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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127438092 | 12743809 | 2 | F | 20160915 | 20160914 | 20160920 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-60101BI | BOEHRINGER INGELHEIM | 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 | M | Y | 0.00000 | 20160921 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127438092 | 12743809 | 1 | PS | SIFROL | PRAMIPEXOLE | 1 | Unknown | 0.125 MG | 20667 | .125 | MG | QD | |||||||
| 127438092 | 12743809 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 1 MG | 0 | .5 | MG | BID | |||||||
| 127438092 | 12743809 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG | 0 | .5 | MG | QD | |||||||
| 127438092 | 12743809 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 1 MG | 0 | 1 | MG | QD | |||||||
| 127438092 | 12743809 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0 | .5 | MG | |||||||||
| 127438092 | 12743809 | 6 | C | PAROXETINE. | PAROXETINE | 1 | Unknown | 40 MG | 0 | 40 | MG | QD | |||||||
| 127438092 | 12743809 | 7 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | Unknown | 36 MG | 0 | 36 | MG | QD | |||||||
| 127438092 | 12743809 | 8 | C | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 375 MG | 0 | 375 | MG | QD | |||||||
| 127438092 | 12743809 | 9 | C | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 500 MG | 0 | 500 | MG | QD | |||||||
| 127438092 | 12743809 | 10 | C | MELATONIN | MELATONIN | 1 | Unknown | 5 MG AT BEDTIME AS NEEDED | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127438092 | 12743809 | 1 | Product used for unknown indication |
| 127438092 | 12743809 | 2 | Product used for unknown indication |
| 127438092 | 12743809 | 6 | Product used for unknown indication |
| 127438092 | 12743809 | 7 | Product used for unknown indication |
| 127438092 | 12743809 | 8 | Product used for unknown indication |
| 127438092 | 12743809 | 10 | Sleep disorder therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127438092 | 12743809 | HO |
| 127438092 | 12743809 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127438092 | 12743809 | 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 |