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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122840532 | 12284053 | 2 | F | 201604 | 20160913 | 20160419 | 20160920 | EXP | US-JAZZ-2016-US-006935 | JAZZ | 42.70 | YR | F | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122840532 | 12284053 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 122840532 | 12284053 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 122840532 | 12284053 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 122840532 | 12284053 | 4 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122840532 | 12284053 | 5 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 122840532 | 12284053 | 6 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 122840532 | 12284053 | 7 | C | LASIX | FUROSEMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122840532 | 12284053 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 122840532 | 12284053 | 9 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 10 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 11 | C | Multiple vitamins | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 12 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122840532 | 12284053 | 13 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 14 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 15 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 16 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 17 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 122840532 | 12284053 | 18 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 500-50 DISKUS | U | 0 | ||||||||||
| 122840532 | 12284053 | 19 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 122840532 | 12284053 | 20 | C | LORATADINE. | LORATADINE | 1 | U | 0 | TABLET | ||||||||||
| 122840532 | 12284053 | 21 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | U | 0 | INHALER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122840532 | 12284053 | 1 | Narcolepsy |
| 122840532 | 12284053 | 4 | Product used for unknown indication |
| 122840532 | 12284053 | 5 | Product used for unknown indication |
| 122840532 | 12284053 | 6 | Product used for unknown indication |
| 122840532 | 12284053 | 7 | Product used for unknown indication |
| 122840532 | 12284053 | 8 | Product used for unknown indication |
| 122840532 | 12284053 | 9 | Product used for unknown indication |
| 122840532 | 12284053 | 10 | Product used for unknown indication |
| 122840532 | 12284053 | 11 | Product used for unknown indication |
| 122840532 | 12284053 | 12 | Product used for unknown indication |
| 122840532 | 12284053 | 13 | Product used for unknown indication |
| 122840532 | 12284053 | 14 | Product used for unknown indication |
| 122840532 | 12284053 | 15 | Product used for unknown indication |
| 122840532 | 12284053 | 16 | Product used for unknown indication |
| 122840532 | 12284053 | 17 | Product used for unknown indication |
| 122840532 | 12284053 | 18 | Product used for unknown indication |
| 122840532 | 12284053 | 19 | Product used for unknown indication |
| 122840532 | 12284053 | 20 | Product used for unknown indication |
| 122840532 | 12284053 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122840532 | 12284053 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122840532 | 12284053 | Depression | |
| 122840532 | 12284053 | Gastritis | |
| 122840532 | 12284053 | Hypertension | |
| 122840532 | 12284053 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 122840532 | 12284053 | 1 | 200804 | 200805 | 0 | |
| 122840532 | 12284053 | 3 | 200910 | 0 | ||
| 122840532 | 12284053 | 4 | 20160412 | 0 | ||
| 122840532 | 12284053 | 5 | 201603 | 0 | ||
| 122840532 | 12284053 | 6 | 201603 | 0 | ||
| 122840532 | 12284053 | 7 | 201603 | 0 | ||
| 122840532 | 12284053 | 8 | 201603 | 0 | ||
| 122840532 | 12284053 | 9 | 20151029 | 201604 | 0 | |
| 122840532 | 12284053 | 10 | 20151029 | 0 | ||
| 122840532 | 12284053 | 11 | 20151007 | 0 | ||
| 122840532 | 12284053 | 12 | 20151007 | 201603 | 0 | |
| 122840532 | 12284053 | 13 | 20010101 | 20151029 | 0 | |
| 122840532 | 12284053 | 14 | 20010101 | 20151029 | 0 | |
| 122840532 | 12284053 | 15 | 20010101 | 20151029 | 0 | |
| 122840532 | 12284053 | 16 | 20010101 | 20151029 | 0 | |
| 122840532 | 12284053 | 17 | 20010101 | 20151029 | 0 |