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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125579751 | 12557975 | 1 | I | 20160115 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000877 | JAZZ | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125579751 | 12557975 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 125579751 | 12557975 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 125579751 | 12557975 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, TID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 125579751 | 12557975 | 4 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 5 | C | DULOXETINE. | DULOXETINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579751 | 12557975 | 6 | C | EDLUAR | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 7 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 8 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 9 | C | Calcium | CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 125579751 | 12557975 | 10 | C | Ester-c | CALCIUMVITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 11 | C | Hair, skin + nails | MINERALSVITAMINS | 1 | UNK | U | 0 | ||||||||||
| 125579751 | 12557975 | 12 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | GEL | |||||||||
| 125579751 | 12557975 | 13 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 125579751 | 12557975 | 14 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125579751 | 12557975 | 15 | C | ACYCLOVIR. | ACYCLOVIR | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579751 | 12557975 | 16 | C | DEPLIN | LEVOMEFOLATE CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 17 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 18 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 10-325/15 | U | 0 | ||||||||||
| 125579751 | 12557975 | 19 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 125579751 | 12557975 | 20 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 21 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 125579751 | 12557975 | 22 | C | Acebutolol | ACEBUTOLOL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579751 | 12557975 | 23 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 24 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 25 | C | NAPROXEN. | NAPROXEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 26 | C | RESTORIL | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579751 | 12557975 | 27 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 28 | C | THYROID | LEVOTHYROXINELIOTHYRONINE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125579751 | 12557975 | 29 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 30 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 31 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 32 | C | Msm | DIMETHYL SULFONE | 1 | UNK | U | 0 | ||||||||||
| 125579751 | 12557975 | 33 | C | PHENTERMINE. | PHENTERMINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579751 | 12557975 | 34 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579751 | 12557975 | 35 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579751 | 12557975 | 36 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125579751 | 12557975 | 1 | Narcolepsy |
| 125579751 | 12557975 | 4 | Product used for unknown indication |
| 125579751 | 12557975 | 5 | Product used for unknown indication |
| 125579751 | 12557975 | 6 | Product used for unknown indication |
| 125579751 | 12557975 | 7 | Product used for unknown indication |
| 125579751 | 12557975 | 8 | Product used for unknown indication |
| 125579751 | 12557975 | 9 | Product used for unknown indication |
| 125579751 | 12557975 | 10 | Product used for unknown indication |
| 125579751 | 12557975 | 11 | Product used for unknown indication |
| 125579751 | 12557975 | 12 | Product used for unknown indication |
| 125579751 | 12557975 | 13 | Product used for unknown indication |
| 125579751 | 12557975 | 14 | Product used for unknown indication |
| 125579751 | 12557975 | 15 | Product used for unknown indication |
| 125579751 | 12557975 | 16 | Product used for unknown indication |
| 125579751 | 12557975 | 17 | Product used for unknown indication |
| 125579751 | 12557975 | 18 | Product used for unknown indication |
| 125579751 | 12557975 | 19 | Product used for unknown indication |
| 125579751 | 12557975 | 20 | Product used for unknown indication |
| 125579751 | 12557975 | 21 | Product used for unknown indication |
| 125579751 | 12557975 | 22 | Product used for unknown indication |
| 125579751 | 12557975 | 23 | Product used for unknown indication |
| 125579751 | 12557975 | 24 | Product used for unknown indication |
| 125579751 | 12557975 | 25 | Product used for unknown indication |
| 125579751 | 12557975 | 26 | Product used for unknown indication |
| 125579751 | 12557975 | 27 | Product used for unknown indication |
| 125579751 | 12557975 | 28 | Product used for unknown indication |
| 125579751 | 12557975 | 29 | Product used for unknown indication |
| 125579751 | 12557975 | 30 | Product used for unknown indication |
| 125579751 | 12557975 | 31 | Product used for unknown indication |
| 125579751 | 12557975 | 32 | Product used for unknown indication |
| 125579751 | 12557975 | 33 | Product used for unknown indication |
| 125579751 | 12557975 | 34 | Product used for unknown indication |
| 125579751 | 12557975 | 35 | Product used for unknown indication |
| 125579751 | 12557975 | 36 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125579751 | 12557975 | Fibromyalgia | |
| 125579751 | 12557975 | Hallucination | |
| 125579751 | 12557975 | Oropharyngeal pain | |
| 125579751 | 12557975 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125579751 | 12557975 | 1 | 200810 | 200810 | 0 | |
| 125579751 | 12557975 | 3 | 201307 | 0 | ||
| 125579751 | 12557975 | 5 | 20151207 | 0 | ||
| 125579751 | 12557975 | 6 | 20151207 | 20151207 | 0 | |
| 125579751 | 12557975 | 7 | 20150930 | 20150930 | 0 | |
| 125579751 | 12557975 | 8 | 20150930 | 0 | ||
| 125579751 | 12557975 | 9 | 20150930 | 20150930 | 0 | |
| 125579751 | 12557975 | 10 | 20150930 | 0 | ||
| 125579751 | 12557975 | 11 | 20150930 | 0 | ||
| 125579751 | 12557975 | 12 | 20150930 | 0 | ||
| 125579751 | 12557975 | 13 | 20150930 | 0 | ||
| 125579751 | 12557975 | 14 | 20150930 | 0 | ||
| 125579751 | 12557975 | 15 | 20150928 | 0 | ||
| 125579751 | 12557975 | 16 | 20150928 | 0 | ||
| 125579751 | 12557975 | 17 | 20150928 | 0 | ||
| 125579751 | 12557975 | 18 | 20150928 | 0 | ||
| 125579751 | 12557975 | 19 | 20150928 | 0 | ||
| 125579751 | 12557975 | 20 | 20150928 | 0 | ||
| 125579751 | 12557975 | 22 | 20150925 | 0 | ||
| 125579751 | 12557975 | 23 | 20150925 | 0 | ||
| 125579751 | 12557975 | 24 | 20150925 | 0 | ||
| 125579751 | 12557975 | 25 | 20150925 | 0 | ||
| 125579751 | 12557975 | 26 | 20150925 | 0 | ||
| 125579751 | 12557975 | 27 | 20150925 | 20150930 | 0 | |
| 125579751 | 12557975 | 28 | 20150925 | 0 | ||
| 125579751 | 12557975 | 29 | 20010101 | 20150925 | 0 | |
| 125579751 | 12557975 | 30 | 20150623 | 20150925 | 0 | |
| 125579751 | 12557975 | 31 | 20010101 | 20150928 | 0 | |
| 125579751 | 12557975 | 32 | 20010101 | 20150925 | 0 | |
| 125579751 | 12557975 | 33 | 20010101 | 20150928 | 0 | |
| 125579751 | 12557975 | 34 | 20010101 | 20150925 | 0 | |
| 125579751 | 12557975 | 35 | 20010101 | 20150925 | 0 | |
| 125579751 | 12557975 | 36 | 20150928 | 20160115 | 0 |