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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425382 | 12542538 | 2 | F | 20160624 | 20160709 | 20160709 | EXP | DE-CIPLA LTD.-2014DE00069 | CIPLA | MULLER MJ, PREUB C, PAUL T, STREIT F, BRANDHORST G, SEELIGER S. SEROTONERGIC OVERSTIMULATION IN A PRETERM INFANT AFTER SERTRALINE INTAKE VIA BREASTMILK.. BREASTFEED MEDICINE. 2013;8 (3):327 TO 329 | 0.00 | Y | 0.00000 | 20160709 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425382 | 12542538 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNK | 77397 | ||||||||||
| 125425382 | 12542538 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transmammary | UNK | 77397 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125425382 | 12542538 | OT |
| 125425382 | 12542538 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125425382 | 12542538 | Exposure during breast feeding | |
| 125425382 | 12542538 | Foetal exposure during pregnancy | |
| 125425382 | 12542538 | General physical health deterioration | |
| 125425382 | 12542538 | Muscle tone disorder | |
| 125425382 | 12542538 | Neonatal respiratory distress syndrome | |
| 125425382 | 12542538 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |