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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127472411 | 12747241 | 1 | I | 20160524 | 20160915 | 20160915 | PER | US-JAZZ-2016-US-009692 | JAZZ | 0.00 | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127472411 | 12747241 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127472411 | 12747241 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOAE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127472411 | 12747241 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5.5 G, BID | 21196 | 5.5 | G | ORAL SOLUTION | |||||||
| 127472411 | 12747241 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127472411 | 12747241 | 5 | SS | FENTANYL. | FENTANYL | 1 | Y | 0 | |||||||||||
| 127472411 | 12747241 | 6 | SS | XANAX | ALPRAZOLAM | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 7 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Y | 0 | |||||||||||
| 127472411 | 12747241 | 8 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 9 | C | Hydrocodone/acetaminophen | ACETAMINOPHENHYDROCODONE | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 10 | C | HYDROXYZINE PAMOATE. | HYDROXYZINE PAMOATE | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 11 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 12 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 13 | C | PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 14 | C | SOMA | CARISOPRODOL | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 15 | C | TEMAZEPAM. | TEMAZEPAM | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 16 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127472411 | 12747241 | 17 | C | TYLENOL | ACETAMINOPHEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127472411 | 12747241 | 1 | Narcolepsy |
| 127472411 | 12747241 | 5 | Product used for unknown indication |
| 127472411 | 12747241 | 6 | Product used for unknown indication |
| 127472411 | 12747241 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127472411 | 12747241 | Asthma | |
| 127472411 | 12747241 | Connective tissue disorder | |
| 127472411 | 12747241 | Drug hypersensitivity | |
| 127472411 | 12747241 | Drug ineffective | |
| 127472411 | 12747241 | Fatigue | |
| 127472411 | 12747241 | Feeling abnormal | |
| 127472411 | 12747241 | Feeling jittery | |
| 127472411 | 12747241 | Migraine | |
| 127472411 | 12747241 | Musculoskeletal stiffness | |
| 127472411 | 12747241 | Plantar fasciitis | |
| 127472411 | 12747241 | Pre-existing condition improved | |
| 127472411 | 12747241 | Therapeutic response unexpected | |
| 127472411 | 12747241 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 127472411 | 12747241 | 1 | 200603 | 200603 | 0 | |
| 127472411 | 12747241 | 3 | 200606 | 2006 | 0 | |
| 127472411 | 12747241 | 4 | 201604 | 0 |