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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127444131 | 12744413 | 1 | I | 20160516 | 20160914 | 20160914 | PER | US-JAZZ-2016-US-009261 | JAZZ | 0.00 | F | Y | 0.00000 | 20160914 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127444131 | 12744413 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127444131 | 12744413 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127444131 | 12744413 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | Y | 21196 | ORAL SOLUTION | ||||||||
| 127444131 | 12744413 | 4 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Q6 HRS AS NEEDED | Y | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 7 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 8 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 9 | C | NEUPRO | ROTIGOTINE | 1 | 2/24 MG/HR | U | 0 | PATCH | |||||||||
| 127444131 | 12744413 | 10 | C | NEUPRO | ROTIGOTINE | 1 | 3/24 MG/HR | U | 0 | PATCH | |||||||||
| 127444131 | 12744413 | 11 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | U | 0 | GEL | |||||||||
| 127444131 | 12744413 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 13 | C | DULCOLAX NOS | BISACODYL OR DOCUSATE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 14 | C | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | UNK, QD | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 15 | C | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 16 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127444131 | 12744413 | 17 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | UNK, QD | U | 0 | CAPSULE | |||||||||
| 127444131 | 12744413 | 18 | C | FENOFIBRATE. | FENOFIBRATE | 1 | UNK, QD | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 19 | C | FENOFIBRATE. | FENOFIBRATE | 1 | 134 MG | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 20 | C | METAMUCIL | PLANTAGO SEED | 1 | Oral | UNK, BID | U | 0 | CAPSULE | ||||||||
| 127444131 | 12744413 | 21 | C | METAMUCIL | PLANTAGO SEED | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127444131 | 12744413 | 22 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 23 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 24 | C | Benztropine mesilate | BENZTROPINE MESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 25 | C | Benztropine mesilate | BENZTROPINE MESYLATE | 1 | 0.5 MG | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 26 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 27 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 28 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 1000 ?G, QD | U | 0 | 1000 | UG | TABLET | |||||||
| 127444131 | 12744413 | 29 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 127444131 | 12744413 | 30 | C | GABITRIL | TIAGABINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 31 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 32 | C | AXONA | TRICAPRYLIN | 1 | UNK | U | 0 | POWDER | |||||||||
| 127444131 | 12744413 | 33 | C | Ginkgo biloba | GINKGO | 1 | UNK | U | 0 | ||||||||||
| 127444131 | 12744413 | 34 | C | DOCQLACE | DOCUSATE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127444131 | 12744413 | 35 | C | Ropinirole hcl | ROPINIROLE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 36 | C | TRILIPIX | FENOFIBRIC ACID | 1 | UNK | U | 0 | ||||||||||
| 127444131 | 12744413 | 37 | C | ATENOLOL. | ATENOLOL | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 127444131 | 12744413 | 38 | C | GABAPENTIN. | GABAPENTIN | 1 | 2 AT BEDTIME AND 3 IN THE AM AS NEEDED | U | 0 | CAPSULE | |||||||||
| 127444131 | 12744413 | 39 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | UNK, BID | U | 0 | TABLET | ||||||||
| 127444131 | 12744413 | 40 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK, BID | U | 0 | TABLET | |||||||||
| 127444131 | 12744413 | 41 | C | Ondansetron hcl | ONDANSETRON HYDROCHLORIDE | 1 | UNK, TID | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127444131 | 12744413 | 1 | Narcolepsy |
