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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127089681 | 12708968 | 1 | I | 20160505 | 20160901 | 20160901 | PER | US-JAZZ-2016-US-008464 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127089681 | 12708968 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127089681 | 12708968 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127089681 | 12708968 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127089681 | 12708968 | 4 | SS | NUVIGIL | ARMODAFINIL | 1 | UNKNOWN | 0 | |||||||||||
| 127089681 | 12708968 | 5 | C | ACIDOPHILUS | LACTOBACILLUS ACIDOPHILUS | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 6 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 7 | C | Amantadine | AMANTADINE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 8 | C | B Complete | 2 | U | 0 | ||||||||||||
| 127089681 | 12708968 | 9 | C | BUPROPION HYDROCHLORIDE XL | BUPROPION HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 10 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 11 | C | CORICIDIN HBP | ACETAMINOPHENCHLORPHENIRAMINE MALEATE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 12 | C | Itraconazole bp | 2 | U | 0 | ||||||||||||
| 127089681 | 12708968 | 13 | C | LUNESTA | ESZOPICLONE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 14 | C | Milk thistle | MILK THISTLE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 15 | C | Multivitamin with minerals | MINERALSVITAMINS | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 16 | C | Pantothenic acid | PANTOTHENIC ACID | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 17 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 18 | C | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 19 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 20 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 21 | C | ZUBSOLV | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127089681 | 12708968 | 22 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127089681 | 12708968 | 1 | Hypersomnia |
| 127089681 | 12708968 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127089681 | 12708968 | Pre-existing condition improved | |
| 127089681 | 12708968 | Rash | |
| 127089681 | 12708968 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 127089681 | 12708968 | 1 | 201011 | 201011 | 0 | |
| 127089681 | 12708968 | 3 | 201209 | 0 |