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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125809182 | 12580918 | 2 | F | 2010 | 20160819 | 20160721 | 20160824 | PER | US-SHIRE-US201609125 | SHIRE | 23.60 | YR | F | Y | 54.42000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125809182 | 12580918 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, 1X/DAY:QD | 21977 | 30 | MG | CAPSULE | QD | ||||||
| 125809182 | 12580918 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 50 MG, 1X/DAY:QD (MONDAY THROUGH FRIDAY, SEPTEMBER-MAY) | 21977 | 50 | MG | CAPSULE | QD | ||||||
| 125809182 | 12580918 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, UNK | 21977 | 40 | MG | CAPSULE | QD | ||||||
| 125809182 | 12580918 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | 21977 | CAPSULE | ||||||||||
| 125809182 | 12580918 | 5 | C | MICROGESTIN | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 125809182 | 12580918 | 6 | C | BUPROPION. | BUPROPION | 1 | Oral | 300 MG, 1X/DAY:QD | 0 | 300 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125809182 | 12580918 | 1 | Attention deficit/hyperactivity disorder |
| 125809182 | 12580918 | 5 | Contraception |
| 125809182 | 12580918 | 6 | Depression |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125809182 | 12580918 | Disturbance in attention | |
| 125809182 | 12580918 | Drug ineffective | |
| 125809182 | 12580918 | Gastrooesophageal reflux disease | |
| 125809182 | 12580918 | Inappropriate schedule of drug administration | |
| 125809182 | 12580918 | Product quality issue | |
| 125809182 | 12580918 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 125809182 | 12580918 | 5 | 2010 | 0 | ||
| 125809182 | 12580918 | 6 | 2009 | 0 |