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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238821 | 12523882 | 1 | I | 201512 | 20151221 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022282 | JAZZ | 32.39 | YR | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125238821 | 12523882 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125238821 | 12523882 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | 21196 | ORAL SOLUTION | |||||||||
| 125238821 | 12523882 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125238821 | 12523882 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | TOOK LESS MEDICATION THAN PRESCRIBED DOSE OF 4.5 G | 21196 | ORAL SOLUTION | ||||||||||
| 125238821 | 12523882 | 5 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 7 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238821 | 12523882 | 8 | C | ATIVAN | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 9 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238821 | 12523882 | 10 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238821 | 12523882 | 11 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 12 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 13 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238821 | 12523882 | 14 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125238821 | 12523882 | 15 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 16 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 20 MG | U | 0 | 20 | MG | TABLET | |||||||
| 125238821 | 12523882 | 17 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 30 MG | U | 0 | 20 | MG | TABLET | |||||||
| 125238821 | 12523882 | 18 | C | Gildess Fe | ETHINYL ESTRADIOLNORETHINDRONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125238821 | 12523882 | 19 | C | Omega 3 fish oil | FISH OILOMEGA-3 FATTY ACIDS | 1 | UNK | U | 0 | ||||||||||
| 125238821 | 12523882 | 20 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125238821 | 12523882 | 1 | Narcolepsy |
| 125238821 | 12523882 | 5 | Product used for unknown indication |
| 125238821 | 12523882 | 7 | Product used for unknown indication |
| 125238821 | 12523882 | 8 | Product used for unknown indication |
| 125238821 | 12523882 | 9 | Product used for unknown indication |
| 125238821 | 12523882 | 11 | Product used for unknown indication |
| 125238821 | 12523882 | 13 | Product used for unknown indication |
| 125238821 | 12523882 | 15 | Product used for unknown indication |
| 125238821 | 12523882 | 16 | Product used for unknown indication |
| 125238821 | 12523882 | 18 | Product used for unknown indication |
| 125238821 | 12523882 | 19 | Product used for unknown indication |
| 125238821 | 12523882 | 20 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125238821 | 12523882 | Haemorrhage | |
| 125238821 | 12523882 | Intentional product use issue | |
| 125238821 | 12523882 | Limb injury |
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 |
|---|---|---|---|---|---|---|
| 125238821 | 12523882 | 1 | 201507 | 201507 | 0 | |
| 125238821 | 12523882 | 3 | 201507 | 20151208 | 0 | |
| 125238821 | 12523882 | 4 | 20151209 | 20151220 | 0 | |
| 125238821 | 12523882 | 5 | 20150601 | 20150827 | 0 | |
| 125238821 | 12523882 | 6 | 20151005 | 0 | ||
| 125238821 | 12523882 | 7 | 20151005 | 0 | ||
| 125238821 | 12523882 | 8 | 20150904 | 20151005 | 0 | |
| 125238821 | 12523882 | 9 | 20150826 | 20150827 | 0 | |
| 125238821 | 12523882 | 10 | 20150904 | 20151005 | 0 | |
| 125238821 | 12523882 | 11 | 20150826 | 20150827 | 0 | |
| 125238821 | 12523882 | 12 | 20150904 | 20151005 | 0 | |
| 125238821 | 12523882 | 13 | 20150826 | 20150827 | 0 | |
| 125238821 | 12523882 | 14 | 20150904 | 20151005 | 0 | |
| 125238821 | 12523882 | 15 | 20150827 | 20150904 | 0 | |
| 125238821 | 12523882 | 16 | 20150601 | 20150827 | 0 | |
| 125238821 | 12523882 | 17 | 20150601 | 20150827 | 0 | |
| 125238821 | 12523882 | 18 | 20150601 | 0 | ||
| 125238821 | 12523882 | 19 | 20150601 | 20150827 | 0 | |
| 125238821 | 12523882 | 20 | 20150601 | 0 |