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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090791 | 12709079 | 1 | I | 20160503 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008317 | JAZZ | 0.00 | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127090791 | 12709079 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127090791 | 12709079 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127090791 | 12709079 | 3 | SS | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | U | 0 | |||||||||||
| 127090791 | 12709079 | 4 | SS | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127090791 | 12709079 | 5 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | ||||||||||
| 127090791 | 12709079 | 6 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | U | 0 | |||||||||||
| 127090791 | 12709079 | 7 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 127090791 | 12709079 | 8 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127090791 | 12709079 | 9 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | U | 0 | |||||||||||
| 127090791 | 12709079 | 10 | C | T3 | LIOTHYRONINE SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127090791 | 12709079 | 1 | Fibromyalgia |
| 127090791 | 12709079 | 3 | Product used for unknown indication |
| 127090791 | 12709079 | 4 | Product used for unknown indication |
| 127090791 | 12709079 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127090791 | 12709079 | Abdominal discomfort | |
| 127090791 | 12709079 | Abdominal distension | |
| 127090791 | 12709079 | Drug ineffective | |
| 127090791 | 12709079 | Flatulence | |
| 127090791 | 12709079 | Gastrointestinal disorder | |
| 127090791 | 12709079 | Hallucination | |
| 127090791 | 12709079 | Panic attack | |
| 127090791 | 12709079 | Poor quality sleep | |
| 127090791 | 12709079 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 127090791 | 12709079 | 1 | 200706 | 2013 | 0 | |
| 127090791 | 12709079 | 2 | 201501 | 0 |