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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238791 | 12523879 | 1 | I | 2015 | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022173 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238791 | 12523879 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125238791 | 12523879 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125238791 | 12523879 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 125238791 | 12523879 | 4 | C | Desmopressin | DESMOPRESSIN | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 6 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238791 | 12523879 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 8 | C | BUPROPION. | BUPROPION | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 9 | C | Calcium with Vitamin D | CALCIUMVITAMIN D | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 10 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238791 | 12523879 | 11 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 12 | C | TUMS | CALCIUM CARBONATE | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 125238791 | 12523879 | 13 | C | ALBUTEROL. | ALBUTEROL | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 14 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 15 | C | BUPROPION HYDROCHLORIDE XL | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 16 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238791 | 12523879 | 17 | C | BONIVA | IBANDRONATE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 18 | C | Calcium Magnesium+Zinc | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125238791 | 12523879 | 19 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 20 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238791 | 12523879 | 21 | C | DESMOPRESSIN ACETATE. | DESMOPRESSIN ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 22 | C | Fluoxetine hcl | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 23 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 24 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 125238791 | 12523879 | 25 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 125238791 | 12523879 | 26 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238791 | 12523879 | 27 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125238791 | 12523879 | 1 | Narcolepsy |
| 125238791 | 12523879 | 4 | Product used for unknown indication |
| 125238791 | 12523879 | 5 | Product used for unknown indication |
| 125238791 | 12523879 | 6 | Product used for unknown indication |
| 125238791 | 12523879 | 7 | Product used for unknown indication |
| 125238791 | 12523879 | 8 | Product used for unknown indication |
| 125238791 | 12523879 | 9 | Product used for unknown indication |
| 125238791 | 12523879 | 10 | Product used for unknown indication |
| 125238791 | 12523879 | 11 | Product used for unknown indication |
| 125238791 | 12523879 | 12 | Product used for unknown indication |
| 125238791 | 12523879 | 13 | Product used for unknown indication |
| 125238791 | 12523879 | 14 | Product used for unknown indication |
| 125238791 | 12523879 | 15 | Product used for unknown indication |
| 125238791 | 12523879 | 16 | Product used for unknown indication |
| 125238791 | 12523879 | 17 | Product used for unknown indication |
| 125238791 | 12523879 | 18 | Product used for unknown indication |
| 125238791 | 12523879 | 19 | Product used for unknown indication |
| 125238791 | 12523879 | 20 | Product used for unknown indication |
| 125238791 | 12523879 | 21 | Product used for unknown indication |
| 125238791 | 12523879 | 22 | Product used for unknown indication |
| 125238791 | 12523879 | 23 | Product used for unknown indication |
| 125238791 | 12523879 | 24 | Product used for unknown indication |
| 125238791 | 12523879 | 25 | Product used for unknown indication |
| 125238791 | 12523879 | 26 | Product used for unknown indication |
| 125238791 | 12523879 | 27 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125238791 | 12523879 | Nausea | |
| 125238791 | 12523879 | Peripheral swelling |
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 |
|---|---|---|---|---|---|---|
| 125238791 | 12523879 | 1 | 20150605 | 201506 | 0 | |
| 125238791 | 12523879 | 2 | 201506 | 2015 | 0 | |
| 125238791 | 12523879 | 3 | 2015 | 0 | ||
| 125238791 | 12523879 | 5 | 20150429 | 0 | ||
| 125238791 | 12523879 | 6 | 20150429 | 0 | ||
| 125238791 | 12523879 | 10 | 20150429 | 0 | ||
| 125238791 | 12523879 | 12 | 20150429 | 0 | ||
| 125238791 | 12523879 | 14 | 20150429 | 0 | ||
| 125238791 | 12523879 | 15 | 20150429 | 0 | ||
| 125238791 | 12523879 | 16 | 20150429 | 0 | ||
| 125238791 | 12523879 | 17 | 20150429 | 0 | ||
| 125238791 | 12523879 | 18 | 20150429 | 0 | ||
| 125238791 | 12523879 | 19 | 20150429 | 0 | ||
| 125238791 | 12523879 | 20 | 20150429 | 0 | ||
| 125238791 | 12523879 | 21 | 20150429 | 0 | ||
| 125238791 | 12523879 | 22 | 20150429 | 0 | ||
| 125238791 | 12523879 | 23 | 20150429 | 0 | ||
| 125238791 | 12523879 | 24 | 20150429 | 0 | ||
| 125238791 | 12523879 | 25 | 20150429 | 0 | ||
| 125238791 | 12523879 | 26 | 20150429 | 0 | ||
| 125238791 | 12523879 | 27 | 20150429 | 0 |