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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125877411 | 12587741 | 1 | I | 2009 | 20160629 | 20160725 | 20160725 | PER | US-SHIRE-US201608315 | SHIRE | 32.61 | YR | M | Y | 81.18000 | KG | 20160725 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125877411 | 12587741 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 21977 | 30 | MG | CAPSULE | QD | ||||||
| 125877411 | 12587741 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | 21977 | 40 | MG | CAPSULE | QD | ||||||
| 125877411 | 12587741 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD | 3139680 | 21977 | 50 | MG | CAPSULE | QD | |||||
| 125877411 | 12587741 | 4 | C | ONE-A-DAY /07499601/ | 2 | Oral | UNK, 1X/DAY:QD | 0 | TABLET | QD | |||||||||
| 125877411 | 12587741 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | UNK, UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125877411 | 12587741 | 1 | Attention deficit/hyperactivity disorder |
| 125877411 | 12587741 | 4 | Nutritional supplementation |
| 125877411 | 12587741 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125877411 | 12587741 | Blood bilirubin increased | |
| 125877411 | 12587741 | Disturbance in attention | |
| 125877411 | 12587741 | Libido increased | |
| 125877411 | 12587741 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 125877411 | 12587741 | 1 | 2009 | 201604 | 0 | |
| 125877411 | 12587741 | 2 | 201604 | 20160628 | 0 | |
| 125877411 | 12587741 | 3 | 20160629 | 0 |