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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127790101 | 12779010 | 1 | I | 2016 | 20160616 | 20160926 | 20160926 | PER | US-JAZZ-2016-US-011432 | JAZZ | 0.00 | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127790101 | 12779010 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127790101 | 12779010 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127790101 | 12779010 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127790101 | 12779010 | 4 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNK | N | 0 | ||||||||||
| 127790101 | 12779010 | 5 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNK (DECREASED) | N | 0 | ||||||||||
| 127790101 | 12779010 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | UNKNOWN | N | 0 | ||||||||||
| 127790101 | 12779010 | 7 | C | CULTURELLE | LACTOBACILLUS RHAMNOSUS | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 9 | C | BECONASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 10 | C | PATANASE | OLOPATADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 11 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 12 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 13 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 14 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 15 | C | MOTRIN IB | IBUPROFEN | 1 | U | 0 | |||||||||||
| 127790101 | 12779010 | 16 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127790101 | 12779010 | 1 | Narcolepsy |
| 127790101 | 12779010 | 4 | Product used for unknown indication |
| 127790101 | 12779010 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127790101 | 12779010 | Bacterial vaginosis | |
| 127790101 | 12779010 | Drug hypersensitivity | |
| 127790101 | 12779010 | Feeling jittery | |
| 127790101 | 12779010 | Lip swelling | |
| 127790101 | 12779010 | Nausea | |
| 127790101 | 12779010 | Paraesthesia | |
| 127790101 | 12779010 | Rash | |
| 127790101 | 12779010 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 127790101 | 12779010 | 1 | 201605 | 201606 | 0 | |
| 127790101 | 12779010 | 2 | 201606 | 201606 | 0 | |
| 127790101 | 12779010 | 3 | 201606 | 0 |