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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125230351 | 12523035 | 1 | I | 20160627 | 20160701 | 20160701 | EXP | US-JAZZ-2016-US-012095 | JAZZ | 0.00 | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125230351 | 12523035 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125230351 | 12523035 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | 21196 | 3.25 | G | ORAL SOLUTION | |||||||
| 125230351 | 12523035 | 3 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125230351 | 12523035 | 4 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | TABLET | ||||||||||
| 125230351 | 12523035 | 5 | C | DURAGESIC | FENTANYL | 1 | U | 0 | PATCH | ||||||||||
| 125230351 | 12523035 | 6 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | SPRAY | ||||||||||
| 125230351 | 12523035 | 7 | C | FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125230351 | 12523035 | 8 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | U | 0 | TABLET | ||||||||||
| 125230351 | 12523035 | 9 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | U | 0 | |||||||||||
| 125230351 | 12523035 | 10 | C | LORAZEPAM. | LORAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 125230351 | 12523035 | 11 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125230351 | 12523035 | 12 | C | TOPIRAMATE. | TOPIRAMATE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125230351 | 12523035 | 1 | Narcolepsy |
| 125230351 | 12523035 | 3 | Product used for unknown indication |
| 125230351 | 12523035 | 4 | Product used for unknown indication |
| 125230351 | 12523035 | 5 | Product used for unknown indication |
| 125230351 | 12523035 | 6 | Product used for unknown indication |
| 125230351 | 12523035 | 7 | Product used for unknown indication |
| 125230351 | 12523035 | 8 | Product used for unknown indication |
| 125230351 | 12523035 | 9 | Product used for unknown indication |
| 125230351 | 12523035 | 10 | Product used for unknown indication |
| 125230351 | 12523035 | 11 | Product used for unknown indication |
| 125230351 | 12523035 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125230351 | 12523035 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125230351 | 12523035 | Abdominal pain upper | |
| 125230351 | 12523035 | Headache | |
| 125230351 | 12523035 | Heart rate increased | |
| 125230351 | 12523035 | Nausea | |
| 125230351 | 12523035 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 125230351 | 12523035 | 1 | 201604 | 2016 | 0 | |
| 125230351 | 12523035 | 2 | 201606 | 0 | ||
| 125230351 | 12523035 | 3 | 20151201 | 0 |