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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125495581 | 12549558 | 1 | I | 2015 | 20140424 | 20160712 | 20160712 | EXP | US-PERNIX THERAPEUTICS-2014SO000028 | PERNIX | 0.00 | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125495581 | 12549558 | 1 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 100 MG, UNK | U | UNKNOWN | 0 | TABLET | |||||||
| 125495581 | 12549558 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | 200 MG, UNK | U | 0 | TABLET | |||||||||
| 125495581 | 12549558 | 3 | PS | TREXIMET | NAPROXEN SODIUMSUMATRIPTAN SUCCINATE | 1 | Unknown | ^85 MG^, UNK | U | U | UNKNOWN | 21926 | TABLET | ||||||
| 125495581 | 12549558 | 4 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125495581 | 12549558 | 1 | Bipolar disorder |
| 125495581 | 12549558 | 3 | Product used for unknown indication |
| 125495581 | 12549558 | 4 | Attention deficit/hyperactivity disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125495581 | 12549558 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125495581 | 12549558 | Anxiety | |
| 125495581 | 12549558 | Drug dose omission | |
| 125495581 | 12549558 | Gallbladder operation | |
| 125495581 | 12549558 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125495581 | 12549558 | 1 | 20111207 | 0 | ||
| 125495581 | 12549558 | 2 | 20120126 | 0 | ||
| 125495581 | 12549558 | 3 | 20121010 | 0 |