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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127001871 | 12700187 | 1 | I | 20160812 | 20160830 | 20160830 | PER | US-SHIRE-US201611231 | SHIRE | 0.00 | Y | 0.00000 | 20160830 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127001871 | 12700187 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, UNKNOWN | U | U | 21977 | 40 | MG | CAPSULE | |||||
| 127001871 | 12700187 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 UNK, UNK | U | U | 21977 | 60 | MG | CAPSULE | |||||
| 127001871 | 12700187 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD (IN THE MORNING) | U | U | 21977 | 40 | MG | CAPSULE | QD | ||||
| 127001871 | 12700187 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 20 MG, UNKNOWN | U | U | 21977 | 20 | MG | CAPSULE | |||||
| 127001871 | 12700187 | 5 | SS | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Unknown | 0.5 DF, UNKNOWN | U | U | 0 | .5 | DF | ||||||
| 127001871 | 12700187 | 6 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, 1X/DAY:QD | 0 | 30 | MG | QD | |||||||
| 127001871 | 12700187 | 7 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Unknown | 1 MG (HALF OF A 2 MG), 1X/DAY:QD | U | U | 0 | 1 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127001871 | 12700187 | 1 | Attention deficit/hyperactivity disorder |
| 127001871 | 12700187 | 5 | Product used for unknown indication |
| 127001871 | 12700187 | 6 | Product used for unknown indication |
| 127001871 | 12700187 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127001871 | 12700187 | Apathy | |
| 127001871 | 12700187 | Dizziness | |
| 127001871 | 12700187 | Headache | |
| 127001871 | 12700187 | Incorrect dose administered | |
| 127001871 | 12700187 | Malaise | |
| 127001871 | 12700187 | Nausea | |
| 127001871 | 12700187 | Negative thoughts | |
| 127001871 | 12700187 | Nervousness | |
| 127001871 | 12700187 | Performance status decreased | |
| 127001871 | 12700187 | Tinnitus | |
| 127001871 | 12700187 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |