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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127768811 | 12776881 | 1 | I | 201608 | 20160919 | 20160923 | 20160923 | PER | US-SHIRE-US201612967 | SHIRE | 54.79 | YR | F | Y | 46.71000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127768811 | 12776881 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 60 MG, 1X/DAY:QD | N | 21977 | 60 | MG | CAPSULE | QD | |||||
| 127768811 | 12776881 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD | N | 21977 | 40 | MG | CAPSULE | QD | |||||
| 127768811 | 12776881 | 3 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 40 MG, 1X/DAY:QD | D | 0 | 40 | MG | TABLET | QD | |||||
| 127768811 | 12776881 | 4 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | D | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127768811 | 12776881 | 1 | Attention deficit/hyperactivity disorder |
| 127768811 | 12776881 | 3 | Depression |
| 127768811 | 12776881 | 4 | Eating disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127768811 | 12776881 | Arthralgia | |
| 127768811 | 12776881 | Fatigue | |
| 127768811 | 12776881 | Mood altered | |
| 127768811 | 12776881 | Myalgia | |
| 127768811 | 12776881 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 127768811 | 12776881 | 1 | 201608 | 201608 | 0 | |
| 127768811 | 12776881 | 2 | 201607 | 201608 | 0 | |
| 127768811 | 12776881 | 3 | 1996 | 0 |