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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117054073 | 11705407 | 3 | F | 20160701 | 20151106 | 20160712 | EXP | PHHY2015GB140223 | SANDOZ | 4.00 | MON | F | Y | 2.68000 | KG | 20160713 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117054073 | 11705407 | 1 | PS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Transplacental | U | 75757 | ||||||||||
| 117054073 | 11705407 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Transplacental | U | 75757 | ||||||||||
| 117054073 | 11705407 | 3 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Transplacental | U | 75757 | ||||||||||
| 117054073 | 11705407 | 4 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Transplacental | 0 | |||||||||||
| 117054073 | 11705407 | 5 | SS | CO-DYDRAMOL | ACETAMINOPHENDIHYDROCODEINE | 1 | Transplacental | STRENGTH: 10/500 | 0 | ||||||||||
| 117054073 | 11705407 | 6 | SS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Transplacental | 0 | |||||||||||
| 117054073 | 11705407 | 7 | SS | ORAMORPH | MORPHINE SULFATE | 1 | Transplacental | 15 MG, UNK | 0 | 15 | MG | ||||||||
| 117054073 | 11705407 | 8 | SS | ORAMORPH | MORPHINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 117054073 | 11705407 | 9 | SS | TAPENTADOL | TAPENTADOL | 1 | Transplacental | 100 MG | 0 | 100 | MG | QD | |||||||
| 117054073 | 11705407 | 10 | C | DAKTARIN//MICONAZOLE NITRATE | 2 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117054073 | 11705407 | 1 | Exposure during pregnancy |
| 117054073 | 11705407 | 4 | Exposure during pregnancy |
| 117054073 | 11705407 | 5 | Exposure during pregnancy |
| 117054073 | 11705407 | 6 | Exposure during pregnancy |
| 117054073 | 11705407 | 7 | Exposure during pregnancy |
| 117054073 | 11705407 | 9 | Exposure during pregnancy |
| 117054073 | 11705407 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117054073 | 11705407 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117054073 | 11705407 | Drug withdrawal syndrome neonatal | |
| 117054073 | 11705407 | Foetal exposure during pregnancy | |
| 117054073 | 11705407 | Sepsis neonatal |
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 |
|---|---|---|---|---|---|---|
| 117054073 | 11705407 | 7 | 20150523 | 20150601 | 0 | |
| 117054073 | 11705407 | 8 | 20150523 | 20150601 | 0 |