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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125246421 | 12524642 | 1 | I | 20160131 | 20160623 | 20160704 | 20160704 | EXP | DE-BFARM-16211664 | DE-WATSON-2016-13977 | WATSON | 0.00 | DY | F | Y | 3.25000 | KG | 20160704 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125246421 | 12524642 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | 20 MG, DAILY; IN WEEK 25 REDUCTION TO 20 MG/D | U | UNCONFIRMED | 77034 | 20 | MG | UNK | QD | ||||
| 125246421 | 12524642 | 2 | SS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | 40 MG, DAILY; 0 -24 GW | U | UNCONFIRMED | 77034 | 40 | MG | UNK | QD | ||||
| 125246421 | 12524642 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Transplacental | 0.5 MG, UNK | U | 0 | .5 | MG | |||||||
| 125246421 | 12524642 | 4 | C | ELONTRIL | BUPROPION HYDROCHLORIDE | 1 | Transplacental | UNK; EXPOSED IN 1ST TRIMESTER | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125246421 | 12524642 | 1 | Attention deficit/hyperactivity disorder |
| 125246421 | 12524642 | 3 | Attention deficit/hyperactivity disorder |
| 125246421 | 12524642 | 4 | Attention deficit/hyperactivity disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125246421 | 12524642 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125246421 | 12524642 | Caput succedaneum | |
| 125246421 | 12524642 | Foetal exposure during pregnancy | |
| 125246421 | 12524642 | Hypotonia neonatal | |
| 125246421 | 12524642 | Respiratory disorder neonatal |
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 |
|---|---|---|---|---|---|---|
| 125246421 | 12524642 | 1 | 20160131 | 0 | ||
| 125246421 | 12524642 | 2 | 20150508 | 0 | ||
| 125246421 | 12524642 | 3 | 20150508 | 20160131 | 0 |