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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127436331 | 12743633 | 1 | I | 2013 | 20160906 | 20160914 | 20160914 | EXP | US-JAZZ-2016-US-017241 | JAZZ | 0.00 | F | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127436331 | 12743633 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127436331 | 12743633 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127436331 | 12743633 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127436331 | 12743633 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127436331 | 12743633 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127436331 | 12743633 | 6 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | N | 0 | CAPSULE | |||||||||
| 127436331 | 12743633 | 7 | C | EMLA | LIDOCAINEPRILOCAINE | 1 | UNK | U | 0 | CREAM | |||||||||
| 127436331 | 12743633 | 8 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 127436331 | 12743633 | 9 | C | LIDOCAINE. | LIDOCAINE | 1 | U | 0 | OINTMENT | ||||||||||
| 127436331 | 12743633 | 10 | C | METADATE ER | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 11 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | POWDER | ||||||||||
| 127436331 | 12743633 | 12 | C | Polyethylene glycol | POLYETHYLENE GLYCOLS | 1 | U | 0 | LIQUID | ||||||||||
| 127436331 | 12743633 | 13 | C | PRAVACHOL | PRAVASTATIN SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 127436331 | 12743633 | 14 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | CAPSULE | ||||||||||
| 127436331 | 12743633 | 15 | C | RANITIDINE. | RANITIDINE | 1 | U | 0 | TABLET | ||||||||||
| 127436331 | 12743633 | 16 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 17 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 | |||||||||||
| 127436331 | 12743633 | 18 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 19 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127436331 | 12743633 | 20 | C | Omega 3-6-9 complex | 2 | U | 0 | ||||||||||||
| 127436331 | 12743633 | 21 | C | Omega 3 fish oil EC | 2 | UNK | U | 0 | |||||||||||
| 127436331 | 12743633 | 22 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127436331 | 12743633 | 23 | C | RESTASIS | CYCLOSPORINE | 1 | U | 0 | |||||||||||
| 127436331 | 12743633 | 24 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | CHEWABLE TABLET | ||||||||||
| 127436331 | 12743633 | 25 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | U | 0 | |||||||||||
| 127436331 | 12743633 | 26 | C | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONEBETAMETHASONE DIPROPIONATECLOTRIMAZOLE | 1 | U | 0 | CREAM | ||||||||||
| 127436331 | 12743633 | 27 | C | LIDOCAINE. | LIDOCAINE | 1 | U | 0 | CREAM | ||||||||||
| 127436331 | 12743633 | 28 | C | Multivitamins with iron | IRONVITAMINS | 1 | U | 0 | CHEWABLE TABLET | ||||||||||
| 127436331 | 12743633 | 29 | C | Tylenol arthritis ER | 2 | U | 0 | TABLET | |||||||||||
| 127436331 | 12743633 | 30 | C | Atorvastatin | ATORVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 31 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 32 | C | Methylphenidate CD | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 127436331 | 12743633 | 33 | C | OMEPRAZOLE DR | OMEPRAZOLE | 1 | U | 0 | CAPSULE | ||||||||||
| 127436331 | 12743633 | 34 | C | Polyethylene glycol | POLYETHYLENE GLYCOLS | 1 | U | 0 | POWDER | ||||||||||
| 127436331 | 12743633 | 35 | C | Topiramate ER | 2 | UNK | U | 0 | CAPSULE | ||||||||||
| 127436331 | 12743633 | 36 | C | TRAMADOL ER | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 37 | C | Calcium +D | CALCIUMVITAMIN D | 1 | U | 0 | CHEWABLE TABLET | ||||||||||
| 127436331 | 12743633 | 38 | C | ESTRACE | ESTRADIOL | 1 | U | 0 | CREAM | ||||||||||
| 127436331 | 12743633 | 39 | C | MAGNESIUM CITRATE. | MAGNESIUM CITRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 40 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127436331 | 12743633 | 41 | C | Potassium gluconate | POTASSIUM GLUCONATE | 1 | U | 0 | TABLET | ||||||||||
