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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125310901 | 12531090 | 1 | I | 20160627 | 20160706 | 20160706 | EXP | US-JAZZ-2016-US-012049 | JAZZ | 0.00 | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125310901 | 12531090 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125310901 | 12531090 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125310901 | 12531090 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125310901 | 12531090 | 4 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Y | 0 | TABLET | ||||||||||
| 125310901 | 12531090 | 5 | SS | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125310901 | 12531090 | 6 | SS | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125310901 | 12531090 | 7 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 8 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 125310901 | 12531090 | 9 | SS | Oxymorphone | OXYMORPHONE | 1 | U | 0 | |||||||||||
| 125310901 | 12531090 | 10 | C | AFRIN | OXYMETAZOLINE | 1 | U | 0 | NASAL SPRAY | ||||||||||
| 125310901 | 12531090 | 11 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 125310901 | 12531090 | 12 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | 50-325-40 MG | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 13 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | TABLET | ||||||||||
| 125310901 | 12531090 | 14 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 15 | C | XANAX | ALPRAZOLAM | 1 | 0.5 MG, UNK | U | 0 | .5 | MG | TABLET | |||||||
| 125310901 | 12531090 | 16 | C | XANAX | ALPRAZOLAM | 1 | 1 MG, UNK | U | 0 | 1 | MG | TABLET | |||||||
| 125310901 | 12531090 | 17 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 18 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 19 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | UNK | U | 0 | CREAM | |||||||||
| 125310901 | 12531090 | 20 | C | LACTULOSE. | LACTULOSE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 125310901 | 12531090 | 21 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125310901 | 12531090 | 22 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 23 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 24 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 25 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 26 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 27 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 28 | C | FENTANYL. | FENTANYL | 1 | 25 MCG/ HR | U | 0 | PATCH | |||||||||
| 125310901 | 12531090 | 29 | C | FENTANYL. | FENTANYL | 1 | 100 MCG/HR | U | 0 | PATCH | |||||||||
| 125310901 | 12531090 | 30 | C | DYMISTA | AZELASTINE HYDROCHLORIDEFLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 125310901 | 12531090 | 31 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 32 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125310901 | 12531090 | 33 | C | RESTASIS | CYCLOSPORINE | 1 | UNK | U | 0 | ||||||||||
| 125310901 | 12531090 | 34 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 35 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 36 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 37 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 38 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | ||||||||||
| 125310901 | 12531090 | 39 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 40 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | U | 0 | INJECTION | |||||||||
| 125310901 | 12531090 | 41 | C | Aspirin (e.c.) | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125310901 | 12531090 | 42 | C | Clotrimazole and Betamethasone | BETAMETHASONECLOTRIMAZOLE | 1 | UNK | U | 0 | CREAM | |||||||||
| 125310901 | 12531090 | 43 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125310901 | 12531090 | 1 | Narcolepsy |
| 125310901 | 12531090 | 2 | Somnolence |
| 125310901 | 12531090 | 4 | Product used for unknown indication |
| 125310901 | 12531090 | 5 | Product used for unknown indication |
| 125310901 | 12531090 | 7 | Product used for unknown indication |
| 125310901 | 12531090 | 8 | Product used for unknown indication |
| 125310901 | 12531090 | 9 | Product used for unknown indication |
| 125310901 | 12531090 | 10 | Product used for unknown indication |
| 125310901 | 12531090 | 11 | Product used for unknown indication |
| 125310901 | 12531090 | 12 | Product used for unknown indication |
