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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124111674 | 12411167 | 4 | F | 20160725 | 20160527 | 20160802 | EXP | US-NOVEN PHARMACEUTICALS, INC.-US2016001155 | NOVEN | 0.00 | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124111674 | 12411167 | 1 | PS | DAYTRANA | METHYLPHENIDATE | 1 | Transdermal | TWO 20 MG PATCHES PER DAY | 21514 | TRANSDERMAL PATCH | |||||||||
| 124111674 | 12411167 | 2 | SS | DAYTRANA | METHYLPHENIDATE | 1 | Transdermal | TWO 20 MG PATCHES PER DAY | UNK | 21514 | TRANSDERMAL PATCH | ||||||||
| 124111674 | 12411167 | 3 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | Oral | 10 MG, AT 6 AM AND 1 PM AT SCHOOL | 0 | 10 | MG | ||||||||
| 124111674 | 12411167 | 4 | C | CLONIDINE. | CLONIDINE | 1 | 0.1 MG, BETWEEN 6:30 AND 7 PM | 0 | .1 | MG | |||||||||
| 124111674 | 12411167 | 5 | C | Cetrizine | CETIRIZINE HYDROCHLORIDE | 1 | 5 MG, AT 6 IN THE EVENING | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124111674 | 12411167 | 1 | Attention deficit/hyperactivity disorder |
| 124111674 | 12411167 | 4 | Insomnia |
| 124111674 | 12411167 | 5 | Seasonal allergy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124111674 | 12411167 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124111674 | 12411167 | Aggression | |
| 124111674 | 12411167 | Agitation | |
| 124111674 | 12411167 | Anger | |
| 124111674 | 12411167 | Drug dose omission | |
| 124111674 | 12411167 | Drug withdrawal syndrome | |
| 124111674 | 12411167 | Frustration tolerance decreased | |
| 124111674 | 12411167 | Hunger | |
| 124111674 | 12411167 | Impulsive behaviour | |
| 124111674 | 12411167 | Insomnia | |
| 124111674 | 12411167 | Irritability | |
| 124111674 | 12411167 | Off label use | |
| 124111674 | 12411167 | Oppositional defiant disorder | |
| 124111674 | 12411167 | Prescribed overdose | |
| 124111674 | 12411167 | Product adhesion issue | |
| 124111674 | 12411167 | Psychomotor hyperactivity | |
| 124111674 | 12411167 | Screaming | |
| 124111674 | 12411167 | Thinking abnormal | |
| 124111674 | 12411167 | 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 |
|---|---|---|---|---|---|---|
| 124111674 | 12411167 | 1 | 201509 | 0 | ||
| 124111674 | 12411167 | 2 | 201604 | 0 |