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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127443821 | 12744382 | 1 | I | 20160517 | 20160914 | 20160914 | PER | US-JAZZ-2016-US-009340 | JAZZ | 0.00 | F | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127443821 | 12744382 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127443821 | 12744382 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJSUTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127443821 | 12744382 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127443821 | 12744382 | 4 | SS | PROVIGIL | MODAFINIL | 1 | UNKNOWN DOSE | N | 0 | ||||||||||
| 127443821 | 12744382 | 5 | SS | NUVIGIL | ARMODAFINIL | 1 | 250 MG | U | 0 | TABLET | |||||||||
| 127443821 | 12744382 | 6 | SS | NUVIGIL | ARMODAFINIL | 1 | 150 MG | U | 0 | TABLET | |||||||||
| 127443821 | 12744382 | 7 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 20 MG | U | 0 | TABLET | |||||||||
| 127443821 | 12744382 | 8 | C | ROBAXIN | METHOCARBAMOL | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 9 | C | 5 Hour ENERGY | DIETARY SUPPLEMENT | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 10 | C | IBUPROFEN. | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 11 | C | VICKS NYQUIL | ACETAMINOPHENDEXTROMETHORPHAN HYDROBROMIDEDOXYLAMINE SUCCINATE | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 12 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 13 | C | EPIPEN | EPINEPHRINE | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 14 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 15 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 16 | C | MIRENA | LEVONORGESTREL | 1 | U | 0 | |||||||||||
| 127443821 | 12744382 | 17 | C | Theraflu cold + cough | 2 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127443821 | 12744382 | 1 | Narcolepsy |
| 127443821 | 12744382 | 2 | Cataplexy |
| 127443821 | 12744382 | 4 | Product used for unknown indication |
| 127443821 | 12744382 | 5 | Product used for unknown indication |
| 127443821 | 12744382 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127443821 | 12744382 | Decreased appetite | |
| 127443821 | 12744382 | Throat tightness |
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 |
|---|---|---|---|---|---|---|
| 127443821 | 12744382 | 1 | 201111 | 201111 | 0 | |
| 127443821 | 12744382 | 3 | 201602 | 0 | ||
| 127443821 | 12744382 | 5 | 20160509 | 0 | ||
| 127443821 | 12744382 | 6 | 20150707 | 20150922 | 0 | |
| 127443821 | 12744382 | 7 | 20160509 | 0 |