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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125579241 | 12557924 | 1 | I | 20160113 | 20160114 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000791 | JAZZ | 37.67 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125579241 | 12557924 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125579241 | 12557924 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125579241 | 12557924 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125579241 | 12557924 | 4 | SS | DICLOXACILLIN SODIUM. | DICLOXACILLIN SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579241 | 12557924 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | N | 0 | |||||||||||
| 125579241 | 12557924 | 6 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 8 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 9 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 10 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 11 | C | Aspirin adult | 2 | UNK | U | 0 | CHEWABLE TABLET | ||||||||||
| 125579241 | 12557924 | 12 | C | Multiple vitamins | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 13 | C | HYDROCODONE | HYDROCODONE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125579241 | 12557924 | 14 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 15 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 16 | C | MOBIC | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 17 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 18 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579241 | 12557924 | 19 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125579241 | 12557924 | 1 | Narcolepsy |
| 125579241 | 12557924 | 2 | Cataplexy |
| 125579241 | 12557924 | 4 | Product used for unknown indication |
| 125579241 | 12557924 | 5 | Product used for unknown indication |
| 125579241 | 12557924 | 6 | Product used for unknown indication |
| 125579241 | 12557924 | 7 | Product used for unknown indication |
| 125579241 | 12557924 | 8 | Product used for unknown indication |
| 125579241 | 12557924 | 9 | Product used for unknown indication |
| 125579241 | 12557924 | 10 | Product used for unknown indication |
| 125579241 | 12557924 | 11 | Product used for unknown indication |
| 125579241 | 12557924 | 12 | Product used for unknown indication |
| 125579241 | 12557924 | 13 | Product used for unknown indication |
| 125579241 | 12557924 | 14 | Product used for unknown indication |
| 125579241 | 12557924 | 16 | Product used for unknown indication |
| 125579241 | 12557924 | 17 | Product used for unknown indication |
| 125579241 | 12557924 | 18 | Product used for unknown indication |
| 125579241 | 12557924 | 19 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125579241 | 12557924 | Dizziness | |
| 125579241 | 12557924 | Mastitis | |
| 125579241 | 12557924 | Rash |
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 |
|---|---|---|---|---|---|---|
| 125579241 | 12557924 | 1 | 201111 | 201111 | 0 | |
| 125579241 | 12557924 | 2 | 201111 | 201112 | 0 | |
| 125579241 | 12557924 | 3 | 201112 | 0 | ||
| 125579241 | 12557924 | 4 | 20160113 | 0 | ||
| 125579241 | 12557924 | 6 | 20160113 | 0 | ||
| 125579241 | 12557924 | 7 | 20151224 | 0 | ||
| 125579241 | 12557924 | 8 | 20151224 | 0 | ||
| 125579241 | 12557924 | 9 | 20151224 | 0 | ||
| 125579241 | 12557924 | 10 | 20150603 | 20160114 | 0 | |
| 125579241 | 12557924 | 11 | 20150102 | 0 | ||
| 125579241 | 12557924 | 12 | 20150102 | 0 | ||
| 125579241 | 12557924 | 13 | 20130520 | 20130522 | 0 | |
| 125579241 | 12557924 | 14 | 20130221 | 20150102 | 0 | |
| 125579241 | 12557924 | 15 | 20010101 | 0 | ||
| 125579241 | 12557924 | 16 | 20120925 | 20141002 | 0 | |
| 125579241 | 12557924 | 19 | 20120925 | 0 |