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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125830121 | 12583012 | 1 | I | 2016 | 20160720 | 20160722 | 20160722 | PER | US-SHIRE-US201609144 | SHIRE | 28.85 | YR | F | Y | 61.22000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125830121 | 12583012 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, 1X/DAY:QD | Y | 21977 | 60 | MG | CAPSULE | QD | |||||
| 125830121 | 12583012 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | Y | 21977 | 40 | MG | CAPSULE | QD | |||||
| 125830121 | 12583012 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD | Y | 21977 | 50 | MG | CAPSULE | QD | |||||
| 125830121 | 12583012 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/2WKS | Y | 21977 | 50 | MG | CAPSULE | QOW | |||||
| 125830121 | 12583012 | 5 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 50 MG, 1X/DAY:QD | 0 | 50 | MG | QD | |||||||
| 125830121 | 12583012 | 6 | C | TREXIMET | NAPROXEN SODIUMSUMATRIPTAN SUCCINATE | 1 | Unknown | UNK, AS REQ'D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125830121 | 12583012 | 1 | Attention deficit/hyperactivity disorder |
| 125830121 | 12583012 | 5 | Hormone therapy |
| 125830121 | 12583012 | 6 | Migraine |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125830121 | 12583012 | Anxiety | |
| 125830121 | 12583012 | Distractibility | |
| 125830121 | 12583012 | Disturbance in attention | |
| 125830121 | 12583012 | Drug effect incomplete | |
| 125830121 | 12583012 | Drug effect variable | |
| 125830121 | 12583012 | Drug ineffective | |
| 125830121 | 12583012 | Hypertension | |
| 125830121 | 12583012 | Impulsive behaviour | |
| 125830121 | 12583012 | Product quality issue | |
| 125830121 | 12583012 | Sleep disorder | |
| 125830121 | 12583012 | Stress |
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 |
|---|---|---|---|---|---|---|
| 125830121 | 12583012 | 1 | 201512 | 201602 | 0 | |
| 125830121 | 12583012 | 2 | 2012 | 0 | ||
| 125830121 | 12583012 | 3 | 201512 | 0 | ||
| 125830121 | 12583012 | 4 | 201602 | 0 | ||
| 125830121 | 12583012 | 5 | 2011 | 0 | ||
| 125830121 | 12583012 | 6 | 2014 | 0 |