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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120898294 | 12089829 | 4 | F | 2015 | 20160804 | 20160218 | 20160812 | EXP | US-JAZZ-2016-US-002557 | JAZZ | 0.00 | F | Y | 0.00000 | 20160812 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120898294 | 12089829 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 120898294 | 12089829 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 120898294 | 12089829 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 120898294 | 12089829 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | U | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 120898294 | 12089829 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | U | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 120898294 | 12089829 | 6 | SS | Morphine | MORPHINE | 1 | UNK | U | 0 | ||||||||||
| 120898294 | 12089829 | 7 | C | ACTONEL | RISEDRONATE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 8 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 120898294 | 12089829 | 9 | C | Cheratussin | AMMONIUM CHLORIDEDEXTROMETHORPHANSODIUM CITRATE | 1 | UNK | U | 0 | SYRUP | |||||||||
| 120898294 | 12089829 | 10 | C | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 11 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 12 | C | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | UNK | U | 0 | ||||||||||
| 120898294 | 12089829 | 13 | C | Coq10 | UBIDECARENONE | 1 | UNK | U | 0 | ||||||||||
| 120898294 | 12089829 | 14 | C | Fish oil | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 120898294 | 12089829 | 15 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | SPRAY | |||||||||
| 120898294 | 12089829 | 16 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 17 | C | LOVASTATIN. | LOVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 18 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 120898294 | 12089829 | 19 | C | MELOXICAM. | MELOXICAM | 1 | UNK | U | 0 | POWDER | |||||||||
| 120898294 | 12089829 | 20 | C | METAXALONE. | METAXALONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 21 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 22 | C | MUCINEX | GUAIFENESIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 23 | C | NITROFURANTOIN. | NITROFURANTOIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 120898294 | 12089829 | 24 | C | OFLOXACIN. | OFLOXACIN | 1 | UNK | U | 0 | EAR DROPS | |||||||||
| 120898294 | 12089829 | 25 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 120898294 | 12089829 | 26 | C | OXYTROL | OXYBUTYNIN | 1 | UNK | U | 0 | ||||||||||
| 120898294 | 12089829 | 27 | C | SALINE MIST | SODIUM CHLORIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 120898294 | 12089829 | 28 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 29 | C | Triamcinolone | TRIAMCINOLONE | 1 | UNK | U | 0 | CREAM | |||||||||
| 120898294 | 12089829 | 30 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | 37.5 MG | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 31 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | 75 MG | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 32 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 120898294 | 12089829 | 33 | C | Hydroxyzine hcl | HYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120898294 | 12089829 | 1 | Narcolepsy |
| 120898294 | 12089829 | 2 | Cataplexy |
| 120898294 | 12089829 | 6 | Product used for unknown indication |
| 120898294 | 12089829 | 7 | Product used for unknown indication |
| 120898294 | 12089829 | 8 | Product used for unknown indication |
| 120898294 | 12089829 | 9 | Product used for unknown indication |
| 120898294 | 12089829 | 10 | Product used for unknown indication |
| 120898294 | 12089829 | 11 | Product used for unknown indication |
| 120898294 | 12089829 | 12 | Product used for unknown indication |
| 120898294 | 12089829 | 13 | Product used for unknown indication |
| 120898294 | 12089829 | 14 | Product used for unknown indication |
| 120898294 | 12089829 | 15 | Product used for unknown indication |
| 120898294 | 12089829 | 16 | Product used for unknown indication |
| 120898294 | 12089829 | 17 | Product used for unknown indication |
| 120898294 | 12089829 | 18 | Product used for unknown indication |
| 120898294 | 12089829 | 19 | Product used for unknown indication |
| 120898294 | 12089829 | 20 | Product used for unknown indication |
| 120898294 | 12089829 | 22 | Product used for unknown indication |
| 120898294 | 12089829 | 23 | Product used for unknown indication |
| 120898294 | 12089829 | 24 | Product used for unknown indication |
| 120898294 | 12089829 | 25 | Product used for unknown indication |
| 120898294 | 12089829 | 26 | Product used for unknown indication |
| 120898294 | 12089829 | 27 | Product used for unknown indication |
| 120898294 | 12089829 | 28 | Product used for unknown indication |
| 120898294 | 12089829 | 29 | Product used for unknown indication |
| 120898294 | 12089829 | 30 | Product used for unknown indication |
| 120898294 | 12089829 | 32 | Product used for unknown indication |
| 120898294 | 12089829 | 33 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120898294 | 12089829 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120898294 | 12089829 | Allergy to animal | |
| 120898294 | 12089829 | Bladder irritation | |
| 120898294 | 12089829 | Blood pressure increased | |
| 120898294 | 12089829 | Diabetes mellitus | |
| 120898294 | 12089829 | Dyspnoea | |
| 120898294 | 12089829 | Exostosis | |
| 120898294 | 12089829 | Headache | |
| 120898294 | 12089829 | Malaise | |
| 120898294 | 12089829 | Mite allergy | |
| 120898294 | 12089829 | Nephrolithiasis | |
| 120898294 | 12089829 | Panic attack | |
| 120898294 | 12089829 | Peripheral swelling | |
| 120898294 | 12089829 | Pruritus | |
| 120898294 | 12089829 | Swelling | |
| 120898294 | 12089829 | Tooth disorder | |
| 120898294 | 12089829 | Urinary tract infection | |
| 120898294 | 12089829 | Vitamin D deficiency |
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 |
|---|---|---|---|---|---|---|
| 120898294 | 12089829 | 1 | 201108 | 201109 | 0 | |
| 120898294 | 12089829 | 2 | 201109 | 201110 | 0 | |
| 120898294 | 12089829 | 3 | 201110 | 2011 | 0 | |
| 120898294 | 12089829 | 4 | 201506 | 2015 | 0 | |
| 120898294 | 12089829 | 5 | 201602 | 0 | ||
| 120898294 | 12089829 | 9 | 20160201 | 0 | ||
| 120898294 | 12089829 | 10 | 20160201 | 0 | ||
| 120898294 | 12089829 | 11 | 20160201 | 0 | ||
| 120898294 | 12089829 | 15 | 20160201 | 0 | ||
| 120898294 | 12089829 | 16 | 20160201 | 0 | ||
| 120898294 | 12089829 | 17 | 20160201 | 0 | ||
| 120898294 | 12089829 | 19 | 20160201 | 0 | ||
| 120898294 | 12089829 | 20 | 20160201 | 0 | ||
| 120898294 | 12089829 | 21 | 20160201 | 0 | ||
| 120898294 | 12089829 | 22 | 20160201 | 0 | ||
| 120898294 | 12089829 | 23 | 20160201 | 0 | ||
| 120898294 | 12089829 | 24 | 20160201 | 0 | ||
| 120898294 | 12089829 | 27 | 20160201 | 0 | ||
| 120898294 | 12089829 | 28 | 20160201 | 0 | ||
| 120898294 | 12089829 | 30 | 20160201 | 0 | ||
| 120898294 | 12089829 | 32 | 20160201 | 0 |