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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127603031 | 12760303 | 1 | I | 20160908 | 20160919 | 20160919 | EXP | US-JNJFOC-20160916394 | JANSSEN | SHARON N, CULLEN C, MARTINEZ K. A COMPLEX PRESENTATION OF PEDIATRIC NEUROLEPTIC MALIGNANT SYNDROME RELATED TO POLYPHARMACY IN A 12-YEAR-OLD MALE. JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY 2016;26 (6):571-573. | 12.00 | YR | C | M | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127603031 | 12760303 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG IN MORNING AND 1.0 MG AT BEDTIME | Y | Y | 0 | 1.5 | MG | UNSPECIFIED | |||||
| 127603031 | 12760303 | 2 | PS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | Y | Y | 20272 | .5 | MG | UNSPECIFIED | BID | |||||
| 127603031 | 12760303 | 3 | SS | METHYLPHENIDATE HYDROCHLORIDE. | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | ONCE IN MORNING | Y | N | 21121 | 36 | MG | SUSTAINED RELEASE TABLETS | QD | ||||
| 127603031 | 12760303 | 4 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | EVERY MORNING | Y | 0 | 375 | MG | UNSPECIFIED | QD | |||||
| 127603031 | 12760303 | 5 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | AT BEDTIME | Y | 0 | 500 | MG | UNSPECIFIED | QD | |||||
| 127603031 | 12760303 | 6 | SS | PRAMIPEXOLE. | PRAMIPEXOLE | 1 | Unknown | AT BEDTIME | Y | 0 | .125 | MG | UNSPECIFIED | QD | |||||
| 127603031 | 12760303 | 7 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | EVERY MORNING | Y | 0 | 40 | MG | UNSPECIFIED | QD | |||||
| 127603031 | 12760303 | 8 | C | MELATONIN | MELATONIN | 1 | Unknown | AT BEDTIME AS NEEDED | D | 0 | 5 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127603031 | 12760303 | 1 | Product used for unknown indication |
| 127603031 | 12760303 | 2 | Product used for unknown indication |
| 127603031 | 12760303 | 3 | Product used for unknown indication |
| 127603031 | 12760303 | 4 | Product used for unknown indication |
| 127603031 | 12760303 | 5 | Product used for unknown indication |
| 127603031 | 12760303 | 6 | Product used for unknown indication |
| 127603031 | 12760303 | 7 | Product used for unknown indication |
| 127603031 | 12760303 | 8 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127603031 | 12760303 | HO |
| 127603031 | 12760303 | LT |
| 127603031 | 12760303 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127603031 | 12760303 | Neuroleptic malignant syndrome | Neuroleptic malignant syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |