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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239721 | 12523972 | 1 | I | 2015 | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022275 | JAZZ | 0.00 | F | Y | 0.00000 | 20160704 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239721 | 12523972 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125239721 | 12523972 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125239721 | 12523972 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125239721 | 12523972 | 4 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | 54 MG, QD | 0 | 54 | MG | |||||||||
| 125239721 | 12523972 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 125239721 | 12523972 | 6 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125239721 | 12523972 | 7 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | 3 TABLETS DAILY | U | 0 | ||||||||||
| 125239721 | 12523972 | 8 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239721 | 12523972 | 9 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | ||||||||||
| 125239721 | 12523972 | 10 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239721 | 12523972 | 11 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | POWDER | |||||||||
| 125239721 | 12523972 | 12 | C | INDOMETHACIN. | INDOMETHACIN | 1 | Oral | 75 MG, BID | U | 0 | 75 | MG | CAPSULE | ||||||
| 125239721 | 12523972 | 13 | C | LO LOESTRIN FE | ETHINYL ESTRADIOLNORETHINDRONE ACETATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239721 | 12523972 | 14 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239721 | 12523972 | 15 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239721 | 12523972 | 1 | Narcolepsy |
| 125239721 | 12523972 | 4 | Product used for unknown indication |
| 125239721 | 12523972 | 5 | Product used for unknown indication |
| 125239721 | 12523972 | 6 | Product used for unknown indication |
| 125239721 | 12523972 | 7 | Product used for unknown indication |
| 125239721 | 12523972 | 8 | Product used for unknown indication |
| 125239721 | 12523972 | 9 | Product used for unknown indication |
| 125239721 | 12523972 | 10 | Product used for unknown indication |
| 125239721 | 12523972 | 11 | Product used for unknown indication |
| 125239721 | 12523972 | 12 | Product used for unknown indication |
| 125239721 | 12523972 | 13 | Product used for unknown indication |
| 125239721 | 12523972 | 14 | Product used for unknown indication |
| 125239721 | 12523972 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125239721 | 12523972 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239721 | 12523972 | Anxiety | |
| 125239721 | 12523972 | Decreased appetite | |
| 125239721 | 12523972 | Drug ineffective | |
| 125239721 | 12523972 | Hyperhidrosis | |
| 125239721 | 12523972 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125239721 | 12523972 | 1 | 201503 | 2015 | 0 | |
| 125239721 | 12523972 | 3 | 201507 | 0 | ||
| 125239721 | 12523972 | 6 | 20150423 | 0 | ||
| 125239721 | 12523972 | 7 | 20150325 | 20150506 | 0 | |
| 125239721 | 12523972 | 8 | 20150313 | 0 | ||
| 125239721 | 12523972 | 9 | 20150309 | 0 | ||
| 125239721 | 12523972 | 10 | 20150309 | 0 | ||
| 125239721 | 12523972 | 11 | 20150302 | 0 | ||
| 125239721 | 12523972 | 12 | 20150302 | 0 | ||
| 125239721 | 12523972 | 13 | 20150302 | 0 | ||
| 125239721 | 12523972 | 14 | 20150302 | 0 | ||
| 125239721 | 12523972 | 15 | 20150302 | 0 |