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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238801 | 12523880 | 1 | I | 201512 | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022170 | JAZZ | 26.61 | YR | F | Y | 57.59000 | KG | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238801 | 12523880 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125238801 | 12523880 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125238801 | 12523880 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125238801 | 12523880 | 4 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238801 | 12523880 | 5 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | ||||||||||
| 125238801 | 12523880 | 6 | C | AVIANE 28 DAY | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 7 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 8 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125238801 | 12523880 | 9 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125238801 | 12523880 | 10 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 11 | C | EXCEDRIN MIGRAINE | ACETAMINOPHENASPIRINCAFFEINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 12 | C | Horizant er | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125238801 | 12523880 | 13 | C | IBUPROFEN IB | IBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 125238801 | 12523880 | 14 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 15 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 16 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125238801 | 12523880 | 18 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238801 | 12523880 | 19 | C | Ondansetron hcl | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125238801 | 12523880 | 1 | Narcolepsy |
| 125238801 | 12523880 | 4 | Narcolepsy |
| 125238801 | 12523880 | 5 | Hypersensitivity |
| 125238801 | 12523880 | 6 | Contraception |
| 125238801 | 12523880 | 7 | Depression |
| 125238801 | 12523880 | 8 | Anxiety |
| 125238801 | 12523880 | 9 | Migraine |
| 125238801 | 12523880 | 10 | Product used for unknown indication |
| 125238801 | 12523880 | 11 | Product used for unknown indication |
| 125238801 | 12523880 | 12 | Product used for unknown indication |
| 125238801 | 12523880 | 13 | Product used for unknown indication |
| 125238801 | 12523880 | 14 | Product used for unknown indication |
| 125238801 | 12523880 | 15 | Product used for unknown indication |
| 125238801 | 12523880 | 16 | Product used for unknown indication |
| 125238801 | 12523880 | 17 | Product used for unknown indication |
| 125238801 | 12523880 | 18 | Product used for unknown indication |
| 125238801 | 12523880 | 19 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125238801 | 12523880 | Nausea | |
| 125238801 | 12523880 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125238801 | 12523880 | 1 | 201510 | 201510 | 0 | |
| 125238801 | 12523880 | 2 | 201510 | 201512 | 0 | |
| 125238801 | 12523880 | 3 | 201512 | 0 | ||
| 125238801 | 12523880 | 4 | 20151007 | 0 | ||
| 125238801 | 12523880 | 6 | 20151007 | 0 | ||
| 125238801 | 12523880 | 7 | 20151007 | 0 | ||
| 125238801 | 12523880 | 10 | 20151007 | 20151007 | 0 | |
| 125238801 | 12523880 | 11 | 20151007 | 0 | ||
| 125238801 | 12523880 | 12 | 20151007 | 20151007 | 0 | |
| 125238801 | 12523880 | 13 | 20151007 | 0 | ||
| 125238801 | 12523880 | 14 | 20151007 | 0 | ||
| 125238801 | 12523880 | 15 | 20151007 | 0 | ||
| 125238801 | 12523880 | 16 | 20151007 | 0 | ||
| 125238801 | 12523880 | 17 | 20151007 | 0 | ||
| 125238801 | 12523880 | 18 | 20151007 | 0 | ||
| 125238801 | 12523880 | 19 | 20150101 | 0 |