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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126872071 | 12687207 | 1 | I | 20160811 | 20160826 | 20160826 | EXP | CH-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-122615 | RANBAXY | WINTERFELD U, MERLOB P, BAUD D, ROUSSON V, PANCHAUD A, ROTHUIZEN LE, ET AL. PREGNANCY OUTCOME FOLLOWING MATERNAL EXPOSURE TO PREGABALIN MAY CALL FOR CONCERN. NEUROLOGY. 2016;86 (24):2251-2257 | 0.00 | N | Y | 0.00000 | 20160826 | OT | CH | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126872071 | 12687207 | 1 | PS | PREGABALIN. | PREGABALIN | 1 | Transplacental | U | U | 0 | |||||||||
| 126872071 | 12687207 | 2 | SS | ASPIRIN. | ASPIRIN | 1 | Transplacental | UNTIL 36 GESTATION WEEKS | U | U | 0 | ||||||||
| 126872071 | 12687207 | 3 | SS | ENOXAPARIN SODIUM. | ENOXAPARIN SODIUM | 1 | Transplacental | UNTIL 38 GESTATION WEEKS | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126872071 | 12687207 | 1 | Product used for unknown indication |
| 126872071 | 12687207 | 2 | Product used for unknown indication |
| 126872071 | 12687207 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126872071 | 12687207 | OT |
| 126872071 | 12687207 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126872071 | 12687207 | Foetal exposure during pregnancy | |
| 126872071 | 12687207 | Foetal growth restriction | |
| 126872071 | 12687207 | Hepatocellular injury | |
| 126872071 | 12687207 | Hypotonia | |
| 126872071 | 12687207 | Metabolic acidosis | |
| 126872071 | 12687207 | Renal failure | |
| 126872071 | 12687207 | Respiratory distress | |
| 126872071 | 12687207 | Shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |