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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125632973 | 12563297 | 3 | F | 2016 | 20160805 | 20160715 | 20160812 | EXP | US-JAZZ-2016-US-012765 | JAZZ | 0.00 | M | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125632973 | 12563297 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125632973 | 12563297 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125632973 | 12563297 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125632973 | 12563297 | 4 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 125632973 | 12563297 | 5 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125632973 | 12563297 | 6 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125632973 | 12563297 | 7 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125632973 | 12563297 | 8 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125632973 | 12563297 | 9 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125632973 | 12563297 | 10 | C | RIZATRIPTAN. | RIZATRIPTAN | 1 | UNK | U | 0 | ||||||||||
| 125632973 | 12563297 | 11 | C | L-methylfolate | 2 | UNK | U | 0 | |||||||||||
| 125632973 | 12563297 | 12 | C | PROVENTIL HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125632973 | 12563297 | 13 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 125632973 | 12563297 | 14 | C | LATUDA | LURASIDONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125632973 | 12563297 | 15 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125632973 | 12563297 | 16 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125632973 | 12563297 | 17 | C | ZENZEDI | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125632973 | 12563297 | 1 | Narcolepsy |
| 125632973 | 12563297 | 4 | Product used for unknown indication |
| 125632973 | 12563297 | 5 | Product used for unknown indication |
| 125632973 | 12563297 | 6 | Product used for unknown indication |
| 125632973 | 12563297 | 7 | Product used for unknown indication |
| 125632973 | 12563297 | 8 | Product used for unknown indication |
| 125632973 | 12563297 | 9 | Product used for unknown indication |
| 125632973 | 12563297 | 10 | Product used for unknown indication |
| 125632973 | 12563297 | 11 | Product used for unknown indication |
| 125632973 | 12563297 | 12 | Product used for unknown indication |
| 125632973 | 12563297 | 13 | Product used for unknown indication |
| 125632973 | 12563297 | 14 | Product used for unknown indication |
| 125632973 | 12563297 | 15 | Product used for unknown indication |
| 125632973 | 12563297 | 16 | Product used for unknown indication |
| 125632973 | 12563297 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125632973 | 12563297 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125632973 | 12563297 | Drug interaction | |
| 125632973 | 12563297 | Inappropriate schedule of drug administration | |
| 125632973 | 12563297 | Mania | |
| 125632973 | 12563297 | Memory impairment | |
| 125632973 | 12563297 | Seizure | |
| 125632973 | 12563297 | Somnambulism | |
| 125632973 | 12563297 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 125632973 | 12563297 | 1 | 201601 | 201601 | 0 | |
| 125632973 | 12563297 | 2 | 201601 | 201602 | 0 | |
| 125632973 | 12563297 | 3 | 201602 | 201603 | 0 | |
| 125632973 | 12563297 | 4 | 20151230 | 201603 | 0 | |
| 125632973 | 12563297 | 5 | 201602 | 201606 | 0 | |
| 125632973 | 12563297 | 6 | 20160121 | 201605 | 0 | |
| 125632973 | 12563297 | 7 | 201601 | 201605 | 0 | |
| 125632973 | 12563297 | 8 | 20151230 | 0 | ||
| 125632973 | 12563297 | 9 | 20151230 | 0 | ||
| 125632973 | 12563297 | 10 | 20151230 | 201605 | 0 | |
| 125632973 | 12563297 | 11 | 201501 | 0 | ||
| 125632973 | 12563297 | 12 | 201101 | 0 | ||
| 125632973 | 12563297 | 14 | 201605 | 0 | ||
| 125632973 | 12563297 | 15 | 201605 | 0 |