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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127916191 | 12791619 | 1 | I | 20160915 | 20160929 | 20160929 | EXP | US-AUROBINDO-AUR-APL-2016-11892 | AUROBINDO | 12.00 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127916191 | 12791619 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 40 MG, ONCE A DAY (PAROXETINE 40 MG Q AM) | U | 0 | 40 | MG | QD | ||||||
| 127916191 | 12791619 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG, TWO TIMES A DAY | 0 | .5 | MG | BID | |||||||
| 127916191 | 12791619 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG Q AM | 0 | .5 | MG | ||||||||
| 127916191 | 12791619 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 1 MG, ONCE A DAY (BEDTIME) | 0 | 1 | MG | QD | |||||||
| 127916191 | 12791619 | 5 | PS | Divalproex | DIVALPROEX SODIUM | 1 | Unknown | 375 MG, ONCE A DAY (375 MG Q AM) | U | 90554 | 375 | MG | QD | ||||||
| 127916191 | 12791619 | 6 | SS | Divalproex | DIVALPROEX SODIUM | 1 | Unknown | 500 MG, ONCE A DAY (BEDTIME) | U | 90554 | 500 | MG | QD | ||||||
| 127916191 | 12791619 | 7 | SS | PRAMIPEXOLE. | PRAMIPEXOLE | 1 | Unknown | 0.125 MG, ONCE A DAY (AT BEDTIME) | U | 0 | .125 | MG | QD | ||||||
| 127916191 | 12791619 | 8 | SS | METHYLPHENIDATE HYDROCHLORIDE. | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | 36 MG, ONCE A DAY | U | 0 | 36 | MG | QD | ||||||
| 127916191 | 12791619 | 9 | C | MELATONIN | MELATONIN | 1 | Unknown | 5 MG, ONCE A DAY (AT BEDTIME AS NEEDED) | U | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127916191 | 12791619 | 1 | Product used for unknown indication |
| 127916191 | 12791619 | 2 | Product used for unknown indication |
| 127916191 | 12791619 | 5 | Product used for unknown indication |
| 127916191 | 12791619 | 7 | Product used for unknown indication |
| 127916191 | 12791619 | 8 | Product used for unknown indication |
| 127916191 | 12791619 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127916191 | 12791619 | HO |
| 127916191 | 12791619 | LT |
| 127916191 | 12791619 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127916191 | 12791619 | 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 |