | 1 | Oral | 40 GTT | D | 0 | 40 | GTT |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127853962 | 12785396 | 1 | Product used for unknown indication |
| 127853962 | 12785396 | 2 | Bipolar disorder |
| 127853962 | 12785396 | 3 | Bulimia nervosa |
| 127853962 | 12785396 | 4 | Product used for unknown indication |
| 127853962 | 12785396 | 6 | Bulimia nervosa |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127853962 | 12785396 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127853962 | 12785396 | Drug abuse | |
| 127853962 | 12785396 | Intentional overdose | |
| 127853962 | 12785396 | Negativism | |
| 127853962 | 12785396 | Sopor | |
| 127853962 | 12785396 | Speech disorder | |
| 127853962 | 12785396 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 127853962 | 12785396 | 1 | 20160605 | 20160605 | 0 | |
| 127853962 | 12785396 | 2 | 20160605 | 20160605 | 0 | |
| 127853962 | 12785396 | 4 | 20160605 | 20160605 | 0 |