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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126236031 | 12623603 | 1 | I | 20160222 | 20160804 | 20160804 | PER | US-JAZZ-2016-US-003409 | JAZZ | 0.00 | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126236031 | 12623603 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126236031 | 12623603 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126236031 | 12623603 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126236031 | 12623603 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, SECOND DOSE | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 126236031 | 12623603 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126236031 | 12623603 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126236031 | 12623603 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126236031 | 12623603 | 8 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | 0 | TABLET | ||||||||||
| 126236031 | 12623603 | 9 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 126236031 | 12623603 | 10 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126236031 | 12623603 | 11 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126236031 | 12623603 | 12 | C | MAXALT-MLT | RIZATRIPTAN BENZOATE | 1 | UNK | U | 0 | ||||||||||
| 126236031 | 12623603 | 13 | C | ALEVE | NAPROXEN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 126236031 | 12623603 | 14 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126236031 | 12623603 | 15 | C | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 1 | UNK | U | 0 | ||||||||||
| 126236031 | 12623603 | 16 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 126236031 | 12623603 | 17 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126236031 | 12623603 | 18 | C | Multi vit | 2 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126236031 | 12623603 | 1 | Narcolepsy |
| 126236031 | 12623603 | 8 | Product used for unknown indication |
| 126236031 | 12623603 | 9 | Product used for unknown indication |
| 126236031 | 12623603 | 10 | Product used for unknown indication |
| 126236031 | 12623603 | 11 | Product used for unknown indication |
| 126236031 | 12623603 | 12 | Product used for unknown indication |
| 126236031 | 12623603 | 13 | Product used for unknown indication |
| 126236031 | 12623603 | 14 | Product used for unknown indication |
| 126236031 | 12623603 | 15 | Product used for unknown indication |
| 126236031 | 12623603 | 16 | Product used for unknown indication |
| 126236031 | 12623603 | 17 | Product used for unknown indication |
| 126236031 | 12623603 | 18 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126236031 | 12623603 | Anxiety | |
| 126236031 | 12623603 | Asthenia | |
| 126236031 | 12623603 | Feeling jittery | |
| 126236031 | 12623603 | Hunger | |
| 126236031 | 12623603 | 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 |
|---|---|---|---|---|---|---|
| 126236031 | 12623603 | 1 | 200807 | 200808 | 0 | |
| 126236031 | 12623603 | 3 | 200910 | 201011 | 0 | |
| 126236031 | 12623603 | 4 | 200910 | 201011 | 0 | |
| 126236031 | 12623603 | 5 | 201309 | 201309 | 0 | |
| 126236031 | 12623603 | 7 | 201406 | 0 | ||
| 126236031 | 12623603 | 8 | 20140201 | 0 | ||
| 126236031 | 12623603 | 9 | 20140201 | 0 | ||
| 126236031 | 12623603 | 10 | 20130910 | 0 | ||
| 126236031 | 12623603 | 11 | 20060201 | 0 | ||
| 126236031 | 12623603 | 12 | 20060201 | 0 | ||
| 126236031 | 12623603 | 14 | 20160222 | 0 | ||
| 126236031 | 12623603 | 15 | 20140201 | 0 |