| 127444131 | 12744413 | 4 | Product used for unknown indication |
| 127444131 | 12744413 | 5 | Product used for unknown indication |
| 127444131 | 12744413 | 7 | Product used for unknown indication |
| 127444131 | 12744413 | 8 | Product used for unknown indication |
| 127444131 | 12744413 | 9 | Product used for unknown indication |
| 127444131 | 12744413 | 11 | Product used for unknown indication |
| 127444131 | 12744413 | 12 | Product used for unknown indication |
| 127444131 | 12744413 | 13 | Product used for unknown indication |
| 127444131 | 12744413 | 14 | Product used for unknown indication |
| 127444131 | 12744413 | 16 | Product used for unknown indication |
| 127444131 | 12744413 | 18 | Product used for unknown indication |
| 127444131 | 12744413 | 20 | Product used for unknown indication |
| 127444131 | 12744413 | 22 | Product used for unknown indication |
| 127444131 | 12744413 | 24 | Product used for unknown indication |
| 127444131 | 12744413 | 26 | Product used for unknown indication |
| 127444131 | 12744413 | 27 | Product used for unknown indication |
| 127444131 | 12744413 | 29 | Product used for unknown indication |
| 127444131 | 12744413 | 30 | Product used for unknown indication |
| 127444131 | 12744413 | 31 | Product used for unknown indication |
| 127444131 | 12744413 | 32 | Product used for unknown indication |
| 127444131 | 12744413 | 33 | Product used for unknown indication |
| 127444131 | 12744413 | 34 | Product used for unknown indication |
| 127444131 | 12744413 | 35 | Product used for unknown indication |
| 127444131 | 12744413 | 36 | Product used for unknown indication |
| 127444131 | 12744413 | 37 | Product used for unknown indication |
| 127444131 | 12744413 | 38 | Product used for unknown indication |
| 127444131 | 12744413 | 39 | Product used for unknown indication |
| 127444131 | 12744413 | 40 | Product used for unknown indication |
| 127444131 | 12744413 | 41 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127444131 | 12744413 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127444131 | 12744413 | Arthralgia | |
| 127444131 | 12744413 | Pain | |
| 127444131 | 12744413 | Psychotic disorder | |
| 127444131 | 12744413 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 127444131 | 12744413 | 1 | 200504 | 200505 | 0 | |
| 127444131 | 12744413 | 2 | 200505 | 2016 | 0 | |
| 127444131 | 12744413 | 3 | 2016 | 0 | ||
| 127444131 | 12744413 | 4 | 20151012 | 0 | ||
| 127444131 | 12744413 | 5 | 20140623 | 20151102 | 0 | |
| 127444131 | 12744413 | 6 | 201604 | 0 | ||
| 127444131 | 12744413 | 7 | 201604 | 0 | ||
| 127444131 | 12744413 | 8 | 201604 | 0 | ||
| 127444131 | 12744413 | 9 | 20151012 | 201603 | 0 | |
| 127444131 | 12744413 | 10 | 201603 | 0 | ||
| 127444131 | 12744413 | 11 | 201603 | 0 | ||
| 127444131 | 12744413 | 12 | 20151102 | 201604 | 0 | |
| 127444131 | 12744413 | 13 | 20151014 | 0 | ||
| 127444131 | 12744413 | 14 | 20140101 | 20140623 | 0 | |
| 127444131 | 12744413 | 15 | 20151014 | 0 | ||
| 127444131 | 12744413 | 16 | 20140101 | 20140623 | 0 | |
| 127444131 | 12744413 | 17 | 20151012 | 20151102 | 0 | |
| 127444131 | 12744413 | 18 | 20140101 | 20140623 | 0 | |
| 127444131 | 12744413 | 19 | 20151012 | 0 | ||
| 127444131 | 12744413 | 20 | 20140101 | 20140623 | 0 | |
| 127444131 | 12744413 | 21 | 20151012 | 0 | ||
| 127444131 | 12744413 | 22 | 20140623 | 20151102 | 0 | |
| 127444131 | 12744413 | 23 | 20151012 | 0 | ||
| 127444131 | 12744413 | 24 | 20140623 | 0 | ||
| 127444131 | 12744413 | 26 | 20140623 | 0 | ||
| 127444131 | 12744413 | 27 | 20140623 | 0 | ||
| 127444131 | 12744413 | 29 | 20140623 | 0 | ||
| 127444131 | 12744413 | 30 | 20140414 | 20140623 | 0 | |
| 127444131 | 12744413 | 31 | 20140118 | 20151102 | 0 | |
| 127444131 | 12744413 | 32 | 20140101 | 20140623 | 0 | |
| 127444131 | 12744413 | 33 | 20140101 | 20140623 | 0 | |
| 127444131 | 12744413 | 34 | 20010101 | 20151102 | 0 | |
| 127444131 | 12744413 | 35 | 20010101 | 20151102 | 0 | |
| 127444131 | 12744413 | 36 | 20010101 | 20151102 | 0 | |
| 127444131 | 12744413 | 37 | 201604 | 0 |