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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111727672 | 11172767 | 2 | F | 201403 | 20160916 | 20150608 | 20160922 | EXP | US-RB PHARMACEUTICALS LIMITED-RB-079874-2015 | INDIVIOR | 0.01 | YR | M | Y | 4.31000 | KG | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111727672 | 11172767 | 1 | PS | SUBUTEX | BUPRENORPHINE HYDROCHLORIDE | 1 | Transplacental | 4 MG, DAILY THORUGH OUT PREGNANCY | Y | UNKNOWN | 20732 | SUBLINGUAL TABLET | |||||||
| 111727672 | 11172767 | 2 | SS | SUBUTEX | BUPRENORPHINE HYDROCHLORIDE | 1 | Transplacental | 6 MG, DAILY AT DELIVERY | Y | UNKNOWN | 20732 | SUBLINGUAL TABLET | |||||||
| 111727672 | 11172767 | 3 | SS | PRENATAL VITAMINS /02014401/ | VITAMINS | 1 | Transplacental | UNK, DAILY | Y | UNKNOWN | 0 | ||||||||
| 111727672 | 11172767 | 4 | SS | NICOTINE. | NICOTINE | 1 | Transplacental | 10 MG/CATRIDGE, 4 MG DELIVERED AS 4-12 CARTRIDGES, DAILY | Y | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111727672 | 11172767 | 1 | Drug abuse |
| 111727672 | 11172767 | 3 | Pregnancy |
| 111727672 | 11172767 | 4 | Smoking cessation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111727672 | 11172767 | HO |
| 111727672 | 11172767 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111727672 | 11172767 | Agitation neonatal | |
| 111727672 | 11172767 | Drug withdrawal syndrome neonatal | |
| 111727672 | 11172767 | Foetal exposure during pregnancy | |
| 111727672 | 11172767 | Hypotonia neonatal | |
| 111727672 | 11172767 | Macrosomia |
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 |
|---|---|---|---|---|---|---|
| 111727672 | 11172767 | 1 | 201403 | 201412 | 0 | |
| 111727672 | 11172767 | 2 | 201412 | 20141219 | 0 | |
| 111727672 | 11172767 | 3 | 20140505 | 20141219 | 0 | |
| 111727672 | 11172767 | 4 | 20140717 | 20141219 | 0 |