| 127436331 | 12743633 | 42 | C | Super B maxi complex | 2 | U | 0 | ||||||||||||
| 127436331 | 12743633 | 43 | C | Triamcinolone | TRIAMCINOLONE | 1 | U | 0 | CREAM |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127436331 | 12743633 | 1 | Narcolepsy |
| 127436331 | 12743633 | 2 | Cataplexy |
| 127436331 | 12743633 | 6 | Product used for unknown indication |
| 127436331 | 12743633 | 7 | Product used for unknown indication |
| 127436331 | 12743633 | 8 | Product used for unknown indication |
| 127436331 | 12743633 | 9 | Product used for unknown indication |
| 127436331 | 12743633 | 10 | Product used for unknown indication |
| 127436331 | 12743633 | 12 | Product used for unknown indication |
| 127436331 | 12743633 | 13 | Product used for unknown indication |
| 127436331 | 12743633 | 14 | Product used for unknown indication |
| 127436331 | 12743633 | 15 | Product used for unknown indication |
| 127436331 | 12743633 | 16 | Product used for unknown indication |
| 127436331 | 12743633 | 17 | Product used for unknown indication |
| 127436331 | 12743633 | 18 | Product used for unknown indication |
| 127436331 | 12743633 | 19 | Product used for unknown indication |
| 127436331 | 12743633 | 20 | Product used for unknown indication |
| 127436331 | 12743633 | 21 | Product used for unknown indication |
| 127436331 | 12743633 | 22 | Product used for unknown indication |
| 127436331 | 12743633 | 23 | Product used for unknown indication |
| 127436331 | 12743633 | 24 | Product used for unknown indication |
| 127436331 | 12743633 | 25 | Product used for unknown indication |
| 127436331 | 12743633 | 26 | Product used for unknown indication |
| 127436331 | 12743633 | 27 | Product used for unknown indication |
| 127436331 | 12743633 | 28 | Product used for unknown indication |
| 127436331 | 12743633 | 29 | Product used for unknown indication |
| 127436331 | 12743633 | 30 | Product used for unknown indication |
| 127436331 | 12743633 | 31 | Product used for unknown indication |
| 127436331 | 12743633 | 32 | Product used for unknown indication |
| 127436331 | 12743633 | 33 | Product used for unknown indication |
| 127436331 | 12743633 | 34 | Product used for unknown indication |
| 127436331 | 12743633 | 35 | Product used for unknown indication |
| 127436331 | 12743633 | 36 | Product used for unknown indication |
| 127436331 | 12743633 | 37 | Product used for unknown indication |
| 127436331 | 12743633 | 38 | Product used for unknown indication |
| 127436331 | 12743633 | 39 | Product used for unknown indication |
| 127436331 | 12743633 | 40 | Product used for unknown indication |
| 127436331 | 12743633 | 41 | Product used for unknown indication |
| 127436331 | 12743633 | 42 | Product used for unknown indication |
| 127436331 | 12743633 | 43 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127436331 | 12743633 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127436331 | 12743633 | Drug ineffective | |
| 127436331 | 12743633 | Hyperhidrosis | |
| 127436331 | 12743633 | Joint injury | |
| 127436331 | 12743633 | Sunburn |
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 |
|---|---|---|---|---|---|---|
| 127436331 | 12743633 | 1 | 200501 | 2005 | 0 | |
| 127436331 | 12743633 | 2 | 200702 | 2007 | 0 | |
| 127436331 | 12743633 | 3 | 200707 | 2007 | 0 | |
| 127436331 | 12743633 | 4 | 201411 | 2014 | 0 | |
| 127436331 | 12743633 | 5 | 201412 | 0 | ||
| 127436331 | 12743633 | 6 | 201602 | 0 | ||
| 127436331 | 12743633 | 7 | 201509 | 0 | ||
| 127436331 | 12743633 | 10 | 201604 | 0 | ||
| 127436331 | 12743633 | 16 | 201602 | 0 | ||
| 127436331 | 12743633 | 18 | 201602 | 0 | ||
| 127436331 | 12743633 | 19 | 201609 | 0 | ||
| 127436331 | 12743633 | 21 | 201509 | 0 | ||
| 127436331 | 12743633 | 22 | 201510 | 0 | ||
| 127436331 | 12743633 | 30 | 201410 | 0 | ||
| 127436331 | 12743633 | 31 | 201410 | 0 | ||
| 127436331 | 12743633 | 35 | 201410 | 0 | ||
| 127436331 | 12743633 | 36 | 201410 | 0 | ||
| 127436331 | 12743633 | 39 | 201609 | 0 | ||
| 127436331 | 12743633 | 40 | 201609 | 0 |