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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126018041 | 12601804 | 1 | I | 20160714 | 20160728 | 20160728 | EXP | JP-LUPIN PHARMACEUTICALS INC.-2016-03305 | LUPIN | HIRANO S. NEONATAL DRUG WITHDRAWAL SYNDROME. JAPAN PEDIATRIC SOCIETY OF CLINICAL PHARMACOLOGY AND THERAPEUTICS JOURNAL. 2015;28(1):. | 0.00 | F | Y | 3.56000 | KG | 20160728 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126018041 | 12601804 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNKNOWN | 77670 | ||||||||||
| 126018041 | 12601804 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | UNKNOWN | 0 | ||||||||||
| 126018041 | 12601804 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | UNKNOWN | 0 | ||||||||||
| 126018041 | 12601804 | 4 | C | Bromazepam | BROMAZEPAM | 1 | Transplacental | 0 | |||||||||||
| 126018041 | 12601804 | 5 | C | VALPROIC ACID. | VALPROIC ACID | 1 | Transplacental | 0 | |||||||||||
| 126018041 | 12601804 | 6 | C | Etizolam | ETIZOLAM | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126018041 | 12601804 | 1 | Mental disorder |
| 126018041 | 12601804 | 2 | Mental disorder |
| 126018041 | 12601804 | 3 | Mental disorder |
| 126018041 | 12601804 | 4 | Mental disorder |
| 126018041 | 12601804 | 5 | Mental disorder |
| 126018041 | 12601804 | 6 | Mental disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126018041 | 12601804 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126018041 | 12601804 | Drug withdrawal syndrome | |
| 126018041 | 12601804 | Foetal exposure during pregnancy | |
| 126018041 | 12601804 | Hypotonia | |
| 126018041 | 12601804 | Irritability | |
| 126018041 | 12601804 | Respiratory depression | |
| 126018041 | 12601804 | Resting tremor | |
| 126018041 | 12601804 | Seizure | |
| 126018041 | 12601804 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |