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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118533764 | 11853376 | 4 | F | 2014 | 20160624 | 20151218 | 20160701 | EXP | US-JAZZ-2015-US-021725 | JAZZ | 0.00 | F | Y | 71.66000 | KG | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118533764 | 11853376 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 118533764 | 11853376 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 118533764 | 11853376 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 118533764 | 11853376 | 4 | SS | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 5 | C | ATENOLOL. | ATENOLOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 6 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 7 | C | LASIX | FUROSEMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 9 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 10 | C | Os-cal + d3 | 2 | UNK | U | 0 | |||||||||||
| 118533764 | 11853376 | 11 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 12 | C | ZOMIG | ZOLMITRIPTAN | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 13 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 14 | C | Butalbital | BUTALBITAL | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 15 | C | COZAAR | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 16 | C | ESTRADIOL. | ESTRADIOL | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 17 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 18 | C | LIVALO | PITAVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 19 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 20 | C | ZOCOR | SIMVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 118533764 | 11853376 | 21 | C | Clonidine Hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 22 | C | CARTIA XT | DILTIAZEM HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 118533764 | 11853376 | 23 | C | VALIUM | DIAZEPAM | 1 | 5 MG | U | 0 | TABLET | |||||||||
| 118533764 | 11853376 | 24 | C | VALIUM | DIAZEPAM | 1 | 10 MG | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118533764 | 11853376 | 1 | Narcolepsy |
| 118533764 | 11853376 | 2 | Cataplexy |
| 118533764 | 11853376 | 4 | Product used for unknown indication |
| 118533764 | 11853376 | 5 | Product used for unknown indication |
| 118533764 | 11853376 | 6 | Product used for unknown indication |
| 118533764 | 11853376 | 7 | Product used for unknown indication |
| 118533764 | 11853376 | 8 | Product used for unknown indication |
| 118533764 | 11853376 | 9 | Product used for unknown indication |
| 118533764 | 11853376 | 10 | Product used for unknown indication |
| 118533764 | 11853376 | 11 | Product used for unknown indication |
| 118533764 | 11853376 | 12 | Product used for unknown indication |
| 118533764 | 11853376 | 13 | Product used for unknown indication |
| 118533764 | 11853376 | 14 | Product used for unknown indication |
| 118533764 | 11853376 | 15 | Product used for unknown indication |
| 118533764 | 11853376 | 16 | Product used for unknown indication |
| 118533764 | 11853376 | 17 | Product used for unknown indication |
| 118533764 | 11853376 | 18 | Product used for unknown indication |
| 118533764 | 11853376 | 19 | Product used for unknown indication |
| 118533764 | 11853376 | 20 | Product used for unknown indication |
| 118533764 | 11853376 | 21 | Product used for unknown indication |
| 118533764 | 11853376 | 22 | Product used for unknown indication |
| 118533764 | 11853376 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118533764 | 11853376 | HO |
| 118533764 | 11853376 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118533764 | 11853376 | Colitis ischaemic | |
| 118533764 | 11853376 | Drug ineffective | |
| 118533764 | 11853376 | Dysphonia | |
| 118533764 | 11853376 | Microangiopathy | |
| 118533764 | 11853376 | Neuropathy peripheral | |
| 118533764 | 11853376 | Pernicious anaemia |
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 |
|---|---|---|---|---|---|---|
| 118533764 | 11853376 | 1 | 200908 | 200908 | 0 | |
| 118533764 | 11853376 | 2 | 200908 | 2015 | 0 | |
| 118533764 | 11853376 | 3 | 2015 | 0 | ||
| 118533764 | 11853376 | 4 | 20150101 | 20151211 | 0 | |
| 118533764 | 11853376 | 5 | 20150101 | 0 | ||
| 118533764 | 11853376 | 6 | 20150101 | 20151211 | 0 | |
| 118533764 | 11853376 | 7 | 20150101 | 0 | ||
| 118533764 | 11853376 | 8 | 20150101 | 0 | ||
| 118533764 | 11853376 | 9 | 20150101 | 20151211 | 0 | |
| 118533764 | 11853376 | 10 | 20150101 | 0 | ||
| 118533764 | 11853376 | 11 | 20150101 | 0 | ||
| 118533764 | 11853376 | 12 | 20150101 | 20151211 | 0 | |
| 118533764 | 11853376 | 13 | 20141020 | 20141020 | 0 | |
| 118533764 | 11853376 | 14 | 20141020 | 20141020 | 0 | |
| 118533764 | 11853376 | 15 | 20141020 | 20151211 | 0 | |
| 118533764 | 11853376 | 16 | 20141020 | 20141020 | 0 | |
| 118533764 | 11853376 | 17 | 20141020 | 0 | ||
| 118533764 | 11853376 | 18 | 20141020 | 20151211 | 0 | |
| 118533764 | 11853376 | 19 | 20141020 | 0 | ||
| 118533764 | 11853376 | 20 | 20141020 | 20141020 | 0 | |
| 118533764 | 11853376 | 21 | 20140820 | 20141020 | 0 | |
| 118533764 | 11853376 | 22 | 20110101 | 20140820 | 0 | |
| 118533764 | 11853376 | 23 | 20110101 | 20151211 | 0 | |
| 118533764 | 11853376 | 24 | 20150101 | 0 |