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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117344114 | 11734411 | 4 | F | 20160914 | 20151113 | 20160926 | EXP | PHEH2015US023414 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117344114 | 11734411 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | D | 20007 | ||||||||||
| 117344114 | 11734411 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 04 MG, TWICE DAILY (BID) AND 01 TABLET (DF), Q6H | D | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117344114 | 11734411 | 1 | Foetal exposure during pregnancy |
| 117344114 | 11734411 | 2 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117344114 | 11734411 | CA |
| 117344114 | 11734411 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117344114 | 11734411 | Abdominal pain | |
| 117344114 | 11734411 | Adenoiditis | |
| 117344114 | 11734411 | Anhedonia | |
| 117344114 | 11734411 | Anxiety | |
| 117344114 | 11734411 | Cleft palate | |
| 117344114 | 11734411 | Congenital anomaly | |
| 117344114 | 11734411 | Deafness | |
| 117344114 | 11734411 | Deformity | |
| 117344114 | 11734411 | Dermatitis | |
| 117344114 | 11734411 | Dermatitis contact | |
| 117344114 | 11734411 | Developmental delay | |
| 117344114 | 11734411 | Ear infection | |
| 117344114 | 11734411 | Emotional distress | |
| 117344114 | 11734411 | Feeding disorder | |
| 117344114 | 11734411 | Foetal exposure during pregnancy | |
| 117344114 | 11734411 | Gastrointestinal inflammation | |
| 117344114 | 11734411 | Gastrooesophageal reflux disease | |
| 117344114 | 11734411 | Influenza | |
| 117344114 | 11734411 | Injury | |
| 117344114 | 11734411 | Lactose intolerance | |
| 117344114 | 11734411 | Otitis media chronic | |
| 117344114 | 11734411 | Pain | |
| 117344114 | 11734411 | Patent ductus arteriosus | |
| 117344114 | 11734411 | Pharyngitis | |
| 117344114 | 11734411 | Poor weight gain neonatal | |
| 117344114 | 11734411 | Post procedural complication | |
| 117344114 | 11734411 | Pyrexia | |
| 117344114 | 11734411 | Respiratory disorder | |
| 117344114 | 11734411 | Speech disorder | |
| 117344114 | 11734411 | Tonsillitis | |
| 117344114 | 11734411 | Upper respiratory tract infection | |
| 117344114 | 11734411 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |