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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125813421 | 12581342 | 1 | I | 20160713 | 20160721 | 20160721 | EXP | US-JAZZ-2016-US-013170 | JAZZ | 0.00 | M | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125813421 | 12581342 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125813421 | 12581342 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125813421 | 12581342 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125813421 | 12581342 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 5 | SS | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125813421 | 12581342 | 7 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 8 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 9 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 10 | C | Cetirizine hcl | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 11 | C | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125813421 | 12581342 | 12 | C | Tamsulosin hcl | TAMSULOSIN | 1 | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125813421 | 12581342 | 1 | Narcolepsy |
| 125813421 | 12581342 | 4 | Product used for unknown indication |
| 125813421 | 12581342 | 5 | Product used for unknown indication |
| 125813421 | 12581342 | 6 | Product used for unknown indication |
| 125813421 | 12581342 | 7 | Product used for unknown indication |
| 125813421 | 12581342 | 8 | Product used for unknown indication |
| 125813421 | 12581342 | 10 | Product used for unknown indication |
| 125813421 | 12581342 | 11 | Product used for unknown indication |
| 125813421 | 12581342 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125813421 | 12581342 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125813421 | 12581342 | Hunger | |
| 125813421 | 12581342 | Hypertension | |
| 125813421 | 12581342 | Nephrolithiasis | |
| 125813421 | 12581342 | Pulmonary mass | |
| 125813421 | 12581342 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 125813421 | 12581342 | 1 | 201311 | 201311 | 0 | |
| 125813421 | 12581342 | 2 | 201311 | 201402 | 0 | |
| 125813421 | 12581342 | 3 | 201402 | 0 | ||
| 125813421 | 12581342 | 4 | 20131118 | 0 | ||
| 125813421 | 12581342 | 5 | 20151228 | 0 | ||
| 125813421 | 12581342 | 6 | 20151228 | 0 | ||
| 125813421 | 12581342 | 7 | 20151226 | 0 | ||
| 125813421 | 12581342 | 8 | 20151226 | 20151228 | 0 | |
| 125813421 | 12581342 | 9 | 201605 | 0 | ||
| 125813421 | 12581342 | 10 | 20131112 | 0 | ||
| 125813421 | 12581342 | 11 | 20131104 | 0 |