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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126663151 | 12666315 | 1 | I | 20160324 | 20160818 | 20160818 | PER | US-JAZZ-2016-US-005744 | JAZZ | 0.00 | F | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126663151 | 12666315 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | 21196 | 1.5 | G | ORAL SOLUTION | |||||||
| 126663151 | 12666315 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 126663151 | 12666315 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 126663151 | 12666315 | 4 | SS | SKELAXIN | METAXALONE | 1 | UNK | 0 | TABLET | ||||||||||
| 126663151 | 12666315 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 7 | C | PROGESTERONE. | PROGESTERONE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 8 | C | TESTOSTERONE. | TESTOSTERONE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 9 | C | AMOXICILLIN. | AMOXICILLIN | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 10 | C | TESSALON | BENZONATATE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 11 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 12 | C | GARLIC. | GARLIC | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 13 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 14 | C | Multivitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 15 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 16 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 17 | C | ALEVE | NAPROXEN SODIUM | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 18 | C | Biotin | BIOTIN | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 19 | C | Fish oil | FISH OIL | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 20 | C | METAXALONE. | METAXALONE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 21 | C | TOPIRAMATE. | TOPIRAMATE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 22 | C | XOPENEX HFA | LEVALBUTEROL TARTRATE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 23 | C | TOBRAMYCIN. | TOBRAMYCIN | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 24 | C | Diphenhydramine Hcl | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 25 | C | ECHINACEA | ECHINACEA, UNSPECIFIED | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 26 | C | EXCEDRIN MIGRAINE | ACETAMINOPHENASPIRINCAFFEINE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 27 | C | Immune boost | DIETARY SUPPLEMENT | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 28 | C | LIOTHYRONINE SODIUM. | LIOTHYRONINE SODIUM | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 29 | C | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 30 | C | Probiotic | PROBIOTICS NOS | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 31 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 32 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 33 | C | ZETONNA | CICLESONIDE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 34 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 35 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 36 | C | Immunocal | 2 | U | 0 | ||||||||||||
| 126663151 | 12666315 | 37 | C | LUNESTA | ESZOPICLONE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 38 | C | REMERON | MIRTAZAPINE | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 39 | C | TEMAZEPAM. | TEMAZEPAM | 1 | U | 0 | |||||||||||
| 126663151 | 12666315 | 40 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126663151 | 12666315 | 1 | Somnolence |
| 126663151 | 12666315 | 4 | Product used for unknown indication |
| 126663151 | 12666315 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126663151 | 12666315 | Drug ineffective | |
| 126663151 | 12666315 | Fibromyalgia | |
| 126663151 | 12666315 | Hypersomnia | |
| 126663151 | 12666315 | Vitamin D decreased | |
| 126663151 | 12666315 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 126663151 | 12666315 | 1 | 201506 | 201508 | 0 | |
| 126663151 | 12666315 | 2 | 201508 | 201510 | 0 | |
| 126663151 | 12666315 | 3 | 201510 | 0 | ||
| 126663151 | 12666315 | 4 | 20150930 | 0 |