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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126685561 | 12668556 | 1 | I | 20160401 | 20160819 | 20160819 | EXP | US-JAZZ-2016-US-006356 | JAZZ | 0.00 | F | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126685561 | 12668556 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126685561 | 12668556 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | N | 21196 | ORAL SOLUTION | ||||||||
| 126685561 | 12668556 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | N | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 126685561 | 12668556 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DECREASED DOSE | N | 21196 | ORAL SOLUTION | ||||||||
| 126685561 | 12668556 | 5 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126685561 | 12668556 | 6 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 7 | C | LINZESS | LINACLOTIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685561 | 12668556 | 8 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 9 | C | NUCYNTA | TAPENTADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 10 | C | COLACE | DOCUSATE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685561 | 12668556 | 11 | C | DIAMOX SEQUELS | ACETAZOLAMIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685561 | 12668556 | 12 | C | MEDROL | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 126685561 | 12668556 | 13 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 14 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 15 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 16 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 17 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 18 | C | ADVIL | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 126685561 | 12668556 | 19 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685561 | 12668556 | 20 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 21 | C | SKYLA | LEVONORGESTREL | 1 | UNK | U | 0 | ||||||||||
| 126685561 | 12668556 | 22 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 126685561 | 12668556 | 23 | C | BENADRYL ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126685561 | 12668556 | 24 | C | CAMBIA | DICLOFENAC POTASSIUM | 1 | UNK | U | 0 | ||||||||||
| 126685561 | 12668556 | 25 | C | RELPAX | ELETRIPTAN HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126685561 | 12668556 | 26 | C | TIROSINT | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126685561 | 12668556 | 27 | C | MUCINEX | GUAIFENESIN | 1 | U | 0 | TABLET | ||||||||||
| 126685561 | 12668556 | 28 | C | VICKS DAYQUIL | DEXTROMETHORPHAN HYDROBROMIDEGUAIFENESIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126685561 | 12668556 | 1 | Narcolepsy |
| 126685561 | 12668556 | 5 | Product used for unknown indication |
| 126685561 | 12668556 | 6 | Product used for unknown indication |
| 126685561 | 12668556 | 7 | Product used for unknown indication |
| 126685561 | 12668556 | 8 | Product used for unknown indication |
| 126685561 | 12668556 | 9 | Product used for unknown indication |
| 126685561 | 12668556 | 10 | Product used for unknown indication |
| 126685561 | 12668556 | 11 | Product used for unknown indication |
| 126685561 | 12668556 | 12 | Product used for unknown indication |
| 126685561 | 12668556 | 13 | Product used for unknown indication |
| 126685561 | 12668556 | 14 | Product used for unknown indication |
| 126685561 | 12668556 | 15 | Product used for unknown indication |
| 126685561 | 12668556 | 17 | Product used for unknown indication |
| 126685561 | 12668556 | 18 | Product used for unknown indication |
| 126685561 | 12668556 | 19 | Product used for unknown indication |
| 126685561 | 12668556 | 20 | Product used for unknown indication |
| 126685561 | 12668556 | 21 | Product used for unknown indication |
| 126685561 | 12668556 | 22 | Product used for unknown indication |
| 126685561 | 12668556 | 23 | Product used for unknown indication |
| 126685561 | 12668556 | 24 | Product used for unknown indication |
| 126685561 | 12668556 | 25 | Product used for unknown indication |
| 126685561 | 12668556 | 26 | Product used for unknown indication |
| 126685561 | 12668556 | 27 | Product used for unknown indication |
| 126685561 | 12668556 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126685561 | 12668556 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126685561 | 12668556 | Cataplexy | |
| 126685561 | 12668556 | Impaired gastric emptying | |
| 126685561 | 12668556 | Nausea | |
| 126685561 | 12668556 | Unevaluable event | |
| 126685561 | 12668556 | 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 |
|---|---|---|---|---|---|---|
| 126685561 | 12668556 | 1 | 201510 | 2015 | 0 | |
| 126685561 | 12668556 | 3 | 201603 | 0 | ||
| 126685561 | 12668556 | 6 | 20151020 | 0 | ||
| 126685561 | 12668556 | 7 | 20160319 | 0 | ||
| 126685561 | 12668556 | 8 | 20160211 | 0 | ||
| 126685561 | 12668556 | 9 | 20160209 | 0 | ||
| 126685561 | 12668556 | 10 | 20160206 | 0 | ||
| 126685561 | 12668556 | 11 | 20160115 | 20160130 | 0 | |
| 126685561 | 12668556 | 12 | 20160115 | 20160121 | 0 | |
| 126685561 | 12668556 | 13 | 201601 | 201602 | 0 | |
| 126685561 | 12668556 | 14 | 20160114 | 0 | ||
| 126685561 | 12668556 | 15 | 20151020 | 20151116 | 0 | |
| 126685561 | 12668556 | 16 | 20160104 | 20160113 | 0 | |
| 126685561 | 12668556 | 17 | 20151222 | 20160113 | 0 | |
| 126685561 | 12668556 | 18 | 20151021 | 0 | ||
| 126685561 | 12668556 | 19 | 20151021 | 20151022 | 0 | |
| 126685561 | 12668556 | 20 | 20151021 | 0 | ||
| 126685561 | 12668556 | 21 | 20151021 | 0 | ||
| 126685561 | 12668556 | 22 | 20151021 | 0 | ||
| 126685561 | 12668556 | 23 | 20151021 | 0 | ||
| 126685561 | 12668556 | 24 | 20151020 | 0 | ||
| 126685561 | 12668556 | 25 | 20151020 | 0 | ||
| 126685561 | 12668556 | 26 | 20151020 | 0 |