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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124740622 | 12474062 | 2 | F | 2016 | 20160701 | 20160616 | 20160708 | EXP | US-JAZZ-2016-US-010924 | JAZZ | 45.87 | YR | F | Y | 87.75000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124740622 | 12474062 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124740622 | 12474062 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124740622 | 12474062 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124740622 | 12474062 | 4 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124740622 | 12474062 | 5 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | ||||||||||
| 124740622 | 12474062 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124740622 | 12474062 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | ||||||||||
| 124740622 | 12474062 | 8 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124740622 | 12474062 | 9 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124740622 | 12474062 | 10 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | 40 MG, UNK | U | 0 | 40 | MG | CAPSULE | |||||||
| 124740622 | 12474062 | 11 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | 20 MG, UNK | U | 0 | 20 | MG | CAPSULE | |||||||
| 124740622 | 12474062 | 12 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124740622 | 12474062 | 13 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124740622 | 12474062 | 14 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 124740622 | 12474062 | 15 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | U | 0 | TABLET | ||||||||||
| 124740622 | 12474062 | 16 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 50 MG, UNK | U | 0 | 50 | MG | CAPSULE | |||||||
| 124740622 | 12474062 | 17 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 30 MG, UNK | U | 0 | 30 | MG | CAPSULE | |||||||
| 124740622 | 12474062 | 18 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124740622 | 12474062 | 1 | Narcolepsy |
| 124740622 | 12474062 | 2 | Cataplexy |
| 124740622 | 12474062 | 4 | Product used for unknown indication |
| 124740622 | 12474062 | 5 | Product used for unknown indication |
| 124740622 | 12474062 | 6 | Product used for unknown indication |
| 124740622 | 12474062 | 7 | Product used for unknown indication |
| 124740622 | 12474062 | 8 | Product used for unknown indication |
| 124740622 | 12474062 | 9 | Product used for unknown indication |
| 124740622 | 12474062 | 10 | Product used for unknown indication |
| 124740622 | 12474062 | 12 | Product used for unknown indication |
| 124740622 | 12474062 | 13 | Product used for unknown indication |
| 124740622 | 12474062 | 14 | Product used for unknown indication |
| 124740622 | 12474062 | 15 | Product used for unknown indication |
| 124740622 | 12474062 | 16 | Product used for unknown indication |
| 124740622 | 12474062 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124740622 | 12474062 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124740622 | 12474062 | Diarrhoea | |
| 124740622 | 12474062 | Nausea | |
| 124740622 | 12474062 | Nephrolithiasis | |
| 124740622 | 12474062 | Urinary tract disorder | |
| 124740622 | 12474062 | Uterine leiomyoma | |
| 124740622 | 12474062 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124740622 | 12474062 | 1 | 201604 | 201604 | 0 | |
| 124740622 | 12474062 | 2 | 201604 | 2016 | 0 | |
| 124740622 | 12474062 | 3 | 2016 | 0 | ||
| 124740622 | 12474062 | 4 | 20160508 | 0 | ||
| 124740622 | 12474062 | 5 | 20160424 | 201604 | 0 | |
| 124740622 | 12474062 | 6 | 20151223 | 201604 | 0 | |
| 124740622 | 12474062 | 7 | 20151223 | 0 | ||
| 124740622 | 12474062 | 8 | 20150404 | 20160406 | 0 | |
| 124740622 | 12474062 | 9 | 20151223 | 201604 | 0 | |
| 124740622 | 12474062 | 11 | 20151007 | 201606 | 0 | |
| 124740622 | 12474062 | 12 | 20151223 | 201604 | 0 | |
| 124740622 | 12474062 | 13 | 20151223 | 0 |