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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125424682 | 12542468 | 2 | F | 20160624 | 20160708 | 20160709 | EXP | IT-CIPLA LTD.-2013IT00701 | CIPLA | ELEFTHERIOU G, BUTERA R, COTTI COTTINI F, BONATI M, FARINA M.. NEONATAL TOXICITY FOLLOWING MATERNAL CITALOPRAM TREATMENT.. FETAL AND PEDIATRIC PATHOLOGY. 2013;32:362 TO 366 | 0.00 | Y | 0.00000 | 20160709 | OT | IT | IT |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125424682 | 12542468 | 1 | PS | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Transplacental | UNK | 77044 |
Indications of drugs used
no results found |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125424682 | 12542468 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125424682 | 12542468 | Agitation neonatal | |
125424682 | 12542468 | Foetal exposure during pregnancy | |
125424682 | 12542468 | Hypertonia | |
125424682 | 12542468 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |