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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125647211 | 12564721 | 1 | I | 2015 | 20160118 | 20160718 | 20160718 | PER | US-JAZZ-2016-US-000947 | JAZZ | 0.00 | M | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125647211 | 12564721 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125647211 | 12564721 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | Y | 21196 | ORAL SOLUTION | ||||||||
| 125647211 | 12564721 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125647211 | 12564721 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | UNK | Y | 0 | ||||||||||
| 125647211 | 12564721 | 5 | SS | Codeine | CODEINE | 1 | Y | 0 | |||||||||||
| 125647211 | 12564721 | 6 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125647211 | 12564721 | 7 | C | NUEDEXTA | DEXTROMETHORPHAN HYDROBROMIDEQUINIDINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125647211 | 12564721 | 8 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125647211 | 12564721 | 9 | C | TOVIAZ | FESOTERODINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125647211 | 12564721 | 10 | C | URIBEL | HYOSCYAMINE SULFATEMETHENAMINEMETHYLENE BLUEPHENYL SALICYLATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125647211 | 12564721 | 1 | Narcolepsy |
| 125647211 | 12564721 | 2 | Cataplexy |
| 125647211 | 12564721 | 4 | Epilepsy |
| 125647211 | 12564721 | 5 | Tooth extraction |
| 125647211 | 12564721 | 6 | Product used for unknown indication |
| 125647211 | 12564721 | 7 | Product used for unknown indication |
| 125647211 | 12564721 | 8 | Product used for unknown indication |
| 125647211 | 12564721 | 9 | Product used for unknown indication |
| 125647211 | 12564721 | 10 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125647211 | 12564721 | Affect lability | |
| 125647211 | 12564721 | Atrial fibrillation | |
| 125647211 | 12564721 | Blood uric acid increased | |
| 125647211 | 12564721 | Bronchitis | |
| 125647211 | 12564721 | Chronic sinusitis | |
| 125647211 | 12564721 | Confusional state | |
| 125647211 | 12564721 | Depression | |
| 125647211 | 12564721 | Dizziness | |
| 125647211 | 12564721 | Fall | |
| 125647211 | 12564721 | Fatigue | |
| 125647211 | 12564721 | Hypertension | |
| 125647211 | 12564721 | Incorrect drug administration duration | |
| 125647211 | 12564721 | Osteoarthritis | |
| 125647211 | 12564721 | Pre-existing condition improved | |
| 125647211 | 12564721 | Sedation | |
| 125647211 | 12564721 | Spinal osteoarthritis | |
| 125647211 | 12564721 | Spondylitis | |
| 125647211 | 12564721 | Therapeutic response unexpected | |
| 125647211 | 12564721 | Tooth disorder | |
| 125647211 | 12564721 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125647211 | 12564721 | 1 | 201005 | 201010 | 0 | |
| 125647211 | 12564721 | 3 | 201312 | 0 | ||
| 125647211 | 12564721 | 4 | 20150119 | 20160118 | 0 | |
| 125647211 | 12564721 | 6 | 20150120 | 20150127 | 0 | |
| 125647211 | 12564721 | 7 | 20150120 | 0 | ||
| 125647211 | 12564721 | 8 | 20150120 | 20150127 | 0 | |
| 125647211 | 12564721 | 9 | 20131122 | 20150119 | 0 | |
| 125647211 | 12564721 | 10 | 20131122 | 20150119 | 0 |