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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127476151 | 12747615 | 1 | I | 201107 | 20160526 | 20160915 | 20160915 | PER | US-JAZZ-2016-US-009919 | JAZZ | 33.71 | YR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127476151 | 12747615 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127476151 | 12747615 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 3 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 4 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 5 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 6 | C | Promethazine vc w/codeine | 2 | U | 0 | ||||||||||||
| 127476151 | 12747615 | 7 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 8 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 9 | C | ENTOCORT EC | BUDESONIDE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 10 | C | IMURAN | AZATHIOPRINE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 11 | C | INTUNIV | GUANFACINE HYDROCHLORIDE | 1 | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 127476151 | 12747615 | 12 | C | INTUNIV | GUANFACINE HYDROCHLORIDE | 1 | 3 MG, UNK | U | 0 | 3 | MG | ||||||||
| 127476151 | 12747615 | 13 | C | LO LOESTRIN FE | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 14 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 15 | C | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 16 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127476151 | 12747615 | 18 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127476151 | 12747615 | 1 | Sleep disorder |
| 127476151 | 12747615 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127476151 | 12747615 | Blood pressure increased | |
| 127476151 | 12747615 | Decreased appetite |
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 |
|---|---|---|---|---|---|---|
| 127476151 | 12747615 | 1 | 201107 | 0 |