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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126662401 | 12666240 | 1 | I | 201603 | 20160322 | 20160818 | 20160818 | PER | US-JAZZ-2016-US-005574 | JAZZ | 55.27 | YR | M | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126662401 | 12666240 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126662401 | 12666240 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 126662401 | 12666240 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 126662401 | 12666240 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, SECOND DOSE | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 126662401 | 12666240 | 5 | SS | PROVIGIL | MODAFINIL | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 6 | C | L-glutamine | 2 | U | 0 | ||||||||||||
| 126662401 | 12666240 | 7 | C | Ropinirole hcl | ROPINIROLE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 9 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 10 | C | CIALIS | TADALAFIL | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 11 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 12 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 13 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 14 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 15 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 126662401 | 12666240 | 17 | C | ZETIA | EZETIMIBE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126662401 | 12666240 | 1 | Narcolepsy |
| 126662401 | 12666240 | 5 | Product used for unknown indication |
| 126662401 | 12666240 | 8 | Hypersensitivity |
| 126662401 | 12666240 | 12 | Blood cholesterol |
| 126662401 | 12666240 | 14 | Herpes virus infection |
| 126662401 | 12666240 | 15 | Hypersensitivity |
| 126662401 | 12666240 | 16 | Dyspepsia |
| 126662401 | 12666240 | 17 | Blood cholesterol |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126662401 | 12666240 | Insomnia | |
| 126662401 | 12666240 | Personality change |
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 |
|---|---|---|---|---|---|---|
| 126662401 | 12666240 | 1 | 201603 | 2016 | 0 | |
| 126662401 | 12666240 | 2 | 2016 | 2016 | 0 | |
| 126662401 | 12666240 | 3 | 2016 | 0 | ||
| 126662401 | 12666240 | 4 | 2016 | 0 |