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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117998114 | 11799811 | 4 | F | 20160815 | 20151203 | 20160819 | EXP | US-JAZZ-2015-US-020537 | JAZZ | 0.00 | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117998114 | 11799811 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 117998114 | 11799811 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 117998114 | 11799811 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 117998114 | 11799811 | 4 | SS | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 117998114 | 11799811 | 5 | SS | Diclofenac | DICLOFENAC | 1 | U | 0 | |||||||||||
| 117998114 | 11799811 | 6 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | UNK | 0 | EYE DROPS | ||||||||||
| 117998114 | 11799811 | 7 | C | ALPHAGAN P | BRIMONIDINE TARTRATE | 1 | UNK | 0 | DROP | ||||||||||
| 117998114 | 11799811 | 8 | C | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | Ophthalmic | UNK | 0 | SOLUTION | |||||||||
| 117998114 | 11799811 | 9 | C | PREDNISOLONE ACETATE. | PREDNISOLONE ACETATE | 1 | UNK | 0 | EYE DROPS | ||||||||||
| 117998114 | 11799811 | 10 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 11 | C | Atorvastatin | ATORVASTATIN | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 12 | C | BEANO | ASPERGILLUS NIGER .ALPHA.-GALACTOSIDASE | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 13 | C | Doxepin | DOXEPIN | 1 | Oral | UNK | 0 | ||||||||||
| 117998114 | 11799811 | 14 | C | FINASTERIDE. | FINASTERIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 15 | C | Lactaid fast act | LACTASE | 1 | UNK | 0 | |||||||||||
| 117998114 | 11799811 | 16 | C | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 17 | C | METFORMIN HYDROCHLORIDE. | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 18 | C | Multivitamins with iron | IRONVITAMINS | 1 | UNK | 0 | CHEWABLE TABLET | ||||||||||
| 117998114 | 11799811 | 19 | C | NASONEX | MOMETASONE FUROATE | 1 | UNK | 0 | NASAL SPRAY | ||||||||||
| 117998114 | 11799811 | 20 | C | Nystatin w/triamcinolone | 2 | UNK | 0 | CREAM | |||||||||||
| 117998114 | 11799811 | 21 | C | PRAMIPEXOLE. | PRAMIPEXOLE | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 22 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 117998114 | 11799811 | 23 | C | Tamsulosin hcl | TAMSULOSIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 117998114 | 11799811 | 24 | C | Tylenol arthritis er | 2 | UNK | 0 | TABLET | |||||||||||
| 117998114 | 11799811 | 25 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 117998114 | 11799811 | 26 | C | Verapamil er | VERAPAMIL HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 27 | C | ZAFIRLUKAST. | ZAFIRLUKAST | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 28 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | 0 | TABLET | ||||||||||
| 117998114 | 11799811 | 29 | C | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 117998114 | 11799811 | 30 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 117998114 | 11799811 | 31 | C | RITALIN SR | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117998114 | 11799811 | 1 | Narcolepsy |
| 117998114 | 11799811 | 2 | Cataplexy |
| 117998114 | 11799811 | 4 | Product used for unknown indication |
| 117998114 | 11799811 | 5 | Product used for unknown indication |
| 117998114 | 11799811 | 6 | Product used for unknown indication |
| 117998114 | 11799811 | 7 | Product used for unknown indication |
| 117998114 | 11799811 | 8 | Product used for unknown indication |
| 117998114 | 11799811 | 9 | Product used for unknown indication |
| 117998114 | 11799811 | 10 | Product used for unknown indication |
| 117998114 | 11799811 | 11 | Product used for unknown indication |
| 117998114 | 11799811 | 12 | Product used for unknown indication |
| 117998114 | 11799811 | 13 | Product used for unknown indication |
| 117998114 | 11799811 | 14 | Product used for unknown indication |
| 117998114 | 11799811 | 15 | Product used for unknown indication |
| 117998114 | 11799811 | 16 | Product used for unknown indication |
| 117998114 | 11799811 | 17 | Product used for unknown indication |
| 117998114 | 11799811 | 18 | Product used for unknown indication |
| 117998114 | 11799811 | 19 | Product used for unknown indication |
| 117998114 | 11799811 | 20 | Product used for unknown indication |
| 117998114 | 11799811 | 21 | Product used for unknown indication |
| 117998114 | 11799811 | 22 | Product used for unknown indication |
| 117998114 | 11799811 | 23 | Product used for unknown indication |
| 117998114 | 11799811 | 24 | Product used for unknown indication |
| 117998114 | 11799811 | 25 | Product used for unknown indication |
| 117998114 | 11799811 | 26 | Product used for unknown indication |
| 117998114 | 11799811 | 27 | Product used for unknown indication |
| 117998114 | 11799811 | 28 | Product used for unknown indication |
| 117998114 | 11799811 | 29 | Product used for unknown indication |
| 117998114 | 11799811 | 30 | Product used for unknown indication |
| 117998114 | 11799811 | 31 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117998114 | 11799811 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117998114 | 11799811 | Arthritis | |
| 117998114 | 11799811 | Condition aggravated | |
| 117998114 | 11799811 | Disturbance in attention | |
| 117998114 | 11799811 | Dizziness | |
| 117998114 | 11799811 | Nerve compression | |
| 117998114 | 11799811 | Prostatomegaly | |
| 117998114 | 11799811 | Pruritus | |
| 117998114 | 11799811 | Shoulder operation | |
| 117998114 | 11799811 | Sinusitis | |
| 117998114 | 11799811 | Skin disorder | |
| 117998114 | 11799811 | Sleep apnoea syndrome | |
| 117998114 | 11799811 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 117998114 | 11799811 | 1 | 200503 | 200504 | 0 | |
| 117998114 | 11799811 | 2 | 2005 | 200911 | 0 | |
| 117998114 | 11799811 | 3 | 200911 | 0 | ||
| 117998114 | 11799811 | 6 | 20140630 | 0 | ||
| 117998114 | 11799811 | 7 | 20140613 | 0 | ||
| 117998114 | 11799811 | 8 | 20140613 | 0 | ||
| 117998114 | 11799811 | 9 | 20140613 | 0 | ||
| 117998114 | 11799811 | 10 | 20140110 | 20140130 | 0 | |
| 117998114 | 11799811 | 11 | 20131028 | 0 | ||
| 117998114 | 11799811 | 12 | 20130925 | 0 | ||
| 117998114 | 11799811 | 13 | 20130925 | 0 | ||
| 117998114 | 11799811 | 14 | 20130925 | 0 | ||
| 117998114 | 11799811 | 15 | 20130925 | 0 | ||
| 117998114 | 11799811 | 16 | 20130925 | 0 | ||
| 117998114 | 11799811 | 17 | 20130925 | 0 | ||
| 117998114 | 11799811 | 18 | 20130925 | 0 | ||
| 117998114 | 11799811 | 19 | 20130925 | 0 | ||
| 117998114 | 11799811 | 20 | 20130925 | 0 | ||
| 117998114 | 11799811 | 21 | 20130925 | 0 | ||
| 117998114 | 11799811 | 22 | 20130925 | 0 | ||
| 117998114 | 11799811 | 23 | 20130925 | 0 | ||
| 117998114 | 11799811 | 24 | 20130925 | 0 | ||
| 117998114 | 11799811 | 25 | 20130925 | 0 | ||
| 117998114 | 11799811 | 26 | 20130925 | 0 | ||
| 117998114 | 11799811 | 27 | 20130925 | 0 | ||
| 117998114 | 11799811 | 28 | 20120625 | 20130924 | 0 | |
| 117998114 | 11799811 | 29 | 20130924 | 0 |