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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124974352 | 12497435 | 2 | F | 2012 | 20160701 | 20160624 | 20160708 | EXP | US-JAZZ-2016-US-011470 | JAZZ | 0.00 | M | Y | 0.00000 | 20160708 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124974352 | 12497435 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124974352 | 12497435 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 124974352 | 12497435 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 124974352 | 12497435 | 4 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974352 | 12497435 | 5 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974352 | 12497435 | 6 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974352 | 12497435 | 7 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974352 | 12497435 | 8 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974352 | 12497435 | 9 | C | COMBIVENT RESPIMAT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124974352 | 12497435 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124974352 | 12497435 | 11 | C | ALEVE | NAPROXEN SODIUM | 1 | U | 0 | |||||||||||
| 124974352 | 12497435 | 12 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124974352 | 12497435 | 13 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 | CAPSULE | ||||||||||
| 124974352 | 12497435 | 14 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974352 | 12497435 | 15 | C | LISINOPRIL. | LISINOPRIL | 1 | U | 0 | TABLET | ||||||||||
| 124974352 | 12497435 | 16 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 124974352 | 12497435 | 17 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124974352 | 12497435 | 18 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124974352 | 12497435 | 19 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124974352 | 12497435 | 20 | C | Tamsulosin hcl | TAMSULOSIN | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124974352 | 12497435 | 1 | Narcolepsy |
| 124974352 | 12497435 | 2 | Cataplexy |
| 124974352 | 12497435 | 4 | Product used for unknown indication |
| 124974352 | 12497435 | 5 | Product used for unknown indication |
| 124974352 | 12497435 | 6 | Product used for unknown indication |
| 124974352 | 12497435 | 7 | Product used for unknown indication |
| 124974352 | 12497435 | 8 | Product used for unknown indication |
| 124974352 | 12497435 | 9 | Product used for unknown indication |
| 124974352 | 12497435 | 10 | Product used for unknown indication |
| 124974352 | 12497435 | 11 | Product used for unknown indication |
| 124974352 | 12497435 | 12 | Product used for unknown indication |
| 124974352 | 12497435 | 13 | Product used for unknown indication |
| 124974352 | 12497435 | 14 | Product used for unknown indication |
| 124974352 | 12497435 | 15 | Product used for unknown indication |
| 124974352 | 12497435 | 16 | Product used for unknown indication |
| 124974352 | 12497435 | 17 | Product used for unknown indication |
| 124974352 | 12497435 | 18 | Product used for unknown indication |
| 124974352 | 12497435 | 19 | Product used for unknown indication |
| 124974352 | 12497435 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124974352 | 12497435 | HO |
| 124974352 | 12497435 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124974352 | 12497435 | Blood cholesterol increased | |
| 124974352 | 12497435 | Drug intolerance | |
| 124974352 | 12497435 | Feeling abnormal | |
| 124974352 | 12497435 | Hepatic function abnormal | |
| 124974352 | 12497435 | Intentional product use issue | |
| 124974352 | 12497435 | Osteoarthritis | |
| 124974352 | 12497435 | Renal impairment | |
| 124974352 | 12497435 | Sleep apnoea syndrome | |
| 124974352 | 12497435 | Staphylococcal infection |
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 |
|---|---|---|---|---|---|---|
| 124974352 | 12497435 | 1 | 201106 | 201106 | 0 | |
| 124974352 | 12497435 | 2 | 201106 | 0 | ||
| 124974352 | 12497435 | 4 | 20160215 | 0 | ||
| 124974352 | 12497435 | 5 | 20160215 | 0 | ||
| 124974352 | 12497435 | 6 | 20140926 | 0 | ||
| 124974352 | 12497435 | 7 | 20140926 | 0 | ||
| 124974352 | 12497435 | 8 | 20140911 | 0 | ||
| 124974352 | 12497435 | 9 | 20131104 | 0 | ||
| 124974352 | 12497435 | 10 | 20131104 | 0 | ||
| 124974352 | 12497435 | 14 | 201206 | 0 | ||
| 124974352 | 12497435 | 17 | 201406 | 0 | ||
| 124974352 | 12497435 | 18 | 201406 | 0 | ||
| 124974352 | 12497435 | 19 | 201206 | 0 | ||
| 124974352 | 12497435 | 20 | 201606 | 0 |