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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580571 | 12558057 | 1 | I | 201511 | 20160115 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000832 | JAZZ | 55.64 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580571 | 12558057 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125580571 | 12558057 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125580571 | 12558057 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125580571 | 12558057 | 4 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | ||||||||||
| 125580571 | 12558057 | 5 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125580571 | 12558057 | 6 | C | HALCION | TRIAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 7 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125580571 | 12558057 | 8 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 9 | C | Cranberry concentrate | CRANBERRY CONCENTRATE | 1 | UNK | U | 0 | ||||||||||
| 125580571 | 12558057 | 10 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580571 | 12558057 | 11 | C | Bupropion hcl | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 12 | C | Hydromorphone | HYDROMORPHONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 13 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 14 | C | NITROFURANTOIN. | NITROFURANTOIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580571 | 12558057 | 15 | C | OXYBUTYNIN CHLORIDE. | OXYBUTYNIN CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 16 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 17 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580571 | 12558057 | 18 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125580571 | 12558057 | 1 | Somnolence |
| 125580571 | 12558057 | 4 | Product used for unknown indication |
| 125580571 | 12558057 | 5 | Product used for unknown indication |
| 125580571 | 12558057 | 6 | Product used for unknown indication |
| 125580571 | 12558057 | 7 | Product used for unknown indication |
| 125580571 | 12558057 | 8 | Product used for unknown indication |
| 125580571 | 12558057 | 9 | Product used for unknown indication |
| 125580571 | 12558057 | 10 | Product used for unknown indication |
| 125580571 | 12558057 | 11 | Product used for unknown indication |
| 125580571 | 12558057 | 12 | Product used for unknown indication |
| 125580571 | 12558057 | 13 | Product used for unknown indication |
| 125580571 | 12558057 | 14 | Product used for unknown indication |
| 125580571 | 12558057 | 15 | Product used for unknown indication |
| 125580571 | 12558057 | 16 | Product used for unknown indication |
| 125580571 | 12558057 | 17 | Product used for unknown indication |
| 125580571 | 12558057 | 18 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125580571 | 12558057 | Alopecia | |
| 125580571 | 12558057 | Anxiety | |
| 125580571 | 12558057 | Hair texture abnormal |
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 |
|---|---|---|---|---|---|---|
| 125580571 | 12558057 | 1 | 201510 | 201511 | 0 | |
| 125580571 | 12558057 | 2 | 201511 | 201511 | 0 | |
| 125580571 | 12558057 | 3 | 201511 | 201601 | 0 | |
| 125580571 | 12558057 | 6 | 20151224 | 0 | ||
| 125580571 | 12558057 | 7 | 20151224 | 0 | ||
| 125580571 | 12558057 | 8 | 20151224 | 0 | ||
| 125580571 | 12558057 | 9 | 20151029 | 0 | ||
| 125580571 | 12558057 | 10 | 20151029 | 0 | ||
| 125580571 | 12558057 | 11 | 20151028 | 0 | ||
| 125580571 | 12558057 | 12 | 20151028 | 20151117 | 0 | |
| 125580571 | 12558057 | 13 | 20151028 | 0 | ||
| 125580571 | 12558057 | 14 | 20151028 | 0 | ||
| 125580571 | 12558057 | 15 | 20151028 | 0 | ||
| 125580571 | 12558057 | 16 | 20151028 | 0 | ||
| 125580571 | 12558057 | 17 | 20151028 | 0 | ||
| 125580571 | 12558057 | 18 | 20151028 | 20151029 | 0 |