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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117178168 | 11717816 | 8 | F | 20160922 | 20151110 | 20160930 | EXP | PHEH2015US022849 | SANDOZ | 0.00 | F | Y | 45.35000 | KG | 20160930 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117178168 | 11717816 | 1 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | UNK | 0 | ||||||||||
| 117178168 | 11717816 | 2 | PS | ONDANSETRON. | ONDANSETRON | 1 | Unknown | 8 MG, QID | 77517 | 8 | MG | TABLET | QID | ||||||
| 117178168 | 11717816 | 3 | SS | ONDANSETRON. | ONDANSETRON | 1 | Oral | 4 MG | 0 | 4 | MG | DISPERSIBLE TABLET | |||||||
| 117178168 | 11717816 | 4 | SS | ONDANSETRON | ONDANSETRON | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 117178168 | 11717816 | 5 | SS | ONDANSETRON | ONDANSETRON | 1 | Oral | UNK | U | 0 | DISPERSIBLE TABLET | ||||||||
| 117178168 | 11717816 | 6 | SS | ONDANSETRON DR REDDY | ONDANSETRON | 1 | Unknown | 4 MG, THREE TO FOUR TIME DAILY | 0 | 4 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117178168 | 11717816 | 1 | Vomiting in pregnancy |
| 117178168 | 11717816 | 2 | Vomiting in pregnancy |
| 117178168 | 11717816 | 3 | Vomiting in pregnancy |
| 117178168 | 11717816 | 4 | Product used for unknown indication |
| 117178168 | 11717816 | 5 | Product used for unknown indication |
| 117178168 | 11717816 | 6 | Vomiting in pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117178168 | 11717816 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117178168 | 11717816 | Anxiety | |
| 117178168 | 11717816 | Emotional distress | |
| 117178168 | 11717816 | Injury | |
| 117178168 | 11717816 | Maternal exposure during pregnancy | |
| 117178168 | 11717816 | Pain | |
| 117178168 | 11717816 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 117178168 | 11717816 | 1 | 201112 | 201204 | 0 | |
| 117178168 | 11717816 | 2 | 20110902 | 20110906 | 0 | |
| 117178168 | 11717816 | 3 | 20120205 | 20120410 | 0 | |
| 117178168 | 11717816 | 6 | 20111026 | 20120127 | 0 |