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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124357852 | 12435785 | 2 | F | 201603 | 20160705 | 20160603 | 20160712 | EXP | US-JAZZ-2016-US-009957 | JAZZ | 31.96 | YR | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124357852 | 12435785 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124357852 | 12435785 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124357852 | 12435785 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 124357852 | 12435785 | 4 | C | LEVOXYL | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 6 | C | ALEVE | NAPROXEN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 124357852 | 12435785 | 7 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 8 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357852 | 12435785 | 9 | C | Probiotic acidophilus | LACTOBACILLUS ACIDOPHILUS | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357852 | 12435785 | 10 | C | NIFEDICAL XL | NIFEDIPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 11 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357852 | 12435785 | 12 | C | CLINDAMYCIN HYDROCHLORIDE. | CLINDAMYCIN HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357852 | 12435785 | 13 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357852 | 12435785 | 14 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 15 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 16 | C | NIFEDIPINE. | NIFEDIPINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 17 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 18 | C | Hydroxychloroquine | HYDROXYCHLOROQUINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 19 | C | DOXYCYCLINE HYCLATE. | DOXYCYCLINE HYCLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 124357852 | 12435785 | 20 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 21 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 22 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 124357852 | 12435785 | 23 | C | NUVARING | ETHINYL ESTRADIOLETONOGESTREL | 1 | UNK | U | 0 | ||||||||||
| 124357852 | 12435785 | 24 | C | Multivitamin | VITAMINS | 1 | U | 0 | TABLET | ||||||||||
| 124357852 | 12435785 | 25 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 124357852 | 12435785 | 26 | C | NAPROXEN. | NAPROXEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124357852 | 12435785 | 1 | Narcolepsy |
| 124357852 | 12435785 | 2 | Cataplexy |
| 124357852 | 12435785 | 3 | Somnolence |
| 124357852 | 12435785 | 4 | Product used for unknown indication |
| 124357852 | 12435785 | 5 | Product used for unknown indication |
| 124357852 | 12435785 | 6 | Product used for unknown indication |
| 124357852 | 12435785 | 7 | Product used for unknown indication |
| 124357852 | 12435785 | 8 | Product used for unknown indication |
| 124357852 | 12435785 | 9 | Product used for unknown indication |
| 124357852 | 12435785 | 10 | Product used for unknown indication |
| 124357852 | 12435785 | 11 | Product used for unknown indication |
| 124357852 | 12435785 | 12 | Product used for unknown indication |
| 124357852 | 12435785 | 13 | Product used for unknown indication |
| 124357852 | 12435785 | 14 | Product used for unknown indication |
| 124357852 | 12435785 | 15 | Product used for unknown indication |
| 124357852 | 12435785 | 16 | Product used for unknown indication |
| 124357852 | 12435785 | 17 | Product used for unknown indication |
| 124357852 | 12435785 | 18 | Product used for unknown indication |
| 124357852 | 12435785 | 19 | Product used for unknown indication |
| 124357852 | 12435785 | 20 | Product used for unknown indication |
| 124357852 | 12435785 | 21 | Product used for unknown indication |
| 124357852 | 12435785 | 22 | Product used for unknown indication |
| 124357852 | 12435785 | 23 | Product used for unknown indication |
| 124357852 | 12435785 | 24 | Product used for unknown indication |
| 124357852 | 12435785 | 25 | Product used for unknown indication |
| 124357852 | 12435785 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124357852 | 12435785 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124357852 | 12435785 | Abdominal pain lower | |
| 124357852 | 12435785 | Anxiety | |
| 124357852 | 12435785 | Arthralgia | |
| 124357852 | 12435785 | Back pain | |
| 124357852 | 12435785 | Blood pressure increased | |
| 124357852 | 12435785 | Dizziness | |
| 124357852 | 12435785 | Dyspnoea | |
| 124357852 | 12435785 | Gait disturbance | |
| 124357852 | 12435785 | Groin pain | |
| 124357852 | 12435785 | Heart rate increased | |
| 124357852 | 12435785 | Joint instability |
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 |
|---|---|---|---|---|---|---|
| 124357852 | 12435785 | 1 | 201210 | 201211 | 0 | |
| 124357852 | 12435785 | 2 | 201211 | 201403 | 0 | |
| 124357852 | 12435785 | 3 | 201403 | 0 | ||
| 124357852 | 12435785 | 4 | 201605 | 0 | ||
| 124357852 | 12435785 | 5 | 201605 | 0 | ||
| 124357852 | 12435785 | 6 | 20150921 | 0 | ||
| 124357852 | 12435785 | 7 | 20150921 | 201605 | 0 | |
| 124357852 | 12435785 | 8 | 20150921 | 0 | ||
| 124357852 | 12435785 | 9 | 20150921 | 0 | ||
| 124357852 | 12435785 | 10 | 20150825 | 0 | ||
| 124357852 | 12435785 | 11 | 20150331 | 201605 | 0 | |
| 124357852 | 12435785 | 12 | 20150225 | 20150305 | 0 | |
| 124357852 | 12435785 | 13 | 20141223 | 0 | ||
| 124357852 | 12435785 | 14 | 20141124 | 20141201 | 0 | |
| 124357852 | 12435785 | 15 | 20140702 | 20160430 | 0 | |
| 124357852 | 12435785 | 16 | 20140401 | 20140702 | 0 | |
| 124357852 | 12435785 | 17 | 20140401 | 20150921 | 0 | |
| 124357852 | 12435785 | 18 | 20140225 | 0 | ||
| 124357852 | 12435785 | 19 | 20130626 | 20150921 | 0 | |
| 124357852 | 12435785 | 20 | 20130513 | 20150921 | 0 | |
| 124357852 | 12435785 | 21 | 20130305 | 201603 | 0 | |
| 124357852 | 12435785 | 22 | 20110601 | 0 | ||
| 124357852 | 12435785 | 23 | 20090901 | 20160525 | 0 |