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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116854965 | 11685496 | 5 | F | 20160816 | 20151030 | 20160825 | EXP | PHEH2015US021763 | SANDOZ | 0.00 | N | M | Y | 0.00000 | 20160825 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116854965 | 11685496 | 1 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 0 | |||||||||||
| 116854965 | 11685496 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 0 | DISPERSIBLE TABLET | ||||||||||
| 116854965 | 11685496 | 3 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 0 | TABLET | ||||||||||
| 116854965 | 11685496 | 4 | PS | ONDANSETRON. | ONDANSETRON | 1 | Transplacental | MOTHER DOSE: 8 MG Q6H | 78050 | DISPERSIBLE TABLET | |||||||||
| 116854965 | 11685496 | 5 | SS | ONDANSETRON DR REDDY | ONDANSETRON | 1 | Transplacental | MOTHER DOSE: 4 MG Q6H | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116854965 | 11685496 | 1 | Foetal exposure during pregnancy |
| 116854965 | 11685496 | 2 | Foetal exposure during pregnancy |
| 116854965 | 11685496 | 3 | Foetal exposure during pregnancy |
| 116854965 | 11685496 | 4 | Foetal exposure during pregnancy |
| 116854965 | 11685496 | 5 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116854965 | 11685496 | CA |
| 116854965 | 11685496 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116854965 | 11685496 | Anhedonia | |
| 116854965 | 11685496 | Anxiety | |
| 116854965 | 11685496 | Cleft lip and palate | |
| 116854965 | 11685496 | Congenital anomaly | |
| 116854965 | 11685496 | Craniofacial dysostosis | |
| 116854965 | 11685496 | Foetal exposure during pregnancy | |
| 116854965 | 11685496 | Injury | |
| 116854965 | 11685496 | Pain | |
| 116854965 | 11685496 | Skull malformation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |