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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124129052 | 12412905 | 2 | F | 201411 | 20160629 | 20160527 | 20160707 | EXP | US-JAZZ-2016-US-009519 | JAZZ | 53.26 | YR | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124129052 | 12412905 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124129052 | 12412905 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124129052 | 12412905 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, FIRST DOSE | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 124129052 | 12412905 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124129052 | 12412905 | 5 | C | IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124129052 | 12412905 | 6 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 5-325 | U | 0 | ||||||||||
| 124129052 | 12412905 | 7 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 7.5-500 | U | 0 | ||||||||||
| 124129052 | 12412905 | 8 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124129052 | 12412905 | 9 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124129052 | 12412905 | 10 | C | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124129052 | 12412905 | 11 | C | SINEMET | CARBIDOPALEVODOPA | 1 | UNK | U | 0 | TABLET | |||||||||
| 124129052 | 12412905 | 12 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | UNK | U | 0 | ||||||||||
| 124129052 | 12412905 | 13 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124129052 | 12412905 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124129052 | 12412905 | 15 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124129052 | 12412905 | 16 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124129052 | 12412905 | 17 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | U | 0 | TABLET | ||||||||||
| 124129052 | 12412905 | 18 | C | LASIX | FUROSEMIDE | 1 | U | 0 | TABLET | ||||||||||
| 124129052 | 12412905 | 19 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | U | 0 | TABLET | ||||||||||
| 124129052 | 12412905 | 20 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124129052 | 12412905 | 21 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | SYRUP | |||||||||
| 124129052 | 12412905 | 22 | C | PROVENTIL HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 124129052 | 12412905 | 23 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124129052 | 12412905 | 1 | Narcolepsy |
| 124129052 | 12412905 | 2 | Cataplexy |
| 124129052 | 12412905 | 5 | Product used for unknown indication |
| 124129052 | 12412905 | 6 | Product used for unknown indication |
| 124129052 | 12412905 | 8 | Product used for unknown indication |
| 124129052 | 12412905 | 9 | Product used for unknown indication |
| 124129052 | 12412905 | 10 | Product used for unknown indication |
| 124129052 | 12412905 | 11 | Product used for unknown indication |
| 124129052 | 12412905 | 12 | Product used for unknown indication |
| 124129052 | 12412905 | 13 | Product used for unknown indication |
| 124129052 | 12412905 | 14 | Product used for unknown indication |
| 124129052 | 12412905 | 15 | Product used for unknown indication |
| 124129052 | 12412905 | 16 | Product used for unknown indication |
| 124129052 | 12412905 | 17 | Product used for unknown indication |
| 124129052 | 12412905 | 18 | Product used for unknown indication |
| 124129052 | 12412905 | 19 | Product used for unknown indication |
| 124129052 | 12412905 | 20 | Product used for unknown indication |
| 124129052 | 12412905 | 21 | Product used for unknown indication |
| 124129052 | 12412905 | 22 | Product used for unknown indication |
| 124129052 | 12412905 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124129052 | 12412905 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124129052 | 12412905 | Back pain | |
| 124129052 | 12412905 | Depression | |
| 124129052 | 12412905 | Hypertension | |
| 124129052 | 12412905 | Irritable bowel syndrome | |
| 124129052 | 12412905 | Osteoporosis | |
| 124129052 | 12412905 | Restless legs syndrome | |
| 124129052 | 12412905 | Seasonal allergy | |
| 124129052 | 12412905 | Spinal fusion surgery |
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 |
|---|---|---|---|---|---|---|
| 124129052 | 12412905 | 1 | 200609 | 2006 | 0 | |
| 124129052 | 12412905 | 2 | 200611 | 200706 | 0 | |
| 124129052 | 12412905 | 3 | 200707 | 0 | ||
| 124129052 | 12412905 | 4 | 200707 | 0 | ||
| 124129052 | 12412905 | 5 | 201605 | 0 | ||
| 124129052 | 12412905 | 6 | 20160422 | 0 | ||
| 124129052 | 12412905 | 7 | 20140117 | 20140119 | 0 | |
| 124129052 | 12412905 | 8 | 201604 | 0 | ||
| 124129052 | 12412905 | 9 | 201604 | 0 | ||
| 124129052 | 12412905 | 10 | 201602 | 0 | ||
| 124129052 | 12412905 | 11 | 201512 | 0 | ||
| 124129052 | 12412905 | 12 | 201411 | 0 | ||
| 124129052 | 12412905 | 13 | 201411 | 0 | ||
| 124129052 | 12412905 | 14 | 20141031 | 201602 | 0 | |
| 124129052 | 12412905 | 15 | 20140820 | 201505 | 0 | |
| 124129052 | 12412905 | 16 | 20130226 | 201405 | 0 | |
| 124129052 | 12412905 | 20 | 201605 | 0 | ||
| 124129052 | 12412905 | 21 | 201605 | 0 | ||
| 124129052 | 12412905 | 22 | 201305 | 0 | ||
| 124129052 | 12412905 | 23 | 201505 | 0 |