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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124031944 | 12403194 | 4 | F | 20160811 | 20160525 | 20160819 | EXP | US-JAZZ-2016-US-009306 | JAZZ | 0.00 | F | Y | 0.00000 | 20160819 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124031944 | 12403194 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124031944 | 12403194 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124031944 | 12403194 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 124031944 | 12403194 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124031944 | 12403194 | 5 | C | TRAMADOL ER | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124031944 | 12403194 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 8 | C | EXCEDRIN EXTRA STRENGTH | ACETAMINOPHENASPIRINCAFFEINE | 1 | UNK | U | 0 | ||||||||||
| 124031944 | 12403194 | 9 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 124031944 | 12403194 | 10 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 30 MG | U | 0 | 30 | MG | CAPSULE | |||||||
| 124031944 | 12403194 | 11 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 15 MG | U | 0 | 15 | MG | CAPSULE | |||||||
| 124031944 | 12403194 | 12 | C | Anusol-hc | 2 | UNK | U | 0 | CREAM | ||||||||||
| 124031944 | 12403194 | 13 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124031944 | 12403194 | 14 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124031944 | 12403194 | 15 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 16 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 17 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 18 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 19 | C | Dexilant dr | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 124031944 | 12403194 | 20 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 21 | C | Glumetza er | 2 | UNK | U | 0 | TABLET | ||||||||||
| 124031944 | 12403194 | 22 | C | LIDODERM | LIDOCAINE | 1 | UNK | U | 0 | PATCH | |||||||||
| 124031944 | 12403194 | 23 | C | PRENATAL PLUS IRON | .ALPHA.-TOCOPHEROL ACETATE, DL-.BETA.-CAROTENEASCORBIC ACIDCALCIUM CARBONATECHOLECALCIFEROLCUPRIC OXIDECYANOCOBALAMINFERROUS FUMARATEFOLIC ACIDNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVINTHIAMINE MONONITRATEVITAMIN A ACETATEINC OXIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 24 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 124031944 | 12403194 | 25 | C | ROXICODONE | OXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 26 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 27 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 124031944 | 12403194 | 28 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 29 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124031944 | 12403194 | 30 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124031944 | 12403194 | 1 | Narcolepsy |
| 124031944 | 12403194 | 5 | Product used for unknown indication |
| 124031944 | 12403194 | 6 | Product used for unknown indication |
| 124031944 | 12403194 | 7 | Product used for unknown indication |
| 124031944 | 12403194 | 8 | Product used for unknown indication |
| 124031944 | 12403194 | 9 | Product used for unknown indication |
| 124031944 | 12403194 | 10 | Product used for unknown indication |
| 124031944 | 12403194 | 12 | Product used for unknown indication |
| 124031944 | 12403194 | 13 | Product used for unknown indication |
| 124031944 | 12403194 | 15 | Product used for unknown indication |
| 124031944 | 12403194 | 16 | Product used for unknown indication |
| 124031944 | 12403194 | 18 | Product used for unknown indication |
| 124031944 | 12403194 | 19 | Product used for unknown indication |
| 124031944 | 12403194 | 20 | Product used for unknown indication |
| 124031944 | 12403194 | 21 | Product used for unknown indication |
| 124031944 | 12403194 | 22 | Product used for unknown indication |
| 124031944 | 12403194 | 23 | Product used for unknown indication |
| 124031944 | 12403194 | 24 | Product used for unknown indication |
| 124031944 | 12403194 | 25 | Product used for unknown indication |
| 124031944 | 12403194 | 26 | Product used for unknown indication |
| 124031944 | 12403194 | 27 | Product used for unknown indication |
| 124031944 | 12403194 | 28 | Product used for unknown indication |
| 124031944 | 12403194 | 29 | Product used for unknown indication |
| 124031944 | 12403194 | 30 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124031944 | 12403194 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124031944 | 12403194 | Anxiety | |
| 124031944 | 12403194 | Condition aggravated | |
| 124031944 | 12403194 | Initial insomnia | |
| 124031944 | 12403194 | Intervertebral disc protrusion |
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 |
|---|---|---|---|---|---|---|
| 124031944 | 12403194 | 1 | 201509 | 201510 | 0 | |
| 124031944 | 12403194 | 2 | 201510 | 201603 | 0 | |
| 124031944 | 12403194 | 3 | 201603 | 0 | ||
| 124031944 | 12403194 | 4 | 201603 | 0 | ||
| 124031944 | 12403194 | 5 | 201605 | 0 | ||
| 124031944 | 12403194 | 6 | 20151229 | 201605 | 0 | |
| 124031944 | 12403194 | 7 | 20151116 | 0 | ||
| 124031944 | 12403194 | 8 | 20151116 | 0 | ||
| 124031944 | 12403194 | 9 | 20151116 | 0 | ||
| 124031944 | 12403194 | 10 | 20150825 | 20151116 | 0 | |
| 124031944 | 12403194 | 11 | 20151105 | 20151116 | 0 | |
| 124031944 | 12403194 | 12 | 20151105 | 20151116 | 0 | |
| 124031944 | 12403194 | 13 | 20150825 | 20151116 | 0 | |
| 124031944 | 12403194 | 14 | 20151105 | 0 | ||
| 124031944 | 12403194 | 15 | 20151105 | 20151116 | 0 | |
| 124031944 | 12403194 | 16 | 20150825 | 20151116 | 0 | |
| 124031944 | 12403194 | 17 | 20151105 | 0 | ||
| 124031944 | 12403194 | 18 | 20151105 | 201605 | 0 | |
| 124031944 | 12403194 | 19 | 20150825 | 0 | ||
| 124031944 | 12403194 | 20 | 20150825 | 201605 | 0 | |
| 124031944 | 12403194 | 21 | 20150825 | 201605 | 0 | |
| 124031944 | 12403194 | 22 | 20150825 | 0 | ||
| 124031944 | 12403194 | 23 | 20150825 | 0 | ||
| 124031944 | 12403194 | 24 | 20150825 | 0 | ||
| 124031944 | 12403194 | 25 | 20150825 | 201605 | 0 | |
| 124031944 | 12403194 | 26 | 20150825 | 0 | ||
| 124031944 | 12403194 | 27 | 20150825 | 0 | ||
| 124031944 | 12403194 | 28 | 20150825 | 0 | ||
| 124031944 | 12403194 | 29 | 20150825 | 20150911 | 0 | |
| 124031944 | 12403194 | 30 | 20150825 | 0 |