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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580951 | 12558095 | 1 | I | 201601 | 20160112 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000617 | JAZZ | 36.18 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580951 | 12558095 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | Y | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 125580951 | 12558095 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 125580951 | 12558095 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125580951 | 12558095 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | Y | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 125580951 | 12558095 | 5 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125580951 | 12558095 | 6 | C | IBUPROFEN. | IBUPROFEN | 1 | UNK, PRN | U | 0 | ||||||||||
| 125580951 | 12558095 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580951 | 12558095 | 8 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK, PRN | U | 0 | TABLET | |||||||||
| 125580951 | 12558095 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 30 MG, CAPSULE | U | 0 | TABLET | |||||||||
| 125580951 | 12558095 | 10 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580951 | 12558095 | 11 | C | ADAPALENE. | ADAPALENE | 1 | UNK | U | 0 | GEL | |||||||||
| 125580951 | 12558095 | 12 | C | Bupropion Hcl | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580951 | 12558095 | 13 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580951 | 12558095 | 14 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125580951 | 12558095 | 15 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125580951 | 12558095 | 1 | Narcolepsy |
| 125580951 | 12558095 | 5 | Smoking cessation therapy |
| 125580951 | 12558095 | 6 | Product used for unknown indication |
| 125580951 | 12558095 | 7 | Affective disorder |
| 125580951 | 12558095 | 8 | Smoking cessation therapy |
| 125580951 | 12558095 | 10 | Acne cystic |
| 125580951 | 12558095 | 11 | Acne cystic |
| 125580951 | 12558095 | 12 | Smoking cessation therapy |
| 125580951 | 12558095 | 13 | Product used for unknown indication |
| 125580951 | 12558095 | 14 | Product used for unknown indication |
| 125580951 | 12558095 | 15 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125580951 | 12558095 | Anxiety | |
| 125580951 | 12558095 | Diarrhoea | |
| 125580951 | 12558095 | Dizziness | |
| 125580951 | 12558095 | Hangover | |
| 125580951 | 12558095 | Headache | |
| 125580951 | 12558095 | Hyperhidrosis | |
| 125580951 | 12558095 | Intentional product use issue | |
| 125580951 | 12558095 | Nausea | |
| 125580951 | 12558095 | Presyncope | |
| 125580951 | 12558095 | Sleep disorder | |
| 125580951 | 12558095 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125580951 | 12558095 | 1 | 201512 | 201601 | 0 | |
| 125580951 | 12558095 | 2 | 201601 | 201601 | 0 | |
| 125580951 | 12558095 | 3 | 201601 | 2016 | 0 | |
| 125580951 | 12558095 | 4 | 2016 | 0 | ||
| 125580951 | 12558095 | 6 | 20160111 | 0 | ||
| 125580951 | 12558095 | 7 | 20160111 | 0 | ||
| 125580951 | 12558095 | 8 | 20151223 | 0 | ||
| 125580951 | 12558095 | 9 | 20151009 | 0 | ||
| 125580951 | 12558095 | 10 | 20151223 | 0 | ||
| 125580951 | 12558095 | 11 | 20151009 | 0 | ||
| 125580951 | 12558095 | 12 | 20160111 | 0 | ||
| 125580951 | 12558095 | 13 | 20151009 | 0 | ||
| 125580951 | 12558095 | 14 | 20151009 | 0 | ||
| 125580951 | 12558095 | 15 | 20151009 | 0 |