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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117324815 | 11732481 | 5 | F | 20160914 | 20151113 | 20160921 | PER | PHEH2015US023413 | NOVARTIS | 0.00 | F | Y | 75.74000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117324815 | 11732481 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | U | 20007 | ||||||||||
| 117324815 | 11732481 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, BID | U | 0 | 4 | MG | TABLET | BID | |||||
| 117324815 | 11732481 | 3 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, BID | U | 0 | 4 | MG | TABLET | BID | |||||
| 117324815 | 11732481 | 4 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 1 DF, Q6H | U | 0 | 1 | DF | TABLET | Q6H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117324815 | 11732481 | 1 | Vomiting in pregnancy |
| 117324815 | 11732481 | 2 | Vomiting in pregnancy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117324815 | 11732481 | Abdominal pain upper | |
| 117324815 | 11732481 | Chest pain | |
| 117324815 | 11732481 | Cough | |
| 117324815 | 11732481 | Dyspnoea | |
| 117324815 | 11732481 | Emotional distress | |
| 117324815 | 11732481 | Headache | |
| 117324815 | 11732481 | Injury | |
| 117324815 | 11732481 | Maternal exposure during pregnancy | |
| 117324815 | 11732481 | Oropharyngeal pain | |
| 117324815 | 11732481 | Product use issue | |
| 117324815 | 11732481 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 117324815 | 11732481 | 2 | 20140329 | 0 | ||
| 117324815 | 11732481 | 3 | 20140417 | 0 |