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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124344492 | 12434449 | 2 | F | 2015 | 20160628 | 20160603 | 20160706 | EXP | US-JAZZ-2015-US-017226 | JAZZ | 0.00 | M | Y | 98.00000 | KG | 20160706 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124344492 | 12434449 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124344492 | 12434449 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | N | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124344492 | 12434449 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124344492 | 12434449 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | N | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124344492 | 12434449 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 TO 4 G, BID | N | 21196 | ORAL SOLUTION | ||||||||
| 124344492 | 12434449 | 6 | SS | PROVIGIL | MODAFINIL | 1 | U | 0 | |||||||||||
| 124344492 | 12434449 | 7 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124344492 | 12434449 | 8 | C | CARAFATE | SUCRALFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124344492 | 12434449 | 9 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124344492 | 12434449 | 10 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124344492 | 12434449 | 11 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 5-325 MG | U | 0 | TABLET | |||||||||
| 124344492 | 12434449 | 12 | C | VALIUM | DIAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124344492 | 12434449 | 13 | C | Flonase allergy RLF | 2 | UNK | U | 0 | SPRAY | ||||||||||
| 124344492 | 12434449 | 14 | C | MINIPRESS | PRAZOSIN HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124344492 | 12434449 | 15 | C | RESTORIL | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124344492 | 12434449 | 16 | C | RESTORIL | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124344492 | 12434449 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 124344492 | 12434449 | 18 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124344492 | 12434449 | 19 | C | Doxepin | DOXEPIN | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124344492 | 12434449 | 1 | Narcolepsy |
| 124344492 | 12434449 | 6 | Product used for unknown indication |
| 124344492 | 12434449 | 7 | Gastrooesophageal reflux disease |
| 124344492 | 12434449 | 8 | Gastrooesophageal reflux disease |
| 124344492 | 12434449 | 9 | Nausea |
| 124344492 | 12434449 | 10 | Product used for unknown indication |
| 124344492 | 12434449 | 11 | Product used for unknown indication |
| 124344492 | 12434449 | 12 | Product used for unknown indication |
| 124344492 | 12434449 | 13 | Product used for unknown indication |
| 124344492 | 12434449 | 14 | Product used for unknown indication |
| 124344492 | 12434449 | 15 | Product used for unknown indication |
| 124344492 | 12434449 | 17 | Product used for unknown indication |
| 124344492 | 12434449 | 18 | Product used for unknown indication |
| 124344492 | 12434449 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124344492 | 12434449 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124344492 | 12434449 | Blood triglycerides increased | |
| 124344492 | 12434449 | Hunger | |
| 124344492 | 12434449 | Hyperphagia | |
| 124344492 | 12434449 | Insomnia | |
| 124344492 | 12434449 | Loss of consciousness | |
| 124344492 | 12434449 | Nausea | |
| 124344492 | 12434449 | Retching | |
| 124344492 | 12434449 | Somnolence | |
| 124344492 | 12434449 | Weight increased | |
| 124344492 | 12434449 | 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 |
|---|---|---|---|---|---|---|
| 124344492 | 12434449 | 1 | 201012 | 201012 | 0 | |
| 124344492 | 12434449 | 2 | 201012 | 0 | ||
| 124344492 | 12434449 | 3 | 201504 | 201505 | 0 | |
| 124344492 | 12434449 | 4 | 201505 | 201506 | 0 | |
| 124344492 | 12434449 | 5 | 201506 | 0 | ||
| 124344492 | 12434449 | 8 | 20141001 | 0 | ||
| 124344492 | 12434449 | 10 | 20151023 | 0 | ||
| 124344492 | 12434449 | 11 | 20151023 | 0 | ||
| 124344492 | 12434449 | 12 | 20151023 | 0 | ||
| 124344492 | 12434449 | 13 | 20151009 | 0 | ||
| 124344492 | 12434449 | 14 | 20141001 | 20151021 | 0 | |
| 124344492 | 12434449 | 15 | 20141001 | 20150415 | 0 | |
| 124344492 | 12434449 | 17 | 20141001 | 0 | ||
| 124344492 | 12434449 | 18 | 20101209 | 20120101 | 0 | |
| 124344492 | 12434449 | 19 | 20101209 | 20101220 | 0 |