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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119226045 | 11922604 | 5 | F | 20160720 | 20160115 | 20160728 | EXP | US-JAZZ-2016-US-000448 | JAZZ | 0.00 | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119226045 | 11922604 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 119226045 | 11922604 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 119226045 | 11922604 | 3 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | ||||||||||
| 119226045 | 11922604 | 4 | C | ENABLEX | DARIFENACIN HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 5 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 119226045 | 11922604 | 6 | C | Baby aspirin | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 119226045 | 11922604 | 7 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 8 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 119226045 | 11922604 | 9 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 10 | C | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 1 | UNK | U | 0 | ||||||||||
| 119226045 | 11922604 | 11 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 12 | C | DICLOFENAC POTASSIUM. | DICLOFENAC POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 13 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 14 | C | Duloxetine hcl | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 119226045 | 11922604 | 15 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 119226045 | 11922604 | 16 | C | Hydroxyzine hcl | HYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 17 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 18 | C | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | UNK | U | 0 | ||||||||||
| 119226045 | 11922604 | 19 | C | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 20 | C | OXYBUTYNIN CHLORIDE. | OXYBUTYNIN CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 21 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 22 | C | RIZATRIPTAN. | RIZATRIPTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 23 | C | TIZANIDINE. | TIZANIDINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 24 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 25 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 119226045 | 11922604 | 26 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 119226045 | 11922604 | 27 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 119226045 | 11922604 | 28 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119226045 | 11922604 | 1 | Fibromyalgia |
| 119226045 | 11922604 | 3 | Product used for unknown indication |
| 119226045 | 11922604 | 4 | Product used for unknown indication |
| 119226045 | 11922604 | 5 | Product used for unknown indication |
| 119226045 | 11922604 | 6 | Product used for unknown indication |
| 119226045 | 11922604 | 7 | Product used for unknown indication |
| 119226045 | 11922604 | 8 | Product used for unknown indication |
| 119226045 | 11922604 | 9 | Product used for unknown indication |
| 119226045 | 11922604 | 10 | Product used for unknown indication |
| 119226045 | 11922604 | 11 | Product used for unknown indication |
| 119226045 | 11922604 | 12 | Product used for unknown indication |
| 119226045 | 11922604 | 13 | Product used for unknown indication |
| 119226045 | 11922604 | 14 | Product used for unknown indication |
| 119226045 | 11922604 | 15 | Product used for unknown indication |
| 119226045 | 11922604 | 16 | Product used for unknown indication |
| 119226045 | 11922604 | 17 | Product used for unknown indication |
| 119226045 | 11922604 | 18 | Product used for unknown indication |
| 119226045 | 11922604 | 19 | Product used for unknown indication |
| 119226045 | 11922604 | 20 | Product used for unknown indication |
| 119226045 | 11922604 | 21 | Product used for unknown indication |
| 119226045 | 11922604 | 22 | Product used for unknown indication |
| 119226045 | 11922604 | 23 | Product used for unknown indication |
| 119226045 | 11922604 | 24 | Product used for unknown indication |
| 119226045 | 11922604 | 25 | Product used for unknown indication |
| 119226045 | 11922604 | 26 | Product used for unknown indication |
| 119226045 | 11922604 | 27 | Product used for unknown indication |
| 119226045 | 11922604 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119226045 | 11922604 | DS |
| 119226045 | 11922604 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119226045 | 11922604 | Breakthrough pain | |
| 119226045 | 11922604 | Disability | |
| 119226045 | 11922604 | Fibromyalgia | |
| 119226045 | 11922604 | Headache | |
| 119226045 | 11922604 | Migraine | |
| 119226045 | 11922604 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 119226045 | 11922604 | 1 | 200504 | 200504 | 0 | |
| 119226045 | 11922604 | 2 | 200504 | 0 | ||
| 119226045 | 11922604 | 3 | 20150327 | 0 | ||
| 119226045 | 11922604 | 4 | 20150326 | 20160106 | 0 | |
| 119226045 | 11922604 | 5 | 20140203 | 0 | ||
| 119226045 | 11922604 | 6 | 20130403 | 0 | ||
| 119226045 | 11922604 | 7 | 20130104 | 0 | ||
| 119226045 | 11922604 | 8 | 20050101 | 20160106 | 0 | |
| 119226045 | 11922604 | 9 | 20050101 | 0 | ||
| 119226045 | 11922604 | 10 | 20160106 | 0 | ||
| 119226045 | 11922604 | 11 | 20160106 | 0 | ||
| 119226045 | 11922604 | 12 | 20160106 | 0 | ||
| 119226045 | 11922604 | 13 | 20160106 | 0 | ||
| 119226045 | 11922604 | 14 | 20160106 | 0 | ||
| 119226045 | 11922604 | 15 | 20160106 | 0 | ||
| 119226045 | 11922604 | 16 | 20160106 | 0 | ||
| 119226045 | 11922604 | 17 | 20160106 | 0 | ||
| 119226045 | 11922604 | 18 | 20160106 | 0 | ||
| 119226045 | 11922604 | 19 | 20160106 | 0 | ||
| 119226045 | 11922604 | 20 | 20160106 | 0 | ||
| 119226045 | 11922604 | 21 | 20160106 | 0 | ||
| 119226045 | 11922604 | 22 | 20160106 | 0 | ||
| 119226045 | 11922604 | 23 | 20160106 | 0 | ||
| 119226045 | 11922604 | 24 | 20160106 | 0 | ||
| 119226045 | 11922604 | 25 | 20160106 | 0 | ||
| 119226045 | 11922604 | 26 | 20160106 | 0 | ||
| 119226045 | 11922604 | 27 | 20160106 | 0 | ||
| 119226045 | 11922604 | 28 | 20140203 | 0 |