| 125310901 | 12531090 | 13 | Product used for unknown indication |
| 125310901 | 12531090 | 14 | Product used for unknown indication |
| 125310901 | 12531090 | 15 | Product used for unknown indication |
| 125310901 | 12531090 | 17 | Product used for unknown indication |
| 125310901 | 12531090 | 18 | Product used for unknown indication |
| 125310901 | 12531090 | 19 | Product used for unknown indication |
| 125310901 | 12531090 | 20 | Product used for unknown indication |
| 125310901 | 12531090 | 21 | Product used for unknown indication |
| 125310901 | 12531090 | 22 | Product used for unknown indication |
| 125310901 | 12531090 | 23 | Product used for unknown indication |
| 125310901 | 12531090 | 24 | Product used for unknown indication |
| 125310901 | 12531090 | 25 | Product used for unknown indication |
| 125310901 | 12531090 | 26 | Product used for unknown indication |
| 125310901 | 12531090 | 27 | Product used for unknown indication |
| 125310901 | 12531090 | 28 | Product used for unknown indication |
| 125310901 | 12531090 | 30 | Product used for unknown indication |
| 125310901 | 12531090 | 31 | Product used for unknown indication |
| 125310901 | 12531090 | 32 | Product used for unknown indication |
| 125310901 | 12531090 | 33 | Product used for unknown indication |
| 125310901 | 12531090 | 34 | Product used for unknown indication |
| 125310901 | 12531090 | 35 | Product used for unknown indication |
| 125310901 | 12531090 | 36 | Product used for unknown indication |
| 125310901 | 12531090 | 37 | Product used for unknown indication |
| 125310901 | 12531090 | 38 | Product used for unknown indication |
| 125310901 | 12531090 | 39 | Product used for unknown indication |
| 125310901 | 12531090 | 40 | Product used for unknown indication |
| 125310901 | 12531090 | 41 | Product used for unknown indication |
| 125310901 | 12531090 | 42 | Product used for unknown indication |
| 125310901 | 12531090 | 43 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125310901 | 12531090 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125310901 | 12531090 | Depression | |
| 125310901 | 12531090 | Drug ineffective | |
| 125310901 | 12531090 | Dyspepsia | |
| 125310901 | 12531090 | Eye contusion | |
| 125310901 | 12531090 | Fall | |
| 125310901 | 12531090 | Hyperhidrosis | |
| 125310901 | 12531090 | Nausea | |
| 125310901 | 12531090 | Nephropathy | |
| 125310901 | 12531090 | Pain | |
| 125310901 | 12531090 | Rash | |
| 125310901 | 12531090 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125310901 | 12531090 | 1 | 201312 | 201312 | 0 | |
| 125310901 | 12531090 | 2 | 201312 | 201503 | 0 | |
| 125310901 | 12531090 | 3 | 201503 | 0 | ||
| 125310901 | 12531090 | 5 | 20101001 | 20131206 | 0 | |
| 125310901 | 12531090 | 6 | 20150818 | 201601 | 0 | |
| 125310901 | 12531090 | 7 | 20160620 | 0 | ||
| 125310901 | 12531090 | 14 | 201605 | 0 | ||
| 125310901 | 12531090 | 15 | 20150818 | 0 | ||
| 125310901 | 12531090 | 16 | 201605 | 0 | ||
| 125310901 | 12531090 | 17 | 201602 | 0 | ||
| 125310901 | 12531090 | 18 | 201601 | 0 | ||
| 125310901 | 12531090 | 19 | 20150818 | 201606 | 0 | |
| 125310901 | 12531090 | 20 | 20150818 | 0 | ||
| 125310901 | 12531090 | 21 | 20150818 | 0 | ||
| 125310901 | 12531090 | 22 | 20131213 | 201606 | 0 | |
| 125310901 | 12531090 | 23 | 20131119 | 0 | ||
| 125310901 | 12531090 | 24 | 20131119 | 201501 | 0 | |
| 125310901 | 12531090 | 25 | 20131119 | 201606 | 0 | |
| 125310901 | 12531090 | 26 | 20130819 | 201606 | 0 | |
| 125310901 | 12531090 | 27 | 20130819 | 201501 | 0 | |
| 125310901 | 12531090 | 28 | 20130519 | 201606 | 0 | |
| 125310901 | 12531090 | 30 | 20130101 | 0 | ||
| 125310901 | 12531090 | 31 | 20121119 | 201605 | 0 | |
| 125310901 | 12531090 | 32 | 20121119 | 201501 | 0 | |
| 125310901 | 12531090 | 33 | 20111119 | 0 | ||
| 125310901 | 12531090 | 34 | 20110725 | 20160620 | 0 | |
| 125310901 | 12531090 | 35 | 20100101 | 201606 | 0 | |
| 125310901 | 12531090 | 36 | 20100101 | 201606 | 0 | |
| 125310901 | 12531090 | 37 | 20080101 | 201501 | 0 | |
| 125310901 | 12531090 | 38 | 20040101 | 20150131 | 0 | |
| 125310901 | 12531090 | 39 | 20040101 | 201501 | 0 | |
| 125310901 | 12531090 | 40 | 20040101 | 201401 | 0 | |
| 125310901 | 12531090 | 41 | 20030101 | 201401 | 0 | |
| 125310901 | 12531090 | 42 | 20000101 | 201606 | 0 | |
| 125310901 | 12531090 | 43 | 20000101 | 201401 | 0 |