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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127018321 | 12701832 | 1 | I | 201511 | 20160421 | 20160831 | 20160831 | PER | US-JAZZ-2016-US-007622 | JAZZ | 29.75 | YR | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127018321 | 12701832 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127018321 | 12701832 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127018321 | 12701832 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127018321 | 12701832 | 4 | SS | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 5 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 6 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 7 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 8 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 9 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 10 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 11 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 13 | C | DILANTIN | PHENYTOIN | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 14 | C | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 15 | C | KEPPRA | LEVETIRACETAM | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 16 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 17 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127018321 | 12701832 | 18 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127018321 | 12701832 | 1 | Narcolepsy |
| 127018321 | 12701832 | 2 | Cataplexy |
| 127018321 | 12701832 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127018321 | 12701832 | Drug ineffective | |
| 127018321 | 12701832 | Hypertension | |
| 127018321 | 12701832 | Weight decreased | |
| 127018321 | 12701832 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127018321 | 12701832 | 1 | 201205 | 201205 | 0 | |
| 127018321 | 12701832 | 3 | 201206 | 0 |