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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121819095 | 12181909 | 5 | F | 2015 | 20160713 | 20160315 | 20160721 | EXP | US-JAZZ-2016-US-004509 | JAZZ | 0.00 | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121819095 | 12181909 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121819095 | 12181909 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 121819095 | 12181909 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 121819095 | 12181909 | 4 | SS | Morphine | MORPHINE | 1 | UNKNOWN DOSE | U | 0 | ||||||||||
| 121819095 | 12181909 | 5 | SS | HYDROCODONE | HYDROCODONE | 1 | UNKNOWN DOSE | U | 0 | ||||||||||
| 121819095 | 12181909 | 6 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121819095 | 12181909 | 7 | C | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | UNK | U | 0 | INHALER | |||||||||
| 121819095 | 12181909 | 8 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 121819095 | 12181909 | 9 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 10 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121819095 | 12181909 | 11 | C | Naltrexone | NALTREXONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121819095 | 12181909 | 12 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 13 | C | XOPENEX HFA | LEVALBUTEROL TARTRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 121819095 | 12181909 | 14 | C | XOPENEX HFA | LEVALBUTEROL TARTRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 121819095 | 12181909 | 15 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0.088 MG, UNK | U | 0 | .088 | MG | TABLET | |||||||
| 121819095 | 12181909 | 16 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0.1 MG, UNK | U | 0 | .1 | MG | TABLET | |||||||
| 121819095 | 12181909 | 17 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121819095 | 12181909 | 18 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121819095 | 12181909 | 19 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 121819095 | 12181909 | 20 | C | ANUCORT-HC | HYDROCORTISONE ACETATE | 1 | UNK | U | 0 | SUPPOSITORY | |||||||||
| 121819095 | 12181909 | 21 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 22 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121819095 | 12181909 | 23 | C | Doxepin | DOXEPIN | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 24 | C | ESTRACE | ESTRADIOL | 1 | UNK | U | 0 | CREAM | |||||||||
| 121819095 | 12181909 | 25 | C | Hydroxocobalamin | HYDROXOCOBALAMIN | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 26 | C | KAPIDEX | DEXLANSOPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 27 | C | LIDODERM | LIDOCAINE | 1 | UNK | U | 0 | PATCH | |||||||||
| 121819095 | 12181909 | 28 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | ||||||||||
| 121819095 | 12181909 | 29 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | U | 0 | POWDER | ||||||||||
| 121819095 | 12181909 | 30 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121819095 | 12181909 | 1 | Sleep disorder |
| 121819095 | 12181909 | 4 | Product used for unknown indication |
| 121819095 | 12181909 | 5 | Product used for unknown indication |
| 121819095 | 12181909 | 6 | Product used for unknown indication |
| 121819095 | 12181909 | 7 | Product used for unknown indication |
| 121819095 | 12181909 | 8 | Product used for unknown indication |
| 121819095 | 12181909 | 9 | Product used for unknown indication |
| 121819095 | 12181909 | 10 | Product used for unknown indication |
| 121819095 | 12181909 | 11 | Product used for unknown indication |
| 121819095 | 12181909 | 12 | Product used for unknown indication |
| 121819095 | 12181909 | 13 | Product used for unknown indication |
| 121819095 | 12181909 | 15 | Product used for unknown indication |
| 121819095 | 12181909 | 17 | Product used for unknown indication |
| 121819095 | 12181909 | 18 | Product used for unknown indication |
| 121819095 | 12181909 | 19 | Product used for unknown indication |
| 121819095 | 12181909 | 20 | Product used for unknown indication |
| 121819095 | 12181909 | 21 | Product used for unknown indication |
| 121819095 | 12181909 | 22 | Product used for unknown indication |
| 121819095 | 12181909 | 23 | Product used for unknown indication |
| 121819095 | 12181909 | 24 | Product used for unknown indication |
| 121819095 | 12181909 | 25 | Product used for unknown indication |
| 121819095 | 12181909 | 26 | Product used for unknown indication |
| 121819095 | 12181909 | 27 | Product used for unknown indication |
| 121819095 | 12181909 | 28 | Product used for unknown indication |
| 121819095 | 12181909 | 29 | Product used for unknown indication |
| 121819095 | 12181909 | 30 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121819095 | 12181909 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121819095 | 12181909 | Buttock injury | |
| 121819095 | 12181909 | Constipation | |
| 121819095 | 12181909 | Exostosis | |
| 121819095 | 12181909 | Fall | |
| 121819095 | 12181909 | Haemorrhoids | |
| 121819095 | 12181909 | Intervertebral disc degeneration | |
| 121819095 | 12181909 | Intervertebral disc protrusion | |
| 121819095 | 12181909 | Kidney infection | |
| 121819095 | 12181909 | Neuralgia | |
| 121819095 | 12181909 | Pruritus | |
| 121819095 | 12181909 | Skin cancer | |
| 121819095 | 12181909 | Spinal disorder | |
| 121819095 | 12181909 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 121819095 | 12181909 | 1 | 200807 | 2008 | 0 | |
| 121819095 | 12181909 | 2 | 2008 | 2011 | 0 | |
| 121819095 | 12181909 | 3 | 201104 | 0 | ||
| 121819095 | 12181909 | 6 | 20160222 | 0 | ||
| 121819095 | 12181909 | 7 | 20150923 | 0 | ||
| 121819095 | 12181909 | 8 | 20150917 | 0 | ||
| 121819095 | 12181909 | 9 | 20150910 | 20150923 | 0 | |
| 121819095 | 12181909 | 10 | 20150101 | 0 | ||
| 121819095 | 12181909 | 11 | 20150101 | 0 | ||
| 121819095 | 12181909 | 12 | 20150101 | 0 | ||
| 121819095 | 12181909 | 13 | 20150101 | 20150923 | 0 | |
| 121819095 | 12181909 | 15 | 20140918 | 20160201 | 0 | |
| 121819095 | 12181909 | 17 | 20140617 | 0 | ||
| 121819095 | 12181909 | 18 | 20130723 | 0 | ||
| 121819095 | 12181909 | 19 | 20120419 | 0 | ||
| 121819095 | 12181909 | 21 | 20130722 | 0 | ||
| 121819095 | 12181909 | 26 | 20130722 | 0 | ||
| 121819095 | 12181909 | 28 | 20130722 | 0 |