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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126454351 | 12645435 | 1 | I | 201601 | 20160223 | 20160811 | 20160811 | PER | US-JAZZ-2016-US-003525 | JAZZ | 63.44 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126454351 | 12645435 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126454351 | 12645435 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 126454351 | 12645435 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 126454351 | 12645435 | 4 | SS | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | TWO PILLS BEFORE BED TIME | U | 0 | ||||||||||
| 126454351 | 12645435 | 5 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126454351 | 12645435 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126454351 | 12645435 | 7 | C | Hydromorphone hcl er | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126454351 | 12645435 | 8 | C | MISOPROSTOL. | MISOPROSTOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126454351 | 12645435 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 126454351 | 12645435 | 10 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126454351 | 12645435 | 11 | C | Aspirin e.c | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126454351 | 12645435 | 12 | C | BISACODYL. | BISACODYL | 1 | UNK | U | 0 | SUPPOSITORY | |||||||||
| 126454351 | 12645435 | 13 | C | Docusate sodium 100 | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 126454351 | 12645435 | 14 | C | Docusate sodium 250 | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 126454351 | 12645435 | 15 | C | ESTRACE | ESTRADIOL | 1 | UNK | U | 0 | CREAM | |||||||||
| 126454351 | 12645435 | 16 | C | GEODON | ZIPRASIDONE HYDROCHLORIDEIPRASIDONE MESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126454351 | 12645435 | 17 | C | Glucosamine | GLUCOSAMINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126454351 | 12645435 | 18 | C | HEPARIN SODIUM. | HEPARIN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 126454351 | 12645435 | 19 | C | LACTULOSE. | LACTULOSE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 126454351 | 12645435 | 20 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126454351 | 12645435 | 21 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | OINTMENT | |||||||||
| 126454351 | 12645435 | 22 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 126454351 | 12645435 | 23 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126454351 | 12645435 | 24 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126454351 | 12645435 | 25 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126454351 | 12645435 | 1 | Narcolepsy |
| 126454351 | 12645435 | 2 | Insomnia |
| 126454351 | 12645435 | 4 | Product used for unknown indication |
| 126454351 | 12645435 | 5 | Product used for unknown indication |
| 126454351 | 12645435 | 6 | Product used for unknown indication |
| 126454351 | 12645435 | 7 | Product used for unknown indication |
| 126454351 | 12645435 | 8 | Product used for unknown indication |
| 126454351 | 12645435 | 9 | Product used for unknown indication |
| 126454351 | 12645435 | 10 | Product used for unknown indication |
| 126454351 | 12645435 | 11 | Product used for unknown indication |
| 126454351 | 12645435 | 12 | Product used for unknown indication |
| 126454351 | 12645435 | 13 | Product used for unknown indication |
| 126454351 | 12645435 | 14 | Product used for unknown indication |
| 126454351 | 12645435 | 15 | Product used for unknown indication |
| 126454351 | 12645435 | 16 | Product used for unknown indication |
| 126454351 | 12645435 | 17 | Product used for unknown indication |
| 126454351 | 12645435 | 18 | Product used for unknown indication |
| 126454351 | 12645435 | 19 | Product used for unknown indication |
| 126454351 | 12645435 | 20 | Product used for unknown indication |
| 126454351 | 12645435 | 21 | Product used for unknown indication |
| 126454351 | 12645435 | 22 | Product used for unknown indication |
| 126454351 | 12645435 | 23 | Product used for unknown indication |
| 126454351 | 12645435 | 24 | Product used for unknown indication |
| 126454351 | 12645435 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126454351 | 12645435 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126454351 | 12645435 | Dizziness | |
| 126454351 | 12645435 | Fall | |
| 126454351 | 12645435 | Hand fracture | |
| 126454351 | 12645435 | Medication error | |
| 126454351 | 12645435 | Pelvic fracture | |
| 126454351 | 12645435 | Wrist fracture |
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 |
|---|---|---|---|---|---|---|
| 126454351 | 12645435 | 1 | 200702 | 200704 | 0 | |
| 126454351 | 12645435 | 3 | 201602 | 0 | ||
| 126454351 | 12645435 | 5 | 20160201 | 0 | ||
| 126454351 | 12645435 | 6 | 20160101 | 0 | ||
| 126454351 | 12645435 | 7 | 20150128 | 20160121 | 0 | |
| 126454351 | 12645435 | 8 | 20140701 | 0 | ||
| 126454351 | 12645435 | 9 | 20160127 | 0 | ||
| 126454351 | 12645435 | 10 | 20160127 | 0 | ||
| 126454351 | 12645435 | 11 | 20160201 | 0 | ||
| 126454351 | 12645435 | 12 | 20160127 | 0 | ||
| 126454351 | 12645435 | 14 | 20160127 | 0 | ||
| 126454351 | 12645435 | 15 | 20160127 | 0 | ||
| 126454351 | 12645435 | 17 | 20160201 | 0 | ||
| 126454351 | 12645435 | 18 | 20160127 | 0 | ||
| 126454351 | 12645435 | 19 | 20160201 | 0 | ||
| 126454351 | 12645435 | 21 | 20160127 | 0 | ||
| 126454351 | 12645435 | 24 | 20160127 | 0 | ||
| 126454351 | 12645435 | 25 | 20160127 | 0 |