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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117130793 | 11713079 | 3 | F | 20160816 | 20151109 | 20160829 | PER | PHEH2015US022888 | NOVARTIS | 0.00 | F | Y | 81.63000 | KG | 20160829 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117130793 | 11713079 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | U | 20007 | ||||||||||
| 117130793 | 11713079 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | U | 20007 | DISPERSIBLE TABLET | |||||||||
| 117130793 | 11713079 | 3 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | U | 20007 | SOLUTION FOR INJECTION | |||||||||
| 117130793 | 11713079 | 4 | SS | ONDANSETRON DR REDDY | ONDANSETRON | 1 | Oral | 8 MG, TID | 0 | 8 | MG | TABLET | TID | ||||||
| 117130793 | 11713079 | 5 | SS | ONDANSETRON AUROBINDO | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 8 MG, Q4H | 0 | 8 | MG | DISPERSIBLE TABLET | Q4H | ||||||
| 117130793 | 11713079 | 6 | SS | ONDANSETRON AUROBINDO | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | 8 MG, TID | 0 | 8 | MG | DISPERSIBLE TABLET | TID | ||||||
| 117130793 | 11713079 | 7 | SS | ONDANSETRON TEVA//ONDANSETRON | ONDANSETRON | 1 | Oral | 8 MG, TID | 0 | 8 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117130793 | 11713079 | 1 | Vomiting in pregnancy |
| 117130793 | 11713079 | 2 | Product used for unknown indication |
| 117130793 | 11713079 | 3 | Product used for unknown indication |
| 117130793 | 11713079 | 4 | Vomiting in pregnancy |
| 117130793 | 11713079 | 5 | Vomiting in pregnancy |
| 117130793 | 11713079 | 7 | Vomiting in pregnancy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117130793 | 11713079 | Anxiety | |
| 117130793 | 11713079 | Emotional distress | |
| 117130793 | 11713079 | Injury | |
| 117130793 | 11713079 | Maternal exposure during pregnancy | |
| 117130793 | 11713079 | Pain | |
| 117130793 | 11713079 | 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 |
|---|---|---|---|---|---|---|
| 117130793 | 11713079 | 4 | 20120605 | 201212 | 0 | |
| 117130793 | 11713079 | 5 | 20120813 | 0 | ||
| 117130793 | 11713079 | 6 | 20121119 | 201212 | 0 | |
| 117130793 | 11713079 | 7 | 20121010 | 201212 | 0 |