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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126040501 | 12604050 | 1 | I | 2015 | 20160208 | 20160728 | 20160728 | PER | US-JAZZ-2016-US-002422 | JAZZ | 0.00 | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126040501 | 12604050 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | 21196 | ORAL SOLUTION | |||||||||
| 126040501 | 12604050 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126040501 | 12604050 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126040501 | 12604050 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126040501 | 12604050 | 5 | SS | HALDOL | HALOPERIDOL | 1 | 0 | TABLET | |||||||||||
| 126040501 | 12604050 | 6 | C | LAMICTAL | LAMOTRIGINE | 1 | 200 MG TABLET | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | 100 MG TABLET | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 8 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 9 | C | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 10 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 11 | C | METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126040501 | 12604050 | 12 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 126040501 | 12604050 | 13 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 14 | C | VISTARIL | HYDROXYZINE PAMOATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126040501 | 12604050 | 15 | C | VIIBRYD | VILAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 16 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 17 | C | CAFFEINE. | CAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 18 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 19 | C | LITHIUM CARBONATE ER | LITHIUM CARBONATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 20 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 21 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 22 | C | Benztropine mesilate | BENZTROPINE MESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 23 | C | MOBIC | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 24 | C | REMERON | MIRTAZAPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 25 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | GEL | |||||||||
| 126040501 | 12604050 | 26 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040501 | 12604050 | 27 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126040501 | 12604050 | 1 | Narcolepsy |
| 126040501 | 12604050 | 2 | Somnolence |
| 126040501 | 12604050 | 5 | Product used for unknown indication |
| 126040501 | 12604050 | 6 | Bipolar disorder |
| 126040501 | 12604050 | 8 | Bipolar disorder |
| 126040501 | 12604050 | 9 | Drug dependence |
| 126040501 | 12604050 | 10 | Narcolepsy |
| 126040501 | 12604050 | 11 | Narcolepsy |
| 126040501 | 12604050 | 12 | Product used for unknown indication |
| 126040501 | 12604050 | 13 | Product used for unknown indication |
| 126040501 | 12604050 | 14 | Product used for unknown indication |
| 126040501 | 12604050 | 15 | Product used for unknown indication |
| 126040501 | 12604050 | 16 | Product used for unknown indication |
| 126040501 | 12604050 | 17 | Product used for unknown indication |
| 126040501 | 12604050 | 18 | Product used for unknown indication |
| 126040501 | 12604050 | 19 | Product used for unknown indication |
| 126040501 | 12604050 | 20 | Product used for unknown indication |
| 126040501 | 12604050 | 21 | Product used for unknown indication |
| 126040501 | 12604050 | 22 | Product used for unknown indication |
| 126040501 | 12604050 | 23 | Product used for unknown indication |
| 126040501 | 12604050 | 24 | Product used for unknown indication |
| 126040501 | 12604050 | 25 | Product used for unknown indication |
| 126040501 | 12604050 | 26 | Product used for unknown indication |
| 126040501 | 12604050 | 27 | Bipolar disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126040501 | 12604050 | Arthritis | |
| 126040501 | 12604050 | Drug ineffective | |
| 126040501 | 12604050 | Muscle spasms |
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 |
|---|---|---|---|---|---|---|
| 126040501 | 12604050 | 2 | 201304 | 201305 | 0 | |
| 126040501 | 12604050 | 4 | 201406 | 2015 | 0 | |
| 126040501 | 12604050 | 6 | 20150824 | 0 | ||
| 126040501 | 12604050 | 7 | 20130807 | 20150824 | 0 | |
| 126040501 | 12604050 | 9 | 20130409 | 0 | ||
| 126040501 | 12604050 | 10 | 20130409 | 0 | ||
| 126040501 | 12604050 | 12 | 20151201 | 0 | ||
| 126040501 | 12604050 | 13 | 20150506 | 20150824 | 0 | |
| 126040501 | 12604050 | 14 | 20141014 | 0 | ||
| 126040501 | 12604050 | 15 | 20131111 | 20150824 | 0 | |
| 126040501 | 12604050 | 16 | 20130409 | 20150824 | 0 | |
| 126040501 | 12604050 | 17 | 20130409 | 0 | ||
| 126040501 | 12604050 | 18 | 20130409 | 20150824 | 0 | |
| 126040501 | 12604050 | 19 | 20130409 | 20150824 | 0 | |
| 126040501 | 12604050 | 20 | 20130409 | 20150824 | 0 | |
| 126040501 | 12604050 | 21 | 20130409 | 20150824 | 0 | |
| 126040501 | 12604050 | 22 | 20151031 | 0 | ||
| 126040501 | 12604050 | 25 | 20160208 | 0 |