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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85474136 | 8547413 | 6 | F | 20111025 | 20160627 | 20120504 | 20160705 | EXP | JP-JNJFOC-20120501374 | JANSSEN | MIYAJI N, OMORI S, YAMADA M, OKISHIO E, TAKAMURA K, FUKE T, ET AL. NEONATAL ABSTINENCE SYNDROME IN A NEWBORN BORN TO A MOTHER USING FENTANYL TRANSDERMAL PATCH IN PREGNANCY. JOURNAL OF JAPAN SOCIETY OF PERINATAL AND NEONATAL MEDICINE MAY-2016;52(1):105-109. MIYAJI N, KURATSUJI G, OKISHIO E, TAKAMURA K, ICHIKAWA T, OMORI S. A CASE OF NEONATAL ABSTINENCE SYNDROME CAUSED BY MATERNAL TREATMENT WITH FENTANYL. JOURNAL OF JAPAN SOCIETY OF PERINATAL AND NEONATAL MEDICINE JUN-2012;48(2):460. | 0.00 | DY | N | M | Y | 2.46000 | KG | 20160705 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85474136 | 8547413 | 1 | PS | DUROTEP MT | FENTANYL | 1 | Transplacental | N | 19813 | MATRIX PATCH | |||||||||
| 85474136 | 8547413 | 2 | SS | FENTANYL CITRATE. | FENTANYL CITRATE | 1 | Transplacental | N | 0 | 10 | ML | SOLUTION | |||||||
| 85474136 | 8547413 | 3 | SS | PHENOBARBITAL. | PHENOBARBITAL | 1 | Intravenous (not otherwise specified) | Y | 0 | 19 | MG | UNSPECIFIED | |||||||
| 85474136 | 8547413 | 4 | SS | PHENOBARBITAL. | PHENOBARBITAL | 1 | Intravenous (not otherwise specified) | Y | 0 | 45 | MG | UNSPECIFIED | |||||||
| 85474136 | 8547413 | 5 | SS | MORPHINE HYDROCHLORIDE | MORPHINE HYDROCHLORIDE | 1 | Transplacental | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 85474136 | 8547413 | 6 | SS | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Transplacental | 0 | 5 | MG | TABLET | ||||||||
| 85474136 | 8547413 | 7 | SS | ULTIVA | REMIFENTANIL HYDROCHLORIDE | 1 | Transplacental | 0 | .6 | MG | INJECTION | ||||||||
| 85474136 | 8547413 | 8 | C | SEVOFLURANE. | SEVOFLURANE | 1 | Intravenous (not otherwise specified) | 0 | UNSPECIFIED | ||||||||||
| 85474136 | 8547413 | 9 | C | ROCURONIUM BROMIDE. | ROCURONIUM BROMIDE | 1 | Unknown | 0 | 40 | MG | INJECTION | QD | |||||||
| 85474136 | 8547413 | 10 | C | NITROUS OXIDE. | NITROUS OXIDE | 1 | Intravenous (not otherwise specified) | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85474136 | 8547413 | 1 | Foetal exposure during pregnancy |
| 85474136 | 8547413 | 2 | Foetal exposure during pregnancy |
| 85474136 | 8547413 | 3 | Product used for unknown indication |
| 85474136 | 8547413 | 4 | Product used for unknown indication |
| 85474136 | 8547413 | 5 | Foetal exposure during pregnancy |
| 85474136 | 8547413 | 6 | Foetal exposure during pregnancy |
| 85474136 | 8547413 | 7 | Foetal exposure during pregnancy |
| 85474136 | 8547413 | 8 | General anaesthesia |
| 85474136 | 8547413 | 9 | Muscle relaxant therapy |
| 85474136 | 8547413 | 10 | General anaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85474136 | 8547413 | HO |
| 85474136 | 8547413 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85474136 | 8547413 | Analgesic drug level increased | |
| 85474136 | 8547413 | Blood alkaline phosphatase increased | |
| 85474136 | 8547413 | Drug withdrawal syndrome neonatal | |
| 85474136 | 8547413 | Exposure during breast feeding | |
| 85474136 | 8547413 | Feeding disorder | |
| 85474136 | 8547413 | Gamma-glutamyltransferase increased | |
| 85474136 | 8547413 | Hyperreflexia | |
| 85474136 | 8547413 | Irritability | |
| 85474136 | 8547413 | Premature baby | |
| 85474136 | 8547413 | Transient tachypnoea of the newborn | |
| 85474136 | 8547413 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 85474136 | 8547413 | 1 | 2005 | 20111027 | 0 | |
| 85474136 | 8547413 | 2 | 20111025 | 20111025 | 0 | |
| 85474136 | 8547413 | 3 | 20111027 | 20111031 | 0 | |
| 85474136 | 8547413 | 4 | 20111027 | 20111027 | 0 | |
| 85474136 | 8547413 | 7 | 20111025 | 20111025 | 0 | |
| 85474136 | 8547413 | 8 | 20111025 | 20111025 | 0 |