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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127441462 | 12744146 | 2 | F | 2015 | 20160914 | 20160914 | 20160921 | PER | US-SHIRE-US201612534 | SHIRE | 0.00 | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127441462 | 12744146 | 1 | PS | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | 20 MG, 2X/DAY:BID | 21303 | 20 | MG | CAPSULE | BID | ||||||
| 127441462 | 12744146 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 25 MG, OTHER (TAKE 1/2 50 MG TABLET FOR ONE WEEK AND THEN INCREASE TO 50 MG) | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127441462 | 12744146 | 1 | Attention deficit/hyperactivity disorder |
| 127441462 | 12744146 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127441462 | 12744146 | Adverse event | |
| 127441462 | 12744146 | Decreased appetite | |
| 127441462 | 12744146 | Drug dose omission | |
| 127441462 | 12744146 | Drug intolerance | |
| 127441462 | 12744146 | Fatigue | |
| 127441462 | 12744146 | Inappropriate schedule of drug administration | |
| 127441462 | 12744146 | Prescribed overdose | |
| 127441462 | 12744146 | Stress | |
| 127441462 | 12744146 | 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
| no results found |