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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944362 | 12494436 | 2 | F | 201605 | 20160629 | 20160623 | 20160707 | EXP | US-JAZZ-2016-US-011224 | JAZZ | 48.35 | YR | M | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124944362 | 12494436 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124944362 | 12494436 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 124944362 | 12494436 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124944362 | 12494436 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124944362 | 12494436 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944362 | 12494436 | 6 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124944362 | 12494436 | 7 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944362 | 12494436 | 8 | C | Aspire | 2 | UNK | U | 0 | TABLET | ||||||||||
| 124944362 | 12494436 | 9 | C | LANTUS | INSULIN GLARGINE | 1 | UNK | U | 0 | ||||||||||
| 124944362 | 12494436 | 10 | C | Multivitamin and mineral | 2 | UNK | U | 0 | TABLET | ||||||||||
| 124944362 | 12494436 | 11 | C | NOVOLOG | INSULIN ASPART | 1 | UNK | U | 0 | ||||||||||
| 124944362 | 12494436 | 12 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124944362 | 12494436 | 13 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | SPRAY |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124944362 | 12494436 | 1 | Narcolepsy |
| 124944362 | 12494436 | 5 | Product used for unknown indication |
| 124944362 | 12494436 | 6 | Product used for unknown indication |
| 124944362 | 12494436 | 7 | Product used for unknown indication |
| 124944362 | 12494436 | 8 | Product used for unknown indication |
| 124944362 | 12494436 | 9 | Product used for unknown indication |
| 124944362 | 12494436 | 10 | Product used for unknown indication |
| 124944362 | 12494436 | 11 | Product used for unknown indication |
| 124944362 | 12494436 | 12 | Product used for unknown indication |
| 124944362 | 12494436 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124944362 | 12494436 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124944362 | 12494436 | Anxiety | |
| 124944362 | 12494436 | Balance disorder | |
| 124944362 | 12494436 | Condition aggravated | |
| 124944362 | 12494436 | Feeling drunk | |
| 124944362 | 12494436 | Poor quality sleep | |
| 124944362 | 12494436 | Somnolence | |
| 124944362 | 12494436 | Type 1 diabetes mellitus |
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 |
|---|---|---|---|---|---|---|
| 124944362 | 12494436 | 1 | 201604 | 201605 | 0 | |
| 124944362 | 12494436 | 2 | 201605 | 201605 | 0 | |
| 124944362 | 12494436 | 3 | 201605 | 20160522 | 0 | |
| 124944362 | 12494436 | 4 | 20160523 | 0 | ||
| 124944362 | 12494436 | 5 | 20150403 | 201606 | 0 | |
| 124944362 | 12494436 | 6 | 20150302 | 0 | ||
| 124944362 | 12494436 | 7 | 20140822 | 0 | ||
| 124944362 | 12494436 | 8 | 20130222 | 0 | ||
| 124944362 | 12494436 | 9 | 20130222 | 0 | ||
| 124944362 | 12494436 | 10 | 20130222 | 0 | ||
| 124944362 | 12494436 | 11 | 20130222 | 0 | ||
| 124944362 | 12494436 | 12 | 20130222 | 0 |