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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124357883 | 12435788 | 3 | F | 201605 | 20160701 | 20160603 | 20160708 | EXP | US-JAZZ-2016-US-010023 | JAZZ | 30.35 | YR | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124357883 | 12435788 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | U | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 124357883 | 12435788 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSAGE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124357883 | 12435788 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124357883 | 12435788 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124357883 | 12435788 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5.5 G, BID | U | 21196 | 5.5 | G | ORAL SOLUTION | ||||||
| 124357883 | 12435788 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN LOWER DOSE | U | 21196 | ORAL SOLUTION | ||||||||
| 124357883 | 12435788 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5.5 G, BID | U | 21196 | 5.5 | G | ORAL SOLUTION | ||||||
| 124357883 | 12435788 | 8 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357883 | 12435788 | 9 | SS | GABAPENTIN. | GABAPENTIN | 1 | 300 MG, QD | U | 0 | 300 | MG | CAPSULE | |||||||
| 124357883 | 12435788 | 10 | SS | MIRTAZAPINE. | MIRTAZAPINE | 1 | UNK | N | 0 | TABLET | |||||||||
| 124357883 | 12435788 | 11 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 124357883 | 12435788 | 12 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357883 | 12435788 | 13 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357883 | 12435788 | 14 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357883 | 12435788 | 15 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357883 | 12435788 | 16 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357883 | 12435788 | 17 | C | ASMANEX | MOMETASONE FUROATE | 1 | UNK | U | 0 | ||||||||||
| 124357883 | 12435788 | 18 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124357883 | 12435788 | 19 | C | ALBUTEROL. | ALBUTEROL | 1 | UNK | U | 0 | INHALER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124357883 | 12435788 | 1 | Narcolepsy |
| 124357883 | 12435788 | 8 | Product used for unknown indication |
| 124357883 | 12435788 | 10 | Product used for unknown indication |
| 124357883 | 12435788 | 11 | Product used for unknown indication |
| 124357883 | 12435788 | 12 | Product used for unknown indication |
| 124357883 | 12435788 | 13 | Product used for unknown indication |
| 124357883 | 12435788 | 14 | Product used for unknown indication |
| 124357883 | 12435788 | 15 | Product used for unknown indication |
| 124357883 | 12435788 | 16 | Product used for unknown indication |
| 124357883 | 12435788 | 17 | Product used for unknown indication |
| 124357883 | 12435788 | 18 | Product used for unknown indication |
| 124357883 | 12435788 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124357883 | 12435788 | HO |
| 124357883 | 12435788 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124357883 | 12435788 | Anxiety | |
| 124357883 | 12435788 | Depression | |
| 124357883 | 12435788 | Headache | |
| 124357883 | 12435788 | Intentional product use issue | |
| 124357883 | 12435788 | Intentional self-injury | |
| 124357883 | 12435788 | Memory impairment | |
| 124357883 | 12435788 | Mental impairment | |
| 124357883 | 12435788 | Panic attack | |
| 124357883 | 12435788 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 124357883 | 12435788 | 1 | 201006 | 2010 | 0 | |
| 124357883 | 12435788 | 2 | 2010 | 2010 | 0 | |
| 124357883 | 12435788 | 3 | 201101 | 2014 | 0 | |
| 124357883 | 12435788 | 4 | 201508 | 201512 | 0 | |
| 124357883 | 12435788 | 5 | 201512 | 0 | ||
| 124357883 | 12435788 | 6 | 201605 | 201605 | 0 | |
| 124357883 | 12435788 | 7 | 201605 | 0 | ||
| 124357883 | 12435788 | 8 | 20160509 | 201605 | 0 | |
| 124357883 | 12435788 | 9 | 201605 | 0 | ||
| 124357883 | 12435788 | 10 | 201605 | 201605 | 0 | |
| 124357883 | 12435788 | 12 | 20141001 | 20150831 | 0 | |
| 124357883 | 12435788 | 13 | 20131231 | 0 | ||
| 124357883 | 12435788 | 14 | 20131231 | 20150805 | 0 | |
| 124357883 | 12435788 | 15 | 20131204 | 20150805 | 0 | |
| 124357883 | 12435788 | 16 | 20131101 | 20160509 | 0 | |
| 124357883 | 12435788 | 17 | 20100101 | 20110101 | 0 | |
| 124357883 | 12435788 | 18 | 20100101 | 20100701 | 0 | |
| 124357883 | 12435788 | 19 | 20010101 | 0 |