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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126903452 | 12690345 | 2 | F | 201410 | 20160830 | 20160826 | 20160907 | EXP | PHHY2016DE114451 | SANDOZ | KRUGER T, JOCKERS-SCHERUBL M, GROHMANN R, RUTHER E, DEGNER D.. DEVELOPMENT OF EPILEPTIC SEIZURES UNDER THERAPY WITH OLANZAPINE AND VENLAFAXINE ER WITH FATAL OUTCOME. PSYCHOPHARMAKOTHERAPIE. 2016;23(3):125-8 | 76.00 | YR | Y | 0.00000 | 20160907 | OT | DK | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126903452 | 12690345 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG, AT NIGHT | 201588 | 5 | MG | ||||||||
| 126903452 | 12690345 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 2.5 MG, UNK | 201588 | 2.5 | MG | ||||||||
| 126903452 | 12690345 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 15 MG, QW | 0 | 15 | MG | /wk | |||||||
| 126903452 | 12690345 | 4 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 30 MG, UNK | 0 | 30 | MG | ||||||||
| 126903452 | 12690345 | 5 | SS | DOXEPIN | DOXEPIN | 1 | Unknown | 25 MG, UNK | 0 | 25 | MG | ||||||||
| 126903452 | 12690345 | 6 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 37.5 MG, UNK | 0 | 37.5 | MG | ||||||||
| 126903452 | 12690345 | 7 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 75 MG, UNK | 0 | 75 | MG | ||||||||
| 126903452 | 12690345 | 8 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 112.5 MG, UNK | 0 | 112.5 | MG | ||||||||
| 126903452 | 12690345 | 9 | SS | DABIGATRAN | DABIGATRAN | 1 | Oral | 2 X 110 MG, QD | 0 | 110 | MG | QD | |||||||
| 126903452 | 12690345 | 10 | SS | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 1 MG, UNK | 0 | 1 | MG | ||||||||
| 126903452 | 12690345 | 11 | SS | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0.75 MG, UNK | 0 | .75 | MG | ||||||||
| 126903452 | 12690345 | 12 | SS | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0.5 MG, UNK | 0 | .5 | MG | ||||||||
| 126903452 | 12690345 | 13 | SS | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0.25 MG, UNK | 0 | .25 | MG | ||||||||
| 126903452 | 12690345 | 14 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 126903452 | 12690345 | 15 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 126903452 | 12690345 | 16 | C | OXYCODONE HCL W/NALOXONE HCL | 2 | Unknown | 2 X 10/5 MG, QD | 0 | QD | ||||||||||
| 126903452 | 12690345 | 17 | C | FESOTERODINE | FESOTERODINE | 1 | Unknown | 8 MG, QD | 0 | 8 | MG | QD | |||||||
| 126903452 | 12690345 | 18 | C | CALCIUM | CALCIUM | 1 | Unknown | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 126903452 | 12690345 | 19 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | 1X/WEEK | 0 | /wk | |||||||||
| 126903452 | 12690345 | 20 | C | PIPERACILLIN/TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126903452 | 12690345 | 1 | Sleep disorder |
| 126903452 | 12690345 | 2 | Anxiety |
| 126903452 | 12690345 | 3 | Rheumatoid arthritis |
| 126903452 | 12690345 | 4 | Sleep disorder |
| 126903452 | 12690345 | 5 | Sleep disorder |
| 126903452 | 12690345 | 6 | Depression |
| 126903452 | 12690345 | 9 | Deep vein thrombosis |
| 126903452 | 12690345 | 10 | Depression |
| 126903452 | 12690345 | 14 | Product used for unknown indication |
| 126903452 | 12690345 | 15 | Product used for unknown indication |
| 126903452 | 12690345 | 16 | Pain |
| 126903452 | 12690345 | 17 | Product used for unknown indication |
| 126903452 | 12690345 | 18 | Product used for unknown indication |
| 126903452 | 12690345 | 19 | Product used for unknown indication |
| 126903452 | 12690345 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126903452 | 12690345 | DE |
| 126903452 | 12690345 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126903452 | 12690345 | Drug ineffective | |
| 126903452 | 12690345 | Drug intolerance | |
| 126903452 | 12690345 | Epilepsy | |
| 126903452 | 12690345 | Fracture | |
| 126903452 | 12690345 | Generalised tonic-clonic seizure | |
| 126903452 | 12690345 | Haematoma | |
| 126903452 | 12690345 | Multiple fractures | |
| 126903452 | 12690345 | Osteoporosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |