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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239111 | 12523911 | 1 | I | 20151222 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022424 | JAZZ | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239111 | 12523911 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125239111 | 12523911 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125239111 | 12523911 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, BID | 21196 | 5 | G | ORAL SOLUTION | |||||||
| 125239111 | 12523911 | 4 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125239111 | 12523911 | 5 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125239111 | 12523911 | 6 | C | DARVOCET | ACETAMINOPHENPROPOXYPHENE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125239111 | 12523911 | 7 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 125239111 | 12523911 | 8 | C | LUNESTA | ESZOPICLONE | 1 | UNK | U | 0 | ||||||||||
| 125239111 | 12523911 | 9 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239111 | 12523911 | 10 | C | Thyroid gland | 2 | UNK | U | 0 | |||||||||||
| 125239111 | 12523911 | 11 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | ||||||||||
| 125239111 | 12523911 | 12 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239111 | 12523911 | 1 | Fibromyalgia |
| 125239111 | 12523911 | 4 | Product used for unknown indication |
| 125239111 | 12523911 | 5 | Product used for unknown indication |
| 125239111 | 12523911 | 6 | Product used for unknown indication |
| 125239111 | 12523911 | 7 | Product used for unknown indication |
| 125239111 | 12523911 | 8 | Product used for unknown indication |
| 125239111 | 12523911 | 9 | Product used for unknown indication |
| 125239111 | 12523911 | 10 | Product used for unknown indication |
| 125239111 | 12523911 | 11 | Product used for unknown indication |
| 125239111 | 12523911 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239111 | 12523911 | Incorrect dose administered | |
| 125239111 | 12523911 | Insomnia | |
| 125239111 | 12523911 | Prescribed overdose | |
| 125239111 | 12523911 | Psychomotor hyperactivity |
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 |
|---|---|---|---|---|---|---|
| 125239111 | 12523911 | 1 | 200702 | 200703 | 0 | |
| 125239111 | 12523911 | 3 | 200803 | 0 |