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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127956751 | 12795675 | 1 | I | 20160921 | 20160929 | 20160929 | EXP | US-JAZZ-2016-US-018505 | JAZZ | 0.00 | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127956751 | 12795675 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127956751 | 12795675 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127956751 | 12795675 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127956751 | 12795675 | 4 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127956751 | 12795675 | 5 | SS | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | 0 | |||||||||||
| 127956751 | 12795675 | 6 | SS | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 127956751 | 12795675 | 7 | C | HORIZANT | GABAPENTIN ENACARBIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 8 | C | SUCRALFATE. | SUCRALFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 9 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127956751 | 12795675 | 10 | C | LIDOCAINE HCL | LIDOCAINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127956751 | 12795675 | 11 | C | SOTRADECOL | SODIUM TETRADECYL SULFATE | 1 | UNK | U | 0 | ||||||||||
| 127956751 | 12795675 | 12 | C | REMERON | MIRTAZAPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 13 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 14 | C | SKELAXIN | METAXALONE | 1 | UNK | U | 0 | ||||||||||
| 127956751 | 12795675 | 15 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 16 | C | ASPIRIN (E.C.) | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 17 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 18 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127956751 | 12795675 | 19 | C | LEVOTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 20 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 21 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 22 | C | PEPCID /00305201/ | ALUMINUM HYDROXIDEMAGNESIUM CARBONATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 23 | C | RETIN-A | TRETINOIN | 1 | UNK | U | 0 | CREAM | |||||||||
| 127956751 | 12795675 | 24 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 25 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127956751 | 12795675 | 26 | C | CALCIUM AND VITAMIN D3 | CALCIUMCHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 127956751 | 12795675 | 27 | C | FLONASE /00908302/ | MOMETASONE FUROATE | 1 | U | 0 | NASAL SPRAY | ||||||||||
| 127956751 | 12795675 | 28 | C | IPRATROPIUM | IPRATROPIUM | 1 | U | 0 | SPRAY |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127956751 | 12795675 | 1 | Sleep disorder |
| 127956751 | 12795675 | 4 | Product used for unknown indication |
| 127956751 | 12795675 | 5 | Wrist fracture |
| 127956751 | 12795675 | 6 | Upper limb fracture |
| 127956751 | 12795675 | 7 | Product used for unknown indication |
| 127956751 | 12795675 | 8 | Product used for unknown indication |
| 127956751 | 12795675 | 9 | Product used for unknown indication |
| 127956751 | 12795675 | 10 | Product used for unknown indication |
| 127956751 | 12795675 | 11 | Product used for unknown indication |
| 127956751 | 12795675 | 12 | Product used for unknown indication |
| 127956751 | 12795675 | 13 | Product used for unknown indication |
| 127956751 | 12795675 | 14 | Product used for unknown indication |
| 127956751 | 12795675 | 15 | Product used for unknown indication |
| 127956751 | 12795675 | 16 | Product used for unknown indication |
| 127956751 | 12795675 | 17 | Product used for unknown indication |
| 127956751 | 12795675 | 18 | Product used for unknown indication |
| 127956751 | 12795675 | 19 | Product used for unknown indication |
| 127956751 | 12795675 | 20 | Product used for unknown indication |
| 127956751 | 12795675 | 21 | Product used for unknown indication |
| 127956751 | 12795675 | 22 | Product used for unknown indication |
| 127956751 | 12795675 | 23 | Product used for unknown indication |
| 127956751 | 12795675 | 24 | Product used for unknown indication |
| 127956751 | 12795675 | 25 | Product used for unknown indication |
| 127956751 | 12795675 | 26 | Product used for unknown indication |
| 127956751 | 12795675 | 27 | Product used for unknown indication |
| 127956751 | 12795675 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127956751 | 12795675 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127956751 | 12795675 | Drug ineffective | |
| 127956751 | 12795675 | Gastrointestinal disorder | |
| 127956751 | 12795675 | Neuralgia | |
| 127956751 | 12795675 | Pre-existing condition improved | |
| 127956751 | 12795675 | Therapeutic response unexpected | |
| 127956751 | 12795675 | Upper limb fracture | |
| 127956751 | 12795675 | Wrist fracture |
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 |
|---|---|---|---|---|---|---|
| 127956751 | 12795675 | 1 | 200311 | 200402 | 0 | |
| 127956751 | 12795675 | 2 | 200402 | 201204 | 0 | |
| 127956751 | 12795675 | 3 | 201604 | 0 | ||
| 127956751 | 12795675 | 5 | 2015 | 0 | ||
| 127956751 | 12795675 | 7 | 201608 | 0 | ||
| 127956751 | 12795675 | 8 | 20160526 | 0 | ||
| 127956751 | 12795675 | 9 | 20160120 | 0 | ||
| 127956751 | 12795675 | 10 | 20151202 | 20151202 | 0 | |
| 127956751 | 12795675 | 11 | 20151202 | 20151202 | 0 | |
| 127956751 | 12795675 | 12 | 20151123 | 0 | ||
| 127956751 | 12795675 | 13 | 20151103 | 201607 | 0 | |
| 127956751 | 12795675 | 14 | 20151103 | 20151103 | 0 | |
| 127956751 | 12795675 | 15 | 20151013 | 20151013 | 0 | |
| 127956751 | 12795675 | 16 | 20151013 | 20151102 | 0 | |
| 127956751 | 12795675 | 17 | 20151013 | 20151103 | 0 | |
| 127956751 | 12795675 | 18 | 20151013 | 201608 | 0 | |
| 127956751 | 12795675 | 19 | 20151013 | 0 | ||
| 127956751 | 12795675 | 20 | 20151013 | 0 | ||
| 127956751 | 12795675 | 21 | 20151013 | 20151103 | 0 | |
| 127956751 | 12795675 | 22 | 20151013 | 0 | ||
| 127956751 | 12795675 | 23 | 20151013 | 0 | ||
| 127956751 | 12795675 | 24 | 201408 | 0 | ||
| 127956751 | 12795675 | 25 | 201408 | 0 | ||
| 127956751 | 12795675 | 26 | 200608 | 0 |