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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125059862 | 12505986 | 2 | F | 201604 | 20160922 | 20160628 | 20160930 | EXP | US-JAZZ-2016-US-011580 | JAZZ | 46.98 | YR | M | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125059862 | 12505986 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125059862 | 12505986 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125059862 | 12505986 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125059862 | 12505986 | 4 | C | Clonidine Hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 5 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 6 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 7 | C | VIMPAT | LACOSAMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 8 | C | Multivitamin | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 9 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 10 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 11 | C | MARINOL | DRONABINOL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125059862 | 12505986 | 12 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 13 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 14 | C | PINDOLOL. | PINDOLOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 15 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 16 | C | BUTRANS | BUPRENORPHINE | 1 | 10 ?G/HR | U | 0 | PATCH | |||||||||
| 125059862 | 12505986 | 17 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 18 | C | Hydrocodone and acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | UNK | U | 0 | ||||||||||
| 125059862 | 12505986 | 19 | C | AVALIDE | HYDROCHLOROTHIAZIDEIRBESARTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 20 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 125059862 | 12505986 | 21 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 22 | C | FENTANYL. | FENTANYL | 1 | UNK | U | 0 | AMPOULES | |||||||||
| 125059862 | 12505986 | 23 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125059862 | 12505986 | 24 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 25 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 26 | C | XANAX XR | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125059862 | 12505986 | 27 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125059862 | 12505986 | 1 | Narcolepsy |
| 125059862 | 12505986 | 2 | Cataplexy |
| 125059862 | 12505986 | 4 | Product used for unknown indication |
| 125059862 | 12505986 | 5 | Product used for unknown indication |
| 125059862 | 12505986 | 6 | Product used for unknown indication |
| 125059862 | 12505986 | 7 | Product used for unknown indication |
| 125059862 | 12505986 | 8 | Product used for unknown indication |
| 125059862 | 12505986 | 9 | Product used for unknown indication |
| 125059862 | 12505986 | 10 | Product used for unknown indication |
| 125059862 | 12505986 | 11 | Product used for unknown indication |
| 125059862 | 12505986 | 12 | Product used for unknown indication |
| 125059862 | 12505986 | 13 | Product used for unknown indication |
| 125059862 | 12505986 | 14 | Product used for unknown indication |
| 125059862 | 12505986 | 15 | Product used for unknown indication |
| 125059862 | 12505986 | 16 | Product used for unknown indication |
| 125059862 | 12505986 | 17 | Product used for unknown indication |
| 125059862 | 12505986 | 18 | Product used for unknown indication |
| 125059862 | 12505986 | 19 | Product used for unknown indication |
| 125059862 | 12505986 | 20 | Product used for unknown indication |
| 125059862 | 12505986 | 21 | Product used for unknown indication |
| 125059862 | 12505986 | 22 | Product used for unknown indication |
| 125059862 | 12505986 | 23 | Product used for unknown indication |
| 125059862 | 12505986 | 24 | Product used for unknown indication |
| 125059862 | 12505986 | 25 | Product used for unknown indication |
| 125059862 | 12505986 | 26 | Product used for unknown indication |
| 125059862 | 12505986 | 27 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125059862 | 12505986 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125059862 | 12505986 | Chest pain | |
| 125059862 | 12505986 | Condition aggravated | |
| 125059862 | 12505986 | Malaise | |
| 125059862 | 12505986 | Pain in extremity | |
| 125059862 | 12505986 | Postural orthostatic tachycardia syndrome |
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 |
|---|---|---|---|---|---|---|
| 125059862 | 12505986 | 1 | 200410 | 200411 | 0 | |
| 125059862 | 12505986 | 2 | 200411 | 200711 | 0 | |
| 125059862 | 12505986 | 3 | 200711 | 0 | ||
| 125059862 | 12505986 | 4 | 20151207 | 0 | ||
| 125059862 | 12505986 | 5 | 20151207 | 0 | ||
| 125059862 | 12505986 | 6 | 20151207 | 0 | ||
| 125059862 | 12505986 | 7 | 20151207 | 0 | ||
| 125059862 | 12505986 | 8 | 20150925 | 0 | ||
| 125059862 | 12505986 | 9 | 20150924 | 0 | ||
| 125059862 | 12505986 | 10 | 20150924 | 0 | ||
| 125059862 | 12505986 | 11 | 20150924 | 20150925 | 0 | |
| 125059862 | 12505986 | 12 | 20150924 | 0 | ||
| 125059862 | 12505986 | 13 | 20150908 | 0 | ||
| 125059862 | 12505986 | 14 | 20150115 | 0 | ||
| 125059862 | 12505986 | 15 | 20150111 | 0 | ||
| 125059862 | 12505986 | 16 | 20140901 | 0 | ||
| 125059862 | 12505986 | 17 | 20140901 | 0 | ||
| 125059862 | 12505986 | 18 | 20140901 | 0 | ||
| 125059862 | 12505986 | 19 | 20140101 | 20150908 | 0 | |
| 125059862 | 12505986 | 20 | 20140101 | 20150908 | 0 | |
| 125059862 | 12505986 | 21 | 20140101 | 20150908 | 0 | |
| 125059862 | 12505986 | 22 | 20010101 | 20150908 | 0 | |
| 125059862 | 12505986 | 23 | 20010101 | 20150908 | 0 | |
| 125059862 | 12505986 | 24 | 20010101 | 20150908 | 0 | |
| 125059862 | 12505986 | 25 | 20010101 | 20150908 | 0 | |
| 125059862 | 12505986 | 26 | 20010101 | 20150908 | 0 | |
| 125059862 | 12505986 | 27 | 20010101 | 20150908 | 0 |