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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117344226 | 11734422 | 6 | F | 20160915 | 20151113 | 20160927 | EXP | PHEH2015US023443 | SANDOZ | 0.00 | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117344226 | 11734422 | 1 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | D | 0 | ||||||||||
| 117344226 | 11734422 | 2 | PS | ONDANSETRON | ONDANSETRON | 1 | Transplacental | MOTHER'S DOSE: 4 MG 1 TO 2 TIMES A DAY | D | 77517 | |||||||||
| 117344226 | 11734422 | 3 | SS | ONDANSETRON | ONDANSETRON | 1 | Transplacental | MOTHER'S DOSE: 4 MG 1 TO 2 TIMES A DAY | D | 0 | |||||||||
| 117344226 | 11734422 | 4 | SS | ONDANSETRON DR REDDY | ONDANSETRON | 1 | Transplacental | MOTHER'S DOSE: 4 MG 1 TO 2 TIMES A DAY | D | 0 | |||||||||
| 117344226 | 11734422 | 5 | SS | ONDANSETRON AUROBINDO | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 4 MG 1 TO 2 TIMES A DAY | D | 0 | |||||||||
| 117344226 | 11734422 | 6 | SS | ONDANSETRONE RANBAXY | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 4 MG 1 TO 2 TIMES A DAY | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117344226 | 11734422 | 1 | Foetal exposure during pregnancy |
| 117344226 | 11734422 | 2 | Foetal exposure during pregnancy |
| 117344226 | 11734422 | 3 | Foetal exposure during pregnancy |
| 117344226 | 11734422 | 4 | Foetal exposure during pregnancy |
| 117344226 | 11734422 | 5 | Foetal exposure during pregnancy |
| 117344226 | 11734422 | 6 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117344226 | 11734422 | OT |
| 117344226 | 11734422 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117344226 | 11734422 | Anhedonia | |
| 117344226 | 11734422 | Anxiety | |
| 117344226 | 11734422 | Atrial septal defect | |
| 117344226 | 11734422 | Cleft palate | |
| 117344226 | 11734422 | Congenital anomaly | |
| 117344226 | 11734422 | Emotional distress | |
| 117344226 | 11734422 | Foetal exposure during pregnancy | |
| 117344226 | 11734422 | Gastrooesophageal reflux disease | |
| 117344226 | 11734422 | Hyperkalaemia | |
| 117344226 | 11734422 | Injury | |
| 117344226 | 11734422 | Laryngomalacia | |
| 117344226 | 11734422 | Micrognathia | |
| 117344226 | 11734422 | Multiple congenital abnormalities | |
| 117344226 | 11734422 | Pain | |
| 117344226 | 11734422 | Pierre Robin syndrome | |
| 117344226 | 11734422 | Renal failure | |
| 117344226 | 11734422 | Renal hypertension |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |