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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121350603 | 12135060 | 3 | F | 201602 | 20160627 | 20160301 | 20160701 | EXP | US-JAZZ-2016-US-003497 | JAZZ | 58.68 | YR | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121350603 | 12135060 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 121350603 | 12135060 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 121350603 | 12135060 | 3 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 4 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 121350603 | 12135060 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121350603 | 12135060 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 8 | C | CARISOPRODOL. | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 9 | C | CARISOPRODOL. | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 10 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 11 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 12 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 13 | C | ACIPHEX | RABEPRAZOLE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 14 | C | Biotin | BIOTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121350603 | 12135060 | 15 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 16 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 121350603 | 12135060 | 17 | C | ELIDEL | PIMECROLIMUS | 1 | UNK | U | 0 | CREAM | |||||||||
| 121350603 | 12135060 | 18 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 121350603 | 12135060 | 19 | C | HYDROCODONE BITARTRATEIBUPROFEN | HYDROCODONE BITARTRATEIBUPROFEN | 1 | UNK | U | 0 | ||||||||||
| 121350603 | 12135060 | 20 | C | LINZESS | LINACLOTIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121350603 | 12135060 | 21 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 22 | C | MOBIC | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 23 | C | MODAFINIL. | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 24 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | UNK | U | 0 | ||||||||||
| 121350603 | 12135060 | 25 | C | Potassium | POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 26 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 27 | C | PROVENTIL HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 121350603 | 12135060 | 28 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 29 | C | SOMA | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 30 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 121350603 | 12135060 | 31 | C | TIROSINT | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 121350603 | 12135060 | 32 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 121350603 | 12135060 | 33 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121350603 | 12135060 | 1 | Narcolepsy |
| 121350603 | 12135060 | 2 | Cataplexy |
| 121350603 | 12135060 | 3 | Product used for unknown indication |
| 121350603 | 12135060 | 4 | Product used for unknown indication |
| 121350603 | 12135060 | 5 | Product used for unknown indication |
| 121350603 | 12135060 | 6 | Product used for unknown indication |
| 121350603 | 12135060 | 7 | Product used for unknown indication |
| 121350603 | 12135060 | 8 | Product used for unknown indication |
| 121350603 | 12135060 | 10 | Product used for unknown indication |
| 121350603 | 12135060 | 12 | Product used for unknown indication |
| 121350603 | 12135060 | 13 | Product used for unknown indication |
| 121350603 | 12135060 | 14 | Product used for unknown indication |
| 121350603 | 12135060 | 15 | Product used for unknown indication |
| 121350603 | 12135060 | 16 | Product used for unknown indication |
| 121350603 | 12135060 | 17 | Product used for unknown indication |
| 121350603 | 12135060 | 18 | Product used for unknown indication |
| 121350603 | 12135060 | 19 | Product used for unknown indication |
| 121350603 | 12135060 | 20 | Product used for unknown indication |
| 121350603 | 12135060 | 21 | Product used for unknown indication |
| 121350603 | 12135060 | 22 | Product used for unknown indication |
| 121350603 | 12135060 | 23 | Product used for unknown indication |
| 121350603 | 12135060 | 24 | Product used for unknown indication |
| 121350603 | 12135060 | 25 | Product used for unknown indication |
| 121350603 | 12135060 | 26 | Product used for unknown indication |
| 121350603 | 12135060 | 27 | Product used for unknown indication |
| 121350603 | 12135060 | 28 | Product used for unknown indication |
| 121350603 | 12135060 | 29 | Product used for unknown indication |
| 121350603 | 12135060 | 30 | Product used for unknown indication |
| 121350603 | 12135060 | 31 | Product used for unknown indication |
| 121350603 | 12135060 | 32 | Product used for unknown indication |
| 121350603 | 12135060 | 33 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121350603 | 12135060 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121350603 | 12135060 | Anxiety | |
| 121350603 | 12135060 | Arthritis | |
| 121350603 | 12135060 | Depression | |
| 121350603 | 12135060 | Intervertebral disc protrusion |
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 |
|---|---|---|---|---|---|---|
| 121350603 | 12135060 | 1 | 201408 | 0 | ||
| 121350603 | 12135060 | 3 | 20160223 | 0 | ||
| 121350603 | 12135060 | 4 | 20151230 | 0 | ||
| 121350603 | 12135060 | 5 | 20151230 | 0 | ||
| 121350603 | 12135060 | 6 | 20151230 | 0 | ||
| 121350603 | 12135060 | 7 | 20151230 | 0 | ||
| 121350603 | 12135060 | 8 | 20141015 | 20151230 | 0 | |
| 121350603 | 12135060 | 9 | 20151201 | 0 | ||
| 121350603 | 12135060 | 10 | 20140822 | 20141006 | 0 | |
| 121350603 | 12135060 | 11 | 20141006 | 0 | ||
| 121350603 | 12135060 | 12 | 20141006 | 0 | ||
| 121350603 | 12135060 | 13 | 20140822 | 0 | ||
| 121350603 | 12135060 | 14 | 20140822 | 0 | ||
| 121350603 | 12135060 | 15 | 20140822 | 0 | ||
| 121350603 | 12135060 | 16 | 20140822 | 0 | ||
| 121350603 | 12135060 | 17 | 20140822 | 20151230 | 0 | |
| 121350603 | 12135060 | 18 | 20140822 | 20160101 | 0 | |
| 121350603 | 12135060 | 20 | 20140822 | 0 | ||
| 121350603 | 12135060 | 21 | 20140822 | 20151230 | 0 | |
| 121350603 | 12135060 | 22 | 20140822 | 0 | ||
| 121350603 | 12135060 | 23 | 20140822 | 0 | ||
| 121350603 | 12135060 | 24 | 20140822 | 0 | ||
| 121350603 | 12135060 | 25 | 20140822 | 0 | ||
| 121350603 | 12135060 | 26 | 20140822 | 0 | ||
| 121350603 | 12135060 | 27 | 20140822 | 0 | ||
| 121350603 | 12135060 | 28 | 20140822 | 0 | ||
| 121350603 | 12135060 | 29 | 20140822 | 20140827 | 0 | |
| 121350603 | 12135060 | 30 | 20140822 | 0 | ||
| 121350603 | 12135060 | 31 | 20140822 | 0 | ||
| 121350603 | 12135060 | 32 | 20140822 | 0 | ||
| 121350603 | 12135060 | 33 | 20151101 | 0 |