Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5633488 | 6567691 | I | 5633488-9 | 20071115 | 20080204 | 20080219 | EXP | SPV1-2008-00237 | SHIRE | 26 | YR | M | N | 54.4 | KG | 20080215 | CN | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5633488 | 1009544693 | PS | ADDERALL XR 30 | 1 | ORAL | 20 MG, 1X/DAY: QD, ORAL; 30 MG, 4X/DAY: QID, ORAL; 20 MG, 1XDAY: QD, ORAL | Y | D | 21303 | ||
| 5633488 | 1009587466 | C | ADDERALL 10 | 1 | |||||||
| 5633488 | 1009587467 | C | NEXIUM | 1 | |||||||
| 5633488 | 1009587468 | C | KLONOPIN | 1 | |||||||
| 5633488 | 1009587470 | C | LEVSIN (HYOSCYAMINE SULFATE) | 2 | |||||||
| 5633488 | 1009587471 | C | SIMETHICON (SIMETHICONE) | 2 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5633488 | 1009544693 | ATTENTION DEFICIT/HYPERACTIVITY DISORDER |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5633488 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5633488 | ABDOMINAL DISCOMFORT |
| 5633488 | AGGRESSION |
| 5633488 | ANGER |
| 5633488 | ANXIETY |
| 5633488 | DRY MOUTH |
| 5633488 | DYSURIA |
| 5633488 | EXOPHTHALMOS |
| 5633488 | INTENTIONAL DRUG MISUSE |
| 5633488 | MEMORY IMPAIRMENT |
| 5633488 | OVERDOSE |
| 5633488 | VASODILATATION |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5633488 | CSM |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5633488 | 1009544693 | 20071115 | 20071101 | ||
| 5633488 | 1009544693 | 20080102 | 20080101 | ||
| 5633488 | 1009544693 | 20080101 | 20080211 |