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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127019431 | 12701943 | 1 | I | 2015 | 20160418 | 20160831 | 20160831 | PER | US-JAZZ-2016-US-007331 | JAZZ | 37.54 | YR | F | Y | 69.84000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127019431 | 12701943 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | 21196 | ORAL SOLUTION | |||||||||
| 127019431 | 12701943 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | 21196 | ORAL SOLUTION | |||||||||
| 127019431 | 12701943 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, FIRST DOSE | 21196 | 3.25 | G | ORAL SOLUTION | |||||||
| 127019431 | 12701943 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127019431 | 12701943 | 5 | SS | CLARITIN | LORATADINE | 1 | 0 | ||||||||||||
| 127019431 | 12701943 | 6 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 7 | C | ALLEGRA-D | FEXOFENADINEPSEUDOEPHEDRINE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 8 | C | COLACE | DOCUSATE SODIUM | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 9 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 10 | C | Phillips | DOCUSATE SODIUM | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 11 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 12 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 13 | C | CHLORDIAZEPOXIDE. | CHLORDIAZEPOXIDE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 14 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 15 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 16 | C | ROPINIROLE. | ROPINIROLE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 17 | C | CLARITIN-D 12 HOUR | LORATADINEPSEUDOEPHEDRINE SULFATE | 1 | U | 0 | |||||||||||
| 127019431 | 12701943 | 18 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127019431 | 12701943 | 1 | Narcolepsy |
| 127019431 | 12701943 | 5 | Product used for unknown indication |
| 127019431 | 12701943 | 13 | Anxiety |
| 127019431 | 12701943 | 15 | Affective disorder |
| 127019431 | 12701943 | 16 | Restless legs syndrome |
| 127019431 | 12701943 | 18 | Affective disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127019431 | 12701943 | Drug ineffective | |
| 127019431 | 12701943 | Hypersensitivity | |
| 127019431 | 12701943 | Pre-existing condition improved | |
| 127019431 | 12701943 | Therapeutic response unexpected | |
| 127019431 | 12701943 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127019431 | 12701943 | 1 | 201511 | 2015 | 0 |