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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124207722 | 12420772 | 2 | F | 20160923 | 20160531 | 20160928 | PER | US-JAZZ-2015-US-016567 | JAZZ | 0.00 | M | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124207722 | 12420772 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124207722 | 12420772 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 124207722 | 12420772 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 124207722 | 12420772 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124207722 | 12420772 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124207722 | 12420772 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 124207722 | 12420772 | 7 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 8 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 9 | C | PEPCID | FAMOTIDINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 10 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | 10 MG, UNK | U | 0 | 10 | MG | TABLET | |||||||
| 124207722 | 12420772 | 11 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | 10 MG, UNK | U | 0 | 10 | MG | TABLET | |||||||
| 124207722 | 12420772 | 12 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | 5 MG, UNK | U | 0 | 5 | MG | TABLET | |||||||
| 124207722 | 12420772 | 13 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 40 MG, UNK | U | 0 | 40 | MG | CAPSULE | |||||||
| 124207722 | 12420772 | 14 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, UNK | U | 0 | 20 | MG | CAPSULE | |||||||
| 124207722 | 12420772 | 15 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 16 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124207722 | 12420772 | 17 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 124207722 | 12420772 | 18 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 19 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 20 | C | BUSPIRONE HYDROCHLORIDE. | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124207722 | 12420772 | 21 | C | MUCINEX | GUAIFENESIN | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124207722 | 12420772 | 1 | Narcolepsy |
| 124207722 | 12420772 | 2 | Cataplexy |
| 124207722 | 12420772 | 7 | Somnolence |
| 124207722 | 12420772 | 9 | Product used for unknown indication |
| 124207722 | 12420772 | 10 | Product used for unknown indication |
| 124207722 | 12420772 | 13 | Product used for unknown indication |
| 124207722 | 12420772 | 15 | Product used for unknown indication |
| 124207722 | 12420772 | 16 | Product used for unknown indication |
| 124207722 | 12420772 | 17 | Product used for unknown indication |
| 124207722 | 12420772 | 18 | Product used for unknown indication |
| 124207722 | 12420772 | 19 | Product used for unknown indication |
| 124207722 | 12420772 | 20 | Product used for unknown indication |
| 124207722 | 12420772 | 21 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124207722 | 12420772 | Anxiety |
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 |
|---|---|---|---|---|---|---|
| 124207722 | 12420772 | 1 | 201005 | 201006 | 0 | |
| 124207722 | 12420772 | 3 | 201108 | 2013 | 0 | |
| 124207722 | 12420772 | 4 | 201108 | 2013 | 0 | |
| 124207722 | 12420772 | 5 | 201407 | 201409 | 0 | |
| 124207722 | 12420772 | 6 | 201504 | 0 | ||
| 124207722 | 12420772 | 7 | 20150113 | 20151013 | 0 | |
| 124207722 | 12420772 | 8 | 20150921 | 0 | ||
| 124207722 | 12420772 | 9 | 20151013 | 0 | ||
| 124207722 | 12420772 | 10 | 20140626 | 20150113 | 0 | |
| 124207722 | 12420772 | 11 | 20150921 | 20151019 | 0 | |
| 124207722 | 12420772 | 12 | 20150921 | 20151013 | 0 | |
| 124207722 | 12420772 | 13 | 20140626 | 20150413 | 0 | |
| 124207722 | 12420772 | 14 | 20150413 | 0 | ||
| 124207722 | 12420772 | 15 | 20140626 | 20150413 | 0 | |
| 124207722 | 12420772 | 16 | 20140626 | 20150413 | 0 | |
| 124207722 | 12420772 | 17 | 20140626 | 0 | ||
| 124207722 | 12420772 | 18 | 20140601 | 20140626 | 0 | |
| 124207722 | 12420772 | 19 | 20140328 | 20150401 | 0 | |
| 124207722 | 12420772 | 21 | 20100101 | 20120309 | 